WSJ: Ambush in Angleton - So where does the jury verdict leave Merck? Perhaps in Chapter 11.

...Forget the jury's whopping quarter-billion-dollar verdict in Ernst v. Merck, because it's cut 90% by the caps that Texas law places on punitive damages....

But in truth, we should be grateful to any firm that speeds its product to market when its anticipated use promises many more benefits than adverse side-effects. Merck should not apologize for pushing hard to win quick market acceptance; before Vioxx was withdrawn, countless people with chronic pain were able to get on with their lives. Now these folks are left far worse off because of a double whammy: a Food and Drug Administration that yanks too many drugs off the market because it has no idea how to evaluate risk, and individual jurors who think it is their solemn duty to "send a message" to the drug companies on whose products we so desperately depend.

So, in return, I would like to send my message to Mr. Lanier and those indignant jurors.... None of you have ever done a single blessed thing to help relieve anybody's pain and suffering. Just do the math to grasp the harm that you've done.

Right now there are over 4,000 law suits against Merck for Vioxx. If each clocks in at $25 million, then your verdict is that the social harm from Vioxx exceeds $100 billion, before thousands more join in the treasure hunt. Pfizer's Celebrex and Bextra could easily be next. Understand that no future drug will be free of adverse side effects, nor reach market, without the tough calls that Merck had to make with Vioxx. Your implicit verdict is to shut down the entire quest for new medical therapies. Your verdict says you think that the American public is really better off with just hot-water bottles and leftover aspirin tablets....

Good article by Walter E Williams. The FDA will be afraid to approve drugs even if the pharmaceutical industry is able to afford to make them.

http://www.townhall.com/columnists/walterwilliams/ww20050810.shtml - Making Intelligent Errors.

Food and Drug Administration (FDA) officials, in their drug approval process, can essentially make two errors. They can approve a drug that has unanticipated dangerous side effects (type II). Or, they can disapprove, or hold up approval of, a drug that's perfectly safe and effective (type I). In other words, they can err on the side of under-caution or err on the side of over-caution. Which error do FDA officials have the greater incentive to make?

If a FDA official errs by approving a drug that has unanticipated, dangerous side effects, he risks congressional hearings, disgrace and termination. Erring on the side of under-caution produces visible, sick victims who are represented by counsel and whose plight is hyped by the media.

Erring on the side of over-caution is another matter. A classic example was beta-blockers, which an American Heart Association study said will "lengthen the lives of people at risk of sudden death due to irregular heartbeats." The beta-blockers in question were available in Europe in 1967, yet the FDA didn't approve them for use in the U.S. until 1976. In 1979, Dr. William Wardell, a professor of pharmacology, toxicology and medicine at the University of Rochester, estimated that a single beta-blocker, alprenolol, which had already been sold for three years in Europe, but not approved for use in the U.S., could have saved more than 10,000 lives a year. The type I error, erring on the side of over-caution, has little or no cost to FDA officials. Grieving survivors of those 10,000 people who unnecessarily died each year don't know why their loved one died, and surely they don't connect the death to FDA over-caution. For FDA officials, these are the best kind of victims -- invisible ones. When an FDA official holds a press conference to announce its approval of a new life-saving drug, I'd like to see just one reporter ask: How many lives would have been saved had the FDA not delayed the drug's approval?

The bottom line is, we humans are not perfect. We will make errors. Rationality requires that we recognize and weigh the cost of one error against the other.

On a much smaller level I know where the author is coming from. A couple of years ago, Glaxo and other producers of asthma medications began phasing out the inhaled versions of Serevent, a wonder-drug that had kept me asthma-free for more than four years, replacing it with a dry-powder "discus" from which the medication needs to be forcefully sucked in to the lungs. It's nasty and ineffective. What's more, Glaxo had the nerve to declare, on its website, that they had withdrawn the inhalant-based form of the drug "to save the ozone layer."

I can truly pity someone who has come to depend on the availability of a miracle drug that treats pain and enables him to live a normal life, only to have that drug made suddenly unavailable through a caprice of government. It's positively cruel.

I am glad the WSJ disclosed that Mr. Epstein consults with the pharmaceutical industry (does not mean his opinion is any less valid, it just makes the piece transparent). I agree about the problems with Merck...they really spun the results of their studies to physicians and tried everything possible to play down the cardiac risks that showed up in the studies...to the point that they did not release some of it until much later...that is why there is little sympathy for them from physicians.

If Merck had been more transparent then I think that it would have been possible to conduct a risk/benefit analysis to better see which patients would benefit from Vioxx with recognition of the increased (but small) cardiac risk. There are some patients who really benefited from Vioxx and now that it is gone are pretty miserable.

Another thing that really upsets me is that Merck was marketing Vioxx (direct to consumer ads) with skaters and everyone else---young people who could well take a regular NSAID (ibuprofen, etc) and for that reason I have less sympathy for them....I am sorry, but there is/was never a reason a 20 year old healthy guy with a strained knee or back needed Vioxx---but by God that is to whom Merck was marketing Vioxx!!!

Another problem with Epstein's piece is that he does not point out that the risk/benefit analysis he discusses was never allowed to come about because of Merck's handling of the study data.

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