Saturday, May 27, 2006

ConsumerLab.com co-founder on NPR

It took a quiet Saturday morning for me to catch up on the fact that the co-founder of ConsumerLab.com, Dr William (Bill) Obermeyer, was featured on NPR earlier this week. Allison Aubrey of NPR's Morning Edition produced a thoughtful four-and-a-half minute segment on the seven-year mission of Dr Obermeyer and colleagues to provide consumers with independent laboratory testing of specific brands of herbal medicines and dietary supplements.

Readers of Terra Sigillata will know that I have long recommended ConsumerLab.com as one of the top subscription services to learn about herbal medicines. (See my lengthy post on the best objective herbal medicine information sources for under $100 per year).

Of course, there are limits to what ConsumerLab.com can do as they do not conduct clinical trials with specific supplements nor do they determine whether recommended doses produce blood levels of active constituents consistent with biological effects observed in vitro.

But their services are an admirable good start: they assess specific supplement formulations for content of purported active constituents and assure purity by testing for heavy metal contamination. The latter point is critical since many plants will sequester metals from the soil they are grown in and the Eastern herbal medicine cultures often intentionally add heavy metals like mercury and arsenic to their supplements.

You may be asking how this can happen in the US where a major pharmaceutical company is currently being decimated by lawsuits as to whether their anti-inflammatory drug did or didn't create cardiovascular risks. Well, a regulatory double-standard exists here for "drugs" vs. "supplements", where the latter are classified under the food side of the Food and Drug Administration.

The most interesting part of Dr Obermeyer's story is that he worked for the US FDA prior to starting ConsumerLab.com. In fact, it was he, pharmacognosy colleague Dr Joseph Betz, and their team who published a 1998 New England Journal of Medicine report on the mistaken adulteration of a herbal laxative supplement with Digitalis lanata, the plant source of useful but potentially toxic cardiac glycosides. Dr Obermeyer observed first-hand how limited the power of the FDA was in preventing such incidents from occurring in the first place.

In defense of the FDA, they can only enforce laws that are legislated by the US Congress. In the past, any proposals for stricter regulation of the dietary supplement industry has been met with strong opposition, usually funded by a natural foods industry whose monetary and political influence rivals that of medium-sized pharmaceutical companies.

There remain some concerns of potential conflicts of interest in that ConsumerLab.com outlicenses for a fee their seal of approval. In addition, companies can pay a fee to submit their products for comparative testing if they were not selected originally by ConsumerLab.com. But frankly, it is impossible to keep up with the dozens or hundreds of supplements that contain a certain herb, say, like valerian (Valerian officinale) as discussed in the NPR story, for the organization to test all on the support of $27/year subscriptions.

As you might suspect, ConsumerLab.com is not terribly popular among those in the herbal industry. In fact, a defamation suit was brought against them by a trade-group calling themselves the Council for Responsible Nutrition (CRN). Last week, the suit was wisely struck down by the New York State Supreme Court. CRN was also playing some nasty games:
"CRN distributed a press release in January 2005 publicizing a letter that it simultaneously sent to the FTC alleging that ConsumerLab.com violated the FTC Act. CRN entitled its letter "Enforcement Action against ConsumerLab.com," creating the false impression that the FTC was involved in an action, which was never the case. The news release and letter were rife with false and misleading information about ConsumerLab.com. The FTC refused to take action with respect to CRN complaint, issuing a "no action" letter."

This is the same Council for Responsible Nutrition cited last week at Respectful Insolence for objecting to the reliance on evidence-based studies by a NIH-convened scientific panel to assess the utility of vitamin and mineral supplements:
The dietary supplement industry criticized the panel for not considering less scientifically rigorous studies that point to multiple benefits from multivitamin and mineral use.

"They have done exactly what they set out to do, which is a review based solely on randomized controlled trial data, which results in a misleading picture," said Annette Dickinson, past president of the Council for Responsible Nutrition, an industry trade association.
Hmmm...I'd be a wee bit embarrassed to be a paying member of CRN.


Terra Sig applauds Dr Obermeyer and colleagues for doing what our government refuses to do - protect the consumer (and his/her money) from unsafe or substandard supplements.

4 Comments:

At Mon May 29, 11:06:00 AM EDT, Anonymous Anonymous said...

Sorry to take this roundabout way to contact you. I just received e-mail from "SpamArrest" purporting to represent you. It think it was phishing. Are you using such a service?

You and I have previously exchanged e-mail, and the notice said I will be blocked if I don't respond.

Joe

 
At Mon May 29, 11:38:00 AM EDT, Blogger Abel PharmBoy said...

Hi Joe, Nope, it's real but I neglected to import my approved senders file into the spam filter before setting up protection of my account. Many apologies. I'll import yours and everyone else's address into the new program. You shouldn't have to respond to the e-mail in order to continue corresponding with me. Many apologies for the trouble.

 
At Mon May 29, 09:48:00 PM EDT, Blogger Shelley said...

Hi Abel-
This may be a long shot, and feel free to disregard, but what is the pharmacological action of DMSO? This is the chemical in "patches" like nicotine and pain patches that delivers the drug thru the skin.

Know how it works?

Shelley

 
At Tue May 30, 05:07:00 AM EDT, Blogger Abel PharmBoy said...

Not a long shot at all as I've had many colleagues working in this area of pharmaceutics. There's a superb article on this field from Prof Rolf Daniels at the Technical University of Braunschweig, formerly at Pfizer.

The DMSO serves two purposes: skin permeabilization and simply being a great solvent for organic molecules. The horny cells of the stratum corneum are the greatest barrier to transdermal absorption. As indicated in the section below, DMSO helps to transiently break down this layer to permit absorption. Moreover, DMSO also serves a useful purpose in the patch itself to keep the drug dissolved at the necessary high concentrations to drive diffusion across the epidermis.

I'd read the whole article because he does a great job on describing the physical and anatomical barriers of skin, but section 4.3 quoted below gets to the heart of your question:

"Several excipients are able to promote the transport of an active substance across the skin barrier by a variety of mechanisms. The most important are:

• Extraction of lipids from the stratum corneum
• Alteration of the vehicle/skin partitioning coefficient
• Disruption of the lipid bilayer structure
• Displacement of bound water
• Loosening of horny cells
• Delamination of stratum corneum

"Chemical enhancers can be categorized into different groups. Solvents like alcohols, alkylmethyl sulfoxides, and polyols mainly increase solubility and improve partitioning coefficient. Moreover, some solvents, e.g. [Dimethlysulphoxide] (DMSO), ethanol, may extract lipids, making the stratum corneum more permeable. Oleic acid, Azone® (epsilon-Laurocapram), and isopropyl myristate are typical examples of chemical enhancers which intercalate into the structured lipids of the horny layer where they disrupt the packing. This effect makes the regular structure more fluid and thus increases the diffusion coefficient of the permeant. Ionic surfactants, decylmethyl sulfoxide, DMSO, urea interact with the keratin structure in the corneocytes. This opens up the tight protein structure and leads to an increased diffusion coefficient D mainly for those substances which use the transcellular route."


-courtesy Prof Dr Rolf Daniels at
http://www.scf-online.com/english/37_e/skinpenetration37_e.htm

 

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