We understand that Ampyra has many risks. However, it is important to note that the FDA’s role is to determine whether the benefits of a drug outweigh its possible risks for the United States population as a whole. Only you/ your son and his health care provider can decide if the potential benefits of a drug outweigh its potential risks for him. Consequently, many products that are FDA-approved have associated risks, but remain on the market because of their potential to bring benefit to many patients.
Just out of curiosity, are there alternative (safer, better, etc) treatments that does what Ampyra does but isn't FDA approved?
At present there is no real evidence that ampyra actually works however there was 4-AP basically the same chemical without the time release feature and it's cost was about $60 a month compared to acorda's ampyra at about $1700 a month
I know there are some that think ampyra has helped them and they like it to be approved by the fda so it is covered by insurance. But a billion dollars later there is still no evidence it works and it certainly doesn't help to control the high cost of medical care.
Just out of curiosity, are there alternative (safer, better, etc) treatments that does what Ampyra does but isn't FDA approved?
At present there is no real evidence that ampyra actually works however there was 4-AP basically the same chemical without the time release feature and it's cost was about $60 a month compared to acorda's ampyra at about $1700 a month
I know there are some that think ampyra has helped them and they like it to be approved by the fda so it is covered by insurance. But a billion dollars later there is still no evidence it works and it certainly doesn't help to control the high cost of medical care.
Every country has some form of citizen protection for drug or device allowances by their government. The FDA in the US is undergoing reforms, however, to take them out of the equation would be a disaster. If you want to "fix" something at the FDA, you could become a US citizen and get involved with Faster Cures.
DJ: Would you honestly propose to take your Health Canada down for the betterment of it's citizens and create a political movement to do so for unregulated medicine?
Geeta has never applied to the FDA for a human trial in the USA. In order to do that, she'd have to disclose what types of cells she's injecting into humans which she refuses to do. One would have no idea if the cells are causing tumors and other problems. She hasn't even run a clinical trial in her own country.
There are several countries with near non-existent oversight that already go unchecked. They're virtually drug free zones. There's not much anyone can do for people when they return to the US and have their life savings cleaned out and they're suffering neurological losses. The very doctors that are dealing with sick patients that have visited these drug free zones are the ones that will never allow this to happen in the USA. Human testing already takes place in the US under controlled conditions called IRB at specific research focused hospitals such as Cleveland Clinic.
I highly doubt that creating a drug free zone in the US would be beneficial for anyone wanting to have magical potions pumped into them. These doctors take their magic potions overseas. Doctors and research scientists do believe in "DO NO HARM" so it's simply not going to happen in the USA in the coming decades. So yes, in my opinion it is fanatical hysteria over nothing and I simply wouldn't waste my time trying to create a new world order for such a thing.
paolo...is the issue the model or is it human nature and greed/manipulation? Im not certain that if a better business model was presented the same problems would inevitably occur.
When i have been in discussion before i have been advised that the monies are there for research to ultimately find a cure but the science has not been found yet.
We need a governing body to oversee the governing body lol
Every country has some form of citizen protection for drug or device allowances by their government. The FDA in the US is undergoing reforms, however, to take them out of the equation would be a disaster. If you want to "fix" something at the FDA, you could become a US citizen and get involved with Faster Cures.
DJ: Would you honestly propose to take your Health Canada down for the betterment of it's citizens and create a political movement to do so for unregulated medicine?
Geeta has never applied to the FDA for a human trial in the USA. In order to do that, she'd have to disclose what types of cells she's injecting into humans which she refuses to do. One would have no idea if the cells are causing tumors and other problems. She hasn't even run a clinical trial in her own country.
There are several countries with near non-existent oversight that already go unchecked. They're virtually drug free zones. There's not much anyone can do for people when they return to the US and have their life savings cleaned out and they're suffering neurological losses. The very doctors that are dealing with sick patients that have visited these drug free zones are the ones that will never allow this to happen in the USA. Human testing already takes place in the US under controlled conditions called IRB at specific research focused hospitals such as Cleveland Clinic.
I highly doubt that creating a drug free zone in the US would be beneficial for anyone wanting to have magical potions pumped into them. These doctors take their magic potions overseas. Doctors and research scientists do believe in "DO NO HARM" so it's simply not going to happen in the USA in the coming decades. So yes, in my opinion it is fanatical hysteria over nothing and I simply wouldn't waste my time trying to create a new world order for such a thing.
I understand but I never mentioned getting rid of the FDA, I was simply questioning if what they do is truly beneficial to us or if it's just a hype and another source of revenue. Obviously they filter what's good from what's bad and they claim that they'll make sure the positive effects outweigh the negative effects but I'm really not seeing that with a lot of FDA approved prescription drugs.
paolo...is the issue the model or is it human nature and greed/manipulation? Im not certain that if a better business model was presented the same problems would inevitably occur.
When i have been in discussion before i have been advised that the monies are there for research to ultimately find a cure but the science has not been found yet.
We need a governing body to oversee the governing body lol
You've been told correctly Lara. The FDA isn't withholding a cure here the USA and a cure for paralysis isn't going to happen by allowing drug free zones anyway. Research scientists simply don't have all the answers yet. More money and efforts need to be focused into research rather than mucking about with the Federal Drug Administration. Anyway, that's the situation for spinal cord injury, but who knows, maybe a cancer patient would see something different.
Every country has some form of citizen protection for drug or device allowances by their government. The FDA in the US is undergoing reforms, however, to take them out of the equation would be a disaster. If you want to "fix" something at the FDA, you could become a US citizen and get involved with Faster Cures.
DJ: Would you honestly propose to take your Health Canada down for the betterment of it's citizens and create a political movement to do so for unregulated medicine?
Geeta has never applied to the FDA for a human trial in the USA. In order to do that, she'd have to disclose what types of cells she's injecting into humans which she refuses to do. One would have no idea if the cells are causing tumors and other problems. She hasn't even run a clinical trial in her own country.
There are several countries with near non-existent oversight that already go unchecked. They're virtually drug free zones. There's not much anyone can do for people when they return to the US and have their life savings cleaned out and they're suffering neurological losses. The very doctors that are dealing with sick patients that have visited these drug free zones are the ones that will never allow this to happen in the USA. Human testing already takes place in the US under controlled conditions called IRB at specific research focused hospitals such as Cleveland Clinic.
I highly doubt that creating a drug free zone in the US would be beneficial for anyone wanting to have magical potions pumped into them. These doctors take their magic potions overseas. Doctors and research scientists do believe in "DO NO HARM" so it's simply not going to happen in the USA in the coming decades. So yes, in my opinion it is fanatical hysteria over nothing and I simply wouldn't waste my time trying to create a new world order for such a thing.
I understand but I never mentioned getting rid of the FDA, I was simply questioning if what they do is truly beneficial to us or if it's just a hype and another source of revenue. Obviously they filter what's good from what's bad and they claim that they'll make sure the positive effects outweigh the negative effects but I'm really not seeing that with a lot of FDA approved prescription drugs.
You mean you see the Federal Drug Administration in the United States as a for profit business? Out of the thousands of submissions for drug approvals you're sure to have a few drugs slide through that probably should not have been on the market. It's not a totally infallible system in any country. They're understaffed and underfunded like so many other government agencies. And yet another problem will always be desperate patients demanding immediate release of nearly anything they view as a possible cure for their condition.
I understand but I never mentioned getting rid of the FDA, I was simply questioning if what they do is truly beneficial to us or if it's just a hype and another source of revenue. Obviously they filter what's good from what's bad and they claim that they'll make sure the positive effects outweigh the negative effects but I'm really not seeing that with a lot of FDA approved prescription drugs.
You mean you see the Federal Drug Administration in the United States as a for profit business? Out of the thousands of submissions for drug approvals you're sure to have a few drugs slide through that probably should not have been on the market. It's not a totally infallible system in any country. They're understaffed and underfunded like so many other government agencies. And yet another problem will always be desperate patients demanding immediate release of nearly anything they view as a possible cure for their condition.
A government agency that's understaffed and underfunded? You mention that sometimes they let drugs slide that shouldn't be on the market, but why? They only have one job and I don't think being understaffed or underfunded justify's why.
paolo...is the issue the model or is it human nature and greed/manipulation? Im not certain that if a better business model was presented the same problems would inevitably occur.
When i have been in discussion before i have been advised that the monies are there for research to ultimately find a cure but the science has not been found yet.
We need a governing body to oversee the governing body lol
We do need better management of research. In addition to what I have already reported about Ampyra, I would also like to point out that this drug is not a cure and does not stop the further degeneration associated with MS. It was already tried for spinal cord injury without success. And, yet there are even more trials going on with this drug. One trial is being paid for by the Dept. of Education.
Those lobbyists are worth their weight in gold
My point is that there are some other possible treatments that should be moved ahead of any further trials on Ampyra.
Hi Paolo you remind me of another guy in another forum who used to push the cure issue with a very good critical eye. Just curious if you are the same guy.
Regards
Delboy
Hi Delboy, yes I am the same of CareCure. It has become a little too wild that place lately and there are some technical problems too. Some people would say I have been a bit too aggressive there at times (which could be true), but I am convinced some agitators are needed there to expose some misleading info that were/are taken for good stuff.
Paolo
Not at all Paolo you where one of those that could call a spade a spade. As for the ASIA A walking claimed by the revered doctor and all the hype over a year has past and no proof whatsoever has unfolded. I can only say one thing screw all internet claims.
paolo...is the issue the model or is it human nature and greed/manipulation? Im not certain that if a better business model was presented the same problems would inevitably occur.
When i have been in discussion before i have been advised that the monies are there for research to ultimately find a cure but the science has not been found yet.
We need a governing body to oversee the governing body lol
Lara,
this thread is getting complex.. maybe too many problems are being discussed at the same time...
I would break down the problems at least in 3 main areas:
1) Founding - probably it's not enough, but sure first we need to review how money are spent. Most of SCI research money are not spent for cure research, so, in my opinion, that is one of the reasons why progress toward a cure is much slower than it could be. Maybe I should start a specific thread for that..
2) Then if you look at how money that goes to CURE basic research are spent there is another mess. See the first article I posted to get an idea to start from..
Long story short: Stem Cell Inc. is a California based company that had a therapy to test on people with SCI. They did not even try to get US FDA approval for the trail beacuse they knew it would have been a waste of time and money, so they tried with the Canadian FDA, but they failed. So they ended up in Switzerland. The first cohort of patients showed no adverse effect and some sensory recovery. See this article after results were reported: news.nationalpost.com/2012/09/18/canadian-stem-cell-trials-impeded-by-federal-regulations-doctors-say/ "What went unsaid was that the breakthrough could have taken place in Canada."
With that results they went back to the Canadian FDA and finally got a green light. Then they went to the US FDA and recently got the green light from them too.
If the US FDA would have been a reasonable authority Stem Cell Inc. could have saved easily two years and get the trial started in the US.
US FDA is slowing down the cure process. That's a fact.
To have and FDA free zone does not mean to have a "rules free zone" IMO. I actually don't know for sure what Bill Frezza meant to say in the article, but I believe he didn't mean to get a free zone to kill people doing experiments in a NAZI kind of way.
BTW you can consider Switzerland an "FDA free zone" while Switzerland is a very regulated country (I live 30 minutes away from switzerland and I go there often), but they use common sense in making and applying rules.
Hope I didn't just get you confused with all this stuff
Thankyou paolo for the reply and information I am going to take a good read of it (and the links) in the morning when my brain functions better...as its getting on to midnight here.
1) Founding - probably it's not enough, but sure first we need to review how money are spent. Most of SCI research money are not spent for cure research, so, in my opinion, that is one of the reasons why progress toward a cure is much slower than it could be. Maybe I should start a specific thread for that..
2) Then if you look at how money that goes to CURE basic research are spent there is another mess. See the first article I posted to get an idea to start from..
I think it would be a great way to develop understanding to break the issues down into threads but for this reason i will look at these two points first within this one reply and we can see how we get along .
My question in reference to the above quote: You imply that SCI research money is not being used to find a cure...and that money that is going towards to cure research is being wasted as suggested by your thread topic. Whilst it is important to focus on a cure...is it not also important areas of SCI issues that need researching to be focused on also?
I appreciate that a cure is the ultimate to aim for and what is the most beneficial for us but a cure may at this point although not unrealistic is without the science to achieve it at this point.
I have taken this extract below from an article i read earlier..sourced from Here
Just a decade ago scientists believed that little could be done to help a person with a spinal cord injury. They thought that once damaged, neurons could not be repaired. This view changed in 1990 when a high dose of intravenous methylprednisolone, administered within eight hours after injury, was shown to improve motor function. Methylprednisolone, a synthetic steroid which has been used for the last half-century primarily as an anti-inflammatory agent, is the only drug currently approved to treat spinal cord injury.
The research that discovered this SCI treatment may well be within the 'other' area of SCI research that you suggest? If so then it seems a very legitimate and worthwhile use of research money.
Secondly...Is it known specifically how the money is distributed within the research are and can organizations or individuals request that the funds go to specific areas of research?
paolo my questions are aimed to help myself and other members get a clearer picture and understanding..I appreciate your time in clarifying the points
paolo I have taken this extract below from an article i read earlier..sourced from Here
Well Dr Hall from that article is claiming he founded the methylprednisolone treatment, but he's not alone And guess what it is no longer believed to work.
Grass roots advocacy fertilized by Big Pharma-DICHOTOMY at it's best