Putting the drug companies' research to the test
The Irish Times - Saturday, September 29, 2012
MARK HENNESSY, London Editor
Millions of drugs are being prescribed every day on faulty evidence, claims a new book on the pharmaceutical industry
THE FIRST medical test recorded is recounted in the Bible, when Daniel, imprisoned by Nebuchadnezzar in Babylon, refused orders to eat the food and wine from the king’s table. Instead, he demanded that the Jews brought from Jerusalem should eat only fresh vegetables and drink fresh water and then be compared with those who ate the king’s offerings. “At the end of the 10 days they looked healthier and better nourished than any of the young men who ate the royal food,” Daniel 1:12 records. Two thousand years on, the writer, doctor and journalist Ben Goldacre believes the example has much to recommend it.
Following his success with Bad Science, a book that sold 400,000 copies, Goldacre has turned his attentions to the world’s pharmaceutical industry in Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients. The public believes that drugs are tested over years in carefully-run trials before being prescribed by doctors familiar with the research that led to their creation. Much of that image is a fiction; drugs are often tested against placebos filled with sugar, or against drugs that have been shown repeatedly not to work, while results are often manipulated, says Goldacre.
However, Goldacre moves to dispel myths of “cartoonish evil”, or conspiracy theories of the “they have the cure for cancer, but they won’t tell us” variety. “This is not just a book about bad people. In fact, it is possible for good people, in perversely designed systems, to casually perpetrate acts of great harm on strangers, sometimes without even realising it.
“Drugs are tested by the people who manufacture them, in poorly-designed trials, on hopelessly small numbers of weird, unrepresentative patients,” he writes.
Academic papers “are often covertly planned and written by people who work for the companies without disclosure”, while many diseases are ignored because the potential rewards of developing a treatment for them are insufficient.
Regulators have failed miserably, with the European Medicines Agency worst of all, refusing, as it does, to publish information gathered, it says, in the interests of transparency.
Pressured by lack of money, governments could be about to make the situation even worse by giving pharmaceutical companies a greater role in deciding on patients’ treatment, he warns.
“Companies are perfectly entitled to conduct seven studies, but only publish the two positive ones, and this behaviour is common-place,” he writes.
“Because so much trial data is withheld from patients and doctors, we can have no clear idea of the true effects of the treatment that we use every day in medicine.”
Some of the problems are created by the ties of friendship. “If you are a regulator, who can you talk to about your work at the home, or in the pub? Nobody will understand it.
“So you end up having more in common with people you know who are working for pharmaceutical companies’ regulatory departments,” he tells The Irish Times, sitting in the lobby of a London hotel. “If you are a young doctor, you go to the drugs company’s dance in the hospital. Your colleagues are going, so you want to fit in. And there’ll be nurses there.”
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