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]
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]
Merck's cancer vaccine approved
I mentioned back on May 17 how the FDA was scheduled to make a decision on Merck's new HPV vaccine, Gardasil, by June 8. The FDA handed down their approval today, a decision which is no surprise to anyone, since it's 100% effective against one strain of HPV, and 99% effective against two others. The vaccine is a huge boon for the public, and also for the beleaguered Merck:
This cancer kills 3,700 women each year in the United States and hundreds of thousands more worldwide.
[...]
Gardasil, manufactured by Merck & Co. Inc., protects against the two types of HPV responsible for about 70 percent of cervical cancer cases. The vaccine also blocks infection by two other strains responsible for 90 percent of genital wart cases. It will be available by the end of June.
It is likely that Merck will market Gardasil as a cancer vaccine rather than an STD vaccine for political reasons. There has been some speculation that the religious right would opposed the vaccine if they thought that it would lead to premarital and/or teenage sex. To combat this, Merck launched their "tell someone" anti-HPV campaign several months ago to soften the social impact of the drug before the approval was granted. I'm sure we'll see Merck tie a new marketing campaign for Gardasil into this tell someone HPV campaign to allow a smooth transition from one to the other — despite their assertions to the contrary. Even if a direct connection between Gardasil and the tell someone campaign isn't made, Gardasil is currently the only vaccine approved to prevent HPV, so a woman asking about her doc about HPV prevention is almost akin to her asking for Gardasil — even if she doesn't know it. (Not that this is necessarily a bad thing.)
In any event, this is great news for everyone in the first world and the third. Hopefully this will mean that HPV-induced cervical cancer will finally go the way of polio. This is some of the biggest cancer news in a week already chock-full of cancer breakthroughs.
[tags]Medicine, pharmacy, Gardasil, HPV, genital warts, STDs, cancer, oncology, Merck, vaccine, cancer vaccine[/tags]
Tykerb: GSK's rising star?
ASCO's annual meeting is going on right now, which means lots of news from the world of oncology. Much of the material is revolutionary — real breakthroughs that offer real hope to cancer patients everywhere. Clinical findings are announced, the results of drug trials are presented, and anything new and exciting that deals with cancer is pored over at ASCO.
One of the exciting results announced at ASCO has been the affect of Tykerb on patients who have failed Herceptin therapy. The trial compared breast cancer patients on chemotherapy to those on chemotherapy + Tykerb. The results were that the 320 women who took Tykerb alongside their chemo went 4 months longer than those on just chemo without their cancer progressing. As a bonus, Tykerb is administered orally rather than intravenously.
GSK is expected to submit the findings to the FDA this year, and Tykerb could hit the market as early as 2007. Hopefully Tykerb will not get tripped up like Avastin did under further review. If it remains a success, Tykerb could be a very big seller, and benefit thousands of women in the US alone. In the future, Tykerb could compete against Herceptin more directly.
[tags]Medicine, pharmacy, ASCO, Tykerb, GSK, cancer, oncology[/tags]
A shingles vaccines and biologic generics
There's been a lot in the news about vaccines. Cervical cancer vaccines, avian flu vaccines, vaccines for ear infections. Now Merck has another new vaccine that has just been approved by the FDA to treat shingles in people age 60 and over. Shingles is typically treated with Valtrex or another antiviral once it flares up. Zostavax, though, keeps the virus from flaring up before it happens, and it is the only pharmaceutical capable of doing so.
This is just the latest trend in a newly-rekindled vaccination industry. Turns out there's money in vaccines after all.
But analysts reckon the vaccine market will grow much faster than the market for prescription drugs. "We're in a period where pharmaceutical sales are growing at 5% to 6% a year," says Novartis Chief Executive Daniel Vasella. "In contrast, the vaccine industry is looking at nearly 20% annual growth over the next five years."
Generic Imitrex approved by the FDA
GSK has tentatively lost patent protection on two of its popular drugs: Coreg and Imitrex. Imitrex is the more profitable of the two, with 2004 sales of $1.1 billion in the US, but the loss of Coreg is substantial as well. Together the two had combined sales of almost $2 billion in 2004. 2005's were even more impressive: $1.4 billion in the US and over $2.42 billion globally for Coreg. The announcement of the FDA's approval of Mylan's generic sumatriptan comes hot on the heels of Imigran (the UK name for Imitrex) going over-the-counter in that country in an effort to retain some of its sales.
Mylan will now have a mandatory 180 day monopoly on the sale of three strengths of Imitrex: 50mg, 100mg, and 150mg tablet forms thanks to the Hatch-Waxman Act that I've talked about before, provided GSK doesn't pay them to not sell it so they can extend their effective patent life by another 6 months, which is certainly a possibility. Injectable and intranasal forms of Imitrex remain covered by patent, and I don't think we'll see Imitrex tablets going OTC in this country anytime soon.
[tags]Imitrex, GSK, Sumatriptan, medicine, pharmacy, Coreg, carvedilol[/tags]