Tuesday, February 15, 2005

Changes in the Drug Safety Landscape

The New York Times today has two articles about changes at the FDA.  One mentions that the Agency has a new commissioner.  The second informs us that the FDA is creating anew board to monitor drug safety.  Also the New England Journal of Medicine published today was a set of early-release articles about the safety concerns that have arisen regarding Cox-2 inhibitors (Vioxx, Bextra, Celebrex).  The articles are on the NEJM website now, and will be printed in the 3/17/2005 issue. 

The Cox-2 story has attracted a lot of attention, and I am not sure I have anything to add to the volumes written already.  However, the Corpus Callosum is all about connections, and the two topics -- the changes at the FDA, and the Cox-2 story -- are indeed connected.  The top job at the FDA has been vacant for a long time, possibly because not a lot of people actually want the job right now.  And the creation of a new drug safety board is a direct response to the public concern about the Cox-2 inhibitors, among other recent and brewing matters.  However, the Bush Administration does not have good record when it comes to addressing matters of public safety.  Do the current efforts exceed our expectations, or do they fall short?

The NYT article about the new commissioner, Dr. Lester M. Crawford, informs us that he is a veterinarian with a PhD in pharmacology.  He has experience in government, academia, and in the food industry.  Reviews of his selection have been mixed:
"By rewarding Mr. Crawford for buckling under political pressure, President Bush is showing his true colors once again," said Nancy Keenan, president of Naral Pro-Choice America, an abortion rights group. "In this administration, keeping far-right activists happy is the most important thing."
Frankly, I'm not sure that Dr. Crawford views this new job as a "reward."  Nor am I sure that NARAL has the expertise to make an informed judgment on this topic.  Other reviewed were mixed, or positive:
Not all consumer groups agreed. "He's not my ideal candidate, but the devil you know is better than the one you don't," said Dr. Michael F. Jacobson, executive director of the Center for Science in the Public Interest, a frequent critic of the government and the food industry.
Senator Edward M. Kennedy, the Massachusetts Democrat whose opposition could have proved troublesome, said, "Dr. Crawford has had a long association with the F.D.A. and is intimately familiar with the issues facing the agency."
My concern is not about the man, since I frankly don't know the guy, and as far as I know, he appears to be qualified.  At least he's willing to do it, despite the fact that he undoubtedly will face intense scrutiny and frequent criticism, no matter what he does.  Rather, my concern is about the new drug safety board. 

One of the editorials in the NEJM (subscription required for full text) states:
COX-2 Inhibitors -- Lessons in Drug Safety
Bruce M. Psaty, M.D., Ph.D., and Curt D. Furberg, M.D., Ph.D.
February 15, 2005

[...] We believe that to protect the public, Congress needs to provide the FDA with the necessary authority and also to create an independent Center for Drug Safety with new authority and funding.  Civil penalties should be commensurate with drug sales.  Provisional approval and regular repeated review would provide opportunities to reevaluate risk and benefit.  In addition, congressional oversight of the FDA would afford an important forum for the public discussion of drug safety.  [...]
However, the new board, as currently conceptualized, will not be independent, there is no provision for direct congressional oversight, appears to have no new authority, and there is not sufficient funding:
F.D.A. to Establish Group to Monitor Approved Medicines

WASHINGTON, Feb. 15 - Responding to widespread criticism that government oversight of drug safety problems is inadequate, the Food and Drug Administration announced today that it is creating an independent drug-safety board.

Dr. Lester Crawford, the F.D.A.'s acting commissioner, said that the board would be made up of scientists from several government departments as well as the chairmen of the F.D.A.'s independent advisory boards.

When drug controversies erupt, the board will examine the science involved and decide how the agency should respond and what to tell patients. [...]

Dr. Crawford, who is being nominated by President Bush to head the agency, acknowledged that its present system for monitoring unexpected and sometimes lethal drug reactions is a passive system.

"We need an active system," he said.

The announcements drew muted praise from drug-safety advocates and academics. Advocates have been calling for a more muscular drug-safety agency that would be entirely independent of the F.D.A. or at least independent of the agency's drug review division. The new board will not be completely independent of either.

In addition, academics note that creating an active drug reaction surveillance system could cost tens of millions of dollars each year. So far, there is no money in the agency's budget for such an expense. [...]
Creating a separate agency would be politically unpopular, in these days of budget cutting and supposedly smaller government.  The last major restructuring of the FDA included a provision for partial funding from the drug industry.  That seemed like a good idea at the time, since it took some burden off of taxpayers.  Now, however, it is one factor that has been implicated in the creation of the more recent controversies.  Having an independent review board would enable the FDA to  receive funding from industry, but eliminate or reduce the worry about conflict of interest. 

The NEJM editorial by Drs. Psaty and Furberg mentions that the new board should have real authority.  This should include the ability to mandate remedial action by industry.  Currently, the FDA negotiates with industry about any proposed changes.  Of course, the companies come to these negotiations armed with reams of data and carefully-crafted arguments, often the result of lengthy, costly preparations by a small army of experts.  To counter that, the FDA has few harried scientists, understaffed, with limited financial resources.  In that context, negotiation is not very effective.  They need legal authority.  The editorial mentions several areas specifically.  These include the ability to change product labels, mandate physician or patient education, limit or ban certain advertising campaigns, modify approved uses of medications, or to restrict the use of medication to certain subgroups of patients.  Perhaps most importantly, they need authority to mandate the completion of post-marketing surveillance studies. 

Yes it would cost money.  Remember, though, that we are spending over a billion dollars a week fighting an unnecessary war, in an adventure that is costing more American lives than it ever will save.  In that perspective, spending tens of millions of dollars per year, to save thousands -- maybe tens of thousands -- of lives, looks like a pretty good deal.

(Note: The Rest of the Story/Corpus Callosum has moved. Visit the new site here.)
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