As the battle against COVID-19 continues, physicians and a patient advocacy group say it’s time to rethink so-called Evidence-Based Medicine Protocols (EBMs).
EBMs were designed to help physicians make treatment decisions based on rapidly growing data and studies in medical literature. Instead, a growing number of doctors are finding EBMs to be a bureaucratic straitjacket that promotes a one-size-fits-all approach, often against their better judgment.
An example was cited by Twila Brase, president and co-founder of Citizens’ Council for Health Freedom.
“To save his patients from EBM protocols, New York City physician, Dr. Cameron Kyle-Sidell, made a public plea online for every hospital to change ventilator protocols because they were damaging lungs,” Brase said. “But why did he, a physician, even have to ask for permission? Evidence-based medicine protocols can act like handcuffs, preventing the proper care of patients.”
EBMs can prove to be restrictive to medical professionals, says Chad Savage, M.D., an internist who founded a direct primary care practice in Brighton, Michigan and a policy advisor to The Heartland Institute, which publishes Health Care News.
“It’s not that evidence-based protocols used as tools to assist with complex decision-making are wrong, it’s that they are mandated,” Savage said. “I trained in the ‘90s and protocols and treatment algorithms were just coming into common practice. However, at that time they were covered in disclaimers that indicated these should never replace clinical judgment. However, over time that has inverted. Now they supersede clinical judgment. So this may work for the majority of patients, but it places the minority of patients whose need deviate from these protocols at risk.”
Doctors treating COVID-19 patients are especially adamant about the need to use their professional judgment first and foremost, which may require care much different from the hospital’s EBM protocol.
On June 5, the Association of American Physicians and Surgeons (AAPS) sued the Food and Drug Administration(FDA) in the U.S. District Court for the Western District of Michigan for limiting the use of hydroxychloroquine, a controversial anti-malaria drug that some doctors have been using to treat coronavirus patients.
“The FDA has no right to regulate the practice of medicine,” said Jane Orient MD, AAPS executive director and policy advisor to The Heartland Institute. “Once a drug is approved, doctors may prescribe for additional indications.”
Such a practice is known as “off-label” prescriptions, and it can be a great tool for medical professionals to provide early and efficient care to patients, especially when it comes to treating a new disease such as COVID-19, Orient says.
“About 20 percent of prescriptions and most pediatric prescriptions are ‘off label,’” Orient said. “It is prohibitively expensive to test for every new indication. FDA restricts marketing but not prescribing for ‘off-label’ uses. Restrictions on HCQ are unprecedented. It has been safely used for 65 years in hundreds of millions of patients. Depriving patients of early access will probably cost thousands of lives. It is senseless.”
Let Doctors Be Doctors
The traditional doctor-patient relationship should be instrumental in determining a treatment program, instead of an impersonal “system,” Orient says.
“Physicians have always used evidence—from literature, from consultants, from their own observations,” Orient said. “Without freedom there is no progress. With EBMs, staff focus on drop-down menus and ‘quality’ metrics, not how the patient is doing. Protocols do not include intravenous vitamin C or other potentially life-saving therapies; they may require a harmful ventilation protocol; they may even make patients an automatic DNR (do not resuscitate).”
Physicians should be free to use whatever they think is the best care for that the specific patient, as long as the physician tells the patient why the MD thinks the plan is right and what evidence led them to that conclusion, says Deane Waldman, author of Curing the Cancer in U.S. Healthcare: StatesCare and Market-Based Medicine.
“This should hold true even if the treatment is experimental and even if it doesn’t have the FDA stamp of approval,” Waldman said. “The EBM issue is a matter of control and the desire to have objective standards by which to judge physicians. However, the standard by which we should be judged is, by definition, subjective. We should be judged by the subject and by his or her result, not by some metric that is population based. Patients are unique, not assembly line widgets.”
Ashley Herzog (email@example.com) writes from Avon Lake, Ohio.