ARE DRUG STUDIES MANIPULATED?
likely to be published than negative ones. And even seemingly small differences can “represent billions of dollars on the world market,” says Gøtzsche. The principle, nonetheless,
“The manipulation of clinical studies is so widespread and so serious that you should only consider the reports on these studies as advertisements for medical drugs,” says Professor Peter Gøtzsche, director of the Nordic Cochrane Center in Copenhagen – a statement that is sure to make him some enemies. These are extremely harsh words, directed not only against the pharmaceutical industry but also against those doctors and researchers who remain silent on the matter. The truth is, that’s what most doctors do. But what does that mean for patients?
New research has found that clinical trials and research funded by pharmaceutical companies is more likely to produce results that are biased in favour of the sponsor’s medicine.
Joel Lexchin, a Toronto doctor, analysed 30 reports examining pharmaceutical industry-funded research and found that the studies were four times more likely to be positive than research funded by independent sponsors. “What we found was that in almost all cases there was a bias – a rather heavy bias – in favour [of a drug] when the study was industry funded,” said Lexchin. In actual fact, pharmaceutical companies don’t need to invent or make up results – it’s enough to weigh facts differently or leave them out entirely. Positive studies are far more
“The pharmaceutical industry spends twice as much on advertising as it does on research and development.” DR JOEL LEXCHIN, YORK UNIVERSITY OF TORONTO
seems simple: those who have the financial clout decide the results, something confirmed by random spot checks carried out by the Cochrane Center. These showed that at least 50% of funded drug studies financed by pharmaceutical companies are influenced in their favour. However, such manipulated studies do not stand in the way of drugs being approved – because to date there are “neither cross-disciplinary standards for the peer review process, nor measurable quality criteria” according to Professor Flaminio Squazzoni from the University of Brescia in Italy.
The real scandal, however, is that it is no secret.
According to research carried out by the Cochrane Collaboration, tens of thousands of manipulated studies have been published. Doctors should know about this. They have a huge responsibility to their patients, who expect them to be informed about significant medical developments, particularly when these pertain to a drug that they prescribe. But history shows that many drugs or treatments continue to be prescribed even though studies no longer support their use. Consider PSA tests for the early diagnosis of prostate cancer. Even the man who developed them, Dr Richard Ablin, now advises against their use because most of these cancers are slow-growing and do not require treatment. But doctors continue to use them. The same is true of the sedative diazepam (Valium). Although it’s been known for 30 years that the drug is as addictive as heroin, it is still prescribed.