Will Trump trump the FDA?
Our President-elect recently released his health care policy agenda and it looks like the FDA is a target in terms of reducing oversight. Over at the Washington Post, Carolyn Johnson has a nice article on this development.
One point in the agenda in particular has caught people’s attention as potentially the key indicator of what is to come for regulatory oversight of biomedical products:
- “Reform the Food and Drug Administration, to put greater focus on the need of patients for new and innovative medical products”
This one sentence says a great deal in terms of signaling that Trump wants dramatically less oversight or at least that’s how “reform” is being interpreted.
For those of us in the stem cell field this sentence from Trump sounds very reminiscent of language from proponents of reduced regulation and even stem cell clinics, who say they are just in it for the patients but keep keeping racking up profits.
This signal from Trump does not bode well for stem cell and regenerative medicine oversight in the coming years, but we’ll have to stay tuned to see how this develops.
1 thought on “Trump Has FDA in Crosshairs: Impact on Stem Cell Oversight?”
Everyone should unite with the legions of patients harmed and injured by medical and dental devices that were not “right for them” due to biocompatibility issues, which have not been acknowledged by FDA device regulations. While we trumpet Precision Medicine and innovation, most importantly we need a framework for Precision Devices, to ensure prescreening of individuals for biocompatability – tolerance vs. toxicity – of device materials.
FDA device policies are practically medieval, with a pre-Civil War era product still in widespread use, and women subject to morcellators and Essure that can not only damage internal organs, but spread cancers, systemic inflammation and autoimmune diseases.
There is no disclosure to patients or parents of materials used in common dental materials, no warnings of side effects and contraindications such as dentists get from manufacturers, no written informed consent, and no prescreening for immune reactivity befoe installing materials that have 24/7/365 impacts. Meanwhile, FDA overruled its 2006 and 2010 Dental Products Panels in refusing to warn patients of potential harm from neurotoxins installed that offgas with heat and abrasion. The Children’s Amalgam Trial’s findings of amalgam safety have been retracted four times by eminent toxicologist James S Woods et al, after finding neurobehavioral deficits and kidney damage in boys with a half dozen gene types. Girls have stronger immune systems, so damage from merccury takes longer.
Let us join together to build a bigger tent for medical and dental device safety first for all devices, and reboot FDA in full for patient safety, or transfer its functions to a new and more responsible agency. This is the time to act. Kindly contact me with any thoughts and ideas.
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