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May 13, 2009
What Bayer knew about Trasylol: Insider unveils fraud & corruption
Insider unveils fraud & corruption at BAYER
It is a a major breakthrough in combating fraud and corruption: At today’s annual general shareholders meeting of Germanys Bayer AG, a former pharmaceutical employee intends to unveil severe corruption practices within BAYER. Alfredo Pequito worked for years for Bayer in Portugal. Pequito has survived several assaults threatening his life and now lives under police protection. We now publish Peequitos speech in full length – exclusive at LifeGen.de.
Speech Alfredo Pequito Bayer Shareholder Meeting
It is with humility, pleasure and also enormous apprehension that I am addressing to you, but before and above that, let me pay my sincere homage and thanks to all members of this noble organization, CBG, specially to Mr. Philipp Mimkes, who has been giving me a precious help in face of the moral and material damages that Bayer A.G. caused to me, which remain and even last, both at personal and professional level.
My name is Alfredo Pequito, Portuguese citizen and perhaps to most of you as a unknown man, to others the man who denounced to the Portuguese authorities the illegal corruption and bribery activities used by Bayer in Portugal – and continues to be used – specially among the Portuguese medical society (doctors).
In 1992 I worked in another pharmaceutical company as an expert on the hospital sector, when a high Bayer responsible invited me to join his company, which happened in December of that same year.
As soon as I started my work for Bayer I was informed that a high amount of money was at my disposal that was supposed to support and help doctors in their activities. This amount would be available whenever requested.
I never used such type of money, because I thought it was not necessary in my job, that is, to give to doctors detailed information on and about the qualities of Bayer’s products. That was, I thought, my main activity, as medical adviser.
Bayer classified Portuguese doctors as A, B and C, in accordance with the prescription power of each one. The Bayer representatives were supposed to search additional information about the doctors, such as number of children, hobbies, political tendency and even sexual tendency. These dossiers could be used to force doctors to prescribe Bayer’s products.
My question to the board is: do these kind of files also exist for German doctors?
At a certain time I was called to a meeting in the head office with my direct manager, the sales director, today member of he Board of Bayer Portugal, and the marketing manager who confronted me with the following question: the amounts at your disposal should be spent fast, and at the maximum of its value, so that, next year, Bayer reinforces our corresponding budget. We verify that you do not buy doctors, do not make credits in travel agencies on their behalf, and therefore doctors can not raise this money or spend their vacations or do anything, whatever and whenever they want. You do not present invoices of meals which can be transformed in money, for example invoices for €800.00 when the real value was € 15.00/20.00, you do not ask for electro domestic devices, informatic material, you do not revert the money in golden pens, or make special protocols so that the doctors would be obliged to prescribe only our products.
I resisted to those fake practices and was put aside. On a certain day, after a normal working meeting, I was summoned to the Personnel Director office, where the Marketing and Pharmaceutical managers already were present and with a chilly clearness they told me: you do not buy doctors, therefore you do not understand and comply with the spirit of Bayer: you are fired… The General Health Inspection verified later on, that in 1997 Bayer Portugal spent between 5-10% of their profits in this type of activity, which corresponds to today’s’ value of 1 – 2 million Euros.
I thought it was my duty to inform the President of the Bayer Board at that time, Manfred Schneider, of such irregular situation. The answer and information that I received was that Bayer Portugal was an independent and autonomous organ, with its own management. This explanation was, and still is, an aberration and an excuse that belongs to the long history of excuses of this Company.
After my duly documented accusation, it was naturally brought an investigation, at government level, (General Health Inspection), led by a Magistrate of the Public Accusation (Ministério Público), who concluded that corruption had spread throughout the country. The conclusions are, if you wish to known its extent, compiled in 3 or 4 bulky books. And the conclusion of the investigation is that only those doctors who work for the public health department can be involved in accusation that means, around ten thousand doctors.
Which consequences did Bayer draw from these revelations?
Bayer then contracted a very well known Lisbon lawyers society – Jardim, Sampaio, Caldas e Associados – who were, at the time, respectively Minister of Justice, President of the Republic and Minister of Defence. Apparently the power of money is always in good terms with the political power.
Bayer and their cooperating politicians found a solution: the anniversary celebrating the democratic revolution of April 25th 1974 was a good pretext to announce a general amnesty, naturally including corruption crimes, which were therefore pacifically legitimated. The amnesty was granted to Bayer by the President of the Republic J. Sampaio and the Minister of Justice, V. Jardim – those same men who used to be active members of the lawyers society which defended the interests of Bayer.
There are also other activities that lead Bayer to be a bad example in the commercial activities. I refer essentially to medical experiments and clinical tests carried on in Portugal, without any control and knowledge of the authorities of my country.
For example Bayer in Portugal made a clinical test with a substance called Ecadotril. In an internal company’s memorandum one could read “placebo 0 deaths – ecadotril 8 deaths”. Besides the responsibility for these deaths, why did Bayer tried to hide, even to deny, this study ?
Is the Board prepared and willing to reveal all the clinical essays, as well the consequences thereafter ? Or is this dirty material is not to be disclosed to the public ?
The Infarmed, the Portuguese Pharmaceutical Department, that controls all the aspects concerning medicaments used in Portugal, was not aware of Bayer’s activities, which were hidden with the cooperation of the doctors involved. As a consequence physical damages occurred, including deaths, hidden to the general public and that only very, very late were disclose by Expresso, a weekly Portuguese newspaper.
Portugal never reported any secondary effects of Lipobay, a medicament that caused thousands of cases of mortality and morbidity everywhere in the world. I ask the board, now many people in Portugal were prescribed Lipobay and how many got health problems?
Portugal also never disclosed the morbidity and mortality with Trasylol. For decades it is commonly known that Trasylol causes very serious secondary effects, and Bayer, the producer, also knows it. How many people were affected by Trasylol in Portugal? When do you finally exclude this medicament from the market ? Or it is the greedy and desire for higher profits, at any price (specially of human lives) that does not allow this?
Conscientious of all those facts, does not Bayer board feel shame and guilty of the various misfortunes that cause throughout the world ?
What directs this company to “buy” the medical prescription, or said in a direct and cruel form, to corrupt doctors and pharmacies, everywhere ?
Or does Bayer simply not trust their own products ?
I question myself if you, with full knowledge of the daily sufferance caused by your products, are able to simply sleep in peace and appeased conscience ?
And finally, all this shameful policy of yours does not honour a powerful State like Germany. This country deserves the best respect of all, I repeat, all of us.
I hope that the Board has the courage and nobleness to answer all these questions; on the other hand I deserve the right to an answer, because, I confess, I am creditor of hard suffering in my life and my Family’s life, caused by Bayer.
Thank you very much.
Continue reading, What Bayer knew about Trasylol: Insider unveils fraud & corruption
March 6, 2009
Supreme Court Ruling Supports Drug Lawsuits
The Supreme Court enhanced the ability of injured patients to hold drugmakers responsible Wednesday, in a 6-3 decision that affirmed a jury award for a woman who lost an arm to gangrene after injection of an anti-nausea drug.
The broadly written decision sends a strong signal to lower court judges to let state liability lawsuits go forward even when the federal government regulates the area. The court rejected arguments by the Bush administration last year and drug manufacturer Wyeth that federal law overrides certain state claims.
Lawyers on both sides of the issue deemed the ruling significant, although it is not clear how widely it will apply beyond certain drug cases.
“The message here is that consumers will get their day in court,” said lawyer David Frederick, who represented Diana Levine, a former guitarist who lost her arm after she had gone to a health clinic in April 2000 for treatment of a migraine. A clinician injected Wyeth’s Phenergan drug directly into a vein, allowing the drug to reach an artery. It caused immediate gangrene.
A jury found that Wyeth’s label had inadequate warnings about the dangers of the IV-push method used; Levine won $6.7 million. (She settled a separate case with the health center and clinician.)
The Vermont Supreme Court upheld the verdict and rejected Wyeth’s arguments that Levine’s state failure-to-warn claims should have been thrown out because the Food and Drug Administration had approved the label.
Levine, 63, said her knees buckled when she heard she won at the high court. “I was hanging on and crying for dear life,” said Levine, who runs a small record company. “If I had lost, the rights of people to tell their story in court if they were hurt by a drug unnecessarily would have been taken away.”
Wyeth had argued that it could not change the label after the FDA approved it. The company said allowing suits based on the liability laws of 50 states would thwart U.S. regulatory goals.
Bert Rein, representing Wyeth, said Wednesday FDA medical experts can best decide what a label should say.
Justice John Paul Stevens wrote for the majority that Congress had not displaced state law. He rejected the FDA’s “recently adopted position” that state suits interfere with its regulation.
Dissenting justices noted Levine’s loss even as they insisted that the majority broke from court precedent. “This case illustrates that tragic facts make bad law,” Justice Samuel Alito wrote, joined by Chief Justice John Roberts and Justice Antonin Scalia.
Tom Dewey, a New York lawyer who has represented the drug industry, said the decision will make it harder for companies to win quick dismissal of cases in the states. “This was one of the threshold defenses,” he said. “If the FDA signed off on the label, they were done.”
Continue reading, Supreme Court Ruling Supports Drug Lawsuits
December 5, 2008
Another Trasylol Study Finds Cheaper Drugs Less Risky
Another study is questioning the safety of Trasylol (aprotinin). Trasylol, a drug made by Bayer for use in cardiac surgery, was withdrawn from the market last year amid safety concerns.
Trasylol was approved by the US Food & Drug Administration (FDA) in 1993 and, before it was withdrawn, had been used in a third of all heart surgery patients in the US. However, Trasylol has been the subject of concern for years, and its safety has been reviewed by the FDA several times.
Last October, the Canadian Data Safety Monitoring Board stopped a Trasylol trial – known as the BART clinical study – after a data analysis indicated that the 30-day mortality risk in the study’s Trasylol patients was nearing “statistical significance”. Following the revelations over the Canadian Trasylol study, Bayer suspended sales of the drug in the US, Canada and Germany.
Bayer decided to take Trasylol off the market for good after an analysis of the Canadian study was published this past May in The New England Journal of Medicine. The analysis found that of the 2,331 people enrolled in the BART study, the death rate among Trasylol patients was 6 percent, while the rate for those being treated with other drugs known as lysine analogues – namely tranexamic acid or aminocaproic acid – was 4 percent. That represented an increased death rate of 53 percent for Trasylol patients, which translates to one extra death for every 50 patients treated with Trasylol.
According to this new study, Trasylol is much riskier than less expensive alternatives. To reach that conclusion, researchers at the Institute for Clinical Evaluative Sciences (ICES) in Toronto reviewed 49 randomized trials comparing Trasylol to tranexamic acid or aminocaproic acid. The review, which appears in the Canadian Medical Association Journal, included new information from the earlier BART study.
“Compared with aprotinin, lysine analogues are almost as effective, are cheaper and do not appear to increase mortality,” the authors concluded after reviewing the randomized trials. “Either tranexamic acid or epsilon aminocaproic acid should be recommended to prevent bleeding after cardiac surgery,” the team wrote.
Continue reading, Another Trasylol Study Finds Cheaper Drugs Less Risky
December 5, 2008
Latest Canadian Trasylol Study: Alternative Medications are Safer and Cheaper
A study out of Canada that casts more doubt on the safety of a drug commonly used in major heart surgery won’t affect doctors in the United States, where the drug has been taken off the market.
The newest study compared aprotinin, sold under the brand name Trasylol, a drug commonly used to control blood loss and transfusions during cardiac surgery, with lysine analogues other drugs that control bleeding. The results of the study will be published next month in the Canadian Medical Association Journal.
A Canada health expert advisory panel met Wednesday to decide on the future use of aprotinin. The study was released in advance of the meeting.
Trasylol has been available since 1987 and widely used, but recently has become a controversial drug.
A landmark clinical trial comparing aprotinin to alternatives was suspended last October when it was found that the rate of deaths among people who were given the drug was higher than that of people who got the older, cheaper drugs.
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A team of Canadian researchers conducted the newest analysis of clinical trials of the drug and concluded that cheaper, safer alternatives work nearly as well and should be recommended. “Either tranexamic acid or epsilon aminocaproic acid should be recommended to prevent bleeding after cardiac surgery,” the team wrote.
While Trasylol was heavily marketed for years, it is not used in the United States, said Dr. Anil Deshpande, program director for the Cardiothoracic Surgery Services at St. Mary Medical Center in Middletown.
“It is useful during surgery, but it has some severe side effects,” he added. Among them are strokes and heart attacks following surgery.
Previously at St. Mary, Trasylol was used only for complicated open heart surgeries, Deshpande added. “Fortunately, we haven’t seen any problems,” he said.
Continue reading, Latest Canadian Trasylol Study: Alternative Medications are Safer and Cheaperl
December 2, 2008
Wrongful Death Lawsuit Filed Against Bayer Over Drug Trasylol
An Illinois woman has filed a wrongful death suit against Bayer, alleging her 79-year-old husband died after being injected with Trasylol, a drug used in coronary artery bypass graft surgeries.
Sneathia James claims her husband, Sam Lee Erby, suffered acute renal failure after undergoing the surgery at St. Vincent’s Hospital in Birgingham, Ala., in October 2006.
Trasylol was typically used in patients who are at an increased risk for blood loss, so it was administered to Erby before his surgery, according to the complaint filed Nov. 24 in St. Clair County Circuit Court.
But because of the acute renal failure the drug caused, Erby died on Dec. 7, 2006, the suit states.
Acute renal failure is characterized by retention of waste products normally excreted by the kidney. It can be accompanied by the decrease or cessation of urine production, according to the complaint.
James claims neither she nor her husband knew about the risks involved in taking the drug.
There were no warnings about Trasylol until January 2006, when an article published in the New England Journal of Medicine revealed the drug doubles the risk of renal failure, according to the complaint.
The U.S. Food and Drug Administration issued a Public Health Advisory on Feb. 8, 2006, regarding the findings, according to the complaint.
And even though Bayer knew of Trasylol’s risk, it did not warn consumers of the risk of renal dysfunction, kidney failure, dialysis and other kidney problems until December 2006, the suit states.
Finally, on Nov. 5, 2007, the FDA and Bayer suspended the marketing of Trasylol, which still remains off the market today, James claims.
After being injected with Trasylol and until his death, Erby suffered injury, incurred medical expenses, suffered from disability and a diminished ability to enjoy life and experienced pain and suffering, according to the complaint.
Because of Erby’s death, James incurred funeral and burial expenses and sustained a loss of Erby’s companionship, society and consortium, according to the complaint.
Bayer was negligent in putting the drug on the market in 1993 without performing adequate tests, according to the complaint.
“Adequate testing would have shown that Trasylol possessed serious potential side effects with respect to which full and proper warnings accurately and fully reflecting symptoms, scope and severity should have been made with respect to the use of Trasylol,” the suit states.
The company also failed to take the drug off the market, despite the fact it knew Trasylol caused “unreasonable, dangerous side effects which many users would be unable to remedy by any means,” the suit states.
Bayer failed to provide adequate warnings about Trasylol, James claims.
The company also practiced misconduct when it “intentionally” concealed information about the drugs potential serious adverse effects from Erby, according to the complaint.
“Defendant knew that the Plaintiff would suffer mental distress and anxiety upon learning that Trasylol possessed a likelihood of serious adverse effects as described herein, thereby potentially causing acute renal failure,” the suit states.
In the 22-count suit, James is seeking a judgment in excess of $1.1 million, plus costs, attorneys’ fees and other relief the Court deems just.
Continue reading, Wrongful Death Lawsuit Filed Against Bayer Over Drug Trasylol
December 2, 2008
Trasylol Alternatives Less Risky, Cheaper and Nearly as Effective: New Study
A new analysis of clinical trials of a controversial anti-bleeding drug used in heart surgery says that cheaper, safer alternatives work nearly as well and should be recommended.
The review was rushed to print Tuesday by the Canadian Medical Association Journal in advance of a hearing Wednesday of a panel of experts who have been asked to advise Health Canada on future use of the drug, aprotinin.
“For routine use there is no clear advantage of aprotinin that justifies the apparent increase in mortality and the undoubted increase in cost,” said Dr. David Henry, lead author of the review and CEO of the Institute of Clinical Evaluative Sciences in Toronto.
“So that in routine clinical practice, there is not now a role for this drug as an adjunct to cardiac surgery.”
Aprotinin – which is sold under the brand name Trasylol – was used to reduce bleeding and minimize the need for blood transfusions during coronary artery bypass surgery. Made by pharmaceutical giant Bayer Inc., the drug was thought to be more effective than older anti-bleeding therapies tranexamic acid and aminocaproic acid.
But a landmark clinical trial comparing aprotinin to the alternatives was stopped in October 2007 when it was found that the rate of deaths among people who were given the drug was higher than that of people who got the older, cheaper drugs.
Called the BART trial and led by researchers at the Ottawa Health Research Institute, that study found the rate of deaths among people who got aprotinin was 50 per cent higher than that of the people who got two older anti-bleeding drugs.
Put another way, they found that for every 100 patients who got aprotinin during high-risk cardiac surgery, six died. For every 100 patients getting tranexamic acid or aminocaproic acid, four died. The findings were published in May in the New England Journal of Medicine.
The drug is currently the subject of a number of class action lawsuits in the United States and Canada.
Based on the BART trial findings, Health Canada asked Bayer last November to suspend marketing the drug in this country. The drug maker complied and announced it was temporarily suspending marketing of the drug worldwide. But it said it would make the drug available through a special access program for the very high risk surgeries in which it is still thought to be the preferred treatment.
Henry and his group have been studying the results of clinical trials of these types of drugs – known as antifibrinolytics – for the past decade for the Cochrane Collaboration, an international not-for-profit organization that aims to improve health care by regularly gathering up the best scientific data about a drug, medical procedure or health intervention and publishing the resulting analysis.
A 2007 Cochrane review on anti-bleeding drugs by Henry and his colleagues found the medications in the class did not increase rates of death or heart attacks in people who were given them during surgery.
With the publication of the BART trial results, the group conducted a new analysis, looking at data from new clinical trials in addition to the previously analyzed studies.
The picture that came into focus, Henry said, is that aprotinin is probably a bit better at controlling bleeding than the other drugs, “but the effects seem to be quite small.”
For some patients at severe risk of hemorrhaging during bypass surgery, aprotinin might be the better option, he admitted – but the available data can’t help doctors figure out who they are.
“We legislate and regulate for the average individual,” Henry said.
“Therefore the regulatory decision will be based on the average individuals, not the exceptional case. And I have to say to be honest that our data don’t allow us to . . . clearly identify the subgroup in whom the benefits outweigh the harms. So consequently there is a case to be made for not using the drug.”
Continue reading, Trasylol Alternatives Less Risky, Cheaper and Nearly as Effective: New Study
December 2, 2008
Another Study Warns of Risk From Cardiac Surgery Drug Trasylol
A new study casts more doubt on the safety of the drug Trasylol (aprotinin), used to limit bleeding in patients undergoing surgery.
Trasylol is already the subject of controversy in the United States, where it was removed from the market in 2007.
In the new study, Canadian and Australian researchers reviewed findings from 49 randomized clinical trials. They concluded that Trasylol posed a higher risk of death for patients than other anti-bleeding drugs, called lysine analogues.
While Trasylol was somewhat more effective at controlling blood loss and transfusions than lysine analogues, its higher risk of death and significantly higher price are deterrents to its use, said the authors. They recommended tranexamic acid or aminocaproic acid as alternatives to prevent blood loss during surgery.
“Lysine analogues are almost as effective as aprotinin in controlling blood loss, are cheaper, and appear not to increase mortality,” concluded Dr. David Henry and his co-authors of the study, which will be published in the Jan. 20 issue of the Canadian Medical Association Journal.
The findings were released early in advance of a Health Canada expert advisory panel meeting scheduled for Wednesday. The panel is expected to make a decision about the use of aprotinin.
The review included new information from the Blood Conservation Using Antifibrinolytics in a Randomized Trial (BART) study published by the New England Journal of Medicine earlier this year. That study found that patients treated with aprotinin were 53 percent more likely to die than those treated with two similar drugs, Cyklokapron (tranexamic acid) and Amicar (aminocaproic acid). The death rates were 6 percent, 3.9 percent and 4 percent, respectively.
Due to the significant risk of death associated with Trasylol, the BART study was stopped in October 2007, before the schedule completion date.
In November 2007, Trasylol manufacturer Bayer AG suspended the drug’s marketing in the United States after the preliminary results from the BART trial were released. Bayer removed all remaining stocks of the drug from the U.S. market earlier this year. However, the German drug maker continues to sell Trasylol in some areas of the world.
Trasylol has been on the market since 1987 and widely used. At the time of the BART study’s release, one expert questioned why the truth about the dangers of the drug took so long to come out and how many patients may have died “because of this misadventure in therapeutics?”
“Did the clinical community accept it too readily? Was the manufacturer not willing to do the appropriate trials?” asked Dr. Eric J. Topol, director of the Scripps Translational Science Institute and dean of the Scripps School of Medicine.
The U.S. Food and Drug Administration is high on the blame list, Topol told HealthDay.
“The FDA has to be considered part of the problem,” he said. “Why weren’t trials like this part of the early approval process, rather than getting the data many years later?”
Continue reading, Another Study Warns of Risk From Cardiac Surgery Drug Trasylol
October 10, 2008
Trasylol Named in Two Lawsuits in St. Clair County, IL
Trasylol, Bayer AG’s now-withdrawn anti-bleeding medication, is the subject in two Illinois lawsuits. One of the plaintiffs claims Trasylol was the cause of her husband’s death, and the other alleges the drug caused him to suffer acute renal failure. Bayer permanently withdrew Trasylol from the market in May 2008, after a study found that it increased patients’ risk of death by more than 50 percent.
Trasylol was approved by the US Food & Drug Administration (FDA) 1993 and, before it was withdrawn, had been used in a third of all heart surgery patients in the US. However, Trasylol has been the subject of concern for years, and its safety has been reviewed several times. Last October, the Canadian Data Safety Monitoring Board stopped a Trasylol trial – known as the BART clinical study – after a data analysis indicated that the 30-day mortality risk in the study’s Trasylol patients was nearing “statistical significance”. Following the revelations over the Canadian Trasylol study, Bayer suspended sales of the drug in the US, Canada and Germany.
Bayer decided to take Trasylol off the market for good after an analysis of the Canadian study was published in a May issue The New England Journal of Medicine. The analysis found that of the 2,331 people enrolled in the Canadian study, the death rate among Trasylol patients was 6 percent, while the rate for those being treated with other drugs – namely Amicar or Cyklokapron – was 4 percent. That represented an increased death rate of 53 percent for Trasylol patients, which translates to one extra death for every 50 patients treated with Trasylol.
According to complaints filed last month in St. Clair County Circuit Court, both Gary Harms and Richard Kopsie were given Trasylol during a coronary artery bypass graft surgery. Harms underwent the surgery in which he was given the drug in 2005 at Des Peres Hospital in St. Louis, while Kopsie had his in August 1996 at Christian Hospital in St. Louis, the suit states.
The drug caused damage to both Harms’s and Kopsie’s kidneys, resulting in acute renal failure. Both required dialysis treatment. Kopsie died on March 23, 2003, at the age of 53 as a result of Bayer’s negligence, his widow, Linda Kopsie, claims.
According to the lawsuit, Bayer issued no warnings until Dec. 15, 2006, on the increased risk of kidney failure posed by the drug, despite the fact that by 2006 about 10,000 patients were on dialysis because of their exposure to Trasylol.
Linda Kopsie is seeking a judgment in excess of $1.1 million, plus costs and attorney’s fees. Harms is seeking a judgment in excess of $550,000, plus costs and attorney’s fees.
Continue reading, Trasylol Named in Two Lawsuits in St. Clair County, IL
October 9, 2008
Bayer Withdraws Heart Surgery Drug from U.S. Market Following New Study Results Revealing Harm
Drug maker Bayer AG has recalled all remaining stocks of the anti-bleeding medication Trasylol (aprotinin) from the U.S. market after a New England Journal of Medicine Study demonstrated that the drug increased heart surgery patients’ risk of death by 53 percent.
Canadian researchers compared rates of massive bleeding, organ failure, death and other serious complications in 2,331 heart surgery patients given either Trasylol, Cyklokapron (tranexamic acid) or Amicar (aminocaproic acid). The anti-bleeding drugs are often prescribed during high-risk heart surgeries.
The researchers found that while about 4 percent of surgery patients given either Amicar or Cyklokapron died, the death rate among Trasylol patients was 6 percent.
“This represents a 53 percent [higher] relative risk of dying,” said researcher Paul C. Hebert, “which translates into for every 50 patients treated with aprotinin, one [extra] patient would die.”
The experimental phase of the current study was halted in October 2007, when it became clear that Trasylol patients were dying at a much higher rate than those given other drugs. In November, Bayer temporarily suspended marketing of the drug in the United States, but left existing supplies on the market. Now even those stores have been recalled. The company still sells the drug in other countries, however.
Trasylol was introduced in 1987, based on studies demonstrating that it reduced bleeding in surgical patients.
“Future studies of drugs to prevent blood loss in cardiac surgery must be designed to look at death and other important clinical consequences, rather than only focusing on blood loss,” said Wayne A. Ray, director of Vanderbilt University School of Medicine’s Division of Pharmacoepidemiology.
Eric J. Topol, director of the Scripps Translational Science Institute and dean of the Scripps School of Medicine, questioned who was to blame for allowing Trasylol to place patients at risk for 20 years.
“Did the clinical community accept it too readily? Was the manufacturer not willing to do the appropriate trials?” he said. “The FDA [also] has to be considered part of the problem. Why weren’t trials like this part of the early approval process, rather than getting the data many years later?”
Continue reading, Bayer Withdraws Heart Surgery Drug from U.S. Market Following New Study Results Revealing Harm
August 13, 2008
A Thousand Patients Killed Each Month by Cardiac Bypass Anti-Bleeding Drug Trasylol
by David Gutierrez
(NaturalNews) The FDA’s delay in taking Trasylol off the market led to 1,000 deaths each month for a year and a half, according to the doctor who first alerted the agency to the dangers of the drug.
“Between my study and November 5, [2007] when it was taken off the market, there were approximately 431,000 patients who received the drug,” said Dr. Dennis Mangano. “As I calculated, 22,000 lives could have been saved. It’s about a 1,000 lives saved per month delay in taking that drug off the market.”
Trasylol, made by Bayer, was approved by the FDA in 1993 as a drug to prevent bleeding in high-risk surgical patients. In 1998, this approval was extended to cover all heart bypass surgery patients. Due to aggressive marketing, the drug became a major moneymaker for Bayer, with sales of $300 million by 2005 and sales of $750 million projected for 2006.
Then in 2006, Mangano and colleagues found that patients being given Trasylol suffered significantly more kidney failure and death than patients being given alternate anti-bleeding drugs, or even those being given no drugs at all. Mangano alerted the FDA, which issued a warning to doctors and scheduled a meeting about the drug for eight months later.
The FDA decided to keep the drug on the market. Then Harvard researcher Alexander Walker told the agency that at Bayer’s behest, he had conducted a study similar to Mangano’s, with similar results. The company had never revealed those results to the FDA.
The agency responded by issuing another warning and scheduling a meeting about the drug for one year later.
In 2007, a large Canadian trial of the drug had to be halted early because so many patients were dying. Germany immediately banned Trasylol, while Canada and the FDA asked Bayer to voluntarily remove it from the market. Bayer complied.
To date, surgeons in the United States are still allowed to use Trasylol in special cases.