Why the proposed FDA NDI policy for supplements would be so horribly harmful....
Today's Post: Friday, 8-26-2011
Open letter to:
Kathleen Sebelius, Secretary of the Department of Health and Human Services
FDA Commissioner Margaret Hamburg
You are charged with protecting the public health of the United States.
Realistically, events may prevent you from doing some of the good things you’d like to do protect the public health.
The proposed labels on packs of cigarettes are truthful and likely would cut consumption providing millions or even billions of dollars in reduced health care costs.
You may or may not succeed in this as you know.
But you DO have the ability to avoid harming the public health due to your own decisions that are carried out.
Do you want to be known in the history books for significantly harming the public health of the United States on your watch?
If you allow the currently proposed FDA NDI policy for supplements to be enacted, you will do exactly that.
Further, at a time of seriously too high health care costs, the added and even higher and now avoidable health care costs this policy would make happen, would harm our economy so much, if this policy is put in place, this would guarantee your place in future history books.
This policy would at a stroke make the current supplement industry illegal and slam shut the access of the public to supplements. Only the few supplements that the drug industry thinks it can make drugs of would survive. It would take up to 10 years or more to regain access to those. And, they would be ten to a hundred times as expensive as the existing supplements are now.
As things are now, thousands and thousands of Americans take inexpensive to moderately priced supplements that prevent diseases and the necessity for very expensive medical care to treat them.
Worse, since many more people could do this and save on our health care costs, wiping out supplements would make improving our high health care costs dramatically more difficult.
Lastly, this could not possibly come at a worse time for the impact of high or even higher health care costs on the economy of the United States.
Demographic forces are inexorable and can be seen years in advance. Two very scary trends now exist. The baby boomers are now beginning to cascade into the years when they need the most health care if they have not taken good preventive steps to avoid it. In addition, the generation of children who will be adults soon have been raised on soft drinks, fast food, and sugary and fatty snacks. Too many of them will get diseases in their thirties and soon after that people only used to get after age 65.
As you may not now be aware, many supplements now available are successfully keeping a lid on avoidable and very large increases in our health care costs.
I’ll use myself as an example to make the point clear and easy to see. There are thousands of dollars of health care costs I have not had and very likely won’t have if supplements continue to be available.
1. Supplements, available as they are now, prevent heart disease and the related costs to treat it. And, I have the blood tests to prove it. I’m NOT guessing.
My family history is such that if I took no action to prevent it, it’s quite likely that I would have had a heart attack already or will have one in the next 10 years.
My blood tests show clearly that the healthy lifestyle I’ve followed and that the supplements I’ve taken have protected me so far. And the chances of me getting a heart attack in the next ten years is close to zero.
When I began to pay attention, my LDL cholesterol was 130 while the family history suggests it might well have been over 160 had I not eaten well, exercised, and taken the two supplements I took then.
When I found out 130 was still relatively high risk I took a bit more of one supplement and added two more. My blood tests show that this lowered my LDL to scores from 96 to 106. That’s a low risk range.
Then more recently I added two other supplements for other reasons. I was then delighted to find that my LDL cholesterol had gone down to the mid 70’s. That’s extremely low risk.
Even better, my HDL has been over 80 & my triglycerides have been under 50. Some of that has been from not eating junk and my regular exercise. But some of my supplements have added to this positive and protective effect.
These are such good readings a cardiologist would turn cartwheels if their patients had them or they did themselves.
Why take an action to prevent me and thousands like me from protecting ourselves by destroying the supplement industry?
Have you priced emergency room visits for heart attacks or stays in the ICU or the cost of balloon angioplasty lately?
Please do not take an action that would incur these costs for me and thousands like me. It would gravely harm the public health and do even worse harm for our economy.
2. Unfortunately earlier in my life I gained too much belly fat, was under too much chronic stress, and drank too much coffee. As a result, I got GERD, acid reflux disease. To avoid heartburn pain from ruining my sleep and getting esophageal cancer, I’ve taken proton pump inhibitors ever since.
But that has a downside. We now know that taking proton pump inhibitors causes depletion of magnesium to the extent that it makes leg and hip bones brittle and they often break when they otherwise would not. Magnesium is also essential for many other normal health functions as well. But the FDA’s own publication had data that found that just supplementing magnesium prevented this in 75% of the people studied.
I take more magnesium than the people studied and eat nuts daily. I also do weight bearing exercise and eat foods daily that are high in calcium and I take vitamin D3 at close to its real optimum dose. So, I do not expect this to be a problem for me. But if I no longer have access to magnesium or D3 as this would proposal would guarantee, that might well change.
Have you seen the dollar cost of treating hip fractures lately? Are you aware of the extent to which they make working at an economically productive job far less likely?
Please do not take an action that would incur these costs for me and thousands like me. It would gravely harm the public health and do even worse harm for our economy.
Second, taking proton pump inhibitors can cause or worsen B12 deficiency. That has been shown to lower the cognitive ability of older people or even contribute to dementia. Again that’s not been a problem for me in part due to having access to a B12 supplement that allows me to absorb it directly from my mouth before the drug prevents me access to it in my stomach or small intestine.
Have seen the dollar cost of treating people with dementia recently? Are you aware of how much less economically productive the baby boom generation will be if such supplement unavailability reduces our brain power?
Please do not take an action that would incur these costs for me and thousands like me. It would gravely harm the public health and do even worse harm for our economy.
There are dozens of similar examples of good health habits plus the right supplements preventing health care costs.
These are two I happen to know well
But cancers, high blood pressure, type 2 diabetes, BPH, Alzheimer’s disease and many others have similar stories.
(The book, Anticancer, A New Way of Life, New Edition by MD, PhD, David Servan-Schreiber describes how certain life styles and supplements effectively prevent cancer as another example. It’s well though of by the top cancer doctors in the country. I recommend it highly as it shows how both Western medicine and preventive strategies like supplements are each valuable and how they differ.)
But there’s far more reason to not implement this policy of pulling supplements from the market and treating them as if they were drugs.
With the exceptions of companies that allow harmful contamination of their products and/or add real drugs that are not announced on their labels, the supplement industry has an exemplary safety record.
Those real problems could be better addressed directly which the FDA already has the authority to do.
Destroying the entire supplement industry to solve these problems is like burning down a whole multi-story building with the people in it to swat a mosquito on the second floor.
This draconian, proposed FDA policy simply cannot be justified. The requisite public harm does not exist.
Worse, there ARE federal government regulations that prevent the public from real harm. The policies on clean air and water have been proven to protect the public health.
If this policy is put into place, the public will rightly see the federal government as enacting regulations that do no good and are horribly harmful to the public health and our economy.
This will strengthen the hands of people who want to eliminate the regulations that do protect us.
Please protect us from this policy and do not allow this proposed FDA policy or even one similar to it to be enacted on your watch.
The bad consequences would unbelievably harmful in all these ways at once.
Today's Post: Friday, 8-26-2011
Open letter to:
Kathleen Sebelius, Secretary of the Department of Health and Human Services
FDA Commissioner Margaret Hamburg
You are charged with protecting the public health of the United States.
Realistically, events may prevent you from doing some of the good things you’d like to do protect the public health.
The proposed labels on packs of cigarettes are truthful and likely would cut consumption providing millions or even billions of dollars in reduced health care costs.
You may or may not succeed in this as you know.
But you DO have the ability to avoid harming the public health due to your own decisions that are carried out.
Do you want to be known in the history books for significantly harming the public health of the United States on your watch?
If you allow the currently proposed FDA NDI policy for supplements to be enacted, you will do exactly that.
Further, at a time of seriously too high health care costs, the added and even higher and now avoidable health care costs this policy would make happen, would harm our economy so much, if this policy is put in place, this would guarantee your place in future history books.
This policy would at a stroke make the current supplement industry illegal and slam shut the access of the public to supplements. Only the few supplements that the drug industry thinks it can make drugs of would survive. It would take up to 10 years or more to regain access to those. And, they would be ten to a hundred times as expensive as the existing supplements are now.
As things are now, thousands and thousands of Americans take inexpensive to moderately priced supplements that prevent diseases and the necessity for very expensive medical care to treat them.
Worse, since many more people could do this and save on our health care costs, wiping out supplements would make improving our high health care costs dramatically more difficult.
Lastly, this could not possibly come at a worse time for the impact of high or even higher health care costs on the economy of the United States.
Demographic forces are inexorable and can be seen years in advance. Two very scary trends now exist. The baby boomers are now beginning to cascade into the years when they need the most health care if they have not taken good preventive steps to avoid it. In addition, the generation of children who will be adults soon have been raised on soft drinks, fast food, and sugary and fatty snacks. Too many of them will get diseases in their thirties and soon after that people only used to get after age 65.
As you may not now be aware, many supplements now available are successfully keeping a lid on avoidable and very large increases in our health care costs.
I’ll use myself as an example to make the point clear and easy to see. There are thousands of dollars of health care costs I have not had and very likely won’t have if supplements continue to be available.
1. Supplements, available as they are now, prevent heart disease and the related costs to treat it. And, I have the blood tests to prove it. I’m NOT guessing.
My family history is such that if I took no action to prevent it, it’s quite likely that I would have had a heart attack already or will have one in the next 10 years.
My blood tests show clearly that the healthy lifestyle I’ve followed and that the supplements I’ve taken have protected me so far. And the chances of me getting a heart attack in the next ten years is close to zero.
When I began to pay attention, my LDL cholesterol was 130 while the family history suggests it might well have been over 160 had I not eaten well, exercised, and taken the two supplements I took then.
When I found out 130 was still relatively high risk I took a bit more of one supplement and added two more. My blood tests show that this lowered my LDL to scores from 96 to 106. That’s a low risk range.
Then more recently I added two other supplements for other reasons. I was then delighted to find that my LDL cholesterol had gone down to the mid 70’s. That’s extremely low risk.
Even better, my HDL has been over 80 & my triglycerides have been under 50. Some of that has been from not eating junk and my regular exercise. But some of my supplements have added to this positive and protective effect.
These are such good readings a cardiologist would turn cartwheels if their patients had them or they did themselves.
Why take an action to prevent me and thousands like me from protecting ourselves by destroying the supplement industry?
Have you priced emergency room visits for heart attacks or stays in the ICU or the cost of balloon angioplasty lately?
Please do not take an action that would incur these costs for me and thousands like me. It would gravely harm the public health and do even worse harm for our economy.
2. Unfortunately earlier in my life I gained too much belly fat, was under too much chronic stress, and drank too much coffee. As a result, I got GERD, acid reflux disease. To avoid heartburn pain from ruining my sleep and getting esophageal cancer, I’ve taken proton pump inhibitors ever since.
But that has a downside. We now know that taking proton pump inhibitors causes depletion of magnesium to the extent that it makes leg and hip bones brittle and they often break when they otherwise would not. Magnesium is also essential for many other normal health functions as well. But the FDA’s own publication had data that found that just supplementing magnesium prevented this in 75% of the people studied.
I take more magnesium than the people studied and eat nuts daily. I also do weight bearing exercise and eat foods daily that are high in calcium and I take vitamin D3 at close to its real optimum dose. So, I do not expect this to be a problem for me. But if I no longer have access to magnesium or D3 as this would proposal would guarantee, that might well change.
Have you seen the dollar cost of treating hip fractures lately? Are you aware of the extent to which they make working at an economically productive job far less likely?
Please do not take an action that would incur these costs for me and thousands like me. It would gravely harm the public health and do even worse harm for our economy.
Second, taking proton pump inhibitors can cause or worsen B12 deficiency. That has been shown to lower the cognitive ability of older people or even contribute to dementia. Again that’s not been a problem for me in part due to having access to a B12 supplement that allows me to absorb it directly from my mouth before the drug prevents me access to it in my stomach or small intestine.
Have seen the dollar cost of treating people with dementia recently? Are you aware of how much less economically productive the baby boom generation will be if such supplement unavailability reduces our brain power?
Please do not take an action that would incur these costs for me and thousands like me. It would gravely harm the public health and do even worse harm for our economy.
There are dozens of similar examples of good health habits plus the right supplements preventing health care costs.
These are two I happen to know well
But cancers, high blood pressure, type 2 diabetes, BPH, Alzheimer’s disease and many others have similar stories.
(The book, Anticancer, A New Way of Life, New Edition by MD, PhD, David Servan-Schreiber describes how certain life styles and supplements effectively prevent cancer as another example. It’s well though of by the top cancer doctors in the country. I recommend it highly as it shows how both Western medicine and preventive strategies like supplements are each valuable and how they differ.)
But there’s far more reason to not implement this policy of pulling supplements from the market and treating them as if they were drugs.
With the exceptions of companies that allow harmful contamination of their products and/or add real drugs that are not announced on their labels, the supplement industry has an exemplary safety record.
Those real problems could be better addressed directly which the FDA already has the authority to do.
Destroying the entire supplement industry to solve these problems is like burning down a whole multi-story building with the people in it to swat a mosquito on the second floor.
This draconian, proposed FDA policy simply cannot be justified. The requisite public harm does not exist.
Worse, there ARE federal government regulations that prevent the public from real harm. The policies on clean air and water have been proven to protect the public health.
If this policy is put into place, the public will rightly see the federal government as enacting regulations that do no good and are horribly harmful to the public health and our economy.
This will strengthen the hands of people who want to eliminate the regulations that do protect us.
Please protect us from this policy and do not allow this proposed FDA policy or even one similar to it to be enacted on your watch.
The bad consequences would unbelievably harmful in all these ways at once.
Labels: currently proposed FDA guidelines for supplements would eliminate the industry and your access to supplements, Why the proposed FDA NDI policy for supplements would be so horribly harmful
posted by David at 2:23 PM
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