Tuesday, December 07, 2004

"Save us from the FDA"

A quick update to my last post:  There is an inspiring editorial in The Berkshire Eagle, from Pittsfield MA. 
Save us from the FDA
[...] The Bush political hacks who run the FDA are having fits. Dr. Graham has been told he may be "reassigned" to what he says would be a do-nothing job in the commissioner's office, where he would be far removed from research and analysis. His lawyer says Dr. Graham has received threatening anonymous calls from within the agency. Dr. Graham is trying to withstand the pressure and keep on with his life's work, which is reviewing the safety of drugs on the market.

In addition to fixing inadequate whistle-blower laws, congressional reformers should attempt to remove the monitoring of problematic drugs from FDA jurisdiction. This month the Journal of the American Medical Association urged just such a move. Drug safety involves life-and-death decisions for millions of Americans and has no place in a process that has been so thoroughly politicized. [...]
The editorial is worded more strongly than I would have put in a newspaper, although it is fine for a blog.  I found the editorial after doing a Waypath search; the reference was in a Livejournal post on Stranger than Fiction.  I mention this to give the author credit, but don't bother reading her post.  It's mostly about the author's social life; she mentions the editorial as an aside.  The JAMA articles that are mentioned in the editorial are available, open access:
Strom discusses the current US spontaneous reporting system and its limitations, concluding that while asking industry to monitor its own drugs is a conflict of interest, there is no need for additional duplicative regulatory oversight. Rather, more funding is needed to support programs that could complement the role of FDA in postmarketing surveillance. FREE ARTICLE

In an editorial, Fontanarosa, Rennie, and DeAngelis discuss recent drug withdrawals from the marketplace and the limitations of the FDA's postmarketing surveillance. They recommend that the drug approval process be decoupled from the postmarketing safety and surveillance system, including the establishment of a new drug safety monitoring agency, completely independent of influence from the pharmaceutical industry. FREE ARTICLE
The articles themselves are highly technical, but the first one mentions this gem about a Massachusetts Liberal:
The Joint Commission on Prescription Drug Use, triggered by Senator Edward Kennedy, called for creating a private nonprofit Center for Drug Surveillance to address these gaps; that call came in 1980. Twenty-four years later, I join Psaty et al in renewing that call. This could be accomplished by vastly increasing the number of CERTs and the funding of each. It also could be accomplished by forming a new organization. Regardless, such investment is critical to optimizing the health outcomes resulting from the substantial sums spent in the United States on therapeutics.
Maybe people should listen to Kennedy more often.

The second article contains specific recommendations for correcting the problems with the monitoring of drug safety. I won't repeat the recommendations here, since JAMA kindly made the entire text freely available.  However, I would like to add my own recommendation. 

Currently, the FDA does not have the authority to mandate specific postmarketing studies.  Yet, the current political climate is such that there is a lot of concern about expanding government, and about the role of legal liability in driving up drug costs.  In addition, there is concern about the propriety of spending a lot of public funds for additional safety testing.  After all, it is the drug company that stands to profit, so it would make sense for them to bear the brunt of the cost. 

In order to address these three concerns simultaneously, I suggest what I might call the Autobahn method.  There was a time that there was no speed limit of the expressways in West Germany.  There were posted speed recommendations, but here was no penalty for driving faster that recommended -- unless you caused an accident.  Then, you faced mush greater liability if you were driving above the recommended speed. 

What I suggest is that a new organization be set up, independent from the FDA, that has the power to recommend specific postmarketing safety studies.  The pharmaceutical company could choose to follow, or to ignore, the recommendations.  If they follow the recommendations, and find a problem, they would be exempt from punitive damages (assuming no actual malfeasance was involved).  Perhaps other liability limits could be set, although I am less sure about the appropriateness of that.  If the company chooses to ignore the recommendation, then they would have no special protection in the courts. 

The advantages are that the company pays for all the studies, so public funds are not used; the government does not take over additional regulatory functions, merely taking an advisory role; and there would be limits to liability, so long as everyone plays by the rules.  I'm not very good at thinking like a Republican, but I should think that this sort of compromise would be acceptable to them.  The drug companies might not like it, but they would go along with it more readily than they would a more intrusive system, and consumers get more protection. 

Liberal activists might argue that it does not go far enough.  Realistically, though, whatever is proposed has to be some kind of compromise.  Congress is close to a stalemate even on the 9/11 Commission reforms, even though just about everyone agrees that reform is necessary.  The Medicare drug benefit almost did not pass, even though the Party in Power (the PIP) hailed it as one of the most important advances put forth by the current administration.  Clearly, something needs to be done, quickly.  And given the near-paralysis of the PIP, there will have to be some serious compromise in order to get anything done.