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CDC's advice to take Tamiflu is compromised by financial conflicts of interest

Tamiflu
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The FDA has determined that the clinical trial data submitted to it for review does not support the claim that Tamiflu “saves lives” or even reduces hospitalizations, including for the elderly and others most at risk.

In his public messages about this year’s influenza outbreak, Dr. Tom Frieden, director of the Centers for Disease Control and Prevention (CDC), has repeatedly urged people to take an antiviral drug such as Tamiflu if they develop symptoms of the flu and their doctor prescribes it.

Taking an antiviral drug is the third piece of “action” advice in the CDC’s new “Take 3” campaign. The other two: get a flu vaccine and practice good “everyday” prevention, such as washing your hands frequently and avoiding close contact with sick people.

The CDC has “compelling evidence” that Tamiflu and other neuraminidase inhibitors work if used early enough in the course of the disease, Frieden has been telling reporters.

“Anti-viral flu medications are greatly underutilized,” he explained at a press conference. “But if you get the flu, and if you get medicines early, they could keep you out of the hospital; they could keep you from having to go into the intensive care unit; and they might even save your life.”  

FDA does not agree

But as Jeanne Lenzer, an independent reporter and associate editor at the medical journal BMJ points out in a recent article, there’s a big problem with Frieden’s advice: The Food and Drug Administration (FDA) has determined that the clinical trial data submitted to it for review does not support the claim that Tamiflu “saves lives” or even reduces hospitalizations, including for the elderly and others most at risk.

When Lenzer asked Frieden to explain this discrepancy, he told her in an email that the CDC’s own review of the scientific literature supports the “observation” that early treatment with drugs like Tamiflu can reduce the “risk of death among hospitalized patients with laboratory-confirmed influenza.” (Note: In his public messages, Frieden has been advocating that doctors prescribe the drug to non-hospitalized people, even when the flu is only a suspected, not a confirmed, diagnosis.)

Frieden also cited a recent meta-analysis of nine clinical trials (4,328 patients) involving Tamiflu. The study, published Jan. 30 in the Lancet, reported that adults with the flu who took Tamiflu were less likely to require hospitalization for lower respiratory tract complications.

That finding, however, directly contradicts the results of another meta-analysis published last year by the Cochrane Collaboration. It reviewed 46 studies (24,251 patients) involving either Tamiflu or another anti-viral flu drug, Relenza, and found that the drugs had limited effects on symptoms and did not reduce serious complications or hospitalizations.

Both studies found that the drugs have unpleasant side effects, most notably nausea and vomiting.

Conflicts of interest

The Cochrane Collaboration is well established as an independent, not-for-profit, global network of scientists. The group of researchers who conducted the Lancet study was described in a commentary that accompanied their study as also being “independent.” But is that true?

No. As Lenzer points out (in her BMJ article and in a later follow-up piece), all four coauthors of the Lancet meta-analysis have received speaker’s or consultancy fees, grants or contracts from either Roche, the company that makes and sells Tamiflu, or Gilead, the company that holds the patent to the drug.

And the conflicts of interest don’t end there. The listed funding source for the Lancet study — the Multiparty Group for Advice on Science (MUGAS) — received an unrestricted grant from Roche specifically to pay for the study.

It gets even murkier. MUGAS was co-founded by the managing director of a Belgium-based public relations firm, Semiotics, which receives 20 percent of its funding from Roche, according to Lenzer.

For the record: The authors of the Lancet study deny that Roche had any influence on their study’s design or its results.

CDC’s conflicts

Yet the web of financial conflicts is even more pervasive than that, for it extends right into the CDC itself, as Lenzer explains:

The CDC Foundation, created by Congress to “connect CDC to the private sector to advance public health,” provides funding to the CDC. The foundation confirmed to The BMJ that the CDC received a directed donation from Roche via the foundation for the [“Take 3”] campaign, stating, “Roche provided a grant of $198,000 to CDC Foundation [which] has an administrative fee of 13.5%, so $174,800 was provided to [the CDC to] support qualitative research into influenza prevention and treatment messaging.”

This is not the only money the CDC takes from the industry. Unbeknownst to many, the CDC receives substantial industry funding through the CDC Foundation. A spokesperson said that over the past three years the foundation has received an average of about $6.3 [million] from the industry a year, 21% of the foundation’s overall funding. Since 1995 the foundation has received funding from more than 150 corporate “partners,” including Gilead, which holds the patent on oseltamivir [Tamiflu], as well as Genentech and Roche, the drug’s manufacturers.

Neither the CDC nor the foundation provided data on how much funding Roche, Gilead, and Genentech have donated to the CDC in addition to that for the Take 3 campaign.

Broken trust

As Marcia Angell, former editor of the New England Journal of Medicine, told Lenzer: “The CDC has enormous credibility among physicians, in no small part because the agency is generally thought to be free of industry bias. Financial dealings with biopharmaceutical companies threaten that reputation.”

More to the point, they threaten the CDC’s reputation with the public — and at a time when we really need people to trust what our public-health officials are saying.

Lenzer’s BMJ article is, unfortunately, behind a paywall on the journal's website. But she’s also posted a follow-up piece on how the media has covered the CDC’s “Take 3” campaign, which contains some of the details in her original BMJ article, on the Minnesota-based Health News Review website. 

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Comments (2)

Big League Public Relations/Birdsnake Oil Sales Homerun

Stepping out of the Wayback Machine in 2003, a few months after after Shock-and-Awe Night in Iraq, we find the company losing money. What will they do?

We don't know, but we get back into the machine, move forward a couple years and step out again on Wednesday, November 2, 2005. Squinting into the Fog of the War on Terror and Evil Doers with Weapons of Mass Destruction we see our President standing at a podium beginning to speak to us about his plan to deal with another urgent aspect of Free World Defense that must be addressed:

"Bush unveils $7.1 billion plan to prepare for flu pandemic

"WASHINGTON (CNN) -- President Bush announced Tuesday that he would ask Congress for $7.1 billion in emergency funding to prepare the country for a possible flu pandemic.

"In a speech at the National Institutes of Health in Bethesda, Maryland, Bush said that THERE HAD NOT BEEN AN OUTBREAK IN THE UNITED STATES OR THE REST OF THE WORLD, but stressed that health officials must be ready...

"The plan also calls for spending $1 billion to stockpile antiviral drugs -- such as Tamiflu..."

http://www.cnn.com/2005/HEALTH/conditions/11/01/us.flu.plan/

Skipping four short months (and one coincidence?) forward to March 12, 2006, we learn:

"Donald Rumsfeld makes $5m killing on bird flu drug

"By Geoffrey Lean and Jonathan Owen | The Independent

"The US Defence Secretary has made more than $5m (£2.9m) in capital gains from selling shares in the biotechnology firm that discovered and developed Tamiflu, the drug BEING BOUGHT IN MASSIVE AMOUNTS BY GOVERNMENTS to treat a POSSIBLE human pandemic of the disease.

"More than 60 countries have so far ordered large stocks of the antiviral medication - the only oral medicine BELIEVED TO BE EFFECTIVE against the deadly H5N1 strain of the disease - to TRY TO PROTECT their people.

"The drug was developed by a Californian biotech company, Gilead Sciences. It is now made and sold by the giant chemical company Roche, which pays it a royalty on every tablet sold, currently about a fifth of its price.

"Mr Rumsfeld was on the board of Gilead from 1988 to 2001, and was its chairman from 1997. He then left to join the Bush administration, but retained a huge shareholding .

"The firm made a loss in 2003, the year before concern about bird flu started. Then revenues from Tamiflu almost quadrupled, to $44.6m, helping put the company well into the black. Sales almost quadrupled again, to $161.6m last year. During this time the share price trebled.

"Mr Rumsfeld sold some of his Gilead shares in 2004 reaping - according to the financial disclosure report he is required to make each year - capital gains of more than $5m. The report showed that he still had up to $25m-worth of shares at the end of 2004, and at least one analyst believes his stake has grown well beyond that figure, as the share price has soared."

http://www.independent.co.uk/news/world/americas/donald-rumsfeld-makes-5...

From the article above:

"...46 studies (24,251 patients) involving either Tamiflu or another anti-viral flu drug, Relenza, and found that the drugs had limited effects on symptoms and did not reduce serious complications or hospitalizations.

"Both studies found that the drugs have unpleasant side effects, most notably nausea and vomiting."

Didn't know the CDC had that private money coming in,...

...thanks much for the info. I had believed they were entirely publicly funded - how wrong !!

The financial investment by the pharmaceuticals industry in various kinds of persuasion across the whole spectrum of those who influence regulation, brand stature, public image and promotion, etc. is REALLY impressive.

Their strategy is so crafty, so comprehensive, their money so well-placed - and in the end, the cost so CHEAP !!! It's amazing what a well-targeted few million here and there can get you.