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Drugs for flu treatment and preventions fail

Leaving out 60% of people in a phase III trial of oseltamivir is strong indirect proof of bias.  From published trials and documents used in the process of licensing of oseltamivir, they found that “the drug did reduce the time to first alleviation of symptoms by an average of 21 hours, it did not reduce the number of people who went on to need hospital treatment.  In other words, billions were wasted on an ineffective drug.  


30 years ago when the first approved flu medication came on the market, I read an article pointing out the the benefits for such treatment was a reduction of duration of illness by one day.  Things haven't changed--jk.

Tamiflu (oseltavmivir) fails

Leaving out 60% of people in a phase III trial of oseltamivir is strong indirect proof of bias.  From published trials and documents used in the process of licensing of oseltamivir, they found that “the drug did reduce the time to first alleviation of symptoms by an average of 21 hours, it did not reduce the number of people who went on to need hospital treatment.  In other words, billions were wasted on an ineffective drug. 

http://www.cochrane.org/features/neuraminidase-inhibitors-preventing-and-treating-influenza-healthy-adults-and-children

Neuraminidase inhibitors for preventing and treating influenza in healthy adults and children

World Health Organization (WHO) recommendations dating from 2002 have encouraged governments around the world to spend billions of dollars stockpiling neuraminidase inhibitors such as oseltamivir (TamifluŽ) and zanamivir (RelenzaŽ) in anticipation of an influenza pandemic. Public health agencies worldwide suggested that these drugs would stop the spread of influenza and reduce the risk of developing serious complications from influenza such as pneumonia or hospitalisation.

Questions about the accuracy of these claims and the 
efficacy of both preparations prompted an international team of researchers, led by Dr Tom Jefferson, a Cochrane Review author and independent epidemiologist based in Rome, Italy, to examine newly available evidence and amalgamate two previously published Cochrane Reviews focusing on the efficacy of these interventions into one comprehensive, updated review, published in the January 2012 issue of the Cochrane Library.

In carrying out this research, the Cochrane team was reluctant to focus their efforts on published trial reports available in scientific journals, because while many trials have been conducted around the world, only a few have been published.

“We identified that a large number of studies, including data from 60% of the people who have been involved in randomised, placebo-controlled phase III treatment trials of oseltamivir, have never been published. This includes the biggest treatment trial ever undertaken on oseltamivir that on its own included just over 1,400 people of all ages,” noted Jefferson. "We are concerned that these data remain unavailable for scrutiny by the scientific community."

Following a public pledge by the manufacturer of oseltamivir, Roche, to make full study reports available to scientific investigators, the Cochrane team decided to focus instead on manufacturers’ clinical study reports (typically submitted to regulators) and regulators’ comments. They called reports and comments “regulatory information”. Availability of documents generated by national and regional regulatory bodies during licensing processes in the UK, USA, continental Europe and Japan, along with partial trial reports from the manufacturer of oseltamivir, Roche, and from the European regulator European Medicines Agency (EMA), enabled the researchers to verify information from the trials.

When the team compared published data with the more complete unpublished trial records, they found apparent inaccuracies in the published record of the trials. For example, while unpublished trial reports mentioned serious adverse events (some even classified as possibly related to oseltamivir), one of the two most cited publications makes no mention of such effects, and the other states “... there were no drug-related serious adverse events”.

Having pieced together information from more than 16,000 pages of clinical trial data and documents used in the process of licensing oseltamivir, the Cochrane team raises critical questions about how well the drug works, as well as about its reported safety profile. While the drug did reduce the time to first alleviation of symptoms by an average of 21 hours, it did not reduce the number of people who went on to need hospital treatment. Results from the reanalysis of data also raise questions about how the drug works as an influenza virus inhibitor.

The Cochrane Review authors conclude that there is an urgent need for independent research on both of these drugs. There is continuing uncertainty about their effects beyond the initial reduction in symptoms, mainly because full access to the data needed has still not been provided. “We believe that until more is known about the mode of action of neuraminidase inhibitors health professionals, patients and other decision makers need to reflect on the findings of this review before making any decision about the use of the drug,” concluded Jefferson.

The decision to base the review’s analysis solely on regulatory information, unprecedented in the history of Cochrane Reviews, marked the team’s concern, increasingly shared by the international community, about the quality and reliability of published sources of evidence. Research was funded by the UK National Institute for Health Research Health Technology Assessment (NIHR HTA) programme.

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Worstpill.org http://www.worstpills.org/member/drugprofile.cfm?m_id=311

As of February 4, 2006, 39 deaths had been associated with oseltamivir in Japan, 13 of which were of children aged 16 and under.5  Several of the deaths in children involved falls from high places.6  In 2008 the FDA and manufacturer Roche issued an advisory warning regarding neuropsychiatric events associated with the use of oseltamivir. Most of these reports were from Japan and included delirium and abnormal behavior leading to injury, and in some cases resulting in death.9

 

 

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