Feb. 17, 2008

One Thousand Lives A Month

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

  • Play CBS Video Video 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.

  • Photo

     (AP / file)

(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.



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.

Continued



Produced By Solly Granatstein
© MMVIII, CBS Interactive Inc. All Rights Reserved.
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by mcvet February 14, 2008 8:05 PM PST
Nothing and I mean NOTHING about the Bush Administration Works. Not the EPA, Not the Justice Department, Not FEMA, Not FDA... NOTHING.
Reply to this comment
by sailingwnd February 15, 2008 1:34 AM PST
I''m not sure but isn''t there legislation giving blanket immunity to pharmaceutical companies? I though it was passed in last couple of years, If I''m right good luck trying to get compensated, Thank You George Bush for another great law to protect our Citizens.
Reply to this comment
by sailingwnd February 15, 2008 1:35 AM PST
I''m not sure but isn''t there legislation giving blanket immunity to pharmaceutical companies? I though it was passed in last couple of years, If I''m right good luck trying to get compensated, Thank You George Bush for another great law to protect our Citizens.
Reply to this comment
by sailingwnd February 15, 2008 1:37 AM PST
I''m not sure but isn''t there legislation giving blanket immunity to pharmaceutical companies? I though it was passed in last couple of years, If I''m right good luck trying to get compensated, Thank You George Bush for another great law to protect our Citizens.
Reply to this comment
by justiceinmi February 15, 2008 4:35 PM PST
Re: sailingwnd''s post: Only one state, my own (Michigan) - provides blanket immunity from civil liability to drug companies. We have lived with this for twelve years. Some of us have died with it.

Meanwhile, 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.



Reply to this comment
by rjaquiss February 17, 2008 1:38 PM PST
As a pediatric heart surgeon, I have followed the controversy about Trasylol with keen interest because I have used it extensively in my patients (children undergoing open heart surgery). In my practice the medication has been miraculous in preventing hemorrhage, without apparent harm. Because of the recent decision by Bayer to stop marketing Trasylol, I have stopped using it, and have tried both of the drugs (aminocaproic acid and tranexemic acid) touted by Dr. Mangano as equal in efficacy and safer. Neither of the drugs were remotely as effective as Trasylol. In fact, several of my patients suffered from far more extensive bleeding than would have been the case with Trasylol. In some the bleeding was so extreme that I resorted to a new recombinant clotting factor, which is effective but completely untested in terms of safety.

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.


Reply to this comment
by rjaquiss February 17, 2008 1:39 PM PST
As a pediatric heart surgeon, I have followed the controversy about Trasylol with keen interest because I have used it extensively in my patients (children undergoing open heart surgery). In my practice the medication has been miraculous in preventing hemorrhage, without apparent harm. Because of the recent decision by Bayer to stop marketing Trasylol, I have stopped using it, and have tried both of the drugs (aminocaproic acid and tranexemic acid) touted by Dr. Mangano as equal in efficacy and safer. Neither of the drugs were remotely as effective as Trasylol. In fact, several of my patients suffered from far more extensive bleeding than would have been the case with Trasylol. In some the bleeding was so extreme that I resorted to a new recombinant clotting factor, which is effective but completely untested in terms of safety.

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.


Reply to this comment
by rjaquiss February 17, 2008 1:54 PM PST
I will watch 60 Minutes this evening, but am prepared to be very disappointed if the coverage is simply an expanded version of the description above. What I hope to see is balanced commentary provided by disinterested experts in the field. Dr. Mangano is a renowned scientist, but his zeal to eliminate Trasylol seems extreme. Likewise, Bayer is unlikely to provide an unbiased counterpoint to Mangano, given the tremendous financial implications of the dispute. This controversy as presented in the popular media (NYT, WSJ, CBS, et al) is entertaining and will doubtless make for good television. Mangano will speak for himself, Bayer and the FDA apparently won''t speak, and it seems likely Mangano will "win". I wonder who will speak for the patients.


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.

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by karencan February 17, 2008 7:24 PM PST
WOW! Doesn''t the bible say "the love of money is the root of ALL evil!" This story of Trasylol proves it!
Shame, shame, double shame!
Reply to this comment
by crazybob9 February 17, 2008 7:26 PM PST
In response to JusticeInMI: All companies should be held fully liable for any wrongdoing, with no limitations on lawsuits. I also live in Michigan and think that limitations on liability have transformed our justice system into a travesty of what it was intended to be. Too bad Bayer isn''t going to be stopped from marketing this and other harmful products. We also need to do a better job of regulating the pharmaceutical industry so that unsafe drugs never make it to the market in the first place.
Reply to this comment
by blondee47 February 17, 2008 7:27 PM PST
Baer is practicing american genocide by not disclosing their study

your canadian friend
Reply to this comment
by dubiosity February 17, 2008 7:31 PM PST
Let''s keep beating up big Pharma until they are all out of business. Then see who''s whining when there are no more new medications being developed.
Reply to this comment
by patsysermers February 17, 2008 7:31 PM PST
I read the doctors comments about certain patients needing Trasylol. Fine. But to continue to push this drug on to every cardiac surgery patient after knowing and not revealing the results of their own studies is criminal. My small part will be to NEVER purchase another Bayer product...
Reply to this comment
by dubiosity February 17, 2008 7:32 PM PST
Let''s keep beating up big Pharma until they are all out of business. Then see who''s whining when there are no more new medications being developed.
Reply to this comment
by free2write February 17, 2008 7:42 PM PST
for 3,000 dead we go to war;
for 20,000 dead we ...
Reply to this comment
by sixtyerrors February 17, 2008 7:44 PM PST
60 Minutes continues to obfuscate the Drug Industry''s control of the FDA Advisory Committee Meetings; perhaps because 60 Minutes make so much money on the advertisement of drugs during commercial breaks in their weekly broadcasts. 60 Minutes is also one of the premier, on-air marketers of drugs, thanks to its cozy relationship with the Health Care Public Relations industry. If you could only go back and count the number of favorable reports on so-called blockbuster drugs by 60 Minutes--usually before a sufficient number of patients have been exposed to the drug to discover its true risk-benefit profile.
...
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.
Reply to this comment
by sixtyerrors February 17, 2008 7:44 PM PST
60 Minutes continues to obfuscate the Drug Industry''s control of the FDA Advisory Committee Meetings; perhaps because 60 Minutes make so much money on the advertisement of drugs during commercial breaks in their weekly broadcasts. 60 Minutes is also one of the premier, on-air marketers of drugs, thanks to its cozy relationship with the Health Care Public Relations industry. If you could only go back and count the number of favorable reports on so-called blockbuster drugs by 60 Minutes--usually before a sufficient number of patients have been exposed to the drug to discover its true risk-benefit profile.
...
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.
Reply to this comment
by sixtyerrors February 17, 2008 7:45 PM PST
60 Minutes continues to obfuscate the Drug Industry''s control of the FDA Advisory Committee Meetings; perhaps because 60 Minutes make so much money on the advertisement of drugs during commercial breaks in their weekly broadcasts. 60 Minutes is also one of the premier, on-air marketers of drugs, thanks to its cozy relationship with the Health Care Public Relations industry. If you could only go back and count the number of favorable reports on so-called blockbuster drugs by 60 Minutes--usually before a sufficient number of patients have been exposed, which elucidates its true risk-benefit profile.
...
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.
Reply to this comment
by sixtyerrors February 17, 2008 7:47 PM PST
60 Minutes continues to obfuscate the Drug Industry''s control over the FDA Advisory Committee Meetings; perhaps because 60 Minutes make so much money on the advertisement of drugs during commercial breaks in their weekly broadcasts. 60 Minutes is also one of the premier, on-air marketers of drugs, thanks to its cozy relationship with the Health Care Public Relations industry. If you could only go back and count the number of favorable reports on so-called blockbuster drugs by 60 Minutes--usually before a sufficient number of patients have been exposed, which elucidates its true risk-benefit profile.
...
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.
Reply to this comment
by aky113 February 17, 2008 7:49 PM PST
The problem is very simple and was stated fairly well by 60 Minutes. FDA, under Republican administrations, was convinced to accelerate drug and device approvals. The big drug and device companies convinced the American public, and - through them - Congress, that the approval processes were too slow. One of the reasons they WERE, indeed, slow was the size of clinical trials that FDA required. One of the changes made to accelerate approval was reduction in the size and duration of clinical trials. Basically, the American public, as a whole, became subjects in various clinical trials WITHOUT "informed consent." Informed Consent was no longer necessary, because the drugs and devices had been approved and were now lawfully marketed. The smaller, shorter duration, clinical trials now accepted may be insufficient to reveal significant adverse events. These events do not show up in numbers until the drugs/devices are used in larger numbers of people for longer periods of time.

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!
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by grama2me February 17, 2008 7:49 PM PST
I just finished watching 60 Min. Shocking!! My husband had 2 open heart surgeries, AAA surg and suffered from kidney failure. I am wondering if the the drug Trasylol contributed to his death in 2005!
Reply to this comment
by gccibt February 17, 2008 7:50 PM PST
Bayer also failed to report deaths in Italy before Baycol was released in the US. Baycol was removed from the market in 2001. Search all the lawsuits over Baycol. Will never by Bayer products. Shame on you.
Reply to this comment
by aky113 February 17, 2008 7:53 PM PST
Writer "SixtyErrors" makes another excellent point. Congress should immediately halt "user fees" for drug, biologics and device review and approval processes. there is an inherent conflict of interest when the salaries of literally hundreds of employees comes from APPROVALS. Employees whose jobs are wholly supported by these user fees!
Reply to this comment
by polliwag1059 February 17, 2008 8:01 PM PST
Maybe the Bayer executives who are responsible for this drug should be forced to use it on themselves or any of their relatives or loved ones who needs surgery. I''m sure they would have voted to remove Trasylol from the market long ago. Can''t our government do something about this and so many other like situations with other drug companies??
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by berlin47112 February 17, 2008 8:10 PM PST
bayer knew from day 1, and that is in the 70/80 about the side effects, but still brought that product on the market.
i hope the get slapped with a billion dollar law suit.

Reply to this comment
by aky113 February 17, 2008 8:15 PM PST
Pollywag,

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.
Reply to this comment
by pjcole1 February 17, 2008 8:24 PM PST
My husband died in April, 2000 after open heart surgery at Baptist Integrist Hospital in Oklahoma City, Oklahoma with symptoms which could possibly been from the Bayer drug Trasylol.

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
Reply to this comment
by jimt154 February 17, 2008 8:37 PM PST
Already mentioned by one commentator but Bayer''s behavior concerning Baycol was similarly indefensable. After the .8 dose had been banned in England they were still supporting it in US. The intimated that Baycol and Gemfibrizol was a safe combo, when in fact this combo resulted in several severe events and deaths. They displayed inordinate gall when the finally withdrew it with a letter to docotors blaming them for not heeding prescribing warnings in stead of the drug itself.

I was not suprised to here of there complicity with an other product
Reply to this comment
by jaynesday February 17, 2008 8:37 PM PST
Now 60 minutes needs to do a report on the gross mismanagement of the FDA and how preemption will take away any possibility of controlling, if you can call it that, the drug companies. Unfortunately this isn''t the only drug that is killing our loved ones. I don''t think anyone wants to keep new drugs from coming on the market but we certainly don''t want unsafe drugs or drugs that kill thousands. And the sad thing is, the public isn''t informed of the harm these drugs can cause so we can make our own choice to use them or not. My mother died from a "precautionary" drug after a very routine surgery. If we had been told that there could be a possibility of death or even an allergic reaction, we would never have allowed it to be used. However, we were not given that option. The sad thing is the Dr and hospital had never heard of the possibility of an allergic reaction. The surgeon no longer uses the drug. He said the benefits don''t outweigh the possible outcome. Bottom line, the public needs to be informed. The drug companies withhold information for their bottom line and the FDA doesn''t have the man power to do anything about it. We''re on a very slippery slope if preemption is passed giving drug companies even more control.
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by meichinger1 February 17, 2008 9:00 PM PST
A stirring and frankly disappointing report with respect to large pharma ethics. Maybe the real story behind the story is how much money does Bayer contribute to political office holders in Washington DC and do those office holders have influence on the FDA? There is no supposition here, just a question that I believe deserves some fair, unbiased news-based investigation.
Reply to this comment
by bills778 February 17, 2008 9:03 PM PST
In 1993 while working for Medtronic, a manufacturer of anticoagulant monitoring equipment, I had the opportunity to address Cardiac Surgeons at the Bayer pre-trial Trasylol meetings. Even then it was apparent to Bayer that adequate management of heparin (anticoagulant used in CABG) was necessary to prevent post surgical thrombotic issues. Trasylol had the unintended impact of extending a then universally used anticoagulant test and could lead to patient underheparization during surgery. This tipped the balance in many patients to clotting at the expense of reducing bleeding, often leading to post surgical thrombosis. Trasylol was eventually approved, but contained a warning in the package insert about ensuring that appropriate anticoagulant monitoring be used during surgery. This could be controlled well in a 15 center trial, but is something that was less likely to be properly monitored once the drug was approved for general use.

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.
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by mozartsmom February 17, 2008 9:09 PM PST
There has been widespread abuse by these big drug companies for years. If I am correct and I know someone will correct me, the drug companies have the market cornered when new drugs come on market for 10 yrs I beleive, then if they change 1 iota in the makeup of the drug, they can call it new and improved and they get to keep all the billions they make off the drugs to keep a generic off the market. I''m sure someone will blast me also as this is not a Republican(I am a die-hard Democrat) but this has been going on for years. I would like for someone to explain to me/all of us, just how you fight the drug companies? I needed an older drug that Parke Davis made for Reflex Sympathetic Dystrophy, old name is gabapin, new name "Neurotin" Gabapin was used for seizures for years and costs pennnies to make, so they come out with it for the neurological disorder, rename the stuff Neurotin and charged me $600 per bottle. Needless to say I could not afford that. Thank the Lord that I no longer require that medicine, but they should be ashamed of themselves for charging that kind of money to poor people.
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by dbcipro February 17, 2008 9:12 PM PST
Remember back in 2001 when there was an anthrax scare? Thousands took another Bayer product, Cipro, and reported serious adverse drug reactions, some of them permanently disabling people both physically and psychologically. Despite continued reports to the FDA via MEDWATCH, people continue to be crippled by this drug. Public Citizen is suing the FDA to act on information that they have been "sitting on" regarding a large number of injuries due to Cipro and similar drugs (http://www.citizen.org/pressroom/release.cfm?ID=2581)
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.
Reply to this comment
by perfectstom February 17, 2008 9:23 PM PST
I''ve been following pharmaceuticals and the FDA for past few months... the news is unbelievably dire. Almost daily there is another report of people being injured or killed by a drug or medical device in parallel with crucial facts being hidden or ignored. That''s bad, but the news gets worse in a compounding manner. The Perfect Storm is about to hit.

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.
Reply to this comment
by rational_1 February 17, 2008 9:41 PM PST
In the video, Sinclair claims he and Obama met on two separate occasions, that Obama used crack cocaine and that Sinclair performed oral sexual act on Obama both evenings.

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.
Reply to this comment
by rudy654-2009 February 17, 2008 9:56 PM PST
Posted by rational_1 at 09:41 PM

That aint Hillary. That there is our Ron Paul Spammer.
Reply to this comment
by joyous88 February 17, 2008 10:13 PM PST
The conservative republican agenda at work

money money money

for republicans it is all about profit

anti american crimanals = republicans
Reply to this comment
by joyous88 February 17, 2008 10:15 PM PST
criminal that is the republican agenda

brought to you by the mindless christian vote
Reply to this comment
by February 17, 2008 10:16 PM PST
My daddy was given trasylol during his heart bypass surgery and now has kidney failure requiring dialysis 3 days a week. He NEVER had kidney problems before being given this drug. He was in great health aside from needing bypass surgery. Now, he also has arterial fibrillation and congestive heart failure. He has been in and out of the hospital for months now and just had to stay 2 weeks for testing at the Mayo Clinic in hopes of being eligible for a kidney transplant.

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.
Reply to this comment
by pensacola88 February 17, 2008 10:43 PM PST
This is outrageous! I can''t accept that we will continue to accept this kind of performance out of the FDA in the future.

Reply to this comment
by rowdytexan2 February 17, 2008 10:45 PM PST
Posted by rational_1 at 09:41 PM : Feb 17, 2008

Hahahaha! It''s not Hillary...it''s either Ron Paul or the KKK...lol...or possibly both.
Reply to this comment
by gunownerdan February 17, 2008 10:53 PM PST
Prescription drugs are much more dangerous than guns, that''s for sure.
Reply to this comment
by graceuntold February 17, 2008 11:21 PM PST
Its all about the money! This is sickening. Shame on Bayer and the FDA because they only reason they didn''t remove that failed drug - Trasylol cost over 1000 bucks a pop, geesh pharmaceutical companies are no different then black gangsta rappers from the ghetto. A human life means nothing to them but the almighty dollar does.

What ashame.
Reply to this comment
by fmrbayemp February 17, 2008 11:26 PM PST
I used to sell Trasylol. The company is poorly managed and I can attest to the fact that there are people in that company who only care about the sales and the $1bill goal. The marketing dept was ran by Pharm D''s and the sales dept was kept out of the dark on a lot of key info. I am embarrassed that I was told to keep selling the drug after all that came out in the NEJM. One of the best things I ever did was resign before it got really bad. At least now we know the risks. There are still patients that benefit from the drug-ie people that don''t take blood transfusions for religious purposes. Heart Surgery is a risky procedure, there are a lot of risks involved that could lead to complications. Check out the surgeons track record- not just the drug. Lastly, I would like it to be available if I ever needed Heart Surgery.
Reply to this comment
by graceuntold February 17, 2008 11:40 PM PST
In reply to: fmrbayemp

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.
Reply to this comment
by beekeeper75 February 17, 2008 11:51 PM PST
Please watch:
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.
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by nor-one February 17, 2008 11:52 PM PST
Why would anyone think that BAYER gives a rats behind about killing people?? Here''s a little history for you, BAYER was and for all practical pusposes still is a major part of IG Farben. That''s the company that ran the factory part of Auschwitz and paid for most of the cost of building the place. They also developed Zyclon B but had it manufactured by a smaller company to have some semblance of deniability.
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!
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by graceuntold February 17, 2008 11:58 PM PST
So it sounds like Bayer corporation is corrupt.

Well its no suprise that when companies operate without integrity and respect for their workers and lives, the company folds.
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by sean7phil February 17, 2008 11:58 PM PST
The FDA and the drug industry need a massive overhaul.

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.
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by standlee5 February 18, 2008 12:02 AM PST
Two years - during which it''s estimated Trasylol was contributing to the loss of one thousand lives a month

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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