FDA's industry ties too binding

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http://www.ajc.com/opinion/content/opinion/stories/0730edfda.html ajc.com > OpinionFDA's industry ties too binding Experts' financial connections can erode credibility Published on: 07/30/06The U.S. Food and Drug Administration has to rely heavily on outside experts to advise it about the safety and effectiveness of new drugs and medical devices. In that kind of system, the credibility and independence of outside experts are critical.And unfortunately, that credibility has been repeatedly compromised by

revelations that supposedly unbiased experts in fact had undisclosed financial ties to companies that were seeking FDA approval of new drugs or devices.That has to change. The FDA needs to adopt a strong new set of proposed guidelines that would, for the first time, force its advisory committee members to detail any ties to industry.Those proposed rules, announced last week, would severely restrict the role played by researchers financed by drug and device manufacturers.But the problem doesn't end there. Physicians rely on medical journals to report without bias or conflict of interest about the results of clinical experiments with new and existing drugs. But there, too, the problem of undisclosed financial ties between researchers and manufacturers has become a serious issue.To rebuild their credibility, journal editors must become more vigilant about forcing researchers to disclose potential conflicts of interest.

Before switching their patients to new therapies for depression, heart disease, cancer and other serious conditions, doctors have the right to know whether researchers presenting evidence of the effectiveness of a new drug or device are being paid by the company that makes it.Industry-sponsored research is nothing new. A good case can be made that privately financed clinical studies have allowed new and effective therapies for dozens of conditions to be developed much faster than if they were carried out solely by government scientists at the FDA and the National Institutes of Health.But the tentacles of industry have spread too deeply into too many areas of medical science in recent years, especially in academic medicine. Many professors at large medical schools act as paid industry consultants or join advisory boards — receiving stipends of a few thousand dollars a year to $50,000 or more — to review and comment on other research or

show up at trade shows to talk about a new drug or device.Large grants by pharmaceutical companies to clinical departments of medical schools also cloud the credibility of academic researchers, even when the researcher is not directly tied to the experiments.When there is scientific disagreement on the value of a new product, some companies go looking for well-known academic experts to play what amounts to a marketing role. Their names alone can help sway clinicians to change what drugs they recommend to patients in the highly competitive pharmaceutical market.Case in point: The prestigious Journal of the American Medical Association this year published a study warning physicians that if women stopped taking anti-depressant medications during pregnancy, they would face increased risk of falling back into depression.The risk posed to mother and child by anti-depressants during pregnancy is hotly debated, and the

study's finding wasn't surprising. However, 13 of the study authors did not disclose that they had been paid consultants or lecturers for companies that make anti-depressant drugs.At a minimum, medical journals owe their readers a disclosure statement detailing any financial ties between researchers and industry. Journal editors could enforce that rule by agreeing that authors who fail to reveal conflicts to one publication will be banned from getting their work printed in all the others.In the eyes of some critics, disclosure alone won't fix the problem at the FDA, however. Its advisory panels, drawn from experts in various research disciplines, play an important role in reviewing the research and deciding which drugs are allowed on the market and which should be removed. The FDA almost always follows its panels' recommendations.The agency has a working set of guidelines covering potential conflicts of interest for its

advisory panel members, but too often it grants waivers for scientists with ties to the pharmaceutical industry.A study of the FDA's advisory panel process this year by Public Citizen's health research group showed more than one out of every four panel members disclosed a financial interest that could be considered a conflict. Yet the agency denied their participation in panel deliberations only about 1 percent of the time.And when The New York Times examined an advisory panel's vote not to recommend removal of a popular painkilling medicine from the market — a decision upheld by the FDA — it found that the panel's recommendation would have turned out differently if experts with industry ties had been excluded.Some critics believe the only solution is to automatically exclude any researcher with a financial relationship with a drug maker, but it may not be necessary for the FDA to go quite that far.It is often

helpful for panels to include scientists with a wide range of experience, including conducting clinical trials sponsored by drug manufacturers (as long as it is not the drug or device under scrutiny at the time.)If the agency is forced to disclose why it has granted a waiver — as well as providing details about panel members ties to the industry — physicians and their patients could still be well served and the credibility of the process maintained.—Mike King, for the editorial board (mking@...)

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