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MUST READ ► My Horrific Experience With A Psychopath

May 20, 2012

by DailyKenn.com

A little over-regulation goes a long way. 

But when it results in human death, it lasts forever. When the person is you, the implications take on a whole new meaning. 

It's serious. 

A Colorado-based company has devised technology that will repair one part of you body (joints) with another part of your body (stem cells from your own bone marrow).

The Federal Drug Administration (FDA) says you can't do that because the cells are technically classified as chemicals. Wedged between taking chemicals out of your body and injecting them back into your body are countless years, millions of dollars, beaucoup tests in squeaky clean labs, etc.

Clinical tests already prove the procedure works, but that is too efficient for government bureaucrats. Regenerative Sciences, the firm that devised the procedure, is anxious, no doubt, to get things moving. They have an investment hole to fill and the prospect of a pile of profit once they get underway.   

The FDA doesn't care about the company's investment and profits. Nor does it seem to care about the well-being of patients. The FDA appears to be concerned with the job security of FDA employees and their subsequent paychecks that last as long as needed to oversee a plethora of tests to prove a procedure is safe even though it has already been proven to be safe.

So what happens when some enterprising entrepreneur invents a drug, device or procedure that will save lives? Do such initiatives get pushed to the front of the line? After all, if someone is going to die by next Thursday if they fail to administer the XYZ drug, the worse that can happen is they will die before Thursday. And if XYZ has been successfully proven to be effective in saving lives, then there is literally nothing to lose -- except for years of FDA employee paychecks. 

When the FDA delays approval of life-saving drugs, people die. When the FDA demands costly tests for life-saving drugs, those costs are attached to the drug, itself, placing it beyond the reach of many patients. More die.

Bydureon, for example, is a life-essential injected taken by diabetics. The FDA dragged out its approval for years costing the manufacturer, Amylin Pharmaceuticals, its valuable affiliation with Eli Lily, Inc.. Once approved analysts projected the drug would generate $940 million in annual sales. The problem is, they say, $1.2 billion in sales is needed to turn a profit. 

The big losers are the patients. 

Regenerative Sciences is good to go with its joint repair procedure, but the federal government refuses to allow patients access. The net result is extended pain, discomfort, and immobility for patients. When the procedure is eventually approved at an inflated cost due to government delays, expect it to be priced out of reach for thousands.



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1 comments:

  1. FDA = Federal Depopulation Agency

    ReplyDelete