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Report: Deaths Caused by the FDA

Alliance for natural health death meterMesh 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

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. ###

6 Comments

  1. Samuel says:

    J&J keeps bragging about their profit increase day after day. Their stock keeps skyrocketing at the expense of all the injured and those who passed away like my wife. Where is the conscious of the justice system in America???

    • Jane Akre says:

      Absolutely. Also astonishing is the financial writers who gloss over the downsides of the industries they cover BUT if you added in the harm caused and the true cleanup costs involved, these companies would not be so profitable. Head in the sand reporting.

  2. mary b says:

    It looks like the FDA needs to learn a lesson instead of helping people they are harming us are they getting paid by the co.that put out bad products i wonder

  3. Still standing says:

    Another serious and toxic chemical that permeates out society is
    Triclosan. It is in this toothpaste, personal hygiene products, such as soaps, deodorant. It is found in cosmetics. It has been used on bed mattresses and other things to make them microbial. Hand sanitizers and kitchen sprays may contain triclosan. It is considered a very toxic chemical and 3 in 4 Americans have triclosan in their urine. It was developed in the late 60s, so in the 70s our wonderful FDA allowed all chemicals that had been on the market to be grandfathered in. They were supposed to be tested and studied, but very few have been. Imagine that. It is so pervasive and many studies are finding the negative impact on people. Triclosan specifically has an effect on hormones…estrogen, thyroid, and androgens. This could be significant as we mesh women try to tease out all the things that are impacting our health. Studies have shown that having triclosan in an “antimicrobial” soap or spray is no better than regular soap and water. It has contributed to the “super bug,”those organismns that are drug resistent. Of particular note,the European Union BANNED Triclosan in 2010. They are working to get it removed from all products on the mar
    ket in all 28 member countries. So,if 28 countries can come to an agreement about banning harmful triclosan, why can’t our one country FDA get this done.? In the meantime, I look at ingredients when I purchase products. Check the ingredients and if triclosan is listed, please select another product. The FDA has not and will not protect us, a very very sad truth. I just wonder how the 15,100 people who currently work for the FDA go about their day. That is a lot of people who are being paid by our tax dollars. Really, what the hell are they doing? I would imagine they will say budget is that tight. However,,their average salaries are about $113,000. Somewhat astonishing given the fact that it they just arent fulfilling their employment demands. Appears they need to do a little streamlining, huh? very disturbing to realize they are being well paid, yet cant do their job. It isnt as if their job has no consequence. I wonder how many of them understand how drastically their decisions or lack of decisions have impacted the lives of those who pay their salaries.

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