By Dr. Sherri Tenpenny, DO, AOBNMM, ABIHM
January 12, 2013: Over the last few weeks, news outlets have been trumpeting reports on the latest influenza epidemic. In addition to the barrage of messages advocating, “Get your flu shot”, there are four FDA-approved drugs that can be prescribed to treat influenza: amantadine, rimantadine, Relenza (zanamivir) and Tamiflu (oseltamivir). Of these, the most recognized and discussed is Tamiflu.
How Tamiflu Works:
The surface of influenza viruses have two proteins. One is called hemagglutinin (H), which plays a role in binding to the cell receptors of the host; the other is the enzyme neuraminidase (N), which plays an important role in spreading viruses to others. To enter the host’s cell, the (H) protein binds must attach to a molecule called sialic acid, which sits on the surface of mucous cells. This lock-and-key configuration opens the door of the cell, allowing the virus to enter and start the process of self-replication.
After new viruses are formed, they must be released to invade adjacent cells. On the way out, (H) receptors are coated with sialic acid. The “dirty” (H) receptors cannot bind to the sialic acid on the surface of the next mucous cell. The virus has a self-cleaning solution: The neuraminidase enzyme (N) scrubs the sialic acid off the (H) binding sites. The “clean” (H) receptors can then attach to the next cell. Without a functional (N) neuraminidase, the virus can’t infect other cells. This discovery lead to the development of drugs known as neuraminidase inhibitors, which block the action of the enzyme. While this class of drugs can inhibit the spread of influenza viruses, they have no effect on the long list of other viruses that are the most prevalent cause influenza-like illnesses.
Tamiflu Gets Approval
In January, 2000, Tamiflu (oseltamivir) became the first oral neuraminidase inhibitor to obtain FDA approval. The pill came to market based on the results of two double-blind trials involving a total of 1,358 patients (one trial was in the United States; the other involved patients from Canada, Europe, and Hong Kong.) Only 62% of patients in the trials culture-confirmed influenza viruses as part of their symptom complex, a serious study design flaw that was overlooked by the FDA.
The effectiveness of Tamiflu was assessed by self-administered “symptom scores”, used to document the reduction of influenza-associated symptoms after taking the drug. The “time to improvement” was calculated from the time they took the medication to the time when all flu-like symptoms, such as nasal congestion, sore throat, cough, aches, fatigue, headaches, and chills and sweats, had decreased to mild or none. Even though symptoms were relieved only 1.3 days sooner with Tamiflu than for placebo, the FDA approved the drug for use, claiming the study has demonstrated “robust results.”
Amazingly enough, the drug had been tested on only 849 people who had culture-confirmed influenza. In an FDA memorandum dated October 25, 1999, the Director of the Division of Antiviral Drug Products, Heidi M. Jolson, MD, MPH, defended approval of the drug by saying:
“The clinical relevance of the modest treatment benefit is a highly subjective question. It is my opinion that a one-day reduction in the duration of moderate-to-severe symptoms, including fever, is likely to be of clinical importance to many individuals. . . . Because influenza symptoms are self-limited in the majority of individuals, it is anticipated that many persons with influenza will neither require, nor desire treatment with antiviral medications.”
There have been a few studies suggesting that Tamiflu could be used to prevent the flu. The New England Journal of Medicine. published at trial involving 1,559 healthy, non-vaccinated adults who were randomized to receive 75 milligrams of Tamiflu or placebo, once or twice daily for six weeks during the peak of the influenza season. The incidence of the flu was only slightly less with Tamiflu (1.2 %) than with placebo (4.8 %), meaning, doing nothing to prevent the flu was just about as effective as taking a ten-day course of Tamiflu.
When Tamiflu was widely used during the 2005 Bird Flu scare, reports that the virus was developing resistance began to surface. Drug resistance means Tamiflu does not inhibit the “cleaning” (N) enzyme, and viruses can continue to spread. Scientists are concerned that Tamiflu-induced drug resistance could lead to the emergence of a “mutant”, a highly aggressive virus that could actually cause a truly deadly pandemic. The FDA published a report in 2004 stating:
“It appears that mutant viruses may be shed at high titers [i.e., in large amounts] by some subjects before being cleared. Therefore, this reviewer has not been reassured that these viruses are harmless to the general population” (Emphasis added.) Instead of alleviating symptoms by a meager one to two days, Tamiflu may lead to the creation of viruses that are more virulent and more aggressive than the original strain of influenza the drug is meant to inhibit.”
If the antiviral medication is used in as few as 1 in 50,000 or even 1 in 500,000 persons, it can promote the spread of resistant, more aggressive strains. When samples of influenza viruses were collected before and during treatment with Tamiflu, resistance was found to develop in 18% of the viruses within 4 days of using the drug. Sensitivity testing revealed that treated viruses could become 300-fold to 1,000,000-fold more resistant than the untreated viruses.
Tamiflu Side Effects
As part of its post-marketing surveillance efforts, the FDA examines side effect reports submitted to the drug Adverse Events Reporting System (AERS) database. Since Tamiflu’s approval, a number of deaths have been reported each influenza season in patients who used the drug.
During the 1999 reporting period, eight children had developed influenza-like illness, started taking Tamiflu then died suddenly in their sleep. Others had severe reactions including anaphylaxis, erythema multifome, and Stevens-Johnson syndrome—a severe, potentially life-threatening immune reaction. Beyond skin reactions, the reports of neuropsychiatric events were highly disturbing and included cases of delirium, convulsions, and encephalitis. However, the most alarming adverse event was the abnormal behavior exhibited by three children after receiving Tamiflu:
“Two children, a twelve- and a thirteen-year-old male, jumped out of the second floor window of their homes after receiving two doses of Tamiflu. Head CT scans showed no abnormalities in either patient. A third case was an eight-year-old boy who also exhibited abnormal behavior when he experienced frightening hallucinations and rushed out of his house onto the street 3 hours after receiving his first dose of oseltamivir (Tamiflu). He was rescued by his family from potential traffic injury.”
In 2007, the Japanese ministry banned the use of Tamiflu in 10- to 19-year-olds after delirious behavior was observed in some children taking the drug. They reported that those patients ages in that age group who Tamiflu had a 54 percent greater chance of exhibiting abnormal behavior than those patients who did not take the medication. Shockingly, there has been a new push has evolved to give Tamiflu to children as young as two weeks of age.
Everyone, especially parents, should be wary of using this drug. It provides — at best — one and a half days of relief from flu-like symptoms and can have lethal consequences. Beyond the lackluster results for the treatment and prevention of influenza, nearly 10% of people who are prescribed Tamiflu can’t tolerate the most common side effect—persistent nausea. With the course of treatment costing up to $200, this drug is best avoided.
What to do instead
The most important tool to use for influenza prevention is Vitamin D in all ages, but especially in children and the elderly. The Sacramento Bee published a good list of useful tips for avoiding the flu. Using an aerosol machine can reduce the spread of viruses and bacteria. A small study involving 11 people found that some people exhale larger amounts of germs than the others when they are sick. A six-minute aerosol treatment using salt-water demonstrated that the numbers of viruses or bacteria being exhaled was sharply reduced—by a whopping 72 percent—for up to six hours. Researchers concluded that, even though the study was small, the administration of a nebulized saline solution could dramatically reduce spread of infection. Homeopathy is a wonderful tool for preventing – and treating – the flu. And of course, one of the most important ways to prevent the flu is to wash your hands.
(Excerpt for this post taken from the book, “FOWL! Bird Flu: It’s Not What You Think.“)