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One researcher’s long quest to make drug data more public

A Q&A with Toronto physician Nav Persaud, who has raised red flags about the effectiveness of the morning sickness pill Diclectin.

BY ANQI SHEN | MAR 13 2017

Back in 2011, when Nav Persaud prescribed the drug Diclectin to a pregnant patient experiencing morning sickness, her skepticism of the medication made him uneasy. After her visit, he looked into clinical practice guidelines for Diclectin and found gaps in the information. What followed was years of back and forth with health agencies in a push to get access to the information and make the evidence public. In January, Canadian Family Physician, the journal that published the original guidelines recommending Diclectin as first-line treatment for nausea and vomiting in pregnancy, said it no longer supports its conclusions based on new research by Dr. Persaud and his colleagues. University Affairs recently spoke with Dr. Persaud about how the process unfolded.

University Affairs: To start off, can you tell me about your background as a researcher and physician?

Nav Persaud:  I’m a family doctor here at St. Michael’s Hospital in Toronto, and I’m also an assistant professor in the department of family and community medicine at the University of Toronto. So, I split my time between caring for a diverse group of patients in my family practice and doing research.

UA: How did you become interested in researching the drug Diclectin?

NP: It was based on a question from a patient. I had prescribed the medication and the patient asked if she should really take it, and I reassured her that it was the first-line treatment as recommended by the Canadian clinical practice guidelines, but she seemed skeptical still by the time she left my office. After she left, I went to look at what the guidelines said, and I found that they didn’t actually cite the evidence that you’d expect to see in a clinical practice guideline that recommended a medication. So, I started trying to track down all the available evidence about this medication, and I found that a lot of the important information was lacking or missing. That was a while ago, I think it was 2011. It’s taken a very long time to actually get access to the information.

UA: How did you get access to it?

NP: I made a request to the U.S. Food and Drug Administration, to the European Medicines Agency and also to Health Canada. I also made requests to the pharmaceutical company that sponsored the study. And it was a lot of waiting, asking for updates. Some of the information I got apparently had to be redacted.

UA: Once you had the information, what were your next steps?

NP: Carefully reviewing it with colleagues. The process we’re going through now – and part of it has been completed – is to try and reanalyze all the information that’s available and to make all of it publicly available so that clinicians and pregnant women, who might be deciding whether or not they take this medication, will have access to all of it. And that is widely accepted as what should always happen. You know, these studies are done for the purpose of improving care, and so obviously, people involved in making decisions about care should have access to all this information.

UA: Have you found that the drug is not safe or simply that it’s not an effective treatment?

NP: I think the main difference between what I’ve found and what is already published is about the effectiveness of the medication. It’s held up to be an effective medication, depending on how you read the guidelines, maybe the most effective medication. That’s not what I’ve found through reviewing the information.

UA: Health Canada has said it stands by its review of the safety and efficacy of the drug. But Canadian Family Physician, the journal that published the guidelines recommending the use of Diclectin, no longer supports that recommendation. Do you anticipate any changes or impacts going forward?

NP: Diclectin is still recommended by one body in Canada, the Society of Obstetricians and Gynaecologists. That recommendation may change in the future; my understanding is that all clinical guideline developers carefully review the literature. Today, the medication is still very commonly prescribed. It is very difficult to undo a recommendation. Ultimately, I hope that clinical practice will be better informed by the evidence. This is about one medication, but there could be other medications commonly prescribed right now where evidence might suggest a different practice.

UA: Some of your peers in medicine say there have been reliable studies backing the use of Diclectin since the clinical trial of the 1970s that you scrutinized. How would you respond to that view?

NP: It’s actually the subject of an ongoing study. My colleagues and I are reanalyzing the most recent study that was published in 2010. Right after that study was done, the FDA in the United States approved the medication. I wish I was at liberty to talk about all the information I have about that study, but it’s the subject of a confidentiality agreement with Health Canada. Hopefully all of the information will eventually be in the public domain. That would be the best way to get to the bottom of what is the most appropriate interpretation of that study’s results.

UA: What obstacles did you face in trying to bring your research to light, and what made you want to keep going?

NP: It was that feeling about making a bad clinical decision that motivated us. In terms of obstacles, there were many. The biggest one was just waiting. I mean, it’s very difficult to conduct research when you have to wait literally years to get the information. It is also difficult when the information is redacted, and there are added obstacles like confidentiality agreements that have to be reviewed by lawyers and restrictions on how you can share the information that make it very difficult to do an analysis of the data and to get it published. We’re still facing some of those obstacles.

UA: What have you learned about being in the public eye and also juggling your responsibilities as a researcher and physician?

NP: It’s been somewhat reassuring that members of the public have been interested in this, and I think it’s helped to ground the research. I guess researchers are sort of used to there being obstacles, but I think members of the public I speak to are shocked that there are so many obstacles to accessing this sort of information which should be publicly available. I think the public attention to that issue has helped to promote progress.

This interview has been edited and condensed for clarity.

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