Mesh Medical Device News Desk, July 5, 2016 ~ Deaths Caused by the FDA
That is the title of a campaign by the Alliance for Natural Health, USA. Digging into the Food and Drug Administrations (FDA) database, the consumer group, that promotes sustainable natural health, counts 750,659 deaths caused by FDA-approved drugs, vaccines and medical devices since 2005.
It does not appear to take into consideration deaths from polypropylene mesh implants.
Mesh News Desk readers understand that the FDA allows medical devices to be sold after a pass through its 510(k) process which requires no clinical trials to assure safety and efficacy. The 510(k) approval is a lesser standard than drugs are required to go through called premarket approval.
The real numbers may actually be five to 100 times higher because most injuries and deaths are not reported to the FDA. The GAO reported 20 years ago that the FDA's databases greatly under represent the actual number of injuries, primarily because people don't know about it and when they do know, it is difficult to navigate.
Making adjustments for under reporting, the Alliance says the number of deaths could range from 3.7 million to 75 million in the same time period.
See the Death Meter here.
The FDA operated with an annual budget in 2015 of $4.7 billion. Even with those resources, the Alliance argues the FDA is fundamentally broken and is in need of reform.
The FDA funding comes from user fees which provide 60% of the its operating budget and those user fees are generated from the very industries it regulates. To protect its bottom line, the FDA does everything to protect its funding source, including colluding with industry and failing to prosecute any wrongdoing. FDA enforcement is often seen against supplement makers or raw milk producers.
One Example (not contained in the report) ~ In May, 2011 the FDA met with Ethicon for a "PFR and SUI Dialogue" which was intended to be an "open dialogue" about SUI and pelvic floor repair requested by Ethicon to the FDA's Ob-Gyn branch. Ethicon stressed the "evidence to support innovation." The FDA admitted in the confidential report that it is in a "learning mode" and was "Green" in its understanding of the use of surgical mesh for SUI and POP repairs." The agency was all ears.
The FDA approves genetically modified organisms (GMO) even though there is no testing to prove it is safe and once released into the environment, cannot be reversed. Read more here.
The group is particularly concerned about the FDA's war on natural medicine and natural food, which it promotes.
The analysis gives examples of how the FDA works against natural alternatives to products on the market that harm health including partially hydrogenated oils and artificial transfats, added sugars, statin drugs, NSAIDs, and unnecessary surgical procedures. Additionally, the FDA blocks the supplement industry from making health claims such as the use of Vitamin D to boost heart health.
The group has a Petition that promotes a complete overhaul of the US Food and Drug Administration. ###