My Take on the Toke – The FDA, Marijuana, Plan B, Politics and Bad Communications

Ph03391i Last week, the FDA issued a statement to the effect that marijuana has no medical value.  Unfortunately, the FDA’s credibility on scientific decisions that have political issues associated with them has been wantonly squandered by agency’s inaction on the RX-OTC switch of Plan B contraceptive.   According to the New York Times, a spokeswoman for the FDA was quoted as saying that the study was released because of a request from members of Congress.  With this action, it would seem that the agency cannot resist the temptation to take a gun, aim at foot, pull trigger. 

This is not said out of a conviction for or against the use of medical marijuana.  Like Plan B, I don’t intend to use it.  However, especially now, the agency should be concerned with communicating issues to carefully try to re-build its reputation, not do it further damage.

The FDA’s announcement puts them squarely at odds with another venerable institution, the Institute of Medicine, which in 1999 issued a report outlining the medical benefits of marijuana.  My guess is that if you would poll people on which of these two institutions, the Institute of Medicine IOM) or the FDA enjoyes more credibility just now, a majority would choose the former over the latter.

The FDA does not seem to realize that its image is in a state of decline that could rightfully be called a "crisis" and as such, the best and first favor you can do for yourself and your constituency is to come clean with the facts.  They would do well to study the posting of April 17 on crisis and learn from it.

As mentioned earlier – a charge unanswered is a charge admitted.  To the charge that the Plan B inaction is politically motivated, the agency has simply responded that it is not, despite evidence to the contrary.  Given the evidence-based nature of their approval of drugs, they should know better.  If it is not political, offer some evidence that the issues cited for study are in fact valid.  But do not expect people to take your word for it.  (Though this week, according to New York Newsday, former FDA Commissioner Lester Crawford, Dr. Janet Woodcock and Dr. Steven Galson are all supposed to have depositions taken in a Plan B-related lawsuit in New York.)

On the medical marijuana front, not only is the agency at odds with IOM, but with its own history on the subject.  The FDA approved Marinol, a synthetic version of marijuana, for medical use, which is at the very least an indication that there  is some benefit from marijuana.  To not answer critics’ questions about the marijuana advisory will only further damage the reputation of the agency.

Perhaps someone at the agency grasps this a bit.  The press release about the marijuana advisory was not listed on the home page of the FDA, unlike most other press releases.  It also did not contain a quote from any individual in the agency.  It would not appear that the agency was all that anxious to be associated with this.  One can only hope.  However, they did it, it did get widespread media coverage and the damage was done. 

As stated in the New York Times Article –

"Unfortunately, this is yet another example of the F.D.A. making pronouncements that seem to be driven more by ideology than by science," said Dr. Jerry Avorn, a medical professor at Harvard Medical School. 

It is now up to the agency to prove this sentiment wrong. 

This entry was posted in FDA Image, FDA Policy. Bookmark the permalink.

1 Response to My Take on the Toke – The FDA, Marijuana, Plan B, Politics and Bad Communications

  1. Ed Vawter says:

    While I don’t think the FDA’s scientific credibility is in crisis just yet, it certainly is in deep, deep trouble. I think the next issue that will be interesting to watch is Merck’s cervical cancer vaccine “Gardasil”. There has been opposition to this from the right wing saying it will lead to sexual promiscuity. They overlook the number of lives that it could save each year. This will be the next test of the FDA’s willingness to use solid scientific evidence to make politcally pressured decisions.

Comments are closed.