Sunday, September 23, 2012
Below is a excerpt of an article by Ben Goldacre (twitter) which appeared in the Guardian on 21 September 2012. The article itself is an edited extract from Bad Pharma, by Ben Goldacre, published by Fourth Estate.
The Drugs Don't Work: A Modern Medical Scandal
(full article at the Guardian here)
"The doctors prescribing the drugs don't know they don't do what they're meant to. Nor do their patients. The manufacturers know full well, but they're not telling.
"I did everything a doctor is supposed to do. I read all the papers, I critically appraised them, I understood them, I discussed them with the patient and we made a decision together, based on the evidence. In the published data, reboxetine was a safe and effective drug. In reality, it was no better than a sugar pill and, worse, it does more harm than good. As a doctor, I did something that, on the balance of all the evidence, harmed my patient, simply because unflattering data was left unpublished. [emphasis added]
"...But after all these methodological quirks [of manipulating drug trial outcomes] comes one very simple insult to the integrity of the data. Sometimes, drug companies conduct lots of trials, and when they see that the results are unflattering, they simply fail to publish them."
"Because researchers are free to bury any result they please, patients are exposed to harm on a staggering scale throughout the whole of medicine.
"This is a bizarre situation to arise in medicine, a discipline in which everything is supposed to be based on evidence.
"That leads us to the second obvious flaw in the current system: the results of these trials are given in secret to the regulator, which then sits and quietly makes a decision. This is the opposite of science, which is reliable only because everyone shows their working, explains how they know that something is effective or safe, shares their methods and results, and allows others to decide if they agree with the way in which the data was processed and analysed. Yet for the safety and efficacy of drugs, we allow it to happen behind closed doors, because drug companies have decided that they want to share their trial results discretely with the regulators. So the most important job in evidence-based medicine is carried out alone and in secret. And regulators are not infallible...
"Missing data poisons the well for everybody. If proper trials are never done, if trials with negative results are withheld, then we simply cannot know the true effects of the treatments we use. Evidence in medicine is not an abstract academic preoccupation. When we are fed bad data, we make the wrong decisions, inflicting unnecessary pain and suffering, and death, on people just like us."