A Canadian doctor who is opposed to a widely used drug for morning sickness has fired another volley.
Writing in the journal PLOS ONE, Dr. Navindra Persaud in the department of family and community medicine at St. Michael's Hospital in Toronto, notes that an unpublished study that supported use of the drug, conducted in the 1970s, is seriously flawed.
On the one hand, this paper is a triumph for scientific openness. Pharmaceutical companies and regulatory agencies often guard this information, making it difficult for scientists to draw independent conclusions about drug-related research.
And there are stories about drugs that have managed to get onto the market based on overly rosy interpretations of study results (think Vioxx, the anti-inflammatory drug that was later pulled after it was linked to higher risk for heart disease). Academic researchers have been pushing for greater openness when it comes to raw data.
The study plays a peripheral role in determining the safety and efficacy of the drug, which was approved by the U.S. Food and Drug Administration in 2013. That new drug application made its case based on other studies, not the flawed data from decades ago. But the FDA did review the previous history of this drug, including the study that Persaud has called into question, and considered it supporting evidence.
The FDA had no qualms about the safety of this drug, marketed in the United States as Diclegis. It's a combination of two common over-the-counter medications: an antihistamine and vitamin B6.Read More...
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