US hospitals are increasingly selling alternative medical treatments, which have not been approved by FDA and are considered unproven therapies, to their patients. Many well-established large hospitals have created spas to offer acupuncture, Reiki, homeopathy, energy treatments, naturopathy, herbal medicines, supplement therapy and several other forms of alternative treatments that previously were frowned upon by physicians trained in Western medicine. While legal, this practice raises serious ethical concerns about trusted physicians using treatments with unproven benefits and potential risks on their patients. Should doctors offer treatment options that they believe may help their patients, even if these options have never been formally tested and approved? Traditional medicine of some or the other form exists in practically all cultures, and till recently was limited to practitioners trained in such therapies. In most countries, outside the US, traditional medicine is approved by special regulators. For example, European Medicines Agency (EMA) has special provisions for Herbal Medicinal Products (HMP), whereby such products are approved for marketing based on non-conventional data. HMPs do not need support from clinical trials and have special GMP requirements very different from that for chemical drugs or biologics. In the US, on the other hand, there is no special regulatory pathway for herbal drugs. Herbal or botanical drugs are treated very similar to other drugs and need clinical and non-clinical data to support market approval. The US FDA does not endorse traditional therapies of any kind, however, its follows enforcement discretion whereby it does not overtly prohibit alternative therapies so long as there are no accidents or major concerns. This worked so far because traditional and alternative therapies had limited appeal to patients due to their presence on the fringes of medical profession. With hospitals directly offering such treatments, this would change. Patients are generally more accepting of alternative medical treatments if offered by their doctors. In an investigation by STAT, most physicians and hospitals managements disavowed traditional treatments when asked directly, calling them anecdotal and other names, but the web-sites of hospitals clearly touted such treatment options and the hospital spas seemed to do robust business. Bringing alternative therapies to mainstream medical centers may give these therapies their due respect as therapeutic options but it also risks loss of credibility for these treatments if improperly administered. Traditional therapy practitioners need formal training and extensive experience both of which are lacking in the US. Many traditional drug products are manufactured at facilities with no formal GMP compliance checks, using raw material of questionable quality, and under conditions with poor quality control. Increase in exposure and, with it, demand, may push alternative treatments over the threshold where FDA may need to step in and enforce the rules of the land, which may, in turn, lead to better quality alternative medicines. Patients need options, whether hospitals offering those options is the best solution, is debatable.
Old Medicine, New Concerns: Should Hospitals Sell Alternative Medicine?
Author

Dr. Mukesh Kumar
Founder & CEO, FDAMap
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