The Trouble with Tamiflu

With the constant appeal of “get a flu shot” echoing throughout the news media, and with so many Americans reeling with the flu, you begin to wonder what you’ll do if you fall victim.

One thing you might consider, but probably should reconsider, according to Dr. Harlan M. Krumholz writing on Forbes.com, is Tamiflu.

Krumholz, professor of Medicine and Epidemiology and Public Health at Yale University School of Medicine, says we don’t know enough about the effectiveness and safety of Tamiflu, and Roche, its manufacturer, isn’t telling.

Flu can make you miserable, with fever, chills body and headaches, a host of respiratory issues and the general sense that you must’ve gotten hit by a truck, except where’s the truck? Unlike a bad cold, flu generally comes on fast and hard; and colds aren’t associated with the extreme body and joint aches you get with flu.

For some people, flu can be life-threatening, especially the very young, very old, people with immune or pulmonary (lung) problems, cardiovascular disease, diabetes, the obese and people younger than 19 who are on long-term aspirin therapy. But even if you’re healthy as a horse (and why they’re healthier than people we have no idea), you really don’t want to get the flu. And if you do, you want to minimize its symptoms and shorten its course.

That’s what Tamiflu, an antiviral agent, promises to do. And a lot of custodians of public health, apparently, believe its promoters-the U.S. reportedly stockpiled $15 billion of Tamiflu not so long ago before a vaccine for H1N1 was developed and fears of an outbreak were widespread.

Tamiflu, whose generic name is oseltamivir, is prescribed for people older than 1 if they’ve have had symptoms for a couple days, to prevent flu if they’ve been with someone who has the flu or sometimes when there’s an outbreak. It’s supposed to stop the spread of the flu virus in the body and shorten the time you have symptoms.

Because Tamiflu battles a virus, it won’t do anything if you have a bacterial infection, which can be a complication of the flu.

But, says Krumholz, Roche won’t divulge all the relevant data it has about its drug. Cochrane, an organization that reviews scientific evidence and analyzes it to assess the value of medical interventions, recently updated its Tamiflu file. Here, says Krumholz, are five things you should know about that examination.

1. The manufacturer of the drug sponsored all the trials. That calls into question the objectivity of the results-if you want to sell something, you have an interest in making sure the drug trials show what you want them to. And, says Krumholz, “reviewers found evidence of publication and reporting biases.” There were no controlled trials conducted by independent sources.

As Krumholz notes, industry trials can be well conducted, but lack of independence has been known to influence study design and what results are released, meaning they probably are designed to have the best chance of showing benefit and the results that are released are probably selective. One of the Cochrane study authors found that 60 percent of the randomized data from Tamiflu trials on people with flulike illness symptoms have never been published, including the biggest trial ever conducted.

You have to wonder: What are they hiding?

2. The studies did not show that Tamiflu reduced the risk of being hospitalized. One reason people might take an antiviral is to prevent the illness progressing to the point where they would need this level of care. There was no evidence that the drug produced that benefit.

3. The studies were inadequate to determine the effect of Tamiflu on complications. Other than hospitalization, people may think Tamiflu would prevent other complications, such as bacterial infections, but the reviewers found that the way the drug trials were designed and reported were too limited to make any conclusions about effects of the drug on complications. “To expect that Tamiflu can reduce complications would be a leap of faith currently unsupported by the available evidence,” Krumholz writes.

Also, the FDA requires Roche to print on the label: “Tamiflu has not been shown to prevent such complications [as serious bacterial infections].”

4. The studies were inadequate to show if Tamiflu could reduce the chances of a sick person transmitting the virus to someone else. One of the Cochrane study authors said, simply, that Roche did not design the trials to answer the question of transmission. The trials, and the FDA’s approval of Tamiflu, were based on the drug’s ability to reduce the chances of “symptomatic influenza.” Because no one knows anything about asymptomatic influenza infections, no one can say if Tamiflu reduces transmission of the virus.

5. The use of Tamiflu did reduce the duration of flu symptoms-by about one day. Several studies showed this, but the duration of symptoms varied a lot among all the different studies the reviewers examined. So if some subjects had symptoms that lasted three days and some subjects had symptoms that lasted two weeks, a day might be meaningful the first group and barely noticeable by the second.

The Cochrane reviewers asked Roche for full clinical study reports so that they could make a more conclusive report about Tamiflu. Roche declined to cooperate. “People face decisions every day about this drug,” Krumholz writes, “and more than ever this season, so it would seem reasonable that the company would share all that they know about the drug.”

According to the National Institutes of Health, some of the lesser side effects of Tamiflu/oseltamivir include:

  • nausea
  • vomiting
  • stomach pain
  • diarrhea
  • headache

These side effects are serious; if you experience any, call your doctor immediately:

  • rash, hives, or blisters on the skin
  • itching
  • swelling of the face or tongue
  • difficulty breathing or swallowing
  • hoarseness
  • changes in behavior

You should also report any adverse side effects to the FDA’s MedWatch program. Call (800) 332-1088, or report online at www.fda.gov/Safety/MedWatch.

Is Tamiflu worth taking? Why is Roche unwilling to share information? Should doctors keep prescribing medicine when “potentially vital” information is being withheld? All questions Krumholz asks, and so should the rest of us.

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