Sun Feb 10, 2013, 09:13 AM
Celebration (15,768 posts)
Bad pharma: Drug research riddled with half truths, omissions, lies
One personal example from the author
Reboxetine is a drug I myself have prescribed. Other drugs had done nothing for this particular patient, so we wanted to try something new. Iíd read the trial data before I wrote the prescription, and I had found only well-designed, fair tests, with overwhelmingly positive results. Reboxetine was better than placebo and as good as any other antidepressant in head-to-head comparisons. Itís approved for use by the Medicines and Healthcare products Regulatory Agency (the MHRA), which governs all drugs in the UK. Millions of doses are prescribed every year around the world. Reboxetine was clearly a safe and and effective treatment. The patient and I discussed the evidence briefly, and we agreed it was the right treatment to try next. I signed a prescription saying I wanted my patient to have this drug.
But we had both been misled. In October 2010, a group of researchers were finally able to bring together all the trials that had ever been conducted on reboxetine. Through a long process of investigation ó searching in academic journals but also arduously requesting data from the manufacturers and gathering documents from regulators ó they were able to assemble all the data, both from trials that were published and from those that had never appeared in academic papers.
When all this trial data was put together it produced a shocking picture. Seven trials had been conducted comparing reboxetine against placebo. Only one, conducted in 254 patients, had a neat, positive result, and that one was published in an academic journal for doctors and researchers to read. But six more trials were conducted in almost 10 times as many patients. All of them showed that reboxetine was no better than a dummy sugar pill. None of these trials were published. I had no idea they existed.
It got worse. The trials comparing reboxetine against other drugs showed exactly the same picture: Three small studies, 507 patients in total, showed that reboxetine was just as good as any other drug. They were all published. But 1,657 patientsí worth of data was left unpublished, and this unpublished data showed that patients on reboxetine did worse than those on other drugs. If all this wasnít bad enough, there was also the side-effects data. The drug looked fine in the trials that appeared in the academic literature. But when we saw the unpublished studies, it turned out that patients were more likely to have side effects, more likely to drop out of taking the drug and more likely to withdraw from the trial because of side effects if they were taking reboxetine rather than one of its competitors.
I did everything a doctor is supposed to do. I read all the papers, I critically appraised them, I understood them and I discussed them with the patient. 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 which, on the balance of all the evidence, harmed my patient, simply because unflattering data was left unpublished.
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Replies to this discussion thread
Bad pharma: Drug research riddled with half truths, omissions, lies (Original post)
Response to Celebration (Original post)
Sun Feb 10, 2013, 09:18 AM
Siwsan (2,600 posts)
1. Rx commercials spend more time on the possible side effects, than the potential benefits
I have zero confidence in big pharm. Maybe if they spent the $$ on research, instead of those damn, non-stop commercials, they would have better outcomes with their products.