A few versions of the story:
1.From Natural News
Roche engages in science fraudRoche claims there are ten studies providing Tamiflu is both safe and effective. According to the company, Tamiflu has all sorts of benefits, including a 61% reduction in hospital admissions by people who catch the flu and then get put on Tamiflu.
The problem with these claims is that they aren't true. They were simply invented by Roche.
A groundbreaking article recently published in the British Medical Journal accuses Roche of misleading governments and physicians over the benefits of Tamiflu. Out of the ten studies cited by Roche, it turns out, only two were ever published in science journals. And where is the original data from those two studies? Lost.
The data has disappeared. Files were discarded. The researcher of one study says he never even saw the data. Roche took care of all that, he explains.
So the Cochrane Collaboration, tasked with reviewing the data behind Tamiflu, decided to investigate. After repeated requests to Roche for the original study data, they remained stonewalled. The only complete data set they received was from an unpublished study of 1,447 adults which showed that Tamiflu was no better than placebo. Data from the studies that claimed Tamiflu was effective was apparently lost forever.
As The Atlantic reports, that's when former employees of Adis International (essentially a Big Pharma P.R. company) shocked the medical world by announcing they had been hired to ghost-write the studies for Roche.
It gets even better: These researchers were told what to write by Roche!
As one of these ghostwriters told the British Medical Journal:
"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."
In other words, the Roche marketing department ran the science and told researchers what conclusions to draw from the clinical trials. Researchers hired to conduct the science were controlled by the marketing puppeteers. No matter what they found in the science, they had already been directed to reach to conclusion that "Tamiflu was the answer."
Now, I don't know about you, but where I come from, we call this "science fraud." And as numerous NaturalNews investigations have revealed, this appears to be the status quo in the pharmaceutical industry.
Virtually none of the "science" conducted by drug companies can be trusted at all because it really isn't science in the first place. It's just propaganda being dressed up to look like science.
Sadly, even the CDC has been fooled by this clinical trial con. As stated by author Shannon Brownlee in The Atlantic:
"...the Centers for Disease Control and Prevention appears to be operating in some alternative universe, where valid science no longer matters to public policy. 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 already proven."
Did you catch that last line? The CDC isn't interested in testing Tamiflu because "the drug's benefits are already proven." Except they aren't. But this is how the pharmaceutical industry operates:
Step 1) Fabricate evidence that your drug works.
Step 2) Use that fraudulent evidence to get your drug approved.
Step 3) Use fear to create consumer demand for your drug (and encourage governments to stockpile it).
Step 4) Avoid any actual scientific testing by claiming the drug has already been proven to work (and cite your original fraudulent studies to back you up).
This is the recipe the CDC is following right now with Tamiflu. It's a recipe of scientific stupidity and circular logic, of course, but that seems to be strangely common in the medical community these days.
Even the FDA says Tamiflu doesn't workThe FDA, remarkably, hasn't entirely given in to the Tamiflu hoax. They required Roche to print the following disclaimer on Tamiflu lables -- a disclaimer that openly admits the drug has never been proven to work:
"Tamiflu has not been proven to have a positive impact on the potential consequences (such as hospitalizations, mortality, or economic impact) of seasonal, avian, or pandemic influenza."
Even further, an FDA spokesperson told the British Medical Journal, "The clinical trials... failed to demonstrate any significant difference in rates of hospitalization, complications, or mortality in patients receiving either Tamiflu or placebo."
It's the same message over and over again, like a broken record: Tamiflu doesn't work. And the "science" that says Tamiflu does work was all apparently fabricated from the start.
2.The Truth About Tamiflu
by Shannon Brownlee and Jeanne Lenzer
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.
Now it looks as if our concerns were correct, and the nation may have put more than a billion dollars into the medical equivalent of a mirage. This week, 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 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.
The dog ate my homework
But when the Cochrane team, led by Chris Del Mar, from Bond University in Australia, re-examined the studies they had previously used in 2006, they found some discrepancies. 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—the researchers who were supposed to have access to all of the data. 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 adults and adolescents aged 13-80, the largest study of the drug ever conducted. Yet the company never published that one either. (A 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.
In the meantime, two former employees of Adis International, 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 the evidence that Tamiflu reduces complications, hospitalizations, or deaths is weak at best, and if the drug does offer any benefit, it is slight indeed. This is precisely the conclusion of the U.S. Food and Drug Administration (FDA), and the UK’s National Institute for Health and Clinical Excellence (NICE). As we reported in our story in The Atlantic, the FDA directed Roche to state on the drug’s label the following caveat: "Tamiflu has not been proven to have a positive impact on the potential consequences (such as hospitalizations, mortality, or economic impact) of seasonal, avian, or pandemic influenza." 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 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.
Another big unknown is just how safe—or dangerous—Tamiflu may be. 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.
All of which leaves open the question of why governments around the world have invested so much—on the order of $3 billion since the emergence of H1N1 last spring, according to investment bank, JP Morgan—in a drug that appears to do so little.
The answer may lie in the politics of disease. 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 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. 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 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, 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.
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.
is a senior research fellow at the New America Foundation and the author of Overtreated (2007). Jeanne Lenzer is an investigative journalist and a frequent contributor to the British medical journal BMJ.
3. LONDON (Reuters) - There is no clear evidence that Roche's widely used drug Tamiflu prevents complications such as pneumonia in people with flu, a group of medical experts said on Tuesday
Governments around the world have mobilized Tamiflu stockpiles to fight swine flu but an updated review of past clinical trial results found there was insufficient data to know if the medicine cut complications in otherwise healthy people.
Roche contested the finding and said it stood behind the robustness and integrity of previous data showing a benefit.
Sales of the antiviral drug, also known by the generic name oseltamivir, have soared since the start of the current H1N1 flu pandemic in April due to massive government orders.
That has provided a windfall for the Swiss drugmaker, which said in October it expected Tamiflu revenue to reach 2.7 billion Swiss francs ($2.65 billion) this year.
The latest analysis, which updates an earlier 2006 review, was published online by the British Medical Journal, whose editor-in-chief, Fiona Godlee, said it left important questions about Tamiflu's effectiveness unresolved.
"Governments around the world have spent billions of pounds on a drug that the scientific community now finds itself unable to judge," she said.
The BMJ report was also the subject of a Channel 4 News story on British television.
At issue is whether or not certain previously published trials on Tamiflu should be included or excluded when analyzing the drug's effectiveness.
For the latest review, a team led by Chris Del Mar from Bond University in Australia looked at 20 trials -- but they decided to drop eight that were included in the earlier review because they were unable to independently verify the results.
As a result they concluded that while Tamiflu reduced flu symptoms by about a day they had no confidence in previous claims that it cut the risk of flu complications.
David Reddy, Roche's pandemic taskforce leader, said the expert group was wrong to exclude the data from the eight studies.
He told reporters that Roche would have supplied full data on the contested studies if the investigators had signed confidentiality agreements, which were drawn up to protect patients.
"We fully stand behind the robustness of the data and the integrity of that data, particularly the efficacy and safety of Tamiflu, the conduct of our clinical studies and the publication process," Reddy said.
Tamiflu, which Roche manufactures under license from Gilead Sciences, has been commercially available for 10 years as a treatment for seasonal flu and used by around 68 million people worldwide.
The pill competes with another less widely used flu medicine from GlaxoSmithKline, called Relenza, which must be inhaled.
See also my previous post on the dangerous side-effects of Tamiflu in children: all in all, the situation is quite scandalous, I'd say; one more scandal among so many others!