When patients undergo a medical procedure or receive a medical device, they need to know that it is worthwhile and justifies its expense, risk, and discomfort. While most medical procedures and devices have measurable benefits, the same cannot be said for every medical treatment. In fact, a recent study has found that nearly 400 medical procedures and devices lack effectiveness and provide no benefits for the patient. This is an alarming finding given the stringency of the regulatory review process for approval of these devices and procedures.
The study, published in the magazine e-Life, analyzed 3,000 randomized controlled trials that were published in three medical journals. The study attempted to identify medical reversals, which is the term for when a new clinical trial contradicts current research and practice and is no better or worse than the practice. This research project did not do any new testing on its own, but instead analyzed the existing testing that was done by each of the three journals. The research was then categorized and bucketed and the results were based on whether the analysis was positive or negative. The study did not limit itself to a particular type of medical procedure, but instead looked generally at all devices, procedures and products. These could either be recommendations that are made or medications that are prescribed.
The most prevalent area where there were medical interventions that just did not provide a benefit was cardiovascular procedures. These constituted roughly 20 percent of the medical reversals that were chronicled in the study. About a third of the medical reversals involved medications. Given the numbers of procedures that were analyzed, over ten percent of the instances studied could be considered to be useless or ineffective.
Ineffective and medically unnecessary procedures and devices has a number of harmful effects on both the patient and the medical industry as a whole. The obvious effect is that it raises medical costs for both the patient and the insurance company. For example, one of the medical reversals in the study was a breast cancer drug that cost the patient $88,000 each year. The drug was ineffective and the FDA revoked its approval of the drug because the medication simply did not deliver the results that were promised. This drug ultimately became a large wealth transfer from patients and their insurance companies to the drug companies without any corresponding benefit for the patient.
Another medical reversal covered by the study was a recommendation that women past 34 weeks of pregnancy who suffer ruptured membranes undergo immediate surgery to deliver the baby. However, the study showed that women who received intensive pregnancy management as opposed to a surgical procedure had the same results with regard to the delivery. In other words, the surgical procedure did nothing to reduce the risk from the ruptured membrane and was costly and wasteful.
Even such long-issued recommendations such as thigh-high compression socks to reduce the risk of deep vein thrombosis after a stroke is considered a medical reversal. These type of stockings have been used as far back as 80 years and became prevalent after a study in 2000. However, the test results show that there are no measurable benefits from wearing these socks.
Unnecessary procedures and drugs ramp up the cost of receiving medical services. While the FDA’s approval process is rigorous, sometimes approval is based on the data that the manufacturer submits from their own testing. This is followed up by other testing that may not be fully objective. However, much of the research that was the basis for this new study was objective third-party research where there was no economic incentive to reach one particular result.
This study should challenge many of the long-held assumptions about pharmaceutical products and result in new rounds of testing about the effectiveness of drugs. However, much of the research that is performed on existing and prospective drugs is industry-funded. Objective research is often in short supply so patients are prescribed medications that do not help them very much at the expense of finding potentially new treatments that can help.
Alternatively, the FDA should make its approval process more rigorous. The fact remains, as evidenced by this study, that too many drugs without practical benefits are approved and become common and accepted medical practice. More stringent testing requirements can help weed out the treatments that do not make any sense.
Medical assumptions often change over time based on the latest knowledge and results of scientific studies. Unfortunately, the medical and pharmaceutical industry is slow to adjust because the profit motive dictates that they keep selling products that they know do not work. If these medical reversals are eliminated and new products and procedures substituted, it will bring about an improvement both in the cost and effectiveness of medical care.