Poor Merck. Just as the champagne has passed their lips, celebrating their win in the second Vioxx case, comes this news from The Associated Press.
AP have obtained a copy of a document that is potentially among the most damaging to emerge since the drug's sales were suspended because it calls into question the bedrock Merck defense that company officials were convinced of Vioxx's safety.
According to the document, Edward Scolnick, the former head of Merck's research labs, was the first to suggest combining Vioxx with a second drug that would block blood platelets from clotting. Such clots can lead to heart attacks and strokes. There are three dates on the document; the first is March 30, 2000.
The document's authors said Vioxx might reduce the production of prostacyclin, which prevents platelet aggregation. The change may cause increased risk of cardiac and cerebral adverse events, the document said.
But as Merck pursued the reformulation, it continued to stand by Vioxx's safety. In a press release dated April 28, 2000, the company "confirmed the favorable cardiovascular safety profile of Vioxx."
Note the two dates!
Indeed, even in their 2001 Report Merck stated:
"In VIGOR, 0.5 percent of patients on Vioxx had a heart attack compared to 0.1 percent on the comparator drug naproxen. Alternative interpretations have been proposed for the difference in the rates of heart attacks in the group treated with Vioxx in comparison with the group treated with naproxen. Explanations that have been proposed include that Vioxx increased the heart attack rate or naproxen decreased the heart attack rate. Although the underlying reason for the difference has not been established in prospectively designed clinical studies, Merck scientists believe the weight of evidence supports the theory that naproxen decreased the heart attack rate."
So why reformulate?
The desire to reformulate the drug suggests a level of urgency that goes beyond previously disclosed internal e-mails that discussed safety risks.
"The document suggests a level of concern about the drug. The fact that they wanted to patent a different product raises questions -- it says something," said Anthony Sebok, a professor at Brooklyn Law School. "Should they have been open about concerns? The failure to be honest is what gets companies (in product liability cases) in trouble."
A copy of the document was provided to The Associated Press on the condition that its source would not be identified.
http://www.mcall.com/news/nationworld/politics/sns-ap-vioxx-safety,0,7176179.story
5 comments:
Shock! Scandal! A research-based pharmaceutical manufacturer was actually exploring ways to develop a safer version of a blockbuster drug! Alert the press, the "smoking gun" has been discovered!
Please.
Oh come on! This is not news. This was highlighted in the Texas case and deemed irrelevant. A drug is a usefull poison... used right it may be safe but their are no cast iron guarantees. Great to see criticism about trying to improve safety!!!
The press have been alerted. Most probably by a whistleblowing insider!
The "shock and scandal" is to do with the covert nature of the deliberations within Merck. Whilst at the SAME TIME maintaining that there was no problem with Vioxx to the outside world.
You have said it yourself : " a safer version of a blockbuster drug".
The issue is that Merck at that time were not even admitting there was a safety problem.
It looks pretty damning to me!
Huh?!?
Let's be clear what this is all about. The root of this "smoking gun evidence" was the discovery of e-mail communications between Merck R&D scientists and the company's patent attornies discussing the possibility of developing a safer version of Vioxx. The idea was to patent the formulation because it was potentially valuable. The communications were "secret" because one doesn't broadcast discussions of intellectual property before filing patents to protect that property. I would hope every company that markets blockbuster drugs is trying to figure out ways to make them safer than they are in current formulations. No drug is without risk, so there's always room for improvement. If the improved product is of potential value, why would any company publicize their R&D efforts? Representing this information as a "smoking gun" is a silly distraction.
10.09 It's a point of view, I suppose. But I'm far more suspicious.
I could quite imagine turmoil within Merck at that time.
Reformulate or not?
Was it the naproxen or not?
Is Vioxx ok or not?
Choices were made at that time....
I wonder why the combo development was not progressed?
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