One Thousand Lives A Month

Researcher Estimates 22,000 Lives Could Have Been Saved Had Trasylol Been Pulled Earlier

(CBS)  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.

"What did you think?" Pelley asks.

"Well, this was the red flag. And it appeared that it was related to the use of Trasylol," he says.

The red flags showed up in some studies, but not others. Safety concerns are often hard to assess until thousands of patients have received a drug. And critics maintain that Bayer never paid for any studies that were large enough to determining whether kidney failure was a problem. All the research did show Trasylol controlled bleeding, so in 1993, the FDA approved it.

"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.

The FDA approved Trasylol for patients at high risk of bleeding and it noted kidney toxicity was a problem. Bayer pushed the drug hard. In 1998, the FDA expanded its approval to cover all heart bypass patients. By 2005, sales of the drug hit $300 million. The next year, $750 million was projected, and Bayer envisioned a billion-dollar drug.

Then came the Mangano study in 2006 that suggested thousands of patients had died. The FDA issued an advisory to doctors alerting them to Mangano's study. But the FDA didn't plan to have a meeting about Trasylol for eight months.

Bayer wanted to have its own study for that meeting to compare with Mangano's, so the company hired Harvard professor Dr. Alexander Walker to look at the records of nearly 70,000 patients. Walker's results were the much the same as Mangano's. Patients on Trasylol, he wrote, had an elevated risk of death and acute renal (kidney) failure.

Meanwhile on Long Island, winter turned to spring, and Joe Randone grew worse.

"It was a domino effect. Once the kidneys stopped working, then it affected other organs. He was so swollen that he couldn't even close his eyes," Josephine remembers.

[dougemac]

i.would like to say bayer has ruine my life there drug taslol ran me thro Hell and back i have never been the same person or nerver will be bayer should pay big time Douglas perry [e-mail]

[josie621]

As a 45 year old survivor of a ventricle remolding with a single bypass at age 43 because of Taxis Stint Failure, I do not hold a positive view of the FDA and their practices! As it turned out the FDA was aware of a sharp increase in deaths for patients who had the Taxus stint implants from the beginning of the approval process. I now have only 72 % of my heart beating in my chest a defibulator implant and decreased quality of life. I find it appalling that they put the profit margin ahead of safety and well being of patients.

[elgregcor]

Hello,

I have a good friend that just went through heart valve surgery. He is now suffering from kidney problems... Is there any ANTIDOTE for the damage that may have been done??? Herbs to heal the kidneys??? Can anyone help?

Thanks, G

[pam12344]

How can I submit a complaint to the FDA regarding Trasylol and drug costs in the USA?

[jgstraka]

Dr. Hiatt is not a scientist.

I was taken back by the interchange between Mr. Pelley and Dr. Hiatt:
"You describe them as concerns about transparency. Tell me how you felt. You had to be surprised," Pelley asks.
"I''m a scientist. I just review the data," Hiatt says. "How do I feel about this? I don''t know."

Immediately following this interchange, Mr. Pelley%u2019s interview went to Dr. Mangano''s office. Behind Dr. Mangano was a poster of Albert Einstein. Dr. Einstein through his example showed that a scientist considers the impacts of the practice of science and takes responsibility and action where appropriate. Dr. Einstein easily could have answered the question, %u201CHow does it make you feel?"

I have been a scientist my entire adult life engaged in both research and teaching. I am appalled at Dr. Hiatt''s arrogance at calling himself a scientist, and hiding behind his self-proclaimed "scientist" moniker. It is clear that he did not %u201Creview the data%u201D (rat and human) before passing judgment, causing even more iatrogenic complications and death.

Dr. Hiatt is a disgrace, and his actions demonstrate that he is no scientist. Real scientists do not "just review the data". We review and interpret data, make judgments based on scientific merit, and examine the impacts that our findings might have. His caricature of a response belongs to a character in "Young Frankenstein", not to a person who was a chair of an FDA committee.
James G. Straka, Ph.D.

[sallens]

My mother had bypass surgery Feb 2004, was in excellent health when she went in, surgeon told us 96% of a chance of success. Surgery went fine, but then problems, grafts closed, then kidneys failed, surgeon blamed aprotinin. Over several months other organs started to fail, she was on a ventilator and they did dialysis, she lived till July 2004 and passed away. She would still be alive today if she had not had the surgery. It is sad that life means so little to these greedy drug companies.

[aky113]

I retired after 33 years with the FDA. Over those years I saw a reduction in regulatory activity every time a Republican administration took control beginning with Saint Reagan.

Republican demands for "smaller" government reduced funding to the FDA to the point that FDA, with the blessing of big drug and device companies, needed to supplement its budget with "user fees" simply because the Federal budget no longer allowed the Agency to adequately carry out its mandate.

I believe user fees present an inherent conflict of interest. FDA has hundreds of employees whose jobs are 100% dependent upon the user fees.

These very large fees squelch innovation and inhibit the development of %u201Csmall businesses,%u201D so allegedly important to the Republican party. A small firm is not likely to have the ability to pay these fees. While the fee rules do address this issue somewhat, the chilling effect on competition to big industry is still present.

Please do not blame Civil Servants. They must do what they are told by their upper managements who are political appointees. Worse, they can only do what their budgets permit. The vast majority of FDA Civil Servants are bright and diligent people dedicated to protecting the public health.

When something like this happens, people ask "Where was the FDA?" That is not the right question. The right question is, "Why has Congress not adequately funded the FDA so the Agency COULD protect us?"

How many times have we heard this same story and our FDA. Profit before health. The FDA needs to be changed with people that are not tied to Big Pharma.

[a-ji]

Bayer killed those people. The victims'' family must stand together and sue Bayer.

[mrsweezie2]

This is truly upsetting. My husband went through three different bypass surgeries. His last surgery in 2004 was a heart transplant, after which his kidneys failed, his spleen, gall bladder, parts of his stomach and intestine had to be removed. He died in the hospital. He had an "unknown" infection, and now I''m wondering if his organs had been cut off from blood circulation resulting in necrosis.

Golden Rule Corollary Number One:
He who owns the gold shouldn''t sleep too soundly.

[mac294-2009]

Is renal failure necessary or can thrombosis alone be also a side-effect of this drug?

[mac294-2009]

Is renal failure necessary or can thrombosis alone be also a side-effect of this drug?

[nothappyatall]

WHat do you expect of corrupt drug companies, or any mega corporation?
Corporations exist for ONE reason, and one reason only- to make a PROFIT any way they can.
The very way corporations are set up shields the CEO''s and the rest from personal liability or financial liability on most everything (except wilfull criminal acts)

[singingrick]

This is what happens when you have a President (Bu$h) that appoints drug lobbyists to run the FDA.

[jsgt]

It is no wonder that Bayer considered profits more important then human lives and that the government agencies (under the Bush administration) who should be protecting consumers are apparently being pressured to release life threating drugs.

[jsgt]

It is no wonder that Bayer considered profits more important then human lives and that the government agencies (under the Bush administration) who should be protecting consumers are apparently being pressured to release life threating drugs.

[jsgt]

It is no wonder that Bayer considered profits more important then human lives and that the government agencies (under the Bush administration) who should be protecting consumers are apparently being pressured to release life threating drugs.

[jsgt]

It is no wonder that Bayer considered profits more important then human lives and that the government agencies (under the Bush administration) who should be protecting consumers are apparently being pressured to release life threating drugs.

[jsgt]

It is no wonder that Bayer considered profits more important then human lives and that the government agencies (under the Bush administration) who should be protecting consumers are apparently being pressured to release life threating drugs.