Clinical Trial

Data analysis points to trial bias in journal reports

John Carroll — Tue, 16 Dec 2008 09:57:24 -0500

Medical journal reports on clinical trial results are intended to paint a clear picture of a drug's safety and efficacy. But a research team at UCSF recently concluded from an analysis of the data gathered in 164 trials that developers often skew their results, purposefully highlighting the positive when describing trial results--or omitting unfavorable information.

"We found really important information from the official trial reports that were either not published at all or that stressed mostly the positive results of trials in the published versions," Kristin Rising told the San Francisco Chronicle. And that leaves an inaccurate impression in the minds of physicians who later prescribe these drugs.

It all amounts to "bias, spin and misreporting" by the industry, says Mayo Clinic physician An-Wen Chan. But Ken Johnson, senior vice president of the Pharmaceutical Research and Manufacturers of America, says that a doctor gets all the information they need on a drug from detailed product labels.

- read the article in the San Francisco Chronicle

Tougher FDA bars seven researchers from new studies

John Carroll — Tue, 10 Jun 2008 08:40:18 -0400

So far this year a more vigilant FDA has barred seven physicians from conducting medical research work. The actions equal the number of actions taken by the agency over the past three years.

The FDA has come under increasing pressure to take action against researchers accused of fraud. Critics have maintained that the agency often takes years before moving to bar a researcher from new studies. And one of the seven barred in the first half of this year was Maria Anne Kirkman Campbell, a researcher who admitted five years ago to research fraud in a Sanofi-Aventis study. An FDA spokesperson says the agency has adopted a new, tougher time line on such actions and is in the process of hiring new staffers to beef up enforcement.

- read the report in Pharmalot

Researchers see FDA uncertainty behind hold on ESC work

John Carroll — Tue, 20 May 2008 09:27:38 -0400

The news that the FDA had put a ‘clinical hold' on Geron's plans to launch the first U.S. clinical trial of a stem cell therapy is attracting considerable scrutiny from researchers. The agency has yet to spell out exactly why it won't let Geron make the leap from preclinical work to a human trial. But Ole Isacson, a neuroscientist at Harvard Medical School, tells Nature that any outfit in Geron's position would have to offer convincing data that none of the transplanted cells could trigger a tumor or some other adverse event.

The problem in ESC research, he adds, is that no one has firmly established the criteria for that standard. Meanwhile, the FDA is still educating itself on the subject, and that is likely to give the agency pause before any human embryonic stem cell trials can be started.

At least one analyst, Steven Brozak of WBB Securities, has fretted that the Bush administration's objections to embryonic stem cell work may have forced the FDA's hand, but researchers say there's every reason to believe that the FDA simply doesn't know how to make sure the trials can be conducted safely. And that could prove to be a much bigger obstacle than politics for other ESC companies also looking to move into the clinic.

- read the article from Nature