To California I go…
I'm off to the airport in about 90 minutes to embark on a 6 day vacation to California. I'm not sure how much writing I'll be doing while I am there — I hope to get a few posts in here and there, but we will see. I'm not sure if where I will be most of the time (a house at Big Bear Lake) has Internet access or not. We shall have to wait and find out…
Cheers!
When litigation chokes a supply line
Forbes is running a rather refreshing article on the state of the vaccine market in the United States. As someone who has spent quite a bit of time on Internet message boards over the years, and been in any number of various and sundry debates ranging from creation/evolution to economic policy, I can tell you that there's a widespread feeling among the lay public that big drug companies don't want to create vaccines because cures put them out of business, and this is why there's no cure or working vaccine for AIDS. Naturally, this is complete and utter bologna. A financial windfall the likes of which has never been seen in Big Pharma awaits the first company to complete such a treatment. (And we're making progress day-by-day.)
Nevertheless, this is a widely-held opinion, even by otherwise educated, intelligent people. We know argumentum ad populum doesn't make truth, but it also doesn't stop people from believing hogwash, either.
The article starts off with what is arguably the greatest vaccination effort in the history of medicine: polio. It quickly runs over the history of the March of Dimes, and how privatization spurred the development of innovative ways of killing the virus, and scaling up the manufacturing of the vaccine to produce millions of doses.
One might consider that the Golden Age of vaccine development. It was all downhill after that when the litigation started:
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]
Medicine and common sense
In the article I referenced in my last post, the last couple of paragraphs stood out to me, because it highlights something that I've noticed lately: a lack of common sense and a treatment of symptoms rather than the cause. Especially for what are mostly simple problems like headaches, dizziness, and that sort of thing.
Voltaire once said "Common sense is not so common." And he was right.
One of his regulars is a 99-year-old woman he nicknames "Maggie Sweet." One day he noticed her pulling and scratching at the back of her neck.
Diagnoses started running through his head — basal cell skin cancer, for one — as he asked her what was bothering her.
The problem was a itchy tag on the back of her dress. He pulled scissors from his lab coat pocket and cut it off.
Entrepreneurs and medicine: the urgent care clinic phenomenon
In the six months or so that I've been paying attention to the business of medicine, I've noticed the undercurrents of change. Those who have been watching the field longer than me are probably tempted to call me a silly newbie. (And they might be right!) There are a number of economic and demographic indicators that make me feel this way, as well as a general dissatisfaction on the part of the public with medical care as it exists now.
I don't know whether there's a doctor shortage or not. As with anything, I suspect it depends on a number of different factors: specialty, location, demographics, etc. I do know that I would never be an MD. The barriers to entry are too high. The amount of debt taken on by aspiring doctors is nothing short of impressive, and the demands on a person after they've graduated and are out practicing are extraordinary. Doctors are blamed for everything: picking the wrong medications, not checking formularies, rushing patients, missing diagnoses, not calling in prior authorizations, being unavailable to patients and other providers alike — the list goes on and on. As someone who believes that just about all doctors do the best they possibly can within the bounds of human limitation, one must then examine the conditions in which they work.
Synthesizing an opiate without addictive qualities… maybe
I came across a Deseret Morning News article yesterday, which pointed out some work being done at BYU by an undergrad, which is unusual. (The article is a CnP of this press release.) Castle's work involves creating a racemic mixture of a compound found in the Japanese tape vine, Hasubanonine, which is the molecule you see in the image. The enantiomer produced by the vine has no pain-killing action, but they hope its opposite does:
And the tape-vine's mirror image is close in structure to the morphine molecule. "We've synthesized a mixture of the two mirror-image compounds, the idea being we can take the mirror image of the natural one, send it to NIH to be tested to see if it kills pain. We are optimistic it has painkilling properties, and, if that's true, we are able to synthesize it fairly easily."
It's not well understood what structural features are responsible for the addictive properties of morphine, Castle said. But it is possible they have found a key to a kinder morphinelike drug that would have potential medicinal applications.
I'm not quite sure how they arrive at "possibly not being addictive" from "it's similar to morphine" but there it is nonetheless. A non-addictive opiate is the holy grail of pain killer research, and quite frankly, I'm surprised someone like Endo hasn't looked into this compound before now. As you can see, it is structurally similar to morphine, but since what makes morphine addictive isn't well-understood, I'm not sure how even potential claims as to this new compound's nature can be made with a straight face. They don't even know if it kills pain yet. (Though I suspect, like they do, that it does.)
Talk about jumping the gun. It almost seems like the biggest story here is innovative research being done by an undergrad which, as I said above, is unusual.
[tags]Medicine, pharmacy, narcotics, addiction, analgesic, pain, morphine, chemistry[/tags]
AIDS vaccine Phase I trial successful
The 49 people who signed up to try out an AIDS vaccine appeared to be immune from HIV-1 and showed no adverse effects after 6 months. Phase I trials, of course, establish safety — it is up to the phase 2 trial to establish clinical efficacy.
"Forty-nine healthy people who received the injection showed no severe adverse reactions after 180 days, proving the vaccine was safe," said Zhang Wei, head of the pharmaceutical registration department of the SFDA.
"The recipients appeared immune to the HIV-1 virus 15 days after the injection, indicating the vaccine worked well in stimulating the body's immunity," he told the press conference.
Then, Phase III trials are usually double-blind, control studies. In the case of this vaccine, I don't see the Phase III trial happening exactly as it would with something like a new blood pressure or cholestrol medication. It would be unethical to expose individuals to the virus if they were only taking a placebo — especially if Phase II trials are also successful. Xinhua reports that the third phase will "will target the protection it offers for high-risk groups" — whatever that means.
The trial, which took place in China, was run by the National Institute for the Control of Pharmaceutical and Biological Products, and they're looking for about 300 at-risk volunteers for Phase 2 testing, and 500 more for Phase III testing.
The individuals in this test were paid $250 for their troubles, and were told they would not be infected by taking the vaccine, as it didn't contained the live virus.
I'll be watching these developments with interest.
[Image from the Duke Human Vaccine Institute]