Merck settles suits over cholesterol drug (USA)

Merck has agreed to pay $688 million to settle lawsuits claiming that it had harmed investors by delaying the release of unfavorable study results for its cholesterol drug Vytorin, the company announced recently. Merck said it had recorded a $493 million charge to cover the cost of the settlement. Merck earned $6.66 billion in net income last year on revenue of about $47 billion based on generally accepted accounting principles. So that charge is only 7.4 percent of last year’s profits. Investors filed two lawsuits against Merck and Schering-Plough, which jointly sold Vytorin. The suits asserted that the companies had known for nearly two years that a clinical trial of the drug failed to show that it was any better than a statin drug at limiting the buildup of plaque in arteries, but they did not make the results public until 2008

FDA OKays combo pill for diabetes, cholesterol

The FDA has approved a fixed-dose combination tablet that combines the diabetes drug sitagliptin with simvastatin, under the brand name Juvisync. It's the first product with drugs for diabetes and high cholesterol in a single pill, the agency noted. Sitagliptin is a DPP-4 inhibitor sold as Januvia, first approved in 2006 as an adjunct to diet and exercise. Simvastatin (Zocor) is one of the most popular statin drugs for reducing total and LDL cholesterol. In the short term, the combination product will come in three strengths, all with 100 mg of sitagliptin and 10, 20, or 40 mg of simvstatin. The FDA advised physicians to consider other drugs that patients may be taking when deciding which strength to prescribe. The product's manufacturer, the Merck subsidiary MSD International GmbH Clonmel, of Tipperary, Ireland, has committed to develop additional strengths with 50 mg of sitagliptin and 10, 20, and 40 mg of simvastatin, according to the agency. "Pending availability of the fixed-dose combination tablets containing 50 mg of sitagliptin, patients who require this dose should continue to use the single ingredient sitagliptin tablet," the FDA said. Sitagliptin is also sold in a 25-mg dose, but it is seldom prescribed and there are no plans to develop Juvisync tablets with that dose, the agency added. The FDA noted that statins can exacerbate hyperglycemia in patients with type 2 diabetes. "This risk appears very small and is outweighed by the benefits of statins for reducing heart disease in diabetes," the agency said. "However, the prescribing information for Juvisync will inform doctors of this possible side effect. The company will also be required to conduct a post-marketing clinical trial comparing the glucose-lowering ability of sitagliptin alone compared to sitagliptin given with simvastatin." Common side effects associated with the combination include upper respiratory infections, rhinitis, sore throat, headache, muscle and stomach pain, constipation, and nausea. (You may wish to consult your own medical expert about this)

Merck clot drug seen unfit for stroke, shares fall

Merck & Co has stopped giving one of its most important experimental drugs, the blood clot preventer Vorapaxar, to some patients in two late-stage studies after it was deemed inappropriate for those who had suffered a stroke. Merck shares tumbled 6.7 percent after the news, as the market appeared to be writing off the value of a drug once thought to have multibillion-dollar sales potential - Reuters

Merck drug for cutting cholesterol is promising (USA)

"Merck has a potential blockbuster in anacetrapib, an experimental cholesterol drug that increases HDL, or 'good' cholesterol even as it lowers LDL, the 'bad' cholesterol. The drug could potentially have sales of more than $1 billion a year, John Boris, an analyst at Citigroup, wrote in a note to investors on Wednesday. But don't hold your breath. Cardiologists, patients and investors will have to wait until at least 2015 to find out whether anacetrapib protects the heart by reducing heart attacks and other cardiovascular problems, Merck said. Anacetrapib works by inhibiting an enzyme called CETP, which is involved in transforming particles of good cholesterol into bad cholesterol" - New York Times

Big Pharma researcher admits to faking dozens of research studies for Pfizer, Merck (USA)

"It's being called the largest research fraud in medical history. Dr. Scott Reuben, a former member of Pfizer's speakers' bureau, has agreed to plead guilty to faking dozens of research studies that were published in medical journals. Now being reported across the mainstream media is the fact that Dr. Reuben accepted a $75,000 grant from Pfizer to study Celebrex in 2005. His research, which was published in a medical journal, has since been quoted by hundreds of other doctors and researchers as "proof" that Celebrex helped reduce pain during post-surgical recovery. There's only one problem with all this: No patients were ever enrolled in the study! Dr. Scott Reuben, it turns out, faked the entire study and got it published anyway. It wasn't the first study faked by Dr. Reuben: He also faked study data on Bextra and Vioxx drugs, reports the Wall Street Journal" - Natural News

FDA won't accept Merck's application for new drug (USA)

"U.S. regulators won't accept drugmaker Merck's application for a new combination cholesterol pill that includes rival Pfizer's Lipitor, the world's top-selling drug. Merck & Co. disclosed the rare move by the Food and Drug Administration in a regulatory filing on Monday. The company had said about 2 1/2 years ago that it planned to make and market a cholesterol pill combining Pfizer Inc.'s Lipitor with Zetia, a cholesterol pill Merck jointly sells with partner Schering-Plough Corp. In September, Merck applied to the FDA for approval of its combo pill. But Merck says the FDA refused to file the application and instead is requiring more data on the manufacturing and stability of the drug. The FDA hasn't responded to requests for comment." AP

Elsevier admits journal error

"Elsevier, the world's leading scientific publisher, said it had failed to meet its own standards for "accuracy and transparency" in producing a publication sponsored by Merck, the US pharmaceutical group, but presented as an independent academic journal. The Australasian Journal of Bone and Joint Medicine, complete with an honorary editorial board of academics from Australia and New Zealand, contained a selection of reprinted articles from other journals concerning Merck's medicines Fosamax and Vioxx, and no disclosure that it was funded by the company. The publication marks a fresh twist in tactics to promote medicines by pharmaceutical companies, which have long provided substantial income to academic journals by paying for large numbers of reprints of articles favourable to their drugs for distribution to doctors. However, the Australasian Journal of Bone and Joint Medicine, which was produced in several issues between 2003 and 2005, has no website and is not listed as a journal in standard depositories of academic literature such as the Medline database" - FT

Merck reaffirms cardiovascular research commitment

"Merck & Co., Inc. has reaffirmed its commitment to discovering and developing novel treatments for a broad range of cardiovascular disorders, including atherosclerosis, hypertension, heart failure and metabolic syndrome. This year marks the 50th anniversary of the launch of the Company's first major medicine for cardiovascular disease" - Merck