Avandia update

Avandia update

The Wall Street Journal is reporting that U.S. doctors have been “shunning” Glaxo Smith Kline’s blockbuster diabetes drug Avandia since last week’s New England Journal of Medicine study indicating that Avadia carries a higher heart attack risk than other diabetes drugs. The Times of London reports that Analyst Peter Cartwright at Evolution Securities said: “Our guess that [UK] patients already taking Avandia won’t switch, because of the risks involved, but in places like the US, particularly because they are so litigious, we expect to see a sharp fall in new prescriptions.” Glaxo has been mounting a spirited defense, but it appears to have been taken by surprise. Meanwhile, Glaxo’s stock price has “nose dived.”

Memorial Day

On Memorial Day, we pay tribute to the soldiers, sailors, and airmen who have fallen in defense of the United States, our country, as well as those who now are in service. At 3 pm todat, I hope that everyone will observe the National Moment of Remembrance. In particular, I will remember my cousin Army Capt. Eric T. Paliwoda (right), 4th Infantry Division, West Point Class of 1997, who was killed in combat in Iraq on January 2, 2004. We will never forget.

FEHBP Personal Healh Records Bill Introduced

As promised at the May 18 FEHBP hearing, Senators Carper (D Del.) and Voinovich (R Ohio) did introduce yesterday their bill (S. 1456) that would mandate FEHB plans to offer the members electronic personal health records. The bill has been referred to the Committee on Homeland Security and Governmental Affairs.

Miscellany / Weekly Wrapup

  • On the HIPAA National Provider Identifier (NPI) compliance date, May 23, CMS finally announced the publication of the NPI dissemination policy, which will permit payors to download NPIs off a CMS website beginning June 28. Of course, CMS has permitted health plans to create NPI contingency plans and Medicare itself has implemented such a plan. The official notice of the NPI dissemination policy will be published in the May 30 Federal Register. An advance copy of the Notice is available here.

  • On May 22, a House Education and Labor subcommittee held a hearing on state health care reform movements and their interrelationship with federal law, particularly ERISA. Rep. Tammy Baldwin (D Wisc.) also testified about her bill (H.R. 506 ) which Sen. Voinovich (R Ohio) endorsed at the FEHBP hearing on May 18. Sen. Voinovich noted that Rep. Baldwin’s bill has been endorsed by both the Brookings Institution and the Heritage Foundation. Sen. Voinovich and Sen. Bingaman (D N.M.) have introduced a companion bill (S. 325) in the Senate. Rep. Baldwin’s bill would create a State Health Coverage Innovation Commission that could forward state health plan reform proposals to Congress for fast track consideration and approval. A Covington & Burling attorney testified about ERISA preemption and against state waivers.
  • On May 10, the House Ways and Means health subcommittee held a hearing on Medicare’s quality initiatives. GAO testified about its own analysis of Medicare participating physician practice patterns which found that the patients of outlier physicians — MDs who treat a disproportionate share of overly expensive patients — were spread across the country and evidently were practicing medicine inefficiently. CMS plans directed education efforts but needs legislative authority to reduce payments to inefficient MDs. In a related development, the Blue Cross and Blue Shield Association proposed legislation to create “a new, independent institute – funded by all healthcare payers – to provide consumers and providers with much needed information on which medical treatments work best.”

Perspective

Glaxo Smith Kline’s CEO Dr. Jean-Pierre Garnier offered this valuable perspective on the Avandia controversy today according to the Wall Street Journal:

“Dr. Garnier stressed that the absolute risk of heart attacks in patients taking Avandia was still low — between 0.43% and 1.85% of patients had heart attacks, according to Dr. Nissen’s paper, which was published in the New England Journal of Medicine. Those odds were 43% higher than the rate of heart attacks among patients taking other drugs or a placebo, which ranged from 0.34% to 1.44%.

Dr. Garnier said Dr. Nissen’s analysis is only one piece in a body of research that overall shows that Avandia is no riskier for the heart than other diabetes medications. “You cannot look at this in isolation,” he said.”

Here we go again!

The same cardiologist, Dr. Steven Nissen, of the Cleveland Clinic, who blew the whistle on the heart risks of the Merck blockbuster arthritis medicine Vioxx, has published a study in the New England Journal of Medicine finding that the blockbuster GlaxoSmithKline diabetes drug Avandia carries a high heart attack risk. In a press release, Glaxo announced that it “strongly disagrees with the conclusions reached in the NEJM article, which are based on incomplete evidence and a methodology that the author admits has significant limitations.” Patients and doctors are understandably confused by these developments; Glaxo’s stock is falling like a rock, and the FDA must be circling the wagons for another round of Congressional oversight hearings.

According to the Wall Street Journal, Dr. Nissen conducted his study using Glaxo studies that he dredged up with the Google search engine. Google Avadia now and you’ll find Avandia Heart Attack Class Action right at the top of the page. There has to be a better way to address these drug safety issues.