nos-trum. pronunciation: \nos'-trum\. noun. Etymology: Latin, neuter of noster our, ours.
1. a medicine of secret composition recommended by its preparer but usually without scientific proof of its effectiveness.
2. a usually questionable remedy or scheme.
See here for more discussion.

Sunday, May 1, 2011

Dr. Mercola Warned By The FDA About Unwarranted Claims

Proof that in the Information Age popularity is a credential that fosters belief.

Dr. Mercola is one of those notorious alternative health gurus who make a lot of unverified claims about the therapeutic benefit of nutritional and other substances.  People who believe his claims point to his popularity as a reason to believe what he says; "he can't be wrong if he's so popular."  "He's appeared on Dr. Oz's show more than once."  Really?

When did popular hysteria become a valid form of reasoning?
And readers know my opinion of the supernatural stuff that Dr. Oz promotes.

In this country, anyone is free to make a claim about things that can't be confirmed or verified, like energy healing, homeopathy, and naturopathy.  No oversight is possible because the foundation of these claims can't be addressed; they all rely on invisible and undetectable forces that only an adept or person with special knowledge (unavailable to normal humans) can identify and exploit.

Conversely, in this country, you can't claim an FDA-approved medical device has capabilities that are beyond those for which the device was approved.  And Dr. M crossed that line.

Dr. Mercola's website claims that his Meditherm camera can diagnose or screen for diseases of the breast, and is more sensitive than mammography.  This is false, and I hope women won't be fooled into avoiding mammography.  The FDA has sent a warning to Dr. Mercola (see here) to stop making this claim, and to withdraw several other statements about his Meditherm camera.

From the FDA letter:
"Your website promotes the Meditherm Med2000 Telethermographic camera for uses for which you have not obtained marketing approval or clearance, which is a violation of the law....The FDA requests that you immediately cease making claims, identical or similar to those described above, for this product. You should take prompt action to correct these violations. Failure to correct these violations promptly may result in the initiation of regulatory action by the Food and Drug Administration without further notice. These actions include, but are not limited to seizure, injunction, and/or civil money penalties."
For the record, the device under consideration merely measures skin temperature over a specified surface area.  Skin temperature fluctuates greatly as the surrounding air temperature changes, basal metabolic rate increases or decreases, with fever, and when substances are in contact with the skin (chemicals, but also clothing).  As such, it is an imprecise measure of temperature at the surface, much less of what's going on below the skin.

The FDA originally approved the Meditherm camera for "viewing and digitally storing thermal patterns generated by the human body..."  Nothing was stated or implied that it was approved for screening, diagnosis, or treatment.

Apparently the good doctor has decided to defy the FDA (Chicago Tribune, 26 Apr).  This is going to be interesting.  It will put him in the same category as Dr. Wakefield, the anti-vaccine "fraudster" who lost his medical license.

In my opinion, some recognized, expert agency needs to exercise oversight of all alternative and complementary substances and devices.  They are sometimes harmful, but we have no way to know until they cause enough harm to surface through anecdotes.  The only reason Dr. M is being stopped is because he's using a medical device that comes under the purview of the FDA.  We need the same regulatory safety for herbals, supplements, and wacky therapies that don't make sense.
Finally, it's OK if you watch Dr. Oz, or read Dr. Mercola's long as it's for the entertainment value and not real health advice.

Doc D


YoursLately said...

Pardon me if I don't know who you are when you write by your by-line "DOC D". It's my first time to your blog site and I can't see any reference to your credentials. It's quite ironic and hypocritical for someone like "DOC D" to be critical of highly public and known (real people not hiding behind Web anonymity) personalities such as Dr OZ and Dr Joseph Mercola. I really would not doubt if DOC D would not care to reply on my comments. Thank you for giving me this forum to express.

Doc D said...

Likewise, your pardon if I point to the "About Me" button above. You can do credential-comparing there. As far as Dr.'s Oz and Mercola go, popularity and publicity are no guarantee; fads like the ones they promote have come and gone throughout history. In my opinion, both are hucksters that prey on human psychological vulnerabilty and blind spots in our reasoning. We are so desperate to have firms beliefs that the cognitive dissonance created by contradictory evidence is ignored or discounted. I do it, too, sometimes. Very little of what Oz and Mercola advocate has withstood the test of verifiable investigation, free from placebo effect, poor methodology, and bias.

But...I think it's very important that we have the freedom to choose and act on our beliefs. As someone said, without the freedom to choose poorly, there is no freedom.

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