FDA Panel BS Watch

I take one of the drugs mentioned in this article for ADHD, and this froightened me somewhat before it pissed me off.

Warning Urged for ADHD Drugs:

Several drugs widely used to treat attention-deficit hyperactivity disorder should carry a prominent "black box" warning because of reports that they may have caused sudden deaths or serious complications, a federal expert advisory panel recommended yesterday.

The proposal to require a warning on medications such as Adderall and Ritalin took the Food and Drug Administration, pharmaceutical companies and advocates by surprise. The panel voted 8 to 7 to call for the labeling change after reviewing reports of several dozen patients who suffered cardiac arrest, toxic reactions or sudden death while using the medications.

[...]

"On the surface, it is hard to believe," said Curt Furberg, professor of public health sciences at North Carolina's Wake Forest University Medical School, who voted for the black-box warning. "What is also interesting is this condition is not really recognized in other countries -- you wonder what we are treating. I am sure there are patients who need these drugs, but it is not 10 percent of all 10-year-old boys."

FDA officials, who convened the panel to discuss how best to assess the risks of the drugs, said they would weigh the recommendation. The panel called for warning labels on methylphenidate drugs, sold under the brand names Ritalin, Concerta, Methylin and Metadate, and on the amphetamines Adderall and Adderall XR.

[...]

Much as in the debate over antidepressants, Nissen and Furberg said the committee was not just weighing uncertain signals of risk but broader questions, such as how often the drugs are used and the impact of drug industry marketing. A black-box warning would probably curb direct-to-consumer advertising.

[...]

"I felt strongly we need to slow the growth of utilization," Nissen said, adding that about 2.5 million children and 1.5 million adults are taking the drugs. "When you have that kind of exposure for drugs that are suspicious, that does create a major public health concern."

No no no no! If you feel that way, get the fuck off the panel. If you want to totally fuck up the public's trust in the FDA, make the issue of whether a drugs side-effects are significant tied to whether you think it should be prescribed less. You're admitting that if this was some anti-allergy drug with the incidence of those side effects, you wouldn't give a shit. The FDA should be judging safety based on the data, not on how much the drugs are used. This is no way to run a drug safety agency. This is the road to PR telling the public what drugs are safe and which aren't. This is the road to influence and bribery infecting the FDA. Nissen and Furberg, resign and stay the fuck away from the FDA. This is a fucking travesty. You were given a simple task of saying whether you think these drugs are safe, and you turn into a medical-political crusade. You're more politicians than men of science you dipshits. Go fuck yourselves.

One Day All My Comments Will Come Home to Roost
Pt. 2

My dissertation on why the Houston Texans should pick Reggie Bush in the NFL draft is available at Football Outsiders. Full text:

“Ironic that the one position where the Texans are strongest is RB. There’ve been a bunch of busts at RB high in the draft too - Dayne, Biakabatuka, Ki-Jana, Blair Thomas, Enis, Salaam, Thomas Jones (ARZ version)… and as Kubiak should be well aware, you can dig up quality RBs pretty much anywhere in the draft.”

Quick question: Who are Curtis Alexander, Chris Howard, Olandis Gary, Quentin Griffin, Ahmad Galloway, and Brad Miree?

The Answer: Running backs drafted after the second round by the Broncos other than Mike Anderson since 1998.

Who was drafted higher, Jonathan Wells, worst starting RB of FO statistics, or Domanick Davis? Jonathan Wells, 99th rather than 101st.

Do you want to know what other RBs have been drafted high in the same time-frame of the players you mentioned? Emmit Smith, Jerome Bettis, Marshall Faulk, Warrick Dunn, Edgerrin James, Shaun Alexander, and LaDainian Tomlinson.

Also, Houston may be strongest at RB, but certainly not very strong at RB. They have Jonathan Wells and some other guy backing up Davis. The fact that they already have Davis actually enhances the potential value of Bush on the team in his rookie year, as Reggie Bush was in a tandem with LenDale White at USC.

“It seems like a no-brainer to me to take D’Brick at #1. OL prospects like him only come around once every few years, and all those Super Bowls that Barry Sanders won are enough to dissuade me from taking Bush. They invested a ton in Carr and Davis too - why waste so much cap space on one position? That’s Detroit’s specialty.”

How many Super Bowls have Willie Roaf or Jonathan Ogden won?

Name the coaches of the Detroit Lions while Sanders was on it. Name any famous players from the Detroit Lions teams Sanders was on.

The problem Houston has had with their line has been since the expansion started, which suggests that it is a problem with the way the team is managed. In all Houston drafts after their first, they have drafted only one OL in the first 4 rounds. To improve the O-line, Houston needs to put actual effort into it and get actual O-line coaching. They do not need to get a superstar lineman to get an average O-line.

D’Brickashaw may be a future HoF lineman, but he is just one guy of 5 that make up the line. And those 5 guys only help other players score touchdowns. D’Brickashaw would be the perfect pick for a team with a potential HoF RB, a good QB, and plans for making a run deep into the playoff, but needs to have an O-line that will dominate good D-lines. (I’m looking at a team with a blue-like colored jersey, not sure which.)

The Texans need to improve both sides of the ball significantly to get back to average, and it will take even longer to make the team great. A great OL who makes the O-line average will not make the whole team average. The way to start rebuilding the team with the intention of it eventually being great is to get some franchise players on the team that can be built around if they are a sucess, and while there are no defensive players who stand out as being potential franchise players, there are obvious potential franchise players at offensive “skill” positions. As for cap problems, the Texans could take Bush and get a good offensive lineman by trading Domanick, or they could take Leinart and get a good offensive lineman by trading Carr.

Taking Vince Young would be a mistake, because perhaps the biggest known factor of the Texans currently is that Carr is at least an average QB who is poorly coached, and has a terrible O-line. Taking Vince Young would make Houston a draft day hero, but it is the equivalent of a hobo with a total of $110 bucks putting $100 on 7 at roulette.

Vince Young may range anywhere from being the last great scrambling QB to average to Ron Mexico to bust. Reggie Bush is widely regarded as one of the best RB ever to play in college football, and it would be a surprise if he is a complete bust for any reason other than injuries. Matt Leinart has a lot of experience for a college QB, plays in a pro style system under a former NFL coach who was good as a coordinator at least. Texans fans should be outraged if the Texans draft Young instead of Bush or Leinart, as it says that the management is willing to risk not having a forseeable winning season in the first 8 years of the franchises existence when they supposedly already have a franchise QB, there is a QB more ikely to suceed in the NFL they could have taken, as well as a RB whose ceiling is probably as high as Young’s who is more likely to actually reach it.

For Tennessee, who has Billy Volek as a backup to McNair, a rebuilding defense, and won’t be able to pick Leinart or Bush, it makes sense to take a chance on Young. But if Houston takes Young, they aren’t trying to rebuild, they are trying to be a hero and get lucky. If Houston was lucky it wouldn’t have the 1st pick of the NFL draft.

And they should not pass up two players, at positions that are the hardest to find good players for, who each have a decent chance to be one of the best of this decade, to draft an offensive lineman who won’t be needed if the team’s target date to have a really great O-line is 5 seasons from now instead of the year after next.

Since this was written, Vince Young's draft stock has dropped quite a bit, and he may fall to the Raiders at the 7th pick. If he does, I think the Raiders will get a steal, even though I am serious about everything I wrote. He is a once-in-a-lifetime roll of the dice, and my problem is that in terms of accounting cost, to borrow economics language, a 7th overall pick, or even a 1st overall pick, is not an unreasonable price. However, the opportunity cost is Reggie Bush or Matt Leinart, and that will likely require a fantastic return to make it a good acquisition. I'm not sold on the odds of that return, and neither should the Texans. However, if the opportunity cost is Jay Cutler, or not even that...roll those dice like you mean it!

In Case You Were Wondering What I Did Tonight

5:30 PM - Put laundry in dryer, went to eat dinner at cafeteria.

7:00 PM - Took laundry out of dryer, began to put it away.

7:30 PM - Watched the Medwin String Quartet perform "Not So Classical," an assortment of classical rock pieces arranged for a string quartet. This included "Eleanor Rigby," "Stairway to Heaven," "Live and Let Die," and "Sunshine of Your Love." Highly enjoyable, and the all-instrumental performance of Stairway confirms my belief that it is a case of "great song, dumb lyrics." They had pizza and other snacks after the performance (If all classical performances did this, you can guarantee that the attendance of college kids would increase). I had a soda and a cookie.

8:30 PM - Returned to my dorm to finish putting away my laundry.

9:00 PM - Arrived at the campus center to watch performances of four campus rock bands. As none had started yet in the blanket enclosed section of the lower floor, I watch tv.

Moments later - I watch the introduction of the Winter Olympics, the weirdest thing I've seen in at least the last month. Weirder than the music video of Hasselhoff singing "Hooked on a Feeling." It was like a psychedelic circus. My mouth is literally hanging open as I watch this.

Moments later - NBC wisely cuts off the performance with a commercial break, not long after the giant pipehorns come out, followed by dancers in cow-patterned suits and dresses come out, as well as what I think the announcers called treemen. The first rock band is ready to start.

Sometime after 9 PM - The mini-concert is MCed by a guy who looks like Brian Rosenworcel with puffier hair. The first band is Jack Bauer and the Traumahawks, a great name but an average college metal band (I define college metal bands as bands that have relatively loud guiitars that dominate the music but can't afford the amps to be real heavy metal). I think it is in the intermission between this and the next act that I go back to the tv just in time to see the Olympic Teams march out. And they are led by women carrying signs with the teams name on it wearing huge white dresses that are meant to look like the Alps by having trees on them.

A moment later - The next band, Adderol, comes on. They were a pop metal band, and I enjoyed listening to them, even if they were really loud. The lead singer looked sort of nerdy-cool, which I think is extremely cool. After came the reason I attended the mini-concert: Copper Tree. This was only the 3rd best of the 4 performances I've seen of them, but that is mostly because the mixing was not good. I swear, when I start a Talking Heads cover band, I will give my two little toes for a good sound technician. They had a new song, unfortunately I couldn't make out most of the words. Copper Tree has good lyrics and a sound that is unlike anything you have ever heard. The role of guitar in rock is split between a precise cello and a manic piano. You should check out the songs on their site.

11 PM - The last band, supposedly "dance rock" is some techno stuff by the Brian Rosenworcel-lookalike. And I was hoping it was actually good to dance to. Instead of listening to it, I watch the end of Ali for the second time on campus tv. That is the only part of the movie I've seen. I then buy some chips, eat them, then go back to my dorm.

That's one way to spend a Friday night.

My First and Last Post on the Mohammed Cartoons

All 12 cartoons can be found here. Most are either just drawings or satires of the newspaper asking for cartoons of Mohammed and the imagined response to the cartoon. Only four of them are actually insulting of Mohammed and by extension Islam. Of the four, two are about suicide bombing done in the name of Islam, one is about Muslims requiring tha women wear burkas, and only one is completely general in its intention to offend, a cartoon of Mohammed with devil horns resembling a halo. The former cartoons are less offensive than people actually carrying out suicide bombings and requiring that women wear burkas in the name of Islam, so one would hope that the people outraged by these cartoons are at least as outraged by those two practices. Unfortunately, reality couldn't be more incongruent.

The objective of the Danish newspaper asking for cartoons was to see if Muslims would tolerate any public speech contrary to their taboos. Somewhere along the line, they decided they also wanted to see the reaction if some of the cartoons were also insulting of Mohammed, so they including four cartoons that were directly offensive to Islam. It is pure conjecture what the response would have been had they left those four cartoons out.

What should have happened at most is peaceful demonstrations and letter-writing campaigns to the newspaper asking for an apology for the offensive cartoons, which they may very well have got. What happened instead, and the only thing I will condemn about this situation, is that there was a global reaction from presumably extremist Muslims demanding that the people making the newspaper be punished, in the least severe request by prosecution by the Danish government, and in the most severe by beheading. There has also been a targeting of Danish diplomatic buildings in Muslim nations, and protests of Denmark as a whole. The protest has also extended to newspapers that have reprinted the cartoons as part of their reporting. Lastly, there has been many demands that Denmark criminalize speech offensive to religions. None of this response is consistent with free democracy.

In short, what has happened is an extreme over-reaction by extremist Muslims. I will condemn this, but not a Danish newspaper that deliberately published offensive cartoons to show that this would happen. All right-thinking Muslims should condemn the actions of the extremists more strongly than they condemn the cartoons, and if they don't it is because they are cowards. That is all I have to say about this.

Indianapolis Was a Fine Place Before The Developers Arrived

One of my rules in life is to never visit a city that has suburban development projects with streets named after guns, Kentucky Derby-winning racing horses, ducks, a second development with streets named after champion race horses, flowers, music terminology, references to Robin Hood, avian fauna, "leisure" words, and patriotic places.

And that just scratches the surface of the oddities of suburbs in Indianapolis. One neighborhood has streets with spanish names, including one named "Gringo Drive." You can not make this stuff up.

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I have a theory about why I hate suburbs. Towns and countryside has a degree of natural and varied development to it in layout, architecture, and names. Cities often have large building squezzed into small spaces, utilitarian architecture, and arbitrary names, usually numbers. Suburbs are cities pretending to be towns, and the deceit implicit in their existence is why I distrust them.