http://www.cbc.ca/radio/asithappens/as-it-happens-wednesday-edition-1.3270429/health-canada-confidentiality-pact-forces-doctor-to-withhold-drug-data-1.3270432
Wednesday October 14, 2015Health Canada confidentiality pact forces doctor to withhold drug data
Dr. Navindra Persaud wants to make public the unpublished clinical trial data on the effectiveness of a morning sickness pill. (CBC)
Diclectin is a morning sickness drug that is prescribed to thousands of expectant mothers in Canada every year. But a Toronto family doctor and drug safety researcher is questioning how well Diclectin actually works. Since 2001, Dr. Navindra Persaud has been fighting for access to documents from Health Canada about the drug's efficacy. And recently, he got those documents. On one condition: he can't tell anybody what they say.
Persaud spoke with As It Happens host Carol Off about the drug and how he plans to challenge Health Canada and the drug company Duchesnay Inc. to release the data publicly.
Carol Off:.Can you tell us, from what you have seen, if there is anything in what you got that alarms you?
Dr. Navindra Persaud: It's a tricky area because of the confidentiality agreement. Before I received the information I was skeptical about how effective the medication was and it seemed to me the medication might not be any more effective than just taking vitamin B6, which is one of the two active ingredients inside those pills. Now, I'm concerned that the medication is**not effective at all.
CO: Not effective, but do you have any concerns? As you know, I don't need to tell you that morning sickness drugs have a very ugly history in this country, so any reason to worry about Diclectin?
NP: Based on the studies that have been done, Diclectin is not like thalidomide, so it's not a medication that greatly increases the risks of birth defects. No medication is perfectly safe though and certainly Diclectin is not perfectly safe. So while there have not been any strong associations between taking Diclectin and birth defects, there are some studies that have found an association with a small increase in certain risks.
CO: Based on what you have read would you still prescribe the drug?
NP: No.
An earlier request for information was heavily redacted. (CBC)
CO: Is it not in the public interest to know about what you now know about this drug?
NP: Yes. Ideally, people would not have to rely on my opinion or my interpretation of the data. People should be able to decide for themselves whether they want to take this medication or whether they want to prescribe this medication to their patient.
CO: How uncomfortable are you as a doctor knowing that you can't even tell your own patients?**
NP: Very uncomfortable. I was alarmed when I got the information and when it prompted me to rethink the medication I felt a lot of pressure knowing that right now I was the only one outside of Health Canada who has access to the information.
CO: At some point you must feel that there's a responsibility for you to ignore this, and in the interest of people and your own patients, to pass this information on.
NP: Well I think the first step is for me to carefully review this large volume of data and then I'll seek to make my findings public. It's frustrating that there is going to be a delay but I do hope that Health Canada will change its approach and bring it more in line with regulators in other jurisdictions where this sort of information would be publicly available. It's also open to the company Duchesnay, that's the company based in Quebec, to make this information publicly available. According to Health Canada, the reason they're not making it publicly available is because the pharmaceutical company, Duchesnay, submitted this information to Health Canada with the expectation that it would kept confidential. But if Duchesnay owns the information they could make it publicly available today if they wanted to.
This interview was edited for length and clarity. To hear the full interview please click on the Listen audio link above.
Wednesday October 14, 2015Health Canada confidentiality pact forces doctor to withhold drug data
Dr. Navindra Persaud wants to make public the unpublished clinical trial data on the effectiveness of a morning sickness pill. (CBC)
Diclectin is a morning sickness drug that is prescribed to thousands of expectant mothers in Canada every year. But a Toronto family doctor and drug safety researcher is questioning how well Diclectin actually works. Since 2001, Dr. Navindra Persaud has been fighting for access to documents from Health Canada about the drug's efficacy. And recently, he got those documents. On one condition: he can't tell anybody what they say.
Persaud spoke with As It Happens host Carol Off about the drug and how he plans to challenge Health Canada and the drug company Duchesnay Inc. to release the data publicly.
Carol Off:.Can you tell us, from what you have seen, if there is anything in what you got that alarms you?
Dr. Navindra Persaud: It's a tricky area because of the confidentiality agreement. Before I received the information I was skeptical about how effective the medication was and it seemed to me the medication might not be any more effective than just taking vitamin B6, which is one of the two active ingredients inside those pills. Now, I'm concerned that the medication is**not effective at all.
CO: Not effective, but do you have any concerns? As you know, I don't need to tell you that morning sickness drugs have a very ugly history in this country, so any reason to worry about Diclectin?
NP: Based on the studies that have been done, Diclectin is not like thalidomide, so it's not a medication that greatly increases the risks of birth defects. No medication is perfectly safe though and certainly Diclectin is not perfectly safe. So while there have not been any strong associations between taking Diclectin and birth defects, there are some studies that have found an association with a small increase in certain risks.
CO: Based on what you have read would you still prescribe the drug?
NP: No.
An earlier request for information was heavily redacted. (CBC)
CO: Is it not in the public interest to know about what you now know about this drug?
NP: Yes. Ideally, people would not have to rely on my opinion or my interpretation of the data. People should be able to decide for themselves whether they want to take this medication or whether they want to prescribe this medication to their patient.
CO: How uncomfortable are you as a doctor knowing that you can't even tell your own patients?**
NP: Very uncomfortable. I was alarmed when I got the information and when it prompted me to rethink the medication I felt a lot of pressure knowing that right now I was the only one outside of Health Canada who has access to the information.
CO: At some point you must feel that there's a responsibility for you to ignore this, and in the interest of people and your own patients, to pass this information on.
NP: Well I think the first step is for me to carefully review this large volume of data and then I'll seek to make my findings public. It's frustrating that there is going to be a delay but I do hope that Health Canada will change its approach and bring it more in line with regulators in other jurisdictions where this sort of information would be publicly available. It's also open to the company Duchesnay, that's the company based in Quebec, to make this information publicly available. According to Health Canada, the reason they're not making it publicly available is because the pharmaceutical company, Duchesnay, submitted this information to Health Canada with the expectation that it would kept confidential. But if Duchesnay owns the information they could make it publicly available today if they wanted to.
This interview was edited for length and clarity. To hear the full interview please click on the Listen audio link above.
