I just saw my first “Have you taken Vioxx and had a heart attack? You may be entitled to monetary compensation, Call 1-800-SLEAZEBAG.” ad. Disgusting.
8:04 pm | 7 comments
Latest Featured Video
sujal
11/24/2008
Newsweek’s Daniel Gross explains the Consumer Price Index (here’s the official BLS site) in a very simple video. I could do without the goofy sound effects, but it’s a good, 2 minute explanation of how the government tracks inflation.
Per David Simon’s Berkeley talk, though, the video doesn’t go into why this matters. Perhaps they’ll cover that in the next installment of the Economics 101 series.
2:42 pm | leave a comment
Donate
|
Blogroll
Friends
CT Politics Politics
Technology
West Hartford Blogs Hartford Blogs |
Active Posts
|
|
Track & Validate
|
October 6th, 2004 at 8:49 pm
which part disgusts you, exactly? and who are you imagining would be the target of a suit? and why should that party not be sued?
I have a feeling that the doctors aren’t the targets here, so if there’s a reason the drug companies aren’t potentially liable, I can’t think of it. “potentially” is a critical word there, but the discovery phase of a trial will be the important part of determining that.
Also, I think an ad like this is no more disgusting than the constant viagra, levitra, allegrix, flonase, prevacid, zoloft, and a half dozen other drugs that advertise constantly on TV… we’re not all doctors…
October 6th, 2004 at 9:04 pm
that came out smarmier than intended, but I’m seriously asking why the drug companies shouldn’t be potentially liable.
October 6th, 2004 at 10:22 pm
Statistically, the number of people who use Vioxx and have heart attacks is going to be greater than the number of people who had heart attacks because they used Vioxx. However, the settlements will never distinguish between the two groups, since it is impossible to do so. The ads are preditory and attempt to use sick people, combined with media sensation, in attempt to get settlements from Merck. The goal being to enrich the lawyers and not compensate the injured. I realize the lawyers need to get paid, but again, this is preditory.
On the whole, Vioxx is very safe. In people who are very high risk for GI bleeding and are in pain, Vioxx might prevent a GI bleed (something that occurs in 15-30% of chronic NSAID users). Many GI bleeds are fatal. The risk of heart attack increase from 1 in 1000 to about 2 in 1000 in those who use Vioxx…a fairly small increase, individually. The problem is that in this country, we see lots of media attention on heart attacks, and not so much about GI bleeds. There happen to be safer (at the moment) drugs out there, hence why Vioxx was pulled. Not that the drug itself is inherantly unsafe.
Frankly, FDA approval should give some limits to liability. Merck has not withheld a study that showed there was a heart attack risk. They were criticized in 2001 when they downplayed the risk, however their argument followed prevailing wisdom. Merck has been fairly responsible in this, and sadly, that will open them up to lawsuits. It they hadn’t pulled the drug, they may have had a better chance at fighting and winning the individual suits.
October 7th, 2004 at 10:31 am
if it’s so safe, why did they pull it?
I would be uncomfortable with a blanket limit to liability without changes to how the FDA approval process works… it seems that limiting liability would remove one of the biggest incentives to not fudge around with the studies…
October 7th, 2004 at 5:12 pm
1) Because there are safer alternatves out there
2) Fear of legal actions
I haven’t read the paper, as it has not yet been published, but I was quite suprised they pulled it. Part of the problem is that it was getting over prescribed. People who weren’t really at risk for GI events, but had heart problems, were getting the medication as first line treatment.
This isn’t the first time that a medication has been pulled due to misprescription. Cisapride (Propulsid) was/is a great drug for people who have decreased gut motility. However, it was marketed for reflux (much bigger market), a problem it doesn’t work for very well. It can cause some changes in the physiology of the heart and there were 80 reported deaths in the US. Despite the millions of prescriptions for it and despite a study that showed 4% of patients taking cisapride also were taking another medication that interacted with cisapride to exacerbate the cardiac effects, the drug was removed from the market. A very good drug was lost to the market because it was being misused.
Another good example is Droperidol. The FDA added a black box warning to it, based on reports of heart problems coming out of Europe. The problem is that the effects were associated with huge doses…doses that aren’t used in the US. The effect is that no one uses it, due to fear of lawsuits. Instead, they have to use a much more expensive drug, incidentally, made by the same company.
So, what I suspect, is that if Vioxx had been used more appropriately and more economically, we would be seeing something totally different. The trial the got Vioxx pulled was an attempt by Merck to show that Vioxx prevents colon cancer, an effect that has already been seen in aspirin. The goal was for Merck to get an indication for the prevention of colon cancer and to expand their market. Since aspirin is very generic, it is unlikely that any one would bother getting this marketing indication for aspirin, hence Vioxx would get prescribed to virtually everyone, for life. This is an economically inappropriate use of Vioxx, but it would have been the result. Aspirin would be the right choice.
In all honesty, Merck screwed themselves over. They went for the whole enchilada and they choked on it. The ultimate losers are people in pain and at high risk of a GI bleed. There are alternatives, but Vioxx seemed to be the best of the class.
October 7th, 2004 at 5:14 pm
On the FDA-liability issue, if you commit fraud, you don’t get protection from liability.
October 7th, 2004 at 5:20 pm
Some how, my much larger response didn’t post and I’m not into rewriting it.
The gist:
Vioxx probably got pulled 1) because there are safer alternatives and 2) concerns over liability. However, part of the reason it was pulled is that it was being over used and prescribed for people who really didn’t need it. This isn’t the first time that a drug has been pulled due to problems associated with using a drug outside what it should be used for. The trial that got Vioxx pulled was designed to get it an indication for the prevention of colon cancer…something that is already shown to occur with the much cheaper aspirin.
If Vioxx has been kept as a second line drug for people who can’t tolerate standard NSAIDs or for people at high risk for GI bleeds, the cardiovascular effects would never have become an issue.