God bless the tinfoil hat brigade:

Arthur Firstenberg says he is highly sensitive to certain types of electric fields, including wireless Internet and cell phones.

"I get chest pain and it doesn't go away right away," he said.

Firstenberg and dozens of other electro-sensitive people in Santa Fe claim that putting up Wi-Fi in public places is a violation of the Americans with Disabilities Act.

Psst, Arthur, this is what we call a somatization disorder.

Sante Fe, the rest of the country is laughing at you.

It saddens me when a case is settled not on the facts of the case, but rather on issues that are only tangentially related to the matter at hand, at best. That said, perhaps Flea was confident in his anonymity, but probably shouldn't have been. Being nearby, I considered going to the courthouse in Boston and asking a court clerk where and when "the malpractice case of the pediatrician" was being heard, simply because most of my days are free, and I would have liked to observe the trial. I wouldn't have revealed Flea's identity.

Unfortunately, hindsight is 20-20, and things that are obvious after the fact are often not so obvious while they are occurring. We've all done things that were dumb in hindsight — myself especially — so I will refrain from being an armchair jackassexpert and saying that Flea should have known better.

But ultimately we have a legal outcome wasn't about the truth. The truth — whatever it happens to be — is apparently irrelevant. Unimportant, even. I think that alone is poor commentary on our legal system.

[tags]Medical malpractice, malpractice[/tags]

In any event, it looks like it's for real. As far as I know, this is the only time in recent history where a generic has been withdrawn. I think I recall similar things happening for Lanoxin (digoxin) and Synthroid (levothyroxine), but generics for those drugs were withdrawn because of problems with bioequivalence rather than as a result of litigation.

It's going to suck explaining the reasons why clopidogrel is temporarily going the way of the Dodo. People don't take too kindly to the idea of their copayments doubling (or more). I'm thinking I should write a little handout for people explaining what happened so we don't have to have the same conversation 500 times. After telling something a dozen or so times, you've heard all the wisecracks and complaints that such a topic engenders, and it just gets redundant and tiresome.

I also think the idea of jerking patients/consumers around like this is ethically wrong, patents and the justice system be damned. But then morality is entirely dependent on one's point of view, now isn't it?

[tags]Medicine, pharmacy, big pharma, plavix, clopidogrel, ethics[/tags]

It's a clear victory for Big Pharma, and a loss for consumers and any company that's not Sanofi-Aventis or BMS. Plavix was #2 on the top 200 list in 2005, with sales totaling $5.2 billion. Had Apotex been successful and not settled out of court, there would have been a generic Plavix available relatively quickly. Unfortunately they settled for the guaranteed money, and exclusive rights for 8 months. As I've said before, the value of the generic drug market is tiny compared to Big Pharma — by taking the settlement BMS, S-A, and Apotex all win. (Personally if I was Apotex, I'd have pushed for a higher figure, just because Plavix is so valuable.)

As soon as the results were announced, ten lawsuits by health plans, unions, and other businesses were immediately filed in retaliation, alleging the deal violates federal antitrust laws. The FTC has said that they will examine the case to see if there are any laws being broken. Frankly, I don't know enough about antitrust law to speculate whether the new round of litigation holds any water. It will certainly be an interesting case to watch, and has implications for further back-room licensing deals between major pharmaceutical companies and generic drugmakers, though nothing as unique as this has happened in recent memory that I am aware of.

Don't be surprised to see the number of similar lawsuits mushroom over the next five years as pipelines run dry and patents expire — it will be the only way Big Pharma will be able to maintain their otherworldly revenues for a precious few extra years. I have not seen a change in the way Big Pharma conducts their R&D efforts, and even if they did, there would still be a multi-year dearth of new drugs in the near-term. The path Big Pharma chose back when direct-to-consumer advertising restrictions were lightened has resulted in fat profits when their focus shifted to marketing instead of R&D. Unfortunately for them and everyone else, this more litigation and fewer breakthroughs.

[tags]Medicine, Pharmacy, Sanofi-Aventis, BMS, Plavix, clopidogrel, Big Pharma, antitrust law[/tags]