Tuesday, August 30, 2016

FDA threatens access to effective supplements…

Today's Post:  Tuesday, 8-30-2016

I.  In 1994, a law was passed, called DSHEA, that guaranteed the public access to supplements mostly consisting of vitamins and minerals and food and herbal extracts and a few other beneficial substances found in foods or herbs.

Since 1994 the supplement industry has found another 60 or so such substances that have health benefits – very important health benefits in some cases.

Because of the food ingredient base of these supplements, with few exceptions these supplements have had a sterling safety record. 

(All of them combined have a much better safety record than aspirin by itself!)

Now, with many thousands of users for years they have ALREADY had much more thorough and varied testing than any drug goes through. 

And, it’s not even close.  These supplements have had more people using them but all of the very largest drug testing programs can afford to study.

The hundreds of thousands of people who prevent heart attacks and strokes and osteoarthritis and relieve pain more safely than drugs in some cases -- and more -- by taking these supplements are getting benefits and health protection they cannot get from drugs.

So depriving these people of those supplements and that protection would certainly harm them.

But there is an even bigger issue than just harming individuals at stake.

 Because of this protection from disease of hundreds of thousands of people, the millions of dollars that they would otherwise have had to pay or burden taxpayers with for less effective medical care have NOT happened.

Because of the high costs of the harmful and fattening foods and drinks the average American has been consuming and the few people who get the exercise they need and smoking --
AND the baby boom generation cascading into the over 65 years when they are most likely to need medical care, we are already facing continuous increases in health care costs.

This is already so much the case it is harming our economy!

It would be a disaster for this to get even worse in amounts this large.

Now the drug companies want to have the FDA remove the public access to these 60 supplements so that they can make patented versions they can sell decades in the future.

This ensures their monopoly and makes them undeserved money.

But it removes safe and effective supplements from the public and just at this time when boosting health care costs more would be criminal negligence to do.

Now the FDA has finalized a “Guidance” that enables them to do exactly that!

It’s not needed to protect the public.  And the harm it would do individuals and our economy with this added increase in health care costs simply cannot be tolerated.

So this guidance must simply not be allowed to go forward.

II. But in addition to that, this problem exists in the first place because of a structural defect in the current FDA and how it’s funded.

The FDA is an important federal agency that is supposed to regulate food, and drugs, and supplements.

But it is badly underfunded. So much so that their real source of income is the testing fees for drugs.

So in practice, the FDA has become mostly an agency of the drug company’s interests with Federal authority to regulate.

This means that it tends to do a poor job in regulating all three things.

They haven’t enough money to do effective and win-win regulation of ethical food providers and supplement companies.

And, they have been too willing to approve drugs that are not effective or only partly effective which have bad and occasionally fatal side effects.

The drug companies are their main source of income.  So the FDA tends to do what those companies want them to do. 

Unfortunately this often means the FDA acts in ways that harm the public interest and give the drug companies undeserved money.

The bad news is that the FDA needs far more funding from the US government; AND it needs three separate parts that are funded and managed separately:

One for drugs; one for food; and one for supplements!

Since the better doctors and pharmacists tend to know which of the older drugs are safe and at least somewhat effective, the public is somewhat protected against this system.
But the regulation of the supplements for weight loss and muscle building and youth restoration that are not effective – or much worse contain drugs NOT listed on the label -- the FDA already has the authority to regulate and prevent the worst of these things.

They aren’t funded for it and don’t do much of it. 

They do not need to hand the safe and effective supplements that do exist over to the drug company monopoly to do this job.

They just need more funding and separate management that ensures they do well what they already have the authority to do.

If the part of the FDA that regulates supplements was separate and adequately funded, they might actually do this that they don’t do much of now.

And, since this part of the FDA would NOT be paid by the drug companies, the FDA would NOT be trying to rip off the supplement companies and the public interest to the sole benefit of monopoly drug companies as it is now doing!  

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