Putting the drug companies' research to the test
Years later, the drug sales reps call to clinics, pushing one new product over another, with doctors unable, on the flimsy evidence available, to decide which is best for patients.
Goldacre points to the case of Tamiflu. “Governments around the world have spent billions of dollars to stockpile this flu drug in fear of a pandemic. Yet the evidence on whether it reduces the rate of pneumonia and death is being withheld right now, to this day,” he says. adding that its manufacturer, Roche, “said completely different things in different jurisdictions”.
Vioxx, a painkiller that provoked multi-billion euro lawsuits, was tested against an older drug to see if it was less likely to cause stomach problems, but also more likely to cause heart attacks. However, the test did not run for long enough for the heart attacks to appear, so the results were skewed and the data gap was never declared clearly in subsequent publications.
“If the raw data on patients was shared, games like these would be far easier to spot, and people might be less likely to play them in the first place,” he contends.
Regulators get too close, leaving them “reluctant to take [a drug] off the market in case it is seen as an admission of their failure to spot problems in the first place”.
Even if regulators are prepared to act, other problems appear. In 2008, the Medicines and Healthcare Regulatory Agency in the UK published a note in its Drug Safety Update, a little-read journal. Statins, used by tens of millions to lower cholesterol and prevent heart attacks, had been shown, it said, after a review of clinical trial data, to cause adverse reactions in some. Patients should be made aware that “treatment with any statin may sometimes be associated with depression, sleep disturbance, memory loss and sexual dysfunction,” it said.
Very rarely, statins might be associated with interstitial lung disease, a serious condition, it went on. The public note to doctors was to be made in February 2008.
In end, the note did not go out until November 2009. Why? Because one drugs company “did not agree with the wording”, a fact that was not revealed by the agency, but, rather, by a medical journal.
“So, a drugs company was able to delay the inclusion of safety warnings on a whole class of drugs prescribed to four million people in the UK for 22 months because it didn’t agree with the wording,” says Goldacre.
Nevertheless, he remains hopeful of change. “I think this could be like the MPs’ expenses scandal, where things that were seen as normal changed when it came into the light.” .
Three things motivate people, he believes: shame, violence and love. “I believe that shame is a very powerful motivator. If people are given clear explanations they will demand change.”
Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients, by Ben Goldacre, is published by Fourth Estate