This letter was posted to the Internet News Group Sci. Life. Extension on the date below.
DHEA..FACTS NOT FICTION - GARBAGE BEING SOLD AS DHEA
NUBRAIN (NO-BRAIN) WROTE IN A PREVIOUS POSTING: Our company is an authorized distributor of the Lifelink DHEA products and they have micronized DHEA in 5-10-25-50 mgs.
*Answer to NUBRAIN and LifeLink's DHEA supplier:
After well over a year of *our complaining about the purity of your industrial grade DHEA, it is gratifying to hear that you are challenging our findings, and will do the proper testing that should have been done well over a year ago. You will find with your testing, if it's done properly, that we are correct in every assertion as we can back up any statement that any employee of ours states regarding your product, or anyone else's. To understand us, you need to understand that *we are primarily in the research business, not the manufacturing business, even though we hold licenses from the DEA and FDA to do both. We only research and produce products when we discover potentially dangerous faults with products, or discover products that are effective against terminal illnesses, that are not available, or restricted in the U.S. by the FDA. Regarding DHEA, we started our research in 1992 and did not find any producers in the U.S. We also found, in checking every DHEA product imported, whether pharmaceutical grade or not, that the products were impure and potentially dangerous, and also found that the bioavailability of the method of delivery via tablet or capsule was highly suspect. Our extensive research indicated that DHEA, if produced in pure form, is best injected, or in the alternative, second best if taken sublingually, not via the stomach in tablet or capsule form. *We developed a pure form of sublingual DHEA as a dietary supplement in 1994, as it does not produce injectables. We developed all of our products basically for doctors, since many doctors have requested pure products with high bioavailability that are either unavailable, or are available but produced in impure form. Even though we sell to the public, we rarely solicit the public, nor do our sales reflect it, as our sales to the public are less than 2% of our total sales. One thing the doctors purchasing our products constantly state is that our products work better than anyone else's. We pride ourselves and state the claim that no one surpasses our products in purity, whether it be Vitamin C, silver products, DHEA, or any other product. Our quality control far exceeds FDA requirements, and our purity levels far exceed USP grades for anything we produce. *We will not take a back seat to anyone in this world either in ethics or quality of products. The few that challenge either our ethics or quality, soon disappear as they are proven wrong. The ethical problem we have with both you and Dave Blanco of LifeLink is that you both have been advised by *us, for well over a year, of the contamination in your product. Yet, LifeLink continues to take the product directly from you, and with your knowledge, mix it with fillers, places it in capsules, and sell it to the public. In hindsight, holding back this information was unethical, and even though *we will likely loose LifeLink as a customer, and the $20,000 in sales produced as a result, *we can no longer sit by and remain silent. Even though *we have been keeping *our ears open for any complaints about LifeLink's DHEA product, and did not hear of any in over a year, it is still unknown whether or not long term ingestion of the contaminants might cause detrimental effects as toxicity testing on the contaminants has never been done. Notwithstanding, one of *our goals has always been to persuade the pharmaceutical and dietary supplement industry to cut the fraud, find some ethics, and produce pure products, as the majority of both, in our opinion, produce close to garbage. There are many more dangerous products in the pharmaceutical and dietary supplement industry than the unsuspecting public knows. This is why *we had to address this issue and forego the monetary influences. In any event, recent advertisements and promotional materials have touted the purity of your product, as sold by LifeLink, and have even gone so far as extolling upon the benefits derived from your product simply because it is "micronized", and thus is superior. Statements made on the Internet by a person known as NUBRAIN (NOBRAIN), seem to imply that "micronized" DHEA is somehow more pure and bioavailable. You no doubt recognize that "micronized" is an unscientific term which means nothing. Micronized DHEA simply implies smaller particle size, but does not otherwise denote any specific chemical property. It does not have anything to do with purity, nor does it guarantee any better bioavailability. The term is pure advertising hype. If you have any scientific reference to the contrary, I would like to see it. Otherwise, I am quite appalled that you would associate such a deceptive meaningless term to your product. I have also received from LifeLink two test results conducted on your product. I did not comment directly to LifeLink about these test results, since I didn't believe it would do any good, nor do I believe that they would understand the comment. They should have already recognized the fallacy of their interpretations of these tests. I have included copies of these test results if you do not already have them. The test results from the University of Missouri seem very accurate, but must be taken at face value, and are thus meaningless as related to the purity of your product. Consider the following facts derived from these test results:
1. Dr. Calvin C. Hales's cover letter confirms that the assay was qualitative and not quantitative, thus no test was performed to determine the actual quantity of DHEA in a 25 mg LifeLink capsule.
2. The DHEA in LifeLink's capsule was compared to reagent grade DHEA of unknown purity.
3. The UV spectrum of Sigma's DHEA produced two peaks; one 211.3 nm and one 292.9 nm. This test was conducted solely to determine the wavelength to monitor during the HPLC test which was conducted next. The fact that this test was performed indicates that no DHEA standard exists. If, for instance, a USP standard was available, the wavelength to monitor during HPLC runs would have been printed in reference material, and determining the UV spectrum on the Sigma DHEA would not have been necessary. Also note that the Sigma DHEA of unknown purity is now being accepted as the standard.
4. The inclusion of UV Scan Curve on the same page as the HPLC graphs is confusing to the untrained layman, and leads to the incorrect conclusion that DHEA produces two peaks on HPLC runs. This is simply false. DHEA should produce one and only one peak on HPLC runs. Granted, DHEA will produce two peaks on a UV spectrum, but not on HPLC.
5. The two or more peaks observed on the HPLC runs of both the Sigma DHEA, and the LifeLink DHEA, determines as a fact, the contamination of both products, but only qualitatively, and not quantitatively. Without first determining the identity of these contaminants, and then determining the optical characteristics of those contaminants, no quantitative conclusions can be drawn from the areas under the curves for either the HPLC run of the Sigma DHEA, or the LifeLink DHEA. Once again, the untrained eye could make all kinds of positive determinations from the percentages stated for the areas under the curves, when in fact, these areas are meaningless.
6. Also note the width of the peak of the Sigma DHEA, as compared to the LifeLink DHEA. The fact that the LifeLink DHEA is noticeably wider than the Sigma DHEA peak indicates that contaminants closely related to DHEA may be in the LifeLink DHEA, and are thus being observed during the HPLC test. The peaks of separate and distinct chemical entities can, in fact, merge and produce one wider peak when observed on HPLC. At best, as the HPLC graph on its face clearly shows Sigma's DHEA, that your product was compared to as close to equal, could not have been above 95% purity, and could be considerably less.
Concerning the test conducted by Irvine Analytical Laboratories, assuming they were sent the same product as UOM their results would therefore be fraudulent via UOM testing results. Not enough information is presented to establish that the test is conclusive or meaningful. No reference is made as to the DHEA used as a standard, thus the 99.9% result is meaningless. The exact determination of a melting point is highly suspect since no range is given. In light of the test conducted at the University of Missouri which absolutely showed contamination, a single melting point determination of 148.1°C would, in fact, be impossible, unless of course, the operator of the equipment simply failed to note the melting points of the contaminants, thus rigging the test to not show a range. In any event, I called Irvine Analytical Laboratories and was verbally told that Aldrich DHEA was used as a standard. Aldrich's DHEA is only guaranteed to be 97% pure and for use as an industrial chemical. Great standard, Issac. IAL seems to be a total fraud regarding their report. Since I don't know the situation which led to the test results produced, I cannot comment on the ethics of the laboratories conducting them, although I suspect that the test results were purposely presented in a fashion to give the appearance of the best possible findings. Whether or not this was done at the instigation of LifeLink is immaterial. LifeLink may have not wished to pay for complete testing, or even worse, set up the labs to produce favorable results. Either way, the ethics of anyone using either of these tests to confirm the purity of your product are, at best, questionable, at the worst, non-existent. *We would suggest that you, LifeLink, NOBRAIN, and other re-packers and formulators that you sell your product to, that do not extensively purify your DHEA product, take your product off the market immediately until all the contaminants within your product are identified as non-toxic, or until toxicity testing is completed. But after having conversations with both you and LifeLink, I'm sure this won't happen. Unfortunately, money is a first priority and comes before ethics, a story all too common in the health product field. I have told LifeLink what our testing reveals, our Liquid DHEA aside, and that there are much purer DHEA products available from foreign sources, and much purer than your product, which could be encapsulated. Remember what happen to l-tryptophan, it killed people with less than a 1% contaminant. The FDA does not like DHEA on the market. It wouldn't take a death to get all DHEA products banned, just a few adverse reports. As you stated some time ago, I sent you a sample of the contaminants extracted from the DHEA you distribute, only now have you decided to conduct adequate tests. I also sent you a sample of our DHEA for testing, and suggested that since there is no standard for DHEA, use ours as a standard, as we can well prove the purity. If you can get your DHEA product to match ours, you'll have a pure product, even close would be helpful. Since you and most every other distributor, and formulator of dietary supplements refuse to reveal the manufacturers of your products, the time bomb is ticking and the FDA is waiting like a vulture. You are, no doubt, aware of my dislike for the FDA. But on this point I have to agree with their philosophy. Buyers of dietary supplements need to be advised they are gambling with their lives every time they purchase a product without the manufacturer of the product being clearly stated on the label. The pharmaceutical industry in this country can locate a manufacturer within minutes if a product has the slightest indication of being harmful, and consumers can be notified and recalls implemented. In your case, as in a good deal of the dietary supplements sold today without a stated manufacturer on the label, if a bad lot got out that was toxic many more people would die and the manufacturer and distributor could disappear in the process. The FDA is waiting silently for this to happen, and is ready to go before Congress to gain full regulation and enforcement power over the dietary supplement industry. Lets not give them the opportunity to say: "See, we told you. These people are dangerous". It is unethical for you to not state the manufacturer of your DHEA, and to not supply a Certificate of Analysis from the manufacturer if requested. What are you hiding? Are you afraid of the manufacturers assays being revealed? Are you afraid that people may find out your source and that you are overcharging for your DHEA? Is the product being produced in a garage somewhere? It is *our opinion that you don't belong in this business if you won't produce the manufacturer or their Certificate of Analysis when requested for each lot number you sell. For LifeLink, or any other of your repackagers who do not purify your product, to not demand the same, indicates they additionally have no ethics. In LifeLink's case, supplying me with test results which they have obviously either knowingly or ignorantly misinterpreted, clearly states their position. I hope this clearly depicts *our opinion of your product and your current operation.
* Certain names had to be removed to prevent them from being inundated with harassing calls.