An AP report today indicates that there has been significant progress made in creating a vaccine for Alzheimer’s Disease.

The new vaccine is DNA-based, and if testing continues successfully, Tokyo Metropolitan Institute for Neuroscience in Japan hopes to have a vaccine for use in humans in 6 or 7 years. Jonathan has coverage of the nuts and bolts of how the vaccine works over at Nobel Intent, if you’re into that sort of thing.

Elan Pharmaceuticals had been working on an Alzheimer’s vaccine several years ago, but they were forced to halt their work due to brain swelling in some of the test subjects. Yoh Matsumoto, the lead researcher on the project says that these problems have been ironed out based on what his researchers learned from the previous failure.

So far we’ve got cervical cancer vaccines, vaccines for otitis media, and a shingles vaccine. That’s a lot of happenings in a field of medical research that has long lay dormant.

[tags]Medicine, pharmacy, vaccines, Alzheimer’s, Elan, biotechnology, biotech[/tags]

With the approval of Gardasil, and the pending approval of Cervarix, major progress can be made against cervical cancer, especially in the third world. Enter the Gates Foundation — one of my favorite charities.

As a first step, PATH plans a program of research in India, Peru, Uganda and Vietnam, with a $27.8 million grant from the Bill & Melinda Gates Foundation, studying the best way to use the vaccines.

PATH will help pilot introduction in the four countries, and both drugmakers have agreed to provide their vaccines to demonstration projects.

This is excellent news, and it’s the right way to go about promoting the vaccine. Best practices for dispensing and usage will lead to greater efficacy and more lives saved in the long term. (After all, a major component of a positive therapeutic outcome is patient compliance — that is, consistent usage in the most effective manner possible in given environmental conditions.) Even better is that it looks like the drug companies will be supplying the PATH project for free during preliminary fact-finding. With the Gates-Big Pharma collaboration, it looks like we can start making inroads against the 200,000 yearly deaths that occur as a result of HPV-mediated cervical cancer.

The first world will largely subsidize the third for the time being, but large orders of the drug could turn a profit for GSK and Merck in the long run, which is why it is in their best interest to provide the drug free of charge for programs like PATH in the beginning. And lest the liberals complain about profiteering off the backs of the poor, consider that the third world is one of medicine’s final frontiers: if companies can profit while helping those unable to help themselves — via charitable and governmental financial proxies — then everyone wins. Especially the poor.

[tags]Medicine, pharmacy, HPV, gardasil, cervarix, gates foundation, bill gates, GSK, Merck, cancer, oncology, cancer vaccine[/tags]

I mentioned back on May 17 how the FDA was scheduled to make a decision on Merck’s new HPV vaccine, Gardasil, by June 8. The FDA handed down their approval today, a decision which is no surprise to anyone, since it’s 100% effective against one strain of HPV, and 99% effective against two others. The vaccine is a huge boon for the public, and also for the beleaguered Merck:

This cancer kills 3,700 women each year in the United States and hundreds of thousands more worldwide.

[…]

Gardasil, manufactured by Merck & Co. Inc., protects against the two types of HPV responsible for about 70 percent of cervical cancer cases. The vaccine also blocks infection by two other strains responsible for 90 percent of genital wart cases. It will be available by the end of June.

It is likely that Merck will market Gardasil as a cancer vaccine rather than an STD vaccine for political reasons. There has been some speculation that the religious right would opposed the vaccine if they thought that it would lead to premarital and/or teenage sex. To combat this, Merck launched their “tell someone” anti-HPV campaign several months ago to soften the social impact of the drug before the approval was granted. I’m sure we’ll see Merck tie a new marketing campaign for Gardasil into this tell someone HPV campaign to allow a smooth transition from one to the other — despite their assertions to the contrary. Even if a direct connection between Gardasil and the tell someone campaign isn’t made, Gardasil is currently the only vaccine approved to prevent HPV, so a woman asking about her doc about HPV prevention is almost akin to her asking for Gardasil — even if she doesn’t know it. (Not that this is necessarily a bad thing.)

In any event, this is great news for everyone in the first world and the third. Hopefully this will mean that HPV-induced cervical cancer will finally go the way of polio. This is some of the biggest cancer news in a week already chock–full of cancer breakthroughs.

[tags]Medicine, pharmacy, Gardasil, HPV, genital warts, STDs, cancer, oncology, Merck, vaccine, cancer vaccine[/tags]

The WaPo has a popular Health article today about the increasing practice of women skipping their periods entirely. (Period: Full stop?) I’ve seen the issue come up a few times in the last year or so. While it may seem “unnatural” or even unhealthy, I thought I’d point out something that the WaPo article didn’t mention.

Throughout history, women have traditionally been married at a young age, often having children much younger than they do in this day and age. Life expectancies were shorter, and when women were being married at 15 and 16, and having children right away, and then dying arounf 30, this meant that they wouldn’t be menstruating as much as they are today. Assuming menopause comes at 50 today, and a girl began menstruating at age 13 (not at all unheard of today), and she has two children (as opposed to 8 or 9), she menstruates 463 times during her life:

(50-13) x (52/4) - (2x9) = 463

Contrast this with a typical medieval scenario: a woman begins menstruation at 15, has 8 children (child mortality was around 30%), and death coming at age 30 (the average life expectancy during the this period):

(30-15) x (52/4) - (8x9) = 123

That’s 340 fewer menstrual cycles. It is my opinion that the human body wasn’t meant to bleed that often, so menstruating once every three months doesn’t seem like it would be that detrimental to a woman’s health, save for the hormones one is ingesting. Like the article says, though, time will have to be the judge of that, but women are certainly having far more periods than they have at any other point in history.

[tags]Medicine, pharmacy, menstruation, monthly period, gynecology, oral contraception, birth control, history[/tags]

An AP article that I found thanks to Drugwonks is proclaiming that there is a problem with spending on specialty drugs. These “specialty drugs” are medicines like Humira, Remicade, and others — that is, biologics.

Specialty drugs are typically biotech medications that treat complex, chronic conditions and often need to be injected. Spending on such drugs reached $40 billion last year or 19 percent of the total on all medicines, according to Express Scripts Inc., a Missouri-based pharmacy benefit manager.

[…]

The explosive growth is spending on specialty drugs is especially problematic because there is no pathway for generic competitors to enter the market.

Continue reading Specialty drug spending problem? I think not. →

ASCO’s annual meeting is going on right now, which means lots of news from the world of oncology. Much of the material is revolutionary — real breakthroughs that offer real hope to cancer patients everywhere. Clinical findings are announced, the results of drug trials are presented, and anything new and exciting that deals with cancer is pored over at ASCO.

One of the exciting results announced at ASCO has been the affect of Tykerb on patients who have failed Herceptin therapy. The trial compared breast cancer patients on chemotherapy to those on chemotherapy + Tykerb. The results were that the 320 women who took Tykerb alongside their chemo went 4 months longer than those on just chemo without their cancer progressing. As a bonus, Tykerb is administered orally rather than intravenously.

GSK is expected to submit the findings to the FDA this year, and Tykerb could hit the market as early as 2007. Hopefully Tykerb will not get tripped up like Avastin did under further review. If it remains a success, Tykerb could be a very big seller, and benefit thousands of women in the US alone. In the future, Tykerb could compete against Herceptin more directly.

[tags]Medicine, pharmacy, ASCO, Tykerb, GSK, cancer, oncology[/tags]

Or sensationalist journalism to sell more magazines? Maybe both?

Probably both. Yep. It’s both.

In the May 8 issue of Forbes magazine, the feature article is about Big Pharma and their marketing efforts. Stories like this are nothing new, nor do they really have anything contructive to say on the topic except to shine a bright light on a problem that has popular appeal. Big Pharma does spend a lot of money on marketing, but is it too much? I don’t think so, and consequently I can’t resist going through the article and picking out bits and pieces that’re off the mark, and the ones that are right on. Yes, this is my idea of fun while being stuck in the lounge of a car dealership, waiting to get my car back…

This article is about 2000 words short, so you may wish to get a coffee before you start reading. Or, you know, go to the bathroom or something.

• The balogna
• Contradictions and lifestyle drugs
• Science or marketing?
• “Me-too” drugs
• Marketing and the game of deception
• Short term profits, long term value and calculated risk
• HMOs to the rescue?
• The problem of medical journals

Continue reading “Pill Pushers” — science for salesmanship? →

There’s been a lot in the news about vaccines. Cervical cancer vaccines, avian flu vaccines, vaccines for ear infections. Now Merck has another new vaccine that has just been approved by the FDA to treat shingles in people age 60 and over. Shingles is typically treated with Valtrex or another antiviral once it flares up. Zostavax, though, keeps the virus from flaring up before it happens, and it is the only pharmaceutical capable of doing so.

This is just the latest trend in a newly-rekindled vaccination industry. Turns out there’s money in vaccines after all.

But analysts reckon the vaccine market will grow much faster than the market for prescription drugs. “We’re in a period where pharmaceutical sales are growing at 5% to 6% a year,” says Novartis Chief Executive Daniel Vasella. “In contrast, the vaccine industry is looking at nearly 20% annual growth over the next five years.”

Continue reading A shingles vaccines and biologic generics →

Sanofi-Aventis and BMS have settled a lawsuit against Apotex, a generic drug-maker for $40 million and manufacturing rights for 8 months. The two had sued Apotex for patent infringement on Plavix, a lawsuit which has pushed off the availability of a generic clopidogrel in the United States. Under the terms of the suit, Apotex will hold off selling their generic clopidogrel in this country until September 2011 — which is 8 months before the patent expires — and will receive $40 million from BMS and Sanofi-Aventis.

It’s a clear victory for Big Pharma, and a loss for consumers and any company that’s not Sanofi-Aventis or BMS. Plavix was #2 on the top 200 list in 2005, with sales totaling $5.2 billion. Had Apotex been successful and not settled out of court, there would have been a generic Plavix available relatively quickly. Unfortunately they settled for the guaranteed money, and exclusive rights for 8 months. As I’ve said before, the value of the generic drug market is tiny compared to Big Pharma — by taking the settlement BMS, S-A, and Apotex all win. (Personally if I was Apotex, I’d have pushed for a higher figure, just because Plavix is so valuable.)

As soon as the results were announced, ten lawsuits by health plans, unions, and other businesses were immediately filed in retaliation, alleging the deal violates federal antitrust laws. The FTC has said that they will examine the case to see if there are any laws being broken. Frankly, I don’t know enough about antitrust law to speculate whether the new round of litigation holds any water. It will certainly be an interesting case to watch, and has implications for further back-room licensing deals between major pharmaceutical companies and generic drugmakers, though nothing as unique as this has happened in recent memory that I am aware of.

Don’t be surprised to see the number of similar lawsuits mushroom over the next five years as pipelines run dry and patents expire — it will be the only way Big Pharma will be able to maintain their otherworldly revenues for a precious few extra years. I have not seen a change in the way Big Pharma conducts their R&D efforts, and even if they did, there would still be a multi-year dearth of new drugs in the near-term. The path Big Pharma chose back when direct-to-consumer advertising restrictions were lightened has resulted in fat profits when their focus shifted to marketing instead of R&D. Unfortunately for them and everyone else, this more litigation and fewer breakthroughs.

[tags]Medicine, Pharmacy, Sanofi-Aventis, BMS, Plavix, clopidogrel, Big Pharma, antitrust law[/tags]

GSK has tentatively lost patent protection on two of its popular drugs: Coreg and Imitrex. Imitrex is the more profitable of the two, with 2004 sales of $1.1 billion in the US, but the loss of Coreg is substantial as well. Together the two had combined sales of almost $2 billion in 2004. 2005’s were even more impressive: $1.4 billion in the US and over $2.42 billion globally for Coreg. The announcement of the FDA’s approval of Mylan’s generic sumatriptan comes hot on the heels of Imigran (the UK name for Imitrex) going over-the-counter in that country in an effort to retain some of its sales.

Mylan will now have a mandatory 180 day monopoly on the sale of three strengths of Imitrex: 50mg, 100mg, and 150mg tablet forms thanks to the Hatch-Waxman Act that I’ve talked about before, provided GSK doesn’t pay them to not sell it so they can extend their effective patent life by another 6 months, which is certainly a possibility. Injectable and intranasal forms of Imitrex remain covered by patent, and I don’t think we’ll see Imitrex tablets going OTC in this country anytime soon.

[tags]Imitrex, GSK, Sumatriptan, medicine, pharmacy, Coreg, carvedilol[/tags]