Last January I
noted that the FDA was barring me from obtaining software that might significantly improve my hearing. The software has been available to European and Canadian recipients of cochlear implants for quite some time, and studies there have shown that most patients experienced significant improvement. A few months ago I participated in a clinical trial of the software (which is necessary before the FDA will consider approving the software here) and found that indeed the software was a significant improvement. Faced with the likelihood that it will take the FDA up to a year to determine that yes, this software is an improvement, I decided to take a trip to Canada to get the software installed there so I wouldn't have to wait for the cumbersome FDA approval process. I even learned that the company that makes the implants is planning to offer the software as a free upgrade to anyone who wants it.
So you would think it wouldn't be a big deal. But today I received this news from the Canadian audiologist I planned to visit: "I was clearing everything with my department head, but I was told that I am not allowed to see patients from out of the country. I was told there were medical legal issues with seeing a patient who is not a resident of Canada."
This is not only a great example of how government bureaucracies can infringe on personal liberties, but also a reminder of how deeply government can intrude in our lives. And here I'm only talking about an innocuous piece of computer code that will eventually be distributed for free. Imagine if it were a life-saving procedure.... The ghost of Kafka must be looking over my shoulder and laughing right now.
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8 comments:
Sorry to hear your situation. I can only cringe at thinking about how we are all going to start getting more of a taste of what government medical care has in store. Take care and great posts.
I agree with Tom.
I'm afraid that your experience is like the ghost of medical care "yet to come."
I recently had to deal with the local office for Michigan's family services agency [the Michigan welfare department] regarding a tenant of mine.
I had faxed a form to the case worker and wanted to know the status of the request I was making on the form.
I called the local case worker's phone number somewhere between 10 and 15 times, leaving a voice mail each time. My voice mail was simply "Can you call me back and let me know the status of my request? Has it been received? Has it been approved? Has it been rejected?"
The case worker never called me back.
This person worked for the bureaucracy. It didn't matter whether he called me back or not.
Customer service doesn't matter to the bureaucracy - where else are you going to go? There is no competitor.
The bureaucracy is a black hole.
I dread the day when the bureaucracy "death star" assumes control of health care.
..... Resistance is futile. You will be assimilated.
It occurs to me that I must be one of a very small number of US citizens seeking medical attention in Canada. Mostly it's Canadians coming to the US to escape the limitations of rationing in their system. So I suppose I shouldn't be surprised to find that rationing applies to foreigners as well as to Canadians.
Mr. Grannis:
That’s a very sad tail. At the end of the day the FDA does about as much harm as good. The FDA gets it about half right at an enormous cost.
The above comments make good points as ObamaCare, through the ridiculous notion of price fixing, would find ways to deny your need as medically unnecessary (code for we are not paying for the upgrade).
Trying to contest some business registration fees we overpaid, by mistake, in Nevada. They don't even give us the courtesy of a response after many, many written requests.
Healthcare by the government will be a disaster. Absolutely no question whatsover about it.
Not rationing since you would have paid for the "upgrade" anyway.
Canadians clued up over the past few years to Americans coming to up here for cheap medicine. The impact on availability has been serious, insofar as the provincial governments negotiated prices discounts with the big pharma to provide goods and services to Canadians.
BTW sorry about all this. Although a little pissed that you could resist a little "dissing" of Canadian health care when it is your "free enterprise" system that screw you over. FDA is well know to be slow to approve non-American procedures or treatment. For years procedures available in Europe and Canada have been withheld from American patients. Welcome to capitalism!
Of course, this is not a new problem. It is not so clear to me that the problem is at the FDA, however. It could as well be a Canadian issue or a commercial issue. If it is an FDA issue, it doesn't have anything to do with policies incorporated in recent health care legislation, but more with regulation of the introduction of new therapies. I don't think anyone would seriously propose eliminating the FDA. Would you suggest fast track review (or no review) of therapies approved by, say, the EU or Canada. How about doubling the number of FDA examiners and charging the manufacturers hefty fees for reviews (like the SEC or the patent office)?
It's clearly an FDA problem, and it has nothing to do with recent healthcare legislation. What irritates me is that the FDA should subject the software to clinical trials, as they would to any material (physical) changes to the implant itself, when there is no possible way that the software could pose a health problem to users. The company explained this to the European and Canadian regulators, and was granted permission in short order.
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