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 The drug was withdrawn after there were 70 reported cases of patients suffering from severe constipation or ischemic colitis which can require surgery — at least one woman had to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.

Using Cow Veins to Improve Human Health

Although Xenotransplantation may seem like an exotic new turn in medical research, but in fact researchers have been doing it for years. When infants are born with defective heart valves, for example, transplants from cows are routinely used to reinforce the heart.

Now researchers at the Toledo Hospital’s Jobst Vascular Center successfully transplanted the jugular van of a cow to replace the weakened femoral vein of a man.

The femoral vein is a major vein in the upper leg that regulates blood flow to the heart. When it is weakened, it results in a condition called chronic venous insufficiency (CVI). The weakened valve makes it difficult for blood to continue up to the heart, causing it to pool in the lower leg leading to extremely painful ulcers.

Why the jugular vein of a cow? “The neck vein of a cow is very similar in size to the femoral vein,” Dr. Hugh Beebe, director of the Vascular Center, told CNN. The bovine vein is treated with drugs before the transplant operation to prevent the body from rejecting it.

Several other hospitals are also experimenting with such transplants to assess the efficacy and safety of the procedure. Assuming the initial positive results hold up, it will still be several years before this sort of operation is widespread, but it does point to a very near future where xenotransplanation will be common.

Source:

Cow vein used in transplant. Jonathan Aiken, CNN, February 23, 2001.

ShareSniffer Exposes Microsoft’s Lack of Security Concerns

ShareSniffer claims to be an alternative person-to-person service like Napster, but strikes me as a parody designed to embarrass Microsoft over the way MS deals with security issues in Windows.

Specifically, a lot of people who have set up home networks have turned file sharing on so they could share files and peripherals over their home LANs. In the process, however, a lot of them have also configured file sharing so that it shares part or all of their hard drives with the Internet. Anyone who knows the correct IP address can access such hard drives as if they were sitting at the computer.

Now Microsoft certainly has a bunch of excuses — essentially blame the users who are misconfiguring file sharing to pointing out that this wasn’t much of an issue until recently because few people had home LANs and even fewer had high speed connections.

The bottom line, however, is that the option to share files over the Internet should not be built into a consumer-level operating system the way Microsoft has done. It shouldn’t even be an issue because it should be something that the average user can’t accidentally do (the irony here, of course, is that while it is often extremely difficult to configure Windows in ways that would be helpful to the average user, it is relatively easy for users to do something almost nobody intentionally wants to do such as placing the contents of their hard drive on the Internet for anyone to come along and access).

And it’s not long the ShareSniffer folks are the first people to realize users are making this mistake. This is a longstanding problem that Microsoft has done nothing to deal with. The obvious way to deal with this would be to take out the option to share the HD over the Internet and put that option in a separate program under the accessories area that explains in detail exactly what enabling the feature will do before users set this option. A few people will still make the mistake of installing it, but nothing like the large number of people who today set it inadvertently while trying to figure out how to make a network function properly under Windows (which is a pain in the neck unless you have a dedicated IT staff, which most home users don’t).

Reports Highlight Africa’s Continuing Poor Human Rights Record

Human Rights Watch and the U.S. State Department each released reports at the end of February highlighting the poor status of human rights on the continent of Africa. Unfortunately there isn’t a lot of cause for hope for things to improve in the immediate future.

Human Rights Watch focused its report on the numerous human rights commissions that have been set up throughout Africa. Currently 20 African nations have human rights commissions of one sort of another to investigate human rights abuses — more than on any other continent. Unfortunately, except for a select few, most of the human rights commission are shams designed to deflect international criticism rather than root out human rights abuses. According to Human Rights Watch,

FOr the most part [the commissions] have proved to be a disappointment. Many have indeed been formed by governments with dismal human rights records, weak state institutions, and no history of autonomous state bodies. Some appear largely designed to deflect international criticism of some serious human rights abuses.

Human Rights Watch’s Binaifer Nowrojee told The GUardian (UK), Millions of Africans are being displaced, tortured or killed. Yet the sad truth is that human rights commissioners in AFrica often turn a blind eye to these abuses. Many commissioners fail to publicly denounce abuses, either from fear of retribution or out of hope of government favor.”

The notable exceptions to this are human rights commissions in South Africa, Ghana and Uganda which have exposed abuses and challenged government practices. Of course the fact that only three out of the twenty African human rights commission are more than public relations tools isn’t a percentage to be proud of.

Meanwhile the State Department noted that although political violence did subside in Africa somewhat since 1999, human rights abuses in Africa were still far too common in 2000. Among those cited,

  • In Sierra Leone there were “reports of … extrajudicial killings, rapes, and beatings in 60 percent of the country.”
  • Arbitrary arrests, disappearances and torture were reported in Angola, Eritera, Ethiopia, Guinea, Nigeria, and Uganda.
  • Mob lynchings occurred in Tanzania.
  • In Burundi, which is run by a military dictatorship, civilians were routinely victimized by summary executions, rape and other violence.
  • Female genital mutilation still thrives in Benin, Ethiopia, Mali and other parts of AFrica.
  • More than 1,500 people died in Nigeria last year as a result of religious fighting between Muslims and Christians

And that list could go on and on. The underlying problem is a lack of liberal democracy and multi-party political systems that could check arbitrary state power.

Sources:

Human rights commissions in Africa ‘are often a sham’. Chris McGreal, The Guardian (UK), February 23, 2001.

US paints grim Africa human rights picture. Agence-Frances Presse, February 26, 2001.