The Toronto Star has one of those heartwarming miracle-operation hospital stories that newspapers run from time to time, whose meaning for American readers is something else entirely.
A 33-year-old Oklahoma man called Jon David Sacker (right) urgently needed a double-lung transplant after his body rejected the ones he'd received two years ago. So he went to the University of Pittsburgh Medical Center, but was too weak to undergo the operation.
The only possibility of saving him was something called the Hemolung Respiratory Assist System, which would stabilize his condition and buy time for the body to re-strengthen and for new lungs to be found.
There was no Hemolung RAS at UPMC, so they dialed around and found one at Novus Medical in Oakville, which is on Lake Ontario just south of Toronto. Murray Beaton of Novus agreed to loan the Hemolung to UPMC, and, given the urgency, offered to shorten the distance by driving down the Queen Elizabeth Way to meet the Pittsburgh guys in the wee small hours at a crossroads at Fort Erie, just across the Niagara River from Buffalo.
Now, if you're a patriotic American on the eve of Independence Day you're surely wondering: why the hell do we need to borrow state-of-the-art medical equipment from some cockamamie town in Canada no one's ever heard of?
But wait, it gets better: The Hemolung RAS was actually invented in Pittsburgh by a UPMC doctor and developed and sold by a Pittsburgh company founded by UPMC doctors. So why are there no Hemolungs in Pittsburgh? The Toronto Star explains:
Hemolungs should have been an easy option. They are made in Pittsburgh by ALung Technologies. The hitch was that there were no devices available in the United States, since they were not approved for use there.
All of the Hemolungs made by ALung had been shipped either to Europe or Canada, where they have been government approved.
Ah. So an American invention is already being used to save lives in Canada and Switzerland and Belgium and Denmark and Germany ...but has not been approved for use in America.
That presented certain challenges with Homeland Security:
At the border on the way back, the guard told them they couldn't cross into the U.S. with the Hemolung, since it wasn't FDA approved.
DeComo said that someone's life was at stake.
Yeah, well, good luck with that. Eventually, Mr DeComo decided to try a different approach:
Then he changed tactics. He said that he wasn't really importing the device. Since it was an ALung product and he was ALung CEO, the Hemolung was his property and he was simply retrieving it.
"He closed his little cabin door," DeComo said. "He made a call and he came out and said, 'Okay you can go.'"
They made it back to Pittsburgh by 8am, inserted the Hemolung into Jon David Sacker, and 20 days later he was strong enough for his new lungs.
Nevertheless: they were lucky. That CBP officer at the border, where they're a highly variable crowd, could have been far more obstructive, and in the middle of the night I wouldn't want to try getting hold of anyone senior enough to overrule him. Additionally, Mr Sacker's doctors were performing an operation that, while legal in Canada, Britain, France, Spain, Norway, Greece, etc, is illegal in the United States:
Drs. Bermudez and Crespo worked with Diana Zaldonis, M.P.H., B.S.N., in the Division of Cardiac Surgery, to notify Food and Drug Administration officials of the intent to use the Hemolung RAS, which isn't approved for use in the U.S., and to get emergency approval from the local hospital officials.
"That machine is a lifesaver," says the patient. Yes, it's American innovation saving lives everywhere else around the developed world - except America.
We have had a vigorous back and forth in Mark's Mailbox in recent weeks about declining innovation. In this case, American innovation is just fine, but the American regulatory regime is killing it. In After America (personally autographed copies of which are exclusively available, etc, etc), I write about an earlier example of US-Canadian medical co-operation:
In October 1920, a doctor in London, Ontario, Frederick Banting, had an idea as to how insulin might be isolated and purified and used to treat diabetes, which in those days killed you. By August 1922, Elizabeth Hughes, the daughter of America's Secretary of State and a diabetic near death, was being given an experimental course of the new treatment. By January 1923, Eli Lilly & Co were selling insulin to American druggists. That's it: A little over two years from concept to patient. Not today: The US Food & Drug Administration now adds half a decade to the process by which a treatment makes it to market, and they're getting slower. Between 1996 and 1999, the FDA approved 157 new drugs. Between 2006 and 2009, the approvals fell by half - to 74. What happens during that half-decade? People die, non-stop - as young Elizabeth Hughes would have died under the "protection" of today's FDA. Because statism has no sense of proportion. You can still find interesting articles about new discoveries that might have implications for, say, Parkinson's disease. But that's all you'll find: articles, in periodicals, lying around your doctor's waiting room. The chances of the new discovery advancing from the magazine on the coffee table to your prescription are less and less. To begin the government-approval process is to enter what the cynics of the 21st century research biz call the valley of death.
Much of American life seems to be seizing up, its lungs in as bad shape as Mr Sacker's, and with no Respiratory Assist System in sight. Powerline is currently examining both the administrative state and many so-called libertarians' indifference to rule by an unaccountable, permanent, hyper-regulatory bureaucracy. At the sharp end of this micro-tyranny, as I say above, "people die - non-stop". Under FDA rules, Mr Sacker is supposed to be dead. He is alive because Messrs DeComo, Bermudez, Crespo and others decided to assert their - what's the word? - independence.
~I'll be on the radio at 6pm Eastern/3pm Pacific for a Third of July visit with Hugh Hewitt, live coast to coast.
