Canada’s patients need the ‘Right to Try’
Terminally ill patients should have every chance to access potentially life-saving treatment.
This is common sense to virtually everyone. We like to think that our health-care system does the best it can. Health Canada’s review and approval process attempts to ensure that only safe, effective treatments go to market, while helping to fund new research.
However, this process can take many years and dollars before bearing fruit. While drugs are stuck in a regulatory bog, patients with life-threatening diseases may exhaust conventional options for treatment, and be stuck waiting for new ones, or hoping to be selected for clinical trial. Crucial drugs may sometimes be available overseas, but cannot be prescribed in Canada because they haven’t been licensed here. Not uncommonly do patients pass away or suffer terribly in the meantime.
If this sounds unconscionable to you, then you’re not alone. In Canada and the United States, “Right to Try” (R2T) movements have taken root, arguing to allow terminally ill patients access to unproven treatments as a last resort. Thirty-three U.S. states have managed to pass R2T laws, with overwhelming bipartisan support. In Canada, this is regulated at the federal level, and we have taken only baby steps.
Health Canada has a special access program for unapproved pharmaceuticals which attempts to offer a way around barriers. But applications must pass through Ottawa, and the criteria can be restrictive. Nor does it address disincentives to drug companies to offer up their experimental products.
In response, a group of amyotrophic lateral sclerosis (ALS) patients has campaigned for R2T in Canada — many are particularly interested in stem cell treatments. They propose a streamlined process, with eligible patients bypassing bureaucracy and working closely with doctors and researchers. The patient, providing full informed consent, would assume all risk in trying the drug.
This is not unlike existing legislation in the U.S., which stipulates that a patient is eligible for R2T provided they have exhausted all other options, and that the drug has passed Phase 1 safety trials.
As with any vulnerable group, there is potential for exploitation. Would Big Pharma attempt to rip off those who don’t know better? Fortunately, it’s worth noting that a patient’s trusted physician would be the intermediary. R2T law could mandate that all prior information on the drug be made available to the physician, who could then educate the patient on risks and benefits. Additionally, these drugs would be those already in clinical trials, intended for future sale. A company would not risk its reputation and millions of dollars of investment to rip off a small pool of brave patients. Notably, most companies already provide drugs through the special access program at a steep discount or entirely free; plus, there’s no reason these costs can’t be covered by our existing health-care system.
A more compelling objection is that companies have little incentive to release these drugs to the public. Notwithstanding that many firms already do (where allowed), this may be more of a case of disincentives. As it stands, many companies have limited funds, mostly dedicated to getting through approval. Yet, there’s no reason why firms couldn’t sell willing buyers (or the government) the drugs at cost, to compensate them.
Another important disincentive is the need for a good trial record to present to regulators. Any cases of adverse effects or ineffective treatment serves as a knock against the drug, and most companies are acutely risk-averse in this regard. A possible fix could be to exclude from the evaluation the drug’s track record in R2T. Indeed, the purpose of clinical trials is to be testing the drug in a controlled environment. R2T is there to save lives, not to give data for an evaluation.
Fundamentally, it comes down to control over one’s life. Remember, we have recently legalized the “right to die,” which rests on similar premises. It seems perverse to allow the terminally ill access to assisted suicide, but not a chance to fight back.
Actively preventing a consenting, competent adult from taking a risk to save their own life is paternalistic at best, and nearly cruel at worst. For opponents of R2T, this truth may be a pill too hard to swallow.