Two US drug safety reviewers have recommended that GlaxoSmithKline PLC’s diabetes drug Avandia be pulled from the market after concluding it is more dangerous to the heart than a rival medicine, documents released on Saturday show.
The US Food and Drug Administration (FDA) will again ask an advisory panel to consider the risks of the drug, which was Glaxo’s second-biggest-selling product before questions about a possible link to heart attacks emerged in 2007.
US Senators Max Baucus and Charles Grassley meanwhile released a report saying evidence suggested Glaxo knew of possible cardiac risks associated with Avandia years before the issue became public.
“I await the recommendations of the advisory committee,” FDA Commissioner Margaret Hamburg said in a statement.
“Meanwhile, I am reviewing the inquiry made by Senators Baucus and Grassley and I am reaching out to ensure that I have a complete understanding and awareness of all of the data and issues involved,” she said.
In an October 2008 memo released by the senators, FDA reviewers David Graham and Kate Gelperin concluded “the risks of [Avandia] are serious and exceed those for” Takeda Pharmaceutical Co’s competitor Actos.
They said there was “strong evidence that [Avandia] confers an increased risk of” heart attack and heart failure when compared with Actos.
They estimated that 500 more heart attacks and 300 cases of heart failure were occuring every month with use of Avandia instead of Actos, based on levels of use at the time of their memo.
Graham, an outspoken critic of the FDA’s handling of drug risks, had argued to an advisory panel in 2007 that Avandia sales should be stopped. The panel voted 22-1 to urge the FDA to keep the drug on the market.
Glaxo said in a statement “the scientific evidence simply does not establish” that Avandia increases risks of cardiovascular problems such as heart attacks.
Sales of Avandia, known generically as rosiglitazone, topped US$3 billion in 2006 but fell to US$1.2 billion last year.
The FDA decided in November 2007 that Avandia should carry a warning saying a review of 42 studies associated the drug with an increased risk of a heart attack or chest pain compared with a placebo.
However, it said overall data were “inconclusive.”
Concerns about Avandia emerged in May 2007 when Cleveland Clinic researchers published a study saying that there was a link between the drug and heart attacks.
The senators’ report said evidence reviewed by investigators on the Senate Finance Committee, which Baucus chairs, showed Glaxo “knew for several years prior to this study that there were possible cardiac risks associated with Avandia.”
Glaxo executives “attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk and sought ways to downplay findings that a competing drug might reduce cardiovascular risk,” the report said.
Committee staff reviewed more than 250,000 documents provided by Glaxo, the FDA and others, the report said. Anonymous whistleblowers provided hundreds of other pages.
The New York Times first reported on the memo from FDA reviewers and the senators’ report on Friday night on its Web site.
Glaxo said it rejected the report’s conclusions. The company said the report “cherry-picks information from documents, which mischaracterizes GlaxoSmithKline’s comprehensive efforts to research Avandia and communicate those findings to regulators, physicians and patients.”
RETHINK? The defense ministry and Navy Command Headquarters could take over the indigenous submarine project and change its production timeline, a source said Admiral Huang Shu-kuang’s (黃曙光) resignation as head of the Indigenous Submarine Program and as a member of the National Security Council could affect the production of submarines, a source said yesterday. Huang in a statement last night said he had decided to resign due to national security concerns while expressing the hope that it would put a stop to political wrangling that only undermines the advancement of the nation’s defense capabilities. Taiwan People’s Party Legislator Vivian Huang (黃珊珊) yesterday said that the admiral, her older brother, felt it was time for him to step down and that he had completed what he
Taiwan has experienced its most significant improvement in the QS World University Rankings by Subject, data provided on Sunday by international higher education analyst Quacquarelli Symonds (QS) showed. Compared with last year’s edition of the rankings, which measure academic excellence and influence, Taiwanese universities made great improvements in the H Index metric, which evaluates research productivity and its impact, with a notable 30 percent increase overall, QS said. Taiwanese universities also made notable progress in the Citations per Paper metric, which measures the impact of research, achieving a 13 percent increase. Taiwanese universities gained 10 percent in Academic Reputation, but declined 18 percent
CHINA REACTS: The patrol and reconnaissance plane ‘transited the Taiwan Strait in international airspace,’ the 7th Fleet said, while Taipei said it saw nothing unusual The US 7th Fleet yesterday said that a US Navy P-8A Poseidon flew through the Taiwan Strait, a day after US and Chinese defense heads held their first talks since November 2022 in an effort to reduce regional tensions. The patrol and reconnaissance plane “transited the Taiwan Strait in international airspace,” the 7th Fleet said in a news release. “By operating within the Taiwan Strait in accordance with international law, the United States upholds the navigational rights and freedoms of all nations.” In a separate statement, the Ministry of National Defense said that it monitored nearby waters and airspace as the aircraft
UNDER DISCUSSION: The combatant command would integrate fast attack boat and anti-ship missile groups to defend waters closest to the coastline, a source said The military could establish a new combatant command as early as 2026, which would be tasked with defending Taiwan’s territorial waters 24 nautical miles (44.4km) from the nation’s coastline, a source familiar with the matter said yesterday. The new command, which would fall under the Naval Command Headquarters, would be led by a vice admiral and integrate existing fast attack boat and anti-ship missile groups, along with the Naval Maritime Surveillance and Reconnaissance Command, said the source, who asked to remain anonymous. It could be launched by 2026, but details are being discussed and no final timetable has been announced, the source