All posts by Rian

Januvia is going to eat Byetta’s lunch

Januvia hit our shelves this past week, and I marveled at how inexpensive it was for a brand new drug. (~$300, if dim memory serves.) I think Merck’s going to have a runaway hit on their hands, and Amylin and Lilly are going to be the ones that lose out. I almost feel like I’m stating the obvious here — heck, maybe I am, I haven’t kept with any business news and speculation in several months.

Exenatide (Byetta) is a glucagon-like peptide analog that responds to glucose by stimulating insulin release and inhibiting glucagon release. It also slows gastric emptying, inhibits synthesis of glucagon, and stimulates beta cell neogenesis by preventing beta cell death. It only responds in the presence of glucose, which means there’s low risk for hypoglycemia.

Unfortunately, GLP-1 is broken down by DPP-IV, which limits native GLP-1 half-life to about 90 seconds. GLP-1 is also efficiently cleared by the kidneys. The other downside to Byetta is the fact that it’s injected.

Sitagliptin (Januvia) prevents the breakdown of the body’s own GLP-1 (and other incretin hormones) by inhibiting DPP-IV. As an oral tablet, patient compliance is likely to be higher, or at the very least, it’s more convenient than poking oneself.

Despite having entirely different mechanisms of action, the net effect is the same: higher levels of GLP-1 in the body, with low risk of hypoglycemia. Both Byetta and Januvia are likely to help patients lose weight as well. There’s been some talk about possibly getting Byetta approved as a weight-loss drug — I don’t know how far along this idea is, however.

It’s only a matter of time before we start getting insurance rejections for prior authorizations telling us that the doctor needs to try Januvia before they’ll approve Byetta. This is good news for those seniors on Medicare Part D plans as well — Januvia can save them a pile of money because it’s just so much cheaper than Byetta.

So to recap:

  • Easier to store (no refrigeration)
  • Oral tablet vs injection
  • Once a day dosing instead of twice a day poking
  • Cheaper

I think all the pieces are in place for Merck is going to eat Eli Lilly and Amylin’s lunch here. It seems one investment house is also predicting something similar. (PDF)

On the absurdity of not having health insurance

As I mentioned about six weeks ago, I ended up going to the hospital while I was on vacation in California. Of course one of the hospitals lost my insurance info so they sent me an itemized bill instead. I’ve posted it here so we can all laugh together at how much they’ve charged me for a few things. I’ve not included a couple of things because they didn’t seem terribly unreasonable to me.

Promethazine 25AMP: $37.88
Sublimaze (fentanyl) 100mcg injection: $47.50
1000mL Normal Saline: $99.01
Contrast with Exam: $412.00

CT scan/body:
CT W/W/O Contrast: $2629.69
CT Pelvis W/W/O Contrast: $2355.70

Emergency Room
Level 3 w/ MD/Nurse procedure: $699.43
Admin of IV Injection: $184.71

——————————

Self-pay adjustment: -$1321.54

Continue reading On the absurdity of not having health insurance

Remicade (infliximab) for ulcerative colitis

I’ve got a soft spot in my heart for GI disorders since I suffer from one myself. They suck. So when I read this the other day I was a bit surprised.

“For people with active ulcerative colitis who do not respond to corticosteroids or immunosuppressive agents, infliximab is effective in inducing clinical remission, inducing clinical response, promoting mucosal healing and reducing the need for colectomy, at least in the short term,” said review co-author Dr. Anthony Kwaku Akobeng.

[…]

“Infliximab is another option if steroids fail,” said Peter Higgins, M.D., an assistant professor in gastroenterology at the University of Michigan Medical Center in Ann Arbor.

And here I was, thinking this was common knowledge. In fact I during my hospitalization a few weeks ago whilst on vacation I had a discussion about UC with the tech doing my CT scan. She was telling me one of her friends had severe UC, and that he was on steroids. I distinctly remember suggesting Remicade or Humira instead of prednisone through my drug-induced stupor. She was telling me he hated the side effects. What a surprise. Then I think I started rambling about monoclonals and the lack of a generic approval pathway for biologics in general. She stopped talking to me after that.

She was cute, too. Really cute.

But hey, more studies are always good. Too bad Remicade is WAY more expensive than prednisone…

[tags]Medicine, pharmacy, Remicade, infliximab, ulcerative colitis[/tags]

Postponing antibiotic usage in children with ear infections

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]

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]

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]

Lipitor: better than the rest of the statins? Not so fast.

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]

Bacteriophages at your local supermarket

Phages attacking listeria bacterium

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]

Tales from the Pharm: The $15,000 delivery error

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.

Enbrel

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

When reaching for pills is easier than making lifestyle changes

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]