First off, lets discuss medical studies and how they are often held up as the gold standard for efficacy when in fact, they are often biased and commissioned by commercial interests to specifically promote the economic success of their formulas. A 2005 study in the peer reviewed Journal, PLOS,
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1182327/ :
Quote:
There is increasing concern that most current published research findings are false. The probability that a research claim is true may depend on study power and bias, the number of other studies on the same question, and, importantly, the ratio of true to no relationships among the relationships probed in each scientific field. In this framework, a research finding is less likely to be true when the studies conducted in a field are smaller; when effect sizes are smaller; when there is a greater number and lesser preselection of tested relationships; where there is greater flexibility in designs, definitions, outcomes, and analytical modes; when there is greater financial and other interest and prejudice; and when more teams are involved in a scientific field in chase of statistical significance. Simulations show that for most study designs and settings, it is more likely for a research claim to be false than true. Moreover, for many current scientific fields, claimed research findings may often be simply accurate measures of the prevailing bias. In this essay, I discuss the implications of these problems for the conduct and interpretation of research.
Dr. Horton in a Lancet
http://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736%2815%2960696-1.pdf comment section, recently published a statement declaring that a lot of published research is in fact unreliable at best, if not completely false.
Quote:
“The case against science is straightforward: much of the scientific literature, perhaps half, may simply be untrue. Afflicted by studies with small sample sizes, tiny effects, invalid exploratory analyses, and flagrant conflicts of interest, together with an obsession for pursuing fashionable trends of dubious importance, science has taken a turn towards darkness.”
Livon Labs, the major manufacturer of Liposomal Vit C commissioned a lab study to evaluate DIY homemade lipo-c formulas in 2011 from FormuMax Labs which came up with the result that there was 0% encapsulation. It is extremely curious that a copy of this study is not easily found on the net and I can not even seem to find a copy of it on Livon's website though it is often referred to as proof our homemade Lipo-C is worthless. They seem not very proud of the study. Here are some aspects of their study:
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In order to ensure that our Lypo-Spheric products are of the highest quality available, we are proactive in analyzing and testing our competitors’ products as well as the various DIY liposomal recipes. We contracted with an outside laboratory that specializes in liposome technology, and asked them to recreate the DIY recipes using the exact methods described on the various websites. After they recreated these recipes, they tested the rate of encapsulation in the end products. They discovered that the rate of encapsulation was virtually 0%. The lecithin and the vitamin C are being mixed together, but the vitamin C is not actually encapsulated. Therefore, the bioavailability of these DIY recipes is no better than buying cheap vitamin C in a pill or powder form.
If you are interested in seeing the study summary report, please feel free to email us at
service@livonlabs.com.
For the skeptics out there, we encourage you to purchase a carton of our Lypo-Spheric Vitamin C and compare the results to those experienced with the DIY liposomal vitamin C. We are confident that our product will produce better results, as the vitamin C is actually encapsulated and is absorbed at the cellular level. If our product does not produce superior results, you may return the empty carton for a full refund.
It is certainly not in Livon Lab's interest for it to get out that one can make an acceptable formulation of lipo-c! Any company faced with that prospect must be quaking in their boots! Anything coming from them is most probably very biased.
Furthermore, their claim that we have 0% encapsulation seems a tip-off to me that they are stacking the deck so to speak as I don't see how at least some percentage could not help be encapsulated. Creating liposomes is not that difficult! Just simple mechanical vortexing of a solution produces them! Finally, as a true proof that encapsulation is taking place in our homemade formula, we all agree that in most all cases , we can take far more of our homemade lipo-c to bowel tolerance than we can without. That in itself should be indication that our process is working! If it were true as Livon suggests that no encapsulation is occurring then taking mega-doses of our lipo-c should not affect diarrhea outcomes when from mega-doses of untreated Vitamin C.
I can't help but believe that the lab test commissioned by LIVON to protect their business interests is biased. Whenever a company commissions a lab test for a competing product, results have to be suspect---having said that, the testing firm, FormuMax Scientific Inc, seems to be legitimate enough. However this does not mean that a bias was not inserted into the testing or its results. The main problem, I see is their test for encapsulation efficiency of vitamin C, described as a “well established Liposome Encapsulation Assay”. This test is not known by me and I cannot obtain a lab protocol for that test on how it should run or its WEAK POINTS. Such a test may be "well established" in LIVON's eyes, but it sure doesn't seem that well used in the real laboratory--at least not from an online search. Actually, I find that the fluorescence assay test to be more widely used to test drug loading in Liposomes. It would have been interesting to see how Livon’s commercial product would have compared in this specific study as well. No, it was never tested at the same time as ours!
Livon’s description of this assay test:
Quote:
Liposome Encapsulation Assay
The encapsulation efficiency of vitamin C in liposomes was measured by a well-established HPLC analytical approach often used for determining the drug encapsulation efficiency in liposomes for pharmaceutical formulations. Specifically, an aliquot (2-3 mL) of the above prepared liposome vitamin C was transferred onto a centrifuge filter (MWCO 10K) and centrifuged at 5000rpm at 15 deg C for 2-3 hour. The clear filtrate collected at the bottom of the tube contains the non-encapsulated vitamin C. The concentrations of the free vitamin C and the total vitamin C in the liposome formulation were determined by a HPLC method developed at our lab. The reported results are an average of two HPLC samples prepared from a single batch of liposomes by each method.
I guess their HPLIC method stands for High-performance liquid chromatography. That process seems to be seldom used for liposome analysis
I did find one reference to an “ultra-filtration method” of determining encapsulating efficiency in liposomes. This article mentioned that when centrifugation is performed at high speeds after the addition of physiological saline (150mM NaCl), the liposomal drug is precipitated. After removal of the supernatant, add saline once again. This procedure usually needs to be repeated two or three times at 100,000rpm. Regardless of the procedure employed, it is absolutely essential to maintain both the inside and outside layers of the liposomes isotonic, and the temperature below the liposome phase –transition temperature throughout the procedure. During centrifugation, the temperature should be below 40.
Furthermore, in regard to the quantitative determination of the encapsulated drug after removal of the non-encapsulated drug according to the methods described above, perform quantitative determination of the drug encapsulated in the liposomes after destroying the liposomes. The Livon study did not destroy any liposomes.
I think the logic behind the Livon test is that if one put X mg of Vit C in a lipo-C batch and if one centrifuged and separated the liposome part from the liquid part, then the remaining "free" Vit C in the centrifuged supernatant could be compared to the total amount used. If none was missing, then none was encapsulated. If there was less Vit C in the supernatant, then it is presumed it is in the liposome part.
Besides all of this. What I really don't understand about their test results is for instance on their tested sample #1 (using the sardi DIY method) in which total Vit C used was 31.58mg/l, the free Vit C found in the supernatant was 31.78mg/l. HEY, they seem to be making Vit C out of nothing! Same holds true for the sample #2, too. The total Vit C put in that sample was 31.61mg/l and they ended up with even more Vit C in the supernatant of 31.70mg/l. I don't get it! Why? Also, strange numbers for their sampling of lipo-c using the Bradley method. only in this case, the sample #1 started out with total Vit C of 31.04mg/l and ended up with free Vit C of 30.2mg/l. This is the only sample that ended up with less Vit C in the supernatant with presuming the missing amount being encapsulated! The second sample using the Bradley method used total Vit C of 31.17mg/l and ended up with free Vit C of 32.31mg/l. Again more Vit C was found than was put into the solution in the first place. It all seems rather strange to me!