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 The drug was withdrawn after there were 70 reported cases of patients suffering from severe constipation or ischemic colitis which can require surgery — at least one woman had to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

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).

Slashdot Drops the Ball Again

According to a post on Slashdot from last night, this story means that,

Blizzard Entertainment is suing New Line for using the word Diablo as the title of a movie release. Blizzard wants to make a movie of their own with the same title and feel New Line is only using the word to cash in on the popularity of the Diablo gaming world. Since when did Blizzard own all rights to the word “diablo”? And what kind of precedent would this set if they were to win.

The first sentence is correct, but everything that comes afterward is nonsense. Blizzard isn’t claiming they own all instances of the word “diablo.” Rather, like any other company making a movie Blizzard applied for a trademark for a film titled “Diablo” back in 1996 which was approved in 2000.

This is a common practice in the movie industry and hardly anything for Slashdot to start creating hysteria over.

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).

Sailing Takes Me Away…Just Not Very Quickly

Reuters reports that a private U.S. group is preparing to launch into space what would be the first spacecraft using solar sails.

Basically, the sails reflect light and the action of photons hitting it causes the vehicle to accelerate. It sounds very sci-fi, but there is no reason in principle that it shouldn’t work. On the other hand, it probably will never be a viable method of space travel.

The problem with solar sails is that they just don’t scale very well. If you want to move even modest payloads at significant speeds the sails end up having to be enormous or you have to use an auxiliary source of light. A lot of futuristic solar sail plans, for example, speculate on building laser arrays on the moon or an asteroid — the laser would be aimed at the solar sails and give it much more acceleration than sunlight.

Unfortunately by the time you’re done working out the kinks from that sort of system — not to mention finding a way to pay for such an elaborate system — it’s a lot cheaper and more efficient to go with other equally exotic but definitely workable propulsion systems such as fusion reactors or matter/anti-matter engines.

For the near term, nuclear power plants will be the main source of long range, fast spacecraft although viable fusion reactors are a lot closer than most people think.

To make space exploration and colonization viable we will have to develop craft capable of speeds approaching 5 to 10 percent of the speed of light which is certainly doable but not with solar sails.

Congress Overstepped Bounds In Grilling Media

The Chicago Tribune’s Steve Chapman wrote an excellent summary of one an extremely appalling episode that happened earlier this month — the House Energy and Commerce Committee grilled officials from all the major television networks and the Associated Press over their mistakes in calling the election.

Certainly the media isn’t exactly to be admired for turning election night into a pseudo-sports cast, but as Chapman wrote, “Being instructed on fairness and accuracy by a member of Congress is a bit like being tutored in hygiene by a buzzard.”

It is interesting that the grilling of the media executives took place in the Republican-controlled House of Representatives with Rep. Billy Tauzin (R-La.) acting as chief inquisitor and fellow Republican Steve Buyer (Ind.) informing the collected media representatives that, “You invite this when such huge mistakes are made.”

Can somebody track these two down and ask them to point out where exactly in the Constitution the House of Representatives is give the power to act as the nation’s editor-in-chief? In my opinion, such hearings were completely unconstitutional at worst and extraordinarily unseemly at best. Making media executives testify under oath is something I’d expect in Vladimir Putin’s Russia or maybe in Robert Mugabe’s Zimbabwe, but not in the United States Congress.

On the other hand, it is equally dismaying that not a single news agency that was called to testify had the guts to tell Rep. Tauzin what he could do with his committee’s request. As usual the media turn gutless when it really counts.

Source:

Who asked Congress to serve as editors? Steve Chapman, Chicago Tribune, February 18, 2001.

IRS to Accomplish what the KKK Couldn’t: Shutting Down The Chicago Defender

One of the components of George W. Bush’s tax relief plan was a repeal of the estate tax. While it initially looked to be an easy early victory, a campaign started a couple weeks ago by billionaires in favor of the estate tax gave Democrats and other opponents of the tax a temporary boost. The basic argument of the billionaires was that a) without the tax, rich people will leave their inheritance to their children which gives them an unfair advantage, and b) without the tax charitable giving will decline.

Perhaps in their next paid advertisements the billionaires will cite the plight of The Chicago Defender as the sort of thing that proves the wonders that can be had by the estate tax.

Earlier in the century, The Defender was the most popular black newspaper, period. Started in 1905 by RObert Abbott with a 25 cent investment and a 300 copy print run, The Defender was the premier black newspaper by World War I with a total readership of upwards of 500,000. For twenty years, Langston Hughes wrote a weekly column for the paper and it played an instrumental role in many of the social and political movements of its day. The paper was, for example, one of the primary advocates of the northern migration of blacks that occurred after World War I.

Abbott didn’t achieve that level of success without some powerful enemies. Because of its coverage of lynchings and other racially tinged issues, white distributors in the South refused to carry the newspaper. The KKK threatened anyone who dared cell the paper and occasionally tried to confiscate copies of the paper that made their way south.

Although the Defender doesn’t have the national impact it once did, today it does have a paid daily circulation of 230,000, making it the fourth largest daily paper in Chicago. Unfortunately it’s run into an enemy that might finally be able to do what the KKK couldn’t: shut The Defender down. The latest enemy is the Internal Revenue Service.

Abbott’s nephew, John Sengstacke, took over publication of the paper. Sengstacke expanded the reach of his uncle’s news empire by buying several other black newspapers. In addition Sengstacke founded the National Negro Publishers Association which is now known as the National Newspaper Publishers Association. But despite all his good works Sengstacke committed the one unforgivable sin in the eyes of the IRS — he died.

Because he died and because The Defender was completely privately owned. At his death Sengstacke’s estate was worth about $10 million, and the IRS wants his heirs to pay a $4 million inheritance tax. Sengstacke’s family would like to keep the newspaper business within the family, but the only way it could meet the $4 million bill the IRS has socked it with would be to sell the paper.

Conservative News Service reports that the family has tried to reach a compromise with the IRS for a deferred tax payment plan which would allow the family to keep the paper and pay the taxes gradually, but the IRS is insisting that they pay the full amount.

This is the reality of the death tax. People who started with nothing and build up relatively modest estates compared to the billionaires who so love the tax end up being unable to keep the small business they created within their families. Instead privately owned papers end up in the hands of large corporations who have the advantage of never dying.

The billionaires in favor of the death tax are essentially arguing that at death every successful small businessman such as Sengstacke should be required to liquidate his assets or else waste hundreds of thousands of dollars on lawyers who can set up foundations and other arrangements that avoid the estate tax penalty but still leave heirs in control of their wealth (this is how, for example, the heirs to Henry Ford maintained control over the Ford Motor Company without having to pay exorbitant death taxes).

It is simply not the government’s role to determine how the wealth of dead people could be best allocated. That role is best left to those who actually earned said wealth. The estate tax should be repealed.

Source:

Legendary black-owned newspaper threatened by death tax. Gene J. Koprowski, Conservative News Service, February 22, 2001.

The Chicago Defender. PBS, No Date Given.