Frontline: Dangerous Prescription

Fri, 14 Nov 2003

Frontline, of Public Broadcasting System aired an investigative news report on Thursday that focused on the FDA’s systemic failure to protect the public from hazardous drugs. FDA had approved at least 12 dangerous prescription drugs–the “dirty dozen”–that killed people before the FDA ordered them pulled from the market. The advice given by former FDA experts is: don’t take a new drug until it’s been on the market at least 2 to 5 years– whoever takes a newly approved drug is an non-consenting guinea pig.

Frontline aims the flashlight where it belongs with FDA officials who have become promoters of industry’s financial interests rather than protectors of public safety.

Frontline examines the Politics, Profits, & Pharma, focusing on the FDA’s culpability in approving hazardous drugs even when prominent doctors alerted the agency about the hazards these drugs posed. The program examines FDA’s acquiescence to Pharma dictates. FDA lost its independence and much of its integrity in 1992 when Congress passed the Prescription Drug User Fee Act which enabled the drug industry to take control of the drug approval process.

Frontline also features some of the “spin doctors” who are contracted by drug companies to promote their (usually expensive, sometimes worthless) drugs to doctors and the in the media. These spin doctors pretend they are objective scientists.

When asked by Frontline, What does “FDA Approved” mean? Dr. Steven Galson, Acting director of the FDA’s Center for Drug Evaluation and Research responded: “What it means when a drug is approved is that the risks are outweighed by the benefits for the indication and under the conditions that are in the label.”

By that approval criteria, antidepressant drugs (such as Prozac and the other SSRIs) should not have been approved. In most company controlled clinical trials the drugs failed to show a benefit greater than placebo. Furthermore, SSRIs produced severe adverse effects during these short clinical trials. Frontline did not investigate this latest hazardous drug controversy.

Previously concealed, compelling evidence from company documents has come to light demonstrating that SSRIs induced suicides and mania in children prescribed antidepression drugs, but not in children on placebo. FDA failed to examine evidence of harm, and is currently attempting to block testimony by an expert psychopharmacologist with an international reputation–whose testimony based on the evidence contained in concealed company documents which he has examined–from testifying before the upcoming FDA advisory committee meeting on Feb 2, 2004.

Transcripts and video tapes available

See: Frontline, Dangerous Prescription http://www.pbs.org/wgbh/pages/frontline/shows/prescription/

FDA Hazardous to your Health? http://www.pbs.org/wgbh/pages/frontline/shows/prescription/hazard/

How Independent is the FDA? http://www.pbs.org/wgbh/pages/frontline/shows/prescription/hazard/independent.html

A Dirty Dozen–drugs recalled between 1997-2001: http://www.pbs.org/wgbh/pages/frontline/shows/prescription/etc/dozen.html

Fen Phen: http://www.pbs.org/wgbh/pages/frontline/shows/prescription/hazard/fenphen.html