The Right to Try.

AuthorOrient, Jane M.
PositionHEALTH BEAT

CONGRESS HAS PASSED, and Pres. Donald Trump has signed, the "Right to Try" bill that gives dying patients limited access to drugs that have not yet been approved by the Food and Drug Administration. Our Founders would be astonished that we need such a bill. Nowhere does the Constitution give the Federal government the authority to regulate the practice of medicine, and it is a very good thing that Federal intervention and standards did not begin in 1789.

Standards inevitably are based on what the authorities think are "best practices." Until rather recently, most medical treatment was ineffective and often quite harmful: e.g., bleeding, purging, and toxic medications like calomel (mercury). Those nevertheless were the "standard of care" accepted by the American Medical Association. The chances that a patient would benefit from seeing a doctor probably were no better than 50-50.

Then came scientific medicine and modem medical miracles. Antibiotics conquered many infectious diseases; I may have seen one of the last patients with a thoracoplasty--his chest wall caved in from removing ribs to collapse a tuberculous lung. Leukemia used to be incurable. Kidney failure meant rapid death.

We have many wonderful treatments today, but people still are dying. Their cancer, for example, may not respond to available chemotherapy. They may have heard of a promising new remedy, but it cannot possibly be approved for years, after at least $1,000,000,000 worth of testing. It might not work for them--but there is nothing else. It might be very toxic--just like other anti-cancer drugs. It even might kill them--but they are dying anyway. What have they got to lose?

From this bill they might not have much to gain. It simply expands access to drugs already in clinical trials, for which a patient might not qualify, possibly because of being too sick.

Opponents of this bill--and similar bills in various states--focus on the potential harm to society by weakening the gatekeeper role of the Food and Drug Administration. Patients might be enticed to spend money on "false hope." Potential subjects might be less willing to volunteer for clinical trials--in which there is a chance they will be "randomized" not to receive the new drug. "Quacks" might take advantage of the law. Patients who are not wealthy would not be able to get experimental drugs not covered by insurance. Worst of all, future patients might not be willing to wait for the FDA--and the willingness of...

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