Use of tiny balloons and metal stents for heart attack patients has been questioned by a major study.
Reporting on the study, announced at a recent medical conference the New York Times entitled its piece: When Blind Faith in a Medical Fix Is Broken:
“Although such treatment can be lifesaving in the early stages of a heart attack, the study found that opening the artery later did no good at all. It merely exposed patients to the discomfort, risk and $10,000 expense of an invasive procedure.
The new report is the latest example of a rigorous experiment turning medical practice on its head by proving that a widely accepted treatment is not the great boon it was thought to be (except maybe to the bank accounts of doctors, drug companies and makers of medical devices).
Ideally, treatments, operations and diagnostic procedures should be thoroughly tested before they come into routine use. But that is not always the case. Drugs and medical devices have to be approved by the Food and Drug Administration, but once they are on the market, doctors can prescribe them in almost any way they see fit, a practice called off-label use.”
Despite these loopholes, wouldn’t principles of evidence-based provide strict controls? After all, complementary and alternative medical therapies are now being subjected to rigorous clinical trials, so that demands for evidence can be satisfied.
The Times explains:
“The approval rules for devices are looser than those for drugs, and while there is little data measuring unapproved uses of medical devices, there are hints that off-label use there is even greater. The F.D.A. does not regulate surgery at all.
Some treatments — like opening a closed artery — appeal so strongly to common sense that it becomes irresistible to go ahead and use them without waiting for scientific proof that they are effective. That is especially true if patients are desperate and have few or no other options.
As the treatments start to catch on, people assume they must work, and it becomes difficult or impossible to study them in the most definitive way — by comparing treated patients with an untreated control group. If most people think a therapy works, who wants to be the control? Doctors may balk at controlled studies, too, calling it unethical to withhold the treatment from patients in the control group.”
This circularity — it seems to work, therefore it must work — is eerily parallel to the argument used against CAM therapies such as homeopathy: ‘it can’t work, therefore it doesn’t.’
The report throws a huge caveat at the notion that medically accepted therapies are safe and effective.
Law Offices of Michael H. Cohen offers general corporate legal services, litigation consultation, and expertise in health law, with a unique focus on alternative, complementary, and integrative medical therapies.
Michael H. Cohen is also President of the the Institute for Integrative and Energy Medicine, also known as the Institute for Health, Ethics, Law, Policy & Society. The Institute serves as a reliable forum for investigation and recommendations regarding the legal, regulatory, ethical, and health policy issues involved in the judicious integration of complementary and alternative medical therapies (such as acupuncture and traditional oriental medicine, chiropractic, massage therapy, herbal medicine) and conventional clinical care.
The most recent book written by Michael H. Cohen on health care law, regulation, ethics and policy pertaining to complementary and alternative medicine and related fields is an interdisciplinary collection of essays entitled, Healing at the Borderland of Medicine and Religion. This is the fourth book in a series, the first being Complementary and Alternative Medicine: Legal Boundaries and Regulatory Perspectives (1998).