Feb. 17, 2008
One Thousand Lives A Month
Researcher Estimates 22,000 Lives Could Have Been Saved Had Trasylol Been Pulled Earlier
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One Thousand Lives A Month
A renowned researcher estimates that 22,000 patients could have been saved if the Food and Drug Administration removed the heart surgery drug Trasylol two years ago. Scott Pelley reports.
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(AP / file)
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.
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.
Produced By Solly Granatstein
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See all 122 CommentsMeanwhile, the Bush Supreme Court has will decide three cases over the next few months that could make "FDA preemption" (full shield from liability) the law of the land. In that case, we (Michigan) are your future.
Accountability is thus hanging in the balance. The New England Journal of Medicine (not known for its love of trial lawyers) has called the issue "momentous" (their word) in its implications for patients'' rights and healthcare. It will take active citizens, and a Congress with guts, to turn the tide. It would be nice to see 60 Minutes take an interest too. The issue has been catastrophically underreported.
The hour is late. And the time is short.
I write to point out unintended consequences of Dr. Mangano''s study: some children will bleed to death who would not have if Trasylol were still available. The tragedy is that the study is far from perfect, and has been widely criticized in medical journals with which reporters may not be familiar. When published, the study was provocative and intended to be so. It was not definitive, no matter how much Dr. Mangano may wish it to have been so. His hyperbolic estimates of excess mortality are sheer conjecture. In Ontario, a better study is underway and may provide confirmation of Mangano''s assertions (or not). We simply don''t know yet.
I write to point out unintended consequences of Dr. Mangano''s study: some children will bleed to death who would not have if Trasylol were still available. The tragedy is that the study is far from perfect, and has been widely criticized in medical journals with which reporters may not be familiar. When published, the study was provocative and intended to be so. It was not definitive, no matter how much Dr. Mangano may wish it to have been so. His hyperbolic estimates of excess mortality are sheer conjecture. In Ontario, a better study is underway and may provide confirmation of Mangano''s assertions (or not). We simply don''t know yet.
I do not mean to say Trasylol is always harmless or that Bayer has been completely forthcoming or that the FDA is perfect. None of those assertions are even remotely true, and there is blame enough to go around. What I do mean to say is that the popular press is not the place to carry out evaluations of medications. I also mean to say that retrospective studies, those that look backwards at what has already happened and which compare groups of patients who are not equal, are not the best way to evaluate medications either. The Mangano study was worrisome and important. It was not definitive and Dr. Mangano, by insisting that is was, runs the risk with his evangelism of harming patients. Some of those patients are mine.
Shame, shame, double shame!
your canadian friend
for 20,000 dead we ...
...
The pharmaceutical industry also provides half of the FDA budget for reviewing drugs, and therefore wields excessive influence on Advisory meetings. They use this influence to place Drug Industry "ringers"--or advocates on the pharmaceutical payroll--on these FDA panels to sway the vote towards maintaining billion-dollar profits, even when these drugs needlessly endanger millions of patients in the U.S.A and around the World. Patient mortality and morbidity are secondary concerns to the FDA and to 60 Minutes when big profits are at stake.
...
The pharmaceutical industry also provides half of the FDA budget for reviewing drugs, and therefore wields excessive influence on Advisory meetings. They use this influence to place Drug Industry "ringers"--or advocates on the pharmaceutical payroll--on these FDA panels to sway the vote towards maintaining billion-dollar profits, even when these drugs needlessly endanger millions of patients in the U.S.A and around the World. Patient mortality and morbidity are secondary concerns to the FDA and to 60 Minutes when big profits are at stake.
...
The pharmaceutical industry also provides half of the FDA budget for reviewing drugs, and therefore wields excessive influence on Advisory meetings. They use this influence to place Drug Industry "ringers"--or advocates on the pharmaceutical payroll--on these FDA panels to sway the vote towards maintaining billion-dollar profits, even when these drugs needlessly endanger millions of patients in the U.S.A and around the World. Patient mortality and morbidity are secondary concerns to the FDA and to 60 Minutes when big profits are at stake.
...
The pharmaceutical industry also provides half of the FDA budget for reviewing drugs, and therefore wields excessive influence on Advisory meetings. They use this influence to place Drug Industry "ringers"--or advocates on the pharmaceutical payroll--on these FDA panels to sway the vote towards maintaining billion-dollar profits, even when these drugs needlessly endanger millions of patients in the U.S.A and around the World. Patient mortality and morbidity are secondary concerns to the FDA and to 60 Minutes when big profits are at stake.
Congress should be pressured to allow FDA to return to requiring more complete data on drugs and devices before they can be approved.
Note: I retired from FDA a year ago!
i hope the get slapped with a billion dollar law suit.
FDA and other Federal Agencies do what they are told and FUNDED to do by the Congress and the administration! The administration has people convinced that they want smaller government with less intrusion into their lives. The administration has the public convinced that they have the knowledge, skills and abilities to make informed decisions about their own therapies. Look at all the ads for "nutraceuticals." Drugs hiding as nutritional supplements. AND THEY GET AWAY WITH IT by saying our claims "have not been reviewed by the FDA." This is a product of perhaps the worst law ever passed by Congress and signed by a President known by its acronym "DSHEA." The Dietary Supplement for Health and Education Act of 1994. FDA is virtually powerless to address the ads and multi-billion dollar sales because of this law.
Do YOU know what''s in the dietary supplements you take? Do YOU know the possible side effects of these "nutritional supplements?" Do YOU know what possible harmful interactions these substances may have with other such substances or with approved drugs you may be taking?
There IS no way to know because no one is making the sellers do any studies at all. Not even the too short and too small ones currently used to support drug and device approvals.
After his death my attorney requested all of my husband''s medical records which were sent to "experts" in researching medical screwups.
It was determined that there was neglience but not enough to file a malpractice suit.
According to those records, a blood clot sluffed and killed a section of my husband''s colon. Before the doctors could determine what had gone wrong, gangrene set in and he died within eight hours.
I feel, after reading the report by correspondent Scott Pelley, that there is possibly enough evidence that this drug that could warrant a class action suit.
I know that there is not enough money to replace the anguish I went through but there needs to be some accountability.
Peggy Cole
Chickasha, Oklahoma
pj-cole@sbcglobal.net
I was not suprised to here of there complicity with an other product
Although the 60 Min report did not address anticoagulation during the recent trials demonstrating thrombotic or renal problems, it would be interesting to understand if problems at specific centers were related to anticoagulant protocols and equipment used. My impression has always been that Trasylol was a safe and effective drug if and only if anticoagulation during the surgery was properly administered.
Google cipro adverse reactions or similar and see how many people have been injured by this drug. Can the FDA protect the US citizen against unscrupulous drug makers? I doubt it.
1. The FDA is broken. Not my opinion - see http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_00_index.html
This is an FDA site!
2. Read the comments of the FDA Scientists in a survey reported by the Union of Concerned Scientists. Again you will not believe what you read about the FDA%u2019s management, or lack thereof.
http://www.ucsusa.org/news/press_release/fda-scientists-pressured.html
3. The Supreme Court will hear cases this year that will decide the issue of preemption. Preemption in a nut shell - When the FDA approves a drug or device, no matter what happens, the drug/device company can not be held liable. Product liability will be a thing of the past if so decided by the Supreme Court.
I%u2019m not a Democrat. This can not be a political issue! It''s a matter of safety. Politics becomes quite pale when you''ve lost a husband, wife, child or parent. There is no pain more devastating. When you know someone could have done something to prevent the death and they chose to protect themselves and their interest instead - the cruelty of the selfishness is criminal.
Now Obama and company are quickly trying to quiet this man, but Sinclair has filed a federal lawsuit. Sinclair filed suit against Obama and his campaign guru David Axelrod in Minnesota district court for allegedly attempting to abridge Sinclair''''s right to free speech, and for waging an intimidation campaign against him.
SNIP
America wants to know: where''''s the media coverage on this???? We deserve to hear the truth!
Posted by TruthBeTold- at 09:10 PM : Feb 17, 2008
Settle down Hillary - this desperation thing you''ve got going on isn''t pretty. If you''re this hysterical at the prospect of losing a nomination, there''s no way you have the backbone to be commander-in-chief. My advice is to get a big glass of good Scotch and then go see what trouble Bubba is up to.
That aint Hillary. That there is our Ron Paul Spammer.
money money money
for republicans it is all about profit
anti american crimanals = republicans
brought to you by the mindless christian vote
My parents cannot even take a 50th anniversary cruise as they had always wanted because he is on dialysis. They are retired and can''t travel anywhere because he has to stay close to home. Trasylol has completely robbed him of his quality of life.
I cannot believe that this was allowed to stay on the market for so long, even after studies had shown ill effects. Where is the CARE in health care? What is the FDA for?!
I believe there are many who don''t even know their problems are due to Trasylol. I know that we didn''t until someone told us to look it up. I am so glad 60 Minutes has done a story on this, so that more people can be made aware. Something has to be done about the "medicines" that are allowed on the market.
After what happened to my father, I no longer trust the health care system to have my best interest at heart. It is so sad that in this country money means everything, even at the expense of lives.
Hahahaha! It''s not Hillary...it''s either Ron Paul or the KKK...lol...or possibly both.
What ashame.
I am 100% in agreement to your comment. I know first hand about these things and the sad thing is that the FDA is almost making money as was Bayer. They made their money now its time for them to be held accountable for the death of thousand of people.
This is one of the problem with pharmaceutical companies, they hired people they think are educated but they are not and they are usually white males.
YouTube - beepassionate''s Channel
What Bayer is doing may be much worse than you think. Beekeepers all over the world have been trying to get something done for years, but not much luck. Bayer has too much clout. Please CBS, watch and help before it is too late. You seem brave to stand up to Bayer.
In the 1980 it took a court order to stop them from selling HIV infected blood products. Just your run of the mill drug company!
Well its no suprise that when companies operate without integrity and respect for their workers and lives, the company folds.
THey are far too in bed with each other. THe FDA needs to cultivate a career track independent from the drug industry.
Also there needs to be a huge increase in prosecutorial investigation of drug industry practices. There are absolute sociopaths at high levels in many drug companies-- and they need to be rooted out by fair, careful, but probing investigations.
That is just frigging bulllsh*t. I swear to god the frigging govt. is trying to kill us all off. Less cost for SS. THey''d rather have the illegal aliens come in and take our place it''ll be cheaper. This govt. has literally fallen apart before our eyes. We have no regulation on anything. It''s become a GD corporate playground free for all. This is what happens when the fox guards the chickencoop. And we''re all the chickens.
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