The US federal “Right to Try” law is allowing companies to sell unapproved stem cell treatments to dying patients free of oversight, legal liability and reporting requirements, according to an Australian stem cell pioneer.
Professor John Rasko, head of Gene and Stem Cell Therapy at Sydney University’s Centenary Institute of Cancer Medicine & Cell Biology, has co-written a letter to Cell Stem Cell saying companies have begun invoking right-to-try laws – which are also on the books of 41 states – “to provide unapproved products to seriously ill patients. The marketing of unproven stem cell interventions to patients is associated with well-documented physical and financial harms and represents a threat to patient safety, honesty in advertising medical goods and services, and stem cell clinical development.”
The law bypasses the involvement of the Food and Drug Administration without actually benefiting patients, Professor Rasko and his US and Japan-based co-authors write. When a promising therapy is still under investigation a pharmaceutical or biotech company may apply to treat a patient through the FDA’s “expanded access” program, and the FDA approves more than 99% of such applications.
The federal legislation applies only to terminally ill patients, unlike state laws such as that of Texas, which allows chronically ill patients to be treated with unapproved products.
But the federal law leaves patients more financially vulnerable than most state laws, they write, as it puts no clear limits on how much a patient may be charged.
Associate Professor Wendy Lipworth, bioethicist and health social scientist at Sydney University’s Sydney Health Ethics, said that while supporters of the laws might make compelling moral claims about patient choice, in reality, healthcare was “a highly imperfect market”.
“One reason for this is that there is often little information, or only misleading information, available to guide purchasers,” she told The Medical Republic.
“Another reason is that seriously ill patients are highly vulnerable to exploitation by doctors who do not have their best interests at heart. While the latter scenario is, fortunately, uncommon, there is plenty of evidence that doctors offering unproven stem cell interventions are motivated not by concern for their patients’ wellbeing, but rather by the desire to make money, achieve fame and satisfy their intellectual curiosity.
“In this context, the ‘consumer choice’ argument simply does not hold water and permissive regulatory environments such as those created by RTT laws are highly problematic.”
As The Medical Republic reported last month, Australia has a high concentration of businesses selling stem cell-based treatments. The Therapeutic Goods Administration last year banned the direct-to-consumer advertising of stem cell therapies (though plenty can still be found online) and removed its exemption on the use of autologous tissue products outside a hospital.