Doctors’ Relationships With Big Pharma Unhealthy

The following material was prepared by Sepp Hasslberger of Health Supreme, credited in the footer. It is a collection of news items and commentaries stimulated by an article appearing in JAMA critical of the relationships cultivated by the pharmaceutical and medical equipment industries with doctors.

I have long believed this unhealthy arrangement results in countless thousands of unnecessary prescriptions, tests and procedures; results in increased pathologies, avoidable injuries and thousands of deaths; all while costing billions of dollars to consumers and tax payers. Will this longstanding problem again be brushed under the carpet?

In Australia several years ago the worst of this business practice was outlawed. More needs to be done. Read the following and form your own opinion about the risks this problem poses.

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Is it time for doctors to sever their close and often corrupting ties with pharmaceutical manufacturers? A group of prominent physicians associated with the George Soros-funded Institute on Medicine as a Profession (IOMP) proposes to eliminate even the smaller gifts such as lunches and office material the pharmaceutical companies are offering doctors routinely in an effort to promote the sale of their drugs over those of the competition.

Merrill Goozner, who directs the Integrity In Science program for the The Center for Science in the Public Interest, a consumer advocacy focussing on health and nutrition, says on GoozNews that the group, who published their proposal in the Journal of the American Medical Association, "proposed prohibiting drug companies from giving small gifts or paying for the meals, travel or continuing medical education of teaching docs." They also recommended "ending the distribution of free drug samples" in favor of giving vouchers to hospitals, in addition to "eliminating from their ranks any physicians with ties to drug manufacturers."

According to an LA Times article, "drug companies are not just infiltrating doctors’ offices and residency training programs but also medical student education". Rachel Sobel, a fourth-year medical student at UC San Francisco, adds:

"A few weeks ago, I had a dreary glimpse of the future, that is, if the current situation continues. A bunch of residents were heading out on a Friday night to dinner at Masa’s. According to the Zagat Survey, the restaurant treats guests "like royalty," and the average price of dinner for one, including one drink and tip, is $92. A drug rep was footing the bill."

That there is inordinate influence of the pharmaceutical manufacturers on medical doctors and the way they treat their patients, is becoming more and more obvious, even to the degreee that doctors and mainstream press are calling for – some – reforms.

The New York Times also carries the story:

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In Article, Doctors Back Ban on Gifts From Drug Makers

By GARDINER HARRIS
Published: January 25, 2006

The gifts, drugs and classes that makers of pharmaceuticals and medical devices routinely give doctors undermine medical care, hurt patients and should be banned, a group of influential doctors say in today’s issue of The Journal of the American Medical Association.

Medical schools and teaching hospitals should be the first to establish a comprehensive ban, the group writes. But the authors argue that all doctors should eventually follow suit.

Broadly adopted, the recommendations would transform doctors’ day-to-day lives and shut off the focus of drug makers’ biggest expenditures. But Dr. David Blumenthal, an author of the article, said it was "not very likely" that many in medicine would listen to the group.

"I’m not very optimistic," said Dr. Blumenthal, a professor at Harvard Medical School who, like many of the article’s 10 other authors, has studied conflicts of interest in medicine for years.

Federal law forbids companies from paying doctors to prescribe drugs or devices, but gifts and consulting arrangements are almost entirely unregulated. Voluntary professional guidelines suggest that doctors refuse gifts of greater than "modest" value. Sanctions against doctors who accept gifts of great value are extremely rare.

The drug industry spends tens of billions of dollars a year to woo doctors, far more than it spends on research or consumer advertising. Some doctors receive a significant part of their income from consulting arrangements with drug and device makers. Others take regular vacations and golfing trips that are paid for by companies.

A recent lawsuit involving the device maker Medtronic revealed that one prominent Wisconsin surgeon received $400,000 for a consulting contract that required him to work just eight days. While such rich arrangements are often restricted to specialists, most physicians routinely accept small gifts from drug salespeople, including pens, mugs, pads and food.

Surveys show that most doctors do not believe that these gifts influence their medical decisions, although most believe that they do affect their colleagues’ medical judgment.

But even small gifts can lead to profound changes in doctors’ prescribing behavior, with "negative results on clinical care," the article states. As a result, all gifts should be banned, the authors conclude.

Ken Johnson, a spokesman for the Pharmaceutical Research and Manufacturers of America, said the drug industry had a voluntary code of marketing conduct.

"Only practices that do not compromise independent judgments of health providers – such as modest working meals, gifts of minimal value that support the medical practice, and distribution of free samples – are permitted," Mr. Johnson said in a statement.

Dr. Duane M. Cady, board chairman of the American Medical Association, said in a statement that "drug and medical device makers can play a role in educating physicians about new products." He said the organization was "in the process of examining and updating its policy on gifts to physicians from industry."

The article is part of a spate of reports in medical journals that have taken a skeptical view of drug makers’ influence on medical practice and research. The New England Journal of Medicine recently published an article accusing Merck of withholding crucial safety information about the withdrawn painkiller Vioxx, a charge that Merck denies. Other articles have criticized drug makers’ tendency to keep the results of human research secret.

Dr. Catherine DeAngelis, editor in chief of The Journal of the American Medical Association, said drug makers were a vital part of the nation’s health care system because of their research efforts.

"But there has been a substantial change in the way pharmaceutical companies function over the last decade," Dr. DeAngelis said. Drug makers are far more aggressive in their marketing efforts, she said, and these efforts are having a deleterious effect on the practice of medicine.

Dr. Steven Shea, vice dean of the faculty of medicine at Columbia University Medical Center, predicted that the journal article would "prompt changes in policy and guidelines at many academic health centers, including ours."

Kaiser Permanente, the California-based managed-care group, is one of the few medical organizations in the United States that have enacted nearly all of the recommendations suggested by the journal article. Kaiser physicians prescribe heavily marketed medicines far less frequently than doctors nationally.

"We thought it was critical for us that our patients never had a doubt that the decision made about a drug or a device was based on the best interests of the patient and not the financial interest of the physician," said Dr. Sharon Levine, associate executive director of Kaiser Permanente Northern California.

The article also argues that "no strings attached" consulting arrangements should be banned, and that all other consulting agreements should be posted on Web sites. Doctors should refuse free drug samples, the article states, because they are "a powerful inducement for physicians and patients to rely on medications that are expensive but not more effective."

Such a refusal would also eliminate one of the principal reasons for which drug salespeople are routinely allowed to enter doctors’ offices, the article states. While the article does not suggest that salespeople be refused entry into offices, it states that such visits have few useful functions.

"Would we be delighted if drug reps never saw the inside of doctors’ offices? Absolutely," said Dr. David J. Rothman, president of the Institute of Medicine and one of the article’s two principal authors. "But you can’t mandate that. It’s a free country."

Two years ago, Dr. Rothman received a $7.5 million grant from the financier George Soros to set up an organization that would study medical professionalism. Today’s article is in part an outgrowth of that grant, he said.

Dr. Troy A. Brennan, former chairman of the American Board of Internal Medicine and the other principal author of the article, said he was looking forward to reading responses to it.

"I don’t think there are a lot of good answers as to why it’s O.K. to accept these gifts and contracts," Dr. Brennan said.

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Vera Hassner Sharav of the ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) comments on the report in JAMA and the New York Times article:

This is a follow-up to Tuesday’s Infomail about the recommendations of a group of prominent physicians who recommend a self-imposed ban on financial ties between academia and drug manufacturers. The recommendations, published in the Journal of the American Medical Association (JAMA): JAMA. 2006;295:429-433, are an outgrowth of a recognition that medicine – in research and practice – has been overrun by industry and the consequences are alarming: 

"Conflicts of interest between physicians’ commitment to patient care and the desire of pharmaceutical companies and their representatives to sell their products pose challenges to the principles of medical professionalism. These conflicts occur when physicians have motives or are in situations for which reasonable observers could conclude that the moral requirements of the physician’s roles are or will be compromised. Although physician groups, the manufacturers, and the federal government have instituted self-regulation of marketing, research in the psychology and social science of gift receipt and giving indicates that current controls will not satisfactorily protect the interests of patients. More stringent regulation is necessary, including the elimination or modification of common practices related to small gifts, pharmaceutical samples, continuing medical education, funds for physician travel, speakers bureaus, ghostwriting, and consulting and research contracts. We propose a policy under which academic medical centers would take the lead in eliminating the conflicts of interest that still characterize the relationship between physicians and the health care industry."

The New York Times reports: "Broadly adopted, the recommendations would transform doctors’ day-to-day lives and shut off the focus of drug makers’ biggest expenditures."

However, it appears the authors of the paper do not agree about its impact: Dr. David Blumenthal is quoted saying it was "not very likely" that many in medicine "would listen to the group." But Dr. Steven Shea, vice dean of the faculty of medicine at Columbia University Medical Center, predicted that the journal article would "prompt changes in policy and guidelines at many academic health centers, including ours."

JAMA editor, Dr. Catherine DeAngelis, pays obligatory lip service by acknowledging: "there has been a substantial change in the way pharmaceutical companies function over the last decade," pharmaceutical companies are "far more aggressive in their marketing efforts." She acknowledges "these efforts are having a deleterious effect on the practice of medicine." 

However, the evidence shows that journals – such as JAMA and The New England Journal of Medicine – are complicit in that "aggressive marketing" by flooding its pages with drug advertisements. Journal editors’ public pronouncments notwthstanding, financial interests trump ethical / scientific standards thereby undermining the integrity of medicine.

Although the Ethical Guidelines adopted by the International Committee of Medical Journal Editors (ICMJE, 2004), include advertising practices in peer-reviewed journals, a newly released, quantitative data analysis found that advertising ratios in JAMA and The NEJM (ratio of advertisements to editorial content) were excessive and disproportionate compared to low-circulation specialty science journals.

Indeed, the authors found that JAMA and the NEJM are saturated with display advertisements – just like high-circulation consumer magazines. Furthermore, 50% of the ads are placed by the Big 5 Pharma corporations.

The authors cite an earlier study that reveiwed the accuracy of advertisements in peer-reviewed journals and found that: "32% of the advertisements misled readers regarding efficacy, 40% did not provide balanced descriptions of the side effects, and 44% could lead to improper prescribing if the physician did not use other sources of information regarding the drug."

So, there is clear-cut evidence that the major, most read, and most influential medical journals are themselves the purveyors of false claims about treatments that lead physicians to improper prescribing practices.

See: Friedman, LS and Richter, ED, Excessive and Disproportionate Advertising in Peer-reviewed Journals, International Journal of Occupational Environmental Health, 2006:12:59-64. (linked as "Inappropriate Ads in Peer-reviewed Journals")

The authors note, "The findings suggest a dissonance between the ethical guidelines and the de facto advertising practices of arguably the two most important member journals of the ICMJE. There is a need to define and apply standards for excessive and disproportionate advertising."

This is but another demonstration of misplaced trust in the gatekeepers of (what are supposed to be) the most authoritative sources of medical information.

Academic medicine is shown again and again to be disinclined to abide by its own declared ethical standards – as long as these standards are self-imposed and voluntary.

When it comes to financial interests, human nature is what it is. Neither highest credentials, or professional standing are a safeguard against bending the rules of conduct, or selling out to the highest bidder. Misplaced trust in the medical establishment has resulted in tainting medical institutions, clinicians, researchers, and our medical knowledge base. The medical profession must be held to standards and enforcement mechanisms as is any other trade or profession.

Vera Hassner Sharav
212-595-8974
veracare@ahrp.org

See also:

Abstract in JAMA:
Health Industry Practices That Create Conflicts of Interest
A Policy Proposal for Academic Medical Centers

Washington Post:
Distance Sought Between Doctors and Drug Industry

LA Times:
An expensive free lunch

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Provided by Health Supreme – Sepp Hasslberger on 1/27/2006

The Food and Drug Administration (FDA) announced today the approval of Ranexa (ranolazine), a new drug for the treatment of chronic angina. Ranexa, a new molecular entity (NME), is the first drug approved to treat chronic angina in over ten years.

Like almost every other approved drug, although several pharmacological activities of ranolazine have been described, the precise way the drug works is not fully understood.  However, since Ranexa affects electrical conduction in the heart (prolongs the QT interval), it should only be used by patients who have not responded to other anti-anginal drugs including long-acting nitrates, calcium channel blockers and beta blockers. 

Chronic angina is characterized by episodes of chest pain, pressure, or discomfort that occur during exercise because the heart muscle is not getting enough oxygen.  The most common cause of angina is coronary heart disease, in which the coronary arteries that supply the heart with oxygen-rich blood become blocked with plaque deposits.

According to the American Heart Association, approximately 6.8 million Americans are diagnosed with angina every year.  While many of these patients respond to other treatments, including surgery and other approved drugs, some remain with angina despite receiving these treatments.  Acute attacks of angina are treated with nitroglycerin placed under the tongue whereas treatments for chronic angina are given to increase the amount of exercise a person can do before angina occurs.  This is usually tested by showing that people with angina can exercise longer on a treadmill or bicycle when they take the
drug.

"Chronic angina limits people’s activities," said Dr. Steven Galson, MD, Director of FDA’s Center for Drug Evaluation and Research. "The approval of Ranexa provides a new treatment option for Americans who continue to suffer symptoms of angina despite using other angina drugs."

Ranexa was studied in patients with chronic angina who still had symptoms despite being treated with other anti-anginal drugs. Two clinical trials, ERICA (Efficacy of Ranolazine in Chronic Angina) and CARISA (Combination Assessment of Ranolazine  In Stable Angina) were conducted. 

In ERICA, 565 patients who were experiencing about 4.5 angina attacks per week while taking a full dose of a calcium channel blocker were randomized to Ranexa or placebo for 6 weeks.  Patients receiving Ranexa had a reduction in angina attacks of about 1 attack per week, compared with those in the placebo
group.

In CARISA, 823 patients on either a calcium channel blocker or beta blocker (atenolol) were randomized to Ranexa or placebo and followed for 12 weeks using a formal exercise treadmill test.  Patients in the Ranexa group had a mean exercise improvement similar to that seen with other anti-anginal therapies.

Interestingly, in both studies, Ranexa appeared to be less effective in women than in men. In clinical studies, common side effects included dizziness, headache, constipation and nausea. Ranexa is manufactured by CV Therapeutics, Inc. in Palo Alto, California.

It is important to realize that, like other drugs for angina, this drug referred to as "treatment" by the FDA is palliative. That is, it does not cure the underlying disease, it merely masks one of its symptoms, the pain. For those experiencing angina and not responding to other drugs, eliminating the pain is of course a welcome end in itself.

However, notwithstanding the role of genetics (an overplayed cop-out actually) heart disease is very largely a result of lifestyle choices you made, whether actively and knowingly or passively by just going along with cultural norms. You didn’t "get" heart disease, you made it yourself by your lifestyle habits. Simply covering up your body’s warning signs with drugs, while you barely modify your lifestyle, represents more choices. The result will be reduced quality and quantity of life.

If that is fine by you and your loved ones then fair enough, you’ve made another choice. On the other hand, if you are interested in actually dealing with the underlying disease then download (see below) the free 24 page Preventing Heart Attack and Stroke Report and discover some important things you actually can do right now to deal with your underlying disease. Do it now, before it is too late.

The report is available to subscribers of the free Xtend-Life newsletter. Your email address will be perfectly safe and you can unsubscribe at any time. Simply go to this page and click on the link on the right of the page to reach the subscription form. Once subscribed you will be able to download the report. Please be sure to read it and then do something about your problem. It’s your choice, it’s your life.

The First Years and FDA notified consumers and healthcare professionals of the voluntary recall of liquid-filled teethers due to possible bacterial contamination. The liquid inside the teethers may contain the bacteria pseudomonas aeruginosa and pseudomonas putida which can cause serious illness in children if the teether is punctured and the liquid from the teether is ingested.

The teethers were sold nationwide including major retailers, grocery, drug and specialty stores from July 2005 to January 2006. This recall is for 6 different styles of liquid-filled teethers for infants (3+ months old) to soothe gums. Consumers should stop using the recalled products immediately. No illnesses have been reported to date in connection with this problem.

The manufacturer’s press release follows. It contains important details about which specific products are considered potentially dangerous and the procedures to follow if you have any of them.

FOR IMMEDIATE RELEASE — STOUGHTON, MA — January 27, 2006 — The First Years, a subsidiary of RC2 Corporation, is voluntarily recalling liquid filled teethers due to possible bacterial contamination. The liquid inside the teethers may contain pseudomonas aeruginosa and pseudomonas putida which can cause serious illness in children if the teether is punctured and the liquid from the teether is ingested.

Consumers should stop using the recalled products immediately.

Products:

Disney Days of Hunny Soft Cool Ring Teether–Style# Y1447
Disney Soft Cool Ring Teether–Style# Y1470
Disney Soft Cool Ring Teether–Style# Y1490
The First Years® Cool Animal Teether/Fish, Zebra and Dinosaur designs–Style# Y1473
The First Years® Floating Friends Teether– Style# Y1474
Sesame Beginningsâ„¢ Chill & Chew Teether– Style# Y3095

This recall is for 6 different styles of liquid-filled teethers for infants (3+ months old) to soothe gums during the feeding stage. The 6 styles affected have the same general construction of a durable vinyl exterior with clear liquid pre-filled inside. Some designs have printed graphics while others have floating internal characters.

No illnesses have been reported to date in connection with this problem.

The teethers are sold nationwide including major retailers, grocery, drug and specialty stores from July 2005 to January 2006 for $2.99 to $3.99.

Consumers should put the teether in its current condition into a sealed plastic storage bag, place in envelope, and return to: Parent Service Center, RC2/The First Years, 100 Technology Center Drive, Stoughton, Massachusetts, 02072. Consumers should include their mailing address in the envelope to receive a replacement teether and free gift.

Consumer Contact: For additional information, consumers can visit: www.thefirstyears.com or call The First Years Parent Service Center at 1-866-725-4407.

This recall is being made with the knowledge of the US Food and Drug Administration. Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787. Or, on the MedWatch web site at www.fda.gov/medwatch.

If you know anyone who has one of these products for their baby or infant please pass this information along to them as they may not have heard about the recall.