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Doctors call for reforms

THE BALTIMORE SUN

Through giveaways and sponsorships, the mamanufacturers of drugs and medical devices can distort the way doctors care for patients, a group of prominent physicians and scientists warns today in a call for reforms.

The group recommends that academic medical centers ban some common practices, regulate others and make a concerted effort to disclose doctors' financial relationships with makers of drugs and devices.

"Marketing and market values should not be allowed to undermine physicians' commitment to their patient's best interest or to scientific integrity," the authors contend.

The group of 11 - from Harvard, Columbia and Tufts universities, among other institutions - calls for the reforms in a special communication in today's Journal of the American Medical Association.

Although the article was not timed to coincide with any event, the authors point to recent congressional investigations, prosecutions and class action lawsuits that have buffeted the medical profession.

Yesterday, The New York Times reported that Medtronic Inc., a manufacturer of medical devices, had paid individual physicians hundreds of thousands of dollars in consulting fees.

In the JAMA report, the authors argue that doctors should no longer accept gifts from companies that make drugs or medical devices, take free samples from pharmaceutical representatives or accept "no-strings" grants.

Pharmaceutical firms should continue to sponsor specific research, Dr. Troyen A. Brennan of Harvard and his co-authors say, but academic medical centers should act as brokers when companies want to make unconditional grants. The institution should dole out the money as the university - not the company - sees fit.

Relationships between the industry and physicians, the authors say, should be publicly disclosed on the Internet.

"The serious threat that this state of affairs poses for professionalism, and for the trust that patients have in physicians, makes the need for effective guidelines on industry-physician relationships both apparent and urgent," the authors contend.

Catalyst for debate?

The paper announces no new research. But two of the authors say they hope it will be a catalyst for debate on the role of academic medical centers in safeguarding patient trust.

Voluntary guidelines by a drug industry group, professional associations and the government have not stemmed abuses, the authors say, and academic medical centers need to step into the breach.

"My mother told me never to accept a gift from strangers," Dr. Jordan J. Cohen, a co-author of the article, said in an interview. "And for good reason: When strangers give you gifts, they expect something in return."

Cohen, president of the Association of American Medical Colleges, said he would bring the recommendations before its governing body next month but was not representing the organization when he signed the article.

The Pharmaceutical Research and Manufacturers of America issued a statement noting that it has a voluntary code that says "entertainment, expensive meals and gifts that are for personal use by the physician are not appropriate."

But the industry group appeared to take issue with the authors' call for a more-distant relationship between sales representatives and doctors.

"Sales representatives are well-trained technically and are prepared to answer doctors' questions about drugs, their side effects and how they work," the group said.

The authors of the JAMA article call for an end to no-strings consultancies, in which companies pay doctors without requiring them to provide advice or expertise on specific issues. Such arrangements are "tantamount to a gift and should be regarded as such," they argue.

The Johns Hopkins School of Medicine requires faculty members to disclose all consulting contracts and reviews them "to make sure it's substantive and not merely window dressing for payments," said Julie Gottlieb, assistant dean for policy coordination.

She said the school wants to prevent companies from buying doctors' loyalties and using them to market products.

In a statement, the American Medical Association said its guidelines call on physicians to avoid industry ties that might cloud their judgment on treatment decisions. The policy does not bar doctors from receiving gifts from pharmaceutical firms.

"The guidelines state that physicians should accept only gifts that entail a benefit to patients and are of modest value, and no gift should be accepted if there are strings attached," said Dr. Duane M. Cady, the AMA's president.

Psychiatrist John Talbott, a professor at the University of Maryland School of Medicine, praised the recommendations in the JAMA article.

"I think university medical centers should take the lead, absolutely," said Talbott, who is overseeing a project to teach the school's medical students about ethics and professionalism. "We should be the leaders in setting the rules."

The medical profession, he said, is responsible for its own ethics.

"One of the characteristics of a profession is self-government," he said. "We have to be scrupulous to keep that trust."

Talbott said studies have shown that doctors' medical decisions are affected when they accept gifts from companies. "You have to go on what the science shows," he said.

Dr. Marcia Angell, a former editor in chief of The New England Journal of Medicine, said she was "delighted" that a working group of influential thinkers had weighed in, noting that many of their recommendations mirror points in her book The Truth About the Drug Companies.

But "there is a lot of weight on the other side, in terms of just the sheer amounts of money, so I think it's going to be very hard to roll back the wholesale bribery that goes on," Angell said. "My hope is ... that it will make academic medicine ashamed of itself."

Dr. Adil E. Shamoo, a University of Maryland professor who teaches research ethics and edits the journal Accountability in Research, said the guidelines proposed in the JAMA article fall far short of what is needed.

"That's the fox guarding the henhouse," he said of the notion that academic medical centers - which also stand to benefit from the money from drug and device makers - would act as independent brokers. "This is totally unworkable and with gaping holes, so its worthiness is in doubt."

The authors of the JAMA article include Brennan, a Harvard professor of medicine, law and public policy who has studied and written about medical professionalism; Dr. David Blumenthal, a Harvard professor of medicine who has written about doctors and drug companies; and Dr. Jerome P. Kassirer, a Tufts University distinguished professor of medicine and author of On the Take: How Medicine's Complicity with Big Business Can Endanger Your Health.

The research was sponsored by the ABIM Foundation, a nonprofit that takes its initials from the American Board of Internal Medicine and is devoted, in part, to supporting medical professionalism; and the Institute on Medicine as a Profession, a nonprofit funded by financier George Soros that conducts its research through Columbia University appointees and has a similar focus.

Common practices

The JAMA special communication - essentially a long opinion piece with footnotes - criticizes many of the ways drug and device makers commonly market products to physicians.

Studies have shown that even small gifts can influence behavior because of recipients' desire to reciprocate, the authors of the JAMA article note.

The article takes issue with widely accepted practices that include allowing companies to sponsor and pay for the continuing education courses that physicians must take to keep their licenses.

The authors also take aim at the practice of allowing drug company salesmen to pay calls on doctors to hand out free samples.

"The purpose behind such industry contacts is unmistakable: Drug companies are attempting to promote the use of their products," the authors write.

They suggest that samples instead be distributed in a way that keeps drug company representatives at arm's length from physicians.

One proposal would give low-income patients vouchers that they could present for free samples, although the authors don't spell out how that would work.

Other suggestions include barring physicians with financial relationships with drugmakers from hospital and medical committees that decide which drugs to prescribe.

Such recommendations, the article acknowledges, are likely to be controversial because they deal with practices that financially benefit physicians and drug companies.

Brennan said he hopes the proposals spark discussion.

"I'd be happy if they debate the issue and come up with a different set of proposals," he said.

David J. Rothman, a Columbia University professor of social medicine and president of the Institute on Medicine as a Profession, said in an interview that recent scandals make the timing right for reforms.

"This is the right thing to do," Rothman said. "Academic medical centers ought to do it in the best spirit of professionalism. Given what's going on out there, if they don't do it, there's a good chance it will be done to them."

juliana.bell@baltsun.com

Sun reporters Jonathan Bor and David Kohn contributed to this article.

Seeking changes

A group of prominent physicians and scientists has called for reforms in how doctors deal with makers of drugs and medical devices. Here are some of the changes they seek:

An end to "no-strings" payments from makers to doctors

Replacing free handouts of drug samples to doctors with a system that would put the medicines in the hands of patients who can't afford them

Barring doctors with financial relationships with drugmakers from hospital and medical association committees that decide which drugs to prescribe

Disclosure of "consulting" contracts between doctors and makers

An end to drug companies sponsoring and paying for the continuing education courses physicians must take to keep their licenses

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