Apologies for the Delay in Posting

For the readers, please accept our apologies for the gap in new posts to this health news blog. Our primary purpose for this space was to create an online respository of health news with relevance for Helm Benefit Design, Inc. and to avoid cluttering the corporate computers with these stories. Examining the statistics, It appears there is more external interest in this summary than initially expected. We shall endeavor to serve our visitors/readers with more frequent updates. Comments w

July 12, 2010 - Lilly Touting Blood Test To Boost Effient Sales.

The New York Times (7/12, Pollack) "Prescriptions" blog reported, "Eli Lilly is about to try a new tack to help flagging sales of its new anti-clotting drug, Effient [prasugrel]." The drugmaker "will urge doctors to" administer "a blood test" developed by Accumetrics to "patients taking a rival drug, Plavix [clopidogrel bisulfate], to see if it is working," and "if it isn't, doctors would presumably switch patients to Effient." According to the Times, the "collaboration is an example of how pharmaceutical companies and diagnostics companies can work together for mutual advantage." Recent studies have demonstrated that effectiveness of clopidogrel may be impaired by using Proton Pump Inhibitor medications.

July 12, 2010 - Texas Monitors Psychotropic Drug Prescribing in Medicaid.

The Texas Tribune (7/12, Ramshaw) reported that in Texas, "officials with the state Health and Human Services Commission say psychotropic drugs represent just two percent of the 30 million Medicaid prescriptions filled every year." However, "they acknowledge the drugs are powerful and need close monitoring, particularly in children. Agency spokeswoman Stephanie Goodman wouldn't say whether Health and Human Services is investigating any particular doctors for overprescribing antipsychotics, but warned that 'any doctor prescribing far more drugs than his counterparts should expect to be on our radar.'"

July 12, 2010 - Actos Vastly Outsells Avandia In US.

The New York Times (7/12, Wilson) "Prescriptions" blog reported, "Avandia had lost a lot of ground in the market to Actos as a medicine for type 2 diabetes, even before the latest round of negative information as the Food and Drug Administration considers whether to order Avandia removed from the market." In 2009, according to IMS Health, "Avandia had $521 million in sales in the United States, compared to market leader Actos with $3.4 billion."

July 12, 2010 - FDA Panel To Review Anti-Obesity Drugs.

The Wall Street Journal (7/12, Gryta, Clark) reports that on Thursday, an FDA panel will review Vivus Inc.'s weight-loss drug Qnexa (phentermine/topiramate). Review of this and two additional formulations may be reviewed with similar criteria. The FDA said it will evaluate the drugs, which include Arena Pharmaceuticals Inc.'s lorcaserin and Orexigen Therapeutics Inc.'s Contrave (naltrexone SR/bupropion SR), under the assumption that patients will use them for the rest of their lives. The Journal notes that during the hearing for Qnexa, questions about the neurologic and psychiatric effects of topiramate, as well as the cardiovascular impact of phentermine are expected. Two of the three medications are merely reformulations of existing medications.

July 12, 2010 - Avandia Controversy May Change FDA Response To Drug-Safety Concerns.

The Wall Street Journal (7/12, Mundy) reports that the controversy surrounding Avandia may even change the way the agency responds to safety concerns surrounding medications, especially those that it has already approved. The Journal quotes former FDA Commissioner David Kessler as calling the Avandia safety discussions "a defining moment" for both Commissioner Hamburg and Deputy Commissioner Sharfstein.

July 10, 2010 - Bosentan May Not Improve Exercise Capacity In Patients With Systemic Sclerosis.

MedPage Today (7/10, Walsh) reported, "Treatment with the endothelin receptor antagonist bosentan (Tracleer) failed to improve exercise capacity in patients with systemic sclerosis, a randomized trial found." James R. Seibold, MD, of the University of Connecticut in Farmington, and colleagues said that after one year of treatment, "there was a nonsignificant mean change in the six-minute walk test in the bosentan-treated patients (−12 meters) compared with the change in the placebo group (9 meters)." In addition, the study found bosentan "had no effect on time to death or worsening pulmonary function test scores."

July 10, 2010 - DC Law Designating Pharmacy Benefit Managers As Fiduciaries Rejected.

The Hill 's (7/10, Pecquet) "Healthwatch" blog said "a local law designating Pharmacy Benefit Managers as fiduciaries was struck down by the DC appeals court today" after a three-judge panel on the US Court of Appeals for the District of Columbia "found that key portions of the 2004 law were unconstitutional." The blog noted that the law never went into effect in DC "because of an injunction filed right after the law passed." The court said "PBMs are regulated exclusively by federal law," so "states and local governments can't impose other requirements."

July 10, 2010 - FDA Advisory Panel To Debate Safety Of Avandia.

USA Today (7/10, Rubin) reported, "A large clinical trial of Avandia, sponsored by its maker, 'was inadequately designed and conducted to provide any reassurance' that the controversial diabetes drug does not increase cardiovascular risk, a Food and Drug Administration scientist wrote in a memo released Friday." The memo, written by Thomas Marciniak is part of a 765-page briefing document prepared by the FDA for the upcoming advisory committee meeting to review Avandia [rosiglitazone]. The New York Times (7/10, A1, Harris) reported on the front page that Dr. Marciniak "found a dozen instances in which patients taking Avandia appeared to suffer serious heart problems that were not counted in the study's tally of adverse events. Such repeated mistakes 'should not be found even as single occurrences' and 'suggest serious flaws with trial conduct,' Dr. Marciniak wrote." The Washington Post (7/10, Stein) reported that “agency experts remained split over the drug." The Wall Street Journal (7/10, Dooren), HealthDay (7/9, Gardner), MedPage Today (7/9, Phend), and MedPage Today (7/9, Walker) also covered the story.

July 9, 2010 – State Medicaid Programs Could Save $100 Million By Mandating Use Of Generics.

The Boston Globe's (7/9, Cooney) "White Coat Notes" blog reports that a study from Health Affairs found that some states are able to switch patients from brand-name to generic drugs more quickly than others when the drugs lose patent protection. "The difference has implications for expanding Medicaid coverage to more people after the national healthcare overhaul takes effect." For the study, researchers "looked at what happened when the patent for Zocor [simvastatin] expired in 2006 and generic versions...became available," and found that for "states that did not require patient consent for substituting" the generic, "98 percent of prescriptions were filled with the generic drug." The authors concluded that when other drugs go off patent "in the next few years, the savings could total $100 million nationwide for Medicaid programs if policies did not require patient consent."