FDA Whistleblower to Air New Pain Drug Analysis

... and needs senatorial protection to do so.

http://biz.yahoo.com/rb/050217/health_painkillers_1.html

Reuters
FDA Whistleblower to Air New Pain Drug Analysis
Thursday February 17, 2:35 am ET By Susan Heavey

WASHINGTON (Reuters) - A veteran U.S. Food and Drug Administration scientist will unveil new data on Thursday before an expert panel charged with determining whether pain relievers similar to Merck & Co. Inc.'s now-withdrawn Vioxx should remain on the market.

David Graham, associate director for science and medicine at the FDA's Office of Drug Safety, will present a safety analysis that he says is larger than any previous related study. Graham is regarded as a maverick for his forthright criticism of the FDA's ability to monitor the safety of drugs once they are on the market.

... On Thursday, Graham will present data culled from California's Medicaid program, called Medi-Cal, that looked at more than 15,000 heart attack patients. The study is awaiting publication, and FDA officials had previously said they prefer that only published data be presented. Graham, who has sought legal counsel from a whistleblower protection group, said earlier this week he would not present the analysis at the meeting because he felt intimidated by supervisors.

He changed his mind after FDA Acting Commissioner Lester Crawford sent a letter saying there would be no reprisal. "I want to assure you that Dr. Graham is free to present from his Medi-Cal study ... without any concerns of retaliation from any FDA employee," Crawford wrote. The letter, provided to Reuters, was sent to Senate Finance Committee Chairman Sen. Charles Grassley, who has defended Graham since the scientist testified at a November hearing.

Intellectual diversity in the pharmaceutical industry and regulatory agencies? Sure. If it's guaranteed by the threat of jail for retaliation against those with opinions outside the main$$tream.

It has been said that today's pharmaceutical industry is having pipeline problems due to "having already picked the low-hanging fruit," despite their research labs spending billions of dollars annually. I have another theory. It may be that the industry has become infected with greedy non-medical MBA's and intellectual lightweights who have then brought in kindred at all levels of leadership. These leaders so bog down creative processes with bureacratic nonsense and create such an anti-intellectual atmosphere, that creativity has suffered severely.

Uncensored commentary on the Yahoo finance message boards on pharma investing, and on independent pharma sales/marketing sites such as www.cafepharma.com , is often quite interesting in this regard.

Creativity is the key resource in an industry such as this. Some pharmas are getting the message and are creating somewhat more independent islands of research in their labs, e.g., GlaxoSmithKline's CEDD's (Centers of Excellence for Drug Discovery).

Others are lumbering on with management models firmly anchored in the past or in the "management mysticism" fads of the consultant du jour. In my opinion, without an environment resembling that in academia, with central activities focusing on the library (both physical and virtual) and with freedom to pursue scientific leads without interference by non-science bureacrats demanding a short-term "return on investment", research labs in pharma may be becoming no more than cookie-cutter bakeries with less chance of innovation than a high school chemistry lab.

As for bioinformatics saving the day, my views on that are here.

-- SS