Avandia and Increased Risk Of Heart Problems

The notice below of the “Two Studies Suggest Diabetes Drug Avandia Increases Risk of Heart Problems” is a further substantiation of our evidence-based review of the BARI2 trial.  Take a look at the reference link to our article as it indicates that the BARI2 trial had substantial methodological problems such that the results cannot be used in clinical practice. It is interesting that subsequent studies substantiated our critique of BARI2.

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BARI2 Trial, Treatment for Type 2 Diabetes Mellitus and Stable Ischemic Heart Disease, Michael Pazirandeh and Craig Stern. California Pharmacist Journal, Vol. LVII, No. 1, Winter 2010, 46-49.

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Two Studies Suggest Diabetes Drug Avandia Increases Risk Of Heart Problems.

ABC World News (6/28, story 7, 2:20, Sawyer) reported, “Two major studies have found the medicine called Avandia [rosiglitazone] could create a significant new risk of heart attack and other serious problems.”

The CBS Evening News (6/28, story 10, 0:30, Smith) reported, “FDA experts meet in two weeks to decide whether or not to pull Avandia off the market.”

NBC Nightly News (6/28, story 8, 0:20, Williams) reported, however, that the drug’s maker, GlaxoSmithKline, “said today the drug is effective and safe.”

The Washington Post (6/29, Stein) reports that one study, “involving more than 35,500 people, found that Avandia significantly raises the chances of a heart attack.” A separate study “of more than 227,500 Medicare patients — the largest such study to date — found that the drug boosts the risk for strokes, heart failure, and death.”

The Los Angeles Times (6/29, Roan) reports that the first study “found Avandia raised the risk of heart attacks by 28% to 39% as compared with other diabetes medications. The study was published online in the Archives of Internal Medicine.”

Bloomberg News (6/29, Cortez) quotes Steven Nissen, MD, lead author of the study, as saying, “I think we’ve got more than enough evidence to say this drug should not be used.”

USA Today (6/29, Marcus) reports that in the second study, published in the Journal of the American Medical Association, “scientists from the Center for Drug Evaluation and Research at the Food and Drug Administration evaluated data from 227,571 Medicare beneficiaries taking either Avandia or Actos [pioglitazone hydrochloride].” The investigators found “no differences in the risk for heart attack between the two drugs, but the study found that compared with Actos, Avandia was associated with a 25% increased risk of heart failure, a 27% increased risk of stroke and a 14% increased risk of death.”

The Boston Globe (6/29, Rowland) quotes the study’s coauthor Dr. David Graham, the FDA’s associate director for science and medicine, as saying, “Look at our study, and then ask yourself, ‘Why would you want to take Avandia?'”

The New York Times (6/29, Harris) reports that “the studies were made public Monday in hopes of influencing an expert panel that will convene on July 13 and 14 to offer advice to the Food and Drug Administration about whether Avandia should be removed from the market.” According to Dr. Joshua M. Sharfstein, the FDA’s principal deputy commissioner, the studies “will be part of the discussion that FDA has as we consider the important question of Avandia’s safety.”

The AP (6/29, Tanner) reports that “at the FDA’s request, Glaxo began a big study last year comparing heart and stroke risks in patients on Avandia or Actos, made by Japan’s Takeda Pharmaceuticals. It aims to enroll thousands of patients, but an editorial in JAMA about the Medicare study says it would be unethical to let the study continue.”

The NPR (6/28, Hensley) “Shots” blog, the Wall Street Journal (6/29, Mundy, Dooren), the Washington Times (6/28, Duke), Reuters (6/29, Fox), AFP (6/29), HealthDay (6/28, Gardner), MedPage Today (6/28, Phend), and WebMD (6/28, DeNoon) also covered the story.

Lawmakers Call For Avandia To Be Pulled From Market. The Hill (6/28, Pecquet) “Healthwatch” blog reported that “Sen. Chuck Grassley (R-Iowa) and Rep. Rosa DeLauro (D-Conn.) on Monday called for the diabetes drug Avandia to be pulled from the market in the wake of two new medical studies.” In a joint statement, Sen. Grassley said, “The serious issues delineated in these two new, independent reports put additional onus on advisory committee members when they meet in July.” Bloomberg News (6/29, Peterson, Cortez) also covers the story.

Rosiglitazone May Reduce Major Cardiovascular Event Risk In Patients With Type 2 Diabetes And Heart Disease. MedPage Today (6/28, Phend) reported that “rosiglitazone (Avandia) reduced major cardiovascular event risk in patients with co-existing type 2 diabetes and heart disease, according to a post-hoc analysis of the BARI 2D trial.” This “trial — sponsored by the National Institutes of Health, GlaxoSmithKline, maker of rosiglitazone, and other drug companies — found a 29% reduced composite relative risk of death, MI, and stroke with the use of rosiglitazone versus no drug in the thiazolidinedione class (3.79 versus 5.81 per 100 patient-years, P=0.002).”

source: AMCP Daily Dose, June 29, 2010

Craig S. Stern, PharmD, MBA
President
Pro Pharma Pharmaceutical Consultants, Inc.

Eisai Cuts Aricept Prices to Foster Asian Sales

The PhRMA argument is that the US should pay for R&D in order to allow them to sell drugs at a discount in other countries. The opposing argument is that R&D is being done in other countries such that the US should not have to carry the load for the world. Of interest is the article below that indicates that PhRMA applies the same marketing economics to building markets in other countries that they do in the US. We expect that an international market for information will make the differences between prices in various countries more transparent and drive price concessions. The drug market is now very much international and must be viewed through a prism that is wider than the US experience.

Eisai has become the latest drugmaker to cut prices in an effort to push sales in emerging markets. On the heels of similar moves by GlaxoSmithKline and Sanofi–Aventis, the Japanese company is cutting prices on its Alzheimer’s remedy Aricept in at least six Asian countries.

The idea is to ratchet up demand by opening the door to less prosperous patients, says Eisai’s Yasushi Okada, who heads up operations in Asia, Oceania and the Middle East. “With the current prices, only a part of the wealthy people can afford to buy our products,” Okada tells Bloomberg. “I want to increase the patient accessibility of the medicines in Asia.”

Okada tells the news service that he expects growth in sales volume to outweigh the price cuts, delivering overall sales growth. And that’s the aim of GSK and Sanofi as well. GSK has announced major price cuts in emerging markets, with prices tiered according to the target population.

In some GSK markets, prices will be less than two-thirds of those in Europe; in the 50 poorest nations, they’ll be 25 percent of Western prices, Bloomberg points out. Meanwhile, Sanofi announced early this year that it would follow suit, cutting prices in Southeast Asia by as much as half.

Okada wouldn’t say just how much Eisai plans to cut the price tags on Aricept. In the coming quarters, however, we’ll be able to see how the cuts affect sales in those markets. For 2008, Aricept’s global revenues amounted to $3 billion; the company loses patent protection in the U.S. in November, so it stands to lose revenues here to generic competition. All the more reason to grow sales in emerging markets.

Craig S. Stern, PharmD, MBA
President
Pro Pharma Pharmaceutical Consultants, Inc.