Health Column: Tamiflu, what Roche did not tell us
MOHLER’S MEDICATION MAXIMS
Free Press Health Columnist
Influenza has invaded the Grand Valley. You experience a sudden onset of severe muscle and joint aching, fever, headache, cough and chills. You want to get better fast, so you Google “influenza” and the first hit is an ad from the folks who make Tamiflu.
A year ago I might have recommended Tamiflu, but new data has come to light that suggests Roche, the manufacturer of this blockbuster drug, was devious about reporting the studies that brought the drug to market.
Roche initially published only three studies that suggested Tamiflu prevented complications: pneumonia, sinusitis and otitis media, prevented hospitalizations and shortened the course of the illness by 30 hours. Along came some tenacious researchers who pushed and shoved Roche into releasing the other eight studies.
Mark Ebell, a family doc and epidemiologist at the University of Georgia, did a review of all 11 Roche studies and published it in a medical journal called “Family Practice” last year.
Five of the trials were so-called failed trials, where Roche was not able to recruit adequate subjects, but the other three “hidden” studies were well done. They, like the published trials, were well-designed randomized, placebo-controlled studies with large numbers of patients. (Five of the six authors were employees or paid consultants of Roche.)
One of the unpublished trials studied only patients with significant heart and/or lung disease. Results: No prevention of complications or hospitalizations and no shortening of the course of the illness.
A second of the unpublished trials studied only old people (over 65). Results: No prevention of complications or hospitalizations and no shortening of the course of the illness.
The third unpublished study included more than 1,500 patients and looked at how well Tamiflu worked to decrease the duration of flu symptoms. Results: If Tamiflu was given in the first 24 hours of illness, symptoms went away 30 hours sooner. If the drug was given in the 24-36 hour window, patients got well 14 hours sooner. If the drug was given more than 36 hours after the onset of illness, the benefit was not significant.
The assertion that Tamiflu was going to keep chronically ill and old people out of the hospital and prevent pneumonias was false and Roche knew it. Roche also advertised an effective decrease in symptoms if given within 48 hours, but their own data suggest that it has little effect if started after 36 hours of illness.
My Take: Roche is in the running for the Pharmaceutical Outrage of the Decade Award. They owe an apology to the participants in their studies for deception in their selective publishing.
If you have a chronic illness or are older than 65, don’t expect to get well any sooner or avoid a complication by taking Tamiflu. If you are young and healthy, have a $100 bill to spend, and get Tamiflu in the first 24 hours, you might get well a day or so sooner. Finally recall that 10 percent of Tamiflu takers will develop significant vomiting.
GJ Free Press health columnist Dr. Mohler has practiced family medicine in Grand Junction for 39 years. He has a particular interest in pharmaceutical education. Phil works part-time for both Primary Care Partners and Rocky Mountain Health Plans. Email him at email@example.com.
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