Experts Question Effectiveness of Tamiflu

(CBS/AP)  An updated review of data about the effectiveness of Tamiflu, the antiviral drug most commonly used against influenza, says there is no clear evidence that it prevents complications like pneumonia in otherwise healthy adults.

According to an article published by the British Medical Journal (part of a joint investigation by BMJ and Britain's Channel 4 News), the study acknowledges that oseltamivir and other neuraminidase inhibitors have a modest effect in reducing flu symptoms and infectivity in otherwise healthy adults by about one day.

But researchers said there is insufficient published data to know if oseltamivir reduces complications in otherwise healthy adults.

The new study updates a 2006 review published in The Cochrane Library.

Twenty published trials focusing on prevention, treatment and adverse reactions were analyzed by researchers led by Professor Chris Del Mar from Bond University in Australia.

Because of a "paucity of good data" from trial authors and Roche, the drug's manufacturer, and the inability to independently verify results of eight key trials which were never fully published (but which were included in the 2006 review) the researchers concluded they have no confidence in claims that oseltamivir reduces the risk of complications of influenza in otherwise healthy adults.

They said they do not believe it should be used in routine control of seasonal influenza.

They also called on governments to set up studies monitoring the safety of neuraminidase inhibitors.

After reviewing observational studies provided by Roche to the Cochrane review's authors, Professor Nick Freemantle and Dr. Melanie Calvert of the University of Birmingham wrote that "oseltamivir may reduce the risk of pneumonia in otherwise healthy people who contract flu. However, the absolute benefit is small, and side effects and safety should also be considered."

They said interpretation of data was difficult in part because "It seems likely that some patients were included in more than one study, which undermines the ability of these studies to provide independent estimates."

Freemantle said he sees "very little evidence to support the widespread use of oseltamivir in the otherwise healthy population who are developing signs of influenza-like illness."

The use of neuraminidase inhibitors (especially oseltamivir) has increased dramatically since the H1N1 pandemic began in April 2009. With no effective vaccine against the flu available or because of resistance to other drugs' effectiveness, neuraminidase inhibitors were seen as an answer.

Governments have stockpiled Tamiflu as part of pandemic preparedness plans, in part because of claims that the drug prevents complications.

BMJ's editor in chief, Dr. Fiona Godlee, wrote that the updated review means important questions about the drug's effectiveness are 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 in a statement.

But the World Health Organization disagreed. They said data from countries around the world show that when given early, Tamiflu can reduce the severity of swine flu symptoms, though the agency recommends the drug be saved for people at risk of complications, like pregnant women, the elderly, children, and those with underlying medical problems.

"This will not change our (Tamiflu) guidelines," said Charles Penn, a WHO antivirals expert.

Penn said that while past studies show Tamiflu only has a modest benefit, when patients with severe illness or at risk of complications are treated early, there are fewer hospitalizations and deaths.

Both the British researchers and WHO said there is little evidence to support the widespread use of Tamiflu in otherwise healthy people - precisely the policy Britain has adopted to fight swine flu.

In addition to recommending Tamiflu be saved for at-risk groups, WHO recommends Tamiflu only be used on a doctor's recommendation.

In Britain, however, Tamiflu is regularly dispensed to healthy people who catch the flu. The drug is given out via a national swine flu hotline by call center workers with no medical training.

The Switzerland-based Roche recently announced revenues from the sales of this drug were $2.5 billion this year.

In an editorial in the BMJ, Dr. Fiona Godlee and Professor Mike Clarke, Director of the U.K. Cochrane Centre, say the updated review is important because it calls into question "not only the effectiveness of oseltamivir but the whole system by which drugs are evaluated, regulated and promoted."

They call for new global legislation to ensure that "once a trial is completed, there needs to be ready access to the raw data behind any analyses used to license and market a drug.

"When vast quantities of public money, and large amounts of public trust, are placed in drugs, the full data must be accessible for scrutiny by the scientific community," they write. "Pending full disclosure and independent review of the raw data from Roche, the risks and benefits of oseltamivir remain uncertain."

In response, Roche said that they "firmly believe in the robustness of the data," and say that full access to data has been granted to Governments and regulatory authorities.

As a result of the BMJ/Channel 4 investigation, Roche announced it will make all study summaries of oseltamivir (including key data) available on a password-protected Web site.


For more info:
British Medical Journal
Channel 4 News
U.K. Conchrane Centre
World Health Organization
tamiflu.com
Tamiflu Product Details (Roche)

[puzzler125]

From articles which said it was impossible to tell seasonal flu from H1N1 flu to articles which said that it was "assumed" if you had the flu it was H1N1 flu I doubt any information that lists statistics regarding flu this season.

[rwsmith29456]

If I have the flu, I'll accept a 'modest improvement in symptoms' as long as the drug isn't doing more harm than good.

[tmittelstaed]

"...but to see a sickly child go from 104 degree temp and hard to lift his head up, to smiling and happy, sounds good to me..."

Uh, mdbill-2009, I've seen my 7 year old daughter go from normal temp, to a sickly child with a 104 degree temp, back to normal temp, smiling and happy, in the space of 24 hours, with NO medical care whatsoever, other than bed rest, water, warm baths, and monitoring of her temp. Did she have H1N1? I have no idea. But, from what I hear, H1N1 has been the only thing going around this year, and my wife knows she was exposed to someone with it.

Please don't assume we are all idiots. The article isn't "sensational journalism" All it is saying is that there's a lack of proof that it works. In fact, the researchers are NOT putting forth any evidence that it DOESEN'T work. And the fact that there's a lack of definitive research on such a widely used drug is shocking. Far from being a criticism of Tamiflu, the article is criticizing the lack of decent research on the drug.

This article is a perfect example of what is wrong with the medical community, in my view. A new drug comes out and a few doctors use it, see what they think are great results, then the whole community runs pell-mell into using the drug, long before any real science has looked at the drug. Then 2-3 years later the real scientists finally complete their research on it, and half of the time they find out the new drug either doesen't work at all, or they find out that it works no better than any other drugs. But by then you have doctors convinced the new (usually much more expensive drug) is better than anything, they continue prescribing it, and Big Pharma rings up the cash register with another financial success.

I've had cancer before and was on Cisplatin. I was given Zofran, one of Galaxo's "ching-ching the cash register" drugs, at the time still under patent. (generics are available now) Pills were $50 PER PILL. Yes, it worked as advertised. So would have Cannabis, if my oncologist had bothered to tell me, and $50 would have bought me enough of THAT to last my -entire- 4 regimens.

[mollydtt]

The media makes such a big deal about every man, woman and child *needing* to take Tamiflu if they *think* they might have the flu.
Even to the point where if their physician advises against it, they go to another doctor.

[stn_sage]

WHAT?! It's been openly tested on the public for years now...and they don't have any results compiled yet?!

Folks! The pharma companies are the poorest excuse and example of scientists that we have in this culture today...excepting the global warming crowd who fake their data.

This is inexcusable when by all rights they should have to prove efficacy BEFORE they "dump" their concoctions on the market and public!

The company heads and politicians...at some point...are going to have to be held responsible for their criminal actions!

[novamba]

But if the government says it is good for you, then it has to be, doesn't it?

[mdbill-2009]

as a pediatrician having recently weathered many 100s of sick children with h1n1, i can assure you all that tamiflu does work, and works very well. one must start it w/i first 24-48 hrs, but if started soon enough it will ameliorate all symptoms very quickly. don't know how well it works in preventing frequent comorbid conditions like pneumonia, but to see a sickly child go from 104 degree temp and hard to lift his head up, to smiling and happy, sounds good to me. i have absolutely no stock or anything to gain by this, just don't want more sensational journalism to keep you folks from doing what's best for your children (in my opinion).

[ibsteve2u]

Now, hold on. Roche - Big Pharma, Big Whoever - isn't officially our government.

Yet.