by Shannon Brownlee and Jeanne Lenzer
December 10, 2009
from TheAtlantic Website
Two months ago, we pointed out in our story on flu in The Atlantic that the antiviral drug Tamiflu might not be 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, and the U.S.
government has spent more than $1.5 billion stockpiling it since
2005 as part of the nation’s pandemic preparedness plan.
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,
The BMJ’s investigation began innocently enough, with an update of a review by the Cochrane Collaboration, a widely-respected international consortium of researchers who periodically examine the medical literature to assess the safety and effectiveness of various treatments.
Roche has 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 lower respiratory tract infections requiring antibiotics by 55%.
A 2006 Cochrane review of Tamiflu came
to similar conclusions - based largely on a paper that looked at ten
studies, all of them funded by the company.
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.
Roche also provided data from a third study, which involved 1,447 adults and adolescents aged 13-80, the largest study of the drug ever conducted.
Yet the company never published that one
summary of this and other studies
is available at
www.roche-trials.com). But with
only partial data, the Cochrane team couldn’t even figure out what
the study had been intended to measure.
One of the ghostwriters told the BMJ,
As we reported in our story in The Atlantic, the FDA directed Roche to state on the drug’s label the following caveat:
An FDA spokesperson told the BMJ,
Yet in the wake of
the H1N1 pandemic,
the FDA gave temporary approval for the drug to be given to
hospitalized flu patients, who are at risk of dying.
According to an FDA spokesperson, side effects may include potentially fatal heart problems. If the drug is going to be used to prevent death, it seems reasonable to ask whether or not its potentially deadly side effects are outweighed by potential benefits.
We asked the FDA whether it had required
Roche to conduct an additional trial or trials looking at whether or
not, on balance, the drug reduces more serious complications than it
causes. This week, a spokesperson reported back that there has been
no such request made to Roche.
Far from a commercial
success when it was initially approved by the FDA in 1999, Tamiflu’s
fortunes began to look up in 2003, after the SARS outbreak and the
emergence of bird flu. Then Hurricane Katrina hit. In the wake of
criticism over its handling of the disaster in New Orleans, the
announced a multi-billion-dollar pandemic and bioterrorism
preparedness strategy, which included stockpiling millions of doses
The agency’s flu recommendations are in lockstep with Roche’s claims that the drug can be life-saving - despite the FDA’s findings and despite the lack of studies to prove such a claim. 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: that Tamiflu reduces the risk of serious complications and saves lives.
Nancy Cox, who heads the CDC’s flu
program, told us earlier this year 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
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, but had in fact been funded by the company and were authored almost entirely by Roche employees or paid academic consultants.
So did the Cochrane Collaboration,
at least in its earlier assessments of Tamiflu. Millions of flu
patients have taken the drug as a result.