But he cannot tell his patients or any other Canadians what’s in them.
Under the terms of a confidentiality agreement he had to make with the federal regulator in order to receive the 35,000 pages, he can’t even tell his wife.
“I think it’s important information that could change clinical practice, that could change the informed decisions that pregnant women make about whether they want this medication,” said Persaud, who teaches at the University of Toronto and researches drug safety at St. Michael’s Hospital.
“But because I have signed this confidentiality agreement, I can’t talk to you about it.”
Persaud has previously raised concerns about Diclectin’s efficacy. This article is about transparency, not drug safety. The maker of Diclectin, a commonly prescribed morning sickness drug, says its product has been proven safe and effective.
The Star first reported on Persaud’s protracted battle with government secrecy in April. A pregnant patient of Persaud’s had questions about Diclectin. So in 2011, Persaud went to Health Canada for all the records it had that could help him give an informed response.
He got a three-and-a-half-year runaround before getting a 359-page document, 60 per cent of it completely censored. Other pages had blacked-out sections under titles such as “Adverse Events.”
Canada’s drug regulator had deemed those details “confidential business information” under access to information legislation, and was required to consult the drug’s manufacturer, Quebec-based Duchesnay, on what should be kept from the doctor.
So Persaud made his request again, this time under the new legislation, Vanessa’s Law. This 2014 law empowers the health minister to disclose this kind of information to a doctor, in some cases without consulting a drug company.
In September, he finally received 35,000 pages, none of them blacked out, the disclosure made by Health Canada for the “exclusive use” of Persaud’s research about the drug.
The release includes a nearly 9,200-page report from a recent clinical trial sponsored by Duchesnay to assess, among other things, the drug’s efficacy — a measure of how well it treats a condition.
“I don’t view it as business information because it’s related to the clinical effects of a medication, and I think the women who would have participated in this trial thought they were contributing to science, not to the business interests of one company,” Persaud said.
“That’s exactly the sort of information that should be publicly available.”
Persaud co-authored an article published Monday in the Canadian Medical Association Journal that calls for North American regulators to make all clinical trial data publicly available.
Health Canada told the Star that the information provided to Persaud, including the unpublished clinical trial data, was submitted over the years to the regulator “with an expectation that Health Canada would maintain its confidentiality.”
Persaud — who has previously said Diclectin may not be better than other morning sickness treatments such as vitamin B6, a component of Diclectin — said, “Now I am worried that the medication might not be effective at all.”
A spokesman for drug manufacturer Duchesnay, which wasn’t consulted by Health Canada before the records were released, said the company stands behind its product.
“Diclectin is the only proven safe and effective treatment approved by Health Canada for the treatment of nausea and vomiting of pregnancy,” said Ron Vaillancourt.
“It is also approved by the Unites States Food and Drug Administration (FDA), who granted Diclectin the highest safety status possible, Pregnancy Category A.”
In 2014, Canadian pharmacies dispensed more than 305,000 prescriptions for Diclectin, according to IMS Brogan, a company that tracks pharmaceutical trends.
Persaud said he has relayed his concerns to Health Canada and the regulator told him it is looking into the matter. Health Canada would not confirm this for the Star.
“Health Canada continually assesses new evidence regarding the safety and efficacy of all therapeutic products on the Canadian market,” a spokesperson said. “Consistent with our mandate, Health Canada will not hesitate to take any necessary actions to safeguard the health and safety of Canadians.”
Persaud aims to publish a medical journal article based on his findings. However, under the terms of the “absurd” confidentiality agreement, Persaud said, he can share his findings but not the data underlying them.
Health Canada noted in a Sept. 16 letter to Persaud, “You should be aware that Health Canada will closely monitor compliance with this Agreement and has recourse to legal action in the event of a breach.”
Though he feels muzzled, Persaud commended the regulator for releasing the documents.
“In the past, information that was confidential business information would not be disclosed at all,” he said. “Health Canada has made (this recent) decision independently and did not consult with the pharmaceutical company Duchesnay, and I think that’s the way that regulators should operate.”
Original Article
Source: thestar.com/
Author: David Bruser
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