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.

Wednesday, March 23, 2011

SUPREME COURT: Cold Remedy Liable For Not Reporting Unproven Adverse Reaction

 
Once again we see a problem arise from categorizing Complementary and Alternative Medications (CAM) as not requiring FDA approval before marketing.

Most people know that Congress gave makers of herbs and complementary medicines a free ticket to market their stuff.  They don't have to go through the drug approval process that every pharmaceutical must weather. The only way a harmful CAM product can be restricted is when enough anecdotal reports of injury or death surfaces by word of mouth.  Then, the FDA can take action.

So when the makers of Zicam, an over-the-counter (OTC) cold remedy that's marketed as a "homeopathic" medicine, learned through customers that a few patients experienced anosmia after using the nasal spray, they were under no regulatory requirement to identify the problem.  Anosmia is the term for losing your sense of smell; something you don't think of as very important until you don't have it.

[BTW, if you used Zicam (no longer sold), know that homeopathic "remedies" consist of serial dilutions of the active ingredient to the point where no, or almost no, molecules of the substance is still present...in this case zinc.  Wikipedia says that "Some of the homeopathic ingredients used in the preparation of Zicam are galphimia glauca, histamine dihydrochloride (homeopathic name, histaminum hydrochloricum), luffa operculata and sulfur.  I haven't a clue what any of these would do to your nose.]

The number of anosmia reports was few and in the opinion of the manufacturer, Matrixx Initiatives, not "statistically significant."

The Supreme Court said (NY Times Health blog, Mar 22) that a lack of statistical significance doesn't let you off the hook as far as liability.  Unusually, the justices were unanimous.

I have mixed feelings about this.  Statistical significance, if properly measured, is very important to determining whether an effect is real...or just a coincidence.

However, I'm not impressed with manufacturers who are not regulated deciding for themselves how and when statistical significance is reached.

There's this big book--so big it's almost unusable--that all doctors have, called the PDR...which stands for Physicians Desk Reference.  It includes every possible side effect and adverse reaction for every pharmaceutical that's marketed in the US.  If it was a list of only those things that are connected to taking the medicine, then it would be useful.  However, drug manufacturers use it as a CYA (cover your you-know-what) document, and include every single thing that any patient has ever reported.

So the book ends up having a list of adverse reactions a mile long for the most innocuous drugs.  Most of the reactions don't have anything to do with the drug, but the manufacturer--if he's ever sued--can say, "It's in the PDR and your doctor was informed."

For an (exaggerated) example, it's important to know that blood pressure medicine X can cause low blood pressure when taken with certain other medications.  But if somebody reports getting belly button lint after taking it...it will be listed  in the PDR.  We just ignore most of the junk like this.

The funny thing about this Supreme Court case is that the anecdotal reports of anosmia surfaced, and patients were warned about it.  The plaintiff in the case is not a patient, but an investor who lost money when the warning about anosmia was issued, and lost money.  The plaintiff filed suit not for product safety, but for securities fraud.  Crazy in America.

Justice Sotomayor wrote
“Given that medical professionals and regulators act on the basis of evidence of causation that is not statistically significant...it stands to reason that in certain cases reasonable investors would as well.” 
So Matrixx Initiatives, who alleged that since the reports of anosmia--which they had known about but not revealed--were not significant, they weren't obligated by law to report them, took it in the shorts.

If Complementary and Alternatives Medicines (CAM) had a regulatory process parallel to pharmaceuticals and medical devices, none of this--neither securities fraud nor product safety issues--would have arisen.

Another Poison Pill from our country's approach to CAM.

Doc D
 

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