DrugMonkey

The US Food and Drug Administration (FDA) began sending warning letters to sellers of so called “bio-identical hormone replacement therapy” today according to an AP report. Apparently the claims for alleviating menopausal symptoms are

not supported by medical evidence and are considered false and misleading.

Needless to say, these “compounded” products are being sold without FDA approval. It’s all a conspiracy man! Dang FDA is a tool of BigPharma trying to keep cheap and effective remedies from the public. Noted tool of TheMan_{(BigPharmaDivision)} Abel Pharmboy has a recent post in which he touches on “cosmeceutical” marketing of drugs and the FDA’s authority to regulate cosmetics under

their regulatory authority is in part ordered by the Federal Food, Drug, and Cosmetic Act of 1938 (and subsequent legislation).

This reminds me of the glory days of the quack remedy / patent medicine era and today, from the mouldering archives, we take up a Case Report published by A. B. Hirsch, M.D. ["Mrs. Winslow's Soothing Syrup. American Medical Journal, 1884, 12(11):504-506] which is available from Google Books here. A footnote indicates that this Abstract was read before the Philadelphia County Medical Society on Sept 17, 1884. Ahh, Mrs. Winslow’s . Used for over 60 years by mothers for their teething children.

Could all those mothers be wrong?

Mrs. A. H. L. took her 20-months-old boy to visit some friends, and, while there, they (all unknown to her) fed him some unpeeled apple and other indigestible material. Being colicky all that night and next morning, she was persuaded by a “friend” to purchase a two-ounce vial of the nostrum sold as “Mrs. Winslow’s Soothing Syrup,” and of this gave him half-teaspoonful doses, as the directions called for, although she insists half of each quantity was spilt through his struggling.

And we parents have all been there, eh? (Did I mention the Google Books has a translation from scan to digitized text? This is duck soup blogging, people.) Okay, so how much did the poor little tyke get?

He took, therefore, the first dose at 4 o’clock on Sunday afternoon (Aug 24), and, there being no effect, another at 8 ; then dozing, but not sleeping, from this time till 3 next morning, the pain starting him again to whining, he was dosed at 5; still crying on, three-quarters of an hour later the final similar amount was administered.

Hmm, okay so dosing as directed didn’t seem to work but a cumulative dose of 1 tsp (or less due to “struggling”) over 3-4 hours does the trick. Whining turned into dozing. Sounds good, eh?

The mother soon became alarmed at the marked stupor which now set in. He would touch none of the breakfast placed before him, Mrs. L. said ; although sitting upright in his high chair, his head hung listlessly and he recognized nobody.

Uh-oh. Time to call the doctor.

The pupil was contracted down to the typical pin-head ; stupor was unmistakable ; respiration was very slow, gasping and shallow, while at irregular intervals he would take two or three rapidly succeeding deep sighs, while the pulse was rapid and small; the extremities were cold throughout the case. Taking all these symptoms into consideration, and the fact that the breath bore the peculiar odor of an opiate, I felt warranted in treating the case for one of poisoning by some preparation or derivative of that drug.

To make a long story short, he saved the kid. And now the reason for the case report:

…this case is merely placed on record to help to expose an existing evil, believing that continuous agitation will finally induce the intelligent public to demand the regulation of the sale of patent medicines; a fact concerning which there never was any doubt in the profession. … The case is the more pertinent at this time, when any fakir or shopkeeper may legally retail unlabeled poison in the guise of patent medicines, while one of our inconsistent laws is now being so interpreted as to inform the patient that, in nine cases out of ten, his doctor has prescribed him medicine containing poison.

There’s a nice little summary on a bottle fanciers site of a range of patent remedies sold for the “soothing” of children which contain opiates. For those that want to really get into it, try here (yea GoogleBooks!) for a review of “Habit Forming Nostrums” published in JAMA May 29, 1909. The link is to a book of the AMA published in 1912 on:

Articles on the Nostrum Evil and Quackery Reprinted, with Additions and Modifications, from The Journal of the American Medical Association

It will come as no surprise to the modern reader to find the active ingredients of “nostrums” were quite frequently cocaine, opium/heroin/morphine or cannabis extracts. Damn right they worked! Specificity and safety might have been a little problem, however…

[Update 1/11/08: According to this site, the dose of morphine in Mrs. Winslow's was 65 mg/fluid oz so a half-teaspoon should be almost 5 mg of morphine. Nice reading there on "Coca Wine" another nice little range of nostrums.]  

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MMR on Spatial Memory; h/t on the idea to Shelley Batts.