Why prevent the FDA from doing harm....

Today's post:  Tuesday, 11-29-2016

The proposed FDA Guidance on supplements requiring that those new in any way since 1994 must have drug style testing is so harmful to the public health and so likely to cause such  huge increases in ineffective medical care costs, it simply must not be allowed to be used.

We cannot afford MORE people with heart failure and cancer and Alzheimer’s disease when we could have less instead.

The planned FDA policy would produce more costs and more people who suffer and harm our economy besides.

The reason this is so is later in this post; but first the background I list first shows that this policy is not needed to get the results that are intended.

1.  Background:

Supplements don’t need this kind of testing.  And the drugs ARE tested in this way do NOT protect the public the way they are thought to do.

The FDA did not work with the supplement industry after DSHEA was passed to develop a reasonable and workable way to introduce new supplements.

Then a law was passed during the Clinton administration in 2008 requiring the FDA to state what tests a new supplement must pass before the makers can make claims for it.

Now it’s almost 8 years later and the FDA was saying it intended to withdraw all supplements that are new even in minor formulation changes since 1994.

The FDA has the authority to remove supplements that have things like contaminants and unannounced drugs but has rarely used it due to having no budget needed to do so.

But the mainstream supplements introduced between 1994 and the present that ARE produced using decent quality control and do NOT have those problems have had fewer reports of minor side effects than aspirin and acetaminophen have deaths in a year.

The statistical chances of a supplement that has been taken 10,000 or 100,000 times with no problems having some problems for a small minority exists but it is quite small.

And, since supplements are extracts of foods and herbs and vitamins and minerals or naturally occurring components of the blood and the like, they do NOT need the kind of testing drugs do with their hundreds of times more concentration or completely off the charts of natural ingredients do.

In fact, the FDA has approved many drugs that have proven to neither be effective or safe to take using the hugely expensive and years long testing for drugs.

Proton Pump Inhibitors and the slightly changed estrogen from horse urine were found after the FDA style of testing to be harmful.

The FDA did not and has not removed these from the market.  Women found that the not bioidentical version of estrogen did not reduce heart disease and did increase cancer.  So they simply stopped taking it.  Fewer people know that proton pump inhibitors cause damage to the insides of the blood vessels of people taking them causing increased stroke risks and kidney damage AND that taking any acid reducer means that failure to supplement with sublingual B12 and taking magnesium and vitamin K2 is necessary to avoid mental decline and hip fractures.

So gradually as people learn this people will stop taking proton pump inhibitors.

So the benefits of causing supplements to do drug style testing are not needed because they are almost always safe without it AND the news travels faster when there are problems with supplements.

A recent Consumer’s Reports issue talked of problems with several supplements.  Only one of these on their list are at all widely sold because people won’t take them because these harms were publicized long ago.

So the rationale behind doing drug style testing on supplements is not needed.  The existing system that actually stops use of problematic supplements that supplements already have is better than drugs have which DO have such testing.

Secondly, much of the research on the benefits of supplements has already been done and is in the data compiled by the Life Extension Foundation.

And, the University of Maryland has a less complete but for some supplements excellent coverage of already done research showing the benefits of the supplement

Asking the supplement makers to pay exorbitantly for research that has ALREADY BEEN DONE is simply not OK.

2.   The existing FDA Guidance on supplements requiring that those new in any way since 1994 must have drug style testing is so harmful to the public health and so likely to cause such  huge increases in ineffective medical care costs, it simply must not be allowed to be used.

We cannot afford MORE people with heart failure and cancer and Alzheimer’s disease when we could have less instead.

The planned FDA policy would produce more costs and more people who suffer and harm our economy besides.

Here’s why that’s so:

Now most of the people who are in the prime working ages and who are educated still eat things that make them fat and sick.  Very few of them get the minimum amounts of vigorous cardio and strength training they need to stay well now and into their seventies and beyond.  Some of them still smoke or use tobacco products as well.

Meanwhile the few who do the reverse – eating & drinking health supporting foods and do the key exercises each week and add targeted supplements to prevent or stop the health problems that would cause death and disability in each key area -- will usually live productive, mobile, and independent lives into their nineties.  And the years of them being economically productive will be far higher than is the case now.

My personal mission is to do things that cause this change for a majority of those in the prime working ages so they are capable and interested in working and buying things they like.

This will cause our medical care costs to go down a bit instead of continuing to go up fast enough to collapse our economy.

The health professionals and doctors who use these lifestyle changes and supplements IN ADDITION TO the appropriate drugs and medical procedures when needed that I have learned from are already bringing this change about.

I am working to triple how fast this change happens.

The existing FDA guidance will slow this change by decades.

That means everyone pays more for health care and health care coverage.  It means far more people with Alzheimer’s disease and cancers of several kinds.

That is simply unacceptable on humanitarian grounds to cause that much avoidable suffering.

The huge increases in medical care costs to treat diseases supplement use is already preventing is simply unacceptable.

Heart failure, heart attacks, strokes, Alzheimer’s disease, and cancers are enormously expensive to treat and cause severe disruption to people who get them while still working.  

Yet lifestyle upgrades plus the supplements that help prevent them, are under attack by this FDA proposed policy.

It would mean far fewer people would prevent these diseases than do now when otherwise it will be more!

This is simply unacceptable.

In addition, in the United States, the shockwave first part of the baby boom is beginning to cascade into the over 65 ages when people who have already lived badly begin to have very large increases in the health care and health care expenses that they need.

This literally means the FDA's proposed policy could destroy our economy helping to bury us in costs and by reducing our productive workforce at the same time!

If the FDA does try to keep this original harmful plan, I urge you to join me in asking our representatives in Congress to act to prevent it.