The FDA yanked the heart surgery drug Trasylol off the market last November, but a medical researcher now claims that 22,000 lives could have been saved if Bayer AG hadn’t withheld the results of an earlier internal study proving the drug’s danger. An FDA committee held hearings in September 2006 to determine Trasylol’s safety, but three of the committee members had a financial interest in Bayer, and the drug maker had underwritten the committee chairman’s research.
[Drug researcher Dr. Dennis Mangano] believes Trasylol should have been taken off the market when he published his study in January 2006, a study that associated the drug’s use with kidney failure requiring dialysis and increased death of those patients. Between the study’s publication and November 2007, when Bayer removed the drug, “There were approximately 431,000 patients who received the drug,” says Mangano. “As I calculated, 22,000 lives could have been saved. It’s about a 1,000 lives per month,” he tells Pelley.
In September 2006, Mangano presented his observational study of 5,065 patients in 17 countries to the FDA in hopes it would persuade them to pull the drug. Bayer senior executives attended the meeting to defend their product and at the time, their company had results from its own research that confirmed Mangano’s results. But the Bayer executives failed to disclose the existence of the study. Mangano says this was irresponsible. “The [Bayer] representatives at the meeting…should have disclosed fully to the FDA that a study was done…even put the meeting in abeyance until the data were found or discussed,” Mangano tells Pelley. “Good medicine demands that you protect the patient. That’s the issue here and not the drug and not the profit margin,” he says.
The chairman of the FDA committee that held that meeting, Dr. William Hiatt, told 60 Minutes that he would have voted to remove Trasylol from the market if he had known about Bayer’s study. He also took issue with Bayer’s failure to disclose it. “I thought it was unusual. I thought it was truly inappropriate,” he tells Pelley.
Dr. Hiatt, who wrote three papers underwritten by Bayer, may be sorry now, but he had no problem skewering Dr. Mangano’s research at the time. The full story complete with scary graphics and ominous music will air tonight on 60 minutes.
22,000 died amid delayed Bayer drug recall: doctor [Reuters]
(AP Photo/Roberto Pfeil)
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In case it isn’t clear,I am not saying it is acceptable for Bayer to hide the results of their study. I am saying that just because a drug has issues, or risks, doesn’t mean some people don’t benefit from it.
@bnb614: In the 60 Minutes piece, the guy who did the independent study and testified before the FDA said that there are 2 other drugs with similar efficacy, none of these negative side effects and they cost about $50/treatment, compared to $1,000/treatment for Trasylol. So, while it’s true that not everyone died, it’s likely that a huge portion of teh 22k people who DID die could have been treated with one of the less-damaging drugs at a much lower cost to their insurance companies.
The best way to rip the Bayer execs and FDA tools a new one would be to get the insurance industry to figure out how much more they spent on Trasylol for 431,000 people than they would have for alternative treatment and let them release the hounds.
@alphafemale: Ah, thank you.
i find it hard to believe that people actually trut the fda to be objective/unbiased in drug regulation. it’s far too lucrative a business. listen to nancy reagan and DONT TAKE DRUGS!
I wonder how many MORE people will die now that they don’t have access to this drug? Sure you save 22k people but kill another 150k in the process?
@NICKRB
The 60 Minutes expose showed two products that existed prior to the use of Trasylol. The two other cost $50 compared to the $1000 price tag of the designer drug. From what the medical experts were saying I understood it that Trasylol was an ideal option only for a VERY few cases, but thanks to widespread and heavy-handed pushing became drug of choice.
So essentially if the drug were completely pulled when Bayer was supposedly became aware it would have saved many, many lives.
Here is a link to the 60 minutes site, where video can be seen:
[www.cbsnews.com]
Sad I got to comment on this too late.
My wife works in heart surgery, and used this drug daily until it’s recall. She still uses it in very bad cases (extra permission of some sort is now needed) because it’s the best drug available. Believe me, she would know.
It basically keeps people from bleeding to death, and has for about 30 years. Funny that they’re seeing increased mortality in a sample group, but not in a population that’s been using it for a few decades, isn’t it?
This study is flawed, plain and simple, so everyone out their blowing your “corporate greed” whistle should wait a second and learn a little about heart surgery before assuming the worst. Trasylol, more commonly referred to as Aprotinin, was used in many (read: nearly all) heart surgery cases that require going on a bypass machine. Patient records do NOT show people dying from this drug in the numbers that this study is showing them, and yes, I am using anecdotal evidence, but it’s more than anyone else on this comment list has, so it’s as fair game as anything else. This drug has been in use for a long time now – check wiki and you’ll see that it’s at least since the 70′s. The heart surgeons who have been in the game for decades are still pissed that they can’t use this – because it’s the best available. They aren’t all assholes trying to make a buck, either – some really do it to save people’s lives, and not using aprotinin makes that harder. I’m not going into details because I can’t (my wife could, but she’s busy in a heart surgery case right now
), but suffice it to say that if you are in very bad shape, you should still use aprotinin, because you’re kidney function (e.g.) is the least of your worries.
That’s what the study isn’t saying – aprotinin is used on people who need it badly, who have a high chance of essentially bleeding to death (for a variety of reasons, generally patient-related, such as previous medications and genetic conditions) during surgery, and these patients are surviving cases that they wouldn’t otherwise because there is NO next best drug. I’m not saying everyone should get this drug, of course. We all watch House, right? It’s not real, sure, but in some circumstances you really do choose between one treatment method with an increased mortality rate and a much lower survival rate during surgery. There are legitimate uses for this drug, and the study numbers are coming back with such high mortality rates because the people who are given the drug *had higher mortality rates*. They were sicker, otherwise they didn’t need aprotinin. Now I’m sure the study is not so poorly done as to not take that into account, but if you worked in a hospital every day or worked with patient records, you would see that this study simply doesn’t jive with real-world numbers.
Read the actual study, and you’ll see that what is raised is “all cause mortality.” It’s a give and take with medications and surgeries, always, and I hope Aprotinin isn’t causing undue harm to anyone. I also think Bayer should have released the results ASAP, and in fact all medical/fda studies should be public a lot sooner than they are, if they ever are.
However, the news (as usual) is not reporting the facts, but instead reporting an alarmist version of them. No where did they mention trasylol’s history. If anyone on this list is asked by a heart surgeon if they would allow aprotinin to be given to them during their surgery, chances are the answer ought to be “yes.”
@luminus: Thank you. This knee-jerk anti-business stuff on this site is getting ridiculous.
Much more likely is that this DR. Mangano has an ego problem. His precious study should trump 40 years of good medicine. 40 years of saving lives. How many of the readers here have parents or grandparents who have had life-saving heart surgery? Well guess what, you owe part of their survival to this drug.
And how many people has Aprotinin saved? I bet you in the millions. That is not an exaggeration.
@swalve: Uhhh.. yeah, because we all know that corporate execs always have the best interests of society when they make their decisions. Maybe the reason so many of us have a knee-jerk reaction to business is because by and large, big business is full of scumbags with little on their minds but padding their own wallets…
@luminus: So Bayer’s OWN report supported the whistle-blowing doctors report, they knew it and withheld it. And since there are two other drugs with similar efficacy rates and no risk of higher mortality, why use it except in the most extreme of circumstances?
@goller321:
That part of the 60 minutes report (about there being 2 identical, significantly cheaper alternatives) is simply not true. I can’t believe they had the gaul to make a claim like that. Ask ANY heart surgeon, and they will tell you that is a load of BS, and that they would still use Aprotinin if it were available 999 out of 1000.
I wonder if 60 minutes will do a follow up report on the number of people who will die from surgical complications because Aprotinin is not available. Somehow I doubt this.
@mattpr: Even if that is true, the fact that they hid a report and essentially lied about its risks is criminal.
@goller321:
The dangers of Aprotinin were already well-known in the medical community. This is another detail glaringly missing from the 60 Minutes piece. I doubt any cardiac surgeon would bat an eyelash to either the NEJM study or Bayer’s follow-up.
Is Bayer’s nose clean on this? Of course not. They should have published the results of the study immediately. It was highly irresponsible on their part.
BUT, as a physician, I found the reporting on 60 Minutes to be very, very distorted and misrepresentative of the facts (not unlike pretty much any medical story in the MSM).
They should all be put on Trasylol
Shouldn’t worst-company-in-America candidates be, well, American? Put Bayer up in the worst-company-in-Germany division.