Now you Europeans can waste your money on aliskiren, too
Novartis has gotten their pointless direct renin inhibitor approved by the European equivalent of the FDA.
How utterly snooze-worthy. Now you Europeans can waste your tax dollars money on the drug, too! Hooray!
Bonus Tekturna story:
Doctor writes a prescription for Tekturna for one of his patients. (One of our drug delivery guys, actually.) Gives him a free sample card, even though he doesn't have insurance and thinks he's doing him a favor. He gets 30 Tekturna for free, and the next month rolls around. That'll be $100, please, even with the employee discount I gave him because he amuses me.
He almost shit a brick.
Remember, folks: giving patients a FREE SAMPLE is great, but it's a complete WASTE OF EVERYONE'S TIME if they are without insurance or if their insurance doesn't cover it.
Mr. Delivery Guy comes back a week later with a prescription for lisinopril, after I write him a note to give to his bonehead physician.
[tags]Tekturna, aliskiren, Rasilez[/tags]
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]
Mandatory HPV vaccination in Maryland
Nearly half of Maryland's state senate has signed onto a bill requiring that all middle school girls receive Gardasil.
"Having the ability to eliminate a disease is something that cannot and should not be overlooked and should be made available to young girls," said Sen. Gwendolyn T. Britt (D-Prince George's), one of 21 senators who have signed onto the bill, sponsored by state Sen. Dolores G. Kelley (D-Baltimore County.)
[...]
Several Maryland lawmakers said the vaccine would affect their families directly. "I have two teenage daughters," said Sen. Brian E. Frosh (D-Montgomery), a co-sponsor. "I don't want them to get cancer."
Not to get too political or anything, but it always strikes me as faintly amusing that disease states don't discriminate between the social classes. Do we need to start sending the children of US Senators to war before that particular idiocy is stopped?
Anyways, on a related note, I got a script for Gardasil at the pharmacy yesterday (first time) that wasn't covered by her insurance. Naturally, we don't stock it normally, but the cost to her would have been $180 per round or $540 in total. Naturally she didn't take it, but it does get me wondering where I could have told her to go to get it for less. She was more interested in her own knee-jerk "No way you're crazy!" reaction than taking a more productive approach, however. But for the future, does anyone have any ideas?
[tags]Medicine, pharmacy, Gardasil, HPV[/tags]
Requiring Gardasil in Washington D.C.
While South Dakota is focusing on girls ages 11-18, Washington D.C. is focusing on girls age 13 and under. Female students enrolling in the sixth grade would be required to show proof that they've received the vaccination. It is possible for parents to opt-out out of the vaccine, but the circumstances this would be permitted under haven't been detailed.
I'm going to go ahead and speculate that these conditions involve "constitutional rights" — that is someone could have a religious aversion to vaccines, so their children would be permitted to opt-out. (A phenomenon that still makes me scratch my head.) No other "valid" reasons for opting out spring readily to mind.
Catania's decision to introduce the vaccine proposal was based in part on the high incidence of cervical cancer in the District. HPV causes cancer in about 10,000 women in the country annually and kills about 3,700, according to the American Cancer Society. The national incidence rate of the disease is 8.8 per 100,000 females, and the District's rate is 13.5 per 100,000, according to the society.
Solid reasoning, I suppose. I wonder why DC has a higher incidence of cervical cancer? Any guesses?
[tags]Gardasil, HPV, cervical cancer, Washington DC[/tags]
Generic clopidogrel: whiplash for the masses
Saturday morning, we received a voicemail sent to all of the branches in our chain about the stopped production of generic clopidogrel. You may recall that Apotex shipped all of the generic it had on hand as soon as their deal with S-A and BMS fell through. Well a judge has just ordered Apotex to stop producing and shipping the generic, so you can see why Apotex was in a hurry to get everything they had out the door, just in case.
Fortunately, there's not going to be a recall, so Judge Stein certainly made the right decision in that case, but I'm waiting to hear what the shakeout ends up being. Will generic clopidogrel remain on the market or will it disappear? The voicemail made it sound like our company's supplies of the generic will hold for as long as it takes to resolve the matter once and for all, but that could just as well have been in response to Apotex assurances that everything would go swimmingly. The possibility that Apotex might lose wasn't even considered, which I found disingenuous. That's in stark contrast to this WaPo article which makes it sound as though Apotex has no chance of winning at all. (Which very well could mean that it was written from a press release from Sanofi-Aventis, given that there's no stock response information for BMS listed, who also has a huge stake in Plavix's fate.)
Frankly, I don't know what to think. I'm not a lawyer, and I'm not familar with the patent dispute in this particular case. The folks at Patent Baristas don't have much more, either. If the generic disappears, it's going to piss a lot of people off, both patients and providers. Myself included. No one likes being jerked around, particularly when it affects their wallet.
[tags]Medicine, pharmacy, plavix, clopidogrel, Apotex[/tags]
Plan B: You know you did something right when you've pissed everyone off
I'm a firm believer that one of the most important aspects of democracy is not a given outcome of a political debate, but is instead the constant push and pull of the ideas behind a decision. The decision to make Plan B available without a prescription was a long time in coming, and I support it fully.
I think it's somewhat sad that it's been overly politicized, but I guess that's the price of doing something controversial in a country where the "religious right" has a lot more clout than is warranted. Politicians on both sides think the FDA has gone too far or hasn't gone far enough. I'd say that the agency has done a good job with their Plan B policy so far, if for no other reason than the fact that no one's completely happy with it.
Some of the nonsense on both sides is actually pretty funny, particularly when viewed with an eye towards history — especially the stuff from the right:
Coburn and other social conservatives said that the high doses of hormones in the pills carry risks, and that making them more easily available will encourage sexual activity and result in more unwanted pregnancies and sexually transmitted diseases.
That, my friends, is Grade A political BS. Opponents of oral contraception said the same stuff about "The Pill" when it first came out. It was then, and still is, a complete load of crap.
First of all, Plan B will prevent unwanted pregnancies. That's why it exists, and it does its job quite well. That whole STD thing… is anyone else having 1960s flashbacks here? Hello, these arguments were made when the pill first came out. They were unsubstantiated then, how is today any different?
"This is a bad decision for women, for girls, for parents and for public health," said Wendy Wright of Concerned Women for America, which led a campaign to block the decision. "The FDA's decision today will only make things worse for American women."
I'd love to hear the logic behind that one, backed up with some numbers. But wait, that'll never happen because the numbers won't be there, and the only thing the right will be able to come up with will be anecdotes here and there. And I'd put some serious money on that.
What does concern me is the current administration's emphasis on teaching abstinence. I think a rigorous sexual education program would go a long way in preventing STD transmission — but that, of course, is a bad idea because it will encourage teenagers to have sex. (Insert a humongous roll-eyes emoticon here.) Nevermind that the US has the highest rates of teen pregnancy and STD transmission of any first world country. Clearly the abstinence emphasis isn't working.
But the left isn't entirely reasonable either.
Plan B's backers, meanwhile, criticized the agency for not allowing the drug to be sold to everyone.
"We urge the FDA to revisit placing age restrictions on the sale of Plan B," said Sens. Hillary Rodham Clinton (D-N.Y.) and Patty Murray (D-Wash.). But because the decision represents "real progress" and an "important step in restoring the American people's faith in the FDA," the senators said, they were lifting a hold they had imposed on von Eschenbach's confirmation as FDA commissioner.
I don't think it's a good idea for it to be sold willy-nilly to anyone that wants it. Ideally it'd be only sold to the person who is going to use it so its use can be more closely monitored, and the procedure for using it — and how it works — can be made clear to the woman who needs it.
So we've got Plan B available OTC. Now it'd be nice if the lay public got on the "Plan B is not abortion" bandwagon. Because it's not.
[tags]Medicine, pharmacy, Plan B, abortion, politics, healthcare policy[/tags]
Money for organ donation redux
Yesterday I got a bit carried away in my post on organ donation. I didn't say it in that post because it seemed fairly obvious to me that the reason it's verboten by Uncle Sam is to ostensibly protect individuals from being exploited for their organs. To me that seems like it would simply force the practice underground, whereas I think it would be better to have it out in the open and regulated for the safety of all parties involved. (I think the same thing about prostitution, as you might guess.) I am not aware of a thriving black market for human organs in the United States, however such markets exist in other countries.
Anyway, the whole point of yesterday's post was to mention baby steps towards creating a legitimate market for organs. A Jerusalem district court ruled that Israeli HMOs must pay kidney donors NIS 63,000 (~$14,300) to cover their expenses, but it stopped short of saying whether they're allowed to pay for a kidney:
The Western world generally forbids organ trade. In Israel the ban came in a directive by the CEO of the Health Ministry. But Jewish law (halakha) does allow payment for organs and even considers selling one to be a mitzvah.
In a precedent-setting ruling on Monday by the Jerusalem District Court, Judge Joseph Shapira instructed HMOs to pay 31 kidney donors NIS 63,000 each to cover expenses. Shapira stipulated that the ruling is not on the more fundamental issue of whether payment should be allowed for the kidney itself.
An interesting ruling. But since most kidneys are donated by living relatives, it would almost seem a little odd for an HMO to be giving money to the donor outside of expenses. It would seem like it would be the responsibility of the private parties to handle that sort of thing.
I believe Levitt is wrong in his blog post on the topic when he says that these people are getting an extra $13,000 in their pockets. It reads to me that the Israeli HMO's are merely covering the expenses of the second party involved rather than allowing them to take home some extra pocket cash. How do you all read it?
[tags]Medicine, organ donation, economics, healthcare, Israel, ethics[/tags]