Monday, April 7, 2008

Risk Analysis Of The F.D.A.

Again the media is all a buzz about the many shortcomings of the FDA (Food & Drug Administration) and its inability to prevent faulty drugs from being sold to the public or even withholding viable drugs from the market, due to politics. This has been an on-going problem as Dr. Henry I. Miller, a former FDA official (1974 to 1994) and a fellow at the Hoover Institution, wrote in his February 2008 letter to the NY Times’ Editor:

“Although it’s true that the Food and Drug Administration lacks “enough money or enough skilled scientists to do its job,” more resources alone are not the answer. The agency’s most significant problems are mismanagement and a culture that is excessively risk-averse. According to a 2006 survey of biopharmaceutical companies’ views of F.D.A. oversight…more than half said that the F.D.A. “needs the most improvement” in “risk-based decision-making,” which is supposed to be regulators’ essential stock in trade.
Dr. Miller’s view is only the latest in a series of complaints and concerns about FDA. In 2004, NY Times reported on FDA preventing Dr. Andrew D. Mosholder, a FDA epidemiologist and top expert, from presenting at a public hearing his study’s findings that “antidepressants cause children to become suicidal.”

The most damning testimony came from Dr. David Graham, the Associate Director of Drug Safety for the FDA. In 2004, Dr. Graham went before Senate Committee and blew the whistle on the FDA. Dr. Graham blamed the FDA for allowing dangerous drugs to stay on the market, which contributed to the deaths of thousands of Americans. In his testimony, Dr. Graham recommended major changes, including “competent management, discipline in the ranks, more effective risk-benefit balancing, a commitment to permitting patients to assume more responsibility for the risk of medicines, and the banishment of politics from regulatory decisions and policy.”

Drs. Graham, Mosholder, and Miller have confirmed what the media had been reporting all along: FDA, a regulatory body that is supposed to be an expert at assessing the risk versus benefit of new drugs, could not perform its fundamental task and allowed dangerous drugs into the market. This is very troubling. So what is being done about this?

Not much, unfortunately. Dr. Graham testified in November 2004 and Dr. Miller wrote about the same issue in February 2008. Nearly four years and three FDA Commissioners later, we have the same problem. One would think that after story after story of FDA woes, the Congress would have shaken up the FDA management.

Instead, we are still reading like lawsuit against J&J for hiding safety risk data on birth-control device and FDA approved drug being revealed as being ineffective (Vytorin and Zetia). (These are only a small sample of issues, as there are many more, including the pet food poisoning in early 2007.)

Are we not outraged at reading about another failure on the part of the FDA to protect the public? We should be. Rather than reading about how the FDA is failing to protect the public from dangerous drugs, we should be reading about how the FDA was able to prevent dangerous drugs from being sold in the U.S. Harmful drugs should be so rare as to cause major public outrage and immediate corrective action, as it was in the case of the 1982 Tylenol scare. Where is the accountability?

Because of this lack of accountability, J&J will probably win the lawsuit by using the “pre-empted” motion that is based on the theory that the FDA is the only agency with enough expertise to regulate drug makers and, therefore, the courts should not second-guess its decisions. (Here are the precedents, and here, that pave the way for J&J having a good chance of winning.)

Corrective Actions
Dr. Graham’s recommendations are still relevant today as it was when he gave them in his testimony before the Senate Committee in 2004:
  • Install competent senior management
  • Have the senior management install discipline in the ranks
  • Institute a more effective risk-benefit balancing
  • Banish politics from regulatory decisions and policy
To Dr. Graham’s list, I will add the following additional corrective actions:
  • Instead of relying on drug maker’s data for drugs’ safety, efficacies, and quality, as it is currently done, have the FDA conduct the clinical tests directly. FDA can outsource the clinical tests to a respected medical research facility that is not affiliated with any drug manufacturer. Also, have the drug companies pay for the clinical tests. This way FDA will receive the drug data immediately and without any delay or redaction of negative data, as is being done now.
  • Make the FDA strictly a medical regulatory body. Hand over the Food regulatory portion to the U.S. Department of Agriculture, which already monitors and regulates food and food products.
  • Combine the FDA, stripped of its responsibility for food, with AHRQ - Agency for Healthcare Research & Quality, ATSDR - Agency for Toxic Substances & Disease Registry, CDC - Centers for Disease Control & Prevention, and NIH - National Institutes of Health to create a new FDA (let’s call it Federal Drug Administration).
The resulting agency will be streamlined and focused on health, medicine, and disease. The cost savings should be realized (especially by leaving the acronym as FDA) as it will remove multiple layers of bureaucracy and cut through red tapes created by competing agencies’ agenda.

I doubt that the Federal Government will make any substantive changes to the FDA. After all, I am not the first one to highlight the multitude of issues with the FDA or make recommendations for its improvement. And I won’t be the last one either. The workings of the government, like major corporations, are driven by life-timer (bureaucrats, in the government), who have been with the organization for decades and are very resistant to change.

Perhaps, if we had a similar law as China, which can be very harsh, things might change that much faster.

Ed Kim
Disclosure: Author holds no positions in Pharmaceuticals

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