Medical Practitioners opine that improved regulation and professional society oversight are necessary to prevent patients from being exposed to new devices and any future innovations that are introduced without proper evidence of improved clinical efficacy and safety. Should doctors use recent and ostensibly high value implantable devices not supported by high quality evidence?
Such regulation is certainly both a practical and ethical challenge. The ethical challenge is how to ensure informed consent in any procedure -- which means doing the best possible to clarify the risks and benefits of any proposed procedure, provided in language understood by the patient/client. A group at IIT (Illinois Institute of Technology) has been exploring exactly these issues for several years (humanimplantethics.org); Frank Lane (chair of the rehabilitation psychology program) and Phil Troyk (biomedical engineer) are the key people in that project. We have found that it takes more than one encounter for an individual to understand the complex issues involved in current implant procedures. It seems important to give the patient/client the ultimate authority to decide whether a procedure is within their own acceptable zone of risk/benefit ratios. Individuals vary, and no "expert" should be deciding for them. Practically, it is an enormous challenge to provide a realistic image of risks and benefits when they are often unclear, and when it is not desirable to emphasize the risks so much that the sense of hope is destroyed. These are very complex issues, and few researchers are focused on them.
The question is interesting, yet seems to also be a loaded one. Regulating evolving technologies is a practical and ethical challenge which, I believe, is being dealt with appropriately at the time being. The beneficial changes require reasonable and, even better, evidential support to move it from being potential to being probable / certain. Bypassing that step contradicts the ultimate goal of Medicine. The answer to the second question thus derives from above: doctors should not use recent and ostensibly high value implantable devices until supported by high quality evidence.
It's the medical profession trying to defend it's own turf & profits. There are certain devices that pose no harm and should be explored-- Rife, Beck, Clark, Lakhovsky, to name a few, ozone therapy, intravenous Vitamin C. Unfortunately these are open-source and impossible for the medical cartel to profit from. Dis-ease is a business, more profitable to manage than cure, I'm not the first to say it.
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