Welcome to my blog, a place to explore and learn about the experience of running a psychiatric practice. I post about things that I find useful to know or think about. So, enjoy, and let me know what you think.

Tuesday, October 29, 2013

Speedy Delivery

I've been reading Ben Goldacre's Bad Pharma. It's even more disheartening than Let Them Eat Prozac. I believe he has a newer edition out, but the one I'm reading was published in 2012, so it's still fairly recent. The problems with how drugs are regulated are mind-boggling.

As an example, the FDA requires only 2 studies for a new drug to get approval. These are drug vs. placebo studies. Basically, the drug company has to show that their new drug was better than placebo for whatever its indication is. It does not have to prove that it's any better than existing drugs with the same indication. And these studies don't have to last very long.

The time to approval has been decreasing, too. In the 80's ACT UP was instrumental in getting laws passed to push not-completely checked out drugs through the system, so that people who were dying of AIDS could have access to potentially life-saving meds. And that makes sense. If you know you're going to die without the drug, and with the drug, you might live a little longer, then it's worth the risk.

But apparently, the legislation that was created for this purpose is now being used to get other, not-as-necessary drugs approved in an expedited way. One requirement that the FDA makes is that, when safety is in question, the drug company promise to do a follow-up study to determine real world effects. This can happen when, for example, a surrogate value is used to establish the efficacy of the drug. So the drug has been shown to lower blood pressure. But it's not clear what it does in terms of improving mortality, or if it may, in fact, be harmful in longer term use than was clear from the initial study.

Well, the drug companies, promise, and largely don't follow through. And the FDA doesn't do much to follow up.

Like I said, Bad Pharma was published in 2012. So this should be old news, with perhaps some improvement since then.

But today, Reuter's published, "Study questions FDA's shorter drug approval times", referencing a study published yesterday in JAMA Internal Medicine.

It found that expedited drugs underwent a median of 5.1 years of clinical testing before being approved, compared with 7.5 years for those that underwent a standard review. But in many cases safety monitoring trials that were supposed to be conducted after the products were approved were either not conducted, not completed, or not submitted to the FDA...

...Of the (20) drugs studied by Moore and Furberg in 2008, the FDA required 85 follow-up trials to monitor for safety. By 2013, only 40 percent of those studies had been completed.

I'm really not sure what the FDA expects when it asks multi-billion dollar Big Pharma to promise to do follow-up studies. Goldacre cites one case in which the FDA followed up so many years later that the drug was off patent, and the pharmaceutical company didn't care if it was removed from the market.

Why not have some teeth? Hey! You want your expensive drug expedited through the approval system? Okay! Chuck over a few million dollars to an independent agency, which will then offer a grant to have the follow-up study done by independent investigators. The drug will go on the market, but a couple years down the line, if that study determines that the drug is less safe than you claimed, you'll be subject to hefty fines, and possible criminal charges.

I mean, seriously? "Big Pharma, pretty please will you do a follow up study?" What are they thinking?


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