1 Boring Old Man

Health Canada hands over documents but muzzles doctor

Toronto doctor muzzled, not allowed to talk about morning sickness drug info

Toronto Star

By David Bruser and Jesse McLean

Oct 14 2015

Dr. Navindra Persaud aims to publish a medical journal article based on his findings on the drug Diclectin. However, under the terms of the confidentiality agreement with Health Canada, Persaud said he can share his findings but not the data underlying them. Four years after he first asked Health Canada for all the information it had on a popular morning sickness drug, Toronto doctor Nav Persaud finally has the documents. 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.

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.”

The BMJ requires data sharing on request for all trials

by Elizabeth Loder and Trish  Groves

British Medical Journal. 2015 350:h2373

Heeding calls from the Institute of Medicine, WHO, and the Nordic Trial Alliance, we are extending our policy. The movement to make data from clinical trials widely accessible has achieved enormous success, and it is now time for medical journals to play their part. From 1 July The BMJ will extend its requirements for data sharing to apply to all submitted clinical trials, not just those that test drugs or devices. The data transparency revolution is gathering pace.2 Last month, the World Health Organization [WHO] and the Nordic Trial Alliance released important declarations about clinical trial transparency.

These announcements come on the heels of the US Institute of Medicine’s [IOM] report on sharing clinical trial data, which called for a transformation of existing scientific culture to one where “data sharing is the expected norm.” The efforts of industry, too, must be acknowledged, some of which caught many people by surprise. In particular, Medtronic’s cooperation with the Yale University Open Data project and GlaxoSmithKline’s leadership on data disclosure efforts stand out…

• agreeing with the BMJ’s move for Data Transparency
• an author on a paper advocating Data Transparency
• having spent countless hours working on a remote desktop that was really hard to work with [we called it the periscope]
• And my coauthors and the journal editors were wondering why I hadn’t posted the data!

I couldn’t post the data because in order to see it, we signed an agreement with GSK that forbade us from taking the data out of the remote desktop or releasing it directly. In our case, there was a fortuitous anomoly, a loophole or workaround. The efficacy data had been posted already by GSK [belatedly] [under court order] in 2012. It’s in graphics-based .pdfs and would have to be transcribed into some kind of tabular form to be analyzed [either by hand or with some super-duper OCR magic that I couldn’t bring off]. I’ve done some of it by hand and can attest to the fact that it’s a Herculean task. In fact, we were doing our paper from that data originally, but changed tactics when we realized that we needed the raw CRFs to analyze the harms. So we applied to GSK for access. I could at least post the links to the public version fulfilling BMJs requirements, though working with the data in this form is a real bear:

I don’t want to seem ungrateful. After all, we did get access in the end and that rarely happens. But the amount of effort it took to reanalyze the data in the format supplied was impressive and, in my opinion, unnecessary. There was nothing in that data that would breach Subject Confidentiality or in any way fit the criteria for Commercially Confidential Information [CCI]. It’s just numbers. So neither argument really offers a reason for secrecy.

I can’t mount a formal argument that the difficulty using the system or the restrictions on publishing the data were deliberate attempts to interfere with our doing the analysis, though it certainly felt that way at times. Since the Subject Confidentiality and Commercially Confidential Information assertions seem spurious, I suspect that the motive was to maintain control. And as I’ve said repetitively, there’s no reason to hide the data except to have the option to distort the analysis without letting others do any checking. There are simply too many examples where corrupted analysis has been documented to justify continuing to see this Clinical Trial data as proprietary.

So I have nothing but sympathy for Dr. Navindra Persaud.  He’s playing against a stacked deck that makes reanalysis a heroic act rather than what it should be – a necessary piece of oversight. In his case, it directly goes against the intent of Canada’s Vanessa’s Law [see doing the right thing…], and I hope he takes it to their Parliament for clarification.