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]
Moving generics to Tier 3 and brand-name meds to Tier 1
A patient was kind enough to bring in a copy of a letter she had received from UnitedHealthcare regarding her prescription drug benefits. The letter was specifically about changes to the coverage of her birth control. BCPs are a bit unique in that often the brand-name medications are less expensive than their generic counterparts. Often the difference is fairly significant. But I've never seen an insurer prefer the brand over the generic — except in the case of Zocor. So this is a fairly new phenomenon.
The letter:
Gardasil working on more than the original 4 HPV strains
Looks like Gardasil may be effective against more than just the four most-prevalent HPV strains (16, 18, 6, and 11): it's showing promise against strains 31 and 45 as well.
HPV types 16 and 18, which are directly targeted by Gardasil, are responsible for 75 percent of all cervical cancer. But scientists found the vaccine also induces an antibody response capable of neutralising strains 31 and 45, which together account for another 8 to 9 percent of cases.
It makes me wonder how much mindshare (and possibly marketshare) Cervarix — the GSK competitor to Gardasil — will garner when it's approved by the FDA. GSK is going to have to work hard to differentiate its vaccine against Gardasil. They'll certainly have their work cut out for them, because you can bet Merck will be testing Gardasil against the remaining 34 strains of HPV (which makes up only a tiny percentage of cases) to see if it has any success there as well. If I were GSK, I'd be thinking about getting some more clinical trials going on strains that Merck isn't playing with yet.
[tags]Medicine, pharmacy, Cervarix, Gardasil, HPV, cancer, oncology[/tags]
Vioxx as cancer prevention
Merck lost their latest Vioxx lawsuit while I was away on my vacation. I didn't care enough to delve into the details, but as someone who thinks rofecoxib should be put back on the market, I thought this new research out of Dartmouth was worth a look. It seems that Dr. John Baron has experimented with rofecoxib as a chemopreventative in the fight against colorectal cancer, with some success. (PDF)
The findings indicate that rofecoxib decreases the incidence of adenomas (polyps) in healthy people as opposed to just those who have familial adenomatous polyposis (FAP), a genetic disorder. Not surprisingly, the 3 year study was funded by Merck before the drug was pulled from the market.
In the year following three years' treatment, patients taking rofecoxib experienced a slightly increased risk of any adenoma, but not of advanced adenomas. However, over the entire length of the trial (three years of treatment and one year off drug), patients taking rofecoxib experienced a reduction of the risk of any adenoma."
Not all was rosy, though. From the discussion:
Given the toxicity associated with the use of rofecoxib, it is unlikely to be attractive for chemoprevention, but it is tempting to conclude that sustained use of other NSAIDs would permit increased surveillance intervals (in the expectation of reduced risks of colorectal cancer) and reduce risks from polypectomy. However, even proven efficacy of these drugs would not automatically justify their wide use for chemoprevention. The cardiovascular effects of non-aspirin NSAIDs are not well understood, and serious gastrointestinal toxicities may be an issue. Potential toxicities of NSAIDs will need to be weighed against their benefits in the context of the risk reduction already provided by periodic surveillance colonoscopy and polypectomy.
[tags]Medicine, pharmacy, Vioxx, rofecoxib, Merck, cancer, oncology[/tags]
Lack of economic demand for infectious disease hurting research
Lots of times when I read press releases, snarky headlines pop into my head, particularly when something seems so painfully obvious you wonder why someone spent their time and money researching the topic. But then I stop and think about the Greek philosophers, and how evidence-based science came to topple some of the most strongly held beliefs of the age. Think Galileo's observations of falling objects, for example. Then of course, there's the whole study of probability. If you've ever spent more than a week in a probability course, you quickly discovered that intuition is often wrong. Until you develop it further and start to understand how things actually are rather than how they appear to be.
Anyway, I'm getting off-track here. It's this train of thought that has prevented me from making fun of scientific research. It's always good to have data to back up your claims because we know that common sense is often not common, or sense.
Research out of the Economic and Social Research Council in the UK indicates that despite increases in drug development for infectious diseases like Malaria, TB, Sleeping Sickness, etc., overall progress is being hampered because there's just not much economic incentive to invent new therapies. This isn't news to anyone who follows the drug industry of course, but maybe it is to some politicians somewhere. It's no secret the lifestyle drugs are often more profitable than life-saving treatments for infectious diseases because the relatively rich people in first-world countries can pay more than an African farmer bringing in $300/year.
The study suggests private-public partnerships (PPPs) to help the problem. Other companies, like Napo Pharmaceuticals, are taking a different approach to drug development banking on an inexpensive treatment with super-wide appeal to make money. Think of it as the Henry Ford way of doing business in a cash-strapped third world. Both ideas are intriguing, but I think the PPP route ultimately will have more traction. In a cash- and research-intensive field like drug discovery, adopting an unprone business models involves a bit more risk than a rich, first-world investor looking to make a buck is willing to take. It'll be up to organizations like the Gates Foundation to pick up the slack left behind by the for-profit sector.
[Image: Trypanosomes surrounded by red blood cells from Nature -- larger image here]
[tags]Medicine, pharmacy, economics, research, healthcare, infectious disease[/tags]
Coming changes to OTP
Since the advent of this blog, I've focused mainly on business. In fact, the vast majority of my posts fall into the "Money" category (85 posts as of now). Very few are in the "new developments" category. This is probably because I was burned out of science, having done it for nearly a year, and feeling like I never knew enough about a given topic to really do it justice.
I still feel that way, but I do enjoy keeping my finger on the pulse of what's happening in terms of developments, so in the coming weeks I will begin posting what will probably be mostly the text from press releases. Maybe one or two per day, out of dozens that are published on a daily basis. Only stuff that's actually really cool or significant… or otherwise nifty. And it'll only be stuff that's life science/medicine-related.
I intend to continue my commentary on the medical industry as a whole, I'd just like to start having some science sprinkled in as well. That means probably a doubling in volume of what you see here, for better or worse. I'm not of the mind that more content is necessarily better, because I've unsubscribed to publications that throw too much at me, but in terms of search engine traffic, it's not a bad thing. (I look at search engine traffic pretty regularly, and there's quite a lot of it.)
In any event, my time will be somewhat more limited in the coming weeks, probably until about the beginning of November. How much time I have to devote to this site here remains to be seen, so I'm not sure what this will do to OTP in terms of fresh content, so WE'LL have to wait and see. The funny thing about free time is that you tend to get more done the less free time you have. Well, I do, anyway…
That's actually one of the reasons for my posting science stuff here as well — besides the fact that I've been wanting to do more of it — it's easier to aggregate than it is to be original. I think a mix of the two is probably the best way to go. I almost wish I had a partner in crime here…
Getting back in the saddle
Well I'm back from vacation — I've actually been home for a few days, I'm just having some difficulty getting back into the saddle, as it were. I'm going to try to start writing this weekend since I'll have some free time.
It was an eventful vacation. Full of firsts, actually, and not good ones. I took my first ambulance ride, was in a parked car when it was hit. (In that order.) Overall, though, it was a good trip. I'd have to say, though, that getting sick on the opposite coast while on vacation is for the birds. I don't advise it at all…
I also don't advise going to an ER where they want to take out your appendix as soon as you say "abdominal pain" regardless of what further examination might find. Seriously. Luckily for me, the surgeon was "out for the night" so they transferred me to a real hospital where I got to add another 1 liter to the total amount of barium I have consumed in my life, bringing the grand total up to 3.5L. Lucky me. Most people imbibe while on vacation, but not pharmaceuticals. Blech.
Hooray for being home.