The trouble with Public Health: HIV/AIDS in Canada as a case in point

Here's my latest Editorial from the February issue of Bioethics

It has been known among HIV/AIDS specialists for many years that infected people are for all practical intent and purposes unable to transmit the virus on to their sex partners, provided they consistently take anti-HIV medicines that render the amount of the virus in their bloodstream undetectable. Common sense would have suggested that Public Health authorities should have acted on this knowledge and ensured that it is deployed in such a way that it contributes toward the maximisation of desirable public health objectives, in this case, obviously the reduction in number of new infections. Public Health agencies should have revamped existing policies demanding that infected people disclose their HIV status to their sex partners to no disclosure required where ‘your viral load is undetectable for 12 months’ or some such figure. This would have dramatically increased the attractiveness of getting tested, of getting infected people discovered in a more timely fashion, getting them treated in a more timely fashion, and ultimately getting their viral load to undetectable in a more timely fashion. The predictable result of this policy change: A significant reduction in new HIV infections. Common sense and Public Health are sadly all too often residing in different realities.

Nothing of this sort occurred during the last few years. HIV infected people with undetectable viral loads were prosecuted for not disclosing their status. Public Health agencies, when given a chance, would disclose their HIV status to their sex partners. The contact tracing Public Health surveillance machine remained in overdrive in countries such as Canada. About 200 carriers of the virus were prosecuted over the years in that country alone. None of this served the public health objective just outlined, and none of this was evidence driven. Rather, it was driven by views on HIV/AIDS that may have had a place in the 1980s to early 1990s when AIDS was considered as a serious public health concern. Today, with negligibly low new infections rates, it is worth asking why HIV remains high on the agenda of Public Health agencies. HIV is clearly not a public health concern in Canada and most other countries of the global north. My suspicion is that the threat of prosecution serves purposes unrelated to HIV, they serve to control consenting adults’ sexual behaviours.

Much is made of the fact that an estimated 1:5 Canadians who are infected with the virus are unaware of their infection. What is typically not mentioned by the same Public Health officials is that they have gone out of their way to make it difficult for Canadians who are HIV infected to find out about their infection. Because the contact tracing government Public Health agencies want to know about each infected Canadian, by name and address, they cannot permit people at risk to test themselves with tests they can conveniently buy down south in the United States in every pharmacy. Unsurprisingly, a different government agency, the drug approval regulator Health Canada, has swung into action and threatened people with prosecution who import and resell reliable, US FDA approved, HIV self-tests into Canada, lest they would find out whether they are infected and Public Health not having their names and addresses on their records. You might not be surprised to learn that while STI testing and treatment is ostensibly free and anonymous at the country's Public Health agencies, in reality patients must show their provincial health insurance cards or else they are out of luck if they carry an STI but fail to provide the said card. The UK's NHS unsurprisingly manages public health in a manner somewhat more focused on infection control than administration.

It is no surprise then that in a country where government surveillance has been prioritised over and at the same time conflated with public health, people at risk of HIV infections remain reluctant to get tested. They have no reason to trust Public Health to act in a timely fashion in response to evidence.

In late 2017, Canada's federal government noticed after much studying what has been known for years about HIV transmission risk and undetectable viral loads. Both federal and provincial justice ministers appear to be finally acting in response to the existing evidence. Prosecutions of HIV infected people with undetectable viral loads who do not disclose their status to their sex partners are likely to be a thing of the past in that country.1

The main lesson I am suggesting we take away from this episode of HIV/AIDS prevention in Canada is to ask that Public Health agencies' policies should be held to public health outcomes, otherwise they serve no purpose. The cavalier approach to civil liberties taken not only by Canada's Public Health agencies, one that was not evidence based for many years, must be replaced by a policy approach based transparently on the latest scientific evidence. A golden rule in most public health ethics documents is that limitations on civil rights (in this case ownership of one's confidential health information) must be justified by significant benefits in public health outcomes, i.e., the public interest. HIV disclosure policies executed by Public Health agencies have failed this test for a very long time. Public Health agencies in Canada in particular have lost trust and support among people at risk of HIV infection because they lost sight of public health outcomes while focusing on Public Health administration and control. A paradigmatic case of how not to implement efficient infection control policies.

Footnote

1. 1
   Harris, K. (2017, December 1). Liberals want to limit prosecutions of people who do not reveal status to sex partners. CBC NEWS. Retrieved from http://www.cbc.ca/news/politics/liberals-hiv-criminalization-1.4428395

Health Canada Badly Fails Canadians at Risk for HIV Infection

A surprising tweet landed in my inbox some time late yesterday afternoon. Health Canada issued a 'warning' about OraQuick in Home HIV Test. It's currently available for sale on the Canadian site of Amazon. Now, you might think, what qualms could one possibly have about Health Canada issuing a warning about this HIV self-test kit? It might be untested, not doing what it promises to do, etc etc. Makes sense then that the agency 'has initiated compliance and enforcement actions', as it notes darkly on its website, showing its regulatory teeth where it purportedly matters. In any case, you might think, why don't people use a self-test kit that has actually been approved by the agency?

Here the plot thickens. Turns out, 'there are currently no HIV test kits authorized by Health Canada for home use.' In other words, our regulator has chosen not to authorize any HIV self-test kits for use by us. Your guess is as good as mine as to why this hasn't happened. Perhaps our draconian and control obsessed public health agencies want to prevent individual access to self-tests. Perhaps there is an assumption by the medical establishment that we're just too daft to administer the self-test. Perhaps there are mistaken assumptions about our ability to cope should the test results give us reasons to be concerned. Countries such as the United States, and the UK as well as quite a few others have given regulatory approval for these test kits. Apparently competent adults are not treated like children in other parts of the world.

So, what about OraQuick's home HIV test? Let's see, here are customer reviews at US pharmacy chain CVS's website. Yep, it's a 5***** product. People who have used it love it. Well, as we all know, people also love homeopathy, so this tells us little about whether a product is good or works. Let's go then to a regulatory agency that, unlike Health Canada, actually does its job. The United States Food and Drug Administration has approved this home test in 2012.

As I said earlier, I don't know why Health Canada is doing such a lousy job on this front and doesn't evaluate and approve HIV home test kits. They work, they are known to be used widely and they serve to make people more knowledgeable about their HIV status who might - for reasons best known to them - do not wish to inform our Public Health Agency of their HIV status. These people are put off testing by the need to see a doctor and get a script to get tested for HIV. This obviously undermines important public health objectives. Fewer people at risk for HIV infection will get tested. Some HIV positive people will remain ignorant of their status and likely pass on the virus to sex partners. It is public health foolishness not to make access to HIV testing as easy as possible. This, of course, conflicts with the never-ending control freakery public health professionals are notorious for.

I understand why Health Canada needs to act on unregistered products being sold in the country. However, there are products and products. This particular product has been approved for use by a serious, better resourced and arguably better functioning regulatory agency than Health Canada, the FDA. Health Canada has failed for years to test (and approve) this particular product. To now go on a twitter campaign and on an enforcement campaign to prevent the sale of this product in the country suggests seriously wrong priorities at the agency. Meanwhile Canadians tired of this nonsense are at least able to hop across the border, go into any pharmacy they fancy and be treated like actual adults. The product triggering Health Canada's 'compliance and enforcement' activities is on the shelves there. Apparently Health Canada has the resources to engage in compliance and enforcement this-n-that, testing and approving sensible products? Not so much.

How about focusing on actual bogus products or products known to be harmful?

Could Canadian patients be prevented from accessing experimental Ebola drugs, too? You bet they could!

Ok, so I'm a tad bit lazy. Sections of the post below are actually a few months old and I'm re-posting them here, because of the current debate about access to the experimental drug deployed in the case of the two Ebola missionaries in the United States. 

First things first though, on the current debate: There has been a bit of a storm in a teacup about the question of whether or not it is just to provide an experimental treatment for Ebola to two sick missionaries who returned home to the United States from West Africa while denying it to dying Africans. Art Caplan has provided a reasonable analysis of the issues in a Washington Post OpEd. I disagree with him on the reasons for why the agent cannot be produced now in larger quantities and shipped to West Africa (poor start-up company and all that jazz). There is no reason to accept an artificial scarcity (i.e. human regulation made) as a kind of natural law, inevitable and beyond our control. Still, Caplan is right, it would be difficult to provide the medication locally in West Africa where it's needed, due to the relatively fragile nature of the experimental agent (it needs special handling, be kept in a freezer and whatnot). And yes, imagine the drug actually was a dud, potentially doing more harm then good. The same professional do-gooders shouting now racism and demanding delivery of the medication to Africa would turn around before you can say 'ouch' and excitedly shout 'exploitation' and 'African guinea pigs' and, yes, 'racism', because that charge usually sticks. 

From the published reports about the experimental agent it's unclear - to me - at what stage in the R&D process it is. It seems to me - I might be mistaken here - that the drug hasn't undergone phase 1 clinical trials (i.e. how dangerous to human health is it?). From the experience with the two missionaries it seems at least as if it ain't too toxic. Still, two folks count for all scientific intent and purposes as an anecdote. Not a big surprise though, that proper trials have not been undertaken, given how quick people die, and in what locations they usually die. Doing placebo-controlled studies - no doubt the methodological gold standard under the circumstances - also seems a dicey proposition seeing the high mortality rate among infected people. 

Fundamentally though, the question is whether knowledgable patients suffering from catastrophic illnesses should be permitted to access experimental drugs. Ebola is just the latest disease triggering this debate. It turns out, the situation the African patients find themselves in isn't that different to the situation faced by Canadians suffering from other catastrophic diseases.  It's here where my mentioned older post kicks in...

Imagine you suffer from a catastrophic kind of illness, an illness that’s invariably going to kill you in the near future. Everything that you and your doctor know about the illness suggests that your death will be anything but peaceful. Doctors can deal with some of your symptoms and palliative care can address some of the pain you are experiencing. But that’s about it.

Sadly this scenario isn’t unrealistic. Many Canadians face this sort of situation today.

During a scheduled visit to your specialist doctor you learn that there’s a brand-new drug currently being tested that might just save your life, if it worked that is. The doctor has already inquired with the researchers testing the drug in a phase-three clinical trial and you would be eligible to participate in that trial.

Phase-three clinical trials are trials at which stage in the drug research and development process we know what its safety profile looks like and we have pretty good evidence to think that it’s effective to some extent. That is so because during earlier trials, involving initially animals and eventually other patients, sufficient evidence has been accumulated to justify letting the phase-three trial go ahead. Now the doctors are trying to recruit a fairly large number of patients in order to establish whether the drug is as good as they thought it is. The nature of your disease is such though that there is no standard therapy around to assist your struggle for survival. The trial design in such cases demands that the experimental agent is tested against a placebo control, a dummy pill. That’s done because we need to know, before doctors can confidently prescribe the drug to patients like yourself, that the drug is doing better than what is the status quo – ie no drug. It’s always possible that an experimental drug actually does worse than the dummy pill.

Now, ask yourself, if you were that patient: Would you be willing to participate in a last-chance clinical trial where you’d have a 50:50 chance of getting a dummy pill? You know already what the dummy pill would achieve: your death. Would you trust the investigators to pull the plug quickly enough for you to survive if they discovered that the experimental drug actually works? In case you want to get a better handle on how it feels to be faced with this sort of decision, check out this blog (adriennes.blog.com) by a Toronto-based melanoma patient.

Many people suffering catastrophic illnesses flat-out refuse to participate in research that’s designed as I have described it. Their argument is not about the trial methodology, it is sound. Their argument is about the ethics of providing dying people with a coercive offer: join my clinical research project on my conditions or die a predictably horrible death.

The good news is that the story doesn’t end here. It has been recognized by regulators both in Canada and elsewhere that such coercive offers to people fighting for their very survival are incompatible with the fundamental values of liberal democracies. We must not reduce patients suffering catastrophic illnesses to mere means to achieve our research objectives. While that’s nothing much other than an honorable principle, there’s also a more pragmatic reason for this. I’ll get to that in a moment.

Health Canada actually permits people who suffer catastrophic illnesses to access drugs that are in the clinical trials system, and they can do so without actually participating in the clinical trials I mentioned earlier. The agency runs a Special Access Program for these sorts of patients. The program permits patients to access the experimental agent without trial participation. In return they promise to have their doctors monitor the impact of the drug carefully and report it back to the manufacturer or whoever runs the clinical trial. One of the ethical reasons for this I have just mentioned. The pragmatic reason for this solution is this: it was discovered during the early days of the AIDS epidemic, when no life-preserving medication existed, that patients who are coerced into placebo controlled trials will simply cheat in order to get access to the actual experimental drug. HIV-infected people enrolled in ostensibly placebo-controlled trials and then took their drugs to chemists to find out who did and who didn’t get the active agent. They then started sharing the actual drug and dumped the placebo. That, of course, rendered the trial pretty useless. True volunteers would have accepted the uncertainties and volunteered to test whether the experimental agent is any better than the placebo control.

The problem patients with catastrophic disease who wish to access experimental drugs through our Special Access Program face today in Canada is two-fold: Health Canada leaves it up to pharmaceutical companies to decide whether or not they provide drugs to eligible patients. Manufacturers who have trouble recruiting sufficient numbers of patients into their trials could deny patients access to the experimental drug to encourage them to join the trial on their conditions. They might also have other reasons for refusing to provide catastrophically-ill patients with access to an experimental drug. Either way, we are back to square one: a coercive situation. This problem occurs more frequently in Canada than you might think. Here is a heart wrenching appeal (http://www.youtube.com/watch?v=olwDT7NPSsM) from one such patient, who has since died. A Toronto paper contacted me about another case recently, both cases interestingly involved pharmaceutical multinational Bristol Myers Squibb refusing to provide an experimental drug that the company is testing in a phase-three clinical trial right now. This issue should be addressed by Health Canada as a matter of urgency. The other problem is that manufacturers are permitted to charge for their experimental drug. That is unreasonable. It costs typically cents to produce such medicines – I am not talking research and development costs but actual production costs. There is no reason whatsoever why pharmaceutical companies should profit from experimental drugs. They should be compelled by Health Canada to provide such agents to clinically eligible patients, while the clinical trials are ongoing and the drug isn’t formally approved as a for-pay prescription medication. If Health Canada were to address these shortcomings of the present Special Access Program it would ensure that catastrophically ill patients are given a fairer shot at actually accessing these experimental drugs.

Udo Schuklenk holds the Ontario Research Chair in Bioethics and Public Policy at Queen’s University, he tweets @schuklenk

There's medicine and then there's other stuff

Today's piece from the Kingston Whig-Standard on 'alternative medicine'.

It’s one of those things: you better not criticize homeopathy or else there will be a deluge of complaints from homeopathy ‘practitioners’ as well as satisfied ‘patients’ questioning your motives, your connections to that oh-so-evil pharmaceutical industry, and whatnot else.

Well, let me start this off then by saying that I am not an industry shill, that — to the best of my knowledge — I own no shares in pharmaceutical companies and that I am not paid by any pharmaceutical company to say what I am about to say.

How do we establish whether a particular chemical substance works as medicine? We test it elaborately in clinical trials. Typically we test the substance first in animal experiments. That has its own set of ethical issue that I won’t go into today. Then we move from animal experiments to toxicity tests in a small number of people. All we want to find out here is whether a particular candidate drug is safe. Once we have established that it’s sufficiently safe to test it on a much larger number of people we begin in all earnest clinical trials. Here we compare our candidate drug either against an already existing drug — to see whether it fares better or worse — or against a placebo if we have no gold standard of care. These trials, while not perfect, give us pretty good indications of whether something ‘works’ for particular conditions. Based on the evidence accumulated in these clinical trials drugs get eventually approved (or rejected, as the case may be) by Health Canada, the FDA in the United States and their equivalents elsewhere. It is a system that isn’t perfect, but as far as the scientific method goes, it’s the best that we can do.

Then there is other stuff out there in the business of health care. Plenty of ‘complementary’, ‘alternative’, ‘natural’, you name it concoctions. We know of many of them that they either definitely do not work at all or that they can in fact be bad for your health. There is ever more evidence accumulating that those much praised anti-oxidants in many ‘natural’ products, for instance, might actually be detrimental to our health. What all these concoctions have in common is that they have not been rigorously tested. Had they been tested they would already have lost their cloaking device of ‘natural’, ‘complementary’ and ‘alternative’. Simply put: any such concoction can in principle be tested for safety and efficacy. Once they have been tested we can know whether they work or not. Once we know they become standard medicines or they are discarded. After all, most of them have chemical substances at their heart that do something, but until we test what they do, they’re just that, untested concoctions that may or may not do what their buyers hope they will do.

Strangely these concoctions can be bought as ‘remedies’ of some sort or another in many alternative health food stores, and sadly even pharmacies. They are actually really expensive, too. I went to such a store a few months ago, and I couldn’t believe how much these little plastic bottles with their miracle powders and natural pills of sorts cost. It all seemed like a rich people’s hobby to me. In any case, this begs the question of why Health Canada approves the sale of such concoctions.

According to an editorial published in the British Columbia Medical Journal, Health Canada has approved the sale of various homeopathic concoctions as flu remedies. They are supposed to prevent flu and its related symptoms. Well, to cut a long story short, these homeopathic concoctions are nothing other than super-highly diluted infectious agents that are orally administered. They are so highly diluted that often you can’t find anything other than water in these homeopathic remedies. The danger here is that people choose to ‘protect’ themselves against the flu by using such untested concoctions. None of them have been shown to actually protect against the flu. Health Canada is seemingly OK with this status quo. It notes on its websites that these concoctions can be used safely as long as the directions from the manufacturer are followed. Funny enough, they can be used safely, because they don’t actually do anything. You could also drink water from the tap safely that’s properly treated. Do you recall the mass ‘suicide’ attempt by homeopathy critics a year or so ago? They publicly, all over the world, ‘overdosed’ on homeopathic sleeping remedies. Ignoring the warning labels they downed full bottles of homeopathic sleeping pills, and, surprise, surprise, they didn’t even get tired.

Health Canada now requires such remedies to show warning labels stipulating that they are not meant to replace properly tested vaccines. That’s all nice and well, but it begs the question why health remedies that have not been shown to have any demonstrable health effects should be on the shelves of health food stores, pharmacies and other outlets at all? The British Columbia Medical Association got it right when it insisted that Health Canada should only permit the sale of such concoctions after they have been shown to be both safe and effective. That is not the case today. There is a reason why the English National Health Service closed down its last homeopathic non-treatment facility, aka hospital. It just doesn’t work.

There is another danger in our regulatory agency’s approach to these kinds of remedies. By virtue of its stamp of approval people skeptical of mainstream vaccines might think of them as possible alternatives, despite the agency’s disclaimer. After all, Health Canada has approved these concoctions for sale. The fewer people get vaccinated, the weaker we are as a group. Herd immunity prevents outbreaks of infectious illnesses, but it requires that most of us participate. We know that in communities with high levels of resistance to mainstream vaccines infectious disease outbreaks occur. Alternative untested flu concoctions will likely contribute to such occurrences if Health Canada does not stop their sale as health products.

Udo Schuklenk teaches bioethics at Queen’s University, he tweets @schuklenk.