Cirrhosis. Supplements and the (lack of) Regulation

In a week where once again a medical article has been published refuting the claims made by the manufacturers of Milk Thistle I though this article I wrote was worth posting.

There is a continual revolving door discussion about supplements and the value (if any) of taking them for cirrhosis. Some people swear by them, some swear at them, some are in doubt. Some are silent.

I come from Europe, the land of rules and regulations. In some parts of Europe like the UK, rules and regulations abound and must be obeyed. The EEC, famed for its idiotic proclamations regularly passes laws on areas of concern like the need for straight bananas and other such buffoonery.

The UK blindly follows such regulations as to do otherwise would ‘not be cricket’. The rest of Europe ignores them and resorts to bribery to flout the law.

In Germany there are rules and regulations. Rules must be obeyed and correct procedures must be followed. That is the German way. The only piece of insanity in an otherwise totally sane country is the autobahn, where there are no rules!

In a ridiculous, burdensome and expensive exercise, Europe is trying to retrospectively have all drugs and supplements proven to be safe, and in the UK the Trades Description Act takes care of the more outlandish claims of manufacturers, especially those who tout so-called ‘diet’ remedies; these tend to be banned.

So what does all this have to do with Cirrhosis?

Actually, rather a lot. The medically correct view is that supplements are unnecessary and a proper diet provides all the nutrition we need. This view is of course complete nonsense! Most people do not eat a purely healthy diet and specifically in the case of alcoholic cirrhosis, most sufferers enter the disease with malnutrition being a major, if not THE major driver.

Believe me, if water is the food of life, alcohol comes a pretty close second. If more doctors placed suspected cirrhotic patients on a massive dose of vitamin supplements (C & B) once liver disease was even suspected then many people would never go down the awful road of becoming decompensated.

In addition, many patients, even those with initial decompensated cirrhosis may be drawn back from the edge of the abyss of progressing towards total liver failure.

It is also undoubtedly true that as people get sicker, they get more desperate and will be tempted to try anything that seems to offer even a glimmer of hope – irrespective of the price or even the efficacy.

There are countless ‘solutions’ out there from the sublime to the ridiculous. Some are exotic, some not so. But the point is that if an obscure piece of lichen only found clinging to the upper slopes of Mount Everest and only discoverable by a certain breed of mountain goat can be marketed as a ‘Wonder Treatment’ for cleansing and detoxifying a liver’ then people will buy it!

But, you say, “These claims are validated and must be true?” “Aren’t they?”

Unfortunately the answer is less than satisfactory. In the USA, we have the Food and Drug Administration. This is the body set up to protect us from the manufacturers of foods including supplements.

So, what is a supplement?

The following are designated supplements by the FDA:

a vitamin,

a mineral,

an herb or other botanical,

an amino acid,

a dietary substance for use by man to supplement the diet by increasing the total dietary intake (e.g., enzymes or tissues from organs or glands), or

a concentrate, metabolite, constituent or extract.

So, the FDA regulates these supplements, yes?

Ummm, well no. It is the responsibility of the manufacturers to determine to that they are safe and any claims about them are not misleading. There is no requirement for the manufacturer to provide the FDA with any evidence to substantiate the safety and effectiveness of its product unless it is classified as a new dietary ingredient.

So, if a new supplement contains a new dietary ingredient the FDA must be informed, yes?

Ummm, well no actually. It is the responsibility of the manufacturers to determine whether their product contains any ‘new dietary ingredient’.

But the labeling must show a list of ingredients and their safe dosages?

Yes and No. The ingredients must be listed but the serving size is determined by the manufacturer and not subject to FDA agreement.

Can I get specific dietary supplement information from the FDA?

No again I’m afraid. The FDA does not maintain a list as there is no requirement for them to do so.

So, exactly who is responsible for ensuring a supplement is safe, is it the FDA?

Umm, you guessed it, No. By law the manufacturer is required to ensure their product is safe.

Do the manufacturers have to prove to the FDA that their product is safe?

Umm, No.

But if I have questions about a supplement’s safety or efficacy, whom do I turn to?

You guessed it, the manufacturer.

Does the FDA regularly test or analyze the contents of supplements?

Well, the FDA has limited funds and resources – remember they have to cover all food and drug products as well. So unless there is a public health emergency, the answer is No.

So, is what you are saying is that there is virtually no control over supplements?

Yep, that pretty much sums it up.

WOW!

So there you have it. In Europe over-zealous regulation abounds and actually costs the manufacturers serious money to bring their products to market. In the USA there are regulations in limitless numbers but no requirement to abide by them other than paying lip service.

In the UK, the outrageous claims made by diet supplement manufacturers are simply not allowed however in the US advertising claims are regulated by – the manufacturer, the FDA, the FTC (Federal Trade Commission) and for junk mail, the US Postal Service. So little chance of getting any agreement there!

So in terms of supplements, the only safe advice is buyer beware. Unfortunately many people are duped out of a lot of money due to marketing bordering on the fringes of legality and a public willing to spend anything if they think it brings a chance of a cure.

But finally, remember in an average experiment, even placebos do reasonably well. Often it is the mental conviction that a supplement works that makes people better and who can argue with that??

One famed carrier of the Hepatitis C virus, a man who is a walking example of embalming, Keith Richard, claims he beat the virus through the strength of his immune system and leaving his body to take care of it!!

Sources: The US Food and Drug Administration Overview of Dietary Supplements – last updated 10/14/2009.