Regulators And Researchers Corrupted By Big Pharma

[Luke T.]

Somewhere, Shanek and Kevin Trudeau are having deep, prolonged orgasms...

Over the past six years, 10 Federal Drug Administration (FDA) approved drugs have been withdrawn from the market due to deaths and injuries, leading lawmakers to accuse the FDA of not doing its job in protecting the public from unsafe drugs and to call for measures of improvement.

On June 20, The New York Times reported that “two influential senators are expected within weeks to introduce a legislative proposal that could drastically change how drugs are tested and approved in the United States.”

http://onlinejournal.com/artman/publish/article_944.shtml

The best example of the administration's efforts to protect Big Pharma was revealed recently when the FDA announced a preemption rule that would disallow lawsuits in state court against drug makers if a drug has been approved by the FDA.

 

[Luke T.]

From the same link:

For instance, Dr Bruce Levine, PhD, clinical psychologist and author of World Gone Crazy, tells a story about Eli Lilly corrupting the judicial process in a case that began in 1989 when Joseph Wesbecker opened fire at his former place of employment, killing eight people and wounding 12 before committing suicide, a month after he began taking Prozac. The victims of the shooting sued Eli Lilly, claiming that Prozac had pushed the guy over the edge.

It has long been known that Prozac induces violence in some patients, but the FDA never required Lilly to list violence on the drug’s label.

Sayyyy, I threatened my shrink's life while I was on Zoloft...

But that could have been because I was freaking nuts.

 

[Mojo]

You might be interested in Ben Goldacre's Bad Science column from the Guardian of 10th June: http://www.badscience.net/?p=251

 

[Earthborn]

Somewhere, Shanek and Kevin Trudeau are having deep, prolonged orgasms...

Shanek complaining that the FDA allowed stuff on the market too quickly? Quite unlikely! In Shanek's view the FDA is a huge hinderance to Big Pharma, and "if only Big Pharma could get its products to market without all that approval, it could save millions of people now dying during these years of unnecessary legal proceedings."

 

[Beerina]

Somewhere, Shanek [is] having deep, prolonged orgasms...

Actually, guys like Shanek and I have deep, prolonged orgasms over the rapidly advancing technology that a free society engenders. This greatly outstrips the occasional death due to a drug reaching the market a little too quickly.

But, sadly and sickeningly for the human race, a few such deaths can easily be placed in front of cameras with weeping widows and blowharding lawyers and politicians, while the tens of thousands, hundreds of thousands, millions, tens of millions, of people who die needlessly early deaths due to lagging technology are never sung or placed in front of cameras.

A 10% discrepancy in the rate of development = 10 years over the course of a century. Which group lives longer, 1990 tech or 2000? How about 1980 vs. 2000? 1970? Over the course of a century, heavy handed socialism might very well cause an even bigger lag. In 2100, how many people will be dying because they only have 2060 tech whereas a freer society (read: with a lazy FDA and evil companies rushing tech to market) has a full-blown 2100-level tech?

Which society has had a net greater death count?

A bird in the hand is worth two in the bush? A dead kid in front of the cameras is worth fifty million dead a hundred years from now.

As for "rushing" drugs themselves, that does contribute to profit motive vs. a 10 year delay. But it also has a net lifesaving ability. A drug that reduces heart disease by 10%, that gets to market in 2 years, will save 10 % x 500,000 lives x 8 years = 400,000 lives. Do you think all the drugs put together that got to market too early will cost 400,000 lives over those 10 years? And that's just comparing the delaying cost of one drug in human lives. There are a lot more beneficial treatments and drugs that are also delayed. Thank god for the "fast track" concept, but it's also sickening that Congress had to be beaten down with embarassment over an issue like Aids to get it implemented.

 

[TragicMonkey]

Actually, guys like Shanek and I have deep, prolonged orgasms over the rapidly advancing technology that a free society engenders. This greatly outstrips the occasional death due to a drug reaching the market a little too quickly.

But, sadly and sickeningly for the human race, a few such deaths can easily be placed in front of cameras with weeping widows and blowharding lawyers and politicians, while the tens of thousands, hundreds of thousands, millions, tens of millions, of people who die needlessly early deaths due to lagging technology are never sung or placed in front of cameras.

A 10% discrepancy in the rate of development = 10 years over the course of a century. Which group lives longer, 1990 tech or 2000? How about 1980 vs. 2000? 1970? Over the course of a century, heavy handed socialism might very well cause an even bigger lag. In 2100, how many people will be dying because they only have 2060 tech whereas a freer society (read: with a lazy FDA and evil companies rushing tech to market) has a full-blown 2100-level tech?

Which society has had a net greater death count?

A bird in the hand is worth two in the bush? A dead kid in front of the cameras is worth fifty million dead a hundred years from now.

As for "rushing" drugs themselves, that does contribute to profit motive vs. a 10 year delay. But it also has a net lifesaving ability. A drug that reduces heart disease by 10%, that gets to market in 2 years, will save 10 % x 500,000 lives x 8 years = 400,000 lives. Do you think all the drugs put together that got to market too early will cost 400,000 lives over those 10 years? And that's just comparing the delaying cost of one drug in human lives. There are a lot more beneficial treatments and drugs that are also delayed. Thank god for the "fast track" concept, but it's also sickening that Congress had to be beaten down with embarassment over an issue like Aids to get it implemented.

I wonder if you realize just what can happen? "The occasional death"? Here's some happy bedtime reading:

http://en.wikipedia.org/wiki/Thalidomide

I'll leave it to you to Google some nice pictures. Once you do, you might be grateful that drugs get tested thoroughly these days. Or is the risk worth it? That the "fast-tracked" drug you take today might not hurt you at all, but might hurt your children? Their children? Risk worth taking?

 

[El Greco]

I've always thought it is incredibly stupid to pick sides lightheartedly. Fighting sCAM doesn't mean that the Big Pharma people are always honest and incorruptible. I have more than often experienced the stupid tendency to justify almost anything the Big Pharma does only because they are not woos. The opposite of woo is NOT honest.

 

[Alphaba]

I've always thought it is incredibly stupid to pick sides lightheartedly. Fighting sCAM doesn't mean that the Big Pharma people are always honest and incorruptible. I have more than often experienced the stupid tendency to justify almost anything the Big Pharma does only because they are not woos. The opposite of woo is NOT honest.

Ditto.

It is even not certain that the "they are not woo" is completely correct: the text linked to by Mojo (thanks), and some of the papers listed below, do pinpoint biases that furiously ressemble some of those typical of woos, notably a wide range of selection biases, like cherry picking (selecting 'good' data/results/trials while discarding the 'not good'). That they are motivated by profit maximization rather than by woo beliefs doesn't render them less biased. Big Pharma people do regularly indulge in the making and the publishing of research papers of woo-like quality.

So yes drugs are useful, save lives, etc.; yes Big Pharma finances research and promotes innovation, etc.; and yes Big Pharma is also (very) big business, spends more money in marketing than in research, and is ultimately more interested in big profits than in sound science, with all unwanted side effects this generates in biomedical clinical sciences and their end users. Sort of a useful necessary evil...

Some additional readings:

A Social Science Perspective on Gifts to Physicians from Industry (JAMA, 2003, pdf)
Stresses the unconscious aspect of self-serving biases, and the likeliness that even small gifts do generate prescription biases.

Who pays for the pizza? Redefining the relationships between doctors and drug companies. 1: Entanglement (BMJ, 2003)
Rather comprehensive and easy to read.

Is academic psychiatry for sale? (British Journal of Psychiatry, 2003)
Two opposite-complementary POV on the issue in the same paper.

Health Economists Meet the Fourth Tempter: Drug Dependency and Scientific Discourse (Health Economics, 2000, pdf)
Quite devastating a review, from a health economic POV.

 

[a_unique_person]

Recent story on Vioxx, it is even more dangerous than it was at first thought.

http://www.mercurynews.com/mld/mercurynews/news/breaking_news/14926302.htm

LOS ANGELES - Merck & Co. did not inform federal authorities about two clinical trials in which users of the painkiller Vioxx were more likely to die than people given a placebo, jurors in the first Vioxx liability case to go to trial in California were told Wednesday.
Dr. Edward Scolnick, the former head of Merck & Co.'s research laboratories, said in a videotaped deposition that he did not believe the numbers were coincidental.
"It's not likely due to chance," he said.
Scolnick's testimony was shown to jurors on the second day of Stewart Grossberg's products liability lawsuit against Merck.
...
Scolnick testified that people who took Vioxx died at a rate four times higher than those who didn't receive the drug in one of the clinical trials, and 2 1/2 times higher in the other. Both trials were done in 2001 to see if Vioxx could help Alzheimers patients.
Merck & Co., however, did not turn over trial results to the U.S. Food and Drug Administration when company officials met with agency representatives in April of that year, Scolnick said.

Throughout history, people have found that it is necessary to regulate political power. Raw money is now just as great a power as many states have, and needs regulation as well.