Allergic to WiFi (so let's sue the city)
America: where's it's your God-given right to sue anyone or anything for whatever the hell you want, no matter how absurd it is.
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.
Generic Famvir: Here today, gone tomorrow
That's my prediction, anyway. Teva has launched their generic Famvir amidst ongoing patent litigation, which is a pretty risky move. They risk damages if they lose their case, because there're no pesky clauses to cover their asses like Apotex had. So far as I know, anyway. As far as I can see, Teva's just using the ponderous judicial process to give them some time to sell a new drug. They'll block proceedings at every turn, that's guaranteed.
Quick review: Hatch-Waxman allows the first generic manufacturer to get its ANDA approved to have 180 days of market exclusivity, unless they sell the rights to this period of time back to the pharmaceutical company that developed the drug. This effectively results in 6 additional months being tacked onto the end of a patent. Apotex had done this with their generic Plavix, but slipped in a clause wherein they could start selling immediately if there was any question about the validity of the patent. Once BMS had inked the deal, Apotex turned around and contested the patent thereby allowing them to start selling immediately without fear of repercussion. Pretty shrewd on their part. (Apotex also has no annoying shareholders to please since they are a privately-held company, so they can get away with stuff like this.)
This was why generic Plavix was available for a while, and then disappeared.
Teva doesn't have anything like this, so they're really going out on a limb, here. I'm not sure how their move is legally defensible, and I'm 95% sure that they're going to lose. The only question will be whether the actuaries did their math right: will the revenue generated during this time will be greater than the damages awarded Novartis for stepping on their toes?
At least this won't be as bad as the Plavix debacle which really pissed a lot of people off on both sides of the counter, myself included. Famvir isn't really a maintenance drug in the same way as Plavix, and there're far fewer people taking it than Plavix. It's also not the only drug in its class, and Valtrex remains more popular. Thank God for small mercies.
Teva are a bunch of twats, though, as far as I can see.
[tags]Teva, Famvir, famciclovir[/tags]
On Flea
I don't often participate in blogosphere or Internet drama, but I do want to briefly add my comments to the general blogosphere reaction to the outcome of Flea's trial. If for no other reason than Flea was one of my favorite blogs, and its disappearance is a loss for medbloggers and the Internet community at large. I won't pontificate long. My thoughts boil down to this:
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]
Bathrooms and litigation
This morning a customer asked us if we had a ladies' room. I told her no, but strictly speaking, this is a lie. We do actually have a ladies room. (I suspect it's probably the law.) It's not public, though — it's located in the back room buried behind mounds of unstable things. We're not supposed to let members of the public back there for fears that they will trip and fall, or something will fall on them. (These fears are probably not unfounded, particularly among the elderly who are more prone to falling.)
It does make me wonder, though, what kind of society we live in where we must cover our asses when it comes to doing someone a favor — like letting them go to the bathroom. Should we let them go if they agree to sign away their right to sue should something untoward happen during their backroom sojourn? The very idea of signing a form to micturate or have a bowel movement is laughable.
Or is it?
Not letting someone use our facilities conflicts with the Entitlement. On the one hand, we are expected to accomodate any and all wishes. On the other, we must cover our asses. The supreme irony is that someone could probably sue us for NOT letting them use the bathroom. The classic damned if you do, damned if you don't scenario.
What a fabulous society we live in.
Zelnorm yanked. But it might come back?
Zelnorm (tegaserod) has been yanked — not a big surprise in our litigation-happy society. I can understand the CYA-above-all-else policy, but in this case, though, I think patient education and discussion would be a far superior option than removing a novel drug from the shelves entirely. I've seen first-hand several instances where Zelnorm worked when nothing else did. (Lubiprostone just came out, remember.)
But in a recent analysis of 18 000 patients in the entire clinical database, adverse cardiovascular events were seen in 13 out of 11 614 patients (0.11%) on Zelnorm, but in only one patient (0.01%) out of 7031 taking placebo, a statistically significant difference.
I happen to know that these people are willing to deal with this risk to continue to lead healthier lives. When a drug is yanked, it's a no-win situation, especially when it's one-of-a-kind like this. The kicker is whether there's even any meaningful risk at all:
Quoted in a company press release as "an independent cardiologist," Dr Jeffrey L Anderson (University of Utah, Salt Lake City) commented, "My review of the data suggested that a causal relationship is unlikely between tegaserod and the rare cardiovascular ischemic events observed in clinical trials. Furthermore, the data did not show any consistent pattern of event type, time to event, or dose relationship in tegaserod-treated patients."
The FDA is willing to consider letting Zelnorm back into the wild again. I hope they do.
Here's to hoping Amitiza (lubiprostone) can fill Zelnorm's shoes as effectively in the meantime. But knowing drugs like this, it'll probably work for some, but not for others, leaving some left out in the cold. Again.
[tags]Medicine, pharmacy, Zelnorm[/tags]
Will Lovenox eventually have an approved generic?
Sanofi Aventis had its patent overturned in a California court the other day, but the millionbillion dollar question is whether or not a generic can be approved to compete with the brand. That's thanks to the lack of a generic biologic approval pathway. Basically, the law which allows non-biologic generic drugs uses the process laid out in 505(b)(2) or 505(j) of the Food, Drug, and Cosmetic Act.
An equivalent approval route for biologic drugs hasn't been established yet, but now the question is whether or not enoxaparin can be approved under 505(b)(2) or 505(j). The door isn't completely closed through 505(b)(2), but it's not exactly black and white whether a follow-on product is possible, either. So now that the patent's been overturned, does it even matter?
[tags]Medicine, pharmacy, Lovenox, enoxaparin[/tags]
Goodbye, generic Plavix (for real)
So it looks like at the end of next week, we're going to run out of generic Plavix. I've not followed the business drama of Big Pharma in a little while because I find it dull, so I have no commentary on the outcome of the lawsuit, which I presume has been settled in S-A and BMS's favor. Apotex had a good run while it lasted. I mentioned in September that we were warned that this might happen.
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]