HCG: Yet another fraudulence.

Sir,

In December 2011, United States Food and Drug Administration (FDA) and the United States Federal Trade Commission (FTC) had exposed the sell of fake Human Chorionic Gonadotropin (HCG) weight loss products in the market. They are sold over the counter without the prescription in the form of oral drops, pellets and sprays and can even be found online and in some of the retail stores. These products claim to be homeopathic and assert that a person can lose around 30 lbs in 30 days. Companies further claim that the HCG act mainly by resetting the hypothalamus, which is the main regulatory organ for human appetite and also by losing fat from the human body.[1] This has no scientific support, yet the companies are marketing this form of products illegally. However, this is not the first time any company has violated the rules, regulation and guidelines of FDA for marketing a product. Furthermore, there is no any scientific literature, homeopathic pharmacopoeia, or recognized Materia Medica that lists HCG as a homeopathic drug. In a double-blind, placebo-controlled study, the effects of HCG on weight loss were compared with placebo injections, and it was found that the weight loss on prescribed diet was similar to that on severely restricted intake.[2] In an another similar comparative study between HCG and placebo, where laboratory studies were performed at the time of initial physical examinations and at the end of the study, it was concluded that there was no statistically significant difference in the means of the two groups in the number of injections received, weight loss, percent of weight loss, hip and waist circumference, weight loss per injections, or in hunger ratings.[3] Findings from these 2 and many other studies suggests that there is no rationale for the use of HCG in the treatment of obesity.

FDA has approved HCG as a prescription only drug, indicated for the treatment of infertility, and is not approved for the OTC sale for any purpose. Chorionic Gonadotropin was approved in 1974 for I.M use with the note on label saying that it has no role in increasing weight loss beyond that resulting from caloric restriction. Further, it has no role in distribution of fat or in decreasing the hunger and discomfort associated with calorie restricted diets.[4] In India, HCG is indicated for anovulatory infertility, prepubertal cryptorchidism in males, male infertility due to hypogonadotrophic hypogonadism and delayed puberty, associated with hypogonadism in males. β-HCG is an excellent tumor marker for the monitoring of germ cell tumors when combined with alpha-fetoprotein. Currently, there are no FDA or CDSCO-approved HCG drug products for weight loss. Central Drug Standard Control Organization, India, has banned human placental extract and its formulations for human use.[5]

Sometimes, products are used to treat conditions that they are not approved for (i.e., “off-label” uses). The “off-label” use of products usually presents greater uncertainty about both the risks and benefits, because less information is available regarding the safety and effectiveness of the products. Unexpected adverse events may occur in this context. FDA has received reports of serious adverse events, associated with the use of HCG injections for weight loss including cases of pulmonary embolism, depression, cerebrovascular issues, cardiac arrest, and death.[6]

HCG is one among 4 important hormones, essential for a normal pregnancy. Human Chorionic Gonadotropin is a glycoprotein, having a molecular weight of about 39,000, and is secreted by the syncytial trophoblast cells into the fluids of the mother. HCG plays an important role in the growth of corpus luteum in the mother's ovary, and also exerts an interstitial cell-stimulating effect on the testes of the male fetus, resulting in the production of testosterone in male fetuses until the time of birth.[7]

Both the United States FDA and the United States FTC have issued 7 warning letters to the companies, directing the companies to take immediate action to correct the violations, without delay. Failure to promptly correct these violations may result in legal action without further notice, including seizure and injunction.[8]

In spite of the strict rules, regulations and guidelines of FDA, the pharmaceutical companies continue to sell their products for some other conditions; may be, for which the drug has not been approved by the concerned regulatory authority. This way of pharmaceutical marketing costs to human life, health and the economy.