Filed under: Capitalism, Economy, Health Care, Science/Technology | Tags: Nonsensical Calls, Regulatory Overreach, The Food and Drug Administration
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.
2 Comments so far
Leave a comment
Personally, I think that there needs to be some government watchdog to avoid the excesses that we saw amply in the past, when all manner of dangerous substances were foisted on unsuspecting people (often made vulnerable by worry), sometimes with irreversible and occasionally widespread costs to society. (Read about the early history of radium-based treatments, for example.) Yeah, people can sue, but not if they’re dead already.
The point about the government regulatory function in this case, also, is to create an impartial arbiter between the manufacturers of drugs and the consumers. That could also be done by a non-governmental group (as is done to certify electrical devices in some countries), but I suspect that the demand for an impartial safety certifier will always be there. (Whether the FDA is impartial is a question I’m not qualified to answer.)
But you are absolutely right that FDA approval of new drugs has become so difficult that innovators abandon promising candidates, and that drugs long approved in other countries must undergo years-long investigations in the United States.
Comment by Subsidy Eye February 6, 2012 @ 8:42 amJust to be clear, the above comments do not relate to the specific case of stem cells being regulated as a drug. In that case, it does sound as less like the FDA protecting the health of the country’s citizens and more like the FDA defending its enforcement turf (and the profits of already-approved drugs).
That said, I would not have been surprised if some organization — government or otherwise — had to approve of the medical procedure. Just because a substance is produced by our body doesn’t mean it is always safe to reinject. We would not necessarily want to extract certain hormones from our bodies and reinject them into our hearts or brains.
Comment by Subsidy Eye February 6, 2012 @ 9:36 am