CHAMPAIGN, Ill. - It's time for Congress to re-examine the ban on experimental or alternative medicine that is not approved by federal regulators, especially drugs and devices aimed at seniors who suffer from life-threatening diseases, a legal scholar says.
A recent article in the Elder Law Journal finds fault with the Food, Drug and Cosmetic Act of 1938, which prohibits interstate commerce in drugs and devices intended for the treatment, cure or prevention of disease without extensive clinical testing and approval by the Food and Drug Administration. The University of Illinois College of Law publishes the journal.
Thad M. Brady, an editor at the journal, argued that the FDA's time-consuming approval process restricts the personal liberty of citizens who seek experimental or alternative drugs outside of the clinical-testing context.
"Patients can choose to end medical treatment, even if doing so would result in death, but they cannot choose to take a potentially life-saving drug, despite being fully informed of the consequences, risks and alternatives, simply because the FDA has not approved the drug," Brady wrote.
This "paternalist" approach to medicine is particularly unfair to the elderly because their risk-benefit profile is different from the population at large. "In comparison to younger generations, an elderly person has fewer years to live and is more likely to be in poor health. Therefore, an elderly person has less to lose and more to gain from an experimental drug and may be more willing to face adverse effects if there is even a small possibility of being cured or of prolonging life."
Because of the extensive clinical testing required, the average drug takes more than eight years to receive FDA approval and become available to the public. Moreover, clinical tests grant patient access only to a limited number of drugs that are undergoing the approval process, which leaves many patients without access to potentially promising drugs that are not being tested on human subjects.
Brady endorses the objectives of the Access to Medical Treatment Act introduced by Rep. Peter A. DeFazio, D-Ore. The bill would allow health providers to provide patients with drugs and medical devices not approved by the FDA, but require practitioners to report any evidence that an unapproved drug or device poses a human danger.
Under the proposed bill, manufacturers of unapproved medical products would present safety and efficacy data to a national center, which would analyze the findings and make the information available to the public through the Internet.
There are legal safeguards in place that would protect the public against harmful or useless treatments, Brady pointed out. "Drug manufacturers would remain liable for their products, and doctors would continue to face medical malpractice suits if they breach the standard of medical care."
Given that Americans already are spending more than $30 billion a year on alternative therapies, products that show promise should be made available to both the elderly and terminally ill. For the treatment of minor diseases where the risk of harm from an experimental drug outweighs the benefits of a potential cure, most elderly patients should be encouraged to use FDA-approved products.
The article is titled, "Paternalism vs. Patient Autonomy: Is the FDA's 'Mothering' Smothering Grandma's and Grandpa's Choice of Prescription Drugs?"