Looking for the complete story about LifeVantage Protandim? Read Lazy Man and Money's post about Protandim.

The Lack of Protandim Clinical Trials

LifeVantage and its Protandim distributors make a big mention about searching PubMed.gov for Protandim. Why? Well, because that is the system that they've chosen to exploit. And that's why Paul Myhill, Inventor of Protandim, admitted that it was for marketing purposes.

It is worth asking the question of, "Where are the clinical studies?" The product has been around 6 years and the studies aren't there. Using LifeVantage's own logic go to ClinicalTrials.gov and search for Protandim (or just click that link).

Two of the studies were on alcoholism, which is something that unrelated to any of the thousand of claims I've seen on Protandim. Both of them are appear to be from Dr. McCord's home-base of University of Colorado, which has clear ties to Joe McCord. One of the studies has a status of "Enrolling by invitation", but it was supposed to have been completed earlier this year. The other one on this topic is a status of unknown and it was supposed to have been completed a year and a half ago (summer of 2010).

other clinical trial attempted was on "Protandim and the Metabolic Syndrome" and that has been withdrawn. Seems like the results weren't what LifeVantage, listed as a collaborator, was looking for.

This speaks volumes about how irrelevant Protandim is with scientists. The three "current" clinical trials have/had ties to LifeVantage. More importantly none of them seem active.

Update: There are some great comments and clarifications in the comments by Vogel.

Originally posted 2011-12-22 01:30:02.

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Looking for the complete story about LifeVantage Protandim? Read Lazy Man and Money's post about Protandim.
4 Responses to “The Lack of Protandim Clinical Trials”
  1. Vogel Says:

    Glad you highlighted this story. A couple of small points to add. Two of the studies weren’t on alcoholism per se, but rather complications associated with alcoholism — a liver disease (steatohepatitis) in one case, and a respiratory disease (ARDS) in the other. In theory, it wouldn’t be unreasonable to investigate those conditions with an antioxidant concoction, particularly liver disease, given that Protandim contains milk thistle (silymarin) and there’s at least some plausible evidence suggesting that silymarin might have some beneficial hepatic effects. But of course, LFVNs research endeavor is a sham. The liver study was supposed to start in 08 and be finished in mid-2011, yet it’s still showing the status as enrolling and it was never updated even once, which is suspect. It’s an inherent assumption that when one lists a study in the registry, they will provide status updates as the study progress — that’s part of the very reason the registry exists.

    For historical context, Clinicaltrials.gov is a registry that enables greater openness and integrity in clinical trial research. The rise in the use of the registry came about in part as a measure to prevent data rigging and data suppression.

    The idea is that a planned clinical trial should be registered at the onset in order to prevent the researchers from (a) moving the goalposts and data mining, and (b) suppressing negative trials.

    In the first instance I’m referring to when a researcher starts a study with a particular clinical endpoint in mind (let’s say for example the change in HDL cholesterol measured in mg/dL) and then after finding that the test agent has no effect on that endpoint of interest, goes looking for some other (typically less important) parameter that might have been significantly affected (e.g., percentage change from baseline in total cholesterol). That’s considered a foul in research for various reasons. One of the reasons is purely statistical. That is, the more parameters you look at, the greater the likelihood that one of them will change perceptibly due to chance alone. It’s akin to spinning a roulette wheel or any other game of chance — spin the wheel enough times and eventually your number will come up, and when it does, it’s only pure luck, not a cause and effect relationship. The other reasons is known as data massaging, where data for a parameter that failed to show a significant effect of a test agent using one type of measurement (e.g. absolute change in serum concentration mg/dL) are expressed using a less clear measure (e.g., relative change from baseline), which allows the investigator to hide obvious weaknesses in the data and basically spin crap into gold.

    By using the trial registry and making it so that the researchers have to commit to measuring particular pre-specified endpoints at the beginning of the study, they can’t move the goalposts after the study is finished. If I’m not mistaken, listing in the registry is now pretty much mandatory for Pharma trials, and some top journals require it as a condition for publication.

    My reference to suppression of negative data refers to the practice of conducting a study and then never reporting the outcome, which used to happen mainly when the test agent was shown to be ineffective or, even worse, potentially harmful. A researcher could simply pretend the study never happened. They could conduct trial after trial generating negative data, never release any of it, and then publish the results of one positive trial where they either got lucky or looked at some other less important parameter.

    So that in a nutshell is the purpose of the clinical trials registry.

    What’s pretty clear here is that LFVN’s entries in this registry show 3 trials that never came to fruition. One can only wonder why. My guess is that LFVN used the registry as advertising to make people think that trials were in progress, possibly knowing that they would never take place. Or perhaps the collaborating researchers and/or institutions lost interest support for some reason.

    This abysmal 0-for-3 record stand in stark contrast with the companies ongoing claims (since 2008) that they have 20-25 studies in progress. There is no verifiable evidence that they have even one clinical study in progress, and if they do, it isn’t listed in the trial registry, so its integrity would be compromised from the get-go.

  2. Jason Says:

    Great information! I did the “protandim” search today on clinicaltrials.gov and it showed 1 withdrawn study, and 2 completed studies.

    I got a bit excited until I looked at the 2 completed studies and saw that no results were posted. Armed with the information in this post it makes me sense the motive behind why they do not post results – was it was shown to be “ineffective, or even worse, potentially harmful”? I think that is most likely, because if the results were great they would not have hesitated to publish them.

  3. protandimscams Says:

    I think the results on ClinicalTrials.gov may have changed since I published this article. I agree that if the results were great it makes sense they would have published them.

  4. Vogel Says:

    One of the 3 studies listed on Clinicaltrials.gov (NCT00936000 — Antioxidant Replacement Therapy in Patients With Alcohol Abuse) was published in 2012:

    Burnham EL, McCord JM, Bose S, Brown LA, House R, Moss M, Gaydos J. Protandim does not influence alveolar epithelial permeability or intrapulmonary oxidative stress in human subjects with alcohol use disorders.Am J Physiol Lung Cell Mol Physiol. 2012 Apr 1;302(7):L688-99.

    That was the study where Protandim — at twice the normal daily dose — had no antioxidant effect and got outperformed by a placebo.

    So of the 3 clinical trials, one crashed on the launch pad (NCT01125501 Protandim and the Metabolic Syndrome; withdrawn), one produced negative results (the published study listed above), and one was allegedly completed but never published (NCT00977730 — Effect of Protandim on NASH).

    This collection of crap research is what lies at the heart of LifeVantage’s deceptive boasting about the expansiveness of their R&D efforts. Smoke and mirrors. Always has been, always will be.

 

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