Pharmaceutical industry

Avandia danger signs covered up by GSK, alleges NYT article

NYT somehow uncovered emails from 2001 implying that SmithKline officials knew Avandia was linked to heart problems, yet sought to cover up the data.

Amazing piece of reporting here, kudos.  This Avandia story is looking like it'll be the Medical Mess of the Week.

We'll all sleep better knowing the Saudi Arabian FDA took decisive action in banning Avandia a few months ago.

FDA urges caution on topical Voltaren

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Even though there is less absorption of the drug into the circulation, even topical diclofenac (Voltaren gel) has the potential to cause liver damage.

This was the subject of a "Dear Doctor" letter from the FDA in December 2009, and it was a topic highlighted by this month's Worst Pills.org.

Cancer clinical trial drug offers hope...for some

NYT today has an excellent long narrative about the clinical trial drug PLX4032.  For some, the drug seems to work very well in eradicating metastatic melanoma.

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.

REMS Programs place undue burden on clinicians

Dr. Jenkins--

I have seen your recent comments on providing REMS programs for opioids. Since you are the director of OND, I was hoping to give you some feedback on these programs, and to alert you to the adverse effect on patient care that they can have.

I am a clinical hematologist and oncologist. I have to contend with many drugs under these programs, including Promacta, Nplate, Thalomid, Tysabri, and Revlimid. Looks like opioids are next on the list.

Bioethics paper: industry "buries" unfavorable studies

The always outstanding Carlat blog has a nice item this morning about the lengths pharmaceutical companies will go to in order to bury unfavorable results.

I used to enjoy playing "Devil's Advocate" with the drug reps, arguing points with them. I now realize that, as they say, the reps are always the last to know, and they just will say what they have been trained to say. Then they get laid off. It must be a tough job.

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.

Pharma pledges $80 billion to health care reform

Spending would mean substantial cut of all revenues. Reuters estimates that the US drug industry the world's largest took in $315 billion in sales in 2007. Today AP reported that the drug industry agreed to contribute $80 billion towards healthcare reform. So we're supposed to believe that the industry is contributing 25% of sales (not profits) to reduce the cost of healthcare in America? Somehow I doubt the shareholders of these publicly traded companies will let this happen.

Glaxo soldiers on with Avandia despite billion-dollar haircut

Glaxo tried to breathe new life into a drug clearly in trouble if anything that sells $1 billion worth per year can be said to be in trouble. This week's Lancet reports a new clinical trial of diabetics treated with Avandia where cardiovascular risk was no worse with the drug. In 2007 reports of cardiovascular side effects led many to question the use of the medicine and sales were cut in half. Glaxo sponsored the study. The editorial in the journal cited "limitations" of the study. This is the first time I can remember so much criticism of a randomized clinical trial.

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