Let Patients -- And Consumers -- Decide How Much Risk They'll Take
Government reaches its grubby regulatory fingers into so many areas of our lives. Some people -- those who are under the impression that government officials are in their jobs out of a deep longing to protect and serve the rest of us -- feel protected and comforted by this.
Others of us -- those who've had the window shades lifted on their naivete -- prefer to make adult decisions for ourselves, and not have the government preventing us from using products or taking advantage of medical innovations we would but for bureaucrats being slow to give them the high sign.
Sure, there are people who can't assess for themselves whether, say, a medical course of action makes sense. If there's more of a free-market/adults decide way of going about making these choices, it seems likely information markets will arise to serve the need for information.
There's a piece by neurosurgeon Kevin Tracey in the WSJ, "Let Patients Decide How Much Risk They'll Take: Take a tip from Sergey Brin: The health-care regulatory burden stops entrepreneurs from getting into the game":
Consider the case of Goran Ostovich, a burly, 47-year-old truck driver from Mostar, Bosnia. Mr. Ostovich has suffered from long-standing rheumatoid arthritis and needed near-permanent bed rest. With his hands and wrists swollen and aching, he could no longer hold on to a wheel or even play with his small children. He tried a variety of medications. None worked.When I met Goran at his doctor's office in 2012, however, he didn't seem at all afflicted with the disease. That's because, one year earlier, he had been offered the opportunity to be the first participant in a clinical trial of a new therapy based on my invention. He received a bioelectronic implant and rapidly improved. His mobility restored, he was soon back at work and even sustained an exertion injury from playing tennis.
Since news of this clinical trial's success became public, people from all over the U.S. stricken with rheumatoid arthritis have emailed, called and sent letters pressing for their shot at potentially effective--but not yet FDA-approved--treatments. Most wrote that they would gladly travel to Europe if it meant they could get access to the device.
That's exactly the point: Some patients are very willing to take a calculated risk, but misaligned incentives in the industry are driving potential stakeholders with new solutions out of the business.
While the FDA does a commendable job, there is no reason it should have the sole responsibility for access to lifesaving treatment. Institutional review boards and human-subject research protocols provide extremely high levels of protection overseeing clinical trials in the U.S. and Europe. These bodies have weeded out the charlatans in the industry, and the ultimate determinant of success will be patient satisfaction.
Mr. Brin and his colleagues took Google public under atypical rules, and to much fanfare. It is time to apply this kind of boldness to realign bioelectronic medicine research with clinical needs. Our patients deserve no less.
This should also apply to consumer products. If you are terrified to eat cheese that has not been rubber-stamped by the USDA, well, then there is a cheese lane for you -- the one currently in the grocery store. There should also be a cheese lane for people like me: Those willing to eat unpasteurized, un-government-rubber-stamped cheese, typically because we know that businesses do not stay in business by poisoning people.








"we know that businesses do not stay in business by poisoning people"
Tobacco companies? Think fast poison vs. slow poison (another
example: pesticide residue)
Ron at July 28, 2014 5:57 AM
Oh, don't forget the alcohol companies, Ron.
I R A Darth Aggie at July 28, 2014 6:37 AM
I like this blog post.
Especially the cheese thing. We're told that Europe, including that darling France, lost all sorts of elegant and traditional foodstuffs because continental regulations made them too burdensome for production... As if there'd never been any liability to discourage poisoning people.
As to Ron's point, it's indisputably true that modern pesticides have extended human life far more than their residues have diminished it. Yet the American dislike of DDT has cost hundreds of thousands of lives (or more) in poorer countries... Places where malaria hasn't been essentially eradicated through hygiene and nutrition, as it was in the wealthy United States. (The incidence of malaria correlates only weakly with tropical heat. Consider the name itself: You're right, it's Italian.)
> Let Patients -- And Consumers -- Decide
> How Much Risk They'll Take
What I worry about is that all Obamacare shenanigans regarding insurance and government administration are a consequence of the fantasy that some larger entity will always be at hand to deal with unfortunate consequences...
In other words, that there can never again be a consumer acceptance of mortal risk... When people make bad choices, they want and expect that the government will cover their misjudgment.
Amy always bought insurance (as did I and many of the blog's other visitors). But over the years I've been amazed by the number who expected their community to cover any shortfalls, even as video games and flat screen and motorcycles came flowing through their lives. Remember commenter brian?
Crid [CridComment at Gmail] at July 28, 2014 7:04 AM
What an amazing assertion, given that widespread poisonings still occur, despite inspection routines.
Yep. All of that nasty mest and poisoned foodstuffs will magically be clean if we just get rid of government inspections, because the public is totally capable of detecting mercury and/or botulism toxin in that can of soup.
How many times do I have to say this before you get it?
Safety programs only work when action is taken before the fact. You cannot make personal injury or death "unhappen" with ANY action afterwards.
Radwaste at July 28, 2014 1:40 PM
Amy Alkon
https://www.advicegoddess.com/archives/2014/07/let-patients---.html#comment-4885945">comment from RadwasteGuess what: You can avoid eating any meat or food that isn't rubber-stamped by a government inspector and if I have a friend who's a dairy farmer who hands me a steaming hamburger, I'll choose to gobble it down and take my chances that I won't die.
Amy Alkon
at July 28, 2014 2:02 PM
How many times do I have to say this before you get it?
Safety programs only work when action is taken before the fact. You cannot make personal injury or death "unhappen" with ANY action afterwards.
Rad, how many times do we have to say 'That isnt the argument we are making'
FYI your blind support of prohibition of drugs and unacceptable foods is the same mentality you rail against when Patrick blindly supports the TSA by claiming 'its the law'
lujlp at July 28, 2014 3:13 PM
Sushi chefs here in Hawaii are fighting a new law that requires them to wear gloves. They spend years training in a delicate art, and many say that gloves would hobble them.
I say let me decide whether I want to eat sushi made by bare hands. As Amy says, poisoning people is bad for business.
Sosij at July 28, 2014 7:39 PM
We just went through the gloves thing with sushi chefs in L.A.
It got rescinded.
Crid [CridComment at Gmail] at July 28, 2014 10:03 PM
Amy Alkon
https://www.advicegoddess.com/archives/2014/07/let-patients---.html#comment-4887092">comment from Crid [CridComment at Gmail]It was ridiculous.
Amy Alkon
at July 28, 2014 10:19 PM
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