FDA Not Satisfied with Just 25 Percent of the U.S. Economy

The agency now aims to regulate your body's cells. Some researchers and physicians have been taking adult stem cells from individual patients and reinjecting them to treat various medical conditions. While certainly not the standard of care yet for treating many ailments, progress is being made. For example, European surgeons have grown and transplanted tracheas using stem cells taken from individual patients. One stunning success is the case of Ciaran Finn-Lynch who received a transplant of a trachea grown using his own stem cells. That operation did not take place in the U.S.

Now the Food and Drug Administration has won a federal court case that allows the agency to regulate adult stem cell treatments as though they are pharmaceuticals. This will do for stem cell research what FDA regulation has done for drugs - slow progress and make treatments much more expensive. As former FDA deputy commissioner and physician Scott Gottlieb and attorney Colleen Klasmaier explain in their Wall Street Journal op/ed [sub required] today: 

At issue are cells taken from our own bodies and then re-implanted with the purpose of treating medical problems. The most inspiring work involves adult stem cells, although the court's ruling in principle extends FDA oversight into things as common as in-vitro fertilization—basically turning reproductive cells into "drugs" under the law.

The adult stem cells can differentiate into many kinds of finished tissues. This enables doctors to use these cells to renew damaged body parts. This science of regenerative medicine has promise across many fields of medicine, from cardiology to brain diseases to orthopedics…

How, for instance, would you run a large-scale, randomized trial and ensure consistency from one use of a drug to another, where the "drug" is really a medical procedure that must vary from one patient to the next because it involves their own unique cells? The FDA requirements, designed for products manufactured and sold on a mass scale, can't be readily satisfied when it comes to treatments that are personalized to individual patients.

When the FDA seeks to hold physician procedures to the same rules as pharmaceutical manufacturers, invariably the doctors have no choice but to bow to regulatory pressure, stalling progress. Regenerative Sciences, the defendant in the case, has moved some of its labs to the Cayman Islands. Most of the science of using adult stem cells for regenerative medicine is unfolding in Britain, Singapore and Israel precisely because of the FDA's bent to hold with misgiving anything novel in medicine…

…it can be deadly when it comes to the agency's impulse to regulate, and thus forestall, cell therapies used to help repair damaged body parts.

As I have pointed out before, speeding new treatments to patients saves lives, delays kill:

A 2005 National Bureau of Economic Research study found that, on balance, the faster FDA drug approvals made possible by new funding legislation passed in the 1990s saved far more lives than they endangered. In fact, new drugs saved up to 310,000 life-years compared to 55,000 life-years possibly lost to the side effects of drugs that were eventually withdrawn from the market.

Both Gottlieb and Klasmaier disclose that they work with companies that are developing cell-based therapies. For more background on FDA overregulation and overcaution, see my columns, "Timid Bureaucrats Kill People," and "Building a 21st Century FDA."

Comments

[Brett L]

I'm nearly certain that advances in technology are about to make the FDA completely irrelevant. The extraction, replication, and other technology for stem cell modification can reasonably be expected to fit on a lab bench and cost less than $20k in 5-10 years. At that point, it'll be Neuromancer easy to get upgrades from a reliable black market street doc.

[WTF]

Yeah, and these will be treated like meth labs with the full War on Drugs application of SWAT.

[Brett L]

Look at how well that's worked stopping people from getting meth.

[Hyperion]

You are both right, of course.

[Whiterun Guard]

Get enough upgrades and you won't have to worry about SWAT application.

[The Hammer]

If you are able to grow yourself wings, will you still have to go through TSA checkpoints?

[fried wylie]

TSA checkpoints, no.

FAA Pilot Licensing, yes.

[James Anderson Merritt]

Keep dreaming. Advances in RF and signal modulation technology rendered the FCC irrelevant a long time ago. The EM spectrum is no longer a "scarce resource," if it ever truly was. Yet, here the FCC remains, stomping all over the First Amendment by deciding who can own a "broadcast press" and dictating content standards. The FDA, you will remember, asserted authority over iPods, if used along with appropriate mp3 recordings, for therapeutic purposes, or if they could be played loudly enough in earbuds to damage hearing. The bureaucrats will always find a way to defend their own relevance, counting on the benefit of the doubt or the people's fear of the unknown to support their mission creep.

The FCC and FDA should both be ended. Anyone who wants to save them should have to make the positive defense that they are fulfilling legitimate constitutional purposes. That is to say, not just that the purposes are legitimately constitutional, but also that the agencies are properly FULFILLING those purposes.

[fried wylie]

Anyone who wants to save them can feel free to provide all the funding, and then abide by the rules.

But yes, as agencies that can appropriate funds from every citizen, and then have any authority, especially the authority to use violence, over those citizens, yeah, that needs to end right quick.

[Matrix]

You see that stem cell that the doctors extracted from your body? you didn't build that. Somebody else made that happen!

[WTF]

Stem cells are neither a food nor a drug; yet a federal court manages to rule that the FDA somehow has authority in this area. I wonder, did the court decision actually come right out and say "Fuck you, that's why"? Because no actual logic would apply here.

[Hyperion]

The FDA probably said that to the judge, and then compliance. The judge may have drank raw milk at one time or have a family member who does, and so...

[James Anderson Merritt]

That's sort of what they said when the Federal government asserted supremacy in immigration in the late 19th century, despite the fact that States had been handling their own immigration issues since 1776.

[o3]

why do you hate the stem cell [CHULDRENZ]?

[Mr. FIFY]

Ask the FDA, stOOOpid.

[Hyperion]

I sure hope you are right. The FDA are very gestapo like. I know about this because I work in an organization that often gets audited by the FDA. Siminars abound on how to properly prepare for an FDA audit, and nearly all of the postings for them have forboding statements like 'YOU COULD BE SHUT DOWN!'.

Myself, I love the trend towards independent and rogue type of research and development in all types of tech. There are a couple of things that came up recently that I am really excited about, that have nothing to do with drugs or the FDA, but if you are into gaming at all, check these out:

Oculus Rift

Leap Motion

Myself, I have always been excited about the possibility of VR and it might, finally, almost be here.

[fried wylie]

I have always been excited about the possibility of VR and it might, finally, almost be here.

Virtual Reality: The Commercial Fusion Power of gaming.

[James Anderson Merritt]

I also once worked five years for an organization that existed in the shadow of the FDA -- in other words, in the "heavily regulated" industry of health care -- and it was like working for the government (especially the military), without the union perks and job security for which the public sector has justly become infamous. I hope never to do anything similar, ever again. (I also worked for ten years in radio, whence originated my loathing of the FCC, long before I considered myself "libertarian" or even knew that word. The regimentation wasn't quite on a par with that I learned to despise under the heel of the FDA, but it was still pretty bad for radio operators -- much worse for radio engineers, I discovered eventually...)

[Robert]

Anybody got a link to the court opinion?

Without the facts of the case I can't tell, but on gen'l principles there are so many arguments that doing a service of this sort is not introducing an article into interstate commerce, that it's hard to see how FDA would've won on this even at the district level (where they have a better won-lost record than at appeals). Is the above blurb mis-stating the facts? What FDA has said in the past -- and which may be the meaning of the decision here -- is that products (such as culture media y containers) could be imputed as being promoted for the particular purposes of this therapy, and that therefore they could be regulated as drugs or medical devices in interstate commerce.

[some guy]

So you're saying FDA probably CAN'T regulate the stem cells, but they CAN regulate anything used to grow, manipulate or transfer the stem cells? God these bureaucrats are fucking legal geniuses. Too bad they're retarded when it comes to all other subjects.

[Robert]

Yes, in effect they've said that if some company that makes flasks knowingly sells them to a clinic using them for IVF or stem cell therapy or whatever, that that particular use of the product can be considered an intended use -- even though in many other cases general use articles are allowed to be sold with no questions asked. So then that product has to be safe and effective for that particular use, which of course depends on the conditions and success of the therapy.

[fried wylie]

Flasks should be illegal anyway. They're only used for making illegal drugs and storing/decanting semi-legal alcohol.

Why do scientists hate Teh Children so much?

[Robert]

Found it:

http://freepdfhosting.com/1d654bbcb4.pdf

[Robert]

Apparently there's precedent I was not aware of that within the meaning of the FFDCA,"a doctor who ha[s] held drugs for use in his practice ha[s] held those drugs for sale".

[fried wylie]

Robert just discovered the Drug-Pusher aspect of being a General Practitioner.

Let's give him a round of applause.

[some guy]

Proper application of the Precautionary Principle and the Hippocratic Oath requires that ALL treatments be prevented. The only way to guarantee a treatment does no harm is to prevent its application.

[Ron Bailey]

sg: Too true!

[fried wylie]

The original greek text makes mention of "do no harm". The modernized version doesn't.

"In the United States, most medical schools administer some form of oath. However, physicians are not required to take the oath.[citation needed]"

Grains of salt, wikipedia research, etc, but basically, it seems like everybody has that "do no harm" idea about the oath, yet, seems like doctors don't swear anything like that.

But yeah, your logical conundrum is amusing.

[James Anderson Merritt]

Actually, this "conundrum" may explain why patient consent is so important. If the conscientious physician attempts a risky treatment competently, with the best of intentions, and if possibilities for harm or side effects have been adequately explained to the patient, then the latter's consent theoretically absolves the physician in the case where doing nothing would necessarily lead to a worse outcome. If a treatment is (except for random chance) neutral or beneficial, of course a physician may pursue it, although also only with the consent of the patient or the patient's guardian.

As I understand it, the point of the "do no harm" clause was to enjoin physicians from doing something that had a high or certain probability of harming patients worse than the harm they would experience, were the doctor not to act.

Also bear in mind that, when the Hippocratic Oath was in its heyday, medicine and surgery were very separate lines of work. The physician was to avoid iatrogenic harm to patients even when that "harm" involved cutting into them to remove something bad. These days, MDs typically perform minor surgeries, so things aren't as compartmentalized as in the ancient times.

[fried wylie]

Oh, so, it all comes down to a contract between consenting adults...

Remind me again why the government is involved? (no, actually, don't, I'd probably have to shoot myself.)

[Zombie Jimbo]

Que no hayan novedades.

New FDA Motto.

[ant1sthenes]

This is why seasteaders should make medical tourism their main business -- doctors could live in America and practice in a free environment, people already are willing to travel overseas when they really need an advanced treatment, and unlike, say, growing weed or running a tax haven, an attack by the U.S. on a floating children's hospital would be difficult to spin into anything short of Nazi-esque.

[Matrix]

Do not underestimate the stupidity of large numbers of people or the audacity of the governments that lead them.

[James Anderson Merritt]

Maybe an FDA-free hospital ship could park next to THIS ship:

http://www.blueseed.co/

It's not quite seasteading, but I'll bet that matters not at all to those in need of care. Plus, the hospital would be a convenient "neighborhood provider" for the ship full of startups.

[fried wylie]

an attack by the U.S. on a floating children's hospital would be difficult to spin into anything short of Nazi-esque.

What Matrix said at 2:26, plus, allow me to add a hearty guffaw at your naivety. Sick kids are only a minor step above dogs, and we know how they get treated when the jackbook descends.

[Cell]

It is important to distinguish the practice of culturing cells for many days/weeks prior to implantation from the use of freshly isolated stem cells. This case applies specifically to the practice of extended culturing and the FDA regulation of this process.

There have not yet been any court cases that address the use of freshly prepared adult stem cells at point of care without expansion in culture.