Policing Unsafe Drugs--A Toothless System

Two brief news items about how hard it is to get the drug industry to behave, and keep unsafe substances off our shelves.

First, among many useful and informative recent items on our fellow blog, Health Care Renewal, is a post:
http://hcrenewal.blogspot.com/2010/08/proprietary-information-confidentiality.html
--which in turn is based on a Wall Street Journal article by Alicia Mundy (see post for link). At issue is the 2007-8 deaths of 81 patients due to contaminated heparin imported from China, and sold in the US by Baxter and Scientific Protein Laboratories LLC. Previous accounts have suggested that we don't know where the contaminants in the heparin came from and who is responsible because the Chinese government investigation sort of petered out, and the FDA lacked the wherewithal to go in themselves and get to the bottom of it. In sum, we treated the deaths of 81 people as if it was a sort of natural disaster, with no one to blame. But Mundy's story tells a rather different tale-- that a Federal judge has ruled in favor of a motion by Baxter and SPL to declare various company documents proprietary and hence protected from publication. Other parties to the suit (admittedly who have their own financial dogs in the fight) objected to this motion on the grounds that the documents, if revealed, would be of great public health importance in identifying the likely sources of the contamination.

So what we seem to have is a Federal court that is willing to help private companies keep documents secret, that could actually have answered at least some of the outstanding questions about a drug safety problem that caused 81 deaths. Suddenly the disaster is not seeming so natural any more.

Next, we can turn to an article in the New York Times by Gardiner Harris (see comment below):
http://www.nytimes.com/2010/08/20/health/policy/20fda.html?scp=2&sq=gardiner%20harris%20glaxo%20memo%20avandia&st=cse
This article shows that one ancient element of FDA lore has not changed over many decades. The FDA ordered GlaxoSmithKline to send out a "dear doctor" letter in July, summarizing the conclusions of an expert panel on the risks of the diabetes drug Avandia (see my previous post about the panel, http://brodyhooked.blogspot.com/2010/07/follow-up-on-fda-avandia-hearings.html). Now, critics are charging that the letter is misleading and amounts to a whitewash of Avandia.

In HOOKED, I described an interesting incident in FDA history about the antibiotic chloramphenicol. It was found to cause a rare but deadly adverse reaction, but neither could the FDA withdraw it from the market because it was the only available treatment for a couple of rare but deadly infections. The end result was a peculiar dance, in which at every point the FDA was outmaneuvered by the manufacturer, Parke, Davis. The FDA would order Parke-Davis to write a "dear doctor" letter telling physicians about the risks of side effects with chloramphenicol, and not to use it for colds and sore throats but to keep it in reserve for really serious infections. Parke, Davis kept sending out letters which said that chloramphenicol had been found to be safe by the FDA--after all, they had not taken it off the market--and so doctors should keep using it with confidence.

Bottom line--if you want the letter to say what you want it to, write it yourself. The fact that the FDA keeps going hat in hand to beg the drug company to say what needs to be said is just one more sign of the system's inability to protect the public health.

My promised comment: I used to regard Gardiner Harris as one of the heroes of investigative journalism for his role in regularly exposing Pharma misdeeds. Now I need sadly to take anything he writes with a grain of salt, after his role earlier this year in trashing the Dartmouth Atlas research group without any discoverable basis in fact.