Saint Paul, MN - December 7, 2011 - In late August, after seeing multiple television ads for HRC Medical Center, Inc. - a St. Louis Park clinic offering bio-identical hormone replacement therapy - the Better Business Bureau of Minnesota and North Dakota (BBB), "secret shopped" the company to investigate their claims and intake process. Based on the experience of their secret shopper, problems customers have reported at the company's headquarters location and advertising claims which the company has thus far failed to substantiate, the BBB is advising consumers, males and females both, to be aware of potential risks involved with this therapy.
According to HRC Medical Center's television commercials, website and a pamphlet they give prospective customers, the bio-identical hormone replacement therapy they offer will treat a wide range of ailments, including: hot flashes, night sweats, diminished sex drive, loss of lean muscle and even depression.
HRC Medical Center, Inc. is headquartered in Nashville, Tennessee. On March 21, 2011, the BBB of Nashville met with the management of HRC Medical there to discuss a pattern of customer complaints that BBB had identified. Specifically, complaints alleged that patients were told they would see a physician before and during hormone therapy sessions; however, customers reported they did not see a physician. In addition, complaints alleged the hormone therapy caused side effects, such as facial and body hair, voice changes, and other physical appearance changes. In response to the pattern of complaints, the company stated, "We have put forth our best efforts to accommodate the high demand for bio-identical hormone replacement, however, HRC Medical can 100% guarantee that a patient's targeted hormone levels will improve; however, symptom improvement is subject to each patient. Like all medical procedures, this is not an exact science; therefore, HRC Medical cannot guarantee results." The BBB in Nashville has given the company a rating of F.
In an intake consult with an HRC nurse at their St. Louis Park location, the BBB’s secret shopper -- who is in her 60s -- was told that bio-identical hormone treatments would restore her hormone levels to the level they were at when she was in her late 20's, stimulate bone growth and that her bone density would improve by a "minimum" of 18%. She was then offered a treatment package for $3450, requiring $500 for an initial B12 shot and blood work, and another $500 for the first injection and all others required for the first year (4-5 total). In addition, she was told her lab results and treatment would be reviewed and overseen by a physician. The BBB later validated that the physician who she was told would oversee her treatments and set the hormone levels is a licensed physician in MN, although she did not see the physician on her initial visit.
Information in BBB files indicates individual HRC Medical Center locations nationwide are connected to the headquarters location, but independently operated. However, due to the pattern of complaints at the company’s headquarters location, the BBB of Minnesota and North Dakota invited management at the St. Louis Park HRC location to meet and discuss their intake procedures, as well as the treatment they offer. This invitation was extended at the end of September, but the company did not follow up to set up a meeting. On October 11, the BBB initiated an advertising challenge wherein the company was asked to substantiate claims made to the BBB’s secret shopper and in their advertising: that bone density would increase by 18%; that bone growth would be stimulated; that their treatments were effective for 99.9% of people; and that hormone levels will be as when customers were in their prime or mid-20's. HRC Medical Center has responded to the BBB, but has thus far has failed to provide information which would substantiate their claims.
Bio-identical hormone replacement therapy (BHRT) is a marketing term not recognized by the Food and Drug Administration (FDA). In fact, these custom-made products are not subject to the same quality assurance standards that commercially available hormonal products must meet. Bio-identical products are typically compounded in pharmacies. According to Kathleen Uhl, M.D., the FDA's assistant commissioner for women's health, "the purpose of compounding is to do it on a patient-by-patient basis, so there's nothing that's submitted to FDA to evaluate, so they're not FDA-approved."
Marketers of bio-identical hormones claim many advantages over standard hormone therapy, such as: they are made from plant derivatives, come in a variety of doses and forms and are custom-made for patients. However, in regard to the treatment of menopause, Dr. Mary Gallenberg of the Mayo Clinic, citing FDA findings, says, "Bio-identical hormones may be riskier than standard hormone therapy, and there's no evidence they're any more effective."
As this treatment is likely not covered by either Medicare or most health plans, the BBB is warning consumers to do their homework, and weigh both the cost and the risks of bio-identical hormone replacement therapy.