Report Advises Ethics Overhaul to Curb Conflicts of Interest

Cheryl Clark, for HealthLeaders Media , April 28, 2009

A widespread practice in which physicians and healthcare institutions receive money, services, drug samples, fees, and gifts from biotech, medical device, and drug industries is a practice that threatens patient care and research integrity and erodes the public trust, says an exhaustive report issued today by the Institute of Medicine.

The 353-page document, titled Conflict of Interest in Medical Research, Education, and Practice gives numerous examples in which research findings may be compromised by a multitude of "disturbing" traditions.

Those traditions include pharmaceutical companies giving physicians drug samples in an effort to influence their prescribing patterns, medical industry representatives funding research and ghost writing study findings, and physicians and researchers receiving consulting fees or other payments from the medical companies, toward which those investigators are supposed to remain objective.   

Research suggests "that physicians who have access to [drug] samples may change their prescribing habits, for example, by not prescribing the drugs that they would prefer for their patients to use or by prescribing drugs in ways that are not consistent with evidence based recommendations," the report said.

"It's time to end a number of long-accepted practices that create unacceptable conflicts of interest, threaten the integrity of the medical profession, and erode public trust while providing no meaningful benefits to patients or society," Bernard Lo, chair of the commission that wrote the report, said in a statement. The director of the medical ethics program at the University of California, San Francisco, acknowledges that there are productive relationships between the medical community and industry, but there are also too many worrisome problems with it.

In a press briefing today, Lo acknowledged that not all relationships between researchers and health providers are problematic. "Patients and the public benefit from constructive relationships [with the medical industry] particularly from moving discoveries from bench to clinical care," he said.

However he says, conflict of interest is such a pervasive issue, "it really goes to the heart of patients' trust, that they're receiving the best advice and medical care."

The 17-member panel of physician and research ethicists recommends 16 policy changes to end or limit these influential relationships, which have the potential to bias how and what kind of patients receive, either overtly, or unconsciously or unintentionally.

"Such conflicts of interest threaten the integrity of scientific investigations, the objectivity of medical education and the quality of patient care," said the report. "They may also jeopardize public trust in medicine."

The panel devoted considerable attention to the relationships between the common practice by which drug companies give physicians free product samples, gifts, and meals.

"Although one argument for the use of drug samples is that they help low-income patients, research suggests that these individuals are not the primary recipients of such samples," the report said. And, free samples are often timed with new brand name drugs "when they are not recommended by evidence based practice guidelines" and when less expensive drugs are available for the same indication, the ethicists wrote.

In the briefing, Lo said, "We call on physicians–no matter where they practice–not to accept gifts from pharmaceutical companies and limit use of samples and interactions with drug representatives."

Although gifts may seem inconsequential, some research suggests they can contribute to unconscious bias in decisions and advice physicians give, the report said.

"It seems unlikely that companies would give such gifts to physicians if they did not believe that they would benefit the company in some way."

Another focus of the report is the fact that medical institutions have great variation in their conflict of interest policies.
 "Relationships and practices that are forbidden by one institution may be allowed and even encouraged by others," the report stated, adding that there have been shortcomings in oversight by federal agencies and medical institutions.

Drug company sponsorship of research also came under attack. When pharmaceutical companies sponsor research, the results "are more likely than other reviews to present conclusions favorable to the company, even when the actual findings are not favorable," the report said.

The 18-member panel of research and physician ethicists advocated the following:

  • Medical institutions should adopt and strengthen conflict of interest policies in a way that can be standardized.
  • The U.S. Congress should require pharmaceutical, medical device and biotech companies, and their foundations to publicly report all payments to physicians, researchers, healthcare institutions, professional societies, patient advocacy and disease specific groups, providers of continuing medical education, and their foundations.
  • Research centers should preclude any investigator with any financial or other interest in the outcome from being involved in studies that include human subjects.
  • Academic medical centers should prohibit faculty, students, residents, and fellows from accepting gifts, including meals, making industry-controlled presentations, or claiming authorship for ghostwritten publications. Physicians likewise should decline any such arrangements.
  • Those who write evidence-based practice guidelines should be required to disclose all funding from industry and all financial interests.
  • The National Institutes of Health should require certain public health institutions to adopt institutional conflict of interest policies.
  • Academic medical centers and teaching hospitals should provide education on how to avoid conflicts of interest and manage relationships with pharmaceutical and medical device industry representatives.
  • Accreditation organizations, public and private health insurers, and associations of medical journal editors should develop incentives to make institutions more accountable for preventing, identifying, and managing conflicts of interest.

The report enumerated several ethical lapses in recent years that potentially altered or influenced patient outcomes.

For example, it described investigations into the 1999 death of  Jesse Gelsinger, a patient in a gene therapy trial at a University of Pennsylvania research institute, which raised questions about whether the institute had properly managed the experiment. Both the university and several officials were found to have significant financial interests in the company that developed the therapy. The company also had  contributed $25 million to the institute's annual budget and had exclusive rights to develop products that emerged from the trial, the report said.

Amgen, the manufacturer of epoetin, a drug that increases hemoglobin levels, was the founding and primary sponsor of the Kidney and Dialysis Outcomes Quality Initiative carried out by the National Kidney Foundation. This project issued practice guidelines recommending an increase in the target hemoglobin level for patients with chronic kidney disease, which would entail the use of higher doses of epoetin and increased sales of the sponsor's product, according to the report.

It's not enough to simply disclose conflicts of interest to the public or to patients, the authors wrote. It also must be properly curtailed.

"When a relationship or conflict of interest is disclosed to individual patients, students or research participants, they often lack the knowledge and perspective to assess . . . and may have no satisfactory options if they have concerns about it."

The report summed, "Society has traditionally granted the medical profession considerable autonomy to regulate itself," the authors summarized. "But concern is growing in the U.S. Congress, state legislatures, federal agencies and elsewhere that stronger measures are needed."

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