Thursday, December 11, 2008

Asthma Medication: Calling Out the Safey Advocates

I posted "The Low Down on LABA's" precisely because I knew there would be a lot coming out in the media on this controversial topic. Of the media reports, the one most interesting to me is Advisory Panel Weighs Conflict on Asthma Drugs from yesterday's NY Times, which highlight what seems like a huge rift between the FDA Safety folks and the FDA's clinical folks. According to the NY Times:

Dr. David Graham, a safety official in the Food and Drug Administration, strongly recommended that the drugs, Advair, Symbicort, Serevent and Foradil, no longer be used to treat asthma in adults or children because they provide few benefits over simple steroid treatment and have serious risks. He said their use in children was particularly problematic.


Do you remember Dr. David Graham? He was the FDA insider who testified in front of Congress back in November 2004 right after the whole Vioxx fiasco. When asked what other drugs to be concerned about, he listed 5: Crestor, Meridia, Accutane, Bextra and Serevent. The head of the FDA immediately sent out a notice the following day stating the Dr. Graham's testimony did not represent that of the FDA, and that Dr. Graham was reporting his own opinion. Thus, Dr. Graham has for a long time been concerned with LABA's, and will likely continue to have strong statements against these medications (who likes to admit they were wrong?).

However, how did he do on the other 4? Well, he was right on Bextra which was pulled from the market in 2005. This is a drug similar to Vioxx, with similar cardiovascular problems. Interestingly, Celebrex (another similar drug) remains on the market and has not shown the same type of problems. Both Accutane and Merridia continue to remain on the market and in the past 4-5 years haven't shown the problems that Dr. Graham was concerned about. Finally, Crestor which folks like Sidney Wolfe wanted off the market was completely vindicated by the FDA in March of 2005, and recently I mentioned that one of the things missed in the media about the Jupiter trial was that in almost 18,000 patients taking Crestor 20mg or placebo there was no difference in side effects. Thus, excluding LABA's, Dr. Graham was only on target about the cousin of Vioxx that Dr. Steve Nissen showed was unsafe.

(Though I have no actual knowledge of this, I suspect it was Graham that tipped off Nissen on the FDA's data on Avandia. I have mentioned countless times (here here and here) about how this one highly publicized, poorly done meta-analysis has caused hysteria about safety issues with this medication that just doesn't seem to hold up with recent data).

Drug safety is incredibly important. As a physician I take an oath not to harm my patients. However, be very cautious in interpreting comments from folks like Drs. Nissen, Wolfe and Graham who also seem to be concerned with safety, but also like to get their name in the papers and push their own agendas. It has been reported that Dr. Nissen is on the list of folks being considered to head up the FDA. Could this explain why he made so much noise about Avandia?

3 comments:

Anonymous said...

My daughter, a very active varsity basketball player, uses albuterol for "exercise induced asthma". Lately she has developed quite noticeable heart palpitations - we have taken her to a cardiologist and all tests are coming back as "she's fine"! In a conversation with my pharmacist today, he informed me that albuterol can have this side effect. I am amazed that the cardiologist didn't pick up on this side effect nor did her pediatrician. Now I'm wondering if Xopenex will work for the asthma while ridding her of the palpitations which are very uncomfortable.

Dr. Matthew Mintz said...

Your daughter needs to see someone who is either a primary care physician well versed in asthma care or an asthma specialist such as a pulmonologist or allergist.
Xopenex may in fact reduce palpitations. She may be taking too much albuterol which is a sign of uncontrolled asthma

Ann said...

This website is informative, visitors will surely be benefited, Its our pleasure to read informative content on this useful website. We have also described about bronchial-asthma, Bronchial Asthma Treatment in our website www.ilovegsh.com