Filed 7:15 PM – Comment Number: 215742

Natural Solutions Foundation
www.healthfreedomusa.org

December 14, 2007

To: Food and Drug Administration
Docket No. 2007D-0388

“Draft Guidance for Industry: Questions
and Answers Regarding Adverse Event
Reporting…”

We recommend that all AERs include clear indications of any and all prescription and over the counter drugs being used by the person involved. We believe that often supposed “adverse reactions” to nutrients are actually drug – nutrient interactions or nutrient depletions caused by drugs, wherein normal structure and function are changed to the detriment of the person.

The Foundation joins in Maury Silverman’s comments below, including urging that all drugs be labeled to indicate the nutrient depletions they cause, so that truthful AERs can be filed.

For the Natural Solutions Foundation
Ralph Fucetola JD, Trustee
http://vitaminlawyerhealthfreedom.blogspot.com

Mr. Silverman’s Comments

“The key dilemma to evaluate any serious adverse event reports to FDA to dietary supplement companies; is to screen out serious drug problems when there is concurrent usage & ingestion of drugs of any type, with dietary supplements & nutrients.

“The problem with this is commonly within the term: POLYPHARMACY. This means concurrent ingestion of many drugs, be they prescription, OTC, illegal, adulterated, counterfeit, and/or other. As drugs are added, concurrently, the incidence, seriousness, and danger of side effects, toxicity, untoward effects, and life-threatening illness, escalates.

“There are two Institute of Medicine reports & recommendations, of very significant relevance to this, from August & September 2006. They are titled: Preventing Medication Errors, August 2006, and The Future of Drug Safety, Sept 2006.

“As for inadequate post-market drug safety surveillance, as more recently seen in the matters of Vioxx and Avandia, the future effect and implementation of the drug safety amendments of the recent FDA ‘revitalization’, now in law as PL 110-85, remain to be seen, in the public health interest, to minimize serious adverse medical events, by proper knowledge of usage, of all of the above named products.

“First, the medical and health professions, the FDA, and the educated consumer must understand the need to prevent drug-drug interactions, so often in polypharmacy usage. This should be included in the AER questions and answers and any regulations.

“Proper prescribing of a pharmaceutical drug is best by a competent medical doctor, who can accurately match the mechanism of action of the drug, with the pathophysiology of the illness/disease being treated. Direct-to-consumer advertising often clouds and distorts proper decision-making in prescribing drugs, be they by a professional clinical scientist & practitioner; or self-prescribed.

“Next, to consider are drug-nutrient interactions:

“The pathway, pioneering treatise and work in this area was by Daphne Roe M.D. of Cornell University who published in two volumes: Drug-Induced Nutritional Deficiencies, in 1976 & 1984.

“The major biochemical & physiologically theme of Dr. Roe’s work is that drug-nutrient interactions are ACTUALLY drug problems, because DRUGS DEPLETE NUTRIENTS.
Alcohol and tobacco also do so.

“Therefore, with regard to AER’s reported to dietary supplement companies, the FDA ought to; and must require that identification of all concurrent drugs of any type be identified, along with data on dosages, and duration of dosage; in relation to the medical history, the current diagnosed pathophysiologies of the complainant; and with retrieval of all relevant medical and treatment records.

“Research needs from this compilation and complexity of data would be the cumulative effects of concurrent usage of products on the enzyme & detoxification systems of the liver, of which synthetic drugs, and environmental pollutants, are of worse impact, than any nutrients, and natural products or remedies of ecological soundness, which are presumed safe under the law.

“To honor all of the above stated concerns will facilitate, enable, and honestly make possible accurate, factual analysis of the terms; ‘causation’ and ‘association’.

“Thank you for listening,
Maury Silverman”