This is a somewhat misleading title, since I really plan to whine about people who whine about the government. In my last post, I mentioned that the Bureau of Land Management was planning to cull the western wild horse herds by killing 6,000 of them. The BLM already has 30,000 animals confined in pens awaiting adoption, and it seems fairly clear that euthanasia is an unavoidable next step. Or at least it was, until Madeleine Pickens offered to take all 30,000 of the horses off the BLM’s hands and place them in a new, one-million acre sanctuary. Before we all get up in arms about the heartless cruelty of the BLM, it seems obvious to me that they are out of space and money. Mostly money. Can you even imagine how much it costs to feed 30,000 horses? I suspect the BLM is between a rock and a hard place.
But today’s target is not the BLM, but the FDA. I’ve been thinking a lot about the FDA recently, because in the last month I’ve been prescribed two drugs “off-label”, meaning, “not approved by the FDA for that use”. The first is a drug called Avastin. This is a cancer treatment drug–though not even approved for all cancers–which prevents the formation of new blood vessels, in an effort to starve tumors which cleverly create their own new blood supply. Opthamologists have been using it for years to stop bleeding in the retina. The company that makes Avastin, Astrazeneca, came up with a modified form of the drug and called it Lucentin, which is presumably more suitable for injection, and Voila! The FDA approved it, just like Astrazeneca wanted them to. At that point, Astrazeneca tried to withdraw Avastin for use by opthamologists, and the doctors went into revolt. Why? Avastin is $300 per dose; Lucentin is $2,000 per dose. Can you say, profit motive? And the FDA was complicit.
The second drug is Crestor, a drug to treat high cholesterol, even though my cholesterol is normal. Just days after I started taking it, an article in the New York Times reported that a new study shows that Crestor, in particular, cuts the risk of heart attack by more than 50%, and the risk of stroke by slightly less than 50% even in people with normal cholesterol levels. If I already hadn’t started taking it, I would have been asking where to sign up. On the other hand, the study, like 99.9% of all such studies, was funded by the drug company which makes it. Three guesses which drug company that is? Close your eyes and guess, and no fair peeking. You got it–Astrazeneca. Hmmmn. I wonder what this study will do for sales of Crestor?
But after whining a bit myself, I did a reality check and here is the reality: the FDA does not have the money to do its own studies. It reviews the data and makes a decision to approve or not approve based on the data it gets from studies commissioned in most cases by the drug companies. And there is a certain level of trust that has to be there; the thinking being that it would not be in a drug company’s best interest to release a drug that kills a bunch of people. (And see how well that worked with the FDA approved drug Vioxx, which killed a bunch of people. At least it was made by Merck.) But if that level of trust were not there, it would take eons for every drug to be approved, if we had to wait for the FDA to verify every single study.
In short, there is no future in whining. If you don’t give the government the resources it needs to do the job properly, then you can’t blame them when things go wrong. The sad part is that rather than acknowledge that we aren’t funding the FDA sufficiently, if something really bad happens (one case of mad cow disease in the U.S. is all it would take) there are people who will be pointing fingers at the FDA and wondering why they didn’t do more with less. Because the government is funded by that evil four-letter word: taxes. The deregulation, government-is-the-problem, let-the-market-handle-it crowd will be howling for the head of the FDA on a platter if there is a true disaster–and there have already been mini-disasters.
What we need is to refocus our priorities. If it were up to me, I’d be throwing a lot more money at the FDA.