Researchers who have fought for years to get full data on Roche’s influenza medicine Tamiflu said yesterday that governments who stockpile it are wasting billions of dollars on a drug whose effectiveness is in doubt.
The row has drawn in the drugmaker as well as industry regulators and independent scientists. Supporters of Tamiflu said the researchers’ conclusions were flawed and insisted the drug is both safe and effective.
The dispute over the benefits of Tamiflu, and to a lesser extent of GlaxoSmithKline’s Relenza, blew up with the joint publication by the respected Cochrane Review research network and the British Medical Journal of an analysis of trial data, which found no evidence behind claims the drugs cut hospital admissions or reduce complications.
The review’s main findings were that the medicines had few if any beneficial effects, but did have adverse side effects that were previously dismissed or overlooked, but Roche, which has been under fire for several years over its refusal to allow the Cochrane team unrestricted access to Tamiflu data, rejected the findings, saying it “fundamentally disagrees with the overall conclusions” of their study.
“We firmly stand by the quality and integrity of our data, reflected in decisions reached by 100 regulators across the world and subsequent real-world evidence demonstrating that Tamiflu is an effective medicine in the treatment and prevention of influenza,” the company said in a statement.
Tamiflu sales hit almost US$3 billion in 2009 — mostly due to its use in the H1N1 flu pandemic — but they have since declined.
The drug, one of a class of medicines known as neuraminidase inhibitors, is approved by regulators worldwide and is stockpiled in preparation for a potential global flu outbreak. It is also on the WHO’s “essential medicines” list.
The US has spent more than US$1.3 billion buying a strategic reserve of antivirals including Tamiflu, while the British government has spent almost ￡424 million (US$703 million) on a stockpile of about 40 million Tamiflu doses.
Heneghan’s team say their analysis is the first based on full data — from 20 trials of Tamiflu, known generically as oseltamivir, and 26 trials of Relenza, also known as zanamivir.
At a briefing in London to present their findings, Heneghan said the money spent on stockpiles “has been thrown down the drain” because until now, the full data had not been seen by regulators, governments, doctors or patients.
“The original evidence presented to government agencies around the world was incomplete and when they [the Cochrane review team] eventually received the full information on these drugs, the complete evidence gives a very much less positive picture,” said Fiona Godlee, editor of the British Medical Journal, which has spearheaded a four-year long campaign to force Roche to reveal all its Tamiflu data.
The Cochrane review found that compared with a placebo, or dummy pill, Tamiflu led to a quicker alleviation of flu-like symptoms of about half a day (down from seven days to six-and-a-half days) in adults, but the effect in children was more uncertain.
There was no evidence of a reduction in hospitalizations or in serious flu complications such as confirmed pneumonia, bronchitis, sinusitis or ear infections in either adults or children, the team said.
Tamiflu also increased the risk of nausea and vomiting in adults by about 4 percent and in children by 5 percent, they said, and there was a reported increased risk of psychiatric events — described as mood changes — of about 1 percent when Tamiflu was used as a preventative drug in uninfected people.
Godlee described the battle with Roche as a “really lengthy cat and mouse, Alice in Wonderland, bizarre experience of trying to get data on a drug which governments around the world were busy buying, stockpiling and spending billions of dollars on.”
ROCKY RELATIONS: The figures on residents come as Chinese tourist numbers drop following Beijing’s warnings to avoid traveling to Japan The number of Chinese residents in Japan has continued to rise, even as ties between the two countries have become increasingly fractious, data released on Friday showed. As of the end of December last year, the number of Chinese residents had increased by 6.5 percent from the previous year to 930,428. Chinese people accounted for 22.6 percent of all foreign residents in Japan, making them by far the largest group, Japanese Ministry of Justice data showed. Beijing has criticized Tokyo in increasingly strident terms since Japanese Prime Minister Sanae Takaichi last year suggested that a military conflict around Taiwan could
Japan is to downgrade its description of ties with China from “one of its most important” in an annual diplomatic report, according to a draft reviewed by Reuters, as relations with Beijing worsen. This year’s Diplomatic Bluebook, which Japanese Prime Minister Sanae Takaichi’s government is expected to approve next month, would instead describe China as an important neighbor and the relationship as “strategic” and “mutually beneficial.” The draft cites a series of confrontations with Beijing over the past year, including export controls on rare earths, radar lock-ons targeting Japanese military aircraft and increased pressure around Taiwan. The shift in tone underscores a deterioration
A retired US colonel behind a privately financed rocket launch site in the Dominican Republic sees the project as a response to China’s dominance of the space race in Latin America. Florida-based Launch on Demand is slated to begin building a US$600 million facility in a remote region near the border with Haiti late this year. The project is designed to meet surging demand for the heavy-lift rockets needed to put clusters of satellites into orbit. It is also an answer to China’s growing presence in the region, said CEO Burton Catledge, a former commander of the US Air Force’s 45th Operations
Germany is considering Australia’s Ghost Bat robot fighter as it looks to select a combat drone to modernize its air force, German Minister of Defense Boris Pistorius said yesterday. Germany has said it wants to field hundreds of uncrewed fighter jets by 2029, and would make a decision soon as it considers a range of German, European and US projects developing so-called “collaborative combat aircraft.” Australia has said it will integrate the Ghost Bat, jointly developed by Boeing Australia and the Royal Australian Air Force, into its military after a successful weapons test last year. After inspecting the Ghost Bat in Queensland yesterday,
RSS