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Conflicts Of Interest Within Clinical Trials Can Jeopardize The Participants

Follow the money.

Earlier this week, I blogged about the growing economic relationships and even mutual dependency between medical device manufactures and physicians, citing a pre-emptive strike against an Institute of Medicine report that recommended closer regulation of medical devices before and after they enter the market. Such ties, though, are only one part of a broader medical-industrial complex that has enormous impact on public policy in the United States.

A 2009 White Paper by the Seton Hall’s Center for Health & Pharmaceutical Law & Policy reported that “ drug and medical device companies fund up to 80% to 90% of all clinical trials; in 2005, and that by 2004, three-quarters of all of the clinical trials paid for by industry were in private physician practices or for-profit research centers.” The paper’s authors argue that such trials “create potential conflicts of interest that possibly jeopardize the rights and well-being of research participants as well as the integrity of research results” and that “the goal for public policy should be to structure physician-investigator payment to achieve financial neutrality between treatment and research.”

A recent web posting by a medical billing company unabashedly crows about the extra income doctors can make from clinical trials. “A single study can pay $70,000; doing 3 or more at once — which is typical — can bring in “significant income” the site claims. Only after discussing the potential income boost did the site talk about other potential benefits to physicians, such as staying involved in the academic side of medicine. Oh, and “additionally, patients may benefit from new or experimental treatments.”

Then there are seeding trials, which critics call industry-funded sham research masquerading as research. Writing in the New York Times, Carl Elliott, a bioethicist at the University of Minnesota, explains how it works. “A pharmaceutical company will identify several hundred doctors and invite them to take part in a research study. Often the doctors are paid for each subject they recruit. As the trial proceeds, the doctors gradually get to know the drug, making them more likely to prescribe it later. “The purpose of seeding trials” he says “is not to advance research but to make doctors familiar with a new drug.”

Legitimate industry-funded clinical research, including trials done in physician’s offices can bring important benefits to patients, but they are“fraught with potential conflicts” as explained in ACP’s Ethics Manual. The manual counsels physicians to “avoid situations in which they are rewarded for particular outcomes. Moreover, physicians who enroll their own patients in office-based research have an ethical obligation to disclose whether they have financial ties to sponsors. Giving or accepting finder’s fees for referring patients to a research study generates an unethical conflict of interest for physicians. Compensation for the actual time, effort, and expense involved in research or recruiting patients is acceptable; any compensation above that level represents a profit and constitutes or can be perceived as an unethical conflict of interest”.

Last week, the federal government released a final rule on preventing conflicts of interest in clinical research. The rule requires investigators to disclose to their institutions all of their significant financial interests related to their institutional responsibilities and lowers the monetary threshold at which significant financial interests require disclosure, generally from $10,000 to $5,000, among other changes. The rule applies only to researchers who receive federal grant support, such as NIH researchers.

Disclosure will help, but is that enough to prevent conflicts of interest? The broader issue is that over time, the medical profession and pharmaceutical and drug manufacturers have developed multiple and complex interlocking economic relationships that are fraught with potential conflicts of interest. The profession has recognized and responded to potential conflicts by putting forward policies to govern physician-industry relations, and the government has stepped in by requiring more transparency. Yet critics argue that more needs to be done to rein in a medical-industrial complex that has undue influence over public policy and patient care. I would love to hear from internists who have accepted drug industry funding for clinical trials in your offices, and the reasons, benefits and risks you have found in such arrangements.

Today’s questions: Do you think industry-funding of clinical trials in doctors’ office is fraught with conflict of interest? What is the role of the profession and government in minimizing such conflicts?

*This blog post was originally published at The ACP Advocate Blog by Bob Doherty*


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