(Excerpts from Shannon Brownlee and Jeanne Lenzer in ATLANTIC MAGAZINE
“The Truth About Tamiflu”, December 2009)
From the British Medical Journal came the call for European countries to sue Roche, the maker of Tamiflu! They claim that Tamiflu is not only worthless but imply that the manufacturer had data showing that. This implies an intentional plot to bilk billions out of governments for profit.
Not only does that defraud people but people may have died, as a result, form reactions and a misleading impression that they were protected from the flu! Will we see action? Probably not since many politicians receive bribes (I mean campaign contributions) from pushing flu shots. It is a very big business “protecting the public”.
According to BMJ, the antiviral drug Tamiflu isn’t as effective or safe as many patients, doctors, and governments think. The drug has been widely prescribed since the first cases of H1N1 flu surfaced last spring. The U.S. government, alone, has spent more than $1.5 billion stockpiling it since 2005 as part of the nation’s pandemic preparedness plan. Now it looks as if the nation may have put more than a billion dollars into the medical equivalent of a mirage.
The British medical journal BMJ published a multi-part investigation that confirms that the scientific evidence just isn’t there to show that Tamiflu prevents serious complications, hospitalization, or death in people that have the flu. The BMJ goes further to suggest that Roche, the Swiss company that manufactures and markets Tamiflu, may have misled governments and physicians. In its defense, Roche stated that the company “has never concealed (or had the intention to conceal) any pertinent data.”
The BMJ’s investigation began innocently enough, with an update of a review by the Cochrane Collaboration, a widely-respected international consortium of researchers. Roche claimed that its drug reduces hospital admissions by 61% in patients who were otherwise healthy before they got the flu. It has also said that Tamiflu reduces such complications as bronchitis, pneumonia, and sinusitis by 67%, and lowers respiratory tract infections requiring antibiotics by 55%. This was based largely on ten studies, all of them funded by the company (no bias there).
The Fox in the Henhouse
However, when the Cochrane team re-examined the studies it turned out that only two of the ten studies had ever been published in medical journals – and those two showed the drug had very little effect on complications compared to a dummy pill, or placebo. So the Cochrane reviewers decided to look at the data for themselves.
First they went to the lead authors of the published studies. One author said he had lost track of the data when he moved offices and the files appeared to have been discarded. The other said he’d never actually seen the data himself, and directed the Cochrane team to go directly to the company.
Four months and multiple requests later, the Cochrane researchers had a hodgepodge of data from the company, including two studies that showed the drug was ineffective, but which the company had never published. Roche also provided data from a third study, which involved 1,447 people. Yet the company never published that one either.
In the meantime, two former employees a large communications company came forward with documents showing they had ghostwritten some of the published studies of Tamiflu. One of the ghostwriters told the BMJ,
“The Tamiflu accounts had a list of key messages that you had to get in. It was run by the [Roche] marketing department and you were answerable to them. In the introduction . . . I had to say what a big problem influenza is. I’d also have to come to the conclusion that Tamiflu was the answer.”
The Cochrane team eventually concluded that if the drug does offer any benefit, it is slight indeed. This is also the conclusion of the FDA and the UK’s National Institute. An FDA spokesperson told the BMJ, “The clinical trials . . . failed to demonstrate any significant difference in rates of hospitalization, complications, or mortality in patients receiving either Tamiflu or placebo.” Yet the FDA gave temporary approval for the drug to be given to hospitalized flu patients, who are at risk of dying (protecting us for votes).
Dangerous as Well as Ineffective
Another big unknown is just how dangerous Tamiflu may be. According to an FDA spokesperson, side effects may include potentially fatal heart problems. It seems reasonable to ask whether or not I’ts potentially deadly side effects are outweighed by potential benefits.
All of which leaves open the question of why governments around the world have invested so much in a drug that appears to do so little. The answer may lie in the politics of disease. In the wake of criticism over its handling of the disaster in New Orleans, the Bush Administration announced a multi-billion-dollar pandemic and bioterrorism preparedness strategy, which included stockpiling millions of doses of Tamiflu.
As the nation’s lead public health agency, the Centers for Disease Control and Prevention appears to be operating in some alternative universe, where valid science no longer matters to public policy. What’s more, neither the CDC nor the FDA has demanded the types of scientific studies that could definitively determine whether or not the company’s claims are true. Nancy Cox, who heads the CDC’s flu program, said she opposes a placebo-controlled study (in which one half of patients would be given Tamiflu and the other half would be given placebo), because the drug’s benefits are already proven????
There are a couple of take-home messages here. One is pretty obvious: Tamiflu may not be doing much good for patients with the flu who take it, and it might be causing harm. The more important issue, however, involves the need for trust in science and medicine. Governments, public health agencies, and international bodies such as the World Health Organization, have all based their decisions to recommend and stockpile Tamiflu on studies that had seemed independent. In fact, they had been funded by the company and were authored almost entirely by Roche employees or paid academic consultants. Millions of flu patients have taken the drug as a result.
That trust appears to have been misplaced, and a drug touted as beneficial on the basis of flimsy evidence has by now become so entrenched that no one appears willing to conduct the sort of study needed to prove whether or not it can, in fact, save lives.
Jefferson T, Jones M, Doshi P, Del Mar C. Neuraminidase inhibitors for preventing and treating influenza in healthy adults: systematic review and meta-analysis. BMJ2009;339:b5106.
Doshi P. Neuraminidase inhibitors—the story behind the Cochrane review. BMJ2009;339:b5164.
Cohen D. Complications: tracking down the data on oseltamivir. BMJ2009;339:b5387.
Smith J, on behalf of Roche. Point-by-point response from Rocheto BMJ questions. BMJ2009;339:b5374.
Turner D, Wailoo A, Nicholson K, Cooper N, Sutton A, Abrams K. Systematic review and economic decision modelling for the prevention and treatment of influenza A and B. Health Technol Assess2003;7:iii-iv, xi-xiii, 1-170. www.hta.ac.uk/execsumm/summ735.htm.
Burch J, Paulden M, Conti S, Stock C, Corbett M, Welton NJ, et al. Antiviral drugs for the treatment of influenza: a systematic review and economic evaluation. Health Technol Assess2009;13:1-265, iii-iv.
Cohen, D. Rosiglitazone: what went wrong? BMJ2010;341:c4848.
Godlee F. NICE at 10. BMJ2009;338:b344.
Eyding D, et al. Reboxetine for acute treatment of major depression: systematic review and meta-analysis of published and unpublished placebo and selective serotonin reuptake inhibitor controlled trials. BMJ2010;341:c4737.