Here’s a crackerjack case that hits all the important issues regarding the role of the FDA in regulating drugs: Gergana Koleva reports for Forbes that Regenerative Sciences is offering a stem-cell treatment for damaged joints that has not been approved by the FDA. The agency has sued the company, claiming that its treatment–in which stem-cells are derived from a patient’s bone marrow and re-injected into damaged joints, according to Koleva–should be regulated under the rules for new drugs.
Koleva quotes from a post on the company’s blog saying the FDA lawsuit is about anyone who wants his or her body “not to be an FDA regulated drug factory.” The idea, I guess, is that because this is a re-injection of a patient’s cells, it isn’t a drug. The post seems to be arguing that living cells are not drugs and so shouldn’t be regulated by the FDA.
The director of a clinic that administers the treatment told Koleva that the lawsuit is a “civil rights issue that will define what control you have about the use of your own cells and tissue.”
And that’s pretty much how the rest of the story goes–strongly tilted in favor of the company’s position. An academic says the treatment poses less of a risk than many drugs. The company says regulation would “impose an unbearable administrative and economic burden,” which is pretty much what all companies say about government regulation. The pharmaceutical industry doesn’t much like the FDA either, but it manages to profit, often enormously, in spite of government regulation.
She continues to quote people sympathetic to the company, and even allows someone to make the charge that the FDA is in cahoots with the pharmaceutical industry, which will somehow get a lock on the market if the FDA acts. She didn’t elaborate on that, and I don’t get it.
Finally, in the fourth-last graf, she quotes somebody saying that the FDA is only trying to protect people by making sure the treatment is safe and effective. Whew. I was able to stop holding my breath, after waiting for something–anything–on the other side of the story.
On a brighter note, Elie Dolgin at Nature Medicine came through last week with a fine piece on the effort to find drugs to prevent suicide. It turns out that that’s not an easy thing to do. Most psychiatric studies, he points out, exclude anyone expressing thoughts of suicide. Many trials that do look at suicide consider only surrogate endpoints, such as “suicidal ideation,” rather than suicide itself. One recent study compared lithium and Depakote, which are both used to treat bipolar disorder, to see whether either reduced the risk of suicide. The trial was “underpowered,” meaning it did not have enough subjects or run long enough to provide an answer.
I could go on, but you should read the piece yourself. It’s a nice piece of work on a rather subtle topic, where many writers could falter.
But read it quickly. According to Dolgin, Nature Medicine allows its news stories to be read for free online only in the first month after publication. Then they are put behind a pay wall. If, for example, you want to read Dolgin’s story from last December about financing vaccines for low-income countries, you’ll have to pay 32 freaking dollars for it. That’s for one article! If you’re a subscriber, that’s more than Nature Medicine charges for an entire issue ($225 for 12 issues).
Does anybody actually pay $32 for one news article? Not with my tax dollars in an NIH grant, I hope. On the other hand, if somebody is paying, I’d like to know who. I’m willing to sell them my Tracker posts for a modest $29.95 each.
What exactly is the business plan here, oh guardians of Nature Medicine? Why do you want to keep your fine journalism locked up, especially if you’ve already given everybody a month to download it? Reminds me of Mission Impossible: This tape will self-destruct in five seconds…Good luck, Elie!
I should let it go, but this silliness upsets me about as much as the fight between Time Warner Cable and the MSG channel that means I can’t watch Jeremy Lin and the Knicks.
Ahhhhh. Sorry for venting at your expense, but I needed that.
– Paul Raeburn
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