One of the primary roles of the U.S. Food and Drug Administration (FDA) is to review the safety and efficacy of new drugs before approving them for the U.S. market.

Clearly an objective, unbiased review is needed for this system to work, but a new study published in The British Medical Journal (BMJ) suggests conflicts of interest are rampant.

A much-used revolving door exists between the FDA and the pharmaceutical industry, which is putting Americans' health at jeopardy for the sake of the drug industry's (and individuals') monetary pursuits.

Such cozy ties have been revealed before, but for the new study the researchers, from Oregon Health and Science University, wanted to find out just how prevalent they actually are.

Concerning Numbers of FDA Employees Leave Agency to Work for Drug Industry

The researchers analyzed data on FDA hematology-oncology drug approvals from 2006 to 2010 along with medical reviews conducted from 2001 to 2010. They then found out the subsequent jobs of the former FDA medical reviewers that worked on those drug approvals.¹

Out of 55 people, 15 left their job at the FDA to work or consult for the biopharmaceutical industry (another 29 continued working at the FDA in some capacity while the rest of the jobs could not be determined).²

Study author Dr. Vinay Prasad, a hematologist-oncologist and assistant professor of medicine at the Oregon Health and Science University, cited a need to understand why so many people are leaving the FDA.

He pointed out that while working at the FDA "they're certainly earning less than what they can make in the [pharmaceutical] industry." He continued in Time:³

"I don't think there is overt collusion going on, but if you know in the back of your mind that a major career opportunity after the FDA is going to work on the other side of the table, I worry it can make you less likely to put your foot down

… Regulators may be less willing to be very tough, and I worry that is happening."

The FDA Is Supposed to Stop Harmful Drugs From Reaching the US Public

The revolving-door trend is particularly troublesome in the hematology-oncology field, an area of medicine where the drugs may be highly toxic with only minimal benefits. The researchers noted much room for "interpretation" when reviewing such drugs.

For instance, many cancer drug studies use surrogate endpoints, which means the study may not reveal whether the drug improves survival or quality of life, but instead may evaluate a different outcome, such as tumor shrinkage.

The problem is that it's often unknown whether the surrogate endpoint, such as tumor shrinkage, leads to better health outcomes.

The end result, as Kaiser Health News reported, is that FDA-approved drugs may appear to be more beneficial than they really are. And, once FDA-approved, these drugs must be covered by Medicare and Medicaid programs, and the agencies are unable to negotiate prices.⁴

Further, when a reviewer is poised to work for the drug company manufacturing a borderline drug, he's likely to be more lenient. If a reviewer plans to someday work for the drug company in question, for instance, Prasad told Kaiser Health News:⁵

"Are you more likely to give [companies] the benefit of the doubt? Are you less likely to beat them up hard over [using bad comparisons in drug studies]?"

… Sometimes, the public needs [the FDA reviewers] to be firm. If they're not, no one else in the health care sector is going to be … The FDA is often the only real wall between ineffective, harmful drugs and patients."