Excessive Caution on FDA Approval May be Risky

The Food and Drug Administration (FDA) is responsible for regulating "food, dietary supplements, drugs, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary products, and cosmetics in the United States."[1]

In 1992, congress passed legislation which imposed FDA user fees on pharmaceutical companies in order to expedite the process of drug approval. With the influx in income the FDA hired 1000 new employees cutting down drug review time from 30 months to 15.

Critics claim that such legislation practically makes the FDA subordinate to drug companies and endangers public health by rushing drugs onto the market. Criticism from senators and other influential people has made the FDA more timid in approving drugs. According to a 2005 issue of The Journal of the American Medical Association "It does seem indisputable that there have been shifts in the acceptable threshold for risk/benefit for many diseases as the depth of scientific understanding increases and as information about the effects of drugs on large patient populations is more readily available." [2] The time from application to approval nearly doubled from 2004 to 2005.

Initially, this change may appear beneficial. The facts, however, seem to make this conclusion an example of how intuition may be misleading. A study conducted by the University of Chicago claims that the expeditious drug approval may have saved 180,000 to 300,000 life-years, while at worst 56,000 life years were lost. [3] However, it is far easier to identify and emphasize cases where drugs have killed rather than where drugs have saved.


[1] http://en.wikipedia.org/wiki/FDA
[2] http://jama.ama-assn.org/cgi/content/full/294/11/1333
[3] http://www.nber.org/digest/jun06/w11724.html

It's true. Look at the fiasco Merck went through a few years back when Vioxx was determined to increase the risk of cardiac episodes. They voluntarily pulled it and suffered major financial setbacks. (Celebrex, a Pfizer product in the same class and with the same side effects as Vioxx, is still on the market and is still widely used.)

More recently, the FDA actually pulled Zelnorm from the market when it was found to cause "severe cardiovascular risks."

Most of the time, the amount of R&D that goes into these meds just isn't enough to determine long term side effects, which effectively turns the patients being prescribed the medication into guinea pigs.

Most of the time, the amount of R&D that goes into these meds just isn't enough to determine long term side effects, which effectively turns the patients being prescribed the medication into guinea pigs.

Hmmm...

I'm not up on medicine at all, but are they allowed to lab-test meds on consenting patients?

They FDA must approve it for clinical testing first, I believe.

Yeah, that sounds familiar. Although if they're complaining about drugs being rushed onto the market, they'd have to be testing it for years to pick up on possible long term effects. Sounds like one of those "lesser evil" things to me.

Yea, the FDA can't honestly test for long-term effects. In my opinion, the regulations should be left as is unless they believe they could optimize even further. The numbers don't lie.

Exactly. It becomes a question of evaluating for years, spending all that extra funding and manpower to do so, and potentially withholding a treatment that could still benefit many people.

I don't think it would be worth it, and the numbers you posted have proved that particular case, at least.

Oh, I agree. Drug prices are high enough as it is. Additional research costs would only cause them to go higher. I think a large portion of the problem is the fact that the public equates "FDA approval" with something being "safe," which, if you read the listings for side effects for any given drug, is obviously not the case. The terrifying truth is this: doctors are given incentives to prescribe certain medications. Health care is a business. Money rules.
Obviously, I've just become fed up with the "take a pill to fix it" society. I'll just leave it at that and not launch into a full blown rant here.

The terrifying truth is this: doctors are given incentives to prescribe certain medications. Health care is a business. Money rules.

This is one thing I'm not happy about personally, public health and safety have long been the responsibility (and purpose) of the domestic government, why is this an exception? It feels entirely wrong to have it controlled by market forces.

This is the first time I've seen people be measured in "life years".

Had an elderly gentleman call in today and ask why his nausea medication had a copay of over $1200. I explained that his insurance did cover about $300 worth of it. He said, "No offense, but I'm not paying for that." I can't blame him. Some of this shit is absoludicrous.

$1200 for NAUSEA medication? Thanks, I'll stay naseous for a bit and BUY MYSELF A NEW COMPUTER.