Pharmaceutical sciences

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.

Drug companies targeted Vioxx critics?

An Australian newspaper reported today that Merck may have targeted particular doctors critical of Vioxx for "neutralization." The implication is that their opinions may have been damaging to the brand so their criticism had to be weakened by the drug company. Dear friends I was not on that list to be sure. Academics and researchers were probably the top targets. The newspaper article quotes court documents detailing some of the strongarm tactics Merck is alleged to have used.

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When A Bribe Is Not A Gift

Violating the anti-kickback statute 42 U.S.C. & 1320a-7b (b) of 1987: The statute is regulated by the Department of Health and Human Services (DHHS www.hhs.gov) and thier Office of The Inspector General (OIG) led by Daniel Levinson. Drug companies violate the False Claims Act (F.C.A.) with their marketing activities often. This can result in causing the submission of false claims in the form of prescriptions to government health care programs. The company knowingly causes to be presented to the Fed. Govt. false/fraudulent claims for payment/approval.

FDA: Need more clarity on genomics of clot drug

FDA: Need more clarity on genomics of clot drug I think this is a good sign that some rationality is present at FDA. The story is that FDA is asking the manufacturer of a popular clot-reducing medicine Plavix for more information. Seems the efficacy data is not as robust as it should be and the FDA has reason to suspect that the reason is patient hereditary variability in drug metabolism. This is shaping up to be the year of pharmacogenomics but progress is slow and limited to certain drugs.

Pharma industry: hands off our prices Medicare!

Pharma industry to Uncle Sam: hands off our prices Medicare!" Got this story off the Schwitzer health news blog always an excellent source. Evidently the pharmaceutical lobbying organization PhRMA is making noise again about Medicare's (lack of) regulation over drug prices. Not to turn this piece into a rant but of all the players in healthcare the drug manufacturers have maintained the most market power over the years. The doctors gave up their ability to regulate their own prices a long time ago and shame on the AMA for allowing that to happen.

Study: Direct-to-Consumer Drug Marketing Produces Lackluster Results

From Harvard Medical School comes the news that the costly advertising of new prescription drugs targeted at the consumer may not have any effect on sales of expensive drugs. Pharmaceutical companies spent about $4.2 billion in direct-to-consumer ads in 2005 yet researchers now report the effect of all that spending may be minimal. A research team set up an experiment using French-speaking Quebec residents as their "control" group.

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