Former NEJM Editors Call for Congressional Investigation of Pharmaceutical Industry




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Drug Companies and Doctors: A Story of Corruption

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Rich Murray: CIRCARE: Angell & Relman: Wash. Post: pharmaceutical
corruption 6.20.1 rmforall

Subject:  Former NEJM Journal editors call for congressional investigation of pharmaceutical  industry_WashPost
   Date:   Wed, 20 Jun 2001 13:11:09 -0400
   From:   "CIRCARE" <>
     To:     "President George W. Bush" <>,
             "Vice Pres Dick Cheney" <>

CIRCARE: Citizens for Responsible Care & Research
A Human Rights Organization
Tel: 212-595-8974  FAX: 212-595-9086 <>
Vera Hassner Sharav   142 West End Ave, Suite 28P New York, NY 10023
Writer Adil E. Shamoo, Ph.D. is vice president and co-founder of CIRCARE

Former editors of the New England Journal of Medicine, Marcia Angell and Arnold Relman call for Congressional hearings to contain abuses by the pharmaceutical industry whose business interests collide with both the public interest and the integrity of science.

"The pharmaceutical giants spend two or three times as much on marketing and administration as they do on R&D, and their profits are about twice their R&D costs."

"The number of innovative drugs reaching the market has actually declined in the past five years."

Prescription for Profit
By Marcia Angell and Arnold S. Relman
Washington Post    Wednesday, June 20, 2001; Page A27

Few Americans appreciate the full scope and consequences of the pharmaceutical industry's hold on our health care system. Prescription drug costs are rising at an unsustainable rate -- 19 percent per year -- and will soon exceed payments to doctors as the largest item on the health bill after hospital costs.

The drug companies maintain that this is the price of success. They portray their industry as a highly risky one in a competitive market -- just able to cover its enormous research and development costs but managing nonetheless to deliver a stream of innovative drugs in the public interest.

Here are the facts. The pharmaceutical giants spend two or three times as much on marketing and administration as they do on R&D, and their profits are about twice their R&D costs. To cite a typical example, last year GlaxoSmithKline spent 37 percent of its revenues on marketing and administration and only 14 percent on R&D, while making a 28 percent profit. Overall, the pharmaceutical industry is by far the most profitable in the United States.

As for being innovative: Yes, the industry has brought important new drugs to market over the past few decades, but many of them stemmed from basic research at the National Institutes of Health or in academic laboratories supported by the NIH. Others were first developed by smaller biotech companies and then licensed to the large companies. It was recently reported that only two of Bristol-Myers Squibb's top 10 drugs were discovered in-house. Moreover, the number of innovative drugs reaching the market has actually declined in the past five years.

The pharmaceutical giants are now putting a major part of their resources into the development and marketing of "me-too" drugs -- variants of  drugs already on the market. Among many examples, Claritin is one of a number of similar antihistamines; Zoloft is like many other antidepressants; and Zocor is just one of a family of cholesterol-lowering drugs. "Me-too" drugs are relatively easy to develop but require massive promotion campaigns to attract consumers to a particular brand and persuade physicians to prescribe one instead of another. Hence, the huge marketing budgets.

Far from being an exemplar of the free market, the pharmaceutical industry enjoys many government protections and subsidies. In addition to benefiting from publicly funded research, drug companies have low tax rates, because they can deduct their marketing expenses as well as their research and development costs.

Most important, their drugs enjoy l7-year (or longer) patent protection.  Once a drug is patented and given a brand name, no one else may sell it, and the company is free to charge whatever the market will bear without fear of competition from generics. No wonder drug companies fight to extend the life of their patents and to obtain new patents for old drugs. That  can be done merely by proposing a new use or a different dosage form, or by combining two old drugs into a single new pill. The anti-diabetes drug Glucophage XR, for example, is Bristol-Myers Squibb's newly patented once-daily replacement for the twice-daily Glucophage, whose patent expired last fall.

The drug companies devote enormous sums to promoting their interests. They have the largest lobby in Washington, and contribute copiously to political campaigns. Half the FDA's budget for the evaluation of new drugs now comes from drug company users' fees, making the agency dependent on the industry it regulates -- an obvious conflict of interest. The industry also spends lavishly to influence doctors, who write the prescriptions, and medical researchers, who test the drugs.

Last year drug companies spent more than $8 billion and employed 83,000 sales representatives to woo doctors. They provided them with gifts, meals and trips, as well as another $8 billion worth of free drug samples. The companies fund and thereby influence much of the continuing medical education doctors need to renew their licenses, and they handsomely support the scientific meetings of medical societies, where they hawk their wares and often sponsor their own programs.

The companies also want to influence researchers who test drugs in human subjects. Increasingly, they are entering into financial arrangements with academic medical centers and their faculties, arrangements that threaten the objectivity and credibility of clinical research. A growing number of drug trials are being managed by investor-owned businesses that are even more beholden to the drug companies because the companies are their only clients.

Furthermore, in their contracts with academic researchers, drug companies now often insist on controlling how the research is done and reported, and whether the results will even be published at all. Recently, there have been several widely publicized instances of drug companies suppressing research results that were not favorable to their drugs.

Prescription drugs are not like discretionary consumer products. For millions of patients, they are necessary to health and even survival. Yet, the drug companies often behave as though their only responsibility is to their shareholders.

It's time to take a hard look at the pharmaceutical industry and hold it accountable. This is particularly urgent now, given the move to add a drug benefit to Medicare. The industry would like to see such a benefit without any new regulation, but that would cause drug prices to rise even faster and hand the companies yet another windfall. Future policy on this and other matters related to prescription drugs should be based on a thorough understanding of the industry's behavior, best achieved through in-depth congressional hearings. We can't think of a more urgent investigative assignment for the Senate Committee on Health, Education, Labor and Pensions.

Marcia Angell is a senior lecturer and Arnold S. Relman is professor emeritus at Harvard Medical School. Both are former editors-in-chief of the New England Journal of Medicine.
© 2001 The Washington Post Company

Marcia Angell M.D.
Academic Title:  Senior Lecturer on Social Medicine
Administrative Title:  Not present in entry.
Department:  Social Medicine
Address:  New England Journ. of Medicine
10 Shattuck St.   Boston, MA 02115
Phone:   (617) 734-9800    Fax:   (617) 739-9864
Institution:   Harvard Medical School
Placebo Politics  by Marcia Angell
in The American Prospect  Vol. 11, No. 23
Marcia Angell, M.D. is a senior lecturer at Harvard Medical  School and former editor-in-chief of The New England  Journal of Medicine.

Vol. 11, No. 14: Conversation: Open Science or Junk  Science?
Vol. 5, No. 17: Health Care: Reformers' Rounds Organizing  Reform "The United States is unique in treating health care as a market commodity distributed according to the ability to pay instead of as a social good distributed according to medical need. The fact that the system targets market transactions, not medical need, is highly inefficient because it requires constant tinkering to deal with the inevitable result: People who cannot pay still get sick and need to be taken care of."
Remarks of   Marcia Angell, M. D.   Delivered  8/16/00
at the HHS Conference on Financial Conflicts of Interest
"What about the integrity of the scientific literature?
As Tom Bodenheimer summarized so well at this conference, there is plenty of good evidence that investigators with financial ties to companies whose products they are studying are indeed more likely to publish studies favorable to those products. And in my two decades at the NEJM, it was my clear impression that papers submitted by authors with financial conflicts of interest were far more likely to be biased in both design and interpretation."
Marcia Angell  "Are we in a health care crisis?"  [photo]
"We certainly are in a health care crisis. If we had set out to design the worst system that we could  imagine, we couldn't have imagined one as bad as we have.  Here's a system in which we spend over twice what the next most  expensive country spends on health care -- that's Switzerland.  We spend roughly $4500 for every American, whether they have insurance or not. Switzerland spends maybe $2500 for every citizen. Canada spends maybe $2,000. Great Britain, poor little Great Britain, spends about $1,000 for every British citizen. And what do we get for it? What do we get for that $4500? Well, we certainly don't get our money's worth. We have roughly 43 million people with no insurance whatsoever, and among the rest of us, many of us are underinsured. That is, we have shrinking packages. This might be covered, but that won't be covered.

Our life expectancy is shorter. Our infant mortality is higher. Our childhood immunization rate is lower. And look at how often we get to see the doctor, how long we get to stay in the hospital. Canadians see their doctors far more often than we do. Americans really can't afford to go see their doctor. There's always some co-payment, some deductible, or they have to pay out of pocket, or something isn't covered. But in Canada, where everybody is covered for everything, they go to the doctor much more often. When they are hospitalized, their hospital stays are longer. If they're having a baby, they get to stay four or five days. Japan has very long hospital stays. Ah, it's almost a rest cure. People in Japan who are hospitalized might lie around the hospital for a week or two just to take a rest. So we're really not getting our money's worth. It's going to all sorts of things, but not to doctors and patients.

What are the dangers that we're facing right now? Well, the danger is that our health care outcomes will start to drop. As I said, they're not all that good in the developed world. We're of the 25 richest countries in the world, we're somewhere around 22-23 in terms of our health."
Biographical Sketch of Marcia Angell, M. D., F.A.C.P.

Marcia Angell, M. D., is Senior Lecturer in the Department of Social Medicine at Harvard Medical School. She stepped down as Editor-in-Chief of the New England Journal of  Medicine on June 30, 2000. A graduate of Boston University School of Medicine, she trained in both internal medicine and anatomic pathology and is a board-certified pathologist. She  joined the editorial staff of the New England Journal of Medicine in 1979, became Executive Editor in 1988, and Editor-in-Chief in 1999.

Dr. Angell writes frequently in professional journals and the popular media on a wide range of topics, particularly medical ethics, health policy, the nature of medical evidence, the  interface of medicine and the law, and care at the end of life. Her critically acclaimed book,  Science on Trial: The Clash of Medical Evidence and the Law in the Breast Implant Case, was published in June, 1996, by W. W. Norton & Company. In addition, Dr. Angell is co-author, with Dr. Stanley Robbins and, later, Dr. Vinay Kumar, of the first three editions of  the textbook, Basic Pathology. She also wrote chapters in several books dealing with ethical  issues.

Dr. Angell is a member of the Association of American Physicians, the Institute of Medicine of the National Academy of the Sciences, the Alpha Omega Alpha National Honor Medical  Society, and is a Fellow of the American College of Physicians. In 1997, Time magazine  named Marcia Angell one of the 25 most influential Americans.

Arnold Seymour Relman M.D.
Academic Title:  Professor of Medicine, Emeritus
Administrative Title:  Not present in entry.
Department:  Emeritus
Address:  Brigham and Women's Hospital
75 Francis St.   Boston, MA 02115
Phone:    (617) 278-0185    Fax:   (617) 278-0186
Institution:  Brigham and Women's Hospital


Foregone conclusions

The public is being regularly deceived by the drug trials funded by pharmaceutical companies, loaded to generate the results they need

Richard Smith
Wednesday January 14, 2004
The Guardian, UK

Drug companies spend hundreds of millions of pounds to bring a new drug to market, and tens of millions of pounds to do the clinical trials that are necessary for both registration and marketing. Understandably, they would prefer not to get results from these trials that are unfavourable to their drug. And, despite the ubiquitous uncertainties of science and medicine, they rarely do. How do they manage it?

In 1994, Canadian researchers looked at 69 trials of anti-arthritis drugs funded by drug companies and published in prominent medical journals. In every case the drug made by the company was as good as the comparative treatment, and in a quarter of the trials it was better. Not once did a company fund a trial that proved unfavourable to it.

Yet the whole scientific point of doing such trials is to answer so far unanswered questions. Supposedly, researchers conduct trials when they are in a charmed state called "equipoise", which means they are genuinely uncertain which is the best treatment. If they think one treatment is better than another, then they shouldn't be conducting the trial.

A review published in 2003 found 30 studies that had compared the results of trials funded by drug companies with those funded from other sources. Trials funded by companies were four times more likely to have results favourable to them than those funded by others.

Yet the technical quality of the trials funded by drug companies was always as good and often better than the quality of those funded by other sources. This is not surprising, as drug company trials are tightly regulated. There are explicit high standards, and companies can afford to hire the best to conduct the trials.

How then do companies usually manage to fund research that is favourable to them? An answer is supplied in a recent issue of the BMJ by Dave Sackett and Andy Oxman, two tireless campaigners for the better use of scientific evidence in medicine. They have founded a spoof company called Harlot - which stands for How to Achieve positive Results without actually Lying to Overcome the Truth. They created the company after it finally dawned on them that "being good and being poor are causally related: being good doesn't pay".

Harlot plc promises to give drug companies and others the results they want. Your drug may be wholly ineffective, Sackett and Oxman promise, but as long as it isn't a lot worse than a sip of triple distilled water, then Harlot can produce positive results from a trial. Importantly, these results are not usually achieved by doing poor quality trials. The trick is in the question asked and the design of the trial. Sackett and Oxman, both experts on the design and analysis of trials, describe 13 methods for getting the results you want.

One of the commonest methods is to test a new drug not against an effective treatment but against a placebo. Ironically, regulators often require companies to do this. But what matters to patients is not whether a company's drug is better than nothing, but whether it is better than established treatments. Companies are nervous about these "head-to-head" trials, particularly if many drugs are being tested - because there may be only one winner and many losers. A huge publicly funded head-to-head trial of treatments for high blood pressure was published recently and threw companies into a tizz because it showed that long-established drugs that are off patent were better than newer, much more expensive drugs.

A company gets huge benefit from showing that its drug is better than a competitor's. But the company needs to control the trial, and Harlot suggests that a company compares its product with an inadequate dose of a competitor's product. This may have been the reason why previous trials on drugs for high blood pressure suggested that newer drugs were better.

A variant on this technique is to compare the drug with an excessive dose of the competitor's product: it is then possible to show that the company's drug has far fewer side-effects (because side-effects are more common with higher doses of a drug). This may have been the method for showing that new and expensive drugs for schizophrenia have fewer side-effects than older drugs.

Perhaps the most common method to avoid unfavourable results is to make sure that a trial is not big enough to show that a competitor product is either better or worse. Such trials are very common, and Silvio Garattini, a leading Italian researcher and critic of the drug industry, has proposed a consent form for them: "I understand that this trial is worthless for science and medicine, but will be of great use to the marketing department of Shangri-la Pharmaceuticals."

All this matters greatly because 70% of trials in major medical journals are funded by the drug industry. Often companies will buy reprints of these articles to use in promoting their drug. Sometimes they may spend up to £750,000.

Virtually all research on drugs is funded by the industry, because governments have taken the view that public money can be better spent elsewhere. The end result is that information on drugs (on which Britain spends £7bn a year) is distorted.

The Harlot article was written to amuse, but is as deadly serious as anything else published in the BMJ in the past 10 years. The public is being regularly deceived and exploited.

·Richard Smith is the editor of the British Medical Journal,3604,1122568,00.html




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