Book ReviewFlorian Fisch
Paperback: 430 pages
Price: 16.45 EUR
Ben Goldacre, M.D. – blogger, broadcaster, critical writer. Photo: Steve Packard
When patients do not get the best treatment available it’s not always due to cost. It’s rather that clinical trials often aren’t available or are based on poor data, poor statistics and poor design. Ben Goldacre, who is renowned for mockingly bashing esoterism and bad science, has found another issue: the pharmaceutical industry.
“Medicine is broken” is the shortest summary of Ben Goldacre’s new book, Bad Pharma. The British journalist and medical doctor, known for his sceptical blog Bad Science, tries to defend this conclusion throughout the rest of the book. Successfully, your reviewer thinks. But decide for yourself. The book’s intro is freely available online (http://bit.ly/RTlPji).
For every life scientist not born in blinkers, the book should hold no surprises. About half of all clinical trials are never published, normally those with negative findings. And often trials are badly designed, favouring biased conclusions – for example by analysing every possible subgroup of patients until you find a positive result.
To get an adequate picture of the effects and side effects when reviewing a drug systematically, we need all the data from all of the studies ever performed on that particular drug. Goldacre has a clear name for this tradition of omitting data: scientific misconduct (although no individual can be held responsible for it). As a psychiatrist, Goldacre also knows far too well how published information is communicated to doctors in a distorted way by pharmaceutical sales representatives (want to see Goldacre’s 13 minute TED-talk on the topic? Look at http://bitly.com/PIjL9Q!)
The value of his new book comes not so much from exposing the existence of “broken medicine” but from giving an outspoken and complete overview as well as providing countless examples. Goldacre delivers plenty of pharmaceutical scandals, usually brought to light by courageous scientists exposing their colleagues in academia and industry alike. “People whose work is cited [...] have taken a personal hit on income and eminence”, acknowledges Goldacre, “They are quiet heroes.”
We all, as potential patients, suffer the consequences of poorly reported side effects when prescribed inferior treatments despite better potential knowledge. The unnecessary suffering and deaths are infuriating. And invoking fury is exactly what Goldacre intends to do. The professional academic bodies, journal editors and regulators have offered nothing but fake fixes. Unregistered trials are still accepted by regulators and editors alike. They have failed in their duties.
To give a single, disturbing example: The Nordic Cochrane Center, a project to perform systematic reviews on medical treatments, asked the European Medicines Agency (EMA) in 2007 for data on two anti-obesity pills, rimonabant and orlistat. The EMA, however, did not hand over the data because they wanted, “to protect the commercial interest and intellectual property of drug companies”. Regulators like the EMA start from the principle that nobody else needs to see the original data because the regulator has done the work. “This misunderstands the crucial difference between the decision made by the regulators and the decisions made by the doctors”, writes Goldacre. Doctors have to make decisions for individual patients, not about average benefits and risks.
The Cochrane Center did not agree with this policy, either, and complained to the European Ombudsman, starting a legal battle with the EMA. “The EMA had failed to explain why doctors and patients having access to study reports and protocols should undermine anyone’s reasonable commercial interests and why these commercial interests were more important than the welfare of patients”, Goldacre remarks. The regulator later even claimed, “that the design of a randomised trial itself is commercially confidential information.” The Ombudsman accused the EMA of maladministration and asked them to hand over the information, but the EMA still did not comply, dismissing the claim that lives were at risk. More than three years and 130 pages later, the EMA finally handed out the data to the Cochrane Institute.
Not just high time, but too late. During that period rimonabant was removed from the market due to heavy side effects.
He makes recommendations for everyone to help change the self-serving and arrogant culture of medicine. The first reactions from the UK pharmaceutical industry do not give much cause for optimism, “We must remember though that the examples he refers to are long documented and historical, and the companies concerned have long addressed these issues.”
Goldacre anticipated this reaction in his book, “I am confident that you will agree, from the evidence set out in this book, that these are systemic problems; and that it would be shameful, or even dishonest, simply to dismiss them.”
Letzte Änderungen: 07.08.2013