Hair Analysis

Since it is believed that blood toxic metal levels are correlated with acute (1 to 2 week) but not chronic toxic metal exposure, hair levels of toxic metals may give a better indication of body toxic metal burden and overall exposure. Hair analysis is extremely cost effective and also gives an indication of total toxic metal load. This is important because one frequently finds exposure to several different toxic metals which would not be apparent from a single blood test. In addition to toxic metals, hair analysis can provide valuable data regarding essential trace minerals in the body. This can be extremely helpful in pinpointing serious deficiencies or imbalances. Doctor's Data utilizes the most up to date and accurate technology available.

More information on Hair Analysis can be found at Doctors DataInc.:

http://www.doctorsdata.com/

Our intention was to find a biomarker that would give us the best indication of overall efficacy. We believe the best to be Total Toxic Metal Body Burden. Many other chelation products have published studies showing increases of a single toxic metal such as lead or mercury in urine and blood after being challenged by the chelator tested. However, measurements of metals in urine and blood provide an indication of only transient changes in metal levels. Urinary levels are a reflection of how much metal is being cleared from blood by the kidneys during a relatively brief interval (hours). Blood levels tend to be transient and within hours are cleared from blood and either excreted or deposited in various tissues. Neither urine nor blood levels provide an indication of other pathways of excretion or of reduction of total body load. While an increased urinary level of lead or mercury provides an indication that a single toxic metal is being excreted, it does not provide data regarding how many other toxic metals are present or how much residual metal is left post- chelation. A recent study of DMSA challenge from Emory University in Atlanta revealed no correlation between past occupational exposure to mercury and mercury excretion before or after DMSA challenge.13 Furthermore, challenge studies incur a significant risk of serious side effects (see below) and also of kidney damage, particularly in older individuals. The best method for determining total toxic metal body burden would probably be some type of MRI spectroscopy. However, MRI for toxic metals has yet to be developed.

The most reliable and cost effective method commercially available, as well as the safest, is hair analysis by a quality laboratory. Hair analysis is very well documented and referenced with respect to measuring body burden of heavy metals such as Lead, Mercury, Cadmium, and Arsenic. The World Health Organization, the International Atomic Energy Agency, and the U.S. Environmental Protection Agency CDC, NIH and Justice Dept. have all recommended hair analysis for determination of heavy metals. . The EPA stated in a report "…if hair samples are properly collected and cleaned, and analyzed by the best analytic methods, using standards and blanks as required, in a clean and reliable laboratory by experienced personnel, the data are reliable." (USEPA 600/4-79-049). ).

Hair analysis provides a vast amount of information regarding toxic and trace minerals which relate to health and nutrition, at a tiny fraction of the cost of other methods such as blood and urine testing, which only reflect recent, but not chronic toxic metal exposure. Just as the measurement of glycosylated hemoglobin (HbA1c} has been found to be a more accurate measure of average blood sugar levels than random blood glucose levels, toxic metal levels in hair provide a more accurate reflection of toxic metal accumulation in the body. Furthermore, a single hair sample provides information concerning levels of an entire spectrum of toxic metals. Hair analysis frequently reveals exposure to several different toxic metals, which would not be apparent from a single blood or urine test. Persons with suspected lead or mercury poisoning need to be tested for all toxic metals, not just lead or mercury because studies have shown that the presence of more than one heavy metal lowers the toxic threshold for each toxic metal. Since our study attempts to determine the efficacy of our formulation as a broad- spectrum chelating agent, hair analysis was the only viable choice.

The evaluation of trace mineral levels in the body is important for several reasons. 1. Low levels of essential minerals such as zinc, selenium, calcium and magnesium are believed to make persons more vulnerable to the toxic effects of heavy metals. 2. High levels of toxic metals are believed to cause depletion of essential minerals such as selenium and zinc, which in turn can have important physiological effects such as impairment of thyroid function and impairment of detoxification mechanisms for chemicals and drugs. 3. Symptoms of trace mineral depletion may be mistaken for metal poisoning or may aggravate metal poisoning.

More government published info on the viability of hair analysis can be found at:
HAIR ANALYSIS PANEL DISCUSSION: EXPLORING THE STATE OF THE SCIENCE

http://www.atsdr.cdc.gov/HAC/hair_analysis/pdfs.html

METHODS
The following is a summary of the testing protocol to which volunteers agreed, resulting in the following data charts.
Volunteer selection criteria: Volunteers selected had at least 1 toxic metal over the normal reference range on a hair analysis performed by Doctors Data, Inc. and agreed to follow the “Volunteers Agreement”. No other discrimination of any other type was used.

Responsibilities of the Volunteer:
Summary:
1) Pre testing (hair)
2) 45 days or 90 doses of METAL FLUSH (as per directions) (hair test at 45 days or 90 doses)
3) Post testing 30 days after 90th dose (to allow for hair sample to grow out)
Before Starting
1) Provide hair sample as per Doctors Data collection procedures. (At home or mail in)
2) Fill out pre-study general health questionnaire.
During 45 day or 90 dose period
1) Take METAL FLUSH twice daily for 45 days (morning & evening) as per directions or once daily for 90 days. Stop at 45 days or (90 dose equivalent)
After 45 days or 90 dose period
1) Provide hair sample as per Doctors Data collection procedures. (At home or mail in) at end of 45 days or (90 doses) (Very important to follow directions-- only hair 1/3” from scalp to be sampled)
2) Fill out follow –up health questionnaire.
At 75 day period or (30 days after 90th dose)
1) No supplement taken
2) Provide Hair sample as per Doctors Data collection procedures. (At home or mail in) at end of second 75 days. (Since hair only grows at avg. 1/3” per month 30 more days must pass to show new toxic metal levels. Very important to follow directions-- only hair 1/3” from scalp to be sampled)
3) Final Health questionnaire.

Detailed original agreements, Doctors Data test reports, software and other original data is maintained in the offices of Science Formulas Inc. To protect patient confidentiality we cannot provide names of volunteers. However raw study data is available for review in excel spreadsheet format with written request to qualified researchers. We hereby certify all the attached data is based on actual final results provided by Doctors Data Inc.

Research Details:
Hair Samples: Hair samples were provided by each volunteer before any METAL FLUSH was consumed. Following completion of the 90-dose period, 30 days were added before the next hair sample was taken in order to allow for the slow growth rate of hair (1/3” to ½” per month) and to obtain a more accurate result of the chelator’s final leveling effect. Samples are taken from the back of head as close as possible to the scalp.

Testing Laboratory Services Discussion
Doctors Data Laboratory was selected as our preferred testing laboratory due to its established quality controls and longstanding reputation with other government agencies including The World Health Organization, the International Atomic Energy Agency, EPA, ATSDR, CDC, NIH and Justice Dept.. Blood & Hair Elemental profiles are measured with ICP-Mass Spectroscopy, and reported back with established comparative reference ranges along with actual results. Doctor’s Data’s reference ranges are established using the standardized protocol published by NCCLS. Reference ranges are determined using a comparative decision making process, utilizing Doctor’s Data’s hundreds of thousands of patient data and an American healthy population study. Doctor’s Data is licensed as a clinical laboratory by CLIA, New York, Florida, and Maryland. Doctor’s Data has scored consistently high on the CLIA mandated CAP, Le Centre de Toxicologie du Quebec, and New York Department of Health proficiency testing programs (PT), and performs interlaboratory comparisons with other labs that use ICP-MS such as Mayo Medical Labs. Doctor’s Data has comparable results to other laboratories using ICP-MS as demonstrated by our successful participation in the comparison program for hair analysis by ICP-MS offered by Le Centre de Toxicologie du Quebec. A summary of Doctor’s Data proficiency testing program results is available upon request. In addition to PT, Doctor’s Data has extensive Quality Control processes that ensure precision and reliability which include calibration verification and monitoring standards; preparation blanks; laboratory controls and reference materials (low, medium, and high controls); spiked samples and duplicate analyses. Doctor’s Data uses a state-of-the-art laboratory clean room specially designed for trace element analysis, which includes metal-free walls, floors, and ceilings, ultra-pure water, and HEPA filtration systems.
Doctor’s Data uses a modified version of the standardized sample preparation method published by the International Atomic Energy Agency (IAEA/RL/50, Vienna). This method consists of cutting the hair into .3cm pieces and mixing to obtain a representative sample, washing the hair three times with Triton X-100 to remove external contamination, and rinsing with acetone and de-ionized water twice. The sample is then digested using trace metal free nitric acid and temperature controlled microwave digestion. This method has been demonstrated to remove external contamination yet retain volatile elements that can be cooked off using other methods such as open beaker digestion. For more information on Doctor’s Data’s method, see "Preparation of Hair for Measurement of Elements by Inductively Coupled-Mass Spectrometry (ICP-MS)", Biological Trace Element Research, Vol. 62, 1998

Hair analysis lab info: To be performed by: DOCTOR’S DATA, INC
ADDRESS: 3755 Illinois Avenue, St. Charles, IL 60174-2420
www.doctorsdata.com EMAIL: inquiries@doctorsdata.com
TEL: 800.323.2784 FAX: 630.587.7860
LABORATORY DIRECTOR: James T. Hicks, MD, Ph.D., FCAP
MEDICARE PROVIDER NO: 148453, CLIA ID NO: 14D0646470
TAX ID NO. (FEIN): 93-0941625

Commonly Misinterpreted Article published in JAMA 1/3/01:
An article entitled "Assessment of Commercial Laboratories Performing Hair Mineral Analysis" by Seidel, et al, was published in the January 3, 2001 edition of JAMA (Vol. 285, No. 1). The authors’ primary conclusion was that hair mineral analysis should not be utilized by health care practitioners due to interlaboratory variability. Although the author’s conclusion is relevant only for hair analysis for “Hair Minerals” and not for “Toxic Metals” (long established as a valid bio-marker), there has been a mis-interpretation by the mainstream press that ALL hair analysis is invalid. The study reported which involved sending samples from one patient to six different labs. Yes JAMA published a ONE patient study! Even though this article is NOT relevant to the validity of our METAL FLUSH data we thought it necessary to clarify that we have investigated this article before choosing one of the 2 labs that were statistically identical (as per the JAMA article) due to their technologically advanced standardized quality testing methods. We have provided for reference a summary of Doctors Data’s initial response as published on their website and printed below.

“The study’s design only supports the answer to one specific question: "Are all hair analysis labs equal?" The answer is a clear-cut NO. We strongly agree that there are several laboratories that do a poor job- employing outdated methodologies; recommending, promoting, and/or selling supplements without ever seeing the patient; and, in one case, misrepresenting their CLIA license status. We strongly disagree that health care practitioners should refrain from using hair analysis based upon the conclusions of this article. The experimental design that was utilized (in the JAMA study) does NOT permit scientifically valid conclusions pertaining to the use or clinical value of hair analysis when performed by a high quality, licensed laboratory that utilizes state of the art methodology. Absolutely no evidence was provided to discredit the high quality hair analyses that are performed at Doctor’s Data.” For further detailed response see “Doctors Data’s Response” at: www.doctorsdata.com JAMA Article link: http://pubs.ama-assn.org