Right-to-die but no right-to-try

Terminally ill patients seek access to unapproved drugs

A group of Canadians with terminal illness is asking for the right to try unapproved drugs or treatments for their conditions. “We have the law that allows us to kill ourselves. We just don’t have the law to do something else,” said Jeff Pereault, one of the founders of the Right to Try campaign, to the National Post.

Activists Owen Thomas, Jeffrey Perreault, and Kim Lewis from the Adaptive Canuck ALS Foundation suffering from amyotrophic lateral sclerosis wrote a letter last October to the government of Canada presenting a proposed law, the Right to Try Act. This law states that a patient who has tried all other therapies approved by Health Canada can access potential life-saving treatment. The act specifies that the physician would have the discretion as to whether to provide this treatment to the patient and that he or she would not be criminally liable for negative effects of the treatment except for cases of gross negligence or willful misconduct.

The group argues that Canada’s current clinical trial system and Special Access Programme (SAP) to unapproved treatments is insufficient to meet the needs of patients with terminal illness. Patients with terminal illness are often excluded from clinical trials and, even if they qualify, may not receive the desired treatment if they are selected to receive the placebo treatment. Meanwhile, getting access to a treatment under the SAP is a lengthy process, while often these patients do not have a long time left to live. As well, drugs currently undergoing clinical trials are not accessible under the SAP.

According to the National Post, Health Minister Jane Philpott met with Perreault in November and said in a statement that the issue is currently being studied by her officials.

There are some criticisms of the proposal. Bioethicist Alison Bateman-House of New York University told the National Post that there is no obligation for pharmaceutical companies to guarantee access to unapproved therapies and that many are already providing experimental drugs to patients on compassionate grounds if government requirements have been met. Timothy Caulfied, the Canada Research Chair in Health Law and Policy, said that many treatments are not available on the market simply because they are not ready for clinical use.

Yet, 31 states in the USA have right to try legislation granting patients with terminal illness access to drugs not approved by the Food and Drug Administration (FDA). The laws, however, have not yet been tested in court and do not supersede FDA regulations. Alex Tabarrok, chair in Economics at the Mercatus Center, and Daniel Klein, a professor of economics at George Mason University, state in a study for the Independent Institute that the FDA should not have regulatory power over drugs and devices. They propose a “voluntary system” where consumers are given “assurance” of the reliability of a drug by private organizations and stakeholders as well as by recourse to the courts if customers are cheated or harmed. In such a system, patients would have greater access to experimental treatments that are not currently approved by health regulators.

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