October 26

Former FDA Commissioner says FDA lost public trust

Former FDA Commissioner says FDA lost public trust

Mon, 17 Oct 2005

The FDA’s failure to ensure drugs are properly tested in trials designed to detect serious adverse effects,  and the agency’s failure to require follow-up post-marketing studies to be reasonably secure in the knowledge that no lethal drugs are unleashed on the public has eroded public trust. Former FDA Commissioner, Dr. David Kessler (who served under both former President George Bush and Bill Clinton) and is now dean of the University of California at San Francisco, told National Public Radio (on All Things Considered, October 12) that the FDA’s credibility is at the lowest level he has ever seen. He said that FDA’s credibility is at its lowest level among physicians and the public. The failure to appoint an  acting commissioner from within the professional ranks of the FDA leads Dr. Kessler to say, he’s “not sure the White House trusts the FDA.”  Listen to audio: http://www.npr.org/templates/story/story.php?storyId=4956167&ft=1&f=1001

A new study to be released on October 18 recommends increasing pharmaceutical user fees specifically to assess the safety of newly marketed drugs: “There is a real, dire need for randomized, clinical trials comparing the safety of drugs for chronic conditions,” said Daniel Carpenter, MD, professor and director of graduate studies in Harvard¹s Department of Government. “Pick the five to ten drugs you’re most worried about and test each of them in long-term comparative clinical trials. This would give valuable information to physicians and consumers, and save lives.”

An expert epidemiologist with a pharmaceutical company suggests that the FDA should:

  1. Require larger studies for approval.
  2. Increase the disincentives for not studying people. If a group is excluded from studies, that fact needs to be on labels.
  3. Require large trials immediately after approval to be completed within two years.

Instead of addressing life-threatening drug safety issues, the FDA has taken steps to protect corporate drug giants. In its latest Amicus brief in response to a Utah federal judge who asked the FDA to state its position re: the association between antidepressants and suicidality in children and adolescents. The FDA has, once again, come to the defense of Pfizer Pharmaceuticals–a clear demonstration of the agency continued disregard for public safety.

The case involves a 15 year old girl, Shyra Kallas, who was prescribed Zoloft (sertraline, in 2002) by her primary care doctor for warts. While taking Zoloft, she shot and killed herself – she died in her father¹s arms. (Kallas v Pfizer, Case No. 2:04-CV-00998 PGC) The FDA argued that a manufacturer’s failure to warn about hazardous, potentially lethal drug effects, is absolved from legal liability if the FDA had not required such warnings. But that argument is flawed for several reasons:

First, the duty to warn about adverse drug effects rests with the manufacturer–the FDA is supposed to ensure that the manufacturer complies with that duty. In the Amicus brief, the FDA counsel SPECULATES that IF Pfizer would have proposed adding a warning (before 2004) about an increased risk for suicide-related behavior in children and adolescents prescribed Zoloft, the FDA would have prevented the company from doing so, arguing–irrationally–that to warn about a safety hazard is to “misbrand” the drug.

Second, FDA’s argument is illegitimate because it cannot provide evidence of Pfizer having, in fact, submitted such a request for a change of label. Since the FDA did not (in fact)  object to a proposed warning, Counsel’s claim is pure specularion. Does FDA’s claim that it would have rejected any proposed warning–without knowing what the proposed warning stated? Does Counsel claim the FDA would have objected without even evaluating the evidence?

Third, FDA’s brief argues from a position of presumed infallibility. But FDA’s judgement about drug safety has been shown repeatedly to have been based on ignorance and failure to analyze a body of evidence. As for example, Zoloft clinical trial data pre-dating 2002. In fact,  FDA’s acknowledgement (in 2004) of a twofold greater risk of suicidal behavior in children taking an SSRI compared to those on a placebo is based on pre-2002 evidence. Thus, FDA’s failure to ensure warnings were issued in a timely fashion when there was “reasonable evidence”–is a crime of omission that led to preventable deaths.

In its brief to the Court, the FDA misrepresented the evidence and the analyses by numerous independent expert scientsts whose conclusions led the agency to add prominent warnings to these drugs’ labels in 2004, and to add Black Box warnings in 2005.

Although its legal mandate is to protect the public, the FDA has assumed the role of advocate for Pfizer whose product label failed to disclose a twofold increased suicide risk for children and adolescents prescribed Zoloft in the knowledge that this age group was being prescribed their drug.

Dr. Kessler’s assessment of FDA’s loss of credibility is correct. An article in The New York Times (F.D.A. Responds to Criticism With New Caution, August 6) claiming that the FDA had undergone a sea change–“Stung by a series of drug safety scandals, the Food and Drug Administration has in recent months issued a blizzard of drug-safety warnings and approval times for new drugs are slower”–was, to say the least, premature.

From thier actions, we see that FDA officials have neither changed their course, or their support for industry–even when innocent lives are put in jeopardy from undisclosed hazardous drug effects. Nor have thes FDA officials learned anything from one after another drug debacle in which the agency had protected industry’s marketing interests and stood silent as the human casualties climbed.

Contact: Vera Hassner Sharav

Health Affairs

Amid growing national concern and decreasing consumer confidence in the safety and efficacy of new drugs, a new study in the journal Health Affairs proposes raising user fees for pharmaceutical companies and using those funds — which could equal as much as $42 million per year — to assess the safety of major new drugs on the market. The study is embargoed until 12:01 a.m., Tuesday, October 18.

Consumer confidence in new drugs — and the ability of the Food and Drug Administration to protect consumers from harm — has dropped markedly in the past several years, especially in light of the Vioxx recall, according to study author Daniel Carpenter, MD, professor and director of graduate studies in Harvard¹s Department of Government and a Robert Wood Johnson Foundation Investigator Award Scholar.

“There is a real, dire need for randomized, clinical trials comparing the safety of drugs for chronic conditions,” said Carpenter. “Pick the five to ten drugs you’re most worried about and test each of them in long-term comparative clinical trials. This would give valuable information to physicians and consumers, and save lives.”

He suggests that drugs with a “Vioxx-like market” would make excellent candidates for comparative trials, and could possibly include Crestor, Celebrex and several of the new SSRI drugs which have been linked to teenage suicide. A slight increase to the user fee already assessed to pharmaceutical companies would go a long way in creating a better and safer system for patients.

Currently, user fees are targeted toward moving new drugs through the approval system to get them on the market as quickly as possible. The FDA has little power to enforce statutes that the pharmaceutical companies study the long-term affects of the drugs. The new fees would focus on assessing the long-term safety of these drugs once they are on the market — something that is not currently done with independent, rigorous clinical trials, according to Carpenter. The fees would fund at least 3 new long-running significant trials per year, which could be conducted by either the National Institutes of Health or other impartial organizations such as academic medical centers.

The study, which is being released as a Web-Exclusive in Health Affairs, embargoed until Tuesday, October 18 at 12:01 a.m., details the steps that can be taken to improve the safety of drugs currently on the market.

For more information or to set up interviews, please contact Jacki Flowers at 301-652-1558.

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