A new paper published by McGill University researchers in JAMA Internal Medicine suggests that some clinical trials may promote the use of ineffective and costly treatments. That’s the opposite of what clinical trials are aimed at, namely preventing ineffective and costly treatments from being taken up by physicians and patients.
The researchers focused their attention on the blockbuster pain drug pregabalin (Lyrica). One of the world’s bestselling drugs, pregabalin is widely used for conditions that are not approved by Health Canada or the FDA (“off-label”). Relying on the published record of trials, they reconstructed the timeline of pregabalin drug development to understand what evidence was available to clinicians and clinical guideline creators when they were making treatment decisions and recommendations, and how testing was coordinated. Their underlying finding was that after pregabalin received its first approval, research was often better at creating the perception that pregabalin might work against other diseases than it was at proving it. For example, they found that despite nearly a decade passing since the publication of a small study suggesting that pregabalin might work to treat patients with low back pain, no large, rigorous follow-up trials have been published to date.
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