Soaring Spirit with Tears



Reject More Regulations

by Ingrid Naiman

More federal regulations should be rejected for a number of reasons. First, despite the serious warnings of former Surgeon General C. Everett Koop regarding the absence of meaningful outcome research, there is an implicit assumption that because a drug has somehow navigated its way through the hurdles of the FDA that it is safe and effective. If the FDA had been performing a meaningful task in an appropriate way, we would not now still be arguing over whether or not mercury in amalgams and vaccine preservatives is safe and we never would have permitted Thalidomide or a host of other hugely dangerous drugs onto the market. The reality is that drug companies submit applications and that if the paperwork looks all right, the drugs are approved whether or not they are safe and effective.

Second, the truth is that conventional medicine is not winning any meaningful battles against any chronic diseases, and its arsenal for acute diseases is swiftly becoming ineffective.

Third, the premises of much of conventional medicine were based on a historic debate between Pasteur and Bechamp and nearly the whole of 20th century medicine was predicated on an argument Pasteur put forth: i.e. that specific germs cause specific diseases. On his deathbed, Pasteur admitted that his data did not support his arguments and that Bechamp should have won the debate, but his estate was prevented from publishing this for two generations. His grandson has now published the correct data, which amounts to a retraction of statements, but academia has yet to catch up because it spent so long denying pleomorphism that it hasn't even got the tools to examine such basic concepts.

Fourth, had 20th century medicine really been progressive, we would know as much about the immune system as about microorganisms, but since we can see microorganisms and only interpret the immune system through secondary observations, we don't really know what enables a person to fend off disease.

I could go on and on. I heard a surgeon on TV boast that he had performed over 7000 operations and that he could state with absolute certainty that he never saw chi inside any body he opened up on his table. There are some real geniuses out there, most of them sitting on conservative medical boards that would freeze knowledge at the mediocre "C" average they obtained 40 years ago.

Here is my vote, an absolutely serious recommendation. The FDA should be permanently shut down because it does not perform a needed service. Every profession should organize into regional and national chapters that are represented by a combination of eminent persons from their own profession. These persons should come from different segments of the profession: professors who teach the disciplines practiced by graduates, practitioners who are in the field and seeing patients on a daily basis, and researchers who are contributing to the future of their profession. All persons serving in national chapters should be elected by their own members and have limited terms. Anyone deriving unusual benefit from patents or investments related to their profession should be barred from holding office and anyone who accepts a nomination for office must be willing to disclose any potential for conflict of interest.

All professions will set the standards for membership and/or licensure of their own members and all governmental and insurance agencies must be bound by the judgment of the boards representing members. Board members must, in turn, be governed by the membership so that they are representing their profession rather than themselves as individuals.

There is zero basis for any further regulation at this time. The government has wholly failed to protect the public from unscrupulous medicines and medical practices. The fact that it foots the bill for certain services does not give it the right to determine efficacy. The merits of a treatment or protocol or procedure depend on outcome. Outcome is not an aspect of the current process for obtaining the recognition required in order that something becomes credible and legal. If conventional medicine were willing to subject itself to scrutiny, it would no doubt be forced to back down.

Finally, the methods used to determine credibility require enormous sums of money. Unless these sums are allocated to those who offer complementary health services and unless they are allocated on the same basis as other grants for research, there would be no way for anyone to perform the required trials . . . and no way to challenge the claims made for superiority of previously approved methods.

If a ballistics missile treaty is out of date because technology has changed, imagine how many medical patents and procedures are based on concepts and treatments that are completely out of date. Give that some thought.

For instance, if DNA is the cutting edge of medicine today (personally, I believe it is another hype but I have no illusions about the number of patents that will be granted for genetic medicines), then we have to ask how many patented and approved drugs cause damage to DNA? Should they all be removed because we now understand more than when the rubber stamps were put on applications? Should Bayer surrender its rights to aspirin because the standards for drug approval must meet the same safety standards as herbs?

If kava kava can be yanked from the market because someone complained of liver problems, then there is hardly a single pharmaceutical drug on the market that could pass the standard being held as appropriate for kava kava. I would wager a lot of foods are not as safe as kava kava. For instance, is there any inorganic food on the market that is safer than kava kava? I will bet that if you drink 16 cups of pesticide enriched coffee or even grape juice that you will be much sicker than anyone taking a medicinal dose of kava kava.

Medicine belongs in the hands of those who understand the needs of patients, not the demands of multinational corporations.


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Poulsbo, Washington