Follow the Money / Can the Institute of Medicine Review the FDA?

Follow the Money / Can the Institute of Medicine Review the FDA?

Wed, 6 Apr 2005

A letter to the editor published in Nature Medicine by Dr. Bernard Carroll, a past chairman of the FDA Advisory Committee for Psychotropic Drugs, and past chairman of the Department of Psychiatry at Duke University Medical Center, provides specific evidence of extensive financial ties between the Institute of Medicine membership and the biotech and pharmaceutical industry: “Some of the most esteemed members of the IOM are employees and executives of major pharmaceutical corporations.”

IOM members’ Individual and institutional financial ties to drug manufacturers presents an unacceptable conflict of interest. The credibility of an FDA commissioned IOM review–one that necessarily requires a determination about whether FDA policies and actions were under the influence of the pharmaceutical industry–is dead on arrival.

In his column, Follow the Money, in The Wall Street Journal, Scott Hensley, cautions physicians: “make no mistake, the soul of the medical profession and the primacy of doctors’ duty to their patients is under siege.” Efforts to lay blame on the media for exposing systemic drug safety failures which killed people, rings hollow. Public trust will not be restored as long as the medical profession won’t cut the financial strings that tie medicine to the drug industry.

It is not enough to adopt Ethical Guidelines that admonish physicians not to take gifts from industry–as the American College of Physicians have–such guidelines must be enforced. The ACP Guidelines advise physicians that even small gifts may “affect clinical judgment,” and directs professional societies to be on guard for potential bias or conflict from such support. Yet, ACP rejected exhibitors who are critical of the ties between physicians and the drug industry, such as, No Free Lunch, from its annual meeting–while inviting pharmaceutical companies with the promise that the ACP meeting “stands out from all other meetings you attend because it offers an unparalleled opportunity to meet with physicians of power — prescribing power.”‘

Contact: Vera Hassner Sharav
212-595-8974

Correspondence
NATURE MEDICINE 2005; 11(4): 369 (April)
CAN THE INSTITUTE OF MEDICINE REVIEW THE FDA?

A Nature Medicine News item 1 reported on the plan of the U.S. Food and Drug Administration (FDA) to seek a review by the Institute of Medicine (IOM) of the National Academy of Sciences. The IOM would review the agency’s “drug safety system and its relationship with drug companies.” Is the IOM the appropriate body to conduct such a review?

The IOM maintains a carefully cultivated image of independent, Olympian wisdom on matters affecting the health of the American public. Congress and the public, in turn, receive pronouncements of the IOM with deference and respect. Congress and the public are mostly unaware that the IOM is riddled with conflicts of interest that bear directly on the institute’s proposed new role.

Some of the most esteemed members of the IOM are employees and executives of major pharmaceutical corporations, the very industry that has come under fire recently for lack of candor concerning toxicity of their products, for failure to make generally known the negative studies of their drugs’ efficacy, and for direct-to-consumer advertising that overstates efficacy while understating potential risks of medications. The ‘big pharma’ group includes IOM members employed by Abbott Laboratories, GlaxoSmithKline, Eli Lilly and Company, Merck and Co., Inc., Pfizer, Inc., and Schering-Plough Research Institute2. These members are not shy about representing their corporate interests in public forums. Indeed, IOM member Peter S. Kim of Merck recently participated in a sharply partisan public exchange about his company’s behavior and interactions with the FDA in the Vioxx matter3.

In addition, many smaller corporations involved in biotechnology research and development are represented in the membership of the IOM. These include the ALZA Corporation, BioCryst Pharmaceuticals, Inc., Celera Genomics, Corcept Therapeutics, Inc., Immusol, Inc., Innovative Drug Delivery Systems, Inc., Neurocrine Biosciences, Inc., Neurome, Inc., Perlegen Sciences Inc., and Quest Diagnostics, Inc. Some of these corporations, such as Neurocrine, already have matters pending with the FDA. Others, like Corcept, have received fast-track status from the FDA for products they hope to bring to market. All will sooner or later be negotiating with the FDA over clinical trials protocols, product approvals, labeling cautions, and post-marketing surveillance. There is even a presence within IOM from the Chemical Industry Institute of Toxicology, which can be sure to take a lively interest in the FDA’s positions on preclinical safety testing.

Moreover, most members of IOM are employees of medical schools that have extensive relationships with pharmaceutical corporations for research support, educational programs and endowments. Corporations routinely cultivate IOM members as ‘academic thought leaders’: it is not unusual for IOM members to have financial arrangements with big pharma and smaller companies as consultants, advisors, board members, stockholders, paid speakers, and research contractors. One IOM member recently listed 46 such financial relationships with 21 corporations4. The potential for bias that attends these institutional and personal competing financial interests should disqualify most IOM members from reviewing FDA safety procedures and relationships with drug companies. The IOM must not imagine that mere disclosure of such conflicts of interest in any way mitigates the compromises they create.

Even more problematic are the informal, often reciprocating relationships among academic and corporate IOM members that create non-transparent conflicts of interest. These relationships, which are not readily discoverable by the IOM leadership, might take many forms: favorable editorial decisions that publicize clinical trials reports; fast-tracking of publications that aid start-up corporations to raise capital; the writing of favorable editorials and commentaries; “product placement” in review articles; deflection of scientific criticism; sponsorship to advisory boards; and preferential treatment for research funding. Regardless of whether these relationships pass ethical muster, their existence creates the potential for bias in any review of the FDA by the IOM.

If its proposed review of the FDA is to be credible, the IOM will need to come to terms with these issues in a public way. Otherwise, the Institute of Medicine of the National Academy of Sciences will be viewed as just another compromised part of the academic-industrial complex in medicine. That would rather defeat the purpose of a review that is meant to restore trust in drug safety and in the FDA.

Bernard J. Carroll

Pacific Behavioral Research Foundation,
100 Del Mesa Carmel
Carmel, CA 93922-3040, USA.

The writer is a past chairman of the FDA Advisory Committee for Psychotropic Drugs, and past chairman of the Department of Psychiatry at Duke University Medical Center.

1. Katsnelson, A. Nat. Med. 10, 1269 (2004).
2. Institute of Medicine Public Directory
http://www.iom.edu/Object.File/Master/7/271/0.pdf (2004).
3. Kim, P.S., Reicin, A.S. N. Engl. J. Med. 351:2875-2878 (2004).
4. Nemeroff, C.B. J. Clin. Psychiatry 65:1562 (2004).

THE WALL STREET JOURNAL
FOLLOW THE MONEY
By SCOTT HENSLEY

Doctors, Drug Makers Too Cozy?
New Guidelines Fuel the Debate
April 5, 2005

Keeping the interactions between doctors and drug makers wholesome is one subject of new ethics guidelines for internists, the doctors most adults see first for medical care. Yet this noble goal faces constant corrosion from financial temptation.

The American College of Physicians releases the fifth edition of its Ethics Manual in the current issue of the Annals of Internal Medicine. These guidelines strongly discourage doctors from accepting “gifts, hospitality, trips and subsidies of all types” from industry, such as pharmaceutical companies, cautioning physicians that small gifts have been shown to “affect clinical judgment” and heighten “the perception (as well as the reality) of a conflict of interest.” For the first time, the manual also directs professional societies, such as the ACP, that accept industry support to be on guard for potential bias or conflict from such support.

But are guidelines and good intentions up to the task? The drug industry’s substantial support of the ACP’s annual meeting raises concerns.

Later this month, the ACP will hold its annual meeting in San Francisco, a gathering expected to draw 7,000 physicians, 4,000 exhibitors, guests and other health-care providers. About half of the $4-million-plus budget for the meeting comes from the sale of exhibition space and sponsorships — companies can pay $60,000 to sponsor the meeting’s tote bags, $50,000 to sponsor the shuttle buses. Drug makers are the biggest spenders, as they are at many medical conferences, despite the large number of recruiters, publishers and educational institutions that rent modest booths.

The prospectus for exhibitors touts the meeting to pharmaceutical companies explicitly, saying it “stands out from all other meetings you attend because it offers an unparalleled opportunity to meet with physicians of power — prescribing power.” John Mitas, executive vice president of the ACP, says the organization enforces a bright line separating the sponsorship from the content of the medical sessions that are the main purpose of the meeting. The ACP, he notes, has turned down groups judged incompatible with its mission, such as car makers eager to market their wares to well-heeled doctors.

Yet, the ACP has also turned down a request to exhibit from an organization that should be compatible with the mission of avoiding conflicts — No Free Lunch, a grassroots group that encourages health-care decision based on unbiased evidence rather than drug-industry promotion. On its Web site nofreelunch.org, the group cheekily promotes an amnesty program for the logo-covered pens given to doctors, along with more serious information that can be used to teach medical students about hidden conflicts.

Robert Goodman, a New York internist who runs No Free Lunch in his spare time, called the ACP’s decision not to let it exhibit “disturbing and astounding” considering that it would prevent doctors from hearing an important educational message to balance out the promotional spiels elsewhere in the exhibit hall.

The ACP maintains that agitators from No Free Lunch caused trouble at its 2001 meeting, even sneaking in an undercover TV crew. Dr. Goodman says that even if there were some problems, which he isn’t sure is the case, that they weren’t orchestrated by the organization.

William Golden, chairman of the ACP’s Ethics and Human Rights Committee, says “the door is open for a better exchange of views.” The ACP also says Dr. Goodman is welcome to attend and participate in the meeting. “Our members are very sympathetic to the issue that Dr. Goodman advocates,” Dr. Golden explains. “But there’s a difference between exhibiting and activism.”

Some doctors look beyond the shortcomings in their relationship with the pharma industry. Prescription drugs remain among the most important tools for treating illness, so doctors have an understandable respect for the power of modern medicines. But while the recent controversy over the safety of prescription pain pills has further dented the already poor reputation of drug makers with consumers, many doctors remain sympathetic with the view that pharmaceuticals companies are on the right path. This, despite the shock from Merck & Co.’s withdrawal of Vioxx last year and intensified worries earlier in 2004 about the role of antidepressants in suicide.

The divergent sentiment was captured in responses from doctors and patients on the question in recent surveys of whether the pharmaceutical industry is so flawed it needs to be overhauled. Almost twice as many consumers, or three-quarters of those polled, agreed strongly with that notion as compared with doctors, only 40% of whom said that was the case, according to surveys conducted in February by NOP World Health and Roper Public Affairs, both units of United Business Media PLC, a provider of business information services based in London.

Doctors blame journalists for exaggerating drug risks, with 81% agreeing completely or mostly with the statement that the media are overplaying the problems. Consumers, too, were mistrustful of media reports, though not quite as much as their doctors. Some 55% of consumers agreed completely or mostly with the notion that the media exaggerate drug-safety problems.

The results come from phone interviews of about 1,000 consumers and Internet questionnaires completed by 350 U.S. doctors, according to NOP World. The error margin for consumers was plus or minus three percentage points and plus or minus six percentage points for physicians. The polling wasn’t performed for a specific client, though NOP World hopes to sell the results to pharmaceutical companies.

The enduring bond between drug makers and the medical profession fuels a concern that the relationship remains too cozy. “There’s no way that drug safety is a problem primarily because the media is blowing it out of proportion,” says Paul Argenti, a professor of communications at Dartmouth College’s Tuck School of Business who reviewed the polling results. “All this tells me is that physicians are being influenced by drug companies even more than we thought.”

The spat between doctors wearing white coats may seem almost comical. But make no mistake, the soul of the medical profession and the primacy of doctors’ duty to their patients is under siege. For now, most consumers view the drug makers very skeptically — an opinion at odds with the one held by most doctors. The relationship of trust that most patients still seek with their doctors is at risk if physicians don’t take a closer look at their own relationship with the pharmaceutical industry.

Mr. Hensley writes about health care and the pharmaceutical industry from The Wall Street Journal’s New York headquarters. He also appears frequently on CNBC. He joined the paper in 2000 and spearheaded coverage of the decoding of the human genome. Previously, he was New York bureau chief for Modern Healthcare, a weekly magazine covering the business of health care. Before becoming a journalist, Mr. Hensley worked for a medical-equipment maker. He holds a bachelor’s degree in natural sciences from Johns Hopkins University and a master’s degree in journalism from Columbia University.

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