February 18, 2005

*Updated:* More blaming the big guys, and this time it's personal

Q&O has posted their take on Drug Companies and the way they're treated in today's world. I agree with their views 100%, and I'll tell you why.

This week... the Food and Drug Administration holds very public hearings on potential health risks of popular prescription pain medications called Cox-2 inhibitors.

They've recently taken two of the newer meds off the market, Vioxx and another I can't remember at the moment. This leaves one Cox-2 inhibitor available, Celebrex.

My wife takes Celebrex, and has for six and a half years. It's one of the drugs she takes daily to manage her severe Fibromyalgia. We've discussed this with her doctor, and there is no good substitute for Celebrex that's available today.

So what would happen to Liz if she were forced to discontinue her use of Celebrex? Within a week she would begin to feel muscular weakness and increased fine-motor impairment. Within two weeks she probably wouldn't be able to walk without a cane. Within a month she'd no longer be able to drive, which means she could no longer work. At that point she would probably also have to return to her wheelchair.

Thirty days to be reduced to near total dependence on others.

Like anything else, there are risks involved in life. The trick is evaluating the risks vs benefits. It's not always so clear cut as in my wife's case, but given the choice between seeing my wife lead a near-normal life or protecting the small number of people who might drop dead from taking the drug, well, I'll be selfish and still sleep just fine at night.

Protect us from dangerous drugs, yes. Play nanny and never allow anything that might possibly hurt a single person, no.

I'm writing my Senators and Congressmen about this.

Update: Nic left some great information in the comments (thanks!). Also, today I read an interview where the head of Merck (who pulled Vioxx earlier this year) (I had incorrectly identified the company as Phizer, who make Celebrex and Bextra - RJ) says that you have to weigh risks and benefits (where have we heard that before?) and that Vioxx may be brought back to the market with stronger and more comprehensive warnings.

Best of all:

Advisers to the Food and Drug Administration concluded Friday the popular painkiller Celebrex poses an increased risk for heart problems but should remain on the market because the benefits outweighs the dangers.

It's not a done deal, but we're breathing easier.

Posted by Ted at February 18, 2005 12:03 PM
Category: Links

Good! (Um, that you are writing to your representatives about this. Not, obviously, the situation.) Also go here:


and submit your comments to the FDA committees that are meeting right now about the COX-2 inhibitors. See if you can get the doctors to comment, too.

I've been trying to blog about this for several days, but I'm up to about 25 pages in the rough draft.

Posted by: nic at February 18, 2005 01:57 PM

As I wrote over at Hold The Mayo: Even a flu shot has a potential side effect of causing [Grampa Simpson] de-e-e-a-a-a-th! [/Grampa Simpson]

And, as Stephen points out: Tobacco, which has no health benefits at all, is a greater risk to more people than Celebrex will ever be, yet it's readily available over the counter with a warning on the package.

As long as people are made aware of the risks, and the odds of those risks, let the patients and doctors determine if it's worth it.

Posted by: Tuning Spork at February 18, 2005 06:12 PM

I agree with the concept of letting doctors and patients decide if the risk is worth it, but the drug companies are also going to be deciding whether the risk is worth it...the risk of lawsuits and diminished sales vs. the cost of production and burden of increased testing/surveillance.

That's another side to the free market economics of it. Merck pulled Vioxx originally, not the FDA.

Posted by: nic at February 19, 2005 08:07 AM

My mother has very severe osteoarthritis. Vioxx worked better than anything she'd taken since Eli Lilly's Opren (which nearly killed her, of course, but it worked). Now she's back on Ibuprofen. She's 75 next week. The vestigial risk of side effects must be weighed against the quality-of-life enhancements that effective analgesia brings.

Posted by: David Gillies at February 19, 2005 08:09 PM

The third of the COX-2 inhibitors is Bextra.

Disclosure: Celebrex didn't do much of anything for me, while Bextra does.

I've been switched to a different NSAID for the time being.

Posted by: CGHill at February 20, 2005 10:55 AM
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