Paxlovid, prescriptions and distribution in Canada
Why paxlovid is not the silver bullet we want it to be
Good news, paxlovid has been approved by Health Canada. Paxlovid is a treatment for covid that:
When taken within five days of infection, Pfizer's clinical trials showed that the drug reduced risk of hospitalization or death by 85 per cent.
But wait,
Canadians will need a prescription to get Paxlovid, according to Health Canada.
[..]
It is important to note that patients seeking the treatment will also need to secure a positive PCR test to confirm they have COVID-19. But in the wake of the latest Omicron wave, lab-testing capabilities have been limited in many parts of the country — meaning just getting a test could pose its own set of challenges.
If a PCR test is not available, Chief Public Health Officer Dr. Theresa Tam said a positive result on a rapid antigen test would also suffice.
Because the drug should be taken early on in the course of your illness — within five days of symptom onset — you are on the clock to get both a positive lab test and the prescription in hand.
Maybe that's not so good. So to get this life saving drug, we have the following roadblocks in place:
Get covid (not a difficult barrier to overcome in Canada these days) and develop symptoms. This starts the five day timer where paxlovid is useful.
Test positive for covid on a PCR or rapid antigen test (PCR tests aren't available to most people in Canada, and rapid antigen tests are not as accurate and also hard to come by)
Get a doctor to give you a prescription for paxlovid (many Canadians don't have doctors, walk-in clinics and ERs are overwhelmed so its hard to actually see a doctor, etc.)
All of this while you're sick with covid. Therefore it's probably going to be pretty hard to get paxlovid! It's ironic, if your covid is mild enough to not be overly affected in terms of judgement or capabilities to get these things done, you probably don't need paxlovid in the first place.
Why does paxlovid require a prescription? Drugs and prescriptions are not a natural phenomenon, they are a human creation, so someone somewhere has chosen this. Who chose it? Ultimate responsibility in a case like this might not be clear, even if we could review Health Canada's correspondence. In a lot of cases, the rules laid out will have certain guidelines, such as which categories of drugs will require prescriptions and which will not. It is an easy choice on behalf of the bureaucracy to follow these guidelines. I thought it might be an interesting test case to examine where this decision to make it a prescription drug came from.
According to Health Canada's website:
Changes to the Food and Drugs Act (section 29.1) will give the Minister of Health the power to establish a list that sets out prescription drugs.
The Prescription Drug List is a list of medicinal ingredients that when found in a drug, require a prescription. It does not include medicinal ingredients that when found in a drug, require a prescription if those ingredients are listed in Controlled Drugs and Substances Act Schedules.
The list includes line listings of ingredients, their salts and derivatives when appropriate, some examples of these ingredients, any applicable qualifiers, and the date the listing came into effect. The list has two sections: one that pertains to human use and the other to veterinary use. Any updates to the list are published on a weekly basis.
So part of some process in Health Canada has Jean-Yves Duclos, Minister of Health decide that:
Paxlovid has ingredient `X`
Drugs with ingredient `X` require a doctor prescription to purchase
Therefore, paxlovid requires a prescription to purchase
Is M. Duclos responsible for requiring a prescription for paxlovid? According to Wikipedia, he is an "economist and politician". Is he qualified for determining if a drug meets the requirements? Let's assume he is capable of reviewing a list of ingredients provided by Pfizer to look for any ingredients on the Prescription Drug List. Would M. Duclos consider himself as responsible for this decision? He probably didn't do more than review a document prepared by an expert that said that paxlovid met the requirements for being on the Prescription Drug List. So, he may say that he signed a document, but he would probably say that the rules are the rules and (while minister) is following the guidance set out by the experts at Health Canada. Okay, so M. Duclos doesn't consider himself responsible, we are going to have to look for a new individual to blame.
Who prepared the document that M. Duclos signed? According to the notice, the Therapeutic Products Directorate Office of Science has conducted a scientific review of the drug and determined essentially that ritonavir tablets are already listed on the Prescription Drug List. Ergo, paxlovid requires a prescription. Let's say that Jane Smith is the Director of the Therapeutic Products Directorate and has signed off on a document saying that paxlovid should be on the Prescription Drug List. Is Jane Smith responsible for this decision? Jane would probably say that ritonavir tablets are already listed on the Prescription Drug List, so the rest of the drug should be as well. Her hands are tied, the rules are the rules. Jane doesn't consider herself responsible, so we are going to have to look for a new individual to blame.
Angela is a junior member of the Directorate, having graduated university in a relevant field recently. As part of the learning experience, junior members usually prepare the documents that Jane Smith will sign off on to send to the Minister. Angela assessed the ingredients of paxlovid and determined that yes, the ingredients are on the list, so paxlovid should be on the list, and so she prepares the document that is approved all the way up. Is Angela responsible for the decision? She wrote the document, she used her university education to assess the requirements. But she's junior in the department and relies on the expertise of her superiors (as she should) and she stands on the shoulders of giants, who determined in the past that these ingredients mean that a prescription should be obtained for particular drugs. Angela doesn't consider herself responsible (rightly so in my opinion). There's no one further down the chain we can look at though, so who's fault is this?
It's at the same time everyone's fault and no one's. The system really made the decision (ingredient x
== prescription). Humans created the system of course, so this is a political decision. Would it be possible for M. Duclos, Jane or Angela to stop and make a different decision? Within the constraints of the system, probably not. Angela would be fired for not doing her job (assess whether ingredient x
== prescription), Jane reassigned (poor judgement at not having her junior staff follow the rules) and M. Duclos shuffled to a new cabinet post by his boss M. Trudeau.
Alex Tabarrok was talking about the delays of approving paxlovid in the United States back in November (months before Health Canada approved it!) and how that was killing people. Now, we have a systemic problem in Health Canada creating road blocks from individuals receiving a life saving drug during a pandemic. Everyone followed the rules, but has anyone stopped to wonder whether these rules are really serving society or not? Is Canada a better place because paxlovid requires a prescription?
Taking the drug within five days of symptom onset is a technical limitation. Requiring a prescription and a positive PCT and/or rapid antigen test are political limitations. These are choices. Society could choose to require a different set of steps. I realize as well that paxlovid is supply constrained and this maybe is a way of relying on medical advice to determine how to best allocate a scarce resource. My issue is that for most people, it will be nigh impossible to get it. By the time you're in the hospital, it's probably almost too late for it to be effective. I'm concerned by the fact that this is a political (as opposed to technical) decision made by essentially no one. Everyone has followed the rules, and the outcome is not ideal.
Maybe apropos of this, John Boyd, colonel in the U.S. Air Force, gave a speech to one of his followers at one point:
And you’re going to have to make a decision about which direction you want to go.” He raised his hand and pointed. “If you go that way you can be somebody. You will have to make compromises and you will have to turn your back on your friends. But you will be a member of the club and you will get promoted and you will get good assignments.” Then Boyd raised his other hand and pointed another direction. “Or you can go that way and you can do something — something for your country and for your Air Force and for yourself. If you decide you want to do something, you may not get promoted and you may not get the good assignments and you certainly will not be a favorite of your superiors. But you won’t have to compromise yourself. You will be true to your friends and to yourself. And your work might make a difference. To be somebody or to do something. In life there is often a roll call. That’s when you will have to make a decision. **To be or to do?** Which way will you go?