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[News] Provent Reportedly Goes Out of Business
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DocWils Offline

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Post: #11
RE: Provent Reportedly Goes Out of Business
Our standards and rules are far different from the FDA - and things not approved by them are passed here, and things passed by them are not, sometimes. Our standards of evidence are very different and stringent, and completely non-political or commercial, but our evidentiary rules and procedures are not the same as the FDA at all. Nor any of the EU regulatory bodies, either. Sometime I think we should all give it up to maybe the WHO to do it, or establish a new, world wide regulatory and testing body, so that each country doesn't have to go the same, lengthy and expensive testing processes time and again.
03-31-2013 04:57 AM
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JJJ Offline

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Post: #12
RE: Provent Reportedly Goes Out of Business
(03-31-2013 04:57 AM)DocWils Wrote:  Sometimes I think we should all give it up to maybe the WHO to do it, or establish a new, world wide regulatory and testing body, so that each country doesn't have to go the same, lengthy and expensive testing processes time and again.

I have thought that for years. It would save billions that each country currently spends individually. The cost of drugs and devices would go down because it would save the massive expenses that companies currently have to pay over and over again to gain approval in each country.

And while we're at it we could create international commissions to regulate the thousands of other things that countries currently do individually.
03-31-2013 11:00 AM
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DocWils Offline

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Post: #13
RE: Provent Reportedly Goes Out of Business
Well, one thought is that once a problem DOES pop up in some country after the drug or device has been passed, generally all countries look at it and adopt similar policies with it, so why not from the start? I think it comes from mutual mistrust - who decides, who sets the rules (and when ever did the US accept rules on anything that another country or independent organisation dictated?) so I think it won't happen, alas.
03-31-2013 12:38 PM
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Moriarty Offline

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Post: #14
RE: Provent Reportedly Goes Out of Business
(03-31-2013 04:57 AM)DocWils Wrote:  ... Sometime I think we should all give it up to maybe the WHO to do it, or establish a new, world wide regulatory and testing body, so that each country doesn't have to go the same, lengthy and expensive testing processes time and again.

Sounds like the EU on steroids... no thank you very much. Smile
03-31-2013 06:36 PM
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JJJ Offline

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Post: #15
RE: Provent Reportedly Goes Out of Business
(03-31-2013 06:36 PM)Moriarty Wrote:  
(03-31-2013 04:57 AM)DocWils Wrote:  ... Sometime I think we should all give it up to maybe the WHO to do it, or establish a new, world wide regulatory and testing body, so that each country doesn't have to go the same, lengthy and expensive testing processes time and again.

Sounds like the EU on steroids... no thank you very much. Smile

Bear in mind that it does not have to hit the ground fully grown and running. You could start with just a couple of countries that are currently doing it themselves, as a pooled effort to save their taxpayers money. Then add more countries as it proves itself. If a country does not want to participate, let them continue to do it themselves.

It would also be best to start it out very conservative. So "approved by <organization> would be a stamp that a lot of countries might accept. Any country, including members of the pool, can refuse to accept the approval for anything, and can approve anything even if the pool does not. You don't give up your sovereignty; you just have a way to save money by accepting the organization's approval if you want to.
03-31-2013 07:05 PM
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DocWils Offline

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Post: #16
RE: Provent Reportedly Goes Out of Business
The problem, besides the knee jerk reaction at the very thought of it that appeared above (and is exactly what I would have expected to hear, to be honest, although not from Oz), is that medical standards vary in each country - even simple things, like anaesthetic procedure for knee arthroscopy vary - the UK still mandates full anaesthetic, for example, while we mandate a spinal block and Sweden does it under local. In all truth, all three mandates are medically valid, but each governing health body has different feelings and experiences about it (although for orthopaedics, whatever the Swedes decide is fine with me - they are the single best in the world for that).

The EU as a whole and the US have very different mandates to certain cancer treatments, both valid, both with around the same mortality expectations, but very different. Would either side of the Pond accept a mandate from a third party body (to be fair, medicine is mostly evidence based world wide, so we tend to see eye to eye on a lot of this, but between us and the patients are layers of bureaus, politicians, regulatory bodies and insurance companies, and they don't think like doctors do, for the most part)? On our own, we tend to examine global trends for success and failure or any medicine, procedure or therapeutic approach, and the wider the sample, so much the better. And to some extent, regulatory bodies take such data into account, but the sovereignty issue remains a very real one.

As for international cooperation in revising medical procedures, that certainly exists, and one success story is a simple one page sheet, free of charge, from WHO and the UN, that has cut mortality rates in operating theatres by a good 30-40% world wide. That simple check-list has revolutionised how we can save lives and helped immensely in avoiding some of the most common mistakes that occur in the OP. On the whole, we medos tend to respond well to such things, so I don't think we would care who is checking out what medicine or what machine is safe and effective to use, so long as we all agree on the testing procedures and criteria. On the other hand, a lot of jobs would be lost in a lot of countries - there is big money involved in passing all this stuff, and that is yet another reason that the current system won't go down without a fight.
03-31-2013 07:55 PM
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SuperSleeper Offline

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Post: #17
RE: Provent Reportedly Goes Out of Business
(03-31-2013 07:55 PM)DocWils Wrote:  The problem, besides the knee jerk reaction at the very thought of it

I think it's important to remember from the American perspective, these days, when many hear "We need another government program" to solve yet another "problem-of-the-day", it sends vibrations of anger and disgust throughout their bodies, knowing that they are being squeezed financially by nameless, faceless bureaucrats who love to turn citizens upside down and shake out even more taxes from them, while at the same time increasing the scope of an already vast, complicated and intrusive government that hangs over and controls every little portion of their lives. Many are sick of it, which is why you see those seemingly "knee jerk" reactions. It's the sound of rebellion against oppressive elitists who fund themselves with ever-increasing tax money taken at gunpoint from average citizens who are only trying to keep a roof over their family's head and food on the table. And yet, the standard elitist response is something like, "But this program won't take that much more from the taxpayers, and it will save money in the long run". (the same argument that has been used to fund big government programs here since the 1930's).

So, yet another government program is born and taxpayers end up paying another dollar or two out of their pay checks each week. Citizens are dying a death of a thousand paper cuts. I personally think Americans are being quite reserved in their attitudes concerning intrusive government these days. If the average citizen of today were to have the determination and character of those who lived here in the late 1700's, they would have taken up arms by now and killed the oppressors just like their forefathers did with the British. Yep, I'd say Americans are pretty calm and cool about all this abuse, and hardly knee-jerk at all. The fact that the elitists don't have bullets in their heads is proof of that.

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04-01-2013 08:51 AM
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zonk Offline

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Post: #18
RE: Provent Reportedly Goes Out of Business
I,m really confused ... US spend more money on health than any other country

UK, Australia, Japan, etc ... spend less than half and get better results
04-01-2013 03:08 PM
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DocWils Offline

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Post: #19
RE: Provent Reportedly Goes Out of Business
Supes, What I was talking about would be cheaper, not more expensive than the current system because it would be shared out between various countries who "sign up"" for it. You would be removing a level of government, not adding. Right now, the cost for drug companies/DM manufacturers, the consumer, the tax payer (not the same thing as the end consumer) and the government is enormous to get things passed for safe use in each country, and most countries come to similar conclusions on each thing (more or less, not always of course), so why all the replication? A drug that would shrink the myomas that my wife suffers from has been available in the US for 5 years, the UK for 3 and will only be passed for use here next year. The results are incredibly good, it seems safe enough, so why are we taking the time and expense to run it through our version of the FDA? Now, we COULD simply say everything the FDA passes should pass here, but we won't do that, for obvious reasons, or we could all get together and share out the costs, giving a better and cleaner method, and of course, lees expensive for all around.

The same drug I mentioned above for my wife has been available in France for 12 years, BTW.....

Zonk, the US spends more for a lot of reasons, but a big one is the daft insurance system they use, which simply runs up massive costs in administration, and of course, the tendency of Americans to sue at the drop of a hat, which means that malpractice costs and insurances are massively high compared to the rest of the world, which of course pushes up so many other costs with it. Beyond that, I have seen lots of reasons listed, most of them are legitimate, some less so, some just embarrassing for the US peoples, but all of it put together brings up the overall spending pretty clearly. BTW, in the US, more is spent in the last four years of life than in the rest combined, in Switzerland it is the last year only - this indicates to me that chronic care is longer and more expense consuming than any form of care in the US - it might well be that they are given far better end of life care than in Europe, but I am not so sure. The old age homes I've dealt with are pretty clean and nice, something I cannot say in the UK (I worked for a few months in a home for Alzheimer's patients there some 25 years back, and it was both shocking and depressing). I don't know how the Americans handle that phase, but I do know that there is a tendency to keep people alive far longer than we would here, well past both suffering and dignity, and that may account for a fair chunk of the spending, too.

Somehow this thread has wandered a bit from Provent, don't you think?Lovely, free form and free association foruming. What fun!
04-01-2013 04:49 PM
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JJJ Offline

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Post: #20
RE: Provent Reportedly Goes Out of Business
(04-01-2013 03:08 PM)zonk Wrote:  I,m really confused ... US spend more money on health than any other country
UK, Australia, Japan, etc ... spend less than half and get better results

A significant part of the reason is the horrible American diet. The obesity rate in the U.S. drives up health care costs and lowers life expectancy at the same time. I note that Wikipedia now lists the U.S. at 40th place in life expectancy (although the sources of some of the statistics may be questionable). We are behind countries such as Costa Rica, Chile and Cyprus.

Others have pointed out other parts of the problem - the high percentage of the health care dollar that is spent on administration, the high cost of malpractice insurance, among others.

The sad part is that none of these causes is easy to fix. You can't just pass a law and change people's eating habits. But just because the U.S. health care system is in sad shape does not mean that those of us who are intelligent and educated cannot take individual actions to improve our own health. Indeed, if you live in the U.S., you have little choice.
04-01-2013 05:25 PM
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