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Avastin is a miss in gastric cancer

Remember 2007?  That was the year Avastin was going to set the world on fire.  There was improved survival success in colon cancer, then lung cancer.  Avastin was on a tear.

Improved survival is an easy sell to the FDA.  The survival advantage wasn't huge, but it was statistically reproducible, and so the benefit of helping people with advanced cancer live longer made this new treatment attractive.

FDA, public comments, and REMS programs

I have long maintained that the FDA REMS programs mainly serve the purpose of big drug companies looking to avoid class-action litigation, while they limit access to drugs and create additional administrative tasks for clinicians.

FDA cracks down on therapeutic ozone devices

I have had people take hyperbaric oxygen therapy for foot ulcers with some success, but otherwise had no idea these things were being used to treat cancer, AIDS, and other illnesses.  The Cochrane Review looks to be gearing up to review the use of ozone in diabetic foot ulcers soon, stay tuned for some of their usually definitive coverage. 

Doctors purveying questionable therapies: if you're not careful, the FDA will sic the US Marshals on you!

Do bacteria in cigarettes cause infections?

A publication in cigaretteEnvironmental Health Perspectives this month challenges a long-held assumption about tobacco and infections.

People assumed that the reason smokers get a lot of respiratory infections was because the smoke was suppressing their immune systems.

New paper: Effient "blockbuster" results for heart patients

Let the gushing begin. The new son-of-Plavix, Brilinta, beat Plavix in a randomized trial, published this week.

Plavix is a leading blood thinner given to patients after a heart attack or stent procedure. Only problem is that it's set to go off patent in 2011, leaving AstraZeneca needing to fill a $6 billion/year revenue hole.

Looks like Brilinta is all but inevitable. The incremental benefit is 1.9%, leaving insurance pharmacy benefit managers having to scratch their heads over whether a 1.9% benefit is worth billions of dollars in incremental drug spending.

Walmart doctors and hospitals to press for drug price regulation (JK)

This post started out about Waxman vs. Tauzin but turned into Walmart hospitals and docs versus pharma. Indulge me if you will. The big healthcare debate has a few new key players: Mr. Billy Tauzin Hon. Henry Waxman Now you may remember Mr. Tauzin as a US Rep from Louisiana but since 2005 he has been working as a lobbyist for the pharmaceutical industry. He started working for them the day he left office and had an instrumental role in the passage of prescription drug coverage for Medicare recipients in that year. Hon. Mr.

Seven billion dollar announcement: Amgen announces positive results with breast cancer bone drug in press release

Results indicate Amgen's denosumab originally developed for osteoporosis helps with bone health in women with advanced breast cancer as well. NYT reported the info yesterday. http://www.nytimes.com/2009/07/08/business/08amgen.html?partner=rss&emc=... The prior major report we had on this drug was from 2008 and showed similar efficacy to conventional bisphosphonates.

Sunscreen debacle: estrogen or dollars?

Today we opened the first sunscreen of the summer a Neutrogena stick containing titanium dioxide and zinc sulfate. Total cost for a small small stick: $7. Ouch! The California Baby version is $15! This works out to something like $1 an ounce or more. I personally am trying to avoid using the "synthetic" sunscreens on kids out of concern for estrogen-like effects. I haven't seen correlations with health outcomes per se but I would rather not add risk especially in my daughter where I don't need to. The titanium based sunscreens do not appear to have a hormonal effect on biology.

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