A new report, published by researchers at McGill University, JAMA internal medicine suggests that some clinical trials may encourage the use of ineffective and expensive treatments. This is exactly the opposite of what clinical trials are aiming for, namely, prevention of ineffective and expensive treatment by doctors and patients.
Researchers turned their attention to blocking painkiller pregabalin (Lyrica). One of the best-selling medicines in the world, pregabalin is widely used under conditions that are not approved by Health Canada or the FDA ("off-label"). Referring to the published test protocol, they are revising the drug development schedule for pregabalin to understand what evidence is available to clinicians and clinicians when making decisions and recommendations on treatment, and how testing has been coordinated. Their primary finding is that once pregabalin has received its first approval, research has often been better to create the feeling that pregabalin can work against other diseases than to prove it. For example, they found that, despite the almost decade of publication of a small study suggesting that pregabalin can work to treat patients with low back pain, no major, rigorous follow-up attempts have been published so far.
Professor McGill Jonathan Kimmelmann, director of Biomedical Ethics at the Faculty of Medicine and senior author of the study, first came up with the idea of studying after watching the documentary Merchants of Doubt. The film shows how the tobacco, chemical and oil industries manipulate science to question regulators and the public about the link between products and public health. Professor Kimmelmann wondered if there might be a similar process in medicine. Instead of raising doubts, he believes that pharmaceutical companies would like to create the feeling that their medicines can be useful under conditions other than those for which they are approved. Researchers find something more complicated in the workplace, however, as many of the surveys in its sample are publicly funded and others that do not account for any industry funding. "We were surprised that the problems we are documenting are partly determined by researchers who receive funding from federal research agencies and / or their own medical centers," said Carroll Federico, PhD. a student under Professor Kimmelmann and lead author of the study.
"Drug development is like a relay race where the first runner is trying to show that the drug might turn out to work, and the second runner proves that the drug actually works," says Professor Kimmelmann. "This relay race works very well before the drug is approved because drug regulators such as Health Canada and FDA do not allow companies to market their medicine until they continue the whole race Once the medicine that is required has been approved to prove that the drug is working on another disease, often puts a stick, doctors are free to use the medicine for other conditions than that for which it is approved, and there is no obligation for companies to prove drugs. although they have approved medicines for new diseases, often encourage the use of treatments that may not be effective. "
Federico quickly added that "there is nothing wrong with the use of drugs outside of the label. Indeed, many drugs that are given off the label are backed up by serious evidence. However, when drugs are prescribed outside the label on the basis of poor evidence, may be harmed because they accept drugs that are ineffective for their condition, and health care systems are hurt if they reimburse the cost of such ineffective treatment. "
"We want to emphasize that perhaps most, if not all, researchers will say that all the individual tests in our sample are both sensible and ethical," says Professor Kimmelmann. "Our goal is not to condemn these separate trials, instead we say that when you go away and look at what's happening at the forest level – the trees start to look less healthy."
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"Evaluation of Pregabalin Post-Acceptance Studies and the Proposal for Efficacy for New Indications: A Systemic Review" by Carole Federico, Jonathan Kimmelman et al. is published online in Bulgaria JAMA internal medicine, 26 November 2018