Actos is in the same class of drugs as Avandia and Rezulin. But strangely it seems to have a beneficial effect on the heart. Still, both Actos and Avandia were tied to a higher rate of bone fractures in women, the companies that make these drugs said earlier this year.
Avandia has been GlaxoSmithKline’s second biggest drug franchise with $3 billion in worldwide sales. But Wall Street reacted by driving down the company’s (NYSE:GSK) share price more than 7 percent yesterday. GlaxoSmithKline is the second largest pharmaceutical company in the world after Pfizer.
All of the country’s national newspapers considered the study big news. The Wall Street Journal covered it as the lead in today’s paper. The New York Times and USA Today also have it on their front pages.
Not only did Avandia and GlaxoSmithKline come under attack. But the report renewed skepticism about the Food and Drug Adminstration’s vigilance in watching out for our health.
Representative Henry Waxman immediately called for a hearing on June 6 by the House Oversight and Government Reform Committee, which he chairs. It will examine the “FDA’s role in evaluating the drug’s safety.” Invited witnesses include Dr. Nissen, FDA Commissioner Andrew C. von Eschenbach, and GlaxoSmithKline CEO Jean-Pierre Garnier.
The leaders of the Senate Committee on Finance, Max Baucus, chairman, and Charles E. Grassley, the ranking member, yesterday wrote the FDA Commissioner to request a personal briefing on the Avandia situation. They want the FDA and GlaxoSmithKline to tell them “what they knew about Avandia, when they knew it, and why they didn’t take immediate action to protect patients.”
That question is so close to the famous question that Republican Senator Howard Baker of Tennessee asked about President Nixon in the Watergate scandal that it gives me goose bumps. The question, “What did the president know and when did he know it?” was a key one leading to the President’s eventual resignation.
Senator Grassley added, “We need to know if this is another Vioxx, where the FDA sat on its hands and endangered lives.”
The link to Vioxx is a strong one. Dr. Nissen co-authored the analysis in 2001 that showed the heart risk of taking Vioxx. While the company that sold Vioxx initially played down that concern, it withdrew that drug in September 2004.
Meanwhile, the FDA issued a “safety alert on Avandia.” It says that, “Patients who are taking Avandia, especially those who are known to have underlying heart disease or who are at high risk of heart attack should talk to their doctor about this new information as they evaluate the available treatment options for their type 2 diabetes.”
GlaxoSmithKline also responded immediately to Dr. Nissen’s challenge. Its key claim is that, “The totality of the data show that Avandia has a comparable cardiovascular profile to other oral anti-diabetic medicines.”
The class-action attorneys are already excited by the prospects. Lawyers are already trolling for clients.
