Governments around the world have spent $9 billion stockpiling a flu drug that's probably no better than aspirin and possibly harmful.
So writes Julia Belluz at Maclean's magazine in Canada. The story was prompted by a study and a new release from the Cochrane Collaboration, a non-profit research group that produces broad reviews of the evidence for and against such things as drugs, medical procedures, and healthcare policies.
In a new review, Cochrane reports that "Tamiflu (the antiviral drug oseltamivir) shortens symptoms of influenza by half a day, but there is no good evidence to support claims that it reduces admissions to hospital or complications of influenza." It reports that the U.S. has spent more than $1.3 billion buying antiviral drugs in case of an epidemic, and the UK has spent "almost £424 million for a stockpile of about 40 million doses."
The scandal is not that the drug doesn't work, but that its makers withheld data that could have shown this years ago, writes Ben Goldacre in The Guardian. The British government bought the drug "in the hope that it would help prevent serious side-effects from flu infection. But the bigger scandal is that Roche [Tamiflu's maker] broke no law by withholding vital information on how well its drug works. In fact, the methods and results of clinical trials on the drugs we use today are still routinely and legally being withheld from doctors, researchers and patients," he writes.
In 2008, Goldacre writes, Cochrane had "found some evidence that Tamiflu does, indeed, reduce the rate of complications of pneumonia." But it soon became clear that the positive result relied primarily on data from "an industry-funded summary of 10 previous trials," only two of which had been published in the scientific literature.
Cochrane wrote Roche to get the data. "Here the problems began," Goldacre writes. Roche said it would hand over some information, but only if the Cochrane researchers signed a confidentiality agreement, and the researchers were not allowed to discuss the terms of the agreement or even acknowledge that it existed. Cochrane asked for clarification and received no reply, Goldacre reports.
He tells the twisting tale of how Roche continued to keep the information secret until last year, when it finally conceded and turned over the data. That led to the conclusion that the drug does not do what governments thought it did when they bought billions of dollars' worth of it.
As Goldacre points out, this is bad, but what's worse is that it was legal, and it still is. Other companies can do the same.
Oddly, Maggie Fox at NBC News found several flu experts who still believe the drug can help in a pandemic, so perhaps we haven't heard the last word on Tamiflu.
But that doesn't address Goldacre's complaint–that drug companies can legally conceal unfavorable data.
This is an issue that could be costing us billions of dollars in expenditures for ineffective drugs. There is no way to know how many billions unless drug companies are required to make all of their findings public.
In the meantime, we'll have to rely on enterprising reporters such as Goldacre to dig up information on suspect pharmaceuticals.
"Drug approval and use cannot be based on biased or missing information any longer," wrote the authors of the review, which was published in the medical journal BMJ. "We urge people not to trust in published trials alone or on comment from conflicted health decision makers, but to view the information for themselves."
Reporters should be urged to do the same.
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