Hat tip to MRSA Notes for this one. An study published in JAMA suggests that by telling parents to wait 48 hours to fill scripts for ear infection, physicians can help curb antibiotic overuse in children. It’s not a bad idea, and it’s something that I’ve often thought about myself. As a child I had chronic ear infections until the age of 10 when I stopped consuming dairy products. I had tubes six times. Throughout that time in my life I was averaging around one ear infection per month. In my case, waiting a day or two didn’t do anything except make things worse.

Ironically, I’m sitting here now and I’ve got an ear infection in my left ear that I’m currently taking antibiotics for. Even more messed up is that I got the infection while on a 7 day regiment of Levaquin and Flagyl. (That’s whack, eh?) Anyway, when I was a kid I wondered what people did before antibiotics. Did they go deaf? Did they walk around with chronic ear pain? Did their eardrums burst? None of my infections ever went away on their own, so I thought they stuck around until you made them go away with drugs.

Of course I know better now, and it warms the concerned medical professional and microbiology enthusiast in me to see experts pushing for moderation in antibiotic use.

Out of 238 patients aged 6 months to 12 years brought to a hospital emergency room complaining of ear infections, two-thirds of the parents who were told to wait ultimately did not fill their prescriptions.

The group that did not fill the prescriptions recovered at the same rate as children who had prescriptions filled right away, an indication the condition often clears up on its own.

Those are some impressive findings. But it doesn’t get past the sense of entitlement that patients have when then visit a doctor’s office. People often want antibiotics now because germs are bad, mmkay? Why else would we have all these alcohol-based antibiotic cleansers on the market that we see so heavily advertised on TV? Surely it’s more than marketing…

[tags]Medicine, pharmacy, antibiotics, ear infections[/tags]

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]

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]

Medpundit’s got a good post on the marketing of Lipitor. It stands alone so I won’t quote anything here, except to re-post the comment that I left there:

Interesting post. Thanks for the analysis. It mirrors what I had suspected recently with regards to the “80mg Lipitor” reduces the risk of stroke. Emphasis on the 80mg part.

AstraZeneca did something similar with their marketing of Nexium, btw. You’ll recall that Prilosec is typically prescribed as 20mg QD. Nexium is most common as 40mg QD. A drug rep (no longer with AZ) told me that they compared the two together — only Nexium was at 40mg and Prilosec was at 20mg. Naturally that part wasn’t emphasized, and a lot of doctors were snowed by it. Hence Nexium’s evergreened, un-deserved, excessively-costly popularity.

In the case of Lipitor, I think marketing will only work for so long. It’s in the government’s interest to conduct head-to-head studies comparing the generic statins to Lipitor because it can save them money. It’s only a matter of time before this is done — and I think the results are not going to be in Pfizer’s favor, which is why I think Lipitor will largely be irrelevant by the time it loses protection in 2010.

And another comment I left on PharmaGossip about a week or so ago:

It seems likely, to me, that this study was conducted with an eye toward generic competition in the form of simvastatin. Pfizer knew Merck was their largest competitor in the statin market, and conducted this study in the hopes of finding this correlation at around this time.

Why?

In the last month, I’ve seen Express Scripts (one of the largest pharmacy PBMs) move toward making Lipitor available only with a Prior Authorization where before it was the preferred statin of choice. Several other PBMs have done the same thing.

The only exception in the case of Express? 80mg Lipitor. I think that’s why Pfizer is emphasizing the “80mg” part as much as the “Lipitor” part: the strength is just as significant (for them) as the drug itself.

My experience is anecdotal in this case — and should be taken as such — but there it is nonetheless.

I should add an addendum that I have since seen Express Scripts cover lower doses of Lipitor, and that different plans probably have different formularies. (Or doctors simply bothered to call in a PA before the patient filled the script which is equally possible.)

Yay marketing!

[tags]Medicine, pharmacy, marketing, Pfizer, Lipitor, cholesterol, statins[/tags]

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]

Today before my shift I got a phonecall asking me to stop by one of our other stores to pick a mis-delivery of Enbrel that had been delivered the day before.

Lucky for us, the pharmacist over there opened the box and saw what it was and was able to refrigerate it before it got warm. What you see in the picture below has an AWP of…

$15,151.48

I wonder if armored car drivers often make delivery errors on this scale? And if their deliveries have to be stored at a specific temperature? ;)

To give you an idea of how valuable this is, the entire volume of liquid here is 56mL. Assuming that it has the density of water, that means there’s 56g of fluid, which is a hair under 2 ounces.

Right now, Gold is sitting at $480 an ounce. Platinum is sitting around $1217 an ounce. Enbrel has a value of $7500 an ounce.

Oopsie.

[tags]Medicine, pharmacy, Enbrel[/tags]

The WaPo has an article on the increased use of sleeping pills, saying that consumers probably rely on them too much.

“We recommend that both the older and newer sleeping pills be taken more judiciously and less often than appears to be the current pattern of use by millions of people in the U.S.,” the report states. CR says increased pill usage is due to a “growing awareness of the health risks of insomnia and intense advertising and marketing to doctors,” as well as direct-to-consumer ads that “imply that medication is the best remedy for sleep problems.”

You don’t say? I could say the same thing for PPIs — why not try lifestyles changes, and then if that doesn’t work, move to an H2 blocker, and then reach for the PPI? Why go right for the Nexium?

Because going for the Nexium and Ambien is simply easier for an overworked doctor to do than help a patient make healthy lifestyle changes that might work just as well, and more permanently. Consumers like magic bullets, too, again because they’re easier. Take this, your problem will disappear. Easy. In the case of PPIs, they’re almost guaranteed to work. The classic case of using a bazooka to kill a gnat — always effective and usually always overkill.

This trend isn’t the healthiest, of course. Or the cheapest. Or the best. I think we’ll see a swinging away from this style of medicine over the next ten years. Insurers are beginning to realize that CBT is often less expensive in the long run than medicating someone ad infinitum.

[tags]Medicine, pharmacy, therapy, ambien, sleep[/tags]

Just a quick one-off post. In my last post on the Part D optimizer, I was thinking how I’d wished I’d had some references for rates of compliance based on qd, bid, tid, qid, etc. dosing. In general, compliance tends to fall off the more often someone has to take a medication. it does for me, for instance, and I know better, as I mentioned in my Atripla post.

Anyway, I messed about with Google Scholar back a few years ago when it first came out. It wasn’t especially useful then, but it seems to have gotten better as its index has grown. In any event, it was nice to find links to extracts of articles dealing with the topic. Most of them related to AIDS — since consistency is so crucial for keeping HIV in remission — but I think the findings can probably be extrapolated to non-HIV-related compliance as well.

Unfortunately most of the databases that are indexed require paid logins to read the fulltext, so it may not be quite so useful to the public at large.

[tags]Medicine, pharmacy, Google scholar, Google, research, science[/tags]

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]

Conceptually, economics is a fascinating field to me, and it’s an invisible factor that’s often overlooked by the mainstream media and by independent writers and bloggers. Naturally, for every action, there are consequences, no matter if the decision is a policy decision or a financial decision, or something in between. The threads that connect everything to everything else are some of the most interesting facets of the world we live in. Healthcare is certainly no exception.

The authors of Freakonomics (an excellent book, by the way) have covered the economics of organ donation in a New York Times article from July 9, 2006. (“Flesh Trade: Why Not Let People Sell Their Organs“) All jokes about people selling kidneys on eBay aside — which has been tried — there doesn’t seem to be anything inherently unethical about doing so. While I wouldn’t sell one of my kidneys (though I might give one away) I don’t see anything wrong with the practice for those interested in doing so. Levitt and Dubner agree, noting that the practice could help alleviate the organ shortage:

Continue reading The economics of organ donation →