Dr. Tadataka Yamada, Chairman of Research and Development at Glaxo – the company that makes the diabetes drug Avandia – was the man that threatened a researcher would be held liable for the $4 billion GlaxoSmithKline PLC lost in stock value as a result of his findings, Dr. John B. Buse testified before congressional investigators yesterday.
Buse told the House Committee on Oversight and Government Reform that he raised concerns about Avandia’s connection to heart problems in 1999 , the year the Food and Drug Administration approved it for sale. He said the Glaxo executive, Dr. Tadataka Yamada, made the “disturbing” comment during a meeting Yamada had with Buse’s department chair at the University of North Carolina. Afterward, Buse said, he faxed a letter to Yamada asking him to “please call off the dogs ” because he feared he could no longer remain civil “under this kind of heat .” Buse, a UNC researcher, is incoming president of medicine and science for the American Diabetes Association’s board.
Buse’s testimony capped a day marked by allegations of witness intimidation and an admission from the FDA that Avandia and Actos , a similar diabetes drug made by Takeda Pharmaceuticals North America Inc. , deserve the agency’s strongest warnings for increasing the risk of congestive heart failure .
The “black box” warnings the FDA is requesting from Glaxo and Takeda would replace less prominent warnings the drugs already carry. Takeda yesterday committed to strengthen its warnings. Glaxo declined to comment because the firm is negotiating the change with the FDA.
Avandia, which generated more than $3 billion in revenue last year, is taken by 1 million Americans.
The public health impact of Avandia’s cardiovascular side effects should have prompted faster action by regulators and the company, said the committee chairman, Representative Henry Waxman.
Instead, Glaxo waited 11 months before telling federal regulators about clinical trial results linking Avandia to heart risks, and government officials ignored years of earlier warnings about the treatment, Waxman said. “Avandia is a case study of the need for reform of our drug safety laws,” he said. “FDA needs the will, the resources, and the authority to be a more effective watchdog.”
Read the full story by Diedtra Henderson here.