'Active Surveillance: Part 2'
CAERS SUBSTACK ARTICLE #14
‘ACTIVE SURVEILLANCE: PART 2’
CAERS SUBSTACK ARTICLE #14
If you have ever lost something, you have probably realized that the most likely way to find it is to look for it. Seems pretty obvious, doesn’t it? Of course, sometimes it shows up without such a search, but generally most of us know that waiting for it to simply show up is usually not the best strategy, especially if that something is important to us or we need it urgently. This principle applies not only to physical objects but to knowledge as well, and sometimes knowledge is not so much lost as it is still unknown. Either way, searching for it will typically yield better results than taking a ‘wait and see’ attitude.
In a previous article (Article #12, ‘Noticing What Isn’t Said’) I explored the fact that occasionally really important concepts are not communicated when perhaps they should be, and that includes critical information. Sometimes that critical information is like an object that we have misplaced, and other times it is not misplaced but simply not known at all. Unlike searching for the valuable object we once had and now have misplaced, sometimes we’ve never known the information yet we still do not bother to actively search for it.
When a new medical therapy is being proposed, we demand that the developers actively search for evidence of the efficacy and safety of their intervention and then communicate that directly. We do not accept a passive ‘wait and see’ attitude, simply hoping that such critical data will just show up on its own sooner or later. Only once a sufficiently vigorous search has taken place, and the data for efficacy and safety meet rigorous standards in a transparent fashion, will authorization for its use in the public domain be granted. We recognize that ethical use of a therapy can only be achieved by seeking to discover not just benefit but also harm, and making that public and accessible.
This has not happened with the various COVID vaccines. That is particularly surprising given that the authorities have repeatedly referred to the virus as ‘novel’, the vaccines utilize not only new technology but genetic technology never before used with a vaccine, and the vaccines are still in the experimental stage (phase 3) of clinical study. So, knowledge about their efficacy and safety is not like looking for something lost, but rather like looking for something that has yet to be discovered at all. But like something lost, the most likely way of finding it is to diligently look for it. In medical research circles that is referred to as ‘active surveillance’, and that is always used during phase 3 of any clinical trial. Except with the COVID vaccines.
What does ‘active surveillance’ normally entail? Let’s look at what happens when researchers are investigating a potential new chemotherapy during phase 3 of a clinical trial, before it has been authorized for use in the public domain. If a person with cancer agrees to receive this experimental treatment, they will be closely monitored not only to see if the chemotherapy is effective but also to identify unexpected side effects, some of which may be unpleasant or even harmful (known as ‘adverse effects’). The patient will meet regularly with the specialists and researchers overseeing the drug’s use during which they will be questioned and examined extensively by these experts and perhaps even undergo tests, such as imaging studies or various blood tests. This close follow-up will happen not just each time they receive the chemotherapy, but also between visits, with the patient being encouraged to maintain contact with the research team and to directly report any changes, good or bad. This intense monitoring might continue for years, even after the chemotherapy is complete. Researchers do not casually and passively lounge around waiting to hear if the chemotherapy is safe and effective; they go out and actively look for that information because peoples’ lives are at stake.
When the COVID vaccines were granted Emergency Use Authorization (EUA) by the Canadian government, they were still in phase 3 of clinical trials and active surveillance should have been engaged. Because virtually every person receiving the vaccine had to book an appointment specifically to receive it, there was ample opportunity for the authorities to question each person at the time of the injection and to follow up with them (by phone, email, regular mail, text messages, etc.) afterwards. This is particularly true because most people went on to receive a second, third or even fourth dose, at which time face-to-face interviews could have been done to inquire about both the efficacy and safety of the previous injections. But none of this was ever done, despite the fact that this was a gene-based injection still in clinical trials. This monitoring would have been so easy and so inexpensive, and would have provided massive amounts of data useful not just for this vaccine and this pandemic, but for all future such vaccines and pandemics.
And yet, active surveillance was not done. By a government claiming to have our health as its primary interest. During the worst pandemic to hit this country in the last 100 years.
Irrespective of how one may feel about COVID and the vaccines, every Canadian should, at the very least, be disappointed that active surveillance has not been done. It is hard to find any ethical or scientific justification for that, given the circumstances.
Sometimes what has not been said or done, like active surveillance, is as important as what has been said and done. And that should worry all of us.
J. Barry Engelhardt MD (retired) MHSc (bioethics)
CAERS Health Intake Facilitator
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