American Elephants

The FDA Claims Your Own Stem Cells Are a Drug by The Elephant's Child

A clinic in Colorado, the Centeno-Schultz Clinic, performs a nonsurgical stem-cell therapy called Regenexx-C.  It is designed to treat moderate to severe joint, tendon, ligament, and bone pain using only adult stem-cells. Doctors draw your blood, spin it through a centrifuge, extract the stem cells, and  then re-inject them into the damaged joints. No other drugs are used. The absence of any drugs means that the Food and Drug Administration is not involved, and has no oversight function.

Yes, you guessed it. The FDA has asserted its authority by claiming that your stem cells — the ones your body produces naturally — are in fact drugs and subject to its regulatory oversight. Your stem cells are a controlled substance!

The FDA argues that 1) stem cells are drugs and therefore fall under FDA jurisdiction, and 2) because the clinic is engaging in interstate commerce, they also fall under FDA jurisdiction. The rationale for the “interstate commerce” bit is that out-of-state patients using Regenexx-C would “depress the market for out-of-state-drugs that are approved by the FDA.”

Does that sound like the FDA is protecting the health or American citizens?  Or does it sound like the FDA is fiercely defending it’s turf and ability to enforce and regulate? This has been a battle going on for over four years. The FDA is under fire from all sides for the difficulty in getting new drugs approved. It is becoming so difficult that innovators abandon promising candidates. Drugs long approved in other countries must undergo years long investigations here. They are causing shortages of needed drugs for hospitals.

There is a mindset in the regulatory crowd that assumes that wise government bureaucrats are smarter than ordinary people out there, and you ordinary people should shut up and let your betters regulate. The trouble is that there is no evidence whatsoever that government is able to do things better. There are very few things that government is good at, even simple things. There are indeed some things that can only be done by governments — armies and navies,  air forces — I was going to add space, but it looks like private enterprise is taking that over. Borrowing — they’re very agile at that — and spending, they set records. But what else? Post Office, nope. The entitlement programs are ridden with fraud, and going broke.

We should expect the federal government to make the case to us — for we are in charge — we the people authorize government activity, why they should be allowed to regulate anything, and demand a better record of good performance.

I’m getting really fed up with this regulatory overreach.

A House Spending Bill Prohibits Funding for EPA’s Damaging Climate Regulations. by The Elephant's Child

A government spending bill written by House Republicans was unveiled on Friday night.  It would prohibit funding for Environmental Protection Agency climate regulations through September, the end of the fiscal year.

The continuing resolution, which is this year’s funding for the government, since Democrats couldn’t get around to passing a budget bill — their primary task — so they passed a temporary “continuing resolution”.  This is Republican’s latest attempt to stop the EPA from regulating greenhouse gas emissions — the EPA’s attempt to accomplish by regulation the cap-and-trade bill that Congress refused to pass.

Republicans state that pending EPA climate rules will significantly damage the economy and result in major job losses.  The bill would block funding for all current and pending EPA climate regulations for stationary sources. Every shop and building could fall under the EPA purview  for emitting CO2 — a beneficent gas that is one of the basic building blocks of life. The notion that CO2 is harmful or a pollutant in any way has been soundly debunked, but the media has not caught up with the science.

The bill cuts EPA funding by $2 billion, 29% below fiscal year 2010.  The legislation cuts funding for the Bureau of Land Managements “wild lands” policy which would allow the Obama administration to protect lands that have not been formally designated as wilderness land. It has been an administration attempt to restrict oil and gas drilling.  The bill also prevents the Nuclear Regulatory Commission from terminating a license review for the Yucca Mountain nuclear waste repository.

All in all a splendid bill, accomplishing important things.  Cutting the EPA’s funding is a major step in reining in an out-of-control agency playing politics with the American economy and American jobs.

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