Tamiflu has been at the center of debate for years. Tamiflu which is FDA approved for treatment of the swine and seasonal flu comes with some strong and relevant questions in regards to its efficacy and safety. Up until a short time ago, most of the clinical studies were not shared with the public, practitioners and academia.
Over the past few years, billions of dollars’ worth of Tamiflu has been purchased by governments to be stockpiled in the case of a flu epidemic. This has all become subject to what is known as open data campaigns, where full transparency was being demanded on the results of the clinical studies to assess efficacy and safety. The goal is to achieve appropriate and necessary independent scrutiny of data from clinical trials.
Some of this data has been released which we will discuss as it provides further question to the need, benefit and risk of this drug. But even while data was being suppressed, agencies continued to recommend Tamiflu without full data being researched and vetted due to the fact that the majority of the drugs maker (Roche) Phase III treatment trials remain unpublished over a decade after completion.
The World Health Organization (WHO) recommends Tamiflu, but has not vetted the Tamiflu data.
The European Medicines Agency (EMA) approved Tamiflu, but did not review the full Tamiflu dataset.
CDC and ECDC encourage the use and stockpiling of Tamiflu, but did not vet the Tamiflu data.
In addition to the questions raised in the reasons for stockpiling Tamiflu even when complete data is absent, leaving many to wonder the financial interests involved, Tamiflu is not side-effect free.
The most common side-effects listed on the Tamiflu packaging are nausea, vomiting and stomachache, although Roche revised the Tamiflu patient information warning that it can cause hallucinations, delirium or abnormal behavior, which sometimes ‘results in fatal outcomes’.
Back in 2008, the FDA started reviewing reports of abnormal behavior and disturbing brain effects in more than 1,800 children who had taken Tamiflu. The symptoms included convulsions, delirium and delusions.
In Japan, five deaths were reported in children under 16 as a result of such neurological or psychiatric problems. Seven adult deaths have also been attributed to Tamiflu, due to its neuropsychiatric effect.
According to a 2009 study, more than half of children taking Tamiflu experience side effects such as nausea and nightmares.
As you can see, for a drug that is recommended and prescribed so easily, and even stockpiled to be handed out in the masses, one has to ask, why is the drug company who makes it not releasing the bulk of the research studies? And yes, the drug can come with some major side-effects, especially in light of the fact that there are other options in treating and preventing the flu.
Thus like anything, the prescribing should come down to a benefit vs risk scenario. As you can see, the risks are there…and the long awaited data and documents have left even greater question on the benefits and need of this drug.
After a multiple year effort to research these regulatory documents, researchers were finally able to assess all 160,000 + pages of them.
What they found was that the evidence does not support claims that this drug lowers the risk of complications from the flu (such as pneumonia) or that the benefits outweigh the risks.
There is also no evidence to support claims that this drug helps to reduce viral transmission.
The results of assessing this data revealed:
- Tamiflu shortens the duration of flu symptoms by less than a day(specifically, by just 16.8 hours)
- Tamiflu did not affect the number of hospitalizations.
- The effects of Tamiflu on pneumonia and other flu complications were unreliably reported and included limitations in diagnostic criteria, problems with missing follow-up on participants
According to the researchers:
“Based on our assessments of the regulatory documents (in excess of 160,000 pages), we came to the conclusion that there were substantial problems with the design, conduct, reporting and availability of information from many of the trials… We identified problems in the design of many of the studies that we included, which affects our confidence in their results.”