Doctor says 22,000 lives could have been saved if Trasylol was removed from the market in 2006

On February 17, 2008, CBS aired a 60 Minutes episode on Trasylol, a controversial drug made by Bayer Pharmaceuticals used during certain heart surgeries to prevent blood loss. The alarming story claimed that if the drug had been taken off the market in 2006, 22,000 lives could have been saved.

Baum, Hedlund, Aristei & Goldman is currently litigating many injury and death cases against Bayer arising from them selling HIV-contaminated plasma-based medication to hemophiliacs in Hong Kong and Taiwan. The firm is now investigating Bayer’s troubled drug, Trasylol, generically referred to as aprotinin. Trasylol is an injection administered to patients during coronary artery bypass graft (CABG) surgery to reduce bleeding and the need for blood transfusions. It was first approved by the FDA in 1993 for patients with high risk of bleeding during heart surgery. The FDA’s approval was later expanded to cover all heart bypass surgery patients.

On November 5, 2007, after a Canadian study on Trasylol was halted due to the high number of deaths associated with the drug, the FDA, as well as other health authorities, requested that Bayer suspend worldwide marketing of Trasylol. In America, the drug is being slowly "phased out" and is still used for special cases in hospitals today.

Mangano's Study

The 60 Minutes segment focused on the interview of Dr. Dennis Mangano, who’s sensational 2006 study of Trasylol sparked early concern among the medical community.

Mangano’s study, The Risk Associated with Aprotinin in Cardiac Surgery, which was published in the New England Journal of Medicine in January, 2006, showed an important association between Trasylol use and kidney failure. Mangano found that continued use of aprotinin doubled the risk of kidney failure requiring dialysis among patients undergoing complex coronary-artery surgery or primary surgery. The study also showed that patients had greater chances of heart failure and strokes after taking the drug.

According to Mangano, this information should have prompted the removal of Trasylol, yet it was not until November of 2007 that any action was taken to remove the dangerous drug from the market. It wasn’t until the Canadian study had to be stopped that the FDA took action.

BART

The rigorous study, dubbed BART (Blood Conservation using Antifibrinolytics in a Randomized Trial) , was originally set up to prove Trasylol superior to the alternatives (aminocaproic acid and tranexamic acid) used to stem bleeding during heart surgery. The results showed a very different story. Researchers at the Ottawa Health Institute found that patients who were given the Bayer drug were more likely to die than those given alternatives or no drug at all, prompting them to put the brakes on their research.

In the 60 Minutes interview, Mangano claimed that if the earlier warnings of his study would have been heeded, 1,000 lives a month could have been saved.

Bayer Withholds Its Own Results at FDA Panel Meeting

Adding to this already outrageous story was the fact that Bayer themselves had funded a study early in 2006 meant to disprove Mangano’s results. This study, conducted by Dr. Sebastian Schneeweiss of Harvard Medical School, showed that the use of Trasylol may increase the chance for death, serious kidney damage, congestive heart failure and strokes. Instead of proving Mangano wrong, the study only reiterated his results.

Adding insult to injury, the preliminary findings of Schneeweiss’s study were omitted by Bayer during a public advisory meeting held by the FDA in September of 2006. This panel meeting was set up to review the results of the Mangano study. The FDA, not knowing that Bayer held a study confirming Mangano’s results, concluded that the benefits of Trasylol outweighed the risks, and therefore kept the dangerous drug on the market

The results of the Bayer funded study were finally presented to the FDA a week after the panel had made its decision The FDA reviewed these findings and on December 15, 2006, the FDA revised the labeling for Trasylol to "strengthen the safety warnings and limit usage to specific situations."

So Trasylol remained on the market for another year until the overwhelming results of the BART study were made public.

How Could They?

To many Americans watching the 60 Minutes program, the news seemed almost impossible to believe. How could a drug this deadly be administered in hospitals? How could the FDA discount such significant findings? How could Bayer withhold such pertinent information without as much as a slap on the wrist?

Many people watching the program were shocked and appalled at the thought of the deadly drug remaining on the market. In fact, Trasylol had been so aggressively marketed that it had become the leading antifibrinolytic used in one third of all cardiac operations in America. While the public became aware of the controversy, to the medical community this was old news.

To fully understand the scope of the controversy, one has to look as far back as the initial testing of the drug. Over twenty years ago, during the developing stages of Trasylol, a researcher found that animals given the drug suffered from severe kidney damage, the same side effects detailed in Mangano’s study. These findings were presented to Bayer, who in turn showed little interest.

20 years later, Bayer saw the sales of Trasylol reaching the billion dollar mark. This is hardly surprising since the drug sells at a rate of over $1,000 per patient. It is hard not to think that Bayer, blinded by the growing profit margin, purposefully ignored results that clearly showed Trasylol to be deadly.

Even after the suspension of Trasylol, Bayer remained optimistic about its drug stating "Bayer believes that the totality of the available data continue to support a favorable risk-benefit profile for Trasylol when used according to labeling."

New Studies

Since the suspension of Trasylol, more and more scientists have taken an interest in the side effects of Trasylol. Two new studies published this year in the New England Journal of Medicine shed an even brighter light on the effects of the dangerous drug.

One study, headed by Duke University’s Dr. Andrew Shaw, found that those who received aprotinin during surgery died at a rate nearly two-and-a-half times higher than patients who either received another drug or no treatment at all.

The Effect of Aprotinin on Outcome after Coronary-Artery Bypass Grafting
Volume 358:784-793 February 21, 2008 Number 8

The second new study, headed by Sebastian Schneeweiss, MD, Sc.D., of Harvard, looked at over 78,000 patients worldwide who underwent coronary-artery bypass grafting surgery. The study focused on a period from Jan 2003 to March 2006. The study showed that the risk of death after surgery, for those who were administered aprotinin, was 64 percent higher than those taking a comparison drug.

Aprotinin during Coronary-Artery Bypass Grafting and Risk of Death
NEJM Volume 358:771-783, February 21, 2008, Number 8

If the second study’s author, Dr. Schneeweiss, sounds familiar, he should. He is the scientist who was hired by Bayer in January of 2006. It was the preliminary results of this study that were withheld by Bayer two years ago.

FDA Explains Themselves

The evidence mounting against Bayer’s Trasylol is becoming impossible to ignore. All evidence points to a drug with risks far outweighing any benefits. Yet Trasylol is still being used in hospitals as you read this page.

Many are wondering why the FDA requested a suspension of marketing instead of banning the drug from the market all together. The FDA argues that it is important to "phase Trasylol out of the marketplace" since there are "not many treatment options for patients at risk for excessive bleeding during cardiac surgery."

Mangano argues that there are alternatives. Those alternatives, aminocaproic acid and tranexamic acid, were used in every study mentioned in this article, including Mangano’s original study. Mangano states "They were as effective in our studies as Trasylol in limiting bleeding, and limiting the amount of blood transfused, with none of the adverse effects."

The events surrounding Trasylol have only fueled anger and outrage in the medical community as well as the general public. It has also amplified the already growing suspicion and mistrust of drug companies as well as the FDA.

Perhaps the sentiment is best put by Dr. Mangano, who in his interview with 60 Minutes stated "Good medicine demands that you protect the patient. That’s the issue here, and not the drug, and not the profit margin."

Baum, Hedlund, Aristei & Goldman litigated over one hundred personal injury and wrongful death cases against Bayer for what was considered at the time one of the worst drug-related medical disasters in history--HIV-contaminated hemophilia medications. Baum Hedlund represented dozens of hemophiliacs' families against Bayer, investigating and exposing the unsafe plasma collection practices that led to the hemophiliac medications becoming HIV contaminated and transmitting HIV to nearly an entire generation of hemophiliacs.

Contact us today for a free initial consultation to discuss your potential claim.