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Drug Intervention Bioeth

The following is set up as a 30 day meditation from the book: 
     Bioethics of Drug Intervention  by Jim Tibbetts 

 
 Introduction -  A Review of the Literature

     A review of the literature clearly shows that there is widespread interest and concern for this major problem with the pharmaceutical industry.  And many of the professionals are medical doctors who are writing about their own industry.  This authors all deal with problems in the medical and health field that are Bioethical in nature. 

     This book is giving a review of the literature which is just the tip-of-the-iceberg.  In order to get a complete review you would have to take and read these books and also a dozen or so others on this same topic which are not reviewed here.  Besides these books there are hundreds, if not thousands of articles written on this topic, many in leading journals.

     In writing this book the following books are the main books reviewed and which were used with material taken from each of these books.  As the titles of each of these books suggest they are all dealing the pharmaceutical industry, all writing on it from their own expertise and experience!  Many of them do cite the same or similar material.  As a group they give a very well rounded understanding of what is really happening in the medical profession because of the pharmaceutical industry. 

1.  Marcia Angel, MD: The Truth About Drug Companies How they deceive Us And What To do About it  
2.  Jerome P. Kassirer, MD: On the Take how Medicines’ Complicity with Big Business can Endanger your Health
3.  John Abramson, MD: Overdosed America the Broken Promise of American Medicine How the Pharmaceutical Companies are Corrupting Science, Misleading Doctors, and Threatening Your Health.
4.  Jerry Avron, M.D.: Powerful Medicines the Benefits, Risks, and Costs of Prescription Drugs
5.  Uffe Ravnskov, MD: PhD, The Cholesterol Myths Exposing the Fallacy that Saturated Fat and Cholesterol cause Heart Disease
6.   Sherry Rogers, MD: The Cholesterol Hoax
7.   James P. Carter, MD, Dr.PH.: Racketeering in Medicine the Suppression of Alternatives 
8.  David Healy, Ph.D., Let Them Eat Prozac the Unhealthy Relationship between the Pharmaceutical Industry and Depression
9.  Seldon Krimsky: Science in the Private Interest has the Lure of Profits Corrupted Biomedical Research?
10.  Merrill Goozner:  The $800 Million Pill the Truth Behind the Cost of New Drugs
11.  Ray Moynihan, Alan Cassels: Selling Sickness How the World’s Biggest Pharmaceutical Companies Are Turning Us All into Patients
12.  Leonard J. Weber: Profits Before People? Ethical Standards and the Marketing of Prescription Drugs
13.  Maggie Mahar: Money-Driven Medicine the Real Reason Health Care Costs so Much
14.  Katharine Greider: The Big Fix How the Pharmaceutical Industry Rips Off American Consumers 
15.  Achieving Evidence-based Practice, a Handbook for Practitioners, second edition
16.  Bandolier’s Little Book of Making Sense of the Medical Evidence  

     Who are some of these writers is something that may help show that these books are well researched documents by knowledgeable and experienced people in the industry.

1) Marcia Angell, MD was editor in chief of The New England Journal of Medicine, with twenty years experience of being with them.  She is author of Science on Trial. 
2) Jerome P. Kaissirer, MD is Distinguished Professor at Tufts University School of Medicine and Adjunct Professor of Medicine and Bioethics at Case Western Reserve University.  He was Editor-in-Chief of New England Journal of Medicine for more than eight years.
3) John Abramson, MD, a family doctor and is on the clinical faculty of Harvard Medical School, where he teaches primary care.
4) Jerry Avorn, M.D., is an associate professor of medicine at Harvard Medical School and chief of the Division of Pharmacoepidemiology and Pharmacoeconomis at Brigham and Women’s Hospital in Boston. 
5) Uffe Ravnskov, M.D., Ph.D, a specialist in internal medicine has published more than 50 critical papers and letters on cholesterol and cardiovascular disease.
6) Sherry A. Rogers, M.D., an internationally known specialist in environmental medicine, published a dozen books and 20 scientific papers. 
7) James P. Carter, M.D., Ph.D., is a clinical professor of pediatrics at Tulane University School of Medicine and author of nearly 50 papers and books.
8) David Healy, Ph.D., is a visiting professor at the Univ. of Toronto, involved in the Univ. of Wales College of Medicine and author of over 120 journal articles.  
9) Sheldon Krimsky is a professor of urban and environmental policy and planning at Tufts University and author of six other books.
10) Merrill Goozner is former chief economics correspondent at the Chicago Tribune. 
11) Ray Moyniham & Alan Cassels are both medical health writers and scholars.
12) Leonard J. Weber is an ethics consultant and on the faculty of the University of Detroit Mercy for over 30 years. 
13) Maggie Mahar is a financial journalists writer and author. 
14) Katharine Greider is a heath writer for magazines and a newspaper reporter 
 
     Obviously these books are written by top professionals in the field who are giving in-depth insight and knowledge about some major Bioethical problems.

Reviewers Comments on the Drug Industry 
     Reviewers comments on these books on the medical industry give a wider view of what others in the country are saying about these books.  This gives a much wider sense of the awareness and concern from other authorities and publications.  A few of these books are cited below showing the breath of people and organizations that acknowledge these books.

     On, The Truth about the Drug Companies, How They Deceive Us and What to Do About It, by Marcia Angell, M.D. (2004, 2005), reviewers write:  

“A scorching indictment of drug companies and their research and business practices… tough, persuasive and troubling.”                                           - The New York Times (Janet Maslin)
“A sober, clear-eyed attack on the excesses of drug company power… a lucid, persuasive, and highly important book.”                                                                         - The Boston Globe
“Always authoritative… [Angell] delivers the message - that drug-company money and power is corrupting American medicine - in a convincing, no-nonsense manner.”
                                                                                      - The Washington Post Book World 
“A hard-hitting condemnation from an expert witness…This is an important book.”
                                                                           - Providence Sunday Journal 

     In the book: On the Take how Medicines’ Complicity with Big Business can Endanger your Health by Jerome P. Kassirer, MD (2005), reviewers write:

“An important and thought-provoking analysis of the extensive conflicts of interest that pervade the relationship between pharmaceutical companies and the medical profession.” 
           - Senator Edward M. Kennedy
“A surprisingly bare-knuckled book by one of the last editors-in-chief at the New England Journal of Medicine.”            - Mother Jones
“From this book’s title to its final words…Jerome P. Kassirer slams his fellow physicians… ‘It shouldn’t have to be patients’ responsibilities to protect themselves against the medical profession,’ Kassirer writes.  Bravo to that.”       - Washington Post Book World
“Documents with well-referenced examples, how conflicts of interest, primarily financial in nature, have infiltrated all areas of the profession.”       - New England Journal of Medicine

     Concerning Overdosed America, How the Pharmaceutical Companies are Corrupting Science, Misleading Doctors, and Threatening Your Health, by John Abramson, M.D. (2004, 2008), reviewers write:

    “Most Americans assume that the scientific information provided to patients and physicians is accurate, that clinical practice is guided by science, and that as a result, more medical care means better medical care.  Overdosed America provides a compelling and well-documented analysis of why each of these assumptions is wrong.  It is a book every American should read.”      - Elliott Fisher, M.D., M.P. H., professor of medicine, Dartmouth Medical School 
“Required reading for all medical students and doctors.”          
     - Journal of the American  Medical Association 
“A powerful and coherent case that American medicine has gone badly astray and needs a new paradigm - one untainted by profits.”         - Publishers Weekly 
“Readers who might be inclined to view Overdosed America as simply another in the growing number of diatribes against drug companies should be aware that this book makes its arguments in a detailed, well-referenced manner.  Moreover, responsibility for the overdoing of America goes far beyond the drug industry, resting equally with the nation’s physicians.”   
                                              - Thomas Bodenheimer, M.D., Health Affairs

     In the book, Selling Sickness, How the World’s Biggest Pharmaceutical Companies are Turning Us All into Patients, by Ray Moynihan, Alan Cassels (2005, 2006) reviewers write:

    “This book is a welcome, bitter tonic to the surfeit of glossy advertising and lucrative enticements that surround any practicing physician today.” 
                - Journal of the American Medical Association   

    “By exposing how the pharmaceutical companies actively set out to make us feel sick so they can sell drugs we don’t need, this brilliant book blows the lid off the carefully cultivated image of medical authority and benign concern.  The drug companies turn out to be the worst sort of corporate pirates - read this book and rage.”            
      - Clive Hamilton, The Australia Institute  
 “In their forceful and well-written book…the two authors highlight the influence of the pharmaceutical companies in ‘disease-mongering.’  These companies use powerful images to provoke fear in healthy people or offer a narrow medical response that downplays diet, exercise, and other approaches for those who may be at risk.”    - Los Angeles Times 

     In the book, The $800 Million Pill, the Truth Behind the Cost of New Drugs, by Merrill Goozner (2004) reviewers write:

    “In order to read a book from cover to cover, I have to find it truly interesting.  I can tell you that I read every word of this book.”                 - New England Journal of Medicine
“Required reading for anybody who wants to understand the role…biotech companies play in driving up healthcare costs in America.  This book does for drugs what Fast Food Nation did for fast food, peeling back the layers of science, clever accounting, and hype to expose the dark side of the nation’s most profitable industry.”          - Washington Monthly  
“Fascinating expose of the pharmaceutical industry…. Goozner describes an industry that has lost its way - and its moral purpose.”                                                - New Statesman 

     In the book, Powerful Medicines, the Benefits, Risks, and Costs of Prescription Drugs, by Jerry Avorn, M.D., (2004) reviewers write: 

    “Powerful Medicine is a must-read for anyone interested in the use, abuse, and economics of prescription drugs.  The issues it addresses are central to the ongoing debate about how to reduce the cost and improve the quality of health care in America.”
         - Senator Edward Kennedy 

    “In Powerful Medicines, Dr. Avorn brilliantly demonstrates the corrosive effects of commercial influence over medical research, education, and clinical care.  This impressive books spells out the adverse effects such as privatization can have on the health care system and, ultimately, on patients.”     - Bernard Lown, M.D., winner of the Nobel Peace Prize 

     Now let us get on with the review of the literature to help us understand what the Bioethics of Drug Intervention is all about and what we can do about it.  As a means of contrast at the end of the book Nutritional Intervention is discussed. Only a few diseases are discussed for sake of brevity.   

 

1.  The Myth of Excellence in Health

 There are two reasons that the myth of excellence in health in the U.S. exists.  The first is “Diet” and the second is “Drugs”.  Because of diet and pharmaceutical drugs the U.S. ranks 22 out of 23 industrialized countries for healthy life expectancy by the World Health Organization.   

 John Abramson, M.D. writes in Overdosed America the Broken Promise of American Medicine how the Pharmaceutical Companies are Corrupting Science, Misleading Doctors and Threatening your Health.  “Clearly these medical breakthroughs have contributed to increased longevity and improved quality of life; this is why I, too, believed that Americans received the best medical care in the world.  Then I saw an article in the Journal of the American Medical Association, in July 2000, claiming that ‘the U.S. population does not have anywhere near the best health in the world.’  On first read, I though that surely the author was overstating the case. 

 In a comparison of 13 industrialized nations that will surprise most Americans – and certainly most American physicians – Dr. Barbara Starfield, University Distinguished Professor at John Hopkins School of Public Health, fund that the health of Americans is close to the worst on most measures and overall ranked second to last.” 

 “The low ranking of America’s health reported in this article was so disparate from what I had believed that I started to look for other sources of comparative data to see if this was right.  An extensive comparison of the health of the citizens of industrialized countries done by the Organization for Economic Co-Operation and Development (OECD) confirmed the conclusion presented in Dr. Starfield’s article.  The United States again ranked poorly, with 18 industrialized countries having greater life expectancy.  Also the United States ranks a lowly 24 among 39 developed countries on infant mortality.

 One of the best single indicators of a country’s health was developed by the World Health Organization (WHO); it is called ‘healthy life expectancy.’  This measure represents the number of years that a child born now can expect to live in good health (i.e. total life expectancy minus years of illness adjusted for quality of life).  Children born in the United Stated today can expect to live the equivalent of about 69.3 healthy years of life, while children born in the other 22 industrialized countries can expect an average of 2.5 additional years of healthy life.  And children in Japan can expect almost six more years of good health than Americans.  American’s healthy life expectancy ranks 22 out of 23 industrialized countries, better only than the Czech Republic. 

 The World Health Organization also developed several broader measures of health system performance, providing more-in-depth comparisons between countries.  On ‘overall achievement,’ the health care system in the United States ranks 15 in the world.  ‘Overall performance’ measures the efficiency of a health system by taking into account the per-person health expenditures required to reach its level of achievement.  On this measure the U.S. health care system ranking falls to 37. Finally, ‘performance on the level of health’ measures the efficiency with which health care systems improve their citizens’ overall health.  On this measure, the United States’ ranking drops to a lowly 72 in the world. 

 Despite the poor performance of the American health care system, our health care costs are simply staggering.  In 2004, health expenditures in the United States are projected to exceed $6100 for every man, woman, and child.  How does this compare with other countries?  The United States spends more than twice as much per person on health care as the other industrialized nations.  Even taking into account our higher per- person gross domestic product, the United States spends 42 percent more on health care per person than would be expected, given spending on health care in the other OECD nations.  This excess spending on health care in the United States is like a yearly tax of more than $1800 on every American citizen.”  

 Notwithstanding the tremendous progress and the enormous costs of American medicine, over the last 40 years the health of the citizens of the other industrialized countries has been improving at a faster pace.  According to researchers from John Hopkins, ‘On most [health] indicators the U.S. relative performance declined since 1960; on none did it improve.’  One of the most telling statistics is the change in the years of life lost below the age of 70, before death due to natural aging starts to become a factor.  In 1960, Americans ranked right in the middle of 23 OECD countries on this measure.  But despite all of the extra money being spent on health care in the United States, the health of the citizens in the other OECD countries is improving more quickly.  By 2000, men in the United States were losing 21 percent more years of life before the age of 70 than men in the other OECD countries, and American women were losing 33 percent more.”  

 John Abramson, MD in Overdosed America, writes that: “In September 2001 an unprecedented alarm was sounded.  The editors of 12 of the world’s most influential medical journals, including the Journal of the American Medical Association, the New England Journal of Medicine, The Lancet, and the Annals of Internal Medicine, issued an extraordinary joint statement in their publications.  In words that should have shaken the medical profession to its core, the statement told of ‘draconian’ terms being imposed on medical researchers by corporate sponsors.  And it warned that the ‘precious objectivity’ of the clinical studies that were being published in their journals was being threatened by the transformation of clinical research into a commercial activity. 

 The editors said that the use of commercially sponsored clinical trials ‘primarily for marketing. ... makes a mockery of clinical investigation and is a misuse of a powerful tool.’  Medical scientists working on corporate-sponsored research, the editors warned, ‘may have little or no input into trial design, no access to the raw data, and limited participation in the data interpretation.’”   
 

 2.   Prescription Drugs, The Number One Cause of Death in the U.S. 

 The number one cause of death in the U.S. is caused by pharmaceutical drugs.  And the number one type of drug addiction in the U.S. is prescription drugs, mostly pain killers.  Usually it is only the celebrities who die because of pharmaceutical drugs, that get publicized, like Michael Jackson or Elvis Presley or other celebrities.  But millions of people die every year because of pharmaceutical drugs or pain killers.   

 Sherry Rogers, M.D., gives some good insight and a basic summary of the problems with the pharmaceutical companies in her book: The Cholesterol Hoax.  The following is a brief review of this issue.  “What is the number one cause of death in the United States?  It’s not high cholesterol or accidents by cars, planes, trains.  It’s not wars.  It’s not drug addiction, and it’s not even disease, so that lets out heart disease, cancer, strokes, diabetes and more.  In Third World countries, infections and malnutrition are major causes of loss of life.  But in the United States the number one cause of death is not any of those things.  It is prescription drugs. 

 As Jay Cohen, M.D., professor of medicine at the University of California, San Diego has provided the sterling and startling evidence for the doubting Thomas.  He meticulously documented how the drug industry surreptitiously hires physicians as consultants who just coincidentally happen to be on the very FDA committees that are responsible for approval of their drugs.  As well, they hire expensive lobbyists who encourage FDA physicians to speed the approval process.  And they hire scientists and physicians to do the research on the drugs, but reserve the right to throw out any research that casts a negative light on their products.  In fact the drug companies forbid hired researchers to talk about or publish discoveries about adverse reactions.  And they hire ghostwriters who have never had anything to do with the drug experiments to write the convincing research papers for publication in the leading medical journals.”  

 “The situation gets much stickier once the drug has been approved because there is even sloppier handling of adverse reactions.  First of all, officials state that only 1-5% of adverse reactions to drugs get reported.  Dr. Cohen does an unprecedented and highly commendable job of detailing over the last decade how, even though the FDA had the evidence that hundreds of people were dying from specific drugs, it took over a year before many drugs were withdrawn from the market.  The reason?  The drugs were bringing in billions (not millions) of dollars a year, making a few hundred lawsuits from folks who died a spit in the ocean comparatively.  Besides that, recognition that the drug was responsible and then proving it against a dozen slick attorneys hired by the drug companies would be beyond the average person’s means. 

 If you still have even the slightest doubt about the unprecedented power of the pharmaceutical industry, I urge you to get the 60 Minutes archived transcript for the TV program aired July 29, 2007.  They carefully documented one congressional event, passage of the Medicare prescription bill.  With over a thousand Pharma lobbyists, the congressmen reported how they were stalked and cajoled into wee hours of the morning on Capitol Hill, while the unprecedented extension of voting time went from minutes to hours.  Attached to the bill was the inability of the United States government to negotiate with pharmaceutical companies for the most favorable price for Medicare prescription drugs.  As a result, compared with the VA hospital system which does negotiate for the best price, Medicare pays well over $800 a year for Lipitor per patient, while the VA pays less than half of that, around $300.  And Zocor was even worse at over $1000 being paid by the government for Medicare recipients versus over 10 times less for VA persons.  And then at the end of the show they showed how over 15 congressman and other government employees went on to be lobbyists and related employees of the pharmaceutical industry.  One congressman’s beginning salary with a pharmaceutical company within weeks of passage of the bill was $2 million a year for starters.  As one of the congressmen intimated, Pharma owns the government.”     “Lipitor, makes well over $10 billion (not a million, but billion) per year, which is over five times the annual budget of the FDA.”   

Multiple Drug Interactions
 Multiple drug interactions is becoming a major problem that is very difficult to deal with never mind solve.  There are so many drugs that the interactions between them in the body is not known, except after things go extremely bad. 

 Jerry Avron in Powerful Medicines writes: “The number of individual patients taking multiple drugs is growing daily.  And they are taking more different kinds of drugs than ever before.  Many over the age of sixty-five take six or more different drugs, in addition to over-the-counter medications.   Some patients see several physicians for their prescriptions and fill them at different pharmacies so that no one tracks their total usage.  

 At the same time, the pharmaceutical industry is flooding the market with ever more drugs to increase sales.  During the 1970’s, the FDA approved 173 new drugs.  That jumped to 279 in the 1980’s and to 359 in the 1990s.  To keep the money rolling in for prescription drugs whose patents are expiring, the industry is beginning to combine two different drugs in a single pill.  This adds up to a growing potential for lethal reactions from a deadly mix of drugs that no one understands – until it’s too late, as was the case with the heart drug encainide, which killed people during the 1980’s, instead of saving them.  Making this even harder to track, the honor system for reporting adverse drug reactions is primitive at best.  The FDA itself has acknowledged that ‘it is impossible to accurately quantify adverse event rates because FDA’s post-marketing surveillance system receives reports on only a relatively small percentage of all adverse events caused by drugs.’  In short, the drugs you take ultimately may harm or kill you, but no one may ever notice, or tell if they do.”  

 
 3.  The Huge Profits in Pharmaceutical Drugs 

 In the book, The Truth About the Drug Companies, How They Deceive Us and What To Do About It,    Marcia Angell, M.D. gives an straightforward and honest look into the pharmaceutical industry from her experience, mostly as the editor, of two decades with The New England Journal of Medicine.  She explains how the drug companies went from being companies whose mission was to discover and manufacture useful drugs to becoming a marketing machine with unprecedented control over their own fortunes.  She explains how they gained nearly limitless influence over medical research, education and how doctors do their jobs.  She exposes the shocking truth about the pharmaceutical industry. 

   Dr. Angell writes: “From 1960 to 1980 were fairly static as a percentage of U.S. gross domestic product, but from 1980 to 2000, they tripled.  They now stand at more than $200 billion a year.    Furthermore, since the early 1980’s, this industry has consistently ranked as the most profitable in the United States – by a long shot.”   “Perhaps the most quoted statistic on the pharmaceutical industry, IMS Health, estimated total worldwide sales for prescription drugs to be about $400 billion in 2002.  About half were in the United States.”

In 2002 the “combined profits for the ten drug companies in the Fortune 500 ($35.9 billion) were more than the profits for all the other 490 businesses put together ($33.7 billion).”   “Drug industry expenditures for research and development, while large, were consistently far less than profits.  For the top ten companies, they amounted to only 11 percent of sales in 1990, rising slightly to 14 percent in 2000.  The biggest single item in the budget is neither R & D nor even profits but something usually called ‘marketing and administration.’”  “According to a report by the nonprofit group Families USA, the former chairman and CEO of Bristol-Myers Squibb, Charles A. Heimbold, Jr., made $74,890,918 in 2001, not counting his $76,095,611 worth of unexercised stock options.  The chairman of Wyeth made $40,521,011, exclusive of his $40,629,459 in stock options.     

 “Drug companies claim drugs are so expensive because they need to cover their very high research and development (R&D) costs.  In 2001, they put these costs at $802 million (in 2000 dollars) for each new drug they bring to market.”  As far as the real costs it is not clear.  “They claim that that information is proprietary.  As Representative Henry Waxman (D-Cailf.) commented, “The basic problem is that all pharmaceutical costs, including research, are in a black box, hidden from view. There is no transparency.”   

“If you look in the year 2000, when the industry claims to have spent $26 billion on R & D and ninety-eight drugs entered the market, the average pretax cost for each drug was, under those assumptions no greater than $265 million, and the after-tax cost about $175 million. ... The consumer advocacy group Public Citizen performed a much more sophisticated analysis using the same approach. They looked at all the drugs that entered the market between 1994 and 2000 (thus smoothing out the yearly variations), and made appropriate allowances for the long lag time between R & D expenditures and the dates the drugs came on the market.  They found that after-tax costs were probably less than $100 million for each drug approved during that period.  Other independent analysts have reached similar conclusions.  Even using PhRMA’s own figures for total R & D costs for the decade of the 1990’s, it can be calculated that the cost per drug came to around $100 million after taxes.  That is a lot, but it’s a far cry from the much-vaunted $802 million.” 

 During the 80’s and 90’s drug companies did a lot of lobbying in Congress and had legislation passed in their benefit such as the Hatch-Waxman Act (1984).  And the armies of lawyers are effective such as, “The result is that the effective patent life of brand-name drugs increased from about eight years in 1980’to about fourteen years in 2000.”   “As their profits skyrocketed during the 1980’s and 1990’s, so did the political clout of drug companies.  By 1990, the industry had assumed its present contours as a business with unprecedented control over its own fortunes.  For example, if it didn’t like something about the FDA, the federal agency that is supposed to regulate the industry, it could change it through direct pressure or through its friends in Congress.”     

4.  Is Academic Medicine for Sale?

 The educational efforts of drug companies usually goes straight to the doctors and to the University professors to speak on behalf of the drug companies interests.  Doctors are invited to expensive dinners to on junkets to luxurious settings to learn, act as consultants or become advisors or to become speakers.  This is especially true for medical school faculties and teaching hospitals. 

 In a section on “Bribing Doctors – or Nurturing Consultants?”  Dr. Marcia Angell writes a very insightful paragraph about the problem.  “I mentioned in chapter 6 that the head of Brown University’s Department of Psychiatry reportedly made over $500,000 in one year consulting for drug companies that made an antidepressants.  When The New England Journal of Medicine, under my editorship, published a study by him and his colleagues of an antidepressant agent, there wasn’t enough room to print all the author’s conflict-of-interest disclosures.  The full list had to be put on the website.  In a footnote, I wrote, ‘Our policy requires authors of Original Articles to disclose all financial ties with companies that make the products under study or competing products.  In this case, the large number of authors and their varied and extensive financial associations with relevant companies make a detailed listing here impractical.  Readers should know, however, that all but on (B.A.) of the twelve principal authors have had financial associations with Bristol-Myers Squibb – which also sponsored the study – and, in most cases, with many other companies producing psychoactive pharmaceutical agents.  The associations include consultancies, receipt of research grants and honorariums, and participation on advisory boards.’  I also wrote an accompanying editorial, titled “Is Academic Medicine for Sale?  in which I expressed my concern about the merging of commercial and academic interests.  In response, a reader sent a letter to the editor asking rhetorically, ‘Is academic medicine for sale?  No.  The current owner is very happy with it.’”      

 Dr. Marcia Angell points out that drug companies claim that they are educating consumers, but they often seek out the suggestible and vulnerable, such as a patient lying in a hospital bed.  “General Electric, with funding from big pharma, launched The Patient Channel, which shows medical programming interspersed with drug ads to patients in hospitals and waiting rooms across the country.  Within a year, some eight hundred hospitals were carrying the network twenty-four hours a day, seven days a week.  Supported entirely by its advertisers, The Patient Channel cost hospitals nothing.  Patients could choose among half-hour segments, such as ‘Cancer Related Fatigue” or ‘Breathe Easy: Allergies and Asthma.’”   

 “Another form of marketing disguised as education is the sponsorship of patient advocacy groups.  Many of these groups are simply fronts for drug companies.  People who suffer from a certain disease believe they have found a support network devoted to expanding awareness of the disease, but it is really a way for drug companies to promote their drugs. Some people aren’t even aware that a drug company is behind their advocacy group; others believe the companies just want to help educate people.”    

 “There is no doubt in my mind that Direct-to-consumer advertising (DTC) ads mislead consumers far more than they inform them, and they pressure doctors to prescribe new, expensive, and often marginally helpful drugs, even when a more conservative option (including no drug) might be better and safer.  Doctors don’t want to alienate their patterns, and too many of them find it faster and easier to write a prescription than to explain why it isn’t necessary.  That is why DTC ads are prohibited in every other developed country (except New Zealand).”     

 Dr. Marcia Angell, MD discusses an aspect of clinical trials.  “You may remember that I mentioned in Chapter 2 the growth of a large industry to perform clinical trials for drug companies.  It consists mainly of private contract research organizations (CRO’s).  These firms run clinical trials for drug companies, using networks of private doctors in their offices.  They concentrate particularly on Phase IV studies.  ‘Phase IV studies are the fastest growing segment of clinical spending,’ CenterWatch wrote.  ‘This sweet spot in the market is being actively pursued by CRO’s and offers unique opportunity for experienced, community-based clinical investigators.’  It’s a ‘sweet spot’ for the doctors, too.  They usually make more working for CRO’s than spending the same time caring for patients.  There are now tens of thousands of private doctors doing this work – many of them essentially being paid to prescribe a company drug.”    

  5.  “Me-Too” Drugs

 The term “Me-Too” drugs are drugs that are copycats, leftovers, slightly changed or imitation drugs from the drugs that have already been formally approved.  These are very easy and inexpensive to make since they are replicated from ones already researched and studied and approved. 

 “In the five years 1998 through 2002, 415 new drugs were approved by the Food and Drug Administration (FDA), of which only 14 percent were truly innovative.  A further 9 percent were old drugs that had been changed in some way that made them, in the FDA’s view, significant improvements.  And the remaining 77 percent?  Incredibly, they were all me-too drugs – classified by the agency as being no better than drugs already on the market to treat the same condition.  Some of these had different chemical compositions from the originals; most did not.  But none were considered improvements.  So there you have it.  Seventy-seven percent of the pharmaceutical industry’s output consisted of leftovers.”   

 “Sometimes it’s simply a matter of extending the life of a blockbuster drug that is going off patent by making a virtually identical drug and shifting users to the new one.  The drug just has to be different enough to qualify for a new patent.  Take the case of Nexium.  Nexium is a heartburn drug of the proton pump inhibitor type made by the British company AstraZeneca.  It came on the market in 2001, just as the company’s blockbuster drug for heartburn, Prilosec, was scheduled to go off patent.  That was no coincidence.  Unless there was a replacement, the loss of Prilosec patent would have been a devastating blow to AstraZeneca.  At $6 billion in annual sales, Prilosec was once the top-selling drug in the world.  When the patent expired, it would face competition from generic manufacturers, and its sales would plummet.  

 Shortly before the patent on Prilosec was set to expire, the company got FDA approval for the newly patented Nexium.  Then it launched a massive advertising campaign to persuade Prilose users and their doctors that Nexium was somehow better.  Very quickly, Nexium became the most heavily advertised drug in the United States. The media was blanketed with Nexium ads – ‘Today’s purple pill is Nexium, from the makers of Prilosec.’  To help with the switch, AstraZeneca priced Nexium slightly below Prilosec, gave discounts to managed care plans and hospitals, barraged doctors with free samples, and even offered coupons in newspapers.  The campaign reportedly cost the company a half a billion dollars in 2001.”    

    6.  Advertising as Selling Sickness

 Ray Moynihan and Alan Cassels in their book: Selling Sickness, have research on, Advertising disease by the drug companies, which truly reflects the subtitle of their book: Selling Sickness, How the World’s Biggest Pharmaceutical Companies are Turning Us All into Patients.  They write: “The pharmaceutical industry in the U.S. now spends more than $3 billion a year on direct-to-consumer advertising, promoting its most lucrative brands…. Prime-time television news bulletins are dominated by drug ads.”  

 “Researchers are finding more and more ads are helping sell the idea that everyday human experiences are symptoms of medical conditions requiring treatment with drugs.  Together with colleagues, the Dartmouth Medical School duo Drs. Steve Woloshin and Lisa Schwartz recently analyzed seventy drug company ads in ten popular U.S. magazines.  They found that almost half tried to encourage consumers to consider medical causes for their common experiences, most often urging them to consult a physician.  The ads targeted aspects of ordinary life including sneezing, hair loss, or being overweight - things many people could clearly manage without seeing a doctor - and portrayed them as if they were part of a medical condition.  The researchers speculated that advertising was increasingly medicalizing ordinary experience, and pushing the boundaries of medical influence far too wide.”   

 “Watching these trends closely is Canadian researcher Dr. Barbara Mintzes, who included in her Ph.D. at the University of British Columbia in Vancouver a rigorous examination of drug company advertising.  She also discovered that many ads now promote medical conditions, rather than just drugs, and are helping to medicalize life, as she puts it.  “To an unprecendented degree they portray the educational message of a pill for every ill - and increasingly an ill for every pill.  It’s a shift from a drug that’s approved to treat people who are actually suffering from an illness to the idea that you just take a pill to deal with normal life situations.”     

 One controversial health concern is Attention-Deficit/Hyperactivity Disorder (ADD).  In the book, Selling Sickness, it points out in one state, “in some school years, up to 20 percent of young white boys are now taking speed-like stimulants for their ADD.”   Drug companies are not successfully partnering with patients and groups. 

 “Growing global controversy about both the nature and extent of attention deficit disorder has not slowed the rapid growth in the use of ADD drugs.  According to those who study this phenomenon, in the decade from 1990 production of the drug Ritalin rose almost 800 percent.  By 2000, with under 5 percent of the world’s population, Americans were consuming 80 percent of the stimulants manufactured worldwide. That same year a leading scientific journal revealed a dramatic increase in the prescription of these drugs to toddlers.  But despite growing disquiet, medication use among kids shows no signs of abating, as drug companies aggressively market new medicines to rival the ever-popular Ritalin.  As with many other conditions, much of the marketing promotes the disease itself, not just the drugs, and who better to help out with such ‘awareness-raising’ that company-sponsored patient advocacy groups.”   

 Concerning these ADD patient advocacy groups, one of these groups “and its drug company partners promote the condition as a common ‘neurobiological’ disorder to be treated primarily with drugs.”  This patient advocacy group states it has about fifteen thousand members and two hundred affiliates across the United States, and it discloses that it gets about $700,000 annually from drug companies for its $3 million dollar a year budget.       

 “Mountains of scientific research have been published on these questions, [of ADD] but there remain strongly conflicting views on what all that research actually means.  Some scientists insist there is now a consensus - that attention deficit disorder is a widespread and proven biological disorder, and that the debate is over.  Others, publishing in exactly the same scientific journals, insist the debate is very much alive.  In stark contrast, these researchers claim there is great uncertainty about how to define this disorder, there is no reliable medical test for it, and no strong evidence that it is biologically determined.  Even the National Institutes of Health in the U.S., one of the biggest biomedical research houses in the world, concludes that the causes of the condition remain speculative, and there is not yet enough evidence to say with certainty that ADD is a brain disorder.”    

  7.   Funding Bias in Journals

 Funding bias is common in the medical industry, even in studies that get published and many that do not get published in medical journals.  There are many kinds of bias in a study such as when investigators choose a sample that is not random.  Bias can enter in as to the type of experiment done.  Bias can enter into the design of the study.  And bias can enter in as part of the selection of evidence or the interpretation of the results of the study.  Bias is not outward deception but a changing of the study to get favorable results, something pharmaceutical companies are looking for in a study. 

In the book, Science in the Private Interest, has the Lure of Profits Corrupted Biomedical Research?  by Seldon Krimsky (2004)   gives an excellent overview of this issue of bias in the journal literature.   

 “Published studies on funding bias can be found in the medical literature.  One of the earliest I discovered appeared in 1986 in the Journal of General Internal Medicine, the official journal of the Society for Research and Education in Primary Care Internal Medicine.  The author examined 107 controlled clinical trials designed to determine whether a new drug therapy was effective.  Pharmaceutical companies typically favor new therapies over older ones.  The logic is that patents for older therapies eventually reach maturity and become subject to competition; new therapies, however usually mean new patent protection and thus larger profits.  The question asked by the author was whether there was an association between the sources of funding and the preference for new therapies.  Out of the 107 trials, 76 favored the new therapy and 31 favored the traditional therapy.  Of those papers favoring the new therapy, 43 percent were supported by drug companies whereas 57 percent were supported by nonprofit institutions (government, foundations, or university funds).  Of those papers favoring traditional therapy, 13 percent were supported by drug companies whereas 87 percent came from nonprofit institutions. 

 The study showed that there was a statistically significant association between privately funded studies and the ‘favoring of new therapies.’  We call this effect ‘funding bias.’  In other words, private funding can bias the outcome of studies toward the interests of the sponsor.  How do we explain the fact that so few of the pharmaceutically supported trails (13 percent) favored the traditional therapy?  Why, in fact would a company want to publish results indicating that a competitor’s drug was better than its own product?  Of course, explanations other than ‘funding bias’ may exist to account for these results.  After all, nearly three-quarters of the published studies favored the new therapy, and that support was almost evenly split between drug company sponsorship and other funding.”   

 “Two Danish researchers posed the following question: Does financial or other competing interests affect the interpretation of the results of randomized clinical trials?  In particular, do such trials tend to favor interventions that benefit their for-profit sponsors?  The investigators chose to focus their study on the internationally distinguished British Medical Journal (BMJ) because the editors of that journal require authors to declare their interests – financial or otherwise.  They identified 159 original randomized clinical trials published in BMJ from 1997 to June 2001.  In ninety-four trials, the authors indicated that they had no competing interests; in sixty-five trials, the authors declared that they received funding from for-profit organizations (defined as a competing interest).  The trials covered several fields of clinical medicine, including psychiatry, orthopedics, and cardiology.  The study results showed that ‘authors’ conclusions were significantly more positive toward the experiment intervention in trials funded by for-profit organizations alone compared with trials without competing interests.”   

 “One of the most elegant and influential studies that demonstrated an association between funding source and outcome was published in 1998 by a Canadian research team at the University of Toronto.  This study appeared in the distinguished New England Journal of Medicine (NEJM), considered by many to be one of the half-dozen leading medical journals in the world. 

 In this study, the authors began with the question, ‘Is there an association between authors’ published positions on the safety of a drug and their financial relationships with the pharmaceutical company?’  They focused their study around a class of drugs called ‘calcium channel blockers’ (CCBs, also called ‘channel antagonists’), which are used to treat hypertension.  Their choice was based on the fact that the medical community debated the safety of these drugs.

 The study’s results showed that the overwhelming number of supportive authors (96 percent) had financial relationships with manufacturers of CCBs while only 37 percent of the critical authors and 60 percent of the neutral authors had such relationships.  The authors of the NEJM study wrote that ‘the results demonstrate a strong association between authors’ opinions about the safety of calcium-channel antagonists and their financial relationships with pharmaceutical manufacturers.’”     

 “Marcia Angel, former editor of The New England Journal of Medicine, commented that it was her impression ‘papers submitted by authors with financial conflicts of interest were far more likely to be biased in both design and interpretation.’   Angel’s impression was validated by findings that appeared in the Journal of the American Medical Association from a systematic study of published research (called meta-analysis) on the ‘extent, impact, and management of financial conflicts of interests in a biomedical research.’  Beginning with a screening of 1,664 original research articles, the authors called 144 that were potentially eligible for their analysis and ended up with 37 studies that met their criteria.  One of the questions the authors pursued in their study was whether there was a funding effect in biomedical research.  Eleven of the studies they reviewed found that industry-sponsored research yielded pro-industry outcomes.  The authors concluded.  

Although only 37 articles met [our] inclusion criteria, evidence suggests that the financial ties that intertwine industry, investigators, and academic institutions can influence the research process.  Strong and consistent evidence shows that industry-sponsored research tends to draw pro-industry conclusions.  By combining data from articles examining 1140 studies, we found that industry-sponsored studies were significantly more likely to reach conclusions that were favorable to the sponsor than were non-industry studies.”   

  8. The $800 Million Pill

 The 2004 book, The $800 Million Pill, the Truth Behind the Cost of New Drugs,   by Merrill Goozner a former chief economics correspondent at the Chicago Tribune, gives a detailed account of the reasons for the costs of drugs.  Some of the books on the pharmaceutical industry bring up the cost of drugs but Merrill Goozner’s, The $800 Million Pill, gives a very accurate assessment of the situation, showing that the cost is far less then $800 million.    

 In the first chapter he emphasizes the fact that most people don’t think about during the drug company inquires.  “Virtually all the basic science that enables modern medicine to move forward takes place in the nonprofit sector – at universities, research institutes, and government labs.  And governments, in particular the U.S. government, are by far its largest financiers.  The pharmaceutical industry and its biotechnology stepchild occasionally contribute to the basic scientific understanding of disease.  But the private sector’s main role is to develop and commercialize therapies based on that knowledge.  It is called applied science.”   

 In chapter 7, the failed crusade, cancer is discussed and Merrill Goozner gives an example on the governments’ financial role:  “Rep. Ron Wyden, a Democrat from Oregon, challenged the ethical implications of the government’s dealings with the firm during hearings in 1991 and 1992, after public interest groups branded the Taxol CRADA a giveaway of taxpayer-funded research.  By that time, the drug’s success in the clinic suggested it might become cancer’s first blockbuster.  Before Taxol, cancer was not a lucrative market, and few drug companies even bothered with the disease. 

 “It had taken more then thirty years to bring Taxol from its initial discovery to a government-approved drug.  Like most chemotherapy agents, Taxol was no cure.  It depleted white blood cells and left patients prone to infection.  Their hair fell out and they lost feeling in their fingers and toes.  But it extended life in some patients.  And in the world of cancer therapy, that was progress.  (In one trial on breast cancer, “one in four patients saw their tumors shrink more than 50 percent.  Their life expectancy increased by nearly a year.)”  

 “Wyden held a hearing of his small business subcommittee to question Taxol’s price and the cozy relationship between NCI and the one pharmaceutical firm that had consistently shown interest in commercializing its products.  Bristol-Myers had set its initial Taxol price eight times higher than the price NCI had paid to its contractors to product the drug.  A typical course of therapy would cost patients or their insurers more than ten thousand dollars.  Ralph Nader and James Love of the Consumer Project on Technology demanded the government exercise its ‘march in’ rights and establish a reasonable price for the drug.  Wyden was listening. 

 At the public hearing, the Oregon representative, whose constituents had jobs because of this new use of its forest products, read a letter from NCI director Sam Broder.  It reviewed the history of Taxol, which showed NCI had not only been instrumental in its development but had been alone nearly every step of the way.  ‘There are limits to what Americans ought to pay for drugs developed through billions of dollars of federal research and federal tax credits.”  Wyden complained.  “Americans should not be held hostage to drug companies who threaten to walk away from cures if the Congress requires reasonable price justification.’”  

 He goes through the history and documents how the government’s role and financing fostered much of the basic science and the early steps of the drug innovation process.  “It has shown how taxpayer-funded directed research played the leading role in the battle against some of the nation’s most pressing health care problems like AIDS and cancer.  In almost every case, pharmaceutical and biotechnology companies also played critical roles in brining new drugs to market.  Sometimes the role began late in the process, in chemically synthesizing a new drug.  Sometimes it began late in the process, when the new drug was well along in clinical trials.  Sometimes the private firms invested large sums in the process.  Sometimes participation cost the drug company next to nothing.”  

 A report came out by the Tufts University Center for the Study of Drug Development.  “The center was started in the mid-1980’s by a group of economists who were largely funded by the drug industry.”  “Their first study pegged the total cost per new drug at $114 million (measured in 1987 dollars).   Then they adjusted that cost for the time needed to secure approval.  Economists call this adjustment the opportunity cost of capital.  It assumes that the money invested in research and development today, which won’t have a payoff for many years down the road, could have been spent on other things or turned back to shareholders as additional profit.  The opportunity cost of research-and-development spending increased the final estimate to $231 million per new drug (or $318 million in 2000 after adjusting the price for inflation).  Tuft’s most recent estimate was released in November 2001.  The average new drug now cost $802 million.” 

 “Why were expenses for industry-run clinical trials rising at such a rapid rate?  One reason was an explosion in the number of trials whose sole purpose was to help companies market their drugs.  Cener Watch, a newsletter that monitors clinical trials, estimated drug manufacturers spent $1.5 billion in 2000 to test medicines already approved by the FDA – the fastest growing component of clinical trials spending.  Some trials were undertaken to provide company salespersons the veneer of science when countering rival claims in the marketplace.  Bistol-Myers Squibb, for instance, spent tens of millions of dollars to prove its cholesterol-lowering statin was no different than Merck’s statin in protecting against heart disease even though it didn’t lower cholesterol quite as much.  Other trials – dubbed seeding trials – designed to get more physicians using an approved drug or to encourage them to sue it for other indications.   

 Most of these post marketing trials were never submitted to the FDA because the did not have placebo controls or were not rigorously designed.  But in conducting the trials the companies did get to ply participating physicians with the drug, share the results with other physicians through detailing, and employ public relations and advertising firms to herald the results at major conferences.  The trend drew a sharp rebuke from the editors of thirteen of the nation’s leading medical journals.  ‘Patients participate in clinical trials largely for altruistic reasons – that is, to advance the standard of care,’ the joint editorial said.  ‘In the light of that truth, the use of clinical trials primarily for marketing, in our view, make a mockery of clinical investigation and is a misuse of a powerful tool.”     

 “As the debate heated up in Congress over a prescription drug benefit for Medicare, Public Citizen/Congress Watch, which was started by Ralph Nader, published a detailed critique of the Tufts assumptions.  Complaining that the drug industry had never opened its books to congressional or outside investigators, the Public Citizen researchers argued that research and development ought to be considered an expense, not an investment, as per accounting purposes (accountants deduct expenses as they occur; investments are depreciated over time since it is assumed their usual life extends beyond the year purchase).  The Naderites suggested an alternative method for calculating the cost of drug development.  They divided the total number of new drugs approved between 1999 and 2000 into the total industry spending on research and development.  They came up with a pretax research expense of $108 million per drug.  Adjusting for the tax deductibility of research-and-development expenses, they pegged the actual cost per new drug at $71 million.  The industry’s oft-repeated claim that lower prices would slow new drug development was nothing more than ‘a misleading campaign to scare policy makers and the public,’ the report said.”      

 “The international humanitarian group Doctors without Borders surveyed the world’s eleven largest pharmaceutical firms and found that of the 1,393 new drugs introduced in the last quarter-century, only thirteen treated tropical diseases that are the biggest killers in the developing world.  The humanitarians had found a way to shame drug companies into providing HIV drugs at costs to the developing world.  But how could they get them to invest $800 million to develop drugs that didn’t already exist for people who didn’t have much money?” 

 “Would the Bill Gate’s Foundation have to invest $800 million to develop a new TB drug?   The Global Alliance commissioned a team of former drug company executives to build their own model of what it costs to develop new drugs.  Their October 2001 report, ‘The Economics of TB Drug Development,’ directly challenged the Tufts studies, which had dominated the field of pharmaceutical economics in the prior decade.  They surveyed contract research organizations that specialize in microbiology, toxicology, and drug metabolism.  They used the Tufts estimate for drug discovery and extrapolations from the cost of government-run clinical trials.  They allowed for failures at every stage of development and inflated the final figures to account for the time value of money.  Though Global Alliance’s methodology was very similar to the Tufts study, their bottom line was very different.  ‘The total costs to discover and develop a new anti-TB drug is roughly estimated to range from $115 million to $240 million.  “On closer inspection, the Global Alliance’s numbers actually jibed with the Tufts studies.”     

  9.  Let Them Eat Antidepressants

 There are a number of books out by doctors on the topic of antidepressants.  David Healy’s research and experience as an expert witness gives a detailed historical review and analysis on this topic.  David Healy, in his book: Let Them Eat Prozac the Unhealthy Relationship between the Pharmaceutical Industry and Depression, gives a detailed account of the antidepressant drugs which have a long involved history.  Antidepressants have become a huge multi-billion dollar business.  Even on some college campuses the pharmaceutical companies are promoting and giving teachings about anti-depressants.  A few selections of this concern follow. 

 “Prozac was launched in the United States and Canada in 1988”  “Almost from its launch, Prozac generated legal actions.  By 1990, fifty-four cases were pending.  By the mid-1990s, Lilly faced a series of civil suits, 160 of which consolidated in a Federal Multi-District Legislation (MDL) case.  The drug was also cited in a number of crimes.”

 Prozac was one of the first, but not the first, Selective Serotonin Reuptake Inhibitor (SSRIs) drugs.  “The origin of the SSRIs lies in the 1960s, when Paul Kielholz became professor of psychiatry in Basel. ... The first patent was published in March 1972, Prozac was patented in 1974.”   

 “In the late 1990’s, the FDA was under considerable pressure to scrap placebos in antidepressant trials.  Concerns had been expressed about the ethics of exposing patients at risk of suicide to a nontreatment.   There was probably at least as great a set of unexpressed embarrassments at how poorly antidepressants did compared to placebo.  This lead to an article by Arif Khan and colleagues in the Archives of General Psychiatry in April 2000,  which presented figures for suicides and suicidal acts from clinical trials submitted to the FDA in the early 1990s as part of the license applications for Zoloft, Paxil, Serzone, Wellbutrin, and Remeron.  Based on the figures accessed, Khan and colleagues were happy to tell the world that placebos did not pose a threat – the rate of suicidal acts was no higher on placebo than on active antidepressants.  Paul Leber, among others, was invited by Archives to comment and welcomed the findings. 

 But insofar as these figures exonerated placebo, they should have posed a problem for anyone who advocated using SSRIs to detect and treat depression in order to avoid the risk of suicide.  An analysis of these figures by Tom Laughren from the FDA shows antidepressants were twice as likely as placebo to be associated with suicide attempts.”   

 “Companies rationalize the counting of washout suicides as placebo suicides by arguing that placebo is ‘nothing’ and therefore, in some real sense, patients on nothing are equivalent to patients on placebo.  If we join the companies in categorizing washout suicidal acts this way, then the number of people who have gone on to placebo in these trials becomes the entire number of people who have gone into the trial.  Once the calculations take into account, rather than double the risk, Zolft, Paxil, or Prozac becomes ten times more likely to trigger suicide than placebo.”   

 In the DSRU studies of SSRIs in Primary Care in the United Kingdom   the suicide rate/100,000 patients for the individual drugs were: Prozac, 244; Zoloft, 173, Paxil, 269; Luvox, 183; and the total SSRIs, 219 (or 219/100,000). 

 “These figures of 219 suicides per 100,000 people treated map almost exactly onto the figures from SSRI trials which give 180 suicides per 100,000 people treated.  This suicide rate of 180 needs to be compared with the rate for primary-care patients, which the Jick and Boardman studies suggest could be as low as 27 suicides per 100,000 patients and cannot be any higher than 68 per 100,000 patients.  Company trials also give placebo suicide rate lying between 44 and 64 per 100,000 patients.  There seems, therefore, in primary-care depression to be a suicide rate of approximately 180 out of 100,000 on SSRIs, which set against with a rate of 60 out of 100,000, suggests a doubling or tripling of the risk on SSRIs compared to placebo or nontreatment.”    

 The law suits finally resulted in, “a first verdict (year 2000) against a pharmaceutical company for a psychiatric side effect of a psychotropic drug.”  “The medico-legal difficulties facing plaintiffs outlined here are compounded by legal jeopardy that stems from the nonrecording of drug-induced side effects such as akathisia, disinhibition, and emotional blunting, which makes certain side effects vanish.  For example, although nobody thought that figure for sexual dysfunction on Prozac could be as high as 50 percent, everybody knew it was probably more than Lilly’s figure of 5 percent.”  

 “Interestingly, in the twelve years (from 2000) following the public emergence of concerns over Prozac, there is not a single study designed to answer the question of whether Prozac or any other SSRI can induce suicidality.    

 What about closing down programs to safer Prozac?  Consider this: As early as 1986, Stuart Montgomery had reported that once-a-week Prozac was as effective as daily Prozac.   This would have probably reduced the risk from key side effects such as the induction of agitation.   It would probably also have reduced profits.  In 1988, a further study showed that 5 mg of Prozac once a day was as effective as the 20 mg tablet.  

 Against this background, the words of former U.S. Attorney General Janet Reno, applied to the tobacco story in 1999, became even more unsettling: ‘The companies that manufacture and sell tobacco have waged an intentional and coordinated campaign of fraud and deceit.... It has been designed to preserve their enormous profits whatever the cost in human lives, human suffering and medical resources.... The truth represents a mortal threat to their business.  At every turn, they denied that smoking causes disease and denied that it is addictive.’     

 Given the way tobacco companies behaved, there was an ethical onus on medical people to research the hazards of tobacco, and independent funding was forthcoming to support them.  Tobacco companies did not control researchers as pharmaceutical companies now control clinical researchers.  In the case of tobacco, the community was never in a position where all its experts were beholden to a corporation for research monies, speaking opportunities, or consultancy fees; where all its researchers could be body-snatched.” 

 “The ultimate irony in the SSRI cases lies in the comparison with the tobacco cases.  On the one hand, lawyers argue that epidemiological studies ‘prove’ nothing. (31)  They want someone to show a jury a cancer growing in front of the eyes in a human lung under the influence of tobacco.  Nothing else constitutes proof.  On the other hand, in the SSRI cases, suicide is seen to grow under the influence of the drug in front of people’s eyes, but (in some cases) the same legal firms who advised the tobacco companies argue this is not proof.  What do they want instead?  They want epidemiological studies.  But these expensive studies put justice out of reach of plaintiffs, as the only bodies that can afford to undertake them are pharmaceutical companies.”  

  10.  Powerful Medicines Risks versus Benefits 

 In a book by a Harvard professor Jerry Avron, M.D., Powerful Medicines the Benefits, Risks, and Costs of Prescription Drugs,   he gives good examples of the risks of taking drugs and the story behind them.  

 In this first chapter he gives an excellent example of the excesses and lapses that can mark the darker side of prescription drug use in America.  Most of the time we don’t get to learn about the background or history of a drug and what went wrong or how it took so long and why so many people suffered because of it?  The following example will give some insight into what goes on with prescription drugs.  One reason for using this as an example is that, from the many studies done on it already, it was considered for decades, to be protective against Alzheimer’s and some types of cancer.  Finally after more studies had been down the opposite was discovered! 

 “The drug is the family of hormone replacement products that include Prempro and Premarin (manufactured from pregnant mare’ urine, hence its name.)  For decades, estrogen replacement in the postmenopausal women was widely believed to have ‘cardio-protective’ properties; other papers in respected medical journals reported that drugs could treat depression and incontinence, as well as prevent Alzheimer’s disease.  The first large, well-conducted, controlled clinical trial of this treatment in women was not published until 1998; it found that estrogen replacement actually increased the rate of heart attacks in the patients studied.  Another clinical trial published in 2002 presented further evidence that these products increased the risk of heart disease, stroke, and cancer.  Further reports a year later found that rather then preventing Alzheimer’s disease, the drugs appeared to double the risk of becoming senile.  The studies resulted in a reduction, but not an end, to the long-term use of these products.  For decades, these were among the most widely prescribed drugs in the nation.”  

 “Eventually, the NIH also began its own studies under the umbrella of the new Women’s Health Initiative, or WHI.  Many feminist health advocates applauded the new studies.... The first study to yield results was a Wyeth-funded [drug company funded] trial that focused on estrogen use in women with preexisting cardiac disease.  It had the wonderful acronym HERS, for Heart and Estrogen-progestin Replacement Study.  Amazement followed publication of its findings in the Journal of the American Medical Association in 1998.  The study that never needed to be done, that had withheld life-giving hormonal therapy from thousands of women in an obsessive exercise of pseudoscientific misogyny, found that subjects given estrogens had significantly more heart attack in the first year of the study than did comparable women given placebo.  The hormone group also had higher rates of blood clots and gallbladder disease.   

 “We’ve now come upon our first example of the struggle to balance the benefits and risks of a drug.  It is a dilemma with which we physicians wrestle (or should) every time we write a prescription; it is one that patients take on, consciously or unconsciously, every time they fill or don’t fill that prescription.  The conflict is at its starkest in designing a drug trial, but it emerges routinely in clinical practice as well.  Once the HERS results were known, what was the right course of action for the doctors running the NIH’s Women’s Health Initiative?  They could abort their study, or continue as if HERS had never happened, or do something in between.  What would be the most ethical way to treat women enrolled?” 

 “However comfortable the investigators were, the women in the WHI study would have to be informed of the latest findings so they could decide for themselves whether to continue as experimental subjects.  A mailing went out to thousands of participants, reporting the HERS findings so that could make informed choices about their participation in the trial. ...  Most large clinical trials convene a data safety monitoring board to periodically review interim findings, to make sure that patients in one treatment group were not doing substantially worse than those in the other.  In May 2002 the WHI safety monitoring board reviewed the outcomes to that point and found that in this trial too, the women assigned to the hormone replacement group were developing heart disease at a higher rate than those in the placebo group.  The same was happening for breast cancer, strokes, blood clots, and gallbladder disease.  On the other side of the ledger were a much smaller benefit in the risk of colon cancer, and the expected reduction in hip fractures – although there were several safer drugs on the market for this purpose that did not have estrogen’s downsides.  In July 2002 the WHI leadership announced that it would be unethical to allow their trial to continue.       

 “Even after the trial was halted, researchers continued to pore over the voluminous data that had already been collected.  An analysis of mental functioning had been another key part of WHI from the start, to determine whether HRT did indeed delay the onset of senility or prevent it altogether, as the observational studies had suggested.  Quite the opposite was found.  Cognitive function was not better in the women randomized to estrogen, and even seemed to be worse, with the treated patients appearing twice as likely to develop the symptoms of Alzheimer’s disease.  A study in Britain that followed over a million women confirmed that estrogen users had a risk of breast cancer that was 66 percent higher than that of nonusers.  In a particularly chilling calculation, its authors determined that HRT use in women aged fifty to sixty-four had produced 20,000 more cases of breast cancer than would have been seen in the United Kingdom without HRT.  A drug taken by tens of millions of women to preserve their health and youth turned out to be worthless for that purpose and instead caused heart disease, cancer, stroke, blood clots, and perhaps even brain damage.”  

 “The tens of thousands of extra breast cancers, pulmonary emboli, strokes, and other drug-related side effects that were caused by the use of estrogens in millions of women didn’t have to happen.  Together, they amount to what is probably the largest epidemic of drug-induced illness in modern times.  This raises disturbing questions that will be addressed throughout the book.  How do we know whether a drug actually works as intended?  How are its adverse events monitored and addressed?  What benefits justify what risks?  What should companies be required to prove about the effectiveness and hazards of their products?  How does our massive regulatory apparatus decide which drug effects will be studied, and by whom?  How do we physicians make prescribing decisions, and from where do we get our information?  Who if anyone is responsible for looking out for how well or carelessly drugs are being prescribed?

 In the 1970’s and 1980’s, hormone replacement therapy was the poster child for the brave new world that modern pharmacology was making possible.  By the start of the present century, it had become a symbol for the excesses and lapses that can mark the darker side of prescription drug use in America.”     

The FDA Daily Reports 
 Dealing with the many problems of pharmaceutical drugs is a huge task, the problems involved in the case study above is a good example.  The following gives a view of the broader perspective of the drug problem.
 
 “Each day, all over the world millions of people die, recover from illness, develop new symptoms, take pills.  Medical interventions and outcomes are happening all the time.  For drugs in widespread use, it is crucial to evaluate adverse events to determine which of them are caused by a given medication, and which would have happened anyway.  Enormous numbers of drug exposures and clinical outcomes must be transformed from mere bits of data into accurate and actionable insights.  Requiring that drugs on the market be completely ‘safe’ is an impossible goal.  The real question is whether a drug’s dangers are in some acceptable proportion to the good it does.” 

 “Imagine that you work at the FDA and come into your office each morning to confront two piles of reports.  Those in an in-box marked ‘1’ describe cases like the following:  A fifty-seven-year-old construction worker in Nevada had been a regular user of inhaled steroids for asthma: a year after being started on a new product, he was diagnosed with leukemia.  A twenty-seven-year-old beautician in Seattle was prescribed a drug to treat her migraine headaches; after five weeks of use, she developed weakness in her limbs that was diagnosed as multiple sclerosis.  A seventy-one-year-old lawyer in New York City was switched to a new cholesterol-lowering medication and three weeks later ruptured a major abdominal blood vessel, requiring emergency surgery and four units of blood transfusion.  A seventy-eight-year-old diabetic nursing home resident started a recently marketed for Alzheimer’s disease; within two weeks he had lost circulation in his left leg, requiring a below-knee amputation.  
 
 Now, consider a second pile of reports, somewhat smaller, that had also arrived in the previous day’s mail.  These are in a separate in-box on your desk labeled ‘2’.  Here are some of the cases it contains: A thirty-two-year-old teacher in Nebraska was given a painkiller for a sprained ankle, and three weeks later developed hepatitis.  A sixty-five-year-old accountant in San Francisco had been treated for rheumatoid arthritis, and was later diagnosed with lymphoma.  A fifty-one-year-old factory worker in Chicago found his seasonal nasal congestion did not respond to his usual allergy medication; his doctor diagnosed an upper respiratory infection and added an antibiotic.  After six days he developed an irregular heartbeat; in the emergency room he had a cardiac and died. 

 What distinguishes Box 1 from Box 2?  Both in-boxes describe clinical events, often tragic, that occurred in patients who were taking medications.  Viewed with the power of hindsight, it turns out that all the events described in Box 1 were random misfortunes, not related in any way to the drug noted on the report form. ... Box 2, by contrast, we now know contains the kind of initial reports that were the first signals of likely drug-induced illnesses – problems that in two of the three cases resulted in a decision that the offending product was too dangerous to be left on the market.  The terrifying reality faced by the people on the receiving end of these reports is that they do not come neatly separated in Box 1 and Box 2.  They are all in the same in-box when they arrive. ... The FDA receives more than a thousand such reports every day.”    

 A major problem with this in-box example of the poor FDA official is that, “Only a few percent of unanticipated drug-induced events are ever reported to the manufacturer or to the FDA.”  A second problem is that physicians usually do not have the time to do the research to make the connections between a patients problems and a drug.  Third if they do make the connection, they would have to take the time to fill out the form and then worry about a patients privacy and fear of litigation.  Fourth these reports of suspected adverse drug events can get lost in the administrative paperwork or even the wrong address.  Finally even though drug companies are required by law to pass along these reports, that may not happen, all the time or in a timely manner.  In what passes for humor in the pharmaco-epidemiology community:

 Two Views of an Adverse Event
PHYSICIAN:  “This drug could be a real threat to the life of my patient!”
MANUFACTURER: “This patient could be a real threat to the life of my drug!”

 “Pharmacoepidemiology is the study of the uses and outcomes of medicines in large populations of patients.  Its first part comes from the Greek pharmakeuein, ‘to administer drugs,’ which in turn is from the Greek pharmakon, which meant ‘magic charm,’ ‘poison,’ or ‘drug’ (my dictionary lists them in that order).  The second part of the word comes from the Greek epidemia, or ‘epidemic,’ derived from epi-, ‘on or upon,’ and demos, ‘people.’”      

   11.  Scientific Research Evidence Unreliability

 Scientific evidence is a new kid on the block in the last 150 years.  Medicine has been around for over 3,000 years and only in the last 150 years has scientific evidence become something of importance.  Yet the reliability, the bias, the conflicts of interest and need for it are bioethics issues.  The people who demand we need it are those that have created it and promote it.  In that sense it is self-serving and unethical.  But let’s take a closer look at it and its internal problems, not usually spoken about.  In a way it has become the Gods we worship today.

 This chapter is based on the book: Achieving Evidence-based Practice, a Handbook for Practitioners, second edition.   The book gives an excellent review of the basis for modern research, the strengths, weaknesses and dimensions.  Some of the key aspect of this book have been related to cancer and Parkinson’s disease.  The bioethics and methodology of cancer and PD are tied into the forms of scientific evidence.

 There are different forms of scientific research and evidence such as:
• Randomized controlled trials 
• Case-controlled study
• Case Study
• Cohort study
• Survey
• Qualitative Study
• Professional Consensus
• Qualitative opinion based evidence

 All of this research can be said to do two basic things in healthcare:
1. That which increases the understanding of health, ill health and the process of healthcare. 
2. That which enables an assessment of the interventions used in order to try to promote health, to prevent ill health or to improve the process of healthcare.     (Muir Gray 1997)

 Randomized controlled trials (RCTs) are often termed the ‘gold standard’ in research evidence.  But this gold is in the eyes of the beholder which are usually the peer review journals that have put them in that light.  These journals hold a particular medical paradigm or philosophy that they want to promote and using RCTs is the best way for them to promote their philosophical (medical paradigm) beliefs.  Part of the reason is because of the cost to do an RCT.  The pharmaceutical companies want to promote their drugs for their profits and thus promote or encourage RCTs because of the high cost of doing an RCT.  It takes upwards of $200 million to get RCTs through the FDA. 

 Beyond the emphasis by journals and pharmaceutical interest is the question of ethical viability of RCTs.  Some people are being helped and others are being wasted.  Humans are used as if they were rats in a study, used for observation.  The RCTs are designed to support a certain medical paradigm, such as Allopathy, thus perhaps it is the whole paradigm that is the real problem?  There are other methods that can be statistically just as effective as RCT’s and for Parkinson’s study, case studies would be a better option for early stages of research.  These case studies could then be generalized to larger studies, once the details of what works best in the case studies is known.   

 “As Klein (1996) has commented, scientific knowledge is only part of the complex process of clinical decision making, but dangers may be associated with the emphasis being placed upon ‘new scientism’ so that the most enthusiastic advocates of evidence-based healthcare may have failed to pay sufficient attention to the inherent uncertainty bound up in the process of clinical decision making.  Not all human life can be reduced to a unit of data in a RCT: indeed, the bias in the positivist paradigm itself reproduces a narrow scientism.”      

 Parkinson’s research is still struggling to define itself, the causes of PD and other issues.  Most of these have been worked through with cancer research and caused modern cancer research to be very narrow minded, a very narrow scientism.  The strong emphasis and money, by the pharmaceutical industry to find a drug cure has pushed the research to find this elusive “silver bullet”.   All other approaches, like nutrition and fasting, would be considered outside the ‘new scientism’ emphasis by cancer researchers.  

 There is a hierarchy in Journals, some are more prestigious then others, this creates a bias in the weight of the journal article and also a bias in the articles being published in the journals.  Journals usually prefer to publish research that shows they are having an effect, thus other studies usually do not get into a journal.  Also journals have a certain medical paradigm (philosophical orientation) such as Allopathic medicine involving drugs, surgery, radiation or related methods that they want to promote.  Thus there are pressures upon researchers to publish in more prestigious, high-impact journals:
“As long as journals continue to pursue their current editorial policies then we are restricting our view of a broader scientific picture.  More worrying, though, if statistical significance increases the chance of a researcher’s work being published, might not he or she be tempted to tamper a little with data?  After all, a career might depend on it.”   (Brookes 1997)   

 “The publication of research evidence in a reputable professional journal is not always a guarantee of its rigor.  In recent years a number of cases of academic fraud, which is considered serious professional misconduct, have resulted in doctors being struck off of the medical register (Dyer 1997).  The editors of journals have also started to reflect on the processes by which they judge papers for publication (Smith 1997).  The process of peer review by professional journals is itself acknowledged as biased, with questions of method and name bias, publication bias and differing value ascribed to differing traditions of enquiry (Wilkie 1997).”  

   12.  Bias; Homeopathy, Acupuncture as an Example 

 Research reviews are often the backbone of evidence-based medicine, this has both strengths and weaknesses.  The weakness is that this is a Western modern mindset.  If one looks at the East and forms of medicine in India and China and some European approaches, which use related experiential or intuitive based approaches to medicine (i.e. Ayruvedic, homeopathic), journal research is not the answer, and oftentimes becomes part of the problem.  Oftentimes these approaches are very individualistic and the Western mindset of Allopathic medicine treats everyone as the same, with the same problem that a drug can address.   

 A good example of bias (or lack of knowledge) is the strong bias is towards homeopathic medicine in America.  Homeopathic medicine has been around longer then allopathic medicine and is used widely in Europe.  One study that came out in a journal in Europe caused a tremendous amount of uproar in the medical community and criticism of that journal.  In Allopathic medicine the higher the concentration the stronger the drug is the fact.   Yet in homeopathy the weaker the concentration the stronger the homeopathic pill is the fact.  Homeopathic pills are the reverse of allopathic drugs.  Also homeopathy is rather subjective in its approach or individualized is a better term.  The homeopathic interview is like a psychological interview only focused at finding the condition to give a homeopathic pill for. 

 What is not understood by many in the medical community is that allopathic drugs work on macro-molecules in biochemistry, whereas homeopathic pills work on energy levels or dimensions in the biochemistry, a subtler dimension then pharmaceutical drugs.  Medical science in the U.S. is still scratching their heads trying to understand how acupuncture works, never mind something as sophisticated as homeopathy!  Thus it is not simply bias but outright rejection of homeopathy by some in the medical establishment; it’s a totally different paradigm. 

 Possibly, homeopathy should be integrated into professional psychological counseling, because of its subjective nature.  A good homeopathy practitioner is really very similar to a psychologist, except that they are giving a homeopathic remedy, rather than advice and guidance. 

 The independent journal Bandolier about evidence-based healthcare, see next section, (ebandolier.com) has a commentary on a homeopathic study.  “For homeopathy a new analysis (K Linde et al., 1997) of placebo-controlled studies gives an insight into the effectiveness of this intervention.  Klaus Linde’s team have done a great job of finding all the trials, and looking for factors which may have led to over-estimations of treatment effect through publication bias and other forms of bias.  For the record, the odds ratios favored homeopathy.  Eighty-nine trials could be analyzed.  They broke down like this:
• The median number of patients studied in each trial was 60.
• There were 24 clinical categories.
• There were four types of homeopathy.
• There were 50 classes of homeopathic remedy.

 This is an important paper because it applies good meta-analytic principles to a difficult subject in complementary therapy.  It examined all comparisons of homeopathy against placebo, and because there was a statistically significant outcome, this will be interpreted by some as ‘homeopathy works’.” 

 The following analysis is from a scientific mindset but homeopathy really works on the intuitive level of the homeopath, not just the intellectual level.  This is a huge difference in the way to create a study since its not the numbers but the subjective level of the homeopath giving the correct intuitive choice to the patient.  The second factor is the patients receptivity, if the patient is not receptive and open the pill given him is not going to work.  No study has taken these two major factors into account concerning homeopathy.  In fact medical science would consider this to be ridiculous since they do not take into account the subjective or intuitive.
 

  13.  The Comprehensive Review - Golden Standard?

 The strengths of a review of the literature is that when properly done it can and does show those methods that have worked, sometimes consistently have worked.  Before the age of computers systematic reviews took a lot of time to acquire and differed in their ability to be comprehensive and unbiased.  But now with the computer age: “Oh, but times, have changed.  Systematic reviews are now considered the ‘gold standard’ for assessing the effectiveness of a treatment or intervention (Egger et al 2001, Khan et al 2004).  A dated but very appropriate definition comes from the Centre for Reviews and Dissemination: ‘Systematic reviews locate, appraise and synthesize evidence from scientific studies in order to provide informative, empirical answers to scientific research questions’” 

 “A comprehensive review means that you will need to identify both published and unpublished material (theses, conference proceedings, special reports) in your review (Egger et al 2003).”   The elements of the search strategy include:
• Database searching
• Hand searching
• Searching reference lists of identified studies
• Contacting researchers in the field
• Finding unpublished literature

 “Database searching should be considered as only one component of the literature search and its limitations need to be recognized (Dickson and Sindhu 1997, Royle and Waugh 2003).  Early work by Dickersin and Min (1993) identified some of the issues related to the effectiveness of database searching.  They compared the results of hand searching with electronic searching of MEDLINE.  Their electronic search of selected journals failed to identify 12% of the trials that had been found through hand searching of the same journals.” 

 Hand searching through the literature and journals is important since many studies have not been indexed by electronic databases.  But this requires knowledge of the field to know where to look.  “Research has shown that hand searching is effective but very time-consuming (Hopewell 2004).”    “One of the best, and at times most enjoyable, ways of identifying ongoing or unpublished studies is to contact researchers in the field of interest.  However, the process is time consuming and can be costly.  There is no best way to carry out this part of the literature search (McGrath et al 1998, Brown and Hooper 2003).”   “There is no standard method for identifying unpublished studies. ...  The identification of unpublished studies is critical because it is the best way of decreasing bias, which may be introduced if you include only published material.”  

 “As stated above, the reason for conducting a comprehensive search of the literature is to identify as much of the available information as possible.  Failure to do so can potentially bias the results of the review.  With the explosion of work in systematic reviews, interest has arisen in components of the reviews that may be biased by the review activities themselves.”    

 “Another issue related to the availability of evidence is the issue of the results of trials supported through industry (e.g. pharmaceutical companies).  It has been documented that data used as part of the US Food and Drug Administration approval processes at times differs from data available in the published domain (Bennett and Jull 2003).  It has also been noted that at times there may be some reporting bias (i.e. not all outcomes are reported – only those that show significant results) occurring in relation to the data that is published by industry-funded research (Lexchin et al 2003, Melander et al 2003).”   

 “Research in languages other than English has historically been included in systematic reviews, although including such material is frequently difficult.  The effects of language bias are being debated, with some researchers finding that, although the foreign language literature tends to show more positive results, the studies are frequently small and the overall effect on the results of the review are  negligible.  (Moher et al 1996, Juni et al 2002).”    

  14.  Quality Control and Conflicts in Medical Evidence  

 A book on the essential tools for assessing medical evidence is: Bandolier’s Little Book of Making Sense of the Medical Evidence.   This technical work goes through clinical trials, observational studies, diagnostic testing and other issues.  Bandolier is an independent journal about evidence-based healthcare published since 1994 in print and online (ebandolier.com) they seek information about evidence of effectiveness (or lack of it) in systematic reviews, meta-analyses, randomized trials, and from high quality observational studies.  These Oxford scientists connected to the Oxford University Medical School, is a premier source of evidence based healthcare information in the UK.  The following comes from this book.   

 “Most of us think that the peer review process in journals should protect us – from mistakes, from inaccurate or inadequate conclusions, or even from fraud.  It does not. ... All too often accepting or rejecting submitted papers seems to be little less than the random play of chance.  A study in neuroscience confirms just that.”   (Rothwell 2002)  A statement of professor David Eddy, (Smith, R 1991) considered an original thinker about evidence, made a radical statement on validity: “There are perhaps 30,000 biomedical journals in the world, and they have grown steadily by 7% a year since the seventeenth century.  Yet about 15% of medical interventions are supported by solid scientific evidence ... only 1% of the articles in medical journals are scientifically sound.”  

 “Bandolier’s experience of reading lots of papers and systematic reviews over the past few decades is that, while the 1% may be difficult to pin down, this is not far from the right order of magnitude.  For instance our own work has identified that in some cases 1 in 10 trial reports contain serious errors (actually 2 in 13)  (Smith, LA 2002)  and others have also found similar problems.”     

 In-addition to this problem with the journals is that people in primary care or hospitals have little time to spare on evidence.  “We are all busy people.  In primary care in Europe, physicians have, on average, only a few minutes to spend with each patient.”   (Deveugele 2002)  The average general practitioner consultation length (in minutes) is: Germany 6.5 minutes; Spain 7 minutes; United Kingdom 9.5 minutes; Netherlands 10 minutes; Belgium 15 minutes; Switzerland 16 minutes.  

 Within the world of published journals conflicts of interest are a major problem.  “Conflicts of interest abound.  For instance, a financial conflict of interest (COI) occurs when a person owns shares in a company and writes a paper about a product from that company.  It is assumed that natural behavior is to praise the product in order to increase the company’s share price and thus become individually wealthier. ...
  
 It has been suggested that the potential threat of funding bias is neither recognized nor taken seriously by clinical investigators,  (Boyd 2003)  over a quarter of whom have industry affiliations  (Bekelman 2003).   According to some sources, the majority of US and UK consumers now believe that potential gain for scientists could affect research quality and are concerned with the commercialization of research.”       

 Conflicts of interest apply in most cases of studies.  “One study looked at a consecutive series of 332 randomized trials published between January 1999 and 2001 in 13 leading medical and surgical journals.  (Bhandari 2004)   It found that industry funding was most often associated with drug trials, but that surgical and other interventions often had no reported funding source.  Statistically significant results were frequent, occurring in two-thirds or more trials.”    Sponsorship in randomized trials for drugs: Industry 62%; Government or foundation 15%; none reported 23%; Statistically significant outcomes 64%; Industry-funded favoring industry product 34%. 

 “The thing with quality control is that the more you look, the more problems you find.  An electronic survey of over 3600 US scientists asked questions about the possible behaviors, using questions build around the results of earlier focus groups.  (Martinson 2005)  Scientists had to answer the questions in a yes or no fashion.”   Some of the results:
• Failing to present data that contradicts one’s own research:  6.0%
• Circumventing certain minor aspects of human-subject requirements:  7.6%  
• Overlooking other’s use of flawed data or questionable interpretation:  12.5%
• Changing the design, methodology, or results of a study in response to pressure from a funding source:  15.5%
• Withholding details of methodology or results in papers or proposals:  10.8%
• Using inadequate or inappropriate research designs:  13.5%
• Dropping observations or data points from analyses based on a gut feel that they were inaccurate:  15.3%
• Inadequate record-keeping related to research projects:  27.5%    

Conflicts of interests will always be around in clinical trials but there are polices, guidelines and ethical considerations in place in place to guard against this type of activity, and there are some trial monitoring and data monitoring committees.  But how much of these polices, guidelines and ethical considerations are followed by the pharmaceutical industry is another issue.  A lot of what happens in the pharmaceutical industry happens behind closed doors and the public doesn’t become aware of what they are doing until they are ready to publish and promote their trials and literature. 

There is an awareness of these problems and “from July 2005 member journals of the International Committee of Medical Journal Editors will require, as a condition of publication of a trial, that it was registered in a public trials registry before patient enrolment.  (DeAngelis 2004)  Such a policy, if extended, should remove much of the disquiet about possible unpublished trials, and should increase transparency in performance and reporting of clinical trials.  It is naïve to assume that, because a paper reaches a particular conclusion, it must be certainly true.  Yet many people seem to consider that publication of any piece of research in a peer-reviewed journal provides sufficient credibility for decision-making.  It doesn’t.”       

  15.  Controlling the data, the analysis and the wording

 In the book; The Big Fix how the Pharmaceutical Industry Rips Off American Consumers,  (2003) by the journalist Katharine Greider, it gives a good review of the problem.  One thing it shows it that the pharmaceutical industry that sponsors a drug study is controlling the raw data, the analysis of the data and the wording in the journals. 

 “The drug industry pays for the majority of this research.  Fully 70 percent of funds to support U.S. drug trials come from drug companies, according to an article in the New England of Medicine by Thomas Bodenheimer, MD, a longtime practicing doctor and health-care policy researcher. Indeed, companies are required to perform the studies in order to gain FDA approval for their products or to support any product claims they might wish to make after approval.  Bodenheimer and others are quick to point out that many of these trials meet the highest standards for scientific inquiry.  With that broad caveat in mind, the process is full of opportunities for drug companies to mold the message that emerges from research. 

 “As Bodenheimer’s New England Journal piece documents, the 1990’s have seen a dramatic change in the way industry sponsored trials are conducted – a shift that gives drug companies more control over how studies are designed, how the resulting data are organized and presented, and whether these data are made public at all.  In some cases , drug companies have bent research to their own purposes, making it not the gold standard for objectivity practicing physicians expect, but, by virtue of this expectation, the ultimate marketing tool.

 In the past, the vast majority of drug trials, including those sponsored by industry, were performed in university hospitals by academic researchers.  In 1991, 80 percent of drug-industry money for trials went to academic medical centers.  By 1998, the majority of these funds had been handed instead to a new animal on the research scene: the contract research organization (CRO).  CRO’s are for profit companies that pull together the various aspects of a clinical trial in much the way producers make movies.  This may include designing the study, setting up a network of research sites in hospitals and doctor’s offices, supervising the collection of data, analyzing those data, and, finally, preparing applications for FDA approval and manuscripts for publication. They do all this more quickly and cheaply than universities do.  These entrepreneurial operations also provide their clients – the drug companies – with an unprecedented level of control over the entire process.”   

 Not only in CRO’s but also in Universities the pharmaceutical industry is having more and more control and engaging in secrecy, letting the public only know the facts that they want to release.  “In a survey of university-industry research centers published in 1994, Carnegie-Mellon University found that 35 percent of signed agreements allowed the sponsor to delete information from publication; 53 percent allowed publication to be delayed; and 30 percent allowed both.  During late 2001 and early 2002, Duke University researchers interviewed officials at 108 medical schools and found that guidelines for agreements between industry sponsors and researchers, issued by the International Committee of Medical Journal Editors, are largely ignored.  Only 1 percent of the agreements guaranteed that authors of reports on multi-site studies would have access to all the trial data.”     

 Using patients through medical doctors as a means of making money and marketing is another conflict of interest and ethical problem.  “A less worrying but more widespread conflict of interest is evident in the office-based doctor who receives a fee for every patient he or she enrolls in a drug-industry trial.  ‘When most research was done in academic medical centers, it was largely the case that the investigator was not your personal physician,’ explains Lois Snyder, J.D., director of the Center for Ethics and Professionalism of the American College of Physicians.” 

 “In fact, some drug-industry studies, known as ‘seeding trials,’ have every appearance of being nothing more than campaigns to convince investigator-doctors and their patients to use the drug in question.  In a 1994 article in the New England Journal of Medicine, then FDA head David Kessler, MD, explained that such trials are distinguished by their apparent lack of intention to find out anything about the drug.  Kessler cited one example in which a company’s sales force recruited 2,500 office-based doctors and paid them $1,050 each to enroll twelve patients in a ‘study’ of its new blood-pressure medicine, which was entering a field crowed with similar products.  There was not control group. In another case, Kessler quotes from a memo a drug-company’s marketing department sent to sales reps: ‘Make no mistake about it: the [name of drug omitted] study is the single most important sales initiative of 1993...If at least 20,000 of the 25,000 patients involved in the study remain on [the drug], it could mean up to $10,000,000 boost in sales. In Phase II, this figure could double.’  To enroll patients in a ‘trial’ that lacks even a shred of scientific worth clearly isn’t right.  But it seems fair to ask whether it’s ethical to enlist human subjects in the production of findings that although scientifically valid, are useful mainly to support marketing claims.”  

 Pharmaceutical companies are able to make something look good by interpreting it in a way that looks favorable since they control the data.  “Of course, once the trials are wrapped and the data analyzed, the results may affect many more patients by influencing medical opinion and practice.  And subtle manipulations of design and analysis are likely to escape the notice of all but the most sophisticated.  Sponsor companies might tip the balance in their favor by using their drug at higher does than a comparison drug.  This was the case, according to a 1994 study, in over half of industry-sponsored trials of non-steroidal anti-inflammatory drugs (NSAIDs) to treat arthritis.  Or the drug can be studied in populations that are healthier than those in which it’s likely to be used.  Companies might also use a shorter timeline than is necessary to study the drug’s full effects.”

 Besides just controlling the data the sponsoring pharmaceutical company also controls the wording, they reserve the right to review and the edit the manuscript.  They have the final say over the published material.  Two other ways that a published paper is influenced by the pharmaceutical companies sponsoring the study is what’s referred to as the three Gs.  “Ghosts” are people who worked on but are not credited since they are associated with the sponsor company.  “Gifts” is the practice of crediting an influential researcher who did little work on the study but will bring prestige and increase the likelihood of publication.  “Guests” are those professionals who are invited, for a fee, to review the finished paper and to put their name on it.  

 “The bottom line shouldn’t be surprising: Company-sponsored trials that do get published tend to say good things, and not bad things, about the drugs in question.  One 1996 study published in the Annals of Internal Medicine reviewed company-supported drug studies published between 1980 and 1989 in peer-reviewed journals or symposia proceedings and found that nearly all of them – 98 percent – favored the company’s drug.”   Drug companies today have more influence, power and money then back in the 1980’s and thus the journal studies probably have a higher percentage favoring the company’s drug.  In a way the journals have become a major marketing arm of the pharmaceutical companies! 

 After all this controlling of the data, the analysis and the journal wording what happens next is obviously marketing.  There are many ways that drugs are marketed including: speaker programs, live symposia, dinner meetings, published journal articles and others to influence the physicians.  “The drug industry’s main promotional tool is the old-fashioned salesperson who spends his or her days calling on physician-customers- and whose ranks have swelled considerably in the last decade, from 56,000 in 1990 to almost 88,000 in 2000.  That’s a 57-percent increase, versus, according to Sager’s analysis, a roughly 10-percent increase in R&D staff during the same period.”   In 2009 the figure of salespeople is over 90,000 but how much more is not known. 

 Drug sales reps are often structured around similar incentives: a bonus based on sales performance.  Bob Goodman, MD, an internist stated: “You want the drug that works best.  But drug reps don’t get paid if doctors are prescribing the correct medication, they get paid if doctors are prescribing their medication.” 
 
 “Intensive marketing of prescription drugs drives up costs in two ways.  First, it’s expensive in itself.  Financial filings suggest some drug makers spend roughly one-fourth to one-third of every sales dollar on marketing.  Second, it does what marketing and advertising are designed to do: get more people to buy more product, creating brand recognition and loyalty, in some cases even stimulating ‘needs’ where none existed before.”   

 This happens for all drugs including Parkinson’s and cancer medications.  Parkinson’s and cancer have the same problems with journal studies and research and the same problems with sales reps and prescribing practices.     

    16. Statin Drugs for Cholesterol a Smoking Gun

 This section is a case study on cholesterol but a chapter could be developed for many different degenerative diseases that pharmaceutical drugs are used to control and manipulate for their benefit.  This is merely one case study of deception that is going on, many more case studies could be done.  

 Using drugs to lower cholesterol is a 25 billion dollar a year industry, and during the 1980’s and 1990’s in the scientific literature this myth has been created and continues to be promoted by the pharmaceutical industry.  There are a number of books on this topic and it is a good case study of one health problem now controlled by the drug industry for their financial gain. 

 John Abramson, M.D. in Overdosed America, in a chapter, “A Smoking Gun, the 2001 Cholesterol Guidelines” writes about an expert panel on high blood cholesterol in adults who came up with updated guidelines for cholesterol, in order to reduce developing coronary heart disease (CHD).  “This goal can be reached, according to the guidelines, by increasing the number of Americans taking statin drugs, from 13 million to 36 million.”  “But careful scrutiny of the full report on the NCEP - and of the key studies supporting its recommendations - reveals a picture strikingly different from what is presented in the executive summary.  Rather than presenting a balanced interpretation of the scientific findings, the report seems intent upon building the case for greater use of statins, preferentially presenting data that support greater statin use and even misrepresenting findings reported in the original articles.”  

 “Five of the 14 experts who participated in writing the guidelines, including the chair of the panel, disclosed financial relationships with manufacturers of statin drugs.  Four of these five, including the chair of the panel, had relationships with all three manufacturers of the best-selling statins. 

 “And  curiously, although the guidelines recommend reduced intake of saturated fat and cholesterol, the words ‘egg,’ ‘beef,’ and ‘dairy’ do not appear anywhere in the executive summary.  (Animal products such as egg yolks, red meat, and dairy fat are the primary dietary sources of saturated fat and cholesterol, and therefore reducing intake of these foods is an integral part of the ‘therapeutic lifestyle interventions’ suggested in the guidelines.)  Perhaps the omission has something to do with the fact that, according to the Center for Science in the Public Interest, several of the authors and expert reviewers of the guidelines have, or have had, financial ties to one of the following organizations: the American Egg Board, the National Cattlemen’s Association, and the National Dairy Promotion and Research Board.  The drug companies have plenty to gain from the pro-drug orientation of the updated guidelines.  If the guidelines are followed, sales of cholesterol-lowering statin drugs will increase by at least $20 billion to $30 billion per year.”   (Statins drugs are now (2009) about a $25 billion dollar a year business.) 

 “Racking up sales of more than $10 billion a year, Lipitor is the world’s top-selling prescription drug, ever.  Its manufacturer Pfizer is the world’s biggest pharmaceutical company.  With head offices in Manhattan, and a market value around $200 billion, Pfizer is one of the largest corporations on earth, thanks in no small part to widespread fears of high cholesterol.”  

 Another book, Ray Moynihan and Alan Cassels in their Selling Sickness, published a year later adds more wood to the fire, as their book has done excellent research on this topic.  “In 2004, yet another new panel of experts updated those guidelines again, recommending that alongside the value of lifestyle changes more than 40 million Americans could benefit by taking the drugs.  This time, the conflicts of interest were even worse.”  

 “Eight of the nine experts who wrote the latest cholesterol guidelines also serve as paid speakers, consultants, or researchers to the world’s major drug companies - Pfizer, Merck, Bristol-Myers Squibb, Novartis, Bayer, Abbott, AstraZeneca, and GlaxoSmithKline.  In most cases the individual authors had multiple ties to at least four of these companies.  One ‘expert’ had taken money from ten of them.  The links were not mentioned in the published version of the cholesterol guidelines, and the extent of the conflicts was not publicly known until the media organizations uncovered them, sparking a major controversy.”   

 “Cholesterol, though, is no different in this regard than many other common conditions.  It is estimated that almost 90 percent of those who write guidelines for their peers have conflicts of interest because of financial ties to the pharmaceutical industry.  The ties between guideline-writers and the industry are just one corner of the vast web of interrelationships between doctors and drug companies.  The industry’s influence over doctors’ practices, medical education, and scientific research is as widespread as it is controversial - not just distorting the way physicians prescribe medicines but actually affecting the way conditions like ‘high cholesterol’ are defined and promoted.”   

 “Next comes the continuing medical education, the refresher courses that physicians are strongly encouraged and sometimes formally required to attend.  In the U.S. this is now a billion dollar enterprise, with close to half that funding flowing directly from the pharmaceutical industry.  Doctors are being ‘educated’ about how to use drugs, and how many of us should take them, in venues sponsored by their makers.”  

 “After the education comes the scientific research.  An estimated 60 percent of biomedical research and development in the U.S. is now funded from private sources, mainly drug companies.   In some areas, like the drugs for depression, the figure is closer to 100 percent. Almost all the clinical trials of the new antidepressants were funded by their manufactures rather than public or non-for-profit sources.  And that research evidence is discussed and disseminated at more than three thousand scientific meetings, events and conferences sponsored by the industry every year, and often hosted by medical societies like the American Heart Association, themselves partially underwritten by drug companies.”  

 “The pharmaceutical industry’s financial entanglement with the medical profession is fast being replicated in the consumer field - through the creation of groups like the Pfizer-funded Boomer Coalition.  A global survey from Britain estimated that two-thirds of all patient advocacy groups and health charities now rely on funding from drug companies or device manufacturers.  The most prolific sponsor, according to the survey results, in Johnson & Johnson and number two is Pfizer.   While creating the appearance of corporate generosity, such sponsorship can bring many benefits to the sponsor as well as the recipient.  Chief among them is that patient groups are a great way to help shape public opinion about the conditions your products are designed to treat.  With high cholesterol, there are clearly differing views within the wider health community about how to define the condition, and for whom drugs might be appropriate.  Sponsoring advocacy groups that tend to keep the message simple, and keep the focus on the fear of high cholesterol, will inevitably help to maximize the sales of cholesterol-lowering drugs.”    

 This problem really gets bad when government funded research centers are also the target of pharmaceutical company interests.  On doctor a major speaker in cholesterol field was a senior figure at the National Institutes of Health (NIH) near Washington, D.C., he “received in the order of two hundred thousand dollars from outside private interests including drug companies, while simultaneously holding down a position as branch chief at the government’s NIH.”    “And he is certainly not the only senior NIH researcher to have close financial ties to the drug industry.  Revelations by investigative journalists and others in recent years have uncovered extensive conflicts of interest, and ultimately sparked congressional inquiries.  At one hearing on Washington’s Capitol Hill, the site of Congress, committee members expressed dismay at one case where an NIH researcher had received $430,000 from industry sources, and another where stock worth almost $2 million had been held.”   

 This section on statins (Heart Disease drugs) could go on and on for many more pages since every book dealing with drugs deals with this topic of Heart disease drugs at some point.  And in a way we owe a debt of gratitude to these writers and journalists writing on these topics.  Let us close this high cholesterol discussion with one last thought about an investigative journalist work, that helped to stop something in the making.  “In fact, right from the beginning of the cholesterol boom in the 1980’s, critical thinkers like investigative journalist and health researcher Thomas Moore have been exposing the weaknesses in the arguments of those who would seem to welcome statins in the drinking water.”       

  17.  Promoting Misleading Statistics – MRFIT
 
 In the book, The Cholesterol Myths, by Uffe Ravnskov, MD, PhD., he shows using the scientific studies that various myths exist about Cholesterol.  Dr. Ravnskov book systematically goes through the journal literature and shows nine myths that exist, his work is very well documented and very understandable.  Each one of these myths is a chapter in the book. 
• Myth 1: High-fat foods cause heart disease. 
• Myth 2: High cholesterol causes heart disease. 
• Myth 3: High-fat foods raise blood cholesterol.
• Myth 4: Cholesterol blocks arteries.
• Myth 5: Animal studies prove the diet-heart idea.
• Myth 6: Lowering your cholesterol will lengthen your life.
• Myth 7: Polyunsaturated oils are good for you. 
• Myth 8: The cholesterol campaign is based on good science.
• Myth 9: All scientists support the diet-heart idea. 

 Following are a few sections in his well-written book.  Throughout the book he gives the evidence of many scientists like himself who agree on these myths.  At the end of the book in Myth 9 he cites many scientists that wrote articles or similar works like his book on the cholesterol hoax.  The politics and economics involving the billions of dollars made by interests groups (pharmaceutical companies, insurance companies and others) is what has kept these ideas alive. 

 This is a good example of one of many large studies that did not turn up statistically significant results so the scientists in the study mislead the public in their statements about the statistics.  Of course they wanted to publish their study and show they had something worth promoting after all their work, so they slanted the statistics or their wording of the statistics.   In the book, The Cholesterol Myths, by Uffe Ravnskov, MD, PhD.    

 “Framingham is a small town near Boston, Massachusetts.  Since the 1950’s a large number of Framingham citizens has taken part in a study surveying all the factors that may play a role in the development of atherosclerosis and heart disease.  Among other things their cholesterol was measured frequently.  

 After five years the researchers made an observation that has become one of the cornerstones of the diet-heart idea.  When they divided the participants into three groups having low, medium and high cholesterol values, they observed that in the latter group more had died from a heart attack than in the two other groups.  A high cholesterol level predicted a greater risk of heart attack, they said: high cholesterol is a risk factor for coronary heart disease. 

 The predictive value of blood cholesterol levels was confirmed in the greatest medical experiment in history, the Multiple Risk Factor Intervention Trial, also called MRFIT.  In that trial researchers measured the blood cholesterol of more than 300,000 American middle-aged men. 

 Six years later professor Jeremiah Stamler, the director of MRFIT, and his co-workers from Chicago asked how many of these men, the so-called “screenees” had died and why.  The participants were divided into ten groups of equal size, so-called deciles, according to their cholesterol values.  The first decile thus consisted of the tenth of the men with the lowest cholesterol values, and the tenth decile consisted of those with the highest cholesterol values.”   (“To be statistically correct, deciles are not defined in this way,” but it is used here to explain things.)   

 “The researchers’ analysis showed that in the tenth decile, four times more men had died of a heart attack than in the first decile.  Professor Stamler’s team put it another way: The risk of dying from a heart attack with cholesterol above 265 was 413 percent greater than with cholesterol below 170.  

 Four hundred and thirteen percent!  How frightening!  But let us look at the real figures, not just at the percentages.  With statistics you can change black to white, or vice-versa, as many politicians will tell you.  How many men in the MRFIT study had, in fact, died of a heart attack?  The total number was 2258, or 0.6 percent of the more than 300,000 men investigated.  You could also say that 99.4 percent did not die from a heart attack. 

 Four hundred ninety four of those with the highest cholesterol value (the tenth decile), or 1.3 percent, died from a heart attack.  We could also describe these results by saying that 98.7 percent, survived.  Thus, the difference in numbers of deaths between the first and the tenth decile was only one percentage point (99.7 percent minus 98.7 percent.)   One percentage point doesn’t have the same alarming effect as Dr. Stamler’s 413 percent, but both figures are correct because 1.3 is 413 percent
of 0.3. 

 The excess of deaths was most pronounced in the tenth decile, which included, it should be remembered, almost all individuals with the rare, inherited disease called familial hypercholesterolemia.  These people have considerable highly cholesterol values than normal individuals, and they often have severe atherosclerosis and cardiovascular disease in early life.  A little less than one percent of humanity has familial hypercholesterolemia or some other kind of genetic problem that interferes with fat metabolism.  This means that about ten percent of the tenth decile (10 times 1 percent) were abnormal in this respect.  Thus, in a complicated way, the statistics demonstrated what we already knew – that patients with an inborn error of cholesterol metabolism have a greater risk of dying from heart disease.  There are more ways that risk factor statistics can be used to magnify trivial differences.”  

  18.  Manipulating Statistics the LBC trials

 Dr. Ravnskov writes: “Diet-heart proponent claim that if we had a drug that could lower blood cholesterol sufficiently without any serious side effects, we could prevent or at least delay all diseases caused by atherosclerosis.  This is a dream come true for doctors.  All that’s necessary to prevent heart disease is a prescription pad and a gadget for measuring cholesterol – and no time-consuming fuss with diet counseling. 

 And what a bonanza for the drug producers!  A lifelong lowering of cholesterol with expensive drugs in a substantial portion of the population.  The profits derived from brief penicillin treatments pale in comparison.  Drug manufacturers calculated the profits in the billions of dollars. 

 Large trials of clofibrate had not been especially encouraging to say the least.  But other, newer drugs seemed more promising.  One of them was cholestyramine (Questran).  The National Heart, Lung and Blood Institute embarked on a new jumbo trial, called the Lipid Research Clinics Coronary Primary Prevention Trial (LRC), to test the effectiveness of cholestyramine.  To find about 4000 test individuals, blood cholesterol was measured in almost one-third of a million middle-aged men.” 

 “Seven to eight years later, the results were analyzed.  Although blood cholesterol in the treatment group had decreased by more than 8 percent, the differences in the numbers of heart attacks were so small that they could only be attributed to chance.  Of those who had taken cholestyramine, 10 percent, or 190 men, had experienced a nonfatal heart attack, as against 11.1 percent, or 212, of the controls, a difference of 1.1 percentage points.  As for fatal heart attacks, the figures were 1.7 and 2.3 percent, a difference of 0.6 percentage points, or 12 individuals. 

 But in the summary of the paper, these unimpressive results were presented in another way, called ‘relative risk.’  The lowering of nonfatal coronary heart attacks was said to be 19 percent and of fatal heart attacks 30 percent.  These figures were obtained by comparing the absolute numbers in the control group while ignoring the total number of men involved.  In essence, the researchers threw out the denominator in their fractions and thus were able to make trivial differences seem important.   

 And this was not the only way in which the LRC figures were manipulated.  In order to reach their 30 percent figure, the LRC directors included the uncertain cases, those who may or may not have died from a heart attack, and to reach their 19 percent figure, they excluded the uncertain cases.  If it had been the other way around, the results would have been 24 percent rather than 30, and 15 rather than 19.  In other words, they selected data that gave them the results they were seeking. 

 Even worse, the LRC directors had lowered their own statistical demands.  In a preliminary report, written several years before the trial ended, they stated that to be convincing, they would accept nothing less than the strongest statistical proof of their findings.  In this case, it was a statistical level of 0.01, meaning that the trial results would be 99 percent accurate; and to ensure statistical accuracy, the researchers said they would use the very demanding two-tailed t-test.”  

 (Footnote: “A two-tailed t-test is much more difficult to satisfy than a one-tailed test, and it is therefore more reliable.  Scientists have agreed that a one-tailed t-test should be used only when it is certain that the result will go in just one direction.  The one-tailed t-test is never to be used when a study – for instance, a drug trial, where the drug may do harm rather than good – may have a negative as well as a positive outcome.”) 

 “Thus, the directors of the LRC trial had begun by embracing the highest standards.  Then, after the fact, when it was clear that the results of the trial did not measure up to their hopes, they shifted their demand for accuracy from 0.01 to the much less stringent 0.05 and to the easy one-tailed t-test. 

 In response to the critical letters to the Journal of the American Medical Association, the directors simply denied that they had ever declared in writing the high standards that they had originally intended to satisfy.  ‘The term “significant” was not defined in terms of a particular statistical probability level,’ they claimed.  Diet-heart supporters look offended if you tell them that of half a million screened men, a mere 12 were rescued from death in the LRC trial.”  “The LRC trials were so feeble that they may well have been caused by mere chance.”   

    “One problem with most studies and drugs is they don’t like to mention the risks and side effects that come with taking any drug, any legal low-dosage of poison.  In the LRC trial with the drug cholestyramine, “Sixty-eight percent of the men taking the cholestyramine experienced gastrointestinal side effects during their first years of treatment: gas, heartburn, belching, bloating, abdominal pain, nausea and vomiting.  Almost 50 percent suffered from constipation or diarrhea.”    

 A more recent drug that was chemically close to cholestyramine had similar side effects, the Helsinki Heart Study in Helsinki, Finland, “During the first year 232 or 11.3 percent of the treated individuals had gastrointestinal symptoms.  Gradually the side effects abated.  The report did not tell whether, as in the LRC trial, they were treated with other drugs to combat the side effects.  What we do know is that in the treatment group 81 were operated on for some gastrointestinal ailment.  In the control group, only 53 received such operations.  Thus, if the difference in the number of heart attacks were real and not caused by chance, the question is this: Would you prefer an operation on your stomach or gall bladder, or a nonfatal heart attack, because the sum of heart attacks and operations was almost identical in the two groups.   

 The Helsinki trial failed to lower mortality from coronary heart disease, and there was no significant difference between the total number of deaths either; if anything, more died in the treatment group than in the control group.”    

  19.  The Lowdown on Cholesterol-Lowering Drugs

 Sherry Rogers, M.D., in her book, The Cholesterol Hoax,   gives an overview of the many problems with cholesterol lowering drugs, documenting her work in the process.  It is amazing that this is not widely publicized. 

(1) “Statin drugs work by poisoning a liver enzyme that makes cholesterol.  When the body makes cholesterol, it uses many pathways but one major bottleneck is a rate-limiting enzyme in the liver called HMG COA reductase (3-hydroxyl-3methylgutaryl-coenzyme A reductase).  The statin category of cholesterol-lowering prescription medications all work by turning off or poisoning this main enzyme that the liver uses to make cholesterol.  It sounds pretty good, doesn’t it?  But I guess prescribing physicians forgot their physiology and biochemistry, because we need cholesterol to keep the brain from aging.  Clearly this drug class will bring on a lot more Alzheimer’s and senility, which are already soaring to unprecedented levels.  More on the amnesia, depression, nerve, heart and muscle damage and suicide that statins bring on later. 
(2) Furthermore, turning off cholesterol production fuels the Viagra epidemic, because you need cholesterol to make your sex hormones like testosterone, estrogen and progesterone.  With-out cholesterol you also get impotency and rock bottom libido. 
(3) And we need cholesterol in the cell membranes so that they can properly release cytokines, like tumor necrosis factor.  Only healthy cell membranes with sufficient cholesterol can release chemicals that we make inside of our cells to kill cancer cells. 
(4) If these side effects were not enough, the same enzyme that statin drugs inhibitor poison, HMG COA reductase, is used by the body to make the fat-soluble vitamin, coenzyme Q10.  This vitamin-like substance is crucial for life!  By poisoning the body’s production of CoQ10, statin drugs actually create a life-threatening
coenzyme Q10 deficiency. 
(5) Cholesterol drugs axe nutrients and invite cancer!  This is one of many reasons why statin drug-takers also have a higher rate of cancer (Newman). 
(6)  Statin drugs damage the good effect of vitamin E.
(7) As well, statin cholesterol-lowering drugs decrease the ability of insulin to metabolize sugars.  When insulin loses its power to lower sugar, the body makes more insulin.  But high insulin promotes ateriosclerosis by many mechanisms.  Damaging the action of insulin also promotes diabetes (which is already escalating at breakneck speeds) and accelerates aging. 
(8) But the harm of stain drugs doesn’t end here.  When you take statin drugs there is a 14-fold increased risk of developing polyneuropath (Gaist).  This nerve damage can cause a wide range of symptoms from numbness and tingling to impotency or paralysis.
(9) Statins have caused serious amnesia within minutes.
(10) Cholesterol drugs cause miserable people.  Studies show that folks taking statin cholesterol-lowering statin drugs are not happy (Morales). 
(11)  Cholesterol drugs guarantee an avalanche of new symptoms, especially cancer and more serious heart disease.  There is so much more that the cholesterol-lowering drugs do that I’ll just show you a smattering. ... A major problem is that these calcium channel blocker drugs (the number one category of prescribed drugs by cardiologists, and usually prescribed for life) have been proven to slowly deteriorate and shrink the brain and deteriorate the intellect within less than five years (Novasc, Procardia, Calan, Dilacor). ... Cholesteriol-lowering drugs cause memory loss, amnesia, Alzheimer’s, and mimic strokes.”   

High Cholesterol Always has to be Treated
 “Wrong.  There are families where the cholesterol is over 400 and folks have lived into their 90s with no medications and no medical problems.  Plus research shows that for folks over 70, those with a little higher cholesterol live longer than those with normal or low cholesterol.  And those with higher cholesterol have less cancer and less suicide than those with a normal level, 200 mg/dl or less.  Furthermore, high profile articles in the Journal of the American Medical Association, for example, show that death rates actually go up, not down when efforts are made to lower cholesterol with drugs (Hulley 1992).  Another study in the prestigious Circulation showed that high cholesterol has no predictive value for who will have an early coronary death (Hulley 1992).”  

The Lower Your Cholesterol, the Better
 “Absolutely not.  Too low of a cholesterol is just as dangerous as too high.  Cholesterol is needed for all membrane structure and function, hormones, hormone receptors, and release of cytokines that fight off infection and cancers.  And when the cell membrane is cholesterol-starved, it can malfunction and trigger autoimmune diseases, cancers, Alzheimer’s and much more.  In fact, folks with a cholesterol under 160 mg/dL have double the risk of brain hemorrhage and increased risk of cancers of the liver, lung, pancreas, and leukemia, plus cirrhosis and suicide (Behar).    In another study, low cholesterol folks had more than double the death rate from non-cardiac conditions.  Besides doubling death, low cholesterol dramatically damages mental-health leading to depression, suicide, mania, and more (Cassidy, Engleberg).  One of the fascinating things is that low cholesterol has been well known to be associated with cancer in scores of studies.  Most of these studies were published well over 20 years ago, and in the most prestigious journals like Lancet, Journal of the National Cancer Institute, Journal of the American Medical Association,
and much more.”   

 
    20.  Racketeering in Medicine

 In order to understand the present and future it is necessary to understand what happen in the past and how the past has evolved.  This section is from James P. Carter, M.D., Dr.P.H., in his book Racketeering in Medicine the Suppression of Alternatives, gives many facts about this problem.  He shows clearly that alternative medical and natural approaches are suppressed and squashed by the controlling medical establishment in the U.S.  Even though this book was published in 1993, the same activities and problems seem to be here today, twenty years later!  If this racketeering has occurred in the past, has it been eliminated now? 

 This book as well as other books written over ten to fifteen years ago are writing about the same problems with the pharmaceutical industry that are still around today 15 years later, even with the legislation that has been passed since then.    

 Dr. Carter writes: “The American public has no idea how politics secretly controls the practice of medicine.  If a doctor dares to introduce a natural, less costly method, no matter how safe or effective, Organized American Medicine can target this doctor for license revocation using fear tactics and legal maneuverings.  Why do holistic therapies threaten medicine?
• They involve a major change in scientific thought,
• They imply that current methods are inadequate, and
• They threaten huge profits of a powerful branch of medicine or drug company.

 Quite the opposite occurred with the immediate embrace of heart bypass surgery and balloon angioplasty.  These money-makers quickly brought wealth and fame to heart specialists and surgeons, large teams of health care professionals, and the hospital industry.  The fact that they save lives and improve the quality of life for many is not disputed.  Such high-tech breakthroughs, however, were never ‘proven’ by double-blind, placebo-controlled studies. 

 But far less risky and cheaper alternative therapies with astonishing healing results are frequently blocked.  Why?  Their safety and effectiveness have not been “proven” through FDA-required studies that now cost over $200 million to complete.  American medicine either doesn’t know or doesn’t know or doesn’t care about naturally-based medical practices, indigenous to cultures all over the world, that have promoted healing at a fraction of the cost.”

 Three examples of this problem are chelation therapy and plant-based diet therapy and fasting.  About 70% of bypass patients can benefit from chelation therapy, by itself or along with surgery methods. 

   The cost of coronary bypass: $40,000 to 80,000 while the cost of chelation is only $3,000 to 4,000.  Dean Ornish, MD became famous in the early 1990’s when he published a study showing that heart disease could be reversed by a strict vegetarian diet, exercise and stress reduction (meditation).  He later published a book, Reversing Heart Disease, and did more studies showing that his could be done.  To this day the medical societies do not actively promote his method.  Doing long water or juice fasts is another highly successful method to cleaning out the arteries.  Both dietary and fasting methods cost even less then chelation therapy.  By using these methods organized medicine could lose over half of the annual $10 billion heart-disease industry.  Thus over 15 years later the medical industry does not promote these cheaper and safer methods:  dietary or fasting or chelation for treating heart disease.

 Heart disease is an easy clear-cut example to use but cancer and Parkinson’s disease are more complex and difficult.  Dietary, fasting and supplementation have been used to cure cancer and Parkinson’s diseases.  But proving this is much more difficult then has been done with heart diseases.  And more importantly there is a lot more money in selling drugs then promoting diet and fasting.    

 “The Office of Technology Assessment, OTA, is the respected research branch department for the U.S. Congress.  Assisted by an advisory board of eminent university faculty, the OTA recently published a report on this matter with the conclusion that ‘only 10-20% of all medical procedures currently used in the medical practice have been shown to be efficacious by controlled trial.’  Therefore, 80-90% of medical procedures routinely performed are unproven.  Does that mean that 80-90% of all procedures are ineffective?  Certainly not.  It does signify that a procedure can be effective without dancing through $200+ million worth of testing as required by the FDA.  The OTA report further notes that the remaining 10-20% of medical procedures which purport to having been proven effective are in some cases based on flawed research.
 
 The double-blind study was developed to prevent bias in agricultural research up in Canada.  To test the effects of fertilizer on crop yields, Canadian agriculturists planted two patches.  The experiment was ‘double-blind’ because neither the harvester who measured the crop nor the researchers knew which patch was fertilized and which one was not, eliminating the element of subjective bias.  Double-blind studies were never meant to be used as the sole criterion for determining scientific truth, however.”         

  21.  The Guesswork of Modern Medicine!  

 Back in the early 1990’s there was considered to be a health-care crisis and Washington started a new federal agency, the Agency for Health Care Policy and Research.  At a conference Dr. David Eddy, Director of the Duke University Center for Health Policy Research said, “We don’t know what we’re doing in medicine.”  Other sobering assessments concerning the status of American medicine back in the early 1990’s noted:

    “Perhaps one-quarter to one-third of medical services may be of little to no benefit to patients.  (Institute of Medicine)
     The link between the process of care and patient outcomes has been established for relatively few procedures.  (Office of Technology Assessment, U.S. Congress) 
     Uncertainty about the most effective diagnostic and therapeutic approaches is pervasive.  (Dr. Dennis S. O’Leary, President, Joint commission on Accreditation of Health Care Organizations.) 
     The embarrassment of our ignorance about the efficacy of health care practices is both hard for us to admit and hard for our clients to accept.  It is difficult [for doctors] to face the disillusionment of the patients and the anger of the payers who ask, ‘But how could this be?  I thought you knew what you were doing.’  (Dr. Donald Berwick, Vice-president of the Harvard Community Health Plan)”

 “Part of the evidence that much of modern medicine is still based on guesswork comes from the recent pioneering work of Dr. John Wennberg, a professor of community and family medicine at Dartmouth Medical School.  For almost twenty years, Wennberg and his colleagues have been collecting evidence of contrasting variations in treatment patterns between different cities, hospitals, and even different doctors, without any appreciable difference in out-come for the patient.”  

 For example hysterectomies use varies widely from one community to another, for no clear reason.  In one city in Maine 70% of the female population lost their uterus by age 75, in a Maine city less than 20 miles away 25% had the operation.  In one city in Vermont, seven times as many children had their tonsils removed then in a city fifty miles away.  In one city in Iowa, 15% of the men have had prostate surgery, contrasting sharply with 60% in another Iowan city.  “Two top teaching hospitals associated with Harvard Medical School showed great differences in the way they delivered babies.  In one hospital, 19% of the newborn babies came into the world surgically - by Caesarean section.  In the other, only a few blocks away, the knife was used 30% of the time, for no apparent medical reason.”  Dr. Wennbert said these variations occurred “because the profession lacks consensus on the correct way to practice medicine… We should invest our time and effort to find out what’s going one.  We don’t know.”  

 All of the above quotes and research came from the early 1990’s, now all of these problems should be solved by the 15 or so year old federal agency, the Agency for Health Care Policy and Research.  But perhaps the question needs to be asked, have all these health care crisis problems been solved, is the guesswork gone from medical practice today?   

    22.  Licensing Boards attack Alternative Methods 

 The real question that needs to be asked is whether the medical establishments are prescribing what’s good for you or what’s lucrative for them?  The average drug has an 800% markup.  No product in any industry can mark up a product that much and get away with it, but drug companies do.  The struggle for the freedom in medicine to use alternative approaches freely is a struggle that Ghandi would call “Right Against Might.” 

In his book, The High Price of Health, Jeffrey York states: “The rhetoric about professional rights and freedom has obscured the fact that doctors are private businessmen who hold a monopoly over the provision of medical services.  They wield extraordinary powers over the market for their services, and they enjoy the right to use hospitals which are paid for, in part, at public expense.  Other monopolies such as AT&T and the Bell Telephone companies are carefully regulated by government, to ensure that the public is protected.”   Medicine is a self-regulating, self-governing profession.

 “A Canadian advocate for preventive medicine, Ron Dugas, asserts that citizens are prisoners of the pharmaceutical industry, and many suspect that the drug companies hold tremendous power over the medical profession, governments, and even citizens.  Alternative-medicine advocates sense that conventional medicine has a monopoly in health care, a monopoly which is closely guarded by professional associations and regulatory bodies.  While a profession, like a trade union, has a right to protect itself and its professional interest, the regulatory bodies are supposed to act in the interest of the public.  There is a growing public awareness, however, that these bodies are safeguarding the monopoly interests of the profession under the guise of protecting the public.” 

 Dr. Carter writes about something that continues today: “About 60% of state medical licensing board efforts are devoted to confronting, rehabilitating or removing the licenses of impaired or incompetent doctors.  Most of these doctors are chemically dependent on alcohol and drugs.  But within the remaining 40% of state medical board efforts, ‘doctor-hunting’ goes on to control the practice of medicine.  The specific purpose is to force conformity in the practice of medicine as protection from financial competition from innovative doctors who dare to use alternative treatments that can frequently cancel the need for surgery and drugs.  The goal is restraint of trade in order to maintain a monopoly with the support of government.”  An example of this problem is, “an M.D. in North Carolina had his license revoked because he incorporated homeopathic medicine (a natural European method based on principle of ‘like cures like’) into his practice after a year of study in Greece with world-renowned Dr. George Vithoulkas, M.D.”   Homeopathy is practiced by N.D.’s and others trained in this field in the U.S. but is not allowed to be practiced by M.D.’s!  There was a medical doctor in Maine (2007) who was using homeopathy very successfully in his practice and the medical authorities wanted to see all his prescriptions given for drugs for his patients, he refused to give them, what happen I (Jim Tibbetts) don’t know.   

 “Currently there exists impressive statistical and clinical (case study) data on alternative approaches to reversing or controlling some cancers without the use of chemotherapy, radiation and surgery.  But covert politicking and overly rigid systems of testing and approval suppress these biological approaches that Americans are increasingly accessing.  Desperate cancer patients rarely learn about all their medical options; in fact, a full 80% of those who travel outside the U.S. for alternative cancer therapies are so terribly advanced in their diseases that it is too late, even for alternative approaches.”  
 
 Alternative therapies are primarily used by people with chronic conditions or degenerative diseases, which are about 80% of our industries society’s illnesses. 
Chelation therapy is an alternative therapy but is a threat to “pharmaceutical manufacturers of the newer cardiac drugs such as beta-blockers and calcium channel blockers; and those who perform surgical procedures such as coronary artery bypass graft and procedures performed during cardiac catheterization, such as balloon angioplasty.” 

   23.  The Health Fraud Committees Evolution 

 The AMA Committee on Quakery was established back in 1963.  It was established “to direct its attention to a study of the chiropractic problem.”  Because chiropractors were taking business away from physicians.  “Mr. H. Doyl Taylor was appointed Secretary of the Committee on Quackery.  In January, 1971, Taylor sent a memo to the AMA Board stating, ‘Your Committee has considered its prime mission to be first the containment of chiropractic and ultimately the elimination of chiropractic.” ... “The AMA campaign to smear chiropractic during the 1960’s and 1970’s is an example of a well-organized dirty tricks campaign.”   

 “The libel and slander campaign of dirty tricks against the chiropractic profession continued well into the 1980’s.  The AMA was aware that it was engaging in a conspiracy to restrict free trade, which is totally illegal.  The chiropractors obtained evidence of this conspiracy to restrict free trade, which is totally illegal.  The chiropractors obtained evidence of this conspiracy and sued the AMA.  The Federal Trade Commission agreed with the chiropractors and ruled that the AMA was in violation of monopoly laws, in their attempts to eliminate the chiropractic profession.
After a lengthy court battle, Wilk v. AMA, in 1987, Federal District Judge Susan Getzendanner ruled that the AMA had indeed led an effort to destroy the chiropractic profession by engaging in ‘systematic, long-term wrong-doing with the long-term intent to destroy a licensed profession.’  This was also the ruling in an anti-trust lawsuit
filed in 1976.”  

 “Shortly after the founding of the Committee on Quackery, another covert group was formed, also under the leadership of Mr. Taylor.  This group was called the Coordinating Conference on Health Information, created in 1964.  In contrast to the Committee on Quackery, this group operated in total secrecy.  The CCHI was made up of representatives of the AMA, the American Cancer Society, the American Pharmaceutical Association, the Arthritis Foundation, ...  The CCHI formally existed for ten years, all that time under the leadership of Mr. Taylor.  It seemingly disbanded in 1974, about the same time that the Committee of Quackery was also formally disbanded.  Evidence, however, gathered by investigator P.J. Lisa indicates that the conspirators simply went underground.  It is Lisa’s contention that the activities of the CCHI were turned over to the National and Regional Councils Against Health Fraud.”  

 “They sound as if they are consumer organizations or advocates of consumers such as Ralph Nader and others.  But when you analyze their make-up and how they came into existence, you soon realize that they don’t represent consumers as all.  They represent the interests of a select group of health-care providers – physicians in the private practice of medicine – and they represent the interests of pharmaceutical manufacturers.  In addition, they include representatives of federal agencies charged with regulatory responsibilities to protect the public.”   

 Even though these groups go through name changes and evolutions they are still primarily funded by the pharmaceutical industry and other self-interest medical groups.   Four of these types of groups include:
• The National Council Against Health Fraud (NCAHF)
• The American Council on Science and Health (ACSH)
• The Committee for the Scientific Investigation of Claims of
    the Paranormal (CSICOP)
• The Consumer Health Information Research Institute (CHIRI) 

 “The NCAHF has chapters in thirteen states and receives funds from pharmaceutical manufacturers.  The ACSH receives most of its funds from industry, e.g. Dow Chemical, the National Agricultural Chemicals Association, E.I. DuPont de Nemours and Co., Montsanto Co., and the Procter and Gamble Fund.  It has received grants from the National Dairy Council and the American Meat Institute, Burger King, Oscar Meyer Foods, Hershey Foods Fund, Frito-Lay and Land O’Lakes.  Not surprisingly, it questions all claims that pesticides and food additives are harmful, praises fast foods, and defends the use of hormones in cattle.”  

 Whereas the ACSH’s source of funds is known, as just cited, The NCAHF and the CHIRI’s funds are very difficult to track.   “The CSICOP organization is targeted against faith healers and other proponents of spiritual healing.  It also discredits extra-sensory perception and paranormal experiences.
 The CHIRI has for its constituency the health insurance industry.  It purports to serve that industry in an advisory capacity, by approving or disapproving a particular treatment provided by a health-care provider.  It plans to serve as a health-insurance consultant regarding the legitimacy of certain disabilities and health practitioners.  An example of an ‘illegal’ disability would be chronic fatigue syndrome.  CHIRI is also said to have a computerized list of more that 40,000 American physicians and other medical practitioners who are suspected of using ‘questionable medical practitioners who are suspected of using ‘questionable medical practices.’”    

 Organizations like the NCAHF will use their influence over the Federation of State Boards of Medical Examiners and their legal authority to issue, suspend, and revoke licensure in order to regulate and control medical practice and to discourage alternative medical therapies. 

 “The actual ‘hit-squads’ in the case of targeted physicians are orchestrated through the Federation of State Boards of Medical Examiners.  Wise Guy members from each of the state boards are contacted.  Then, a letter of complaint against the targeted physician is usually written by one of the members of the regional or national councils.  One member of the Oregon State Board was quoted as saying, ‘You’d be surprised how easy it is to get an alternative practitioner!’

 Next, insurance companies and Medicare are contacted, usually by officials of the FDA or the Health Care Financing Administration, or even higher up in Health and Human Services, at the request of members of the national or regional councils (NCAHF) and involved state board of medical examiners.  Insurance companies and Medicare are directed to deny claim from targeted doctor who is allegedly doing wrong by using experimental or unproven therapies.”   

 There are highly qualified, doctors and health professionals and Institutes in the U.S. that do treat with alternative medicine very successfully.  But they do so silently, don’t advertise or publish their successes which are worthy of Journal publications.  If they did go public they would be considered a Quack or a Health Fraud and a committee such as the ones just mentioned will come after them and report them to the State Boards and possibly even be taken to court and sued.     

  24.  Drug Preferences in Europe

 What about overseas, what is Europe doing? Back in the early 1990’s a survey was revealed by the European Board of Consumers Association.  Studies were done on the fifty most frequently prescribed drugs in Belgium, England, France, Germany and Italy. These countries had similar rates of disease; the same illnesses occurred at the same rates and the same patterns of mortality.  Yet the findings showed:
    “In England, the most prescribed drug is Ventolin, an anti-asthmatic produced by the British drug firm Glaxo.
    In Germany, the most prescribed drug is Erglukol, an oral anti-diabetic produced by the German company Boerhinger. 
    In France, the most prescribed drug is Tanacort, produced by a French company, for poor circulation.
    In Belgium, the most prescribed drug is Fibromycin, an antibiotic from the Flemish company Phizer.
    In Italy, the most prescribed drug is Tagamet for gastric and duodenal ulcers, and (you guessed it) is manufactured by an Italian drug company. 

 So even though the countries have the same disease patterns, they have drugs prescribed that don’t correspond to their disease rates.  There are no more asthmatics in England than in the other countries, so why is an anti-asthmatic most often prescribed?  The French had no more circulatory disease then other countries - why is a circulation drug number one in sales? … We should expect better ethics from those who market drugs for medical conditions then from those who sell, say, toothpaste.  The sad truth, however, is that selling is selling - in many cases it doesn’t seem to matter what the product it, even though the products manufactured by drug companies involve serious matters of life and death.”

 “Before the findings were released and acted upon, only 30% of the population used natural means of health care (acupuncture, homeopathy, nutrition, etc.).  Now [several years later] 50% are using one or more natural remedies.”     

    25. Drug-makers and the FDA

 Mahar Maggie’s, Money-Driven Medicine:  “In 2002 Alistair Wood, a respected clinical pharmacologist at Vanderbilt University, was close to being nominated by President George W. Bush to fill the long-vacant job of FDA commissioner.  But some industry executives, along with free-market enthusiasts that included members of the editorial board at The Wall Street Journal, objected.  When Senator Bill Frist was asked why Wood was dropped from consideration for the top post at the FDA, he summed up the opposition: “There was a great deal of concern that he put too much emphasis on safety.’”   

 “Over the past decade, the FDA’s critics claim that the agency has abdicated its role as the public’s protector.  The agency’s priorities started to shift, they suggest, in 1992 – when the supposedly independent watchdog agency began to depend on the very companies that it regulates for a major chunk of its funding.  That was the year the pharmaceutical industry finally succeeded in persuading Congress to pass the Prescription Drug User Fee Act (PDUFA) – a law that aimed to speed up the drug approval process by letting manufacturers fund drug approvals.... But rather than serving as ‘additional’ funding, the manufacturers’ contributions would become essential – and begin to dictate how the FDA spends its money.  

 “In the process the FDA has met or exceeded nearly all of the PDUFA goals.  By 2003 drug approval time had been cut in half.  But insiders say that the FDA’s independence has been compromised.  

 Dr. Jerry Avorn reprises a conversation between a senior FDA official and an agency scientist whose concerns about the safety of a particular drug had ‘attracted the ire of its manufacturer’: 
 ‘You need,’ the scientist’s boss told him, ‘to understand that the pharmaceutical industry is our client.’
 ‘That’s odd,’ the scientist responded.  ‘I always thought our clients were the people of the United States.’ 

 Even observers like Dr. Eve Slater, former senior vice president of Merck Research Laboratories, and a former assistant secretary for health at the Department of Health and Human Services in the Bush administration until her resignation in 2003, warns that ‘the FDA must evolve beyond satisfying the appetite of industry for faster approval.’  In a 2005 article published in The New England Journal of Medicine, Slater wrote: ‘We must envision the FDA as more than a counterpart to the pharmaceutical industry.  It is time for the agency to realize its full potential as protector and promoter of the public health.’”    

 “Some say that if the FDA is going to recover its independence, it will need more money from Congress.  Not everyone agrees.  Avorn argues that what the agency needs more than money is a backbone.  When doubts emerge about a medicine’s safety, the agency needs to insist that drug makers pay for independent tests, says Avorn.  If companies balk, the agency ‘needs to call a press conference and issue a public notice saying, ‘There are unresolved issues and we are trying to get the company to do a clinical trial and doctors should take that into account,’ says Avorn.  ‘The FDA has moral and extraordinary public relations power if they chose to
use it.’    

 Inside the FDA, old hands agree.  Morale is low.  The biggest problem, longtime employees say, is the lack of follow up on products like the Guidant defibrillator after they have been approved.  Particularly when products are sped to market, their flaws may not become apparent until tens of thousands of patients have begun using them.”   

      26.  Drugs and the Economy

 In round numbers the American medical system spends about $200 billion a year on drugs.  Jerry Avron, MD in Powerful Medicines notes: “Nowhere are the market’s shortcomings clearer than were costs are spiraling the most – prescription drugs.  In 1980, drug expenditures totaled $12 billion, according to the Centers for Disease Control and Prevention (CDC).  By 2002, that figure had climbed to 1,250 percent to $162 billion.  That was eight times more than the increase in spending on national defense; nine times more than the growth in outlays for veteran services and benefits.  In 1980, spending on drugs accounted for a scant 4.9 percent of total health care outlays.  By 2002, it had doubled to 10.4 percent.  It now is on its way to 15 percent.  Only part of the increase is inflation.  The rest is because pharmaceutical companies are selling more drugs to more people for longer periods of time, another indicator of a dysfunctional model.”  “Whatever their purpose, prescription drugs in the United States cost from 30 to 60 percent more than the exact same medications sold anywhere else in the industrialized world.”     

 In Maggie Mahar’s book, Money-Driven Medicine, some good facts on the economy and pharmaceutical drugs is revealed:  “As cost balloon, more and more of the nation’s resources are devoted to medical care.  In 1970 health care spending represented just 7.1 percent of gross domestic product.  By 2005, the nation’s health care bill equaled more than 16 percent of everything the economy produced.  And in 2020, Pricewaterhouse Coopers Health Research Institute projects health care spending will gobble up 21 percent of the pie.  ‘If medical costs continue to outstrip economic growth, eventually there will be no money left for anything else – education, defense, housing, the arts.  We’ll all just be operating on each other,’ one Wall Street observer notes wryly. ‘Health care will swallow GDP.’”

 “Since 2000 the cost of health insurance has spiraled by 73 percent.  Over the same span, the number of uninsured Americans climbed by more than 6 million.   As of 2005 nearly 48 million Americans were ‘going naked,’ in insurance industry parlance – and not all were poor.  Roughly one in three uninsured households earned more than $50,000 a year.  Even for the relatively affluent, health insurance is fast becoming a luxury.  In 2005 the average annual premium for a family policy stood at an astounding $10,880 – close to one-quarter of median annual income before taxes.  In 2005 nearly two-thirds of all families struggling to pay medical bills had insurance, according to a survey conducted by USA Today, the Kaiser Family Foundation, and the Harvard School of Public Health.”   

 In a discussion on why healthcare spending is higher Maggie Mahar sums up the problem stating: “Put simply, over the past 25 years, power in our health care system has shifted from the physician to the corporation. A professional, the physician pledged to put his patients’ interests ahead of his own financial interests.  The corporation, by contrast, is legally bound to put its shareholders’ interests first.  Thus, many decisions about how to allocate health care dollars have become marketing decisions.  Drug-makers, device makers, and insurers decide which products to develop based not on what  patients need, but on what their marketers tell them will sell – and produce the highest profit.  ‘There is a saying in the drug industry,’ one Wall Street analyst notes. ‘A pill you take once is good; a pill you take every day is better.’”  

 “As medicine becomes more corporate, it is, quite naturally, driven by the quest for profits.  A corporation’s first responsibility is to its shareholders.  And corporate planners know that, with some luck, more sales will lead to higher earnings.  But more health-care more devices, more drugs, more procedures – does not necessarily lead to greater health.  Quite the opposite, as some of the latest research confirms. 

 Comparing Medicare patients in regions of the country where Medicare spending is highest to patients in areas where spending is lower, a study published in Annuals of Internal Medicine in 2003 found that more visits to the doctor, more tests, more attention from specialists, and more hospitalization did not result in lower mortality rates or improved health.  In fact, in some cases, more care seemed to produce higher death rates.  ‘Our finding suggests that up to about a third of medical care is devoted to services that do not provide any detectable benefit,’  Dr. Elliott S. Fisher, the Dartmouth Medical School researcher who lead the study, concluded.”       

 “In fact, ‘more care may even lead to worse outcomes,’ says Dr. Elliott Fisher, the lead author of the study.  When he and his colleagues tracked mortality rates for Medicare patients who had fractured a hip, suffered a heart attack, or been hospitalized with colorectal cancer, they discovered that ‘among older patients who were treated for a heart attack or colorectal cancer, there actually was a small but statistically significant increase in the risk of death as intensity [of care] increased.’  In other words, more care is not simply wasteful; it could be hazardous to your health.”     

 “Up to one-third of our health care dollars are squandered on ineffective, sometimes unwanted, and often unproven procedures, says Dr. Jack Wennberg, director of the Center for the Evaluative Clinical Sciences at Dartmouth Medical School.  That’s right – more than $65 billion lost to over treatment.  And much of that waste can be traced to a hospital culture where technology and training support a reimbursement system that favors intervention over what some call ‘thinking medicine’ – i.e., talking to and listening to the patient.  

 A controversial and courageous figure, Wennberg has spent the last 30 years investigating how medical practice varies in different parts of the country.  And what he has discovered, to the chagrin of many in his profession, is that in some parts of the country, patients receive far more aggressive care than their counterparts in other states – and yet, in the end, those who enjoy the most intensive care fare no better than those who receive less lavish care. 

 Lick UCLA economist Thomas Rice, Wennberg believes that waste is, to a large degree, a supply-side problem.  It is not a matter of consumers in certain regions demanding more care, but of hospitals and specialists in some areas recommending more care.  In other words ‘standard practice’ is far from standard nationwide.  How much care two equally sick patients receive when being treated for the very same disease seems to depend, to an astounding and irrational degree, on where they happen to live.” 

 “The medical marketplace is in the business of selling dreams,”  Daniel Callahan, cofounder of The Hastings Center, an independent research institute that focuses on bioethics, observed in 1998.  “The union of technological medicine and the market has intensified the belief that... when all seems lost, medicine can rescue us.” 

 “Dr. Donald Berwick, cofounder of the Institute of Healthcare Improvement, goes a step further, calling the Dartmouth research ‘the most important work that’s been done in this area.  There’s a big agenda here,’ he declares.  ‘To help create a public awareness that ‘more is not necessarily better.’  Frequently it’s worse.  I have said it before and I’ll stand behind it,’ he proclaimed in January of 2005: ‘The waste level in American medicine approaches 50%.’”   

 Make no mistake: Berwick is outbidding the Dartmouth suggestion that one in three health care dollars is wasted.  He is saying that fully half of over $2 trillion that we spend on health care does nothing to relieve pain.  To the contrary, says Berwick: ‘Much of it adds to suffering.’   Berwick’s opinion matters.  In 2005 Modern Healthcare, a leading industry publication, named him the third most powerful person in American health care.  A clinical professor of pediatrics and health care policy at the Harvard School of Public Health, Berwick runs the Institute for Healthcare Improvement (IHI), a nonprofit organization that spearheads pilot projects aimed at providing more effective care.  ‘Berwick is not powerful because of the position he holds,’ notes Boston surgeon Atul Gawande, former secretary of Health and Human Services, ‘Berwick is powerful because of how he thinks.’”  

 “The amount of money at stake is staggering.  In 2006 drugmakers and device makers will take in well over $300 billion – or roughly 15% of the nation’s health care dollars.  The prescription drug industry tends to downplay the cost of its products, pointing to government reports which suggest that drugs account for roughly 11 percent of health care spending.  But in fact, that figure represents only those drugs sold directly to consumers at pharmacies and other outlets.  

What are we paying for?
• Private insurer’ profits and administrative costs 4.5%
• Government programs administrative costs 2.2%
• Nursing home care 7%
• Prescription drugs sold directly to patients 11%
• (Prescription drugs sold to healthcare total 15%) 
• Physicians and other clinical services 22% 
• Other spending (dentists, home health services,
over-the-counter medicines ) 22%
• Hospital care 31% 
Total health care spending in 2003: $1.7 trillion dollars. 

 Hospitals, doctors, nursing homes, and other health care facilities also buy drugs, and when those purchases are included, spending on prescription drugs alone could hit $270 billion to $280 billion in 2006.  Add on the $36 billion that hospitals and other health providers will lay out for devices such as spinal discs, stents, and artificial hips, and the total tab for prescription drugs and devices approaches $310 billion to $320 billion. 

 And in recent years spending on drugs and devices has become the fastest-growing component of health care costs, with outlays for drugs alone doubling between 1995 and 2003, thanks to a combination of higher prices (driving 58 percent of the rise), plus greater demand.   Over that span, prescription drug prices jumped by an average of 7.4 percent a year – almost three times the inflation rate of 2.5 percent.   In 2004 spending on prescription drugs rose another 7.2 percent, with pharmaceuticals accounting for nearly one-quarter of the total increase in the nation’s health care bill.   Meanwhile, Americans popped more pills: from 1993 to 2003 the number of prescriptions purchased climbed by 70 percent while the U.S. population grew by only 13 percent.”   
 

    27.  The Federal Advisory Committees 

 In the book, Science in the Private Interest, has the Lure of Profits Corrupted Biomedical Research? by Seldon Krimsky (2004)   gives an excellent overview of some of the major problems with the Federal Advisory Committees. 

 “Hundreds of advisory panels exist throughout government, some short-term, some long-term.  The idea behind the system of advisory committees is sound.  Government scientists and bureaucrats cannot possibly assemble the expert knowledge necessary to address the diversity of technical problems under the government’s responsibility.  The use of advisory committees not only taps the best available knowledge but also brings diversity into the federal decision-making process.  Moreover, as one government report noted, ‘Advisory committees continue to represent part of federal efforts to increase public participation.’”  

 In fiscal year 1998 (between October 1997-1998), fifty-five federal departments and agencies sponsored 939 advisory committees.  Of those, fifty advisory committees, including twenty-one established by the Congress, directly advised the President.  A total of 41,259 individuals served as committee members, among whom one-third (14,860) were appointed by the Department of Health and Human Services.  In sum, 5,852 meetings were held, and 973 reports were issued.  During the fiscal year, $180.6 million was expended to fund the costs of the advisory committees, including compensation to committee members, travel reimbursement, per diem expenses, staff support, administrative overhead, and consulting fees.   In the year 2000, the FDA had thirty-two standing advisory committees while the NIH maintained over 140 advisory committees.  

 The primary federal legislation governing advisory committees, task forces, and councils – established by either the president, the federal agencies, or Congress – is the Federal Advisory Committee Act (FACA), signed into law in 1972.  Under FACA, membership on committees must be fairly balanced in terms of points of view and functions of the committee.  The statute explicitly forbids FACA committees to be inappropriately influenced by special interests and that provisions be in place ‘to assure that the advice and recommendations of the advisory committee will not be inappropriately influenced by the appointing authority or by any special interest, but will instead be the result of the advisory committee’s independent judgment.’”    

 “In the fall of 2000, USA Today investigative reports studied eighteen expert advisory committees established by the FDA’s Center for Drug Evaluation and Research, which met between January 1, 1998, and June 30, 2000.  These committees typically make recommendations to the agency on whether new drugs should be approved and, if so, on what conditions accompany such approval.  The journalists were able to get information on the number of committee members with financial interests and the number of waivers issued to committee members.  Prior to 1992, the FDA made public the details of advisory members’ financial conflicts of interests.  After a series of controversies, including one involving Prozac, the FDA stopped disclosing the particulars of committee members’ conflicts of interest for the reputed purpose of protecting their privacy.  But they are still required to disclose when a committee member has a conflict of interest in the subject of a meeting.  USA Today founded that there were 159 FDA advisory committee meetings held during the eighteen-month period they studied.  Approximately 250 committee members appeared 1,620 times during the 159 meetings. 

 USA Today reported that ‘more than half of the experts hired to advise the government on the safety and effectiveness of medicine have financial relationships with the pharmaceutical companies that will be helped or hurt by their decisions.’    It noted that 54 percent of the time advisers to the FDA have ‘a direct financial interest in the drug or topic they are asked to evaluate.’   Most of the financial conflicts involved stock ownership, consulting fees, and research grants. 

 How is it that so many members of the eighteen FDA advisory committees who held conflicts of interests were permitted to participate and vote on committee matters?  The law states that an advisory committee member has a conflict of interest when an action taken by the committee could have the ‘direct and predictable effect’ of causing the member to have a financial gain or loss.  The FDA officials issued waivers when they believe the expert’s potential contribution to the committee outweighs the seriousness of the conflict.  Of the 1,620 member appearances, 803 (50 percent) had waivers for COIs, 71 (4.4 percent) had disclosures of financial interests not resulting in waivers, and the remaining 746 (46 percent) constituted member appearances who had no COIs.  Did over 800 committee members with conflicts of interests justify waivers?  Is the FDA issuing so many waivers because the reservoir of independent experts is declining so rapidly that there are fewer experts left without ties to the industry that the FDA regulates? 

 Whatever the reason for all the waivers, they hardly foster public confidence in the system through which government receives expert advice.  Some argue that the very least our government agencies owe to the public is to make the advisory system totally transparent with respect to conflicts of interest.  It is generally through litigation and congressional investigation, however, that the conflicts among members of advisory committees are exposed, usually after decisions are made.”   

 “Wyeth Lederle Vaccines and Pediatrics, a subsidiary of American Home Products, was the first pharmaceutical company to receive FDA approval for a rotavirus vaccine.  The company filed its ‘investigational new drug application’ in August 1987 for ‘Rotashield’ vaccine, and it received approval in August 1998.  Within about a year after the vaccine had been licensed, it was removed from the market after more than one hundred cases of severe bowel obstruction were reported in children who had received the vaccine.”  

 “In August 1999, the U.S. House of Representatives Committee on Government Reform began an investigation into federal vaccine policy, which focused on the conflicts of interest of policy makers in this specific case.  The committee reviewed financial disclosure forms, scrutinized minutes of meetings, and interviewed advisory committee members.  The majority staff report was released in August 2000.      

 The committee investigation revealed that the conflict-of-interest rules employed by two agencies of government responsible for vaccine policy making , the FDA, and the Centers for Disease Control (CDC), ‘have been weak, enforcement has been lax, and committee members with substantial ties to pharmaceutical companies have been given waivers to participate in committee proceedings.’   In a letter to DHHS Secretary Donna Shalala, House committee chair Dan Burton said: ‘It has become clear over the course of this investigation that the VRBPAC [the FDA’s Vaccine and Related Biological Products Advisory Committee] and the ACIP [the CDC’s Advisory Committee on Immunization Practices]  are dominated by individuals with the close working relationships with the vaccine producers.’    

 The Committee on Government Reform found that three out of the five fulltime FDA advisory committee members who voted for the vaccine had financial ties to either Wyeth Lederle or two other companies developing competitive rotavirus vaccines.  Out of the eight CDC advisory committee members who supported the vaccine, four had financial interests with the same companies.  The committee studied the conflicts of interests among VRBPAC members at a critical meeting when the rotavirus vaccine was voted favorably.  The committee  reported that ‘the overwhelming majority of members, both voting members and consultants, have substantial ties to the pharmaceutical industry.’”  

 “The findings of the House committee showed that conflicts of interest are deeply embedded in the vaccine program at FDA and CDC.  The report stated: ‘The FDA standards defining conflicts of interest are ridiculously broad.  For example, a committee member who owns $25,000 in stock in an affected company is deemed to have a low involvement interest, which is usually automatically waived.  In fact, a member could own up to $100,000 in stock in an affected company, a ‘medium involvement’ by FDA standards, and that conflict would generally be waived.’   As a matter of record, a committee member who received $250,000 a year from the maker of a rotavirus vaccine was granted a waiver and actually voted in the VRBPAC deliberations.  The House committee concluded that the CDC has virtually no conflict-of-interest standards because it automatically waives all ACIP members.    

 In 1992, the National Academy of Science’s Institute of Medicine recommended that the FDA initiate some changes in its use of expert advisory committees to avoid potential conflicts of interests.  Eight years later, the FDA continues to be cited for the egregious conflicts of interests its scientific advisers have with the products they are called upon to evaluate.”   

 “On December 7, 2003, the Lost Angeles Times published the results of its investigative study, which disclosed that top scientists in the National Institutes of Health received substantial honoraria and stock options from biomedical firms that, in some cases, doubled their government salaries.  Federal employees struck lucrative deals with private companies who had a lot to gain from the liaisons with the scientists evaluating the company’s products.  All this was occurring beneath the public radar screen.  The Time’s editorial said: ‘the NIH has become an arm of commerce, a place where objective science is being trampled in a stampede for market share.’  Eventually, congressional hearings embarrassed the Department of Health and Human Services to restrict but not prohibit the amount of money its senior officials can earn consulting for pharmaceutical and biotechnology companies.    

 A second scandal illustrates the effects of the privatization and suppression of scientific data.  Reported in the Canadian Medical Association Journal in March 2004 and in The Lancet in April 2004, a major pharmaceutical company allegedly withheld from the medical community clinical trial findings, which indicated that a widely used antidepressant had no beneficial effect in treating adolescents.  According to The Lancet, ‘the Canadian Medical Association Journal revealed excerpts from an internal GlaxoSmithKline memorandum demonstrating how the company sought to manipulate the results of published research.’     

 The antidepressant was banned in some countries because it was believed to increase suicide among treated adolescents.  When British scientists examined the published data on the antidepressant Paxil, it looked like an effective and relatively safe drug for use with adolescents.  However, when they added the unpublished data to the published data little evidence remained to support the drug’s efficacy, while the risks of suicidal ideation remained.  Based on the data, The Lancet study concluded that the drug should not have been used to treat adolescents.” 

 The problem with conflicts-of-interest goes beyond the U.S. and is found in countries overseas too.  “The ideal of university-industry partnerships had been exported to European countries and Asia, which are beginning to face similar problems of trust within their scientific institutions.  For example, at Swedish universities, which are state owned, private corporations are financing an increasing proportion of the professorships.  At the prestigious Karolinska Institute, where an estimated one-third of the professorships are financed by private companies, the pharmaceutical giant Astra-Zeneca has exclusive property rights to all results of one professor’s research in neurology, including results from research that is partially financed by the Swedish National Medical Research Council.  That professor is salaried by the company.   

 A Polish medical scientist summarized the state of affairs as follows: ‘Privatization and commercialization are threatening the objectivity of clinical research and the availability of health care because uncontrolled market mechanisms focused on profit are nurturing conflict of interest that generate bias and unreliability into research and medicine.’   An Italian editor of an international medical journal wrote: ‘Members of corporate driven special interest groups, in virtue of their financial power and close ties with other members of the group, often get leading roles in editing medical journals and in advising non-profit research organizations.  They act as reviewers and consultants with the task of systematically preventing dissemination of data which may be in conflict with their special interests.”     

    28.  Influencing NIH and FDA Decisions

 The questions need to be asked; How can the FDA or the NIH be influenced by or better said, controlled by pharmaceutical companies?  How can so many deaths and injuries from a drug occur and the FDA still allows it to continue?  How can committees appointed by the FDA approve a drug as safe when it is not?  The following account of Rezulin, a fast track drug, helps to give insight to these and other related questions.  Even though this happened back in the 1990’s these financial conflicts of interest still happen today.  After all the drug companies provide a large amount of the FDA’s salaries and many of the expert witnesses and oftentimes committee members are paid by the pharmaceutical companies, and these drug companies can even recommend that individuals who object to a drug, be taken off a committee!    

 Jerome P. Kassirer, M.D. in his book: On the Take, how Medicine’s Complicity with Big Business can Endanger your Health, gives an good insight into numerous topics on this issue.  People often wonder what goes on behind the scenes in the FDA and this example will give some insight of how drugs get approved, even those that should not get approval, that get approved.  Many pharmaceutical drugs have similar histories and similar problems behind the doors of the FDA. 

“Finding a treatment for diabetes is a worthy endeavor.  Rezulin, a drug with effects on sugar metabolism different from the available drugs in the mid-1990’s, seemed to be a promising addition to the medications then in use.  Unfortunately, after only a little more than three years on the market, it had been linked to 63 deaths from liver failure; hundreds more treated with the drug developed liver dysfunction.  By the time it was withdrawn from the market, however, Warner-Lambert (now a division of Pfizer) had sales of several billion dollars.   Financial conflict of interest was only one of the many factors that account for the misfortunes of the patients who were injured by the drug: pressure by Congress to speed up approval of new drugs, excessive kowtowing to industry by government officials, poor judgments by other officials in allowing conflicted scientists to participate in decision making, and aggressive attempts by the company to paper over the gravity of drug complications and to preserve sales all contributed.  Nonetheless, financial arrangements between physicians and industry were important components.” 

 “Rezulin was one of the drugs selected for the National Diabetes Prevention Study by the National Institutes of Health.  Participants who were otherwise healthy received the drug in the hope that its action would prevent the development of the adult type of diabetes. ...As the study progressed, tests of liver functions began to show nearly four times more liver injury in people who were taking Rezulin in the NIH study than those who were taking placebos.  Warner-Lambert believed that the abnormalities would disappear once the drug was discontinued and that close monitoring by repeated testing would provide the signal to hold off giving it.  This assumption later was found to be fatally incorrect.      

 In parallel with the NIH study, the FDA was considering approving Rezulin for use by the nation’s diabetics, and with the pressure from Congress to move new drugs through the approval process rapidly (and presumably to be more friendly to the pharmaceutical industry), the drug was approved after a shorter-than-usual review.  Notably, it was approved over the strong objections of Dr. John Gueriguian, a veteran FDA medical officer, who had reviewed Rezulin’s safety and effectiveness.  Gueriguian was removed from the Rezulin review at Warner-Lambert’s request before the FDA Advisory Committee’s vote in December 1996 that, in turn, led to FDA approval in January 1997. 

 Shortly after Rezulin was approved for use by the nation’s diabetics, it achieved wide use (by December 1998, sales were nearly $1 billion).  Liver injury cases continued to mount, and in December 1997 the FDA’s counterpart in Britain, the British Medicines Control Agency, removed the drug from the market there.  When Audrey LaRue Jones, a healthy schoolteacher who had enrolled in the NIH study, died of liver failure in May 1998 despite close monitoring of her liver function, Rezulin was withdrawn from the NIH’s National Diabetes Prevention Study.  But it was not taken off the market immediately for diabetics.  The FDA only required that Warner-Lambert warn doctors to test liver function more frequently.  Between May 1998 when Ms. Jones died and March 1999, more deaths occurred from liver failure.  In fact, up until December 1998, the FDA had reports of 33 deaths attributed to Rezulin.  

 In January 1999, after the newly appointed FDA Commissioner Jane Henney took office, she called fro reevaluation of Rezulin, and in March the Advisory Committee met again to consider what to do with the drug.  The FDA, like other federal agencies, has well-defined conflict-of-interest regulations, but it can grant a waiver to “Special Government Employees” who have commercial ties that might influence them to serve on its committees under certain circumstances.  In this case, nine of the ten physicians who reported on the safety and effectiveness of Rezulin at the March 26, 1999, meeting were paid Warner-Lambert consultants.   The committee voted 11 to 1 to keep the drug on the market.   Presumably, they must have thought that a small risk of serious complications was worth taking, given that the drug was effective for so many diabetics.  Whether their connection to Warner-Lambert contributed to their opinion is not known. 

 One year later Rezulin was finally removed from the market.  By then 63 deaths from liver failure had been attributed to the drug.  As of March 2003, nearly 9,000 suits had been filed by Rezulin users in various federal and state courts against Pfizer.” 

    29.  Gifts Influencing Drug Decisions

 Dr. Kassirer in his book: On the Take, writes: “Discussions of financial conflicts of interest induce lively debates and often generate heated emotions.  Conflict of interest is a ‘loaded concept,’ one with a moral dimension.”    “When I was editor of the New England Journal of Medicine, I published an opinion piece by Dr. Douglas Waud, a University of Massachusetts professor of pharmacology entitled, ‘Pharmaceutical promotions ... a free lunch?’    Waud asked: ‘So where does one draw the line?  I suggest that we simply not be on the take, whatever the amount or context. ... I do not like the idea of a monetary limit on bribes (unless it is zero).  Nor do I see the subsidization of education as appropriate.  I believe that physicians can buy books and attend meetings without fear of landing in the poorhouse.  I also don’t buy the argument that asks, Would you be willing to have these arrangements generally known?  My motivation comes from within, not from a fear that the Boston Globe may be looking over my shoulder.’

 A huge response to his criticism followed.  Some of the responses were along the lines of the following: ‘Do not...insult my intelligence or my integrity by claiming that I can be bribed into inappropriate professional behavior because of a free lunch.  

 In a letter to the editor of the Boston Globe in 2002, neurologist Paul Rizzoli:  ‘To me as a medical specialist, medications are tools.  New medicines are new tools; who better to hear from than the marker?  I do not necessarily believe every claim by the new-car salesman, and I am certainly not brainwashed by the new-drug salesman.  If the salesman values my time with some [gift] consideration, I don’t see a problem. ... Does the public really think that physicians are so stupid as to be brought by a dinner, prescribed based on our stomachs or wallets, or controlled by a sales pitch?  Does it make sense that we would put into jeopardy our licenses, years of postgraduate education, residency, and specialty training, and years of patient care and established relationships, all for a dinner or a consultant fee?”   

 Jerome Kassierer, M.D. gives numerous examples of responses of physicians to this problem then writes: “Contrary to the introspective opinions of most physicians, but consistent with common sense, studies show that physicians are influenced by gifts and pharmaceutical promotions.  The prescribing practices of physicians have been examined in a few studies in relation to some kind of exposure to a drug-company promotion.  In one, 40 physicians who requested additions to their hospital’s drug formularies (drugs carried and approved by their hospital) were compared to 80 who had not requested any new drugs.  Statistically, doctors who requested the additions were 9 to 21 times more likely than those who did not to have eaten free meals from the companies, to have accepted drug-company money to attend or speak at a company sponsored symposium, and to have accepted research support form the drug companies.   An independent review (in the same study) indicated that the newly requested drugs had little or no advantage over drugs already available.  Another study of the prescribing practices of ten physicians who had attended company-supported symposia in resort locations showed a two- to threefold increase in the physicians’ use of the drugs in the months after their trips.    Interestingly, a majority of physicians attending the symposia claimed that they would not be influenced by the enticements.  Other studies confirmed the strong influence of drug representative interactions and gifts on the requesting of additions to hospital drug formularies.  The drug companies certainly are convinced of the existence of these powerful influences.”    

 Dr. Stephen Goldfinger, former head of the continuing education department at Harvard Medical School and an early champion of avoiding pharmaceutical largesse, once described reciprocity colorfully.  Though his analogy is a bit dated, it captures the context.  He wrote, ‘Indeed, isn’t it a bit sleazy to take the corsage without at least yielding its sender a place on one’s dance card?’”  

 “Although many physicians deny that they can be influenced by gifts, meals and the efforts of drug salesman, the fact that drug companies spend to much money on marketing in silent testimony to the effectiveness of these enormous expenditures.  The industry employs large numbers of intelligent people who make their livelihood from marketing.  By contrast, physicians spend little time contemplating these issues.  In fact, pharmaceutical companies spend more than 21 billion dollars a year on promoting and marketing their products, of which about 88 percent is directed at physicians (the reminder is spent for ‘direct-to-consumer advertising).   With approximately 600,000 physicians in active practice this amounts to more than $30,000 spent on each physician.  Although industry market research data are unavailable, studies of physicians show what common sense predicts, namely that physicians are influenced by all kinds of marketing tactics.”      

   30.  Professional Organizations on the Take 

 Jerome P. Kassirer, M.D. in On the Take, writes: “Hundreds of professional organizations represent physicians in every conceivable specialty, subspecialty, and sub-subspecialty.  Many, such as the American Medical Association, the American Heart Association (AHA) have largely devoted their energies to educational programs, the health of the public, lobbying efforts on behalf of their programs and their members, and support of medical research. 

 Professional societies, often in jeopardy of losing members as dues rise, or intent on continuing to grow their programs, are susceptible to offers of ‘unrestricted grants.’  Many who accept unrestricted grants try hard to ‘keep on message,’ namely to produce an unbiased material as they can.  Some succeed.  Some do not.  It is easy to see why they do not, when you examine the amounts of financial support and the breadth of it.  A few examples from the Center for Science in the Public Interest:  

 In 2002 the American College of Cardiology gave Pfizer their Diamond Heart Award for a donation of $750,000, AstraZeneca and Merck received the Platinum Heart Award for more than $500,000, and Aventis, Bristol-Myers Squibb, GlaxoSmithKline, and Proctor & Gamble Pharmaceuticals got the Gold Heart Award for more than $250,000.  Six more drug and device companies received the Silver Heart Award for donations greater than $100,000.  Half of the remaining 28 donors who gave more than $10,000 were drug or device companies.  Twenty-four of 26 of the American Academy of Family Physicians’ top ‘corporate partners’ are pharmaceutical companies.  Top givers ($40,000 or more) are AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Purdue Pharma, and Schering.  The American Academy of Neurology lists 75 ‘corporate donors.’  Many are drug companies.  Nearly all of 30 corporate sponsors of the American Society of Clinical Oncology (only a partial list) are pharmaceutical or biotechnology companies.  The American Academy of Orthopaedic Surgeons’ Corporate advisory Council is open to any orthopaedic-related company that pays yearly dues of at least $1,000.  In 2003, 41 companies were members.   Needless to say, this list is incomplete.  Similar readily available public records of most professional organizations do not exist.

 We must consider the consequences of these ever-increasing financial entanglements between our medical associations and industry.  Are medical organizations’ objectivity in scientific and medical matters threatened by these collaborations?  How much of their oft-stated goals to serve the public first are empty rhetoric?”    

 Dr. Kassierer, gives numerous examples of societies, here cited is only one of the societies concerning the Psychiatrists.  “Psychiatrists are latecomers to the drug-company money trough but they are making up for lost tie.  Scattered through the book are examples of psychiatrists’ strong ties.  Until 1987, when Prozac was introduced, the drug industry had little interest in collaborating with psychiatrists; the practice of psychiatry was dominated by psychotherapy – talking and analyzing – not pharmacotherapy.  The transformation of psychiatry since the introduction of a new class of drugs, selective serotonin reuptake inhibitors (SSRIs), that benefit many patients with anxiety, depression, and schizophrenia, has been profound.  (The SSRIs include widely prescribed drugs such as Paxil, Lexapro, Zoloft, Celexa, and Effexor.)  In combination with the introduction of these drugs and restrictions by insurers of treatment sessions for psychiatric illnesses, many psychiatrists have left talking sessions behind and become psychopharmacologists, experts in the use of the new psychotropic drugs.     

 The pharmaceutical industry has fostered this transformation by engaging key academic psychiatrists and community opinion leaders as consultants, sponsoring clinical practice guideline committees,   and paying for all kinds of educational venues for psychiatrists.  In some academic psychiatry departments, virtually all the educational meetings and meals are paid for by one company or another.  Dr. Marshall Folstein, former chair of the Department of Psychiatry at Tufts University School of Medicine, told me that drug testing has become widespread in medical centers and was ‘destroying academic psychiatry departments.’   In one of the most striking examples of individual psychiatrists’ involvement with industry, Dr. Folstein described an experience with one psychiatrist who offered to join his department at no cost to the department if Dr. Folstein would put no Constraints on his personal financial involvements with industry.  Folstein refused.  He indicated that some psychiatrists were supplementing their salaries by $300,000 to $400,000 per year through their industry connections. 

 Dr. Carol Nadelson, the former editor of the American Psychiatric Press, Inc. (APPI) and former president of the American Psychiatric Association (APA), said that, as with many other medical professional societies, the annual meeting of the APA is heavily subsidized by industry, as is the APPI.   She noted that many of the drug-company-sponsored symposia at the annual meeting of the APA are better attended than the scientific presentations.  She indicated that she is deeply worried not only about the influence of industry in psychiatry, but by the evolving focus on money making in the APA. 

 One of the latest flaps in psychiatry circles that has spilled into the public press deals with safety of the SSRIs.  Occasional suicides and violent behavior in children have led to calls by some to follow the lead of the British equivalent of our FDA in banning all SSRIs for children except Prozac, and early in February 2004 the FDA was scheduled to hold hearings on the issue.  Days before the hearing, a group of researchers from the American College of Neuropsychopharmacology, headed by two prominent academic psychiatrists, released a preliminary analysis of their Task Force on SSRIs and Suicidal Behavior in Youth.  It concluded that antidepressants did not increase the suicide risk in children, and that the benefits of SSRIs outweighed the risks.   Their report was immediately criticized because nine of the ten panel members allegedly had ‘extensive ties to the pharmaceutical industry.’   Some critics labeled their report ‘junk science’; others were less restrained.   At the hearing, FDA regulators testified that their analysis did suggest that in clinical trails the risk of suicide in children was increased over those taking placebos with some of the SSRIs.  So far, the FDA has decided only to require a warning about possible suicide tendencies in descriptions of these drugs.” 

 Not only are individual medical organizations benefiting from the Pharmaceutical companies but also the major umbrella organizations like the AMA.  Even though the AMA and other organizations will deny any conflict-of-interests with the pharmaceutical companies these involvements do strongly influence their decisions and medical philosophy and moral medical developments.  The AMA has strongly adopted the allopathic model and the pharmaceutical model as not just the standard but the only model that should be allowed to be used.  This has also been shown in previous sections.

 “The grandfather of professional organizations, the 157-year-old American Medical Association, is ‘dedicated to be an essential part of the professional life of every physician’ and to be ‘an essential force for progress in improving the nation’s health.’  It has tried to set high standards of ethical conduct while attending to its members’ interests, but the organization has not always been successful at doing both.  During the twentieth century, the AMA was a force for good in advancing medical education, public health, and high quality of medical care.  But the organization, like many others, has struggled to define its mission.  Should it act like a guild, which primarily services its members’ well-being (especially financial well-being), or should it aspire to higher ideals, which in turn might narrow these financial prospects?  On the one hand, if an organization such as the AMA behaves as a guild, it loses respect as a professional organization.  On the other hand, holding to the highest moral and ethical virtues and values may threaten its members’ income and they may object and resign.  Though at one time approximately 70 percent of American physicians were members, now less than 40 percent are full dues-paying members.”  








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