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Reformulation of Vioxx Causes Concern

Another nail in a killer's coffin

The clot plot thickens 

Just when I thought the Vioxx scandal couldn't get any seedier, some new development in the case knocks me for a loop. I last reported to you on this saga back on November 29th, when I cited a New York Times expose all but proving that despite their denials and stonewalling, Merck and Company knew all about the tendency of their drug to increase the risk of heart attack and stroke in long-term users. 

But now, there's another nail in their coffin: Internal Merck memoranda have surfaced proving that the firm tried to hastily re-formulate Vioxx in late 2000 to ameliorate its clotting tendencies, and hence, its cardiovascular risks! 

According to a breaking Associated Press report, a corporate dialogue between Merck's research and patent departments plainly states that because the way the painkiller works might increase heart attack and stroke risks, it might be prudent to seek patent protection for a new formulation that combines Vioxx with a second drug to lessen these hazards. 

The documents were "mistakenly" handed over to plaintiff's lawyers in one of the Vioxx civil trials that are pending against the company. The judge in that case, a New Jersey liability lawsuit, agreed with Merck's efforts to suppress the correspondence on the grounds that since it was a conversation between the company's research and legal departments, the dialogue is protected under the attorney-client confidentiality provision of the law. Pretty shaky, if you ask me. 

However, the incriminating exchange may yet see the light of day. The documents have made the rounds quickly to other attorneys in the more than 3500 individual Vioxx-related lawsuits pending against Merck. Other judges in other trials may see the matter differently. 

Regardless of whether they do or not, there's still this to hang Merck by: The fact that in 2001, the company filed a PATENT APPLICATION to reformulate Vioxx by combining it with something called a thromboxane inhibitor, a chemical designed to add a measure of heart protection to the drug. The project was later abandoned, but the application remains on file in the patent office. 

Now why would they do that if everything was hunky-dory with the drug? That's exactly the question they'll be asking in all those upcoming trials. Keep reading… 

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Courts: Now's the RIGHT time to open the floodgates! 

I know I spend a lot of time kvetching about the undisciplined farce our legal system has become - especially with regard to huge jury awards in cases of malpractice and other negligence. And let's face it, there's a lot of abuse going on out there; a lot of frivolous suits with penalties being paid by insurance companies monetarily instead of physicians criminally, or with their licenses. These things keep the cost of health care sky-high.
However, holding drug companies accountable is another matter. I honestly believe they've become so powerful and beyond the reach of regulation (or morality) that extreme measures are called for - and the solution may lie within that same bloated legal system that's responsible for such gross largesse in liability awards. 

Here's what I mean: Since drug makers don't respond to anything but dollars and cents, let's make the cost of concealing risk and liability so great that they'll be forced to stay on the straight and narrow or go bankrupt. 

That's exactly what I hope happens as a result of the several thousand wrongful death and liability trials Merck is facing because of its Vioxx scandal. According to one AP article, analysts predict the company's total liability could top $18 billion. That's a good start, but a drop in the bucket compared to other awards (like the ones states have extorted from the tobacco industry). 

In 2003 alone, Vioxx racked up approximately $2.5 billion for Merck. I'm not sure how much the drug has made for the company since its introduction in 1999, but I'll bet it's in the neighborhood of the 18 million they're predicted to shell out in settlements. But I ask you: Is this enough? Is it enough of a penalty for Merck to simply break even? I don't think so… 

I, for one, hope the civil suits far exceed the analysts' estimates. Beyond that, I hope the upcoming state and federal Vioxx trials stick it to them even worse. 

Settling accounts, and counting on settlements, 

 William Campbell Douglass II, MD

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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