Guide Conflicts of Interest and the Future of Medicine: The United States, France, and Japan

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He then analyzes the strategies that each nation employs to cope with them. Unfortunately, many proposals to address physicians' conflicts of interest do not offer solutions that stick.

Conflicts of Interest and the Future of Medicine

But drawing on the experiences of these three nations, Rodwin demonstrates that we can mitigate these problems with carefully planned reform and regulation. He examines a range of measures that can be taken in the private and public sector to preserve medical professionalism--and concludes that there just might be more than one prescription to this seemingly incurable malady. A valuable historical study which is also a major contribution to conflict of interest debates in US and international health care policy, suggesting practical alternatives for the future.

Conflicts of Interest is meticulously researched and beautifully written. It explores the past, illuminates the present, and points us toward a promising future. We ignore Marc Rodwin at our peril. He again enlarges and enlightens the debate and offers useful policy alternatives. Rodwin's analysis is thoughtful and thorough; his recommendations can help guide us to more effective public policies.

His analysis of conflicts of interest in medicine in France, Japan, and the US is both fascinating and sensible. By explaining how this balance is maintained or lost in three countries, Rodwin is able to diagnose the ills of American medicine and suggest appropriate treatment.

Rodwin provides comprehensive, yet accessible information on the complexity of conflicts of interest and how they may shape the future of medicine in different health-care systems. This book is well written and highly topical. It will be of interest for all those who are oncerned about doctors' conflicts of interest, from policymakers and academics to practitioners and the users of medical services. Rodwin presents a coherent account of the development of medicine in three countries, drawing relevant comparisons as he does so, identifying key sites where conflicts of interest are likely to arise.

He is able to show how those sites vary from country to country and explore how they arose through the distinctive evolutionary path of medicine in each. This is a major scholarly achievement I would have no problems recommending it for courses on health policy, but I also hope it will be used in medical schools to explore the kinds of challenges the profession faces in relation to conflicts of interest. Rodwin extends his work on conflicts of interest by directly comparing both problems and policies in the United States, France, and Japan.

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Although he has already published leading work in this field Rodwin , readers, I suspect, will learn a lot from this comparison, which builds on the analytic baseline from that previous work. A reader interested in conflicts of interest and seeking an introduction to the field could surely use this book for that purpose. ELConflicts of Interest and the Future of Medicine demonstrates convincingly that "self-regulation, disclosure, and minor tweaking of legal rules" are highly unlikely to resolve the problems created by conflicts between the interests of those who make their living from medical care and those who need medical care to live.

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Synopsis About this title As most Americans know, conflicts of interest riddle the Us health care system. Check out an interactive that details all of these payments. Corporate payments and other support given to advisers before a drug review are widely acknowledged as troubling. When "a voting member of a committee demonstrably had financial associations with the company or the competitor prior to the meeting, and the FDA doesn't flag it, then somebody's dropping the ball on due diligence," says Yale University physician Robert Steinbrook, editor at large for JAMA Internal Medicine.

Yet benefits that come later, even years after a drug approval vote—jobs, money, professional prestige, and influence—are also fraught, ethicists say. They are a way of "postponing your reward," says Carl Elliott, a medical ethicist at the University of Minnesota in Minneapolis who has persistently criticized the financial inducements pharma gives to researchers. And they do. It might not be a "quid pro quo," according to Prasad, "but you don't have to evoke that to be very concerned.

It's in their best interest to play nice with these companies. FDA declined interview requests about Science 's findings. A spokesperson provided a statement saying people serving on drug approval advisory panels must disclose any "prospective employer," but not anticipated payments.

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The statement further notes that "FDA also screens potential participants for relationships and situations that do not create a financial conflict of interest but that may create the appearance that a committee member lacks impartiality. AstraZeneca spokesperson Karen Birmingham says "we are not aware" of any effort to support advisers after they serve on FDA panels reviewing the company's drugs, "other than the routine involvement in clinical trials or expert panels for which that [adviser] may have been sought independently because of their expertise.

Halperin says a direct payment from a drug company for a lecture or consulting "isn't really very much different than having an insurance company giving you a check for seeing a patient one day. It's the same thing. And Halperin argues that such relationships may be the price of expertise.

But the cardiologist agrees that expectations of future rewards can promote bias. In my case, it's the patient's interest. They ask members who write clinical practice guidelines to avoid financial relationships with affected companies for a period afterward—a tougher standard than what FDA requires for its advisers. That solution and others should be up for debate, say ethicists and regulatory experts, including one prominent former FDA employee. Bush and Bill Clinton.

In , FDA advisers voted to recommend approval for Brilinta, which helps prevent blood clots in heart-disease patients. Four physicians who voted later received funds from AstraZeneca, its maker, and competing firms for consulting and travel, or worked on research underwritten by those companies.

Army in January and gave his heart and soul to it for more than 3 years—for a time serving in Iraq as a Humvee gunner in the infantry. In , the private died in bed at his barracks at Fort Carson in Colorado, where he was being treated for posttraumatic stress disorder PTSD. Months later, the Army finally gave Sitko's heart back to his mom.

Lois Vinall cries softly as she recounts her son's story. Right after his death, the Army told her that Sitko, who was 21 and in good health other than his PTSD, had been killed by "mixed-drug intoxication. The particular mixture had been linked for years to sudden cardiac death, though no evidence has been made public that Sitko was told that. She says a military medical examiner told her Sitko's autopsy hadn't been correctly "certified" and that her son might have suffered cardiac death. Vinall had cremated his body but buried his heart in a veterans' cemetery in Redding, California, close to family.

Two years earlier, two panels of FDA advisers had considered whether to approve Seroquel for new conditions—schizophrenia and bipolar disorder in children, and depression in adults who are taking other medicines. Seroquel was then known to be associated with sudden cardiac death when used with certain drugs, and several antipsychotics similar to Seroquel also had a record of cardiac fatalities. But AstraZeneca presented results from its clinical studies , which company representatives said showed, at worst, minimal risks.

In , both panels voted by wide margins to approve Seroquel for the additional conditions.

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In the years afterward, several FDA advisers received significant financial support from AstraZeneca and the makers of competing drugs. The biggest payments went to Duke cardiologist Christopher Granger, who sat on one of the two groups. According to conflict-of-interest disclosures in journal articles on which Granger was an author, he received additional, unspecified amounts from those companies between and Granger says the industry funds solely underwrote research on cardiovascular topics and did not augment his salary.

But the expectation of future support from the makers of antipsychotics, he adds, did not influence his assessments of Seroquel or similar drugs. Granger says he recommended the drug's conditional approval after becoming convinced—as were nearly all others on his panel—that Seroquel's value outweighed its risks for some people with severe psychiatric disabilities.

In , after mounting evidence of sudden cardiac deaths, FDA forced AstraZeneca to add a warning to Seroquel's label that the drug posed risks of fatal cardiac events when combined with certain other drugs. Sitko died 3 weeks later.