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Report reveals revolving door between U.S. drug regulators and industry

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A new report in the British Medical Journal reveals that many U.S. government regulators who review the safety of prescription drugs later go on to work for the pharmaceutical industry.

The authors of a letter published in the journal Tuesday found that nearly 60 per cent of the people who assessed a specific category of drugs for the U.S. Food and Drug Administration later got jobs in the biopharmaceutical industry.

This isn't entirely surprising. The so-called "revolving door" between government agencies such as the FDA and drug companies has long been a subject of discussion – and criticism. That's because cozy relationships, or the appearance of such, between regulators and the pharmaceutical industry raise important questions about how well the public is being served in matters of drug safety.

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The authors of the analysis wrote that they had often heard about the "revolving door" relationship, but wanted to evaluate the truth to the claim. So they identified individuals working at the FDA who were charged with reviewing hematology-oncology drugs from 2001 to 2010. They identified 55 reviewers. The authors then used sites like PubMed and LinkedIn to determine where those individuals worked years later. They found that 49 per cent were still employed with the FDA. Of the half that left, 58 per cent had moved on to jobs in the biopharmaceutical industry or as consultants to the industry. They could not find employment information for about 31 per cent of the reviewers who no longer work for the FDA.

"We are concerned by these findings," wrote authors Jeffrey Bien, internal-medicine resident and Vinay Prasad, assistant professor of medicine at Oregon Health and Science University. "The transition from regulator to advising companies seems logical, but it raises concern as to whether regulators indefatigably act in the public interest."

Canadian perspective

It's an important issue to consider. Does a revolving door between government regulators and the industry indicate that reviewers tend to go easy during the safety assessments of prescription drugs? How can the public be sure that safety reviewers consistently put the public's best interest ahead of a potential employer?

It's possible to measure the extent of this trend in the U.S. because the FDA holds public meetings about new drug approvals and publishes the names of the reviewers in charge of doing safety assessments. In Canada, however, such information is typically never made available. Health Canada chooses to keep this information private. Therefore, it is impossible for the public to know who was in charge of reviewing a particular drug and whether a "revolving door" relationship also exists with the drug industry.

That's not to say any relationship with the industry is necessarily bad. But it's incumbent on regulators to put the health and safety of the public first. How do Canadians know that standard is being met when they have very limited information about the gatekeepers of prescription drugs in Canada?

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Matthew Herder, associate professor of medicine and law at Dalhousie University, said Health Canada is much less transparent than its counterpart in the U.S.

Canadians should find it troubling that they can't access important information, such as the rationale behind the approval or rejection of a new drug and who is involved in those decisions.

Although it's impossible for Canadians to know the extent of the "revolving door" relationship between Health Canada and the drug industry, there are reasons to be worried about potential conflicts of interest, Herder said. Health Canada employees working with drug companies on a regular basis over a long period of time could form a relationship with those companies, leading to questions about their loyalties.

"Who is the regulator really working for at the end of the day? Is it on behalf of Canadians and making sure they maintain rigorous reviews of drugs or is it, in effect … actually the industry that's becoming the primary focus?"

Under the Protecting Canadians from Unsafe Drugs Act, known as Vanessa's Law, the federal government has the power to be much more transparent and forthcoming about drug reviews and a host of other issues.

The law, named in honour of the daughter of former Conservative MP Terence Young, who died from an adverse drug reaction in 2000, was designed to give the government more power to pull unsafe products from the market and ensure better reporting of problems linked to drugs. Herder notes the law explicitly states that Health Canada can be more transparent with information about drug-safety reviews, but that so far, not much has changed.

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There is a difference between being able to do something and having the will to make it happen. Which direction will Health Canada go?

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