by Erica Cohen
A patient is diagnosed with brain cancer. She sees a slew of doctors, including a doctor of holistic medicine who recommends a combination of 25 different dietary supplements. The patient then reports for her first chemotherapy treatment with 25 bottles of supplements in a giant plastic bag. When the nurse asks the patient for a medication list, she dumps the bag in the nurse’s lap and says, “Here. I can’t remember what they’re called.”
What should the hospital do?
That is a question hospitals and physicians wrestle with all too often as dietary supplements gain popularity. Nearly 40% of adults in the U.S. use some form of complementary and alternative medicine (CAM) therapy, including dietary supplements.
There is often little scientific evidence to support the efficacy of dietary supplements, but that does not stop some patients from insisting that they work. Although they can sometimes be beneficial, they can also cause harm by interfering with a treatment regimen or leading the patient to forego a more proven therapy.
And some dietary supplements are outright dangerous. Some manufacturers make claims that are blatantly false. Some list ingredients that are missing. And some products contain substances that are toxic.
The FDA can act once it recognizes a problem. However, manufacturers are not required to register their products or to gain approval before selling them as they would be if they sold prescription drugs.
Hospitals face a difficult balancing act in deciding what supplements to allow. They must weigh medical value against the risk of patient harm and their concern for liability.
Hospital policies vary all over the map. Some ban them completely. This is the safest route legally, but it can damage patient relationships, and it leaves the risk that patients will continue to use them in secret. Some ban only those known to have negative effects. Others allow patients to take them if a physician orders them, the pharmacy tests them, and they are stored with the patient’s other medications.
To try to limit their liability, some hospitals ask patients to sign waivers related to the use of dietary supplements, often after educating them about risks and benefits. However, most experts believe the waivers would be useless in court because there is little hard data on efficacy and safety that can truly inform patient decisions.
To add to the confusion, regulatory bodies can’t even agree on how to categorize dietary supplements. The FDA defines them as foods, while the Joint Commission, the nonprofit accrediting organization for hospitals, considers them to be medications.
The wide differences in policies – and in many cases lack of policies – cry out for uniform guidelines. Hospitals have little to go on when they try to balance benefits, harms, and the constant fear of liability. Without standards, some patients may be denied beneficial treatments, while others may be harmed by ineffective or dangerous substances.
Until consistent standards are in place, the only reliable guide is to let the patient, and hospital, beware.
Erica Cohen is a third-year law student concentrating in health law at Drexel University Earle Mack School of Law. She graduated from the Scripps School of Journalism at Ohio University with a major in online journalism and minors in business and political science. Prior to attending law school, she worked for DKMS Americas, the world's largest bone marrow donor center. She currently works as a legal intern in the office of general counsel at a local hospital.