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Should the Supreme Court shield drug companies when their products pass FDA scrutiny?

Plummit

Monkey
Mar 12, 2002
233
0
Even if they knowingly lie to the FDA, doctors, and patients? Looks like that's about to happen:
More than 3,000 women and their families have sued Johnson & Johnson, asserting that users of the Ortho Evra patch suffered heart attacks, strokes and, in 40 cases, death. From 2002 to 2006, the food and drug agency received reports of at least 50 deaths associated with the drug.

Documents and e-mail messages from Johnson & Johnson, made public as part of the lawsuits against the company, show that even before the drug agency approved the product in 2001, the company’s own researchers found that the patch delivered far more estrogen each day than low-dose pills. When it reported the results publicly, the company reduced the numbers by 40 percent.

The F.D.A. did not warn the public of the potential risks until November 2005 — six years after the company’s own study showed the high estrogen releases. At that point, the product’s label was changed, and prescriptions fell 80 percent, to 187,000 by last February from 900,000 in March 2004.

Gloria Vanderham, a Johnson & Johnson spokeswoman, said the company acted responsibly.
Responsibly??? More like predictably.

Also predictable:
This legal argument is called pre-emption. After decades of being dismissed by courts, the tactic now appears to be on the verge of success, lawyers for plaintiffs and drug companies say.

The Bush administration has argued strongly in favor of the doctrine, which holds that the F.D.A. is the only agency with enough expertise to regulate drug makers and that its decisions should not be second-guessed by courts. The Supreme Court is to rule on a case next term that could make pre-emption a legal standard for drug cases. The court already ruled in February that many suits against the makers of medical devices like pacemakers are pre-empted.
Of course, because
The F.D.A. does not test experimental medicines but relies on drug makers to report the results of their own tests completely and honestly. Even when companies fail to follow agency rules, officials rarely seek to penalize them. “These are scientists, not cops,” said David Vladeck, a professor at Georgetown Law School.
Now I'm for shielding everyone from frivolous lawsuits and going after the plaintiffs, but this would seem to be something other. Rather than defending J&J's position here, given the facts as they're spelled out in the article, a rational person might think it's time to overhaul the approval process and put in penalties for falsifying data submitted with such applications or prosecute those caused the falsifying, but that's just me...

Whole article here: NYT
 

reflux

Turbo Monkey
Mar 18, 2002
4,622
2
G14 Classified
I have a friend who work in the medical testing industry and she's admitted even to me that samples are not random, results are skewed to produce the desired results, and that the problems are common practice within the industry.
 

Silver

find me a tampon
Jul 20, 2002
10,846
0
Orange County, CA
You can't sue a company for something that is obviously God's divine punishment for using birth control. C'mon. You gonna sue God next?

Remember, the US is a Christian nation...
 

ire

Turbo Monkey
Aug 6, 2007
6,199
4
I wish they would stop letting drug companies advertise directly to consumers :disgust1:
 

reflux

Turbo Monkey
Mar 18, 2002
4,622
2
G14 Classified
I wish they would stop letting drug companies advertise directly to consumers :disgust1:
Chris Rock...
"I saw this drug advertisement the other day. It said, 'Do you go to bed at night and wake up in the morning?' Oh damn, that's me! I gots to get me some of that!"
 

Plummit

Monkey
Mar 12, 2002
233
0
Agree with the comments about drug makers advertising directly to the end user. Reminds me of the comedian, can't remember who, that said something like, "Drug companies are turning our doctors in dealers... Don't get diagnosed, just ask your physician for the drug you saw on TV."

On the issue the NYT was talking about, I can't imagine the legal basis for shielding companies that intentionally falsify data submitted to the gov't body responsible for regulating them.
 

ohio

The Fresno Kid
Nov 26, 2001
6,638
4
SF, CA
Crazy thing is, drug approval takes longer and is more expensive in the US. Drugs and treatments are routinely available in EU and CAD before the US. I wonder if these occurences are more or less common under those systems...