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Location: Blogs Len Monheit Off The Cuff |
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| Posted by: len |
12/7/2007 8:52 AM |
An article that appeared a couple days ago in USA Today has raised again the issue of sports products and the presence of banned substances. The study, performed by UK-based HFL Labs and aggressively promoted by the group InformedChoice, claims that 25 percent of supplements are contaminated with steroids.
An article that appeared a couple days ago in USA Today has raised again the issue of sports products and the presence of banned substances. In this case, a new program called Informed-Choice (US-based -
www.informed-choice.org) has managed testing on several supplements, with the actual analytical testing being done by UK-based HFL Labs, a lab which until earlier this year was an accredited WADA lab. Their current lack of accreditation is not to due failure of performance, rather it is due to sports politics which has determined that it is conflict of interest for a lab to do work for WADA and operate as a commerical testing lab. So HFL has followed the greater opportunity and no longer has WADA accreditation.
The current 'study' has been published by HFL, promoted by Informed-Choice.com with no disclosure of passes and fails. This is a common problem and complaint in the debate between industry and sport. HFL no longer has WADA accreditation and so is described as "WADA experienced". The Informed-Choice website contains at least one misleading statement, that is: HFL might soon be "the only supplement testing program that uses a WADA-experienced lab and ISO 17025 accredited analytical methods." This will not ever be true as there are and will continue to be other testing programs which use WADA 'experienced' labs. The rhetoric doesn't stop there. The press release issued by Informed-Choice is blatant sensationalism. (http://www.marketwatch.com/news/story/story.aspx?guid=%7bF0882252-2DCC-49F5-
AB1F-1866EE8C7A0F%7d&siteid=nbk&symb=) "Research Indicates Nearly 25 Percent of Supplements Are Contaminated With Steroids, Stimulants and Banned Substances" and does no service to industry, or likely to the companies currently working through this new certification program. Apparently, there are also some questions regarding the analytical methods which I hope others will weigh in on. This type of story continues to get 'legs' due to occasional manufacturing and sourcing issues, deliberate adutleration of products as well as distrust between the two communities. GMPs will be part of what makes this better, but not a total solution. I'll add a few other comments and perspectives in the next couple days. |
| Copyright ©2007 Len Monheit, Editor - NPIcenter |
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Comments (4)
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Re: Supplements for Sports - In the News Again
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By Anonymous on
12/7/2007 2:23 PM
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Almost 20 years ago, two researchers named Pons and Fleischmann at the University of Utah announced to the mass media a sensational report of the discovery of cold fusion. They chose to go directly to the mass media, instead of following the normal scientifically rigorous route of publishing the work in a peer-reviewed scientific journal because of what they felt was the importance of the research. Now, almost 20 years later, nobody has been able to conclusively duplicate their results, and most (but not all) researchers consider this research to be "pseudoscience."
Why do I bring this up? HFL has done the exact same thing by publishing results that are sensational and controversial through USA Today, instead of a peer-reviewed scientific journal. Furthermore, the report that they issued provides no details on the analytical methodologies used, no actual results except to say a banned substance was or was not found, and no product names. As an analytical chemist, it is impossible for me to judge the validity of these results, and also impossible for anyone to replicate these results - very convenient.
The number that really piques my interest and raises concern with me is the reported detection limit of 100 ng/g (100 parts per billion) of ephedrine in these multi-component dietary supplements. About 5 years ago AOAC undertook a validation effort for ephedrine alkaloids in botanicals and dietary supplements funded by FDA and NIH-ODS. One of the methods that underwent extensive optimization and validation studies was an LC-MS/MS method, and it was found that the limit of detection of this method for ephedrine in dietary supplements was several orders of magnitude higher than being reported by HFL. In fact, the HFL method can supposedly detect ephedrine in these matrices far lower than any published method that I am aware of.
Why wasn't their method submitted to AOAC for evaluation? Why hasn't it been published (to my knowledge) in the peer reviewed literature? In my personal opinion, at the extremely low levels that they are supposedly finding, there is as much a chance of laboratory cross-contamination as there is product contamination.
I am not saying that HFL's results are invalid or fraudulent. What I am saying is that it is impossible to verify the validity of their results because of the lack of information provided, and the lack of a scientific peer-review process of their methodologies. If the results that HFL found were real, then great - submit them to USA Today AFTER publishing in a peer-reviewed journal.
-Mark Roman
President & Technical Director, Tampa Bay Analytical Research
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Re: Supplements for Sports - In the News Again
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By Anonymous on
12/12/2007 11:13 AM
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Mark Roman's entry (12/7/2007) clearly suggests a need for some clarification from Informed-Choice and HFL.
First, the downloadable research report does indeed provide the necessary assurances for analytical chemists - the key element being that methods are validated to ISO 17025 for all target substances at defined detection limits and specific to the relevant matrix (powders, liquids, capsules, tablets, bars). Any competent lab with similarly validated methods could certainly reproduce the results. Different labs will develop different techniques according to their specific capabilities (equipment etc.).
Second, doping control labs around the world have been refining methods considerably beyond the detection limits that Mark Roman identifies. The key issue is that ALL methods are validated to ISO17025 for the listed substances, at the detection limits quoted. This should absolutely suffice. UKAS (United Kingdom Accreditation Service) independently audit the validated methods. There is then no need to submit the methods for further evaluation.
Finally, it is clearly wrong to suggest that it is not possible to verify the validity of the results. The key issue is that the contamination WAS found at levels ABOVE the detection limits. There may indeed be variation between samples - but this is not the issue. These substances had no place within the supplement. ISO reassures the public that the analytical tests, and therefore the results, are valid.
The intention is to submit the results of the research for peer review and publication in 2008.
David J Hall, Chief Executive, HFL Ltd
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Re: Supplements for Sports - In the News Again
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By Anonymous on
12/13/2007 12:10 PM
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ISO17025 validation means little - especially without a peer review process. Validation is matrix specific - i.e. you need to validate the recovery, selectivity, and precision on each material, and because of the variety and complexity of supplements on the market, HFL would have had to qualify the method on EACH sample for suitability. Any competent lab can not reproduce the results without following the same method on the same materials - this has been proven time and again in AOAC collaborative studies. ISO17025 guidelines for validation are vague and subject to considerable intrepretation; how a laboratory designs a validation study can vary considerably, and may not truly demonstrate the fitness for purpose of a method, but it can still claim to be validated and thus ISO17025. Without publication and peer review of the validation, it can be meaningless.
As an example, one of the steps in the method appears to be a milling in a Waring Blender. With the extremely low levels supposedly found in many of the supplements, the possibility of cross contamination is very real. To look at it this way, suppose there was a truly adulterated supplement that had 10 mg of ephedrine, and this was processed in the waring blended. With a detection limit of supposedly 100 ng/g, nearly a 1 million fold reduction in concentration during the cleaning step would be required, otherwise the next sample processed in that blender would yield a positive hit. Has this cleaning step been validated?
Without independent peer verification of the results, the presented results have little meaning, and certainly the general public can not evaluate the legitimacy of the results. Given that results of this type of testing can ruin the careers of athletes and destroy the reputations of manufacturers, publication of the method and its validation design and results in a scientific peer reviewed journal should be a minimum requirement. Why the resistance to publishing in a scientific journal?
Again, I am not saying the results are invalid, but merely that it is impossible to judge the validity of the results based on the very limited information presented: no product names, no actual amounts found, and no validation information. Claiming ISO17025 is simply not enough.
-Mark Roman
President & Technical Director, Tampa Bay Analytical Research
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Re: Dubious Data and Cross Contamination
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By Anonymous on
12/17/2007 4:22 PM
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Mark, you are right in what you say. I also remember a case we were heavily involved in at FRL years ago involving the alleged colchicine in ginkgo supplements based on research done by a leading group by LC-MS. They were unwilling to share any data about the incident or provide details. We tested two lots of each of as many ginkgo samples on the market we could find using a highly refined method which showed that the lab was most likely integrating one of the many flavonol glycosides as colchicine. Further, it appears that the LC-MS done was actually direct infusion of a tablet extract. Black box science is no good because it does not undergo the peer review process. Perhaps this study is accurate and valid and does represent actual findings. I am not saying that the lab is not competent nor am I saying that their data is not valid. What I am saying is that this means of delivering science to the popular press prior to any peer-review publication process is not the way I was taught to do research. It has the potential to damage reputations and create severe financial loss for companies involved. I can understand if a research group obtained data that constituted a public health emergency going to the popular press but not for this. Some of these values suggest fairy dust amounts of contaminants.
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