Ending Medical Reversal by Vinayak K. Prasad & Adam S. Cifu

Author:Vinayak K. Prasad & Adam S. Cifu [Prasad, Vinayak K. & Cifu, Adam S.]
Language: eng
Format: epub
ISBN: 9781421417721
Publisher: Johns Hopkins University Press
Published: 2015-10-15T04:00:00+00:00

INDUSTRY-SPONSORED TRIALS

Just days after the story broke, the Internet coined a term for the whole affair: “Scamiflu.” In the spring of 2014, a meta-analysis that appeared in the British Medical Journal presented data that showed that oseltamivir (Tamiflu), a medication used widely to treat the flu (influenza), provides very little benefit—even less than was previously thought. This drug, which had been on the market for more than a decade, had been studied in the past, but unlike previous studies, this meta-analysis was performed by independent researchers who had unrestricted access to full study reports of every oseltamivir trial (published and unpublished). Although Tamiflu had been thought to prevent transmission of the flu virus, decrease hospitalizations, and save lives, the study found it did no such thing. Tamiflu decreased flu symptoms by less than a day, from an average of seven days to just over six. It did this while causing nausea and vomiting. The drug did nothing to prevent transmission of the virus or reduce hospitalization. Finally, there was no evidence that it decreased deaths.

These findings were particularly unfortunate because countries around the world had stockpiled Tamiflu for years in preparation for a potential epidemic. Between the United States and the United Kingdom, more than $2 billion was spent to amass Tamiflu stockpiles. Government stockpiles were justified because officials believed that the drug could be used to slow the spread of a future influenza epidemic and save lives. It makes no sense to stockpile a drug (at tremendous cost) that is no better than Tylenol. The case of Tamiflu is another example of medical reversal, a therapy adopted into widespread use that is later found to be no better than our previous less expensive and safer therapy. It is a particularly costly, visible, and painful example that deserves deeper analysis because it illustrates ways that industry-sponsored trials can mislead physicians.

Before we can delve into the details of the Tamiflu case, there are some basics you need to know about the flu. First, when people talk about “the flu,” most of us are really talking about influenza-like illnesses. You have probably experienced at least one of these—you develop fever, cough, aches, and pain. Among people with influenza-like illnesses, some are actually infected with a virus called influenza, while other patients have been infected with other viruses—rhinovirus, coronavirus, and others. These viruses can cause illnesses that mimic true influenza. There is a test to distinguish influenza from influenza-like illnesses; however, for practical reasons, doctors have traditionally not used this test very often. If the treatment is to go home, eat some soup, take some Tylenol, call in sick to work, and get some sleep—does it matter if you have rhinovirus or influenza?

Influenza can be a terrible infection. It accounts for more than 100,000 hospitalizations each year in the United States and more than 50,000 deaths. In the worst years, the numbers can be terrifying. The 1918 Spanish Flu pandemic killed between 20 and 100 million people. Influenza is especially dangerous for people at the extremes of age and for women who are pregnant.

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