Month: February 2001

FDA’s Ban on Lotronex Completely Irrational

In January the New York Times profiled the controversy over the withdrawal of GlaxoSmithKline drug Lotronex. Lotronex had been approved by the U.S. Food and Drug administration in February 2000 as a treatment for women who suffered from chronic diarrhea brought on by irritable bowel syndrome. Doctors quickly began writing off-label prescriptions for men as well. The drug was withdrawn after there were 70 reported cases of patients suffering from severe constipation or ischemic colitis which can require surgery — at least one woman had to have her entire colon removed. There were also five deaths involving people taking Lotronex, three of which The Times reported were “possibly linked” with the drug.

In this case the FDA acted completely irrationally, spurred on in part by the wannabe nanny’s at Ralph Nader’s Public Citizen. After the side effects and deaths began to be reported, Dr. Sidney Wolfe, director of the Public Citizen Health Research Group, began campaigning to have Lotronex pulled from the market saying it was just too dangerous. As The New York Times summarizes Public Citizen’s views about Lotronex, “The group sough tot have Lotronex banned, arguing that it made no sense to use a drug with potentially life-threatening side effects for a disease like irritable bowel syndrome, which is debilitating but does not kill people.”

If that is the standard, then Public Citizen should begin a campaign to ban driving. Approximately 300,000 people took Lotronex in the 10 months it was available, with 70 patients reportedly suffering side effects, and 3 deaths possibly linked to the disease. Assuming that distribution of side effects and deaths would hold for the population as a whole, if every man woman and child in the United States began taking Lotronex we could expect that every year 61,000 people would suffer some form of side effect and 2,600 people would die as a result of taking the drug. In other words taking Lotronex is roughly 20 times safer than driving a car.

And we really don’t need to drive cars to save our lives. Most of us drive cars to improve our quality of life. Isn’t it time the FDA clamped down on those of us who believe that it is okay to risk our lives everyday by driving to work just for a little convenience?

Not surprisingly a lot of irritable bowel syndrome sufferers are not exactly rushing to thank Wolfe. In fact they believe Wolfe and Public Citizen helped force the FDA to remove a drug that had transformed their livs.Richard Fireman, a Lotronex user, told The Times, “Somebody online said they wished they could give Dr. Wolfe irritable bowel syndrome, so he’d know what he was talking about. If eel the same way. I’ve never been so angry.”

This is the problem with nanny agencies such as the FDA and groups such as Public Citizen — rather than letting individuals decide for themselves whether the benefits of a drug such as Lotronex outweigh the risks, they arbitrarily apply a one size fits all risk analysis that is ludicrous. If I had a condition that caused intense abdominal pains and severe diarrhea, would I be willing to take a drug that posed a 1 in 100,000 risk of death from taking it? Yes, for the same reason that I don’t plan to take up walking to work anytime soon.

All of us balance life and death risks every day. Lets keep that choice to ourselves rather than turning it over to bureaucrats and would-be big brothers.

Source:

F.D.A. Pulls a Drug, and Patients Despair. Denise Grady, The New York Times, January 30, 2001.

Camille Paglia on “The Vagina Monologues”

In her latest Salon.Com column, Camille Paglia dismisses the “garish visibility” of Eve Ensler and “The Vagina Monologues.”

The perversion of feminism that Ensler represents — turning Valentine’s Day, the one holiday celebrating romantic harmony between the sexes, into a grisly memento mori of violence against women — has been well demonstrated by the ever-alert Christina Hoff Sommers, who gave early warning in her Feb. 11 article in the Wall Street Journal last year (as well as in her campus lectures, media appearances and an article in the Feb. 8 USA Today). That the psychological poison of Ensler’s archaic creed of victimization is being spread to impressionable women students is positively criminal.

…That in the year 2001 the group chanting of crude four-letter words for female genitalia is viewed as some sort of radical liberation implies that the real issue in the “Vagina Monologues” isn’t male oppression but bourgeois repression — the malady of the dainty, decorous professional class that was created in the first century after the Industrial Revolution.

Like Paglia I’m not quit sure how an auditorium full of people chanting “cunt” — as 18,000 people did at Madison Square Garden this month — is empowering.

Sources:

The Bush look. Camille Paglia, Salon.Com, February 28, 2001.

Clit Club. Sharon Lerner, The Village Voice, February 14-20, 2001.

Putting the U.S. Economic Slowdown Into Perspective

The American economy is slowing and there’s been some doom and gloom reports, though for the most part it doesn’t look like the coming recession will be very deep or very long. That said, lets put the news into perspective.

Across the waters, France’s Prime Minister Lionel Jospin is practically jumping with joy over the incredibly good economic news in that nation. According to the latest figures, unemployment in France is only 9 percent! That’s the lowest level it’s been in ten years (as recently as 1997, unemployment in France was at 12.6 percent).

I guess if you can handle the good news in France, not much else is likely to phase you.

The Single Best Thing That Ever Happened to Microsoft

During the Microsoft trial that eventually ended up in an order for the company to be broken up, a lot of anti-Microsoft folks (I’m thinking specifically of the wonderful folks at Slashdot) were thrilled that Judge Thomas Penfield Jackson understood their anti-MS arguments so well and would stick it to the company.

I felt like a distinct minority arguing that Jackson was the best thing that ever happened to Microsoft. He was so clearly biased in his view of Microsoft and so arbitrary in his rulings and decisions, that he pretty much guaranteed that his ruling against the company would never stand up. Biased judges are nothing new, but usually they try to be a bit more discrete.

Wired summarizes the appellate court’s outrage at Jackson’s behavior with chief justice Harry Edwards saying, “We don’t run off our mouths in a pejorative way…. The system would be a shambles if all judges did that. Good heavens, is that what judges do? They take preferred reporters in?” Edwards went so far as to ask whether or not Jackson’s conduct might have violated the oath he took upon becoming a federal judge.

A lot of anti-MS commentators made much of the fact that as the finder of fact, the appellate court would probably be unwilling to overturn Jackson’s finding that Microsoft had attempted to use its Windows dominance to harm Netscape. But as Judge David Sentelle pointed out during the recent appellate hearing, that assumes that the judge is a neutral fact finder and Judge Jackson was so obviously not neutral, “Why is the finder of fact entitled to deference anymore?”

And once you get beyond Penfield’s longstanding antipathy for Microsoft, the trial court found plenty of evidence that Microsoft engaged in some pretty unethical business practices (which should shock no one) but surprisingly little evidence that Microsoft had illegally leveraged its OS dominance to drive out Netscape (part of the problem being that Netscape did a pretty good job of self-destructing without any help from Gates and company).