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Flu drugs may not be worth stockpiling
April 10th, 2014
02:23 PM ET

Flu drugs may not be worth stockpiling

Tamiflu, commonly used to reduce flu symptoms, may not work as well as the federal government believed when it spent more than $1.3 billion stockpiling it.

The Cochrane Collaboration, a nonprofit network of health practitioners, researchers and patient advocates, recently analyzed 46 clinical study reports on Tamiflu and another influenza drug called Relenza to determine their effectiveness.

The researchers concluded that while both drugs can stop adults' symptoms about half a day earlier, on average, than no treatment, the drugs do not reduce the rate of serious influenza complications, such as hospitalizations and pneumonia. The results were published this week in the British Medical Journal.

"A significant number of doctors see them as pretty mediocre drugs that don't do a whole bunch," said Dr. Peter Doshi, an assistant professor at the University of Maryland School of Pharmacy and associate editor at BMJ.

This isn't news to the FDA, which determined in 1991 that Tamiflu does not reduce influenza-related complications. In fact, the FDA label on Tamiflu packaging says so. It does however, directly oppose one of the Center for Disease Control and Prevention's justifications for stockpiling the drug: that it can reduce complications of the flu.

Additional findings

The Cochrane Collaboration found no significant difference in the time it took for Relenza to alleviate symptoms between adults and children.

However, it does appear children and adults react differently to Tamiflu. The drug decreases the length of influenza symptoms by 29 hours, on average, in children without asthma. For children with asthma, Tamiflu does not decrease the length of symptoms at all. While the potential benefits of Tamiflu are more potent in children, Doshi said there are also more potential harms.

When treated with Tamiflu for influenza, 13% of children experienced vomiting, compared to only 8% of children with influenza and no medication. In adults, Tamiflu increased the rate of vomiting by about 4%. The analysis found no side effects in either adults or children who took Relenza.

"It's a move from the perception that the drugs are risk-free and to the reality that the drugs have some risks," Doshi said of the analysis.

As for the rate of hospitalizations, there simply isn't enough evidence to suggest that they were reduced by the influenza drugs. Doshi said this may be because for most people, the flu isn't catastrophic. With Tamiflu or Relenza or a placebo, so few influenza patients were hospitalized that there wasn't sufficient evidence to determine if the drugs had an impact.

The article also addresses the preventative use of Tamiflu and Relenza. While research shows that both Tamiflu and Relenza do decrease the rate of symptomatic influenza, neither seem to decrease the rate of asymptomatic influenza, meaning people taking the drugs could still be spreading the virus.

This contradicts the belief that preventative treatment with Tamiflu or Relenza could help slow the spread of the virus in a community, which is one reason the government began stockpiling Tamiflu.

Discussion

Dr. William Schaffner, a professor of preventive medicine and infectious diseases at Vanderbilt University Medical Center, wishes there was better data on influenza drugs' effectiveness, but says this new article won't influence common practice.

"Everyone is in agreement that Tamiflu reduces the duration of influenza illness and clearly that's a good thing," Schaffner said.  "The area of  uncertainty is how strong are the data supporting the notion that Tamiflu also reduces the complications of influenza, namely the development of pneumonia,  hospitalizations, intensive care unit admission and death."

Schaffner says patients admitted to hospitals with influenza should be treated with Tamiflu or Relenza.

"Should this review change our practices on a clinical level?  I think not really. I think that if anything we ought to be more aggressive with the use of Tamilfu when patients are admitted because these are already very serious influenza infections.”

Dr. Glenn Wortmann, section chief of infectious diseases at MedStar Washington Hospital Center, agrees.

"For hospitalized patients or patients in the ICU, we would continue to give the drugs because we don't have alternative treatments," Wortmann said.  "I think we've always known that they've not been the most powerful drugs. As far as 10 years ago we knew that they only shortened symptoms by about a day for most patients."

Some background

Clinical study reports are long, in-depth explanations of studies, often ranging from 1,000 to 8,000 pages of material. This is in contrast with medical journal articles, which are typically about 10 pages long. Looking at the full text of the clinical study reports ensures that all data is taken into account.

"We were looking to get around the problem of reporting bias that can creep into published literature, which occurs when not all studies are produced in the publication," Doshi said.

Traditionally, clinical study reports are industry secrets, and other than regulators, no one outside the company sees them. The Cochrane Colaboration was given access to the reports by Roche and GlaxoSmithKline, the manufacturers of Tamiflu and Relenza respectively, and was able to determine that the reported decrease in pneumonia - one of the most common influenza complications - was based on self-reporting by trial participants, not on actual medical diagnoses.

The FDA would have had access to these reports, which could explain how it came to a similar conclusion as The Cochrane Collaboration. The CDC, which suggests the drugs can decrease rates of such complications, would likely not have seen the reports.

The federal government bought a significant amount of the drug - enough for about 25% of the population - during the avian and swine flu scares. It hoped to be able to stop the spread of influenza during an epidemic, but there isn't much evidence that it would have worked, Doshi said.

Roche, Tamiflu's maker, says they stand by the data supporting the efficacy and safety of the drug. According to a statement on their website:

"Tamiflu has been reviewed and approved by regulatory authorities in over 80 countries, it is recommended as a flu antiviral by public health bodies, including the World Health Organization (WHO) and over 95 million patients have received our drug since it was first made available. We cannot undervalue the role of these authorities in approving and monitoring this or any medicine’s use."

Takeaway

Tamiflu does prevent some flu symptoms, but it's worth discussing with your doctor before you take it.

Doshi said this research shows the proven benefits of these drugs are "less than believed and assumed by governments" and that "there are harms as well as benefits."

 


soundoff (36 Responses)
  1. Manic Zorbian

    I would never use Tamiflu again. The flu I had 3 years ago might have killed me might have killed me. Tamiflu almost sealed the deal.

    April 10, 2014 at 15:35 | Report abuse | Reply
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      April 14, 2014 at 00:10 | Report abuse |
  2. truth tellers

    honestly, tamiflu has been over-prescribed by doctors!!! patients who have "colds" and not the "flu" are prescribed tamiflu. it's such a waste especially within the elderly!!

    April 10, 2014 at 15:44 | Report abuse | Reply
  3. Darlene Buckingham

    People are fighting for vaccines, drugs, like tamiflu, MRI's,eX-ray, mammograms, colonscopies while forgetting the basics of good health – clean water,fresh, air, nutritious food, exercise, sunshine and relaxation. These are the basic building blocks of health that are being lost and what we should be fighting for. As our water, air and food become filled with toxic chemicals and there is no time to relax we waste our precious time demanding more pills, vaccines and medical tests when we should be putting our attention on cleaning up our environment and stop supporting the big corporations that are poisoning our planet Earth.

    April 10, 2014 at 16:13 | Report abuse | Reply
    • Whatnow

      Yes! This is most important step we can take to be healthy and provide a healthy life for the future. There is nothing wrong with medical research, but we need to stop pretending that there will always be a prescription for everything, including destruction of the very things in life that improve our immune system and health in general.

      April 10, 2014 at 16:35 | Report abuse |
    • Hector Orozco

      I totally agree with you. Our priority should be to get a healthier environment for us and the rest of the living creatures in this planet.

      April 10, 2014 at 22:01 | Report abuse |
    • Katie

      Totally agree. People need to take more personal responsibility for their own lifestyles and hygiene, they need to stop such heavy reliance on pharmaceuticals (and people need to know that most of the time getting sick is one way of getting stronger in the long run – the way a body naturally responds most illnesses should be allowed to run its course) and they need to understand that a healthy environment means a healthy population.

      April 11, 2014 at 06:21 | Report abuse |
    • VladT

      While I will meet you halfway in that people need to live better and healthier, it is foolish to believe that with all that we would not need modern medicine. For instance, a lot of healthy people (say, around 20 million worldwide) died in 1918 due to the flu.

      Also, if the healthiest people in the world went to Africa right now, I doubt the Ebola virus would much care whether you were vegan or not

      April 11, 2014 at 08:16 | Report abuse |
    • Eeyore

      Darlene, VladT is right. People love to pretend that no one would ever get the flu, or measles, or polio, if they just had enough clean air/water, exercise, sleep, organic food, and blah, blah, blah. It's not true. Vaccines are the most effective way to prevent disease. While death rates from diseases like polio dropped as medical care and access to clean water improved, the incidence of the disease did NOT drop significantly until the advent of vaccines.

      April 12, 2014 at 09:24 | Report abuse |
    • Eeyore

      Whatnow, having an illness like the flu does nothing to "improve" or "strengthen" anyone's immune system. Having the flu one year doesn't mean you'll be immune to it the next year anymore than having a cold this month means you'll be immune to a cold for the rest of the year.

      April 12, 2014 at 09:27 | Report abuse |
  4. debbie

    I had H1N1 a few years back, and Tamiflu absolutely helped. The last time I had influenza I was sick 8 days, 2 days later after feeling better I developed a secondary infection. When I took Tamiflu i was feeling normal in about 5 days Much better than when I had it and was much younger. The thing is you have to start it quickly after the onset of flu or it doesn't work as well

    April 10, 2014 at 18:21 | Report abuse | Reply
    • Chris

      I'm glad for your recovery, but was it because of the Tamiflu, or was it because you did something subtle and different, or were you just slightly healthier than when you were a kid.
      I only ask, because I was a soccer coach and my entire family (2 adults and 4 young children) were directly exposed to 3 children who were diagnosed with H1N1 and recovered. My family and I never have had a flu shot to help prevent it either before or after, nor did we take any medications to try and prevent it. Simple basic things like we all took a shower the same night that we had contact with the children that were infected and made sure to get enough sleep. I don't believe that we "lucked out", I believe it was because of the basic principles of taking care of ourselves properly that helped.
      And yes, there were a few other families from the same teams that ended up getting the H1N1 from them even though the children that were diagnosed with H1N1 all had received 2-3 different flu shots during the period of time just prior to getting it.

      April 10, 2014 at 19:57 | Report abuse |
    • Jonathan

      No Chris...your family lucked out...plain and simple...a shower most certainly did not keep the Flu away...you just got lucky.

      April 10, 2014 at 23:38 | Report abuse |
    • Katie

      It was probably both – a little luck, and adherence to a healthy lifestyle. Tamiflu, in most cases, works as well as a placebo because people sincerely believe they need a pill to help them get over something.

      April 11, 2014 at 06:24 | Report abuse |
  5. mikefats77

    Who is this "Doshi" character? Seriously, he's being quoted throughout the article, but not identified.

    April 10, 2014 at 18:21 | Report abuse | Reply
    • Zane

      "A significant number of doctors see them as pretty mediocre drugs that don't do a whole bunch," said Dr. Peter Doshi, an assistant professor at the University of Maryland School of Pharmacy and associate editor at BMJ.

      April 10, 2014 at 21:21 | Report abuse |
  6. frankmaui73

    Yeah, another study. Every day the results of a new study going public. I guess there has to be with all this money going into research. This study uses the words "may not"...nothing definitive such as "will not"...so what good is this study if it can' t be definitive?

    Study: Coffee may be bad for your heart.
    Two weeks later: Coffee may help prevent heart desease.

    Nobody knows nothing about anything! Unless somebody is being given money then they "may" know something.

    April 10, 2014 at 18:49 | Report abuse | Reply
  7. jim johnson

    Every year my doctor and I have the same conversation:
    Doc: I recommend a flu shot.
    Me: No, they are useless
    After 8 years he no longer argues the point.
    BTW I have never had the flu and have no intention of ever catching it...

    April 10, 2014 at 20:35 | Report abuse | Reply
    • Mark McMorris

      Well, you certainly didn't quiet him with your superior intellect.

      April 10, 2014 at 21:13 | Report abuse |
    • Jonathan

      ...and someday the conversation will go like this...
      Doc: You have the flu, your rapid test was positive for Flu A
      You: I'm dying here doc, the body aches are killing me, the fever is relentless and this cough doesn't let up
      Doc: well your luck finally ran out unfortunately i can only help treat your symptoms...
      You: cant you give me some abx or something?
      Doc: There is no magic pill...its a virus so abx wont work and since you generally avoid coming here you came on the fourth day since symptom onset so i cant Rx you Tamiflu since your out of the treatment initiation window...sorry. You can expect to be sick for 7 to 10 days...but you probably wont feel back up to 100% for about 3 weeks.
      You: oy vey...
      Karma: LOL!

      April 10, 2014 at 23:55 | Report abuse |
    • VladT

      I have had cream cheese on all my bagels the past 8 years also without getting the flu.

      Using your logic, cream cheese kills the flu virus and/or will aid in flu prevention

      April 11, 2014 at 08:18 | Report abuse |
  8. Jonathan

    ...and someday the conversation will go like this...
    Doc: You have the flu, your rapid test was positive for Flu A
    You: I'm dying here doc, the body aches are killing me, the fever is relentless and this cough doesn't let up
    Doc: well your luck finally ran out unfortunately i can only help treat your symptoms...
    You: cant you give me some abx or something?
    Doc: There is no magic pill...its a virus so abx wont work and since you generally avoid coming here you came on the fourth day since symptom onset so i cant Rx you Tamiflu since your out of the treatment initiation window...sorry. You can expect to be sick for 7 to 10 days...but you probably wont feel back up to 100% for about 3 weeks.
    You: oy vey...
    Karma: LOL!

    April 10, 2014 at 23:54 | Report abuse | Reply
    • Katie

      And someday the conversation will go like this:
      Doc: you have the flu
      You: Really? I never had it before.
      Doc: you should have gotten the flu shot
      You: yeah well, I didn't.
      Doc: here, take some antibiotics in case you get pneumonia and some Tamiflu to help lessen the symptoms and here's some cough syrup and don't forget tylenol to knock down the fever and control the aches and pains so you can continue with your life
      You: No thanks, now that I know what I have, I'm going to go home and go to bed and let it run its course. Work can get along without me and I shouldn't be in public anyway, exposing other people.
      Doc: What did you come to me for in the first place?
      You: I've been wondering that myself.
      Karma: Doc gets the flu and ends up in the hospital and you recover without incident in ten days and never get the flu again...

      April 11, 2014 at 06:29 | Report abuse |
    • VladT

      (5 days after letting it run its course)
      Katie: "Where did that secondary pneunmonia come from?" I am so (cough) healthy (cough)."
      Doc: "I told you....."
      Katie: "Don't say flu shot. Jenny McCarthy says they are bad, and she would know....she was on MTV. They don't give jobs like that to just anybody."
      (Doctor walks away laughing, but also shaking head in disgust)

      (Katie loses 3 weeks of work's pay, sues doctor for malpractice, goes to local news channel saying doctor lied about the flu, sells book, and ends up cohost of the View)

      April 11, 2014 at 08:22 | Report abuse |
  9. KieranH

    Man, I lived my whole life without flu shots and all this garbage. When did the flu become ebola?

    April 11, 2014 at 07:38 | Report abuse | Reply
    • VladT

      The Flu can kill, and you have a chance at preventing it.

      April 11, 2014 at 08:22 | Report abuse |
    • Eeyore

      So I guess you can afford to miss a week of work with it, then, Kieran?

      What, are you unemployed?

      Do you care that you can infect others who actually DO have a life simply because you are too stupid to get the vaccine? That some of those who get sick because of you may have compromised immune systems because of their age or a medical condition?

      April 12, 2014 at 09:29 | Report abuse |
  10. mandrzejewsk

    Keep going VladT. Love it!

    BTW, check out: http://www.ted.com/talks/ben_goldacre_battling_bad_science

    CNN medical needs to become a bit more contemporary

    April 11, 2014 at 09:10 | Report abuse | Reply
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    April 11, 2014 at 11:20 | Report abuse | Reply
    • VladT

      Yay....some l0ser had to make it political.

      What's worse, this person actually put "thought" into this, and believed it to be funny. Stick to your day job (if you possess one)

      April 11, 2014 at 23:47 | Report abuse |
  12. Reuben

    Ah, Peter Doshi, non epidemiologist, and quite probably an HIV-AIDS denialist. Why the media keeps going to him for sound bites about epidemiological and public health concepts is beyond me.

    https://thepoxesblog.wordpress.com/2013/07/25/non-epidemiologist-tries-to-do-epidemiology-feeds-anti-vaccine-activists/

    April 14, 2014 at 18:10 | Report abuse | Reply
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