One Thousand Lives A Month

(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.

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Doctors believe one of those patients was Joe Randone. He had a heart murmur since he was born, but that didn't keep him from an active life. On New Year's Eve 2005, Randone seemed to be the picture of health.

Two weeks later, Randone checked himself into a Long Island hospital for heart valve replacement surgery. He was 52, and the surgeon told his wife Josephine and daughter Marissa that the risks were low.

"They said even possibly in five days he would go home. And then, you know, there was a recovery period, as there would be with any kind of heart surgery," Josephine remembers.

"But then he should be in ICU for about 24 hours, and then move up to a regular floor, recuperate and come home," Marissa adds.

Asked if the doctors weren't particularly concerned about this, Josephine says, "No."

"It was routine as far as they were concerned," Marissa tells Pelley.

The surgeon noted the chance of complications at five percent. Trasylol was put in Joe's IV and kept flowing for four hours. At the end of the surgery, the Randones were told that something was wrong.

"They didn't go into specifics," Marissa says. "Just that there were a lot of complications, and that making it through the night was basically our first concern."

Immediately after the surgery, Randone suffered two heart attacks and his kidneys failed. Randone's surgeon wrote in his notes "Aprotinin-induced graft thrombosis." Aprotinin is Trasylol, and thrombosis means blood clotting.

At the same time, in San Francisco, an eminent medical researcher, Dr. Dennis Mangano, was finishing a study that had followed thousands of patients - the largest Trasylol study ever conducted.

Mangano says the study included 5,065 patients in 17 countries.

"It showed an important association between Trasylol use and kidney failure requiring dialysis, Mangano tells Pelley, "And it showed a trend toward increased death in hospital in these patients."

Dr. Mangano was one of the researchers who discovered that aspirin reduces the risk of heart attack. His non-profit institute studies drug safety and how generic drugs can lower health care costs. His work is credited with improving the health of millions. Ten days after Joe Randone's surgery, Mangano's study was published in the New England Journal of Medicine and reported in newspapers across the country, including Long Island.

Marissa says the doctor had just seen an article about the study in the newspaper. "The surgeon told us that he felt that the drug was the reason for all the complications," Marissa says.

"And that he had filed a report with the FDA, and he wanted us to be aware that it was because of this drug," she says.

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[dougemac]

bayer needs to stop draging their feet and pay the people they hurt with trasylol it may help the people live with what bayer has done

[dougemac]

there is no blanket protextion to hearm people with bad drug traslol sham sham on bayer

[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?"

[baileyccc]

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.