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  • A High Cost of Ineffectiveness – Tamiflu

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    Tamiflu (oscltamivir phosphate) is used to treat flu symptoms caused by influenza virus in patients who have had symptoms for less than 2 days. Tamiflu may also be given to prevent influenza in people who may be exposed but do not yet have symptoms. Tamiflu will not treat the common cold. It is an antiviral medication. Common side effects include nausea and vomiting.

    by Catherine J. Frompovich

    Recently, information began surfacing again about the antiviral drug Tamiflu® that has to get healthcare consumers questioning its effectiveness, if not the advertising spin used to promote its intended sales market and branding.

    As a result of the Cochrane Collaboration and British Medical Journal (BMJ) review published early in April 2014, there is “…no good evidence that the drugs prevented the spread of the virus between people, or any of its serious consequences, such as infections. It found Tamiflu increased the risk of psychiatric disturbances, renal problems, nausea, vomiting and headaches.”

    Two antiviral drugs were reviewed after four years of trying to get the full records of more than 24,000 research participants from 20 trials of Tamiflu® made by Roche and 26 Relenza® (made by GlaxoSmithKline) trials.

    According to The Boston Globe,

    They found that compared with a placebo, Tamiflu shortened the duration of flu symptoms by a little less than a day on average – from 7 to 6.3 days – but led to more side effects. These included nausea and vomiting and, in those who took the drugs for weeks to prevent the flu, headaches, kidney problems, and psychiatric conditions such as depression or confusion, according to the findings published Wednesday in the British Medical Journal. Relenza, which is inhaled, had a similar effect on shortening symptoms, with no increased risk of side effects.

    Dr. Fiona Godlee, editor-in-chief of the BMJ who worked with the Cochrane group to procure full release of the manufacturers’ trial data, had this to say:

    This is a situation where the effectiveness of the drugs have been overplayed and the harms underplayed.

    However, Dr. Godlee, if we want to be objective about Big Pharma products, these two antiviral drugs’ effectiveness overplayed and harms underplayed is not an anomaly. It happens all the time, and especially with vaccine trials, I contend. What went on with approving the HPV (human papillomavirus) vaccines needs not only a review but an investigation, I contend. Will you and the Cochrane Collaboration please obtain the research and trial data for both Gardasil® and Cervarix® and see what you come up with? The results, I predict, could be shocking.

    The unfortunate part about those two antiviral drugs reviewed is that governments worldwide bought Big Pharma propaganda, ‘science’, advertising, and branding information “hook, line, and sinker”—that is, they went all out to stockpile them to the tune of billions of dollars. For example: “The US spent $1.3 billion on its stockpile of antivirals, while Britain spent £424 million on Tamiflu alone.” “…Australia had spent on Tamiflu and Relenza, but the current value of the stockpile, which includes those drugs as well as other products, was $192 million.”

    USA Today, April 10th edition online, has this to say:

    “Peter Doshi, an assistant professor of pharmaceutical health services research at the University of Maryland School of Pharmacy and a co-author of the Cochrane review, says the team focused on the 20 trials because it was more interested in the more rigorous randomized, placebo-controlled research. “Many of these 77 trials did not meet that criteria,” he says.

    “I'm not interested in health scares,” Doshi adds. “What we've found here are statistically significant increases. Do I know absolutely for certain, without a shadow of a doubt, that Tamiflu is responsible for these (negative effects), based on the trial methodology? No. But what I'm seeing here are clear reasons to be concerned and to look into it further.”

    Another of the reviewers, Chris Del Mar, Professor of Public Health at Bond University, Australia, had this to say:

    What we did that’s unusual in this review is we didn’t just rely on published data, we realised that this could be biased… that the less good data were being withheld in some way.

    Furthermore, in his paper “The Tamiflu Saga Shows Why All Research Data Should Be Public,” Professor Del Mar makes some important remarks regarding pharmaceuticals, the review process, and that often it’s “a war of words with lots of public relations.” Below are some of Del Mar’s sentiments.

    • Roche performed trials and the results were used to get approval from different regulatory authorities for it to be used routinely. The agencies include the US FDA (Federal Drug Administration), Europe’s EMA (European Medicines Authority), and Australia’s TGA (Therapeutic Drug Administration).
    • The FDA approved Tamiflu for shortening the illness, but not for preventing complications. “Complications” means secondary (bacterial) infections, such as pneumonia. The EMA and TGA approved it for both indications.
    • The approval process is secret, ostensibly for “commercial interests”, although what these are at this stage of the drug’s development (testing how effective the drug is) remains unclear. Still, we often don’t know outside the closed doors what issues are raised in the clinical study reports.

    Probably the most remarkable statement Professor Del Mar made in his paper is this:

    The whole rigmarole has two implications.

    First, we still remain in some doubt about the effectiveness of Tamiflu for preventing influenza complications. This matters because it was the prime reason the world armed itself with warehouses of Tamiflu under the threat of pandemic influenza in 2009.

    Roche sold literally billions of dollars worth of Tamiflu for this singular reason. But has the world been sold a pup? Until the trials are openly released for scrutiny, it’s impossible for us, the world, the purchasers of this drug, to know.

    Second, the implications are far beyond just Tamiflu. Until recently, the world had adopted the randomised controlled trial as the benchmark test for treatments. But there are clearly some problems with this.

    One of these problems is the partial release of trial data (effected [sic] by selective publishing) that will help the sales of a commercial drug or device.

    We are concerned that this might have happened in this instance, even though the drug company in question had declared (several times, including originally in 2009) that it will provide all the data we need.

    Professor Del Mar contends the above scientific sinfulness can be corrected by mandating that all clinical trials be registered. There’s a campaign to do just that; it’s called Alltrials http://www.alltrials.net/.

    What this writer would like to point out in view of the above information, is that selective publishing and other ‘tricks’ are employed to get pharmaceuticals approved, especially vaccines which are ‘sacred cows’ no one seems to want to investigate.

    The recommended oral dose of Tamiflu for treatment of influenza in adults and adolescents 13 years and older is 75 mg twice daily for 5 days. Pediatric dose is determined by the child's weight. Tamiflu is not indicated for treatment in pediatric patients less than 1 year of age. Treatment should begin within 2 days of onset of symptoms of influenza. There may be other drugs that can interact with Tamiflu. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. During pregnancy, Tamiflu should be used only when prescribed. This medication passes into breast milk. Consult your doctor before breast-feeding.

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    Staff Writer

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