Medical Tuesday Blog

8. Voices of Medicine: Why Do We Need a ‘Right to Try’ Bill in America?

Aug 6

Written by: admin
08/06/2019 12:58 AM 

 By Jane M. Orient M.D.

Managing Editor, Journal of American Physicians & Surgeons

 

Congress recently passed, and President Donald Trump 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 (FDA).

Our founders would be astonished that we need such a bill. Nowhere does the U.S. 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 didn’t begin in 1789.

Standards are always 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 were nevertheless the “standard of care,” accepted by the American Medical Association (AMA). The chances that a patient would benefit from seeing a doctor were probably no better than 50-50.

Then came scientific medicine and modern 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 are still dying. Their cancer, for example, may not respond to available chemotherapy. They may have heard of a promising new remedy. But it can’t possibly be approved for years, after at least a billion dollars’ worth of testing. It might not work for them—but there’s nothing else. It might be very toxic—just like other anti-cancer drugs. It might even 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. . .

The “most vulnerable” need to be protected, we often hear. But who is actually being protected? Patients? Or the academic research establishment? The prestigious organizations that write the “guidelines” and determine the “standard of care”? The medical journals that publish the approved research? The companies that sell the extremely expensive products that have no competition? Insurers that profit more from higher premiums to cover these treatments? Pharmacy benefits managers who collect a bigger “rebate” on higher priced products?

As Goldman Sachs pointed out, curing disease is bad for business. . .

Read the entire article on Epoch Times: https://www.theepochtimes.com/why-do-we-need-a-right-to-try-bill-in-america_2561255.html

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