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Friday, December 23, 2016

FDA loses ability to demand thorough drug testing


But it only takes away
He's not even in the White House and the onslaught is already here, he, of course, being Donald Trump. The 21st Century Cures Act is disguised as a boon to research and development and the deception was apparently good enough to entice the naive Democrats, including President Obama. Here's what the LA Times says...
"The 21st Century Cures Act is a huge deregulatory giveaway to the pharmaceutical and medical device industry, papered over by new funding for those research initiatives."
Bernie Sanders calls it a "corporate giveaway," and Elizabeth Warren voiced her concerns stating it favors the pharmaceutical companies. The Times claims it depends on funding that may never be provided through Congress. Michael Carome, director of the Health Research Group at the advocacy organization Public Citizen states it will contribute to further erosion of the standards now followed by the Federal Drug Administration. And with the history of this organization, it cannot afford any loosening of its control over new drugs.

Here's a personal experience with the Act. I am on a gamma globulin infusion to improve my immune system. I am 84 years old and bronchitis has almost put me in the hospital in critical condition at least two times. The doc checked my immune system, finding it very low, thus, the infusion medication. Because the gg is so hard to obtain, the monthly cost to Medicare is $10,000. To me that is absurd, especially for an 84-year old. Apparently, the sponsors of the Cures Act agreed so Medicare will no longer provide this drug.

Okay, I'm 84 and who knows what the longevity holds, but what about those younger on Medicare that this could be life-saving? The pharmacy that provides my infusion tells me there will be alternatives, one an intravenous delivery of this drug or something similar. My wife is giving me the infusion now subcutaneously, but the new system will require a trained nurse to come to my home to give it to me intravenously. What kind of sense does this make, unless the new drug I get is much cheaper, thus, much less effective? This hasn't been explained to me by my pharmacy.

Is the 21st Century Cures Act just the beginning? Here's more from Bernie Sanders...
"At a time when Americans pay, by far, the highest prices in the world for prescription drugs, this bill provides absolutely no relief for soaring drug prices. The greed of the pharmaceutical industry has no limit, and this bill includes numerous corporate giveaways that will make drug companies even richer.”
Has President Barack Obama lost his mind?
  

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