Drug Shortage

Shortage of human chorionic gonadotropin for injection

Human chorionic gonadotropin, beta subunit, contributed to Wikimedia by ProteinBoxBot

The American Society of Health-System Pharmacists reports a shortage of human chorionic gonadotropin for injection. Pictured is the beta subunit of the protein, which results in its specific activity. The alpha subunits of human gonadotropins are the same. Different beta subunits give rise to luteinizing hormone, follicle-stimulating hormone, and thyroid-stimulating hormone.

There are two brand name products available on the US market, Novarel and Pregnyl, both obtained from their natural source, the urine of pregnant women. hCG maintains the corpus luteum during the first trimester of pregnancy. In turn, the corpus luteum produces a hormone which prepares the uterus to support the growth of the fetus.

At the beginning of the decade there was a weight-loss scam for which hCG was marketed in over-the-counter preparations. For safety reasons, the FDA banned these OTC products in 2011. There are a couple of indications that fraudulent misuse continues. The first is this language from both FDA-approved package inserts:

HCG HAS NOT BEEN DEMONSTRATED TO BE EFFECTIVE ADJUNCTIVE THERAPY IN THE TREATMENT OF OBESITY. THERE IS NO SUBSTANTIAL EVIDENCE THAT IT INCREASES WEIGHT LOSS BEYOND THAT RESULTING FROM CALORIC RESTRICTION, THAT IT CAUSES A MORE ATTRACTIVE OR “NORMAL” DISTRIBUTION OF FAT, OR THAT IT DECREASES THE HUNGER AND DISCOMFORT ASSOCIATED WITH CALORIE-RESTRICTED DIETS.

The second is information from the shortage report above concerning how the manufacturers are dealing with the shortage.

Merck states their product is on allocation to prevent use in the gray market.
Ferring is releasing Novarel injection regularly to direct order customers.

The references to “allocation” and “direct order” indicate that the manufacturers are using two different ordering and delivery techniques in an attempt to ensure that their product is only ending up in the possession of buyers who will use it for its intended purposes. That said, any doctor who values dollars more than patients can use hCG as part of a weight-loss scam. Selling it as an ingredient in OTC products is what is prohibited, not prescribing it for off-label uses.

The abuse of anabolic steroids shuts down the bodies’ own production of testosterone and shrinks the testicles. The production of the former and the size of the latter can be restored by hCG injections. The abuse of the two drugs is usually in cycles of anabolic steroids, then hCG.

If a boy’s testicles have not descended normally in the age range of four to seven years, hCG may be carefully used if there is no anatomical obstruction preventing their descent. The care is necessary to avoid premature puberty. If the testicles descended but did not develop after puberty, then hCG is a possible treatment to stimulate testosterone production. If a woman is infertile due to inability to release eggs from her ovaries, hCG will induce their release. There is a risk of ectopic pregnancy in this procedure. These and other pregnancies occurring outside the uterus can be detected by increased levels of the beta subunit above in the blood when ultrasound is unable to detect a fetus in the uterus. In both sexes, high blood levels can indicate the presence of a tumor producing the beta subunit of hCG.

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