Ask Dr. H: Tamiflu evidence lacking; is it still worth taking?

The benefit of a five-day course of Tamiflu is modest at best.
The benefit of a five-day course of Tamiflu is modest at best. (Associated Press)
Posted: December 04, 2012

Question: I was reading a story in the newspaper that the British Medical Journal has accused Roche Pharmaceuticals of failing to provide full access to the research data on Tamiflu. The article said there's really no evidence that Tamiflu can actually stop the flu. Do you agree? Do you recommend that people still take it if they have the flu?

Answer: Even if the antiviral treatment for flu works as stated, it only reduces the duration of symptoms in adults (18 to 65) by an average of 1.3 days; by just one day in folks over 65; and by roughly 36 hours in children. So the benefit of a five-day course of Tamiflu is modest at best.

For some time, investigators have been concerned about Tamiflu for two reasons: (1) Tamiflu's manufacturer, Roche, claims there are 10 studies that show Tamiflu's effectiveness. However, only two studies showing its superiority over placebo were actually published in scientific journals. Further, the original data from those studies is "lost" and unable to be independently verified, reviewed, and critiqued in the usual peer-reviewed fashion; and (2) Roche has been unwilling to provide all requested data that support the effectiveness of Tamiflu.

The FDA still currently approves Tamiflu for the treatment of uncomplicated influenza A and B in people 1 year old and older who have been symptomatic for no more than two days. However, they also acknowledge that the benefit of such treatment is modest at best. Tamiflu has not been shown in any clinical trials to reduce the rate of hospitalization, flu complications, or death compared with people receiving a placebo pill. Until the FDA makes a decision to pull the drug off the market, I will prescribe it with a great deal of skepticism, lots of fluids, rest, and Tylenol/Advil.

Low-dose naltrexone can't cure Hashimoto's thyroiditis

Q: I'm taking Synthroid for a slow thyroid due to Hashimoto's thyroiditis. I read about how a low dose of naltrexone of just 1 mg has been proven to reverse the symptoms of Hashimoto's thyroiditis. My doctor is unwilling to prescribe it for me. Why wouldn't my doctor recommend something that can cure my slow thyroid?

A: Even if low-dose naltrexone works as well as the hype surrounding it, it cannot cure hypothyroidism and would need to be continued for life. At its purported best, it will get you on a reduced dosage of thyroid replacement hormone or possibly no thyroid replacement, forever substituting for it a compounded low dose of the opioid receptor blocker drug naltrexone. A pill for a pill.

Naltrexone was approved by the FDA for the treatment of alcohol and opioid addiction, blocking the effects of those drugs in the brain. In 1985, Bernard Bihari discovered that lower doses of the drug might be helpful in boosting the immune systems of people with AIDS. Since then, low-dose naltrexone has been purported to be useful in both suppressing an overactive immune system and revving up a dampened immune system, depending upon the disease. Diseases that low-dose naltrexone has been purported to help by anecdotal evidence include: HIV, cancer, fibromyalgia, multiple sclerosis, an overactive thyroid, an underactive thyroid, inflammatory bowel disease, lupus, and more. The myriad of disease states that this "wonder drug" can supposedly help should immediately arouse skepticism.

Missing are double-blinded, randomized, placebo-controlled trials that put the claims to the test. For reasons that aren't clear, your body is destroying hormone-producing thyroid as though it were invading tissue. Even if this "miracle" drug could somehow modulate that activity, no claim has ever been made that it can cure Hashimoto's thyroiditis and put things back to a predisease state. I'd stay on thyroid replacement hormone, since that's been proven to work.

Mitchell Hecht specializes in internal medicine. Send questions to him at: "Ask Dr. H," Box 767787, Atlanta, Ga. 30076. Due to the large volume of mail received, personal replies are not possible.

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