It’s well-known information: the flu sucks. Fever, chills, muscle aches, congestion, fatigue, the list goes on – and none of the symptoms are fun at all. With the CDC, once again, recognizing this year’s flu-shot as not very effective, people continue to boost their immune systems in the hopes that this nasty virus will pass them by this winter. But, what happens when that sore throat, shortness of breath, and stomach upset do hit you? Some people feel so awful that they rush to the doctor looking for some kind of relief only to, most likely, walk out with a prescription for Tamiflu(oseltamivir). And, while they’re just hoping to feel better and get back to their lives, many unsuspecting people unfortunately get more than they bargained for. Today, we will be examining the safety of allowing the virus to run its course vs. interfering with Tamiflu.
What is Tamiflu?
In 1999, Roche’s Tamiflu received FDA approval for the treatment of influenza type A&B after safety testing on approximately 1,300 adults with suspected influenza determined it to be “reasonable for the intended indication and population” in the reduction of symptoms by 1 day. While both influenza type A and B remain the most common culprits for the seasonal flu epidemics, during the trial approval only about 3% of those who were influenza-positive suffered from type B. The approval evaluation recognized that “…once an individual contracts infection and develops influenza symptoms, the role of an antiviral remains limited.” One of the main reasons that influenza remains difficult to treat is because it is a self-limited illness: meaning that it typically resolves spontaneously and without specific treatment. Dr. Heidi Jolson, at the end of the evaluation, notes that, clinically, the “treatment benefit is a highly subjective question. Because influenza symptoms are self-limited in a majority of individuals, it is anticipated that many persons with influenza will neither require, nor desire treatment with antiviral medications.” Despite its approval though, the FDA did conclude that the drug “has not been proven to have a positive impact on the potential consequences (such as hospitalizations, mortality, or economic impact) of seasonal, avian, or pandemic influenza.”
One interesting fact to note about the drug is that all clinical studies and randomized trials that exist were funded and sponsored by Roche, the manufacturer of the product. The BMJ, one of the world’s oldest general medical journals, identified 83 trials on Tamiflu use in adults and children, and less than half adequately reported random sequence generation or adequate blinding of participants/staff. It was determined that these studies carried a “high risk of bias”, presented unresolved discrepancy and contained design errors. While this involvement could have no relation to the outcome of the studies, Roche has had a questionable history. In 2012, The European Medicines Agency launched an investigation into Roche for failure to comply with obligations regarding “detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.” The BMJ, in a campaign to achieve necessary independent scrutiny of data from clinical trials, curiously noted that despite the fact that they have never vetted the Tamiflu data, the WHO, ECDC, and CDC recommend and encourage the use of Tamiflu. This is also despite the fact that the majority of Roche’s Phase III (human trials in large numbers) trials remain unpublished years after completion. In fact, in 2009, Roche publicly promised access to “full study reports” for select independent scientists, but has yet to make even one report available.
Does it Work?
Honestly, the answer to that question seems to depend on your person definition of work. 20 studies on the drug have found it to shorten the duration of influenza-like symptoms by less than a day. As noted by the FDA during the approval process, Tamiflu studies continue to show that the drug does not affect one’s risk of needing hospitalization, nor has it been able to reliably report reduction of other complications, like pneumonia, bronchitis, ear infections, or sinusitis.
As with any medication, Tamiflu comes with the risk of potential side effects. The most commonly reported were nausea, vomiting, headache, bronchitis, insomnia, and vertigo which sound, oddly, like the flu. When it comes to the viral shedding and spreading of the flu, studies have determined that Tamiflu does not reduce the length of time one is contagious, or the likelihood that they will pass it on to household members. On their website, Roche recommends the use of Tamiflu even as a preventative for those who have been exposed to the flu, yet the evidence to support this suggestion is, to say the least, lacking. Four studies on the use of Tamiflu as a preventative exist, two of these trials show efficacy rates of 58% and 84%. Only one of these trials was ever deemed adequate by the usual Cochrane Collaboration, as the others were at risk of bias and did not properly describe their methods. In attempts to deal with the shortcomings of the study, Roche Pharmaceuticals failed to provide original data, or any information at all.
Fiona Godlee, editor-in-chief of The BMJ, reminds consumers and taxpayers that approximately 60% of patient data from Roche’s Phase 3 treatment trials remain unpublished and that, at this point, there is a high chance of “overstating of effectiveness and the apparent under-reporting of potentially serious adverse effects.”
Serious Adverse Effects
Because Tamiflu has been prescribed much more extensively in Japan than in the United States or Europe, reports of psychiatric side effects are much more likely to come out of Japan. While the cause of these types of side effects is not well understood at all, some theories suggest that Tamiflu has the ability to cross the blood-brain barrier into the central nervous system. A study on mice found high concentrations of oseltamivir carboxylate, a substance created when the body processes Tamiflu, in the plasma and brains of young mice indicating that children are most at risk of developing adverse reactions to the drug. One interesting case on the psychiatric side effects of Tamiflu can be seen in the study of an, otherwise healthy, 22-year-old male who began reporting mood swings, suicidal impulses, auditory hallucinations, memory deterioration, and insomnia which were brought on suddenly and randomly 5-days after beginning Tamiflu. Upon the patient’s admission into the hospital, his mood was severely unstable, and he reported auditory hallucinations of a phone conversation between a man and woman. He was also unable to sleep more than 2-3 hours in a 24-hour period and, due to memory deterioration, forgot what he had done even hours prior. The patient was admitted under the suspicion of bipolar disorder and delirium and treated with antipsychotic medication. By day 3 of admission, mood and behavior seemed normal and symptoms such as suicidal thoughts, hallucinations, and memory deterioration had improved. Given his rapid improvement, medication was ceased. By day 8 of observation, the patient “revealed no specific psychiatric symptoms” and was discharged with the diagnosis ‘mental and behavioral disorder due to the use of other psychoactive substances.’ At his 10-month follow up, it was noted that the patient had returned to his normal life and suffered no psychiatric symptoms.
It’s not the only story like it. In fact, in 2006 the FDA issued a Neuropsychiatric Events warning stating that “People with the flu, particularly children, may be at an increased risk of self-injury and confusion shortly after taking Tamiflu and should be closely monitored for signs of unusual behavior.” As recent as 2011, in an FDA Pediatric Postmarket Adverse Event Review, it was determined that “the results do not go so far as to show that there is a significant, positive correlation between the use of oseltamivir and abnormal behavior [but that they] do not directly indicate that there is no relationship between the use of oseltamivir and abnormal behavior.”
Tamiflu’s scrutiny really flared in 2005, when 12 Japanese children died after taking Tamiflu. Two years later, in 2007, Japan made the decision to ban the use of Tamiflu in pediatric populations, a decision that is still upheld today. Cases of adverse psychiatric effects associated with this drug continue to be reported, yet its use just continues to be increased. A panel study of about 10,000 flu patients conducted by the Health and Labor Welfare Ministry found that teens who took Tamiflu were at a 1.54 higher risk of abnormal behavior including sudden running or jumping.
In fact, at least half of the children who take Tamiflu will suffer some sort of adverse reaction, most commonly nausea, nightmares, and difficulty concentrating.
It is imperative to weigh the risk of these potential dangers against the benefit of possibly reducing the symptoms by up to a day. While the flu is unquestionably uncomfortable, a magical “cure-all” pill isn’t worth further suffering.
What Should You do Instead?
Incredible natural remedies against the flu have been used long before the release of synthetic anti-virals, like Tamiflu. Elderberry has been scientifically documented for years to shorten the duration of the flu, and help relieve symptoms. Randomized studies which compared the use of 15ml elderberry vs. a placebo found elderberry syrup to reduce the length of the flu by 4 days. The reason for this is because Sambucol, or black elderberry extracts, contains natural antiviral properties which are particularly effective against different strains of the influenza virus. If you’re on the hunt for a quality, organically-made elderberry syrup, you can find some in our store.
Ingesting high levels of Vitamin C naturally increases the body’s production of white blood cells. One study compared individuals with cold and flu symptoms who were consuming high doses (1000 mg) of Vitamin C with a control group who were treating with pain relievers and decongestants. By the end of the study, it was determined that the Vitamin C alone was responsible for reducing the test group’s symptoms by about 85%.
The incredible benefits that come along with ingestion of oregano oil are barely being explored in the Western world today. But the studies are showing some promising results. Carvacrol, the active component in oil of oregano, has shown impressive results as an antiviral within just 1 hour of exposure. Carvacrol’s antiviral properties have even been put to the test, and exceeded expectations, in treating drug-resistant viruses like herpes.
The flu leaves you exhausted, in pain, and just feeling downright awful. At the time, it could be extremely alluring to simply pop a pill that promises to make you feel better. But, it’s important to stop and remember that getting sick is part of life. It happens and, in the majority of cases, aiding your body in doing its job (to fight) by supplementing, staying hydrated, and resting are the best things you can do. When you’re sick, you can’t wait to get over it, but at what cost is it worth it?
Until next time,