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« Bush's Plan is Working: Ba'athist and Foreign Terrorists Split on Tactics and Strategy | Main | Sunday News Dump »
July 11, 2004

Sometimes Government Works

Rare, but it does happen.

The next time I don't notice how few Thalidomide-deformed Americans I'm not meeting, I'll try to remember that it was actually one good bureaucrat doing her job right I have to thank for that:

As autumn closed in on the Christmas holiday season—the most lucrative time of the year for the sale of sedatives—the pharmaceutical company, frustrated by the repeated—and in their view, unnecessary—delays, began to pressure Dr. Kelsey with visits and phone calls to her superiors. Despite the increasing pressure, Dr. Kelsey remained steadfast in her demand for thorough clinical studies demonstrating the drug’s safety.

...

In the few years that the drug was on the world market, thousands of children were born with Thalidomide-related deformities[6]. Many did not survive their first year. Countless more miscarriages were traced to the use of Thalidomide. The damage in the United States, due to the work of Dr. Kelsey, was small by comparison, with 17 children documented to have Thalidomide-associated deformities. These children were affected during clinical trials of the drug, prior to its approval. During this investigational period, Richardson-Merrell distributed more than 2.5 million Thalidomide tablets to more than 1,000 doctors who, in turn, gave the tablets to nearly 20,000 patients—several hundred of whom were pregnant women.


posted by Ace at 12:04 AM
Comments



Yeah, the problem is that there are people who are still trying to keep it off the market for people it can help. My mom has a terminal illness called scleroderma. Thalidomide has shown promise in treating this disease, as well as others. My mom, at 67, is well past menopause. Still, these activists will not allow the drug to be approved byt the FDA for *any* use. The weeping, hand-wringing busybodies go on "Oprah" and weep and wail about how "one baby is one two many", and the mindless audience weeps and applauds....

Posted by: Barry on July 11, 2004 12:10 AM

Interesting point. I hadn't realized anyone was still working with the drug for any purpose.

Posted by: ace on July 11, 2004 12:18 AM

I wonder what other drugs were released prematurely under industry pressure? Probably a lot of them, but they didn't cause a problem.

Posted by: lauraw on July 11, 2004 12:36 AM


It's an orphan drug and is being studied for possible benefit against many diseases. It is being used to help treat leprosy, after having gone through clinical trials.

The people I saw in Germany were my own age. It could have been me. It could have a lot of kids in my grade. All over America. My purpose was to praise one lady who resisted pressure to sign off on a morning-sickness drug that she was suspicious of.

Posted by: Donnah on July 11, 2004 01:12 AM

My dad is a retired doctor, but he told me that the Thalidomide situation at the FDA was merely dumb luck many years ago. It was a lowly bureaucrat doing what they do naturally--mucking things up. I did a little Googling, and it does appear, as other commentators have brought up, that the drug is actually useful. Most drugs have side effects (most not quite as repugnant), but that is merely the nature of the business. Many drugs are poisons which are directed at cells which are killing or seriously harming people. Apparently this drug is no longer banned in the US. Apparently from at least a couple articles which I found at Google, my dad is not the only one to know that this FDA triumph is not as it has been portrayed by the bureaucratic types for many years.

I live in one of the most liberal and nutty places in the USA (Multnomah County, OR). Even though many people gave convincing testimony that the arguments against foam drink and food containers were, at least now, not true, our trusty Portland City Council renewed their ban, simply on nostalgic reasons based on their old victories. Facts and reason are usually lost on bureaucrats, at least that has been my experience with liberal bureaucrats (I suppose that a few conservative bureaucrats do exist, but I have never met one). I do understand that this is a trivial example relative to the stakes involving any powerful drug, but I do think that it is telling.

Posted by: Mike on July 11, 2004 08:08 PM

The lowly bureaucrat was also a doctor. The doctors at the CDC are bureaucrats. I'm a bureaucrat.
So even though she was a doctor who had done research into drugs crossing the placental barrier, and was presented with a drug that was to be marketed for morning-sickness and saw that the clinical data showed no evidence it was safe for pregnant women, still she was basically just a lucky 'tard that she didn't sign off on it? It couldn't possibly be because she was intelligent, professional,and had good judgement?
There were kids two grades above me that had braces on their legs from polio. Stay tuned for my post on Jonas Salk the asshat.

Posted by: Donnah on July 11, 2004 09:20 PM

I'm with Barry on this one. Thalidomide can be used to help keep multiple myeloma, a type of cancer, in check. I'm sure it has other uses, as well. It's clear it should not be given to pregnant women, and there can be some unpleasant side effects, but that doesn't mean it should be banned entirely. If the choice is losing some sensation in ones extremeties (eg, fingers) and dying of cancer, I think I'd go along with the Thalidomide. If properly prescribed, it can be genuinely helpful. The word "properly" is key here, of course...

Posted by: Tom on July 12, 2004 11:02 AM

"Properly" IS key. Bureaucrats have legal depts. that are out to nix anything that remotely smells of a lawsuit. Once the drug is approved the cat is out of the bag and a few "accidental" uses could make big trouble. You'll need some heavy lobbying to get Thalidomide approved.

Posted by: dano on July 12, 2004 05:02 PM

crestor lawsuit

Posted by: crestor lawsuit on April 25, 2005 06:08 PM
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