Last year, I embarked on an arduous journey—one that many have attempted, but on which few have found success. I set out to have a few simple questions answered by Health Canada.
I’m not sure what I expected from an organization that once received an award from the Canadian Association of Journalists for being the most secretive government department in the country. I suppose I thought that Health Canada might be thankful that I, an emergency physician and expert in pharmaceutical policy, wanted to discuss and correct some seemingly-wrong information they were putting into the public about clinical trial registries.
My journey began back in June 2021, when Health Canada held a webinar to discuss its plans to “modernize” the way that it regulates clinical trials. During that webinar, one Health Canada employee explicitly said that the World Health Organization (WHO) no longer wanted individual countries to develop their own clinical trial registries. I was pretty sure that this was not true, and I wanted any written record of the webinar to correct this statement.
While the actual point in question may seem relatively minor, the overall issue about getting accurate, timely and complete information from Health Canada is extremely important, especially as we are seeing an escalating level of misinformation about the COVID-19 pandemic in general and vaccines in particular. If people cannot trust Health Canada on simple issues, then we are doomed when it comes to more complex ones.
The first attempt
My initial email was sent last August to Dr. J Patrick Stewart, the Director General at the Therapeutic Products Directorate, the part of Health Canada in charge of approving new drugs such as pills, tablets, liquids, creams, etc. Attached to my email, I included information that I received from the manager of the WHO International Clinical Trials Register Platform and another one from a PhD student at Oxford University who is studying international registries. In my email to Dr. Stewart, I pointed out that, in contrast to what Health Canada had said in its webinar, both of these experts denied that the WHO had a policy of not wanting countries to develop clinical trial registries.
Clinical trials are essential in understanding the effectiveness and safety of medicines before they are marketed. In the past, some drug companies have tried to hide the results of unfavourable trials by not publishing them, effectively keeping their findings hidden from both doctors and patients. Clinical trial registries make these findings public on government-run websites, laying out characteristics of the trial including: who is paying for it, the names of the principal investigators, how many patients are involved in the trial and where the trial is being run. Even though Health Canada has a clinical trial database, it only lists trials that are actively recruiting patients—much to the frustration of medical experts nationally who would benefit from a much more comprehensive list of trials taking place in Canada and the results of those trials.
The so-called “near future”
Two weeks went by after I sent that first email to Health Canada. As of September 6, I had not heard back, so I sent a second email to remind them. Two days later, I received a canned response: Health Canada had received my email and were reviewing my response. They promised to follow up “in the near future,” which left me feeling hopeful. To any regular person, “the near future” would mean, what, a few days? Perhaps a week or two?
Wrong. Almost two months later, on October 21, the “near future” had still not yet arrived. So, even though I was officially beginning to feel like I was screaming into the void, I sent yet another reminder. I had come this far, and I was determined to make contact.
On October 27, I finally received a substantive email from Dr. Stewart. In the lengthy note, he promised that Health Canada would “strive to be more clear in any forthcoming meeting records or presentations.” He maintained that there would not be any value to a new Canadian registry, and said that Canada should instead look to “the use of existing registries.” According to him, a new registry was not necessary because feedback from webinars and public sessions showed that “86% of those who provided a response do typically register their trials in an international registry (this includes both academic and industry respondents).”
He said “there were appeals to avoid increasing redundancy and/or administrative burden by creating Canada-specific requirements or a new registry.”
Finally, Dr. Stewart continued to put forth the claim that the WHO did not want countries to establish new registries. He cited WHO standards that there should only be one Primary Registry per country and that the WHO encouraged regional registries to replace national registries. Finally, he offered a follow up meeting with his staff “who are involved in the Clinical Trials Modernization efforts.”
Where do we go from here?
Not one to end a discussion with a new penpal, I responded to Dr. Stewart. I pointed out that Canada did not, in fact, have a Primary Registry so the creation of one would not go against the WHO recommendation. Second, since there was no requirement from Health Canada for clinical trials taking place in part or completely in Canada to be registered in any existing registry, Canada was not part of a regional registry. Next, I asked how creating a Canadian-specific registry would increase the workload for researchers.
If, as Dr. Stewart claimed, they were already registering trials in an international registry, switching to registering their trials in a Canadian registry shouldn’t make for more work. Finally, I took up Dr. Stewart’s offer to meet with a member of his staff.
Another month passed, and I realized through our exchange, summer had become fall. Fall was beginning to turn to winter. We had all grown older, but apparently not much wiser. When Dr. Stewart finally replied again, he essentially repeated the points that he had previously made. He promised that “As we continue our analysis under Health Canada’s Modernization of the Regulation of Clinical Trials, we will being (sic) taking into consideration the points that you have raised.”
The elusive meeting
I didn’t feel much encouragement. Was Dr. Stewart using the WHO as a screen to justify Health Canada’s 16 years of inaction on a meaningful clinical trial registry? I would have liked to be able to pose that question. So, in one final, last-ditch attempt to get some concrete answers to my questions, at the end of November I asked Dr. Stewart whether his offer of a meeting with one of his officials still stood.
I knew now not to expect a response right away, but in the middle of December, a Christmas miracle occurred. I opened my email inbox to see that the answer came back from Dr. Stewart. I opened the email with bated breath, wondering if I would finally get a meaningful answer, after having waited so long, bravely slicing through many layers of bureaucracy to get here. I began to feel hopeful again, imagining myself meeting with Health Canada officials to discuss this important matter.
Instead, his response was like a lump of coal in my stocking: Dr. Stewart did not give me any invitation to have a face-to-face meeting with him or any of his colleagues. Instead, I only had an empty-seeming promise that he “would invite [me] to stay tuned for further opportunities to comment on draft guidance via a formalized consultation process.”
But you see, the problem is not with the Health Canada employee at the webinar, nor is it with Dr. Stewart in particular, or any other individual. The problem is with the culture that exists within Health Canada, a culture that seems to regard the public as a nuisance rather than those it needs to serve, and which the Canadian Association of Journalists had ignominiously awarded for secrecy.
At that point, I gave up. Four-month series of fruitless email exchanges had demonstrated that this crucial government ministry appears to have become no less secretive.