A Drug On The Market 14 Years, Killed Aprox. 1,000 Per Month. You Do The Math

[orleans]

60 minutes story tonight:

(CBS) This is the story of a drug that was on the market for 14 years and may have contributed to the deaths of thousands of patients. Trasylol, made by Bayer, is given in the operating room to control bleeding. It was a big money maker.

As correspondent Scott Pelley reports, Bayer marketed Trasylol aggressively until it was used in about one third of all cardiac bypass operations in America.

But then, in 2006, a study showed widespread death associated with Trasylol, and as it turns out there was concern long before that.

How much did Bayer know? And why did it take Bayer and the U.S. Food and Drug Administration nearly two years to take the drug off the market after major studies revealed the danger? Two years - during which it's estimated Trasylol was contributing to the loss of one thousand lives a month.

snip

What the surgeon likely didn't know was that there had been concern about the drug as far back as the early 1980's. It was then, in Bayer's hometown, that Dr. Juergen Fischer, director of the Institute of Experimental Medicine at the University of Cologne, found severe kidney damage in animals given Trasylol. He told Bayer, but he was surprised by the drug company's reaction.

"I felt that Bayer wasn’t interested to examine these side effects," Fischer says.

Soon, the same side effects were being seen in humans in America.

"The most common problem we saw was renal failure. That is, that kidneys did not function properly after surgery," says the Missouri Baptist Medical Center's Dr. Nicholas Kouchoukos, one of this country’s top heart surgeons.

In 1992, he conducted a small study, not funded by Bayer, in which Trasylol was given to 20 patients.

"Thirteen of these patients had problems with kidney function after the procedure," Kouchoukos says.

snip

"Doesn't a drug have to be proven safe before the FDA allows it on the market?" Pelley asks Mangano.

"No," he replies. "The trials that are constructed before a drug is marketed and given approval to be marketed generally address effectiveness of the studies."

"Make sure I understand. If the FDA is not certifying a drug as safe, before it goes on the market, what is it doing?" Pelley asks.

"It's certifying that the drug is effective and that within the small numbers studied, relatively small, it doesn't appear to be unsafe," Mangano says.


(entire transcript/video)
http://www.cbsnews.com/stories/2008/02/14/60minutes/main3831900.shtml

[dkf]

1. What the hell is wrong with these people?

And what is wrong with our FDA? I don't get it.

[seemslikeadream]

2. Coalition against BAYER Dangers

http://www.cbgnetwork.org/4.html

[Robbien]

3. The FDA isn't even certifying drugs are effective

There was the case just last week about that FDA approved cholesterol lowering drug didn't lower cholesterol in the majority of patients who took the drug.

The FDA does nothing but allow favored companies to sell drugs and stop companies it doesn't favor from selling drugs.

[Hekate]

4. Bushco gutted the FDA the way he did FEMA. nt

[rosesaylavee]

5. The FDA has been problematic long before * was in the WH.

His failure with the many other agencies under his control may actually have helped highlight the problems with the FDA along with the others. Remember it was the FDA that approved aspartame at Rumsfeld's assurances of its safety back in the 80s. The FDA has also approved of tamiflu for addressing for treating the bird flu... a product that Rumsfeld has been highly invested in and studies have shown it entirely ineffective in treating. They have been giving approvals to the highest bidder for decades now.

[orleans]

7. i remember i did a lot of reading up on aspartame and tamiflu

when this war got underway--it started with a vaccine soldiers were required to get (i forget specifics) but rumsfuck was hooked up with that too. and it was causing problems/making them sick/etc. maybe it was a pox vaccine (remember that big scare they were trying to sell all of us on a few years back?)

[rosesaylavee]

8. I didn't hear about that one but it doesn't surprise me

He's made a bundle from the war and his investments. I am sure he's quite disappointed that the bird flu hasn't spread as they predicted. Evil man.

[orleans]

10. i didn't really look but managed to cough this one up

off the top of a search

Mystery Deaths Fuel Vaccine Anxieties; Recent pneumonia deaths among soldiers who have been injected with the anthrax and smallpox vaccines are renewing fears that the inoculations are unsafe - The Nation

http://findarticles.com/p/articles/mi_m1571/is_2003_Sept_30/ai_108328458

maybe i'm "misremembering" and the connection was tamiflu--but

wait. got it:

in the meantime millions of doses of Vistide were produced and sold to the US government, to ‘ease’ the effects of smallpox should such an hypothetical attack materialize. The Pentagon was one of the major purchasers of Vistide at the time.

snip

Mr Rumsfeld knew well what he was prescribing for his soldiers. Vistide was also a product of Gilead Sciences, Mr. Rumsfeld’s former company. Rumsfeld was the person who signed off on the decision to give US Troops Vistide. That decision was obviously not made out of benevolence, or concern for the health of the troops on the part of the Defense Secretary, who had been personally involved with the side-efects of Vistide at Gilead since the company first developed it in the late 1990’s as an AIDS treatment. As Rumsfeld well knew, Vistide had some pretty hefty side effects. According to Dr. Christopher J Hogan, MD, Professor at the Department of Emergency Medicine, Medical College of Virginia, complications of Vistide include renal toxicity, neutropenia, fever, anemia, headache, hair loss, uveitis and/or iritis, and abdominal pain.

google search: rumsfeld vaccine troops iraq smallpox gilead vistide. it's the second link

[fed-up]

6. "Oops - Bayer forgot to tell FDA about Lethal Side Effects of Trasylol " Oct 2006

lots of news stories on Trasylol here

http://www.lawyersandsettlements.com/case/trasylol-kidney-heart-failure.html

http://www.lawyersandsettlements.com/articles/bayer-trasylol.html

October 26, 2006. By Evelyn Pringle RSS Del.icio.us Seed Newsvine Facebook
Washington, DC: On September 29, 2006, the New York Times reported that Bayer "failed to reveal to federal drug officials the results of a large study suggesting that a widely used heart-surgery medicine might increase the risks of death and stroke," citing an FDA announcement.

That drug is aprotinin, marketed as Trasylol.

Bayer's memory lapse would be bad enough in itself, but it seems the FDA is particularly annoyed because Bayer scientists appeared at a public meeting with an FDA advisory committee on September 21, 2006, specifically set up to discuss the risks associated with Trasylol, and did not mention a word about the study or its negative findings.

The lethal side effects of Trasylol became public on February 8, 2006, when the FDA issued an advisory to healthcare professionals requesting that they limit the use of the drug based on research in the New England Journal of Medicine that found its use to be associated with a 2-fold increase in renal failure, a 48% increase in myocardial infarction, a 109% increase in heart failure, and a 181% increase in strokes.


http://www.lawyersandsettlements.com/features/trasylol-taking.html

June 11, 2007. By Nate Hendley
San Bruno, CA:
In medicine, some of the most hard-hitting drug research often comes from organizations far removed from the healthcare mainstream. Take the case of Trasylol, for example.

Trasylol is the brand name for Aprotinin, a drug approved by the U.S. Food and Drug Administration in 1993 to reduce bleeding during heart surgeries. Trasylol is made by pharmaceutical giant Bayer—an international conglomerate comprised of 106,000 employees working in 350 companies around the world, with its headquarters in Leverkusen, Germany.

In 2006 and 2007, the Ischemia Research and Education Foundation (IREF) published back-to-back studies that offered devastating critiques of Trasylol's safety record. The first study demonstrated that Trasylol doubled the risk of kidney failure in patients. The second study indicated the drug increased the risk of death.

Based out of San Bruno, California, IREF is a self-described, "independent, non-profit biomedical research organization founded in 1987 and dedicated to performing quality medical and scientific research that saves and extends lives."


..snip

[orleans]

9. i don't ever remembering hearing about this drug before

but 168,000 dead people can make for one HUGE motherf*cking lawsuit.

[girl gone mad]

11. So maybe as many as 200,000 killed by Bayer Corporation?

Ordinarily, I'm wary of the death penalty, but I think prosecutors should seek it for any Bayer executives and their bought off doctors/"researchers" involved in this case.

[orleans]

12. half as hurtful as 9/11, but spread out across time, no one hears about it

or notices a thing

[Contrary1]

13. I have spent the better part of this evening searching

for an itemized hospital bill I requested when my mom had heart surgery in 1992.

She left the hospital with renal failure, and spent the last three years of her life in misery. She died from an ischemic stroke. The doctor told me the primary cause would have been the damage that dialysis had done to her body.

I hope I kept it, but even if I did not, I plan to find out if she too, was given this drug. And, I am so very angry after hearing this news, I plan to go after Bayer if she was given it.

[orleans]

14. Contrary, i'm really sorry about your mom. did you see the whole

segment on 60 minutes? (if not--it's on their website). the family of the 52 year old man they specifically discussed was contacted by his doctor when the dr. became aware of the dangers of this drug upon reading an article in the newspaper.

i hope you can find that hospital bill, and if not, i hope the records in the hospital can help you with it so you can settle your mind (one way or the other).

bayer KNEW there was a problem with this drug from the onset:
"What the surgeon likely didn't know was that there had been concern about the drug as far back as the early 1980's. It was then, in Bayer's hometown, that Dr. Juergen Fischer, director of the Institute of Experimental Medicine at the University of Cologne, found severe kidney damage in animals given Trasylol. "

i'd go after bayer too if i found out they were complicit

:hug:

[alfredo]

15. Are you listening Obama and Clinton. Hit hard on this. Nail those

fuckers to the floor.

[orleans]

20. we can only wish/hope they do something. start with the fda. n/t

[alfredo]

21. bush has put ideology above lives.

[bluedawg12]

16. The study referred to in the CBS article came out in 2006.

The product is a blood clotting agent used during cardio-vascular surgery.

There were published studies going back to 1993, the problem is that they were all smaller and the renal complications did not show up.

Dr. Mangano published his results in the New England Journal Of Medicine in 2006. It's a post marketing study and unusual in that it was well designed, large and forward looking (prospective) not a record review.

After his group collected data from: "... patients scheduled for coronary-artery bypass surgery with cardiopulmonary bypass were prospectively enrolled according to a systematic sampling scheme at 69 institutions in North and South America, Europe, the Middle East, and Asia"

He wrote:
we estimate that for renal complications alone, the replacement of (the product)...would prevent renal failure requiring dialysis in 11,050 patients per year
yielding an indirect savings of more than $1 billion per year,
in addition to direct savings (from reduced drug costs) of nearly $250 million per year.
Replacement of (the product)... ... would prevent 9790 complications necessitating dialysis each year...

Here is some more info:

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

http://www.fda.gov/cder/drug/InfoSheets/HCP/aprotininHCP.htm

The problem is that there is a new article (2007) that shows that the product, while, having increased risk of kidney dysfunction, works better than generic alternatives:demonstrated significant reduction in total blood loss during cardio vascular surgery.


There's medicine, then, there's the government, then there's big pharm., and then there's the law and courts.

It's all an uneasy balance.

Hope this helps folks who wanted to know a little more about it.

[orleans]

17. .

"there were two other drugs that might have been used in Randone's case without the consequences - drugs that cost $50, while Trasylol costs over $1,000.

"They were as effective in our studies as Trasylol in limiting bleeding, and limiting the amount of blood transfused," Mangano says. “With none of the adverse side effects.”
http://www.cbsnews.com/stories/2008/02/14/60minutes/main3831900_page3.shtml

the two drugs that are shown appear to be
http://en.wikipedia.org/wiki/Aminocaproic_acid
and Cykokapron



what is the link to this?
"while, having increased risk of kidney dysfunction, works better than generic alternatives" i didn't find it at the links in your post. is that referring to the two drugs i mentioned above?

and
published studies going back to 93 but "What the surgeon likely didn't know was that there had been concern about the drug as far back as the early 1980's. It was then, in Bayer's hometown, that Dr. Juergen Fischer, director of the Institute of Experimental Medicine at the University of Cologne, found severe kidney damage in animals given Trasylol.

[bluedawg12]

18. what is the link to this?

what is the link to this?
I think It's "Circulation 2007".

"while, having increased risk of kidney dysfunction, works better than generic alternatives" i didn't find it at the links in your post.

is that referring to the two drugs i mentioned above? Mentions the same two drugs. ---Yes.

[orleans]

19. "circulation 2007" is a link?

it's not working for me