Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Thursday, January 14, 2016

Obama is a fox: Califf is the wolf. FDA headed to obsolescence?


Will Commissioner Califf Lead the FDA to Obsolescence? The Answer is Likely Yes.
by Marcie Jacobs                 December 2, 2015         FiDA highlight
The more I think of Obama and his ways, the more I think he is playing chess. He certainly was playing chess with the ACA by pitting large employers and employees (169 million strong) and insurance companies and policyholders against big medicine and now this with the FDA. He knows the FDA runs counter to his mission so what does he do? He appoints a wolf to guard the henhouse. Why? It doesn't make sense unless he is trying to wake us up to smell the coffee. Any other way he dealt with the corrupt FDA would land him in hot water with his contributors and it wouldn't solve the problem. Most doctors come from the same cesspool as Califf and are practicing allopathic medicine because they can't break free from it. It was too profitable for them pre-ACA and now they believe they are trapped.  In addition, anyone he appointed would eventually do the same as our good ole boy Deputy Commissioner Califf.
From a post by Johanna Ryan, The Ghost of Research Future

"Two facts about Robert Califf are beyond question. He is an expert on clinical trials, who is already seen as a leading architect of the future of medical research. And as the New York Times put it, he has “deeper ties to the pharmaceutical industry than any FDA commissioner in recent memory. A lot of senior figures in medicine support Califf in spite of his ties to Pharma. The guy is just so bright, and understands the nuts and bolts of drug research so well! Surely a person like this is more useful than some outsider who offers only a squeaky-clean resume, they argue."

For the sake of argument assume that he does become "The Ghost of Research Future" Ghost is a good word to describe an agency that has already lost its reputation and is about to lose all credibility in the eyes of consumers.  Like medicine, research in this country is being transformed and technology and big data are leading the way. In the future, the management of illnesses will be based on our unique genetic makeup.  Clinical trials will no longer be necessary; they are population-based research; the future of research is individual-based and unique for all of us.  And consumers will demand studies and treatment based on their genome. And they will prevent, treat and maintain their disease based on their own unique biological makeup, not something dictated by corrupt agencies within the government that operate at the benefit of big medicine and big pharma and not for the benefit of patients/consumers. 

Consumers in the new healthcare paradigm will become increasingly hostile towards FDA approvals. If it has the seal of approval from the FDA it has the seal of disapproval from consumers. Consumers will use FDA corruption against them.  Extra, extra read all about it, FDA approves the next new blockbuster drug and no one buys it. Company's revenue drops by double digits.  

So what does Obama accomplish by appointing a wolf? He wakes up the American people on both sides of the aisle and he shows us that the FDA is an organization that can't be trusted. And that lesson is invaluable if you want to stay alive in the 21st century.  It puts the ball in our court. We the People are the ones that will chop down the greed, not the corrupt politicians or the pharma-run cronies at the FDA. It is a brilliant move, force the American people into the battle and soon they will dismiss anything that comes out of the FDA and in doing so they will protect themselves and their families.

In the 21st century, it's all about the individual and their genetics so population-based research (Califf's baby) is out and the FDA is one step closer to obsolescence.  The FDA can control providers, inventors, and corporations, but they cannot control the consumer.  That is why it is up to us to control the market and medical drugs and products as well as what we eat by taking our health care dollars elsewhere no matter who pays.  



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