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]
Merck's replacement for Vioxx (Arcoxia) doing well in trials
Arcoxia (etoricoxib), Merck's replacement for Vioxx, is doing well in tests comparing its upper GI side effects against diclofenac. Results suggest that it's better, though how much better is unclear. This is pretty good news since diclofenac is (mostly) more patient-friendly than ibuprofen, and ibuprofen is of course wildly popular for treating inflammation.
The billion dollar question remains how Arcoxia affects the heart. One study suggests that it's more friendly than diclofenac, but a better question would be how it fares against placebo. Though if it's "better" than diclofenac — a drug that's been on the market for years — does that mean it's a shoe-in for FDA approval when the time comes regardless of how it fares against placebo?
[tags]Medicine, pharmacy, COX-2, NSAIDs[/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]
Bacteriophages at your local supermarket
My first post on bacteriophages was all a build-up to this piece of news that I found while perusing MRSA Notes.
A mix of bacteria-killing viruses may be sprayed on cold cuts, wieners and sausages to combat common microbes that kill hundreds of people a year, federal health officials ruled Friday.
The ruling, by the Food and Drug Administration, is the first approval of viruses as a food additive, said Andrew Zajac of the Office of Food Additive Safety at the agency.
[...]
The viruses, called bacteriophages, are meant to kill strains of the Listeria monocytogenes bacterium, the food agency said.
The bacterium can cause a serious infection called listeriosis, primarily in pregnant women, newborns and adults with weakened immune systems. In the United States, an estimated 2,500 people become seriously ill with listeriosis each year, according to the federal Centers for Disease Control and Prevention. Of those, 500 die.
Being bacteriophages, they don't attack humans. I say bring 'em on.
[tags]Medicine, food, phage therapy, bacteriophages, listeria[/tags]
An anti-smoking vaccine?
Lots of anti-smoking developments in the last 2-3 months. The approval of Chantix was pretty significant (still waiting to see how it works on in the real world in terms of insurers covering it, popularity, and anecdotal success rates), Sanofi-Aventis got Acomplia approved in Europe as a weight-loss drug, and now we've got tests of a vaccine that blocks the nicotine rush. It's called Nabi by NicVax.
Now the Madison man is among 300 people around the country who are testing an experimental vaccine that makes the immune system attack nicotine in much the same way it would fight a life-threatening germ.
The treatment keeps nicotine from reaching the brain, making smoking less pleasurable and theoretically, easier to give up. The small amount that still manages to get in helps to ease withdrawal, the main reason most quitters relapse.
Tysabri: really back now.
On June 7, Tysabri was re-approved for the market. Now it's really, truly back, as in available to patients. But only if they go to special clinics registered with the TOUCH program:
"Under the Programonly prescribers, infusion centers and pharmacies associated with infusion centers registered in the TOUCH program are able to prescribe, infuse or distribute Tysabri," Elan said in a statement.
It said it had contracted with a single distribution company and 12 specialty pharmacies to handle the drug.
Good news for patients, and good news for Elan, who nearly went bankrupt in 2002. Looks like everyone wins this time.
[tags]Medicine, pharmacy, Elan, Tysabri[/tags]
Once a day AIDS drug approved
Hey now this is pretty cool. Atripla is a once-a-day AIDS, 2-in-1 cocktail of Sustiva and Truvada. The hope is that this formulation will help increase patient compliance, which any medical provider will tell you is one of the biggest problems when it comes to achieving positive therapeutic outcomes.
"We know that an HIV-AIDS patient needs to take 95 percent of his or her pills or they won't work," said John C. Martin, chief executive of Gilead Sciences Inc., one of the companies in the Atripla project. "So the fewer pills a patient needs to take, the better the outcome."
Even I'm terrible at compliance, and I understand this better than most. I'd love to see some graphs that show the correlation between the number of times per day that a drug is taken vs compliance over time. I bet you see much higher compliance rates for a once-a-day drug than you do with twice-a-day regimens, and an even steeper drop-off when you've got someone who needs to take something 3 and 4 times a day. I bet it's particularly bad with 4 times a day dosing, because then you're not necessarily tying a dose to a specific daily activity (eating).
Hrm.
[tags]Medicine, pharmacy, Atripla, HIV, AIDS, Sustiva, truvada, patient compliance[/tags]