There have been many calls for reform of the broad influence of pharmaceutical industry money on doctors and other health professionals, hospitals, and medical centers, but few have been so sweeping as the recent article in the Journal of the American Medical Association by Dr. Troyen Brennen of Harvard Medical school, Dr. Jerome Kassirer, who was an editor of the New England Journal of Medicine , and 9 other authors. 1

The drug industry has been roundly criticized for its intense, diverse, and unrelenting efforts to influence doctors and sell more drugs. The criticism has accomplished little, and drug sales have soared. The analysis by Brennen et al. focused on the medical profession, acknowledging that "physicians' behavior is a large part of the problem," and that the stature of the medical profession and the trust of patients have been jeopardized by medicine's many conflicts of interest with the drug industry.

Approximately $19 billion is spent annually by drug companies for marketing to doctors. Tens of thousands of sales representatives descend on doctors' offices every day. Patients in doctors' waiting rooms are often outnumbered by drug reps (typically young, female, attractive). Many doctors deny that gifts and other freebies influence their decisions about medication treatment. Drs. Brennen et al. disagreed:

"Social science research demonstrates that the impulse to reciprocate for even small gifts is a powerful influence on people's behavior. Individuals receiving gifts are often unable to remain objective .... Receiving gifts is associated with positive physician attitudes toward pharmaceutical representatives. ... The rate of drug prescriptions by physicians increases substantially after they see sales representatives, attend company-supported symposia, or accept samples."

Indeed, studies have shown that the drug company influences on doctors often lead to irrational decisions and have a negative impact on the treatment of patients. I am not surprised by these findings. Decades of research have allowed marketers to learn how to influence anyone without his/her knowing it. Doctors are not immune. Moreover, drug companies are subtle. They not only provide gifts and dinners and seminars, but also leave behind carefully select studies that support the use of their drugs. The overarching goal is to control the information that doctors receive about medications.

Drug companies write the package inserts of all drugs, carefully including the information they choose and omitting information they want to avoid. 2 Drug companies underwrite a large percentage of continuing education courses for doctors. In doing so, they make sure that the speakers represent the company view. Drug companies design studies that are meant to produce favorable results and then publish the studies in medical journals. Studies with unfavorable results are not published. Drug reps typically bring stacks of studies, all favorable, which impress doctors, who no longer have the time or motivation to search the medical literature themselves. Drug reps do not include independent studies with less favorable conclusions. Many doctors never see these.

A Call for Strong, Clear, Enforceable Rules
More forcefully and clearly than any before, Drs. Brennen et al. have called for strong, mandatory rules including the outright banning of any gifts or payments for meals, shows, sporting events, travel or meetings. They call for a system in which drug samples are replaced with vouchers for low-income patients. They call for an end of all drug company underwriting of doctors' continuing education, thereby ending drug company influence on the speakers (who are paid directly or indirectly by the drug companies) and on the content of such "education."

The doctors go even further. They call for a ban on the hiring by drug companies of university doctors and other healthcare professionals as speakers for drug companies and their products. Brennan et al. rightly assert that university experts have a special obligation to avoid any appearance of conflict of interest because these experts conduct important research that affects patients and also train medical students.

Academic centers would also ban drug company representatives from meetings, lunches, presentations, and the corridors of medical centers. This is a very important proposal, for another aspect of the pharmaceutical company onslaught has been to embed themselves into all aspects of medical education. Today, young doctors learn that it is perfectly reasonable to accept drug company gifts, partake in drug company lunches and seminars, and to accept drug company selected information. This is a distorted ethic that doctors carry into their practices, and it may explain why so many doctors have opposed efforts to curb drug company influences.

Brennan et al. are realistic. In this era of shrinking government with reduced abilities to support research, drug company money plays an essential role in funding research. Under the doctors' plan, drug companies would be allowed to continue this, but rather than giving money directly to individual researchers, drug company contributions would be channeled through a special office at academic institutions that would determine the actual use of the funds. This would prevent drug companies from exerting direct influence (and, often, control) on the work of the researchers.

Will True Reform Take Place?
The proposals of Brennen et al. make sense and are long overdue. But will they work? Will they even be implemented? Many calls for reform have been issued previously. Some reforms have been implemented, but they have been largely ineffective. So far, medical institutions have balked at implementing strong, enforceable rules. Doctors are independent sorts, and many still insist that they are entitled to receive gifts and other benefits if drug companies want to provide them. Academic institutions do not want to have to police their medical faculty members.

Worse, many academic institutions have become dependent on drug company money and have long become inured to drug company influences. This was best described in 2000 by Dr. Marcia Angell, then the editor-in-chief of the New England Journal of Medicine . Her astonishing article ("Is Academic Medicine for Sale?") described a situation that has not improved:

Academic medical institutions are themselves growing increasingly beholden to industry.... Some academic institutions have entered into partnerships with drug companies to set up research centers and teaching programs in which students and faculty members essentially carry out industry research.... When the boundaries between industry and academic medicine become as blurred as they now are, the business goals of industry influence the mission of the medical schools in multiple ways.... 3 .

With so many high-ranking doctors having financial ties to the drug industry, are there enough doctors who are independent financially or at least in conscience to consider reining in this compromised system? Maybe not. Drug companies are smart. They long ago realized that if they hired as consultants all of the top experts in every medical field, they could sway the entire medical profession with their slant. The result is that today, few independent experts remain. For example, when the FDA convenes medical advisory committees to discuss problems involving medications, it is usually impossible for the FDA to find enough independent experts to outnumber or even equal the experts with drug company ties. At some meetings, 90% of the experts have financial arrangements with drug companies. 4

So the main question is not whether the proposals of Brennen et al. make sense. They do. Absolutely. The question is whether there is enough objectivity, independence, and will in the medical community to follow through. Or has the deliberate strategy of the drug industry to influence medical science and medical experts and medical institutions as much as possible already proceeded beyond control? This brings us to a question raised by another top medical journal, Lancet: "Just How Tainted Has Medicine Become?" I will discuss this article soon in Part 2 of "The Medical Profession and the Culture of Corruption."

Finally, there is an irony in the publication of the Brennan article at this time when corruption in Washington has led to the resignation of the majority leader of the House of Representatives, and scores of politicians are trembling in anticipation of revelations by indicted lobbyist Jack Abramoff. Washington will enact reform, but will it be serious or window dressing? The same question applies to the medical profession and its conflicts of interest with the drug industry.

References
1. Brennan TA, Rothman DJ, Blank L, Blumenthal D, Chimonas SC, Cohen JJ, Golden J, Kassirer JP, Kimball H, Naughton J, Smelser N. Health industry practices that create conflicts of interest: a policy proposal for academic medical centers. JAMA, Jan. 25, 2006;295(4):429-433.
2. Cohen, JS. Over Dose: The Case Against The Drug Companies. Prescription Drugs, Side Effects, and Your Health. Tarcher/Putnam, New York: October 2001.
3. Angell, M. Is Academic Medicine for Sale? New England Journal of Medicine 2000;342:1516-18.
4. Cauchon, D. FDA Advisors Tied to Industry: Approval Process Riddled with Conflicts of Interest. USA TODAY, Sept. 25, 2000.

Source: Dr Jay S. Cohen, M.D., the MedicationSense E-Newsletter, www.MedicationSense.com.

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The truth about medical journals, and how drug companies exert heavy influence over published scientific articles

Can the medical journals be trusted to provide accurate, unbiased information about medicine even as they are almost entirely funded by drug companies? In her book, Vaccination , Peggy O'Mara writes that the current era of medical beliefs (or dogma) began to develop soon after Louis Pasteur's demonstration that some pathogens could be converted into vaccines. The medical community then decided to try the same method for all afflictions. Medical journals were soon afterward reporting the discovery of "miracle" vaccines for every disease under the sun, and drug companies were simultaneously advertising those vaccines on those very same pages.

Medical journals rely on Big Pharma's ads to pay the bills
Mainstream media has long depended on advertising revenue to cover its bills. The money generated by newspaper subscriptions doesn't even begin to scratch the surface of a daily paper's running costs. Television stations also rely on advertising clients to foot the bill for everyday operations. And of course it is no surprise that medical companies are only too happy to shell out some bucks in advertising to make their product a household name. The big difference in medical journals is that readers are hardly likely to see a non-medical ad within its pages.

On television, a plethora of commercials offer products ranging from dog food to cosmetics to medicine. In newspapers, the ads often run the gamut of available products and local services. Medical journals, though, have a specific kind of advertising content within their pages. All their ads are for hospitals or drugs; there's not a non-medical ad in sight.

Since medicine is the subject of the entire journal, medical ads seem par for the course. But what should an editor do if a product advertised on a particular page isn't 100 percent safe? It might not be cost-effective for a budget-strapped medical journal to remove the ad and publish an article discussing the product's drawbacks. They run the risk of angering the pharmaceutical company and losing revenue. Donald M. Epstein, author of Healing Myths , adds that even if the dangers of a drug or medical procedure were to be included in a respected medical journal, often the "religious" belief that doctors, and even patients, have in conventional medicine overrides their decision-making process.

People believe that if a drug is approved and on the market, it must be okay. If a drug proves fatal to 10 or even 10,000 patients, doctors will still staunchly defend it, claiming the benefits outweigh the risks. Epstein's feelings are that anyone with a little common sense should be enraged by the fact that the entire industry is operating with self-imposed blinders -- from the pharmaceutical companies that hawk unsafe drugs to the medical journals that publish doctored clinical studies and misleading ads.

What really makes the controversy interesting for many folks is this: If the journals were ever to publish a study that finds a procedure within a different healing art -- such as herbal or chiropractic medicine -- to be harmful or fatal to patients, there would be a loud and obvious call to outlaw or regulate that practice. Only Big Pharma and the Western health care system are allowed to operate with obvious dangers (like the Vioxx drug killing more Americans than the entire Vietnam War) and get away with it. A further frustration for Epstein is that drugs and procedures proven to be unsafe or ineffective do not deter the medical community from developing new treatments based on the old "biomedical story."

Consumers falsely trust medical journals to be impartial
Richard Smith, the ex-editor of the British Medical Journal (BMJ), publicly criticized his former publication, saying the BMJ was too dependent on advertising revenue to be considered impartial. Smith estimates that between two-thirds to three-quarters of the trials published in major journals -- Annals of Internal Medicine, Journal of the American Medical Association, Lancet and New England Journal of Medicine -- are funded by the industry, while about one-third of the trials published in the BMJ are thus funded.

He further adds that trials are so valuable to drug companies that they will often spend upwards of $1 million in reprint costs (which are additional sources of major revenues for medical journals). Consumers trust medical journals to be the impartial and "true" source of information concerning a prescription drug, but few are privy to what is truly going on behind the scenes at both drug trials and medical journals.

Scientists who conduct drug trials may be hard-pressed to stay impartial when the manufacturers so often pay them for lectures and consultations, or when they are conducting research that has been funded by the company. In addition, as stated by doctors Mark Hyman and Mark Liponis in Ultraprevention , since drug companies are so reliant on the word of doctors, they often visit doctors' offices to hand out free samples, take the staff out to lunch, offer free gifts -- including toys for kids, seminars at expensive restaurants and junkets to the Caribbean islands -- and frequently sponsor continuing education for doctors.

According to Smith, BMJ editors want to be impartial most of the time, but it is often impossible for editors to spot a rigged drug trial, notwithstanding the "peer review" process theoretically used by drug companies in order to have their research independently checked. Smith said that drug companies don't fiddle with the results of a trial, but they obtain positive results by asking the "right" questions. Another pothole mentioned by Smith was the choice a publisher might face to either publish a drug trial that would bring in $100,000 in profit, or lay off an employee in order to meet the end-of-year budget. The answer, according to Smith, is to have more publicly-funded trials, or have journals not publish them at all.

Big Pharma's published studies lack transparency
Smith provided specific examples of wrongdoing, including the testing of a new drug against a treatment already known to be inferior, using too high or too low of a dosage for a competing drug, testing on too small of a scale, or choosing which results they want to make public. The Association of the British Pharmaceutical Industry denied Smith's allegations, stating that it would not rig a trial due to the high risk of being "found out." Richard Ley, a spokesman for the industry group, said that it was not within the interests of the industry to make claims they know to be untrue, since the cost of lawsuits far outweigh any potential income those claims might generate. Ley also said that Smith's suggestion for more publicly-funded trials was not realistic.

Fiona Godlee, current editor of the BMJ, did not debunk Smith's claims; in fact, she agreed with much of what Smith said. "The BMJ takes the issues of transparency very seriously," she said. "We continue to call for public registration of all clinical trials and full disclosure of results, regardless of outcome." Godlee added that there was a need for more transparency in the journal and that it was something they were working on. The difficulty, Godlee said, lies in having to tell a drug company to "clean up their act," while simultaneously relying on them for money. Godlee added, "What we need now is a debate about the issue."

In his book, On the Take , Dr. Jerome Kassirer says he is confident that, for the latter part of the 20th century, drug company ads had no influence on the editorial content of the New England Journal of Medicine. But he also adds that he is not sure the same could be said for other medical journals. He agrees with some of what Smith says, citing a negative study of the pharmaceutical industry published in Annals of Internal Medicine, which resulted in dramatically lower pharmaceutical advertising for the journal. This decrease in advertising interest continued for many months. This is an example of why medical journal editors are, at best, afraid of contradicting their major source of income.

Misrepresenting drug trials is the "norm" in medical journals
The scandal in medical research is far more shocking than the corporate scandals that recently created headlines, according to John Abramson in Overdosed America . Abramson says that the withholding of negative results and the misrepresentation of research are accepted norms in the field of drug trials, or "commercially sponsored medical research."

He even goes as far as to say that there is a web of corporate influence in the form of "regulatory agencies, commercially sponsored medical education , brilliant advertising, expensive public relations campaigns, manipulation of free media coverage," as well as the aforementioned relationship between trusted medical voices and the medical industry. In Abramson's view, this all contributes to the silencing of the industry's corruption. He likens the situation to the recent corporate scandal in which securities analysts received payments in order to write reports that drove up stock prices.

According to Ann Blake Tracy, PhD, author of PROZAC: Panacea or Pandora , a "CBS HealthWatch" article even accused pharmaceutical companies of authoring drug studies themselves, then paying doctors to sign their names onto them. Furthermore, of the approximately 3,000 medical journals published monthly, only 10 percent are cross-indexed into a computer system, according to Charles T. McGee, in his book, Heart Frauds . This cross-indexed material is closely reviewed by "conservative editorial boards" in order to screen out controversial content. The 10 percent of material that's been approved is the only material available to a doctor when he asks a medical librarian to conduct a computer search or a search of a CD-ROM service such as Medline. On top of that is Kenny Ausubel's report, contained in his book, When Healing Becomes a Crime , that many drug companies just cut out the middle-man and publish their own medical journals.

Inexpensive herbal remedies never appear in medical journals
Theoretically, for much the same reason dog food ads are absent from their pages, medical journals never contain advertising or studies about natural or herbal remedies. Supposedly, they're not considered "in tune" with the content of the journals. However, many nutritional experts and some medical doctors postulate that it's actually due to the low amount of revenue generated by such remedies, since herbs are usually significantly less expensive than over-the-counter and prescription drugs. This may be why such inexpensive treatments often seem to be dismissed offhand by medical journal editors.

McGee also writes about Dr. Richard Casdorph, who studied some old experiments in chelation therapy (a procedure that uses ethylenediamine tetra-acetic acid (EDTA) to remove metals from the body) and had success with the treatment by using methods that were not available when the initial experiments were performed. In one case, Casdorph apparently saved two patients from the amputation of their legs via chelation therapy. When he tried to publish his study, many medical journals rejected it, stating that chelation therapy was found to be ineffective years before, and was therefore inappropriate content for their publications. Presumably, Casdorph would have informed the editors that his study involved previously undiscovered methods, in which case their reason for rejection would be a non-sequitur. Casdorph eventually found a journal of alternative medicine that agreed to publish his study.

Opponents of the perceived corruption in medical journals offer many solutions. Smith, as mentioned previously, would either like more privately-funded studies published or have none published at all. Abramson feels that researchers have to have access to all the results of their studies, perform their own analysis of data, write their own conclusions and submit the report to peer-reviewed medical journals. A change may be in the cards, and as Richard Gerber, MD, notes, the number of patients seeking alternative medical answers to their problems is becoming too large for mainstream medical media to ignore. Gerber says that some medical journals are even publishing articles that explore the nature of these "unorthodox" treatments and discuss why patients are seeking alternative health care. October 03, 2005 by: Ben Kage