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."

July 8, 2010 - FDA Cautions Against Using Quinine For Leg Cramps.

The Los Angeles Times (7/8, Maugh) reported, "The Food and Drug Administration on Thursday cautioned consumers against using quinine [Qualaquin] for" nocturnal "leg cramps, warning that the drug could cause severe side effects, including death." Indeed, "studies have shown that it can reduce the incidence of cramps by one-third to one-half." However, "as many as one in every 25 users can suffer serious side effects." The FDA issued the warning due to adverse-event reporting system, according to the Wall Street Journal (7/8, Dooren). Over three and a half years, 38 reports had been submitted. In those reports, "24 instances of serious life-threatening reactions" were noted according to MedPage Today (7/8, Petrochko). "These adverse events resulted in permanent kidney impairment and hospitalization in some people, and death in two." This warning reiterates a prior warning from 2006. Nevertheless according to the FDA, most of the quinine used in the United States continues to be for the prevention or treatment of leg cramps.

July 7, 2010 - Training Can Help Patients Better Control High Blood Pressure At Home.

HealthDay (7/7, Reinberg) reported, "With proper training, people with high blood pressure may be able to control it more effectively on their own at home than through conventional methods." In fact, "through telemonitoring of their blood pressure and adjusting their medications according to guidelines agreed upon in advance, patients assigned to self-managed care saw greater reductions in blood pressure after six and 12 months than patients receiving standard care through health professionals," according to a paper in The Lancet.

July 7, 2010 - Rheumatologists Claim Intimidation From Maker Over Criticism Of Colcrys.

The Wall Street Journal (7/7, Rockoff) reports that last year after the FDA approved URL Pharma, Inc.'s gout treatment, Colcrys (colchicine), several physicians criticized both the drugmaker and the FDA online, and some urged fellow rheumatologists to instead use the generic version which costs pennies a pill, as opposed to Colcrys, which costs $5. URL responded by sending letters to the physicians, warning them that their posts could lead to lawsuits. Several of the physicians, who are members of a discussion group sponsored by the American College of Rheumatology, say that URL is attempting to intimidate them.

July 7,2010 - FDA Approves AD/HD Patch For Adolescent Use.

Businessweek (7/7) reports, "Shire PLC said Tuesday that US regulators approved its attention deficit hyperactivity disorder patch Daytrana [methylphenidate transdermal] for use in adolescents age 13 to 17." The FDA previously "approved Daytrana in April 2006 for use in children age six to 12." The patch "is sold in strengths of 10 milligrams, 15 milligrams, 20 milligrams, and 30 milligrams, and is designed to be worn for nine hours." The Philadelphia Inquirer (7/7, Rudolph) also reported on this story.

July 7, 2010 - FDA Warns Cornerstone Over Zyflo CR Promotional Materials.

Businessweek (7/7) reports, "The Food and Drug Administration said Tuesday it sent a warning letter to Cornerstone Therapeutics Inc. alleging that Cornerstone's promotional materials withheld information about the risks of its asthma drug Zyflo CR [zileuton]." The FDA "said the materials violated the Food, Drug, and Cosmetic Act" by using "outdated labeling" and suggesting "Zyflo CR is more effective than competing drugs like Singulair [montelukast]." In addition, the agency "said a Cornerstone visual aid did not include warnings about the most serious side effects or the most common ones."

July 6, 2010 - Testosterone Gel Trial Halted Due To High Number Of Heart Attacks.

The New York Times (7/6, D7, Rabin) reports, "A federally financed study to see if testosterone gel helps frail elderly men build muscle and strength was abruptly halted late last year after participants taking it suffered a disproportionate number of heart attacks and other serious cardiac problems, and one died of what was apparently a heart attack." The Times says that "researchers were taken aback by the high rate of adverse heart problems." The FDA "has approved it for use only in men with hypogonadism, whose sex glands produce extremely low amounts of testosterone or none at all because of an underlying disorder," yet, "off-label use has increased in recent years."

July 6, 2010 - STD Rates Higher Among Men Taking ED Drugs.

Bloomberg News (7/6, Ostrow) reports, users of medicines for erectile dysfunction (ED) “showed almost triple the rate of sexually transmitted diseases compared with those not taking the medications." In fact, the "higher rate of infections was seen in the year before and after the men started taking the prescription medicines," Harvard researchers explained. Investigators "looked at health insurance claims from 44 large US employers from 1997, one year before Viagra [sildenafil] was introduced, through 2006." The "most frequently reported STD was HIV/AIDS, followed by chlamydia," HealthDay (7/5, Behen) noted. The findings "suggest a need for greater responsibility in prescribing ED medications." The Boston Globe (7/5, Cooney) "White Coat Notes" blog also covered the study.

July 5, 2010 - Study Finds Drug Prices In Europe Comparable To Those In US.

The Financial Times (7/5, Jack) reported on a study from the London School of Economics to be published in Health Economics, Policy and Law. The study shows that despite claims by US pharmaceutical manufacturers, the prices for patented medicines in the US are comparable to those in other OECD nations. The Times considered the report particularly damaging to arguments made by PhRMA, which has long claimed that European policies, such as regulation and price controls, make the continent less appealing to researchers. The new data suggest that drug maker profits, and prices, in the US are only marginally higher than in Europe.

July 2, 2010 - FDA Approves Prograf Generic

Watson Pharmaceuticals Inc. announced it received approval to sell a generic version of the drug Prograf [tacrolimus], which is used to prevent rejection of transplanted organs." The FDA approved the drug "in 5-milligram capsules," and Watson "said it will start shipping the drug immediately."