April 10, 2005


Once 'too slow,' FDA approvals called 'too fast' (Diedtra Henderson and Christopher Rowland, April 10, 2005, Boston Globe)

Over 15 years, the Food and Drug Administration has swung from taking too long to get medicine to dying AIDS patients to drawing fire for rushing drugs to market that wound up killing people.

The agency's troubles were highlighted last week, when it asked Pfizer Inc. to suspend sales of Bextra because the painkiller can cause fatal heart and skin problems. Bextra was the latest casualty in a drug safety controversy that began last fall with Vioxx, an arthritis drug quickly approved by the FDA and then taken off the market. The multiple sclerosis drug Tysabri followed the same script: speedy approval followed by withdrawal, because it may cause a rare brain disease.

The profound change within the agency came from several directions. AIDS activists in the late 1980s besieged the agency to demand it make more drugs available to combat what, at the time, looked like an unstoppable epidemic. Threats by major drug companies to move overseas spurred Congress to pass laws that created a speedier approval process funded by drug makers themselves. The speed movement took hold with people at the top ranks of the FDA, who pressured staffers charged with studying the effectiveness and safety of drugs to hurry up.

''There is no doubt that there has been a cultural change," said John Jenkins, director of the FDA's Office of New Drugs. ''I don't think it needs correction."

The Left's hatreds of business and morality has driven them to the delicious position where several million people shouldn't be able to buy an effective remedy if a handful can't take it but everyone should be administered lethal medications if they merely ask for them.

Posted by Orrin Judd at April 10, 2005 9:37 AM

So what's wrong with wanting a product that works?
The FDA is a quality control agency. Its job is to make sure that drugs being put on the market actually do what they advertise.
If you want to buy snake oil, go ahead. The rest of us would like to make sure that our headache tablets don't cause cancer.

Posted by: Small Town Hick at April 10, 2005 11:37 AM

Couldn't this be handled by a private agency set up by the drug industry in conjunction with the insurance industry and the medical profession?

Clearly if a bad product gets put on the market either causing harmful side effects or failing to do what it promises or both, it would result in litigation against the company that produced it. The company, and/or its insurer, and/or the prescribing physician would be forced to pay. So, it is in everyone's financial interest to put only safe and effective drugs in the marketplace. There is no need for the FDA to be the certifying agency, especially when it does some form of bad job, depending upon whether Luddites or slobs are in charge.

Posted by: bart at April 10, 2005 12:01 PM


The point is that generally effective products get pulled because of easily dealt with effects on a very few.

Posted by: oj at April 10, 2005 12:06 PM

As people routinely note, aspirin couldn't get past the FDA if it were submitted today.

Posted by: David Cohen at April 10, 2005 4:17 PM

No, the point is that with enough money to buy influence and enough tries to get a study that doesn't show the ill-effects of their medication, the drug companies can push anything through that they want. This administration, including the FDA, is simply a rubber-stamp for higher drug company profits (see Medicare bill). If a few people die, well, too bad.

It has nothing to do with "hatreds of business and morality" -- as if those have ever been the same thing -- and much more to do with thinking that a government agency empowered and directed to ensure the quality of the medications being bought and used in the US should actually do its job without business coercion.

Posted by: Rational at April 11, 2005 4:13 PM

Who's pulling all these painkillers?

Posted by: oj at April 11, 2005 4:18 PM