For a university assignment I have recently been asked to write about regulation of human genome editing. Since the essay has not been marked yet, I’m unable to publish it online (I likely will at some point), but it has got me thinking about wider medical regulation. From my perspective, there’s a strong moral argument for weaker regulation of medical technologies; so, I would like to use this space to try to get to grips with my thoughts, and also to see any interesting counter-arguments before I flesh the idea into something more formal.
Imagine there is a disease that kills 100,000 people annually. There are no known measures to prevent contraction, and if you catch it there is a high likelihood of death. Suppose a team of scientists manage to invent a cure for that disease that is readily available and approved to be rolled out. However, they decide not to distribute it until they have agreed how to distribute the profits; effectively, their own greed delays its distribution. As a result, it takes a year for their contractual disagreements to be settled and 100,000 more people die who could have been saved with their cure. Whilst some contrarians would disagree, I can imagine most morally sound individuals would find their conduct unconscionable.
Now let's think of this situation in a different way. Suppose those same scientists don’t delay the rollout of the cure because of greed, suppose they’ve done it because the public health authority of their country has prohibited them from rolling it out. Even for a perfectly safe drug that has gone through all the internal testing with a company, this will still need to get approval - a process that could take an extensive amount of time. In all likelihood this could delay rollout by a year and also result in 100,000 deaths.
Now I won’t go so far as to call these actions morally equivalent. Clearly the latter is motivated by concern for the individual, and in all likelihood will route out some harmful drugs - giving thalidomide to pregnant people comes to mind. However, for every baby saved from the harmful effects of thalidomide there are an unknown number of people needlessly dying by the overbearing nature of the regulators.
Take a drug like paxlovid. A November study by Pfizer found that providing this drug to those suffering from COVID decreased their chance of hospitalisation and death tenfold without detectable side effects. In the words of Scott Alexander “It was so good that Pfizer, “in consultation with” the FDA, stopped the trial early because it would be unethical to continue denying Paxlovid to the control group”.
This drug has now been approved by the FDA, the Americans regulator, but such approval has yet to occur in the UK. Thankfully, today (22nd November) the Government have announced they’ve purchased 2.5 Million treatment courses of this seeming wonder drug, however until it is approved by the Medicines and Healthcare products Regulatory Agency (MHRA).
This is despite cases soaring at the moment due to the omicon variant. Even if we’re right that this variant will not be as damaging, we will still inevitably see an upturn in hospitalisations from the most vulnerable who will catch this. January outside of a pandemic is a turbulent month for the NHS, so any additional pressure given to Omicon could be extremely deadly in that it will both cause deaths directly and indirectly take focus away from other essential services.
This is where I’d like to suppose a policy that is not original, but one I think needs restating. Why don’t we just accept the approval of other established countries? The FDA, love them or hate them, know what they’re doing. If they’ve approved a drug we can assume it’s safe. The same applies for the European Medical Agency. These are all world class scientists applying with great precaution their best judgements in permitting these drugs. We have no reason not to trust them. Now the FDA have approved paxlovid why should we have to wait for the MHRA’s inevitable decision to approve it before the Government can provide the doses they’ve already bought. Unnecessarily more people will die by this delay.
I don’t want to be radical with this policy and suggest abolishing all regulators absolutely and relying on a system of tort law, because that’s firstly not realistic and also not feasible given inadequacies in access to justice in this country. However, it does not seem to be beyond reason that the Government could draw up a list of reputable regulatory agencies like the FDA and the European equivalent and say - if it’s good enough for them, it’s good enough for us. This would lead to a speedier rollout of drugs, making it easier and cheaper to get them into bodies, hopefully saving thousands of lives.