Delaying generics through "citizen petitions"
I saw this a few days ago in the WaPo — which is quickly becoming a favorite news site of mine, due to real, original reporting — and it's another straw on the camel's back, so-to-speak. I find myself defending Big Pharma quite a bit; I feel they're given an unfairly bad rap most of the time. Perhaps because they're easy targets, I'm not sure. But then you read stories like this that make you ready to throw in the towel and write the lot of them off as nothing but greedy money-grubbers.
On the one hand, you've got rules that work in your favor for a certain amount of time in the form of patent protection. They protect your intellectual investments so you can recoup costs and make money. I don't know of a single person that would begrudge anyone this. Without the profit incentive, why innovate? It didn't work particularly well in Soviet Russia, and it doesn't work well today, either. Carrots work better than sticks when it comes to creating and innovating.
On the other hand, you wonder why one of the parties has to be a spoil-sport and ruin the party by trying to bend the rules to their further benefit. Given that any single member of the one group has more resources than all the opposition put together*, this often makes for a pretty lobsided game. Especially when one party begins exploiting safeguards put in place by the government to work on behalf of the People.
An antihistamine to kill malaria?
Infectious diseases that plague the third world are largely money-losers because the people living in countries where things like malaria are scourges can't afford the cost of life-saving medicines. Malaria is of particular interest to me, particularly plasmodium falciparum, because it's such a devious organism.
Now a J&J drug that was pulled off the market back in 1999 — for dubious reasons — is showing promise treating both chloroquine-susceptible malaria (80% efficacy) and chloroquine-resistant strains (40% efficacy) in mice. While not astounding, the results are at the very least, interesting. Tests haven't been conducted in humans yet, but I don't doubt they're coming.
Astemizol, because it is older and less expensive than the more typical artemisinins, would likely be very appealing to third world governments. Currently, malaria is responsible for some 2.7 million deaths — 75% of those deaths being children under the age of 5 in Africa — making it one of the deadliest infectious diseases in history, if not the #1 killer.
(Images from eMolecules. Full size image.)
[tags]Medicine, pharmacy, malaria, plasmodium falciparum, hismanal, astemizol, infectious disease[/tags]
Teva gets generic Zoloft OK (and Lexapro, too!)
Oh those crazy Israelis, constantly beating other generic drugmakers to that six month, government-granted generic drug monopoly. They've done it again with Zoloft, which was approved by the FDA on Friday.
Sucks to be Pfizer, of course. Zoloft is a super profitable drug ($3.1 billion) and enjoyed the #7 spot on the top 200 list last year.
Teva will also enjoy a six-month monopoly on Lexapro when its time comes in December 2009.
I really can't wait to see what (if anything) Novartis does with their Sandoz unit in protecting their intellectual property investments from fast-moving, hard-driving competition from generic hardballers like Teva.
[tags]Medicine, pharmacy, Teva, Zoloft, sertraline, Lexapro, escitalopram, generic drugs[/tags]
Teva's generic Zocor gets the OK, Dr Reddy launches "authorized" simvastatin
Looks like the misguided efforts of Sandoz/Novartis to block the new generic version of Zocor failed, and Teva's shipments of the new drug have already begun. I have to confess an odd sort of geeky excitement going into work this morning. I was expecting to see generic simvastatin on the shelves. Alas, I was disappointed. (I hadn't been following the lawsuits that diligently.) Simvastatin hasn't been added to our database yet, either. (Not a surprise.) I expect to see a large shipment of simvastatin on Monday morning, though.
I am hoping that we go right for the Dr Reddy's "authorized" version. It's just that much easier to convince the fence-sitters to switch to the generic when the new tablets look identical to the old ones.
Speaking of new generics… we are now stocking generic Proscar (finasteride), made by Teva, if memory serves. We are not carrying the 1mg version (marketed as Propecia). Neither of which is a surprise. I wouldn't be surprised to see a generic Propecia within a week or so, though. It's just not as lucrative as Proscar.
Streamlining drug approval
Two of the guys from Drugwonks have written an interesting article in the Washington Times about the Critical Path Initiative that they talk about quite often. I don't take issue with anything specifically in the article, because it's a topic I know next to nothing about. (Though I'm thinking I should learn more…)
It's simply not true that more studies make safer medicines. Over the past 40 years, the percent of medicines withdrawn from the market because of dangerous side effects has been essentially constant at about 2 or 3 percent, even as the number of required clinical studies — a current average of 120 per drug approval — has mushroomed.
The article only take about 5 minutes to read, and it's quite thought-provoking.
Via Drugwonks.
Avastin granted another license by the FDA
Genentech can do no wrong, these days. I've written extensively about Avastin in the past, and now they've been granted another license by the FDA today (and I'm starting to feel like a broken record):
The study showed that patients who received Avastin plus the 5-FU-based chemotherapy regimen known as FOLFOX4 (oxaliplatin/5-FU/leucovorin) had a 25 percent reduction in the risk of death (based on a hazard ratio of 0.75), the primary endpoint, which is equivalent to a 33 percent improvement in overall survival, compared to patients who received FOLFOX4 alone. Median survival for patients receiving Avastin plus FOLFOX4 was 13.0 months, compared to 10.8 months for those receiving FOLFOX4 alone.
Now we'll have to wait and see if the FDA approves Avastin for use in conjunction with taxane chemotherapy for treating colorectal cancer, as well.
[tags]Medicine, pharmacy, cancer, oncology, genentech, avastin, bevacizumab, colorectal cancer, chemotherapy[/tags]
Generic Proscar approved; Propecia loses patent protection today.
Teva has gotten its generic finasteride tablets approved by the FDA. They will begin shipping the new generic for Merck's Proscar immediately. They have a 6-month monopoly on the sale of the new generic, and I wouldn't be surprised to hear about them filing the ANDA for Propecia as well, assuming they haven't already. (Propecia is a low-dose finasteride (1mg) used to treat male pattern baldness that also lost patent protection today.)
The priority, of course, was Proscar since Proscar is a far larger market than the Propecia. Because Propecia is considered a lifestyle and/or cosmetic drug, most insurers won't cover it (even though it's not particularly expensive, all things considered), which isn't the case for the very popular Proscar, which enjoyed $400 million in sales in the US in 2004.
[tags]Medicine, pharmacy, finasteride, propecia, proscar, merck, teva, generic drugs, generics[/tags]