Is Tamiflu Safe & Effective? Cochrane Review vs. Roche Pharma

So is Tamiflu safe and effective? The answer, it turns out, depends on whom you ask. It’s a resounding yes, if you ask its manufacturer, Swiss drug maker Roche Holding. It’s a conditional yes, if you ask the world’s health regulators. And for The Cochrane Collaboration, considered by health experts to be the ‘gold standard’ of medical evidence, the answer is, no — until proven otherwise.

Almost a decade after Tamiflu first hit world markets—and after many governments spent billions of tax dollars to stockpile the drug against pandemic flu—new findings from Cochrane says it’s still not clear whether Tamiflu prevents infections or reduces complications.

In short, Tamiflu does not do what its maker says it’s prescribed to do and the evidence to back up Roche’s claims about drug’s efficacy is severely incomplete.

That’s the conclusion Cochrane reached, after poring over more than 16,000 pages of clinical trial data and documents used by regulators to approve the anti-influenza drug. The researchers published their conclusions on Jan. 18 in the Cochrane Library, an international publication that scrutinizes health information.

Does not lessen complications, hospitalizations
Cochrane’s independent meta-analysis of both published and unpublished data showed that Tamiflu did reduce the time it took for flu symptoms to lift—slashing this to 21 hours from the typical six or seven days.

But Tamiflu it did not reduce the number of people who went on to need hospital treatment, Cochrane said. Neither did it lessen complications, such as pneumonia.

Tamiflu (oseltamivir) is used mainly to shorten the duration of the flu, lessening the chance that an infected person will be able to pass the infection to others—and limiting the spread of the virus in a community.

But it’s also been aggressively marketed by its maker as effective for reducing complications, lessening the number of hospitalizations and reducing transmission of the virus.

These claims, made by clinical trials paid for by Roche, were often cited by health regulators as reasons for using it in a pandemic.

Following a recommendation of the World Health Organization in 2002, governments worldwide spent billions of dollars stockpiling antivirals such as Tamiflu and Relenza (zanamivir) to be used as a first line of defense in the event of a pandemic.

Over the past decade, around 90 million people have taken Tamiflu—and in many of these countries, the drug was given prophylactically during flu season, or as a drug given to people who did not have the flu to prevent them from catching it.

The United Kingdom’s National Health Service only stopped doing that in 2009 when studies showed that more than half of British children given Tamiflu suffered side effects like nausea, insomnia, nightmares and even adverse psychiatric events.

Since 2005, United States federal and state governments have spent more than US$1.5 billion to stockpile Tamiflu and another antiflu drug, Relenza.

Following the bird flu scare in 2005, the UK even spent hundreds of millions of pounds to stockpile the drug for use in a future pandemic. According to the NHS, it spent £245,000 on some 16,000 Tamiflu prescriptions in 2010 alone.

The drug was in such high demand that U.S. pharmacies were running out of it in April 2009, during the swine flu outbreak. Pharmacies in New York reported runs on Tamiflu, and the drug generated 3.2 billion Swiss francs (US$3.37 billion) in sales in 2009, according to Bloomberg Business.

But Professor Sir Iain Chalmers, a founder of the Cochrane Collaboration, told The Bureau of Investigative Journalism that the group’s meta-analysis “found no evidence that it stops complications (from the illness),”