Tag Archives: researchers

FDA promises crackdown on researchers who fail to properly register and report studies

Photo: Ferrous Büller via Flickr

For two decades, researchers have been required to register clinical trials that use any U.S. federal funding at ClinicalTrials.gov before they begin the study. The requirement grew out of a 1997 law aiming to increase transparency with studies that tested drugs, procedures or other treatments on people.

Researchers had to include the planned protocol, including endpoints, when registering their trial. If the endpoints changed during the trial, their registration had to be updated, including the reasons for the change. As of 2007, the law required all trial registrations to be completed within a year after the trial began, regardless of the trial results. Continue reading

Drug firms turn to private doctors for promotion

Pharmaceutical companies are turning to doctors in private practice to promote their products as universities have developed conflict-of-interest policies that limit their doctors’ activities, according to the latest report from John Fauber of the Milwaukee Journal Sentinel.

Fauber, who has been covering conflicts of interest in medical research for more than a year, reports that “So much money is at stake that in January one academic doctor resigned his job at Harvard rather than give up his speaking income.”

Medical schools can restrict doctors who work for them from advocating particular drugs and can require that they inform patients of their ties to drug companies, but private physicians have no such obligations.

In previous articles, Fauber has reported on University of Wisconsin doctors who were making six-figure sums from drug and medical firms by serving as consultants or doing promotional speeches.

Critics say the talks can be biased and contribute to spiraling health care costs by promoting the use of expensive brand-name drugs over generics. The practice, according to critics, also leads to more non-approved and potentially harmful use of those drugs, so-called off-label prescribing.