Curiosity puts profit above patients under microscope

During an epidemiology class, we medical students were asked a stark and simple question. Which was the more lethal, the machine guns and cannons of World War I, from 1914 to 1918 or the submicroscopic virus that caused the flu pandemic of 1918-1919? You probably guessed it. Forty-50 million people died of that flu, while 16 million died in the war.

We now know that the killer virus was an avian virus, an ancestor of the strains of avian and swine flu strains commonly found in modern flu outbreaks which still result in 30,000 deaths annually in the US.

In 2009 the WHO issued an alert that a global flu pandemic was highly imminent. The spread of infection by virtue of international air travel made it seem likely any such infection would spread more quickly than that in 1918. As a result of that alert and the respect for the virus' power I'd gained in medical school, I purchased a supply of Tamiflu (oseltamivir phosphate).

Tamiflu is an antiviral drug marketed by Roche Pharmaceuticals and approved by the US Food and Drug Administration on the basis that studies indicated the drug ameliorated symptoms of flu and prevented the complications, like pneumonia, which were the serious killers.

I wasn't the only buyer. Roche has been selling US$1-2 billion ($1.3-$2.5 billion) of the drug annually since 2007.

In 2009 a post-doctoral student in political interaction with medicine, Peter Doshi, got curious about Tamiflu and began to ask questions about proof of its effectiveness. As a result of his questions, the 32-year-old with no medical training became a major influence on medical research. Doshi, with help from two sceptical medical researchers - British epidemiologist, Dr Tom Jefferson and Japanese pediatrician Dr Keiji Hayashi - sought to review the research basis for the claims of Tamiflu's effectiveness.

Gaining access to the relevant studies was not easy. Roche would provide only two of the 10 studies that had been done at its direction. Roche initially protested that providing clinical trial data compromised its commercial interests.

Then the British Medical Journal found that ghost writers had been used in some of the research on Tamiflu.

Some of those writers claimed they had been pressured to write only positively about the drug. Roche acknowledged that ghost writers had been involved and promised to cease that practice. The company denied it had pressured researchers to provide positive results.

In light of those exposures of the practice of some pharmaceutical research sponsored by Big Pharma, Roche and the others found their integrity in question as they seemed to be placing profit above clinical effectiveness.

Medicine relies upon hierarchies of trust. There are watchdogs, but until recently they have seen only a portion of the necessarily relevant studies. Last year Glaxo, a British multinational pharmaceutical company paid $3 billion in fines for withholding safety information about its diabetes drug, Avandia, and misleading information about its antidepressant drug Paxil.

In need of an image makeover and in response to pressure from multiple sources, independent researchers, reputable medical journals, regulatory agencies, Glaxo and Roche have recently agreed to release all of their clinical results since 2007, Glaxo from 2000.

This is laudable and necessary if patients and their doctors are to have the information about safety and effectiveness necessary. All of us will benefit from this new transparency, being instituted as a result of the curiosity of a small group of researchers asking if Tamiflu really works. Results are not yet in, but stay tuned as they soon will be.