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 →

Before I saw this news story, I was talking to a friend of mine whose girlfriend is a pharmacy student. He mentioned that she hasn’t been vaccinated. At all. Against anything.

My mind was boggled.

1) I thought it was required for all students, particularly those in the medical field, so they don’t endanger their patients — immunocompromised individuals are susceptible to these diseases even if they are vaccinated. I was required to be vaccinated against several specific diseases as a condition of being accepted to pharmacy school. The requirements were different if you were a pre-med or a PA student (which makes sense).

2) Why would a pharmacy student not be vaccinated against things like polio? MMR? Sure, there’s the old (unfounded) worry that MMR vaccines increase rates of autism, but the benefits clearly outweigh the consequences.

It seems there are loopholes: students can apparently opt out of it conflicts with their personal or religious beliefs. I think this is a danger specifically to one’s patients, and to the public at large: by it’s very nature, the medical profession exposes personnel to more sickness and disease than would otherwise be the case. I’d almost go so far as to call not being immunized unethical.

Continue reading Diseases eliminated by vaccines making a triumphant return (in certain circles) →