Merck Jerked
Tim Cavanaugh | August 19, 2005, 5:31pm
A Texas jury rules against Merck & Co., awarding $253.4 million in damages to the widow of a man who died of causes that have not been linked to the withdrawn painkiller Vioxx.
From Forbes:
By one line of thinking, it should have been an easy case, because the patient was said to have died of an arrhythmia, a type of heart problem that Vioxx has not been shown to cause. But Mark Lanier, the lawyer for plaintiff Carol Ernst, was able to convince the jury that her husband Robert, a triathlete, died of a heart attack. "This was my race for Robert," she told CNBC.
"The fact that Merck lost, and that the award was sizable, will likely energize the plaintiffs' [attorneys] and will increase the frequency at which the company gets sued," wrote Timothy Anderson of Prudential Equity Group. "Investors should prepare for a multiyear legal battle."
This is only the first of many cases against Merck. In the coming months, a case will be heard in New Jersey. And the first federal case against Merck will be tried in New Orleans in November. After that, there are some 4,000 other state and federal cases. That number is expected to swell to 10,000 or more.
David R. Henderson and Charles L. Hooper gave the case against the case back in January.
Skeptikos | August 19, 2005, 6:09pm | #
I still say this article is a joke. You can't talk about this subject without mentioning these two warning letters from the FDA to Merck.
1999
2001
Twice they had to be warned to stop misrepresenting the info. From a legal point of view, this was the kind of error on their part that any 16 year old kid who has had a bad day in the principals office could have told you was going to bite them on the ass.
I have also pointed out that the Celebrex, the other COX-2 drug, my have problems because of the CLASS study problem.
Bottom line, those warning letters work like a confession on a jury.
Yes, the decision is ridiculous, but nonetheless, totally expected if you play poker.
I do think some people would be served well by Vioxx, but as someone who has actually reviewed the data, only about 1 in 10 folks who are taking COX-2 drugs, should actually be taking them. Merck played a round of poker with marketing on this one and lost. Inevitable, even with a more corporate friendly court system.
A little bit like a London Police Chief not wanting a certain shooting investigated outside of the London Police department right now. He may not be guilty, but can London afford to hold?
Life is poker. Play the odds or play with the odds, the odds will get you every time.
TomSleeping | August 19, 2005, 10:11pm | #
Well, it's just that there weren't many facts (of the case) in that article, and I'm not the only one who was confused by that sentence. I found this in the Miami Herald:
"The coroner who performed an autopsy on Ernst testified that Ernst more than likely had a blood clot that led to a heart attack. She didn't note either in her report because, she said, vigorous CPR likely dislodged the clot and he died of an irregular heartbeat too fast for his heart to show damage. A pathologist testified for Merck that there was no evidence of either a clot or a heart attack."
http://www.miami.com/mld/miamiherald/business/national/12362129.htm
So I'll buy that MI was likely the cause of death, and that Merck tried to defend itself by pointing out that there was no direct evidence of an MI and it wasn't recorded in the chart. But you can see where there's some uncertainty about this, right?
Also, when second-guessing the motives of scientists, it's best not to play the "economic motive" card too early. (BTW, I'm a pharmacologist, not an accountant) I know quite a few industry scientists, including clinical pharmacologists/toxicologists, and they get paid well, to do their job well. I find it hard to believe that a slight increase in pay (salary, profit-sharing, etc.) that might result from selling a little more Vioxx would be enough to corrupt a large number of people into intentionally lying about or covering up a serious toxicity risk from one of their products. That may sound naive, but scientists are trained in an "honor system" mentality that must exist if scientific knowledge is to be of general benefit.
Merck "dragged its feet" on the Vioxx/MI question because, well, it was considered to be an open question until last year. Even the "damning" FDA letter in 2001 admits the possibility that the increase in MI in subjects treated with Vioxx compared with naproxen may have been attributable to a protective effect of naproxen (for which there already existed at least SOME evidence) as easily as it could have been attributed to a toxic effect of Vioxx. Because the effect was so small, very large controlled trials were needed to confirm that Vioxx caused the toxicity. Merck could have "played it safe" and withdrawn the product earlier, but where do you draw the line on standards of withdrawing drugs from market, remembering that the stricter the standard, the fewer (life-saving) drugs are available to patients?
Skeptikos | August 19, 2005, 10:20pm | #
Gil Roth,
Hard to determine, as a former consultant to big pharma, I never really believed that Pfizer was actually after the cox-2 platform. It was pretty clear (and remember, Pfizer had co-marketing agreement with Searle prior to the Pharmacia merger, and they had full access to all studies) that parecoxib (Bextra) and valdecoxib were in trouble, way before the offer for Pharmacia was even made. I believe it was the massive sales of Celebrex (celecoxib) that will continue for some time. Although I cannot remember right now when the patent runs out. Right now I'm betting Merck. Last time I checked, Celebrex was still selling briskly (by general standards, even if sales have gone down).
Legal Dep't,
Thanx for that. I don't know why no one gets this, if they want to be mad, they should be mad at the completely jack shit nuts risk Merck took on the back door marketing.
That being said, it is a real shame that Vioxx is off the market, when appropiate, it's a good drug.
Lastly, PEOPLE. After talking to literaly thousands of people involved in Pharma...THEY ARE NOT OUT TO CURE YOUR DISEASE. THEY DO NOT CARE. This is not insulting them. They are out to make a buck, the researchers who want to help you are on the bottom of the food chain. The people on top are just managers. They could just as easily work for Chevy.
It is just capitalism. If they could they would sell you snake oil (which I personally have no problem with).
LIKE YOUR MOTHER TOLD YOU...DON'T TRUST STRANGERS.
Actually this is why this all happened, we all trust strangers. That said, the pharma industry, like all industies does good work. But not for you...FOR YOU MONEY...that's why capitalism works.
If you mistrust politicians good, if you mistrust bisinessmen, good, DON'T trust anyone you don't personally know.
Gil Roth | August 20, 2005, 6:06pm | #
[D]o you think the pharmaceutical market is too consolidated?
I don't believe it is. As big as Pfizer is, it doesn't control more than 11-12% of the Pharma market.
I've written a few editorials at
my day job contending that Pfizer mirrors the Yankees, in certain respects, but the market and the existing patent laws are going to whomp Pfizer pretty hard in the next few years.
Keep in mind: till the merger of Aventis & Sanofi, which was pushed forward by the French government for the sake of creating a "national champion", Merck was the 3rd largest Pharma in terms of drug revenues. This year, it fell to fifth.
There's still plenty of competition in the business, and one of the key reasons for that is that R&D productivity simply doesn't follow a linear curve. Having a huge company with giant revenues doesn't guarantee you'll come up with good products from your pipeline.
In the case of Pfizer, that massive cash flow DOES enable it to buy in other companies' promising products, but that can put you right back in the Yankees' current predicament: having so much invested in "free agents" (in-licensed products) rather than the "farm system" (internal development) that you end up in a vicious cycle of having to overpay for yet more external projects.
As long as Lipitor stays safe and keeps finding new indications, the company will be okay, but patent law dictates that Lipitor's gotta go generic SOMEtime, at which point its contribution to Pfizer's bottom line will fall off a cliff, like Bernie Williams.
Sorry to be so specific and not address the woes facing the rest of the industry, but in short I think that consolidation hasn't caused the current crisis in Pharma productivity.