Opalapril - I'm not sure I'm quite as resigned as yourself - recall that my time frame for a likely recovery is 12-24 months - but I am in agreement with most of your positions.
One absolute divergence regards this statement No one and certainly not Congress will get the FDA to reform, speed up, or loosen its grip on drug trials. Ten years or more and millions of dollars to bring a single drug to market simply is too long, too much, and with too much uncertainty.
Perhaps you are unaware that Ariad is associated with Dr. James Wilson of Penn, a leading proponent and practitioner of gene therapy (GT). An eighteen year-old patient (Jesse Gelsinger) died within days of receiving GT by Wilson last fall. An investigation by the FDA and others revealed an abysmal record of poor and deceptive practices - including the lack of full disclosure to patients of side effects found in prior applications. Moreover, the FDA concluded that Gelsinger should not have been treated in the first place since there was indisputable evidence his liver function was below the threshold previously determined for GT. Wilson and his colleagues intentionally ignored these guidelines.
The personal motives of Wilson, financial (he is the founder of Genovo, a private biotech company which has directed significant funds towards his lab at Penn) and machismo, cannot not be discounted and thus are potentially extremely troubling.
The Gelsinger affair only scratched the surface of the industry (within weeks, numerous investigators reported problems with their GT trials, problems that had been concealed until Wilson's revelations). Money really does change everything; without the peer-based review procedures of the FDA, and without the capability of strong enforcement procedures, including costly sanctions for abusing guidelines (the Gene Therapy center at Penn was shut down), the biotech industry would be even more of a morass of executives masquerading as biologists then it is today.
Perhaps the government needs to be a less intrusive force in our lives in other aspects of our society. That is a debate for another time. The government should NOT loosen its regulatory leverage in the biotech industry. The players in this sector simply cannot be trusted to conduct themselves without bias or to present their data objectively. With so much money involved, no one, certainly not congress, will get the biotech industry to reform.
The FDA is a mirror of the industry. If money didn't play such a large role in the presentation of data, then the NEED for the FDA would be significantly reduced. The FDA should be allowed to spend as much time as is reasonably adequate to review trial data without an iota of influence regarding this timeline from the industry or shareholders.
Reform the industry FIRST. Then we can discuss the FDA. |
