Drug companies may delay, withhold trial data from medical journals

Missing data from clinical trials that test the safety and efficacy of pharmaceutical drugs “distorts scientific record” and puts patients lives in danger, the British Medical Journal warns. The medical publication, which serves as a resource for policy makers and doctors, released several papers looking into the problem of unpublished trial data. One study from Yale University found that fewer than half of the 635 National Institutes of Health-funded trials were published in peer-reviewed medical journals within 30 months of trial completion. This includes experimental drugs as well as those already licensed on the market.

Lead researcher Joseph Ross said drug companies that delay publishing these findings, or even deliberately hide trial data, are breaching their ethical duty. “The evidence we publish shows that the current situation is a disservice to research participants, patients, health systems, and the whole endeavor of clinical medicine,” he said.

Data from these trials could provide vital information, such as evidence that a drug is dangerous. For example, Bayer faces lawsuits from women who say that the company was aware that its birth control pills Yaz and Yasmin put them at greater risk than other pills for suffering serious health problems, including blood clots, heart attacks, strokes and gallbladder damage. The company insisted that its oral contraceptives were no more dangerous than other pills. However, newly released studies show that the pills are more risky than older generation birth control pills.

In fact, during a Food and Drug Administration (FDA) advisory committee meeting reviewing the safety concerns associated with Yaz and Yasmin, the former FDA chief testified that Bayer withheld pertinent data on Yasmin and the increased risk for blood clots. (The committee recently recommended that stronger warnings be placed on the packages of Yaz and Yasmin, telling women that studies show the pills carry a greater risk for blood clots that can lead to serious health problems and even death.)

Yaz and Yasmin are among the top selling birth control pills in the United States and the United Kingdom; however, recent press about the drug’s link to blood clots has led to a drop in sales.

“Most clinicians assume that the complex regulatory systems that govern human research ensure that (clinical data) is relevant, reliable and properly disseminated,” Dr. Richard Lehman from Oxford University and the British Medical Journal’s Dr. Elizabeth Loder told the Daily Mail. “It generally comes as a shock to clinicians, and certainly to the public, to learn that this is far from the case.”

Daily Mail