Prairie View

Tuesday, August 04, 2009

The Right Prescription

Oh dear. I hate political machinations. But today I happily advocated in support of two bills introduced by Ron Paul, who was a visible figure in the last presidential election. They were apparently introduced today in the U. S. House of Representatives.

While Ron Paul does not represent my district (Jerry Moran does.), his bills represent exactly what I have been praying would be possible--freedom of speech on the benefits of non-pharmaceutical health products. Check out http://www.lef.org/featured-articles/Health-Government-Reform-Bills-by-Ron-Paul.htm for further information.

Here is a summary of the two bills I asked Moran to support:

HR 3395: The Health Freedom Act. This bill removes FDA’s power of prior restraint over all nutrient-disease relationship claims. Under the bill, the FDA may not prohibit any statement concerning a nutrient affecting a disease (including treatment effects) from being made in the market and may only act against a statement once made if it possesses clear and convincing evidence that the statement is false. Presently the FDA blocks an enormous quantity of truthful information concerning the effects of nutrients and foods on disease from reaching consumers. That barrier is removed by the Health Freedom Act, but the Act preserves the power of the government to prosecute those who communicate falsehood. The essential purpose of the First Amendment is to disarm the federal government of the power to impose a prior restraint on speech. The FDA has imposed a prior restraint for decades to the health detriment of the public. Passage of the Health Freedom Act will restore constitutional governance by reasserting the supremacy of the First Amendment over the Food and Drug Administration.

HR 3394: The Health Information Protection Act. This bill prevents the Federal Trade Commission from taking action against any advertiser that communicates a health benefit for a product unless the FTC first establishes based on clear and convincing evidence that the statement made is false and that its communication causes harm to the public. Presently, the FTC reverses the Fifth Amendment burden of proof on the government when it charges advertisers with deceptive advertising and then demands that they prove their speech true based on contemporaneously held documentation or be deemed to have advertised deceptively. The Fifth Amendment requires that FTC bear the burden of proving advertising deceptive. It may not constitutionally shift the burden to the advertiser to prove its statements not deceptive. The First Amendment requires that FTC not act against speech unless the speech is probably false. It may not constitutionally accuse a party of false advertising yet lack proof that the advertising is false and condemn advertising based on an absence of documentation concerning the truth of the statement rather than the presence of evidence establishing the falsity of the statement.

Here is the text of the note I sent to Jerry Moran:

Please vote to restore the right of free speech to those of us who have experienced very significant health improvements after taking nutritional supplements but are prohibited by law from speaking of it.

The current situation denies not only the right of free speech to many who simply have good news to share, but withholds from others the right to be fully informed of their health care options.

In this time of looking more carefully at health care options, this area urgently needs attention and "treatment." I wish to be a law abiding citizen AND be able to share freely with my loved ones and fellow citizens health information that could significantly improve their quality of life, and make their medical situation less fragile and less expensive to maintain.

For me the bottom line is that nutrition provides the body with the tools to defend, maintain, and repair itself. While these mechanisms are not completely understood, and are very difficult to test empirically, they are clearly present, by God's design, I believe. To be able to attribute positive health effects only to pharmaceutical drugs is just wrong. Yet this is all that is allowed presently. No one is pharmaceutical-drug-deficient, but many are nutrient deficient--which eventually creates symptoms that make pharmaceuticals seem necessary. (I do recognize that they are often needed in the short term, at least.)

I believe that citizens have the intelligence to discern wisely what is in the best interests of their health--if they have full access to all the facts. Currently this is not possible. I appeal to you to do all in your power to change this lamentable situation.

The above website makes it very easy to weigh in on this legislation by writing to your own representative. When you type in your zip code, your communication is automatically routed to your representative.

You may never have given much thought to the issues these bills suggest. Let me spell it out for you in the form of a hypothetical situation:

You have a seven year old daughter who began suffering from severe headaches. When you took her to a doctor, she was eventually diagnosed with a brain tumor. It could not safely be removed, and no medical treatment promised any hope of a cure. Your neighbor told you about a nutritional product that others have taken with good results. She could not promise you that your child would improve if she took the product, but she told you that taking the product is what she would do if she faced a similar diagnosis. She explained what she knew about how the product affected various body mechanisms. You decided to give your daughter the product. Within several weeks, your daughter went from nearly constant screaming with pain to playing happily. Further testing several weeks later revealed only a tiny knob where the tumor had been. You are overjoyed, but you must never, never, mention her "spontaneous remission" in connection with any nutritional product. To do so is a prosecutable offense because you are in violation of the law that prohibits making any health claim in connection with any non-pharmaceutical product. Speaking of the tumor and the nutritional product and the health change and virtual disappearance of the tumor in the same conversation implies a connection between the nutritional product and an improved state of health--making a health claim, in other words--which is illegal. If the doctors had given her chemotherapy or radiation or surgery, and she had recovered, You could proclaim it from the housetops. If she had failed to recover after such treatment, your only legal recourse would have been to file a malpractice lawsuit, which you would not have won, if the doctor was following typical "standard of care" procedures.

Ron Paul's bills seek to alleviate the kind of dilemmas that people face in situations like the one above.

Some may argue that allowing people to make health claims for non-pharmaceutical products opens the door to charlatans who wish to take unfair advantage of gullible people who pay money for products that don't work. That is a possibility, of course. It is a possibility in conventional medicine, as well, that some things that are tried don't work, and they are often very expensive and uncomfortable failed experiments.

I am not on a mission to discredit conventional medicine. Neither am I in favor of reckless promises being made in connection with any non-conventional approaches. It is always God Who heals, and humility about how He chooses to do so is the only reasonable stance. But I think the current legal situation is grossly unfair, and has a great deal more to do with backroom lobbying by pharmaceutical giants than real harm done by nutritional products.

The gold standard for health related research is randomized, double-blind, placebo-controlled studies. Think about it--How would you design such a study for a nutritional product? It is notoriously difficult to design such studies, primarily because nutrients often act in concert with other nutrients, and it's not easy to find research subjects whose entire nutritional intake can be controlled--for sure you can't give some people only the product being tested and give the others nothing at all(They would both die of malnutrition.)--to say nothing of other variables that may affect health--exposure to pathogens or toxins or stress or trauma, for example.

With food (or other nutritional products) you can't in good conscience meet the pharmaceutical standard of seeing how much of the substance the research subjects must ingest before half of them die--to arrive at the LD50 (LD=lethal dose). Neither can you empirically test each food's effects on each disease or health condition separately. (Drugs have a "one product/one claim" limitation.) You probably can't list the deleterious side effects of nutrient intake--another requirement before a pharmaceutical drug can be released. In short, the regulations for pharmaceuticals are very poorly suited for evaluating nutritional supplements. Yet, people (insurance companies included) often say, in effect, If the FDA (Food and Drug Administration) hasn't approved it, I can't trust it.

There are some regulations that do make sense for nutritional products. Some manufacturers of nutritional products agree voluntarily to GMP's (Good Manufacturing Practices). They make sure of several things:

1) There are no contaminants in the product.

2) The product contains what the label claims it contains.

3) Every pill (for example) contains the same amount of the stated contents as every other pill.

From that point on, the consumer is trusted to make an intelligent determination about whether or not to use the product. I think that's a reasonable approach. I personally commit myself to "due diligence" before I take any nutritional product. Checking to see if the manufacturer commits to GMP's is one of the things I will consider.

Will people sometimes take something they don't need? Probably so. Will they suffer harm or lose money because of it? Occasionally, but not usually (for long, at least). Might they benefit substantially? Perhaps, but not if they don't have a chance to learn about it and try it.

Does anyone really believe that the Federal Trade Commission (FTC) functions only to protect the consumer from unscrupulous business practices--like false advertising? I don't doubt that the agency was established in good faith and that it has many times fulfilled its original mission. But I don't doubt either that it has at times been manipulated by clever lobbyists who are unscrupulous through and through.

Two new laws could not possibly set everything right that is wrong now in the regulatory environment regarding nutritional supplements. But I think the bills introduced by Ron Paul go some distance in the right direction.

Ron Paul is a physician. This is one prescription that he got exactly right. Taking the medicine exactly as prescribed offers our country hope of recovery from its current health care ills.
I urge you to add your voice in support of the bills.

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