Been there, done that and they almost killed me. It's nothing but high dollar snake oil and then you have to spend more money to get straight and find out what a fool you are!
By Sean Pendergast
By Sean Pendergast
By Jeff Balke
By Richard Connelly
By Jeff Balke
By Casey Michel
By Craig Hlavaty
By Jeff Balke
Company president Liz Smith explained to the Houston Press that she was well aware of laws regarding false claims, which is why none of their products claim to treat any disease.
After that discussion, the Press sent an e-mail to Physicians Preference, asking why the added claims were legitimate. No one from the company replied, but overnight Hotze's colloidal silver lost its ability to fight infection. The claims on the Web site were changed, and not just for colloidal silver.
Magnesium citrate, which on June 9 could be used in the treatment of congestive heart failure and high blood pressure, is now "primarily taken to support cardiovascular and muscular health." (Also new is the disclosure that magnesium "may cause a laxative effect.")
Also on June 9, Iodoral could treat fibrocystic breast disease, hemorrhoids, ovarian cysts, thyroid disorders and excess mucous production. Now it possesses the power of extreme vagueness: "Using Iodoral could yield maximum benefits."
In 2001, the FDA and the Federal Trade Commission issued a statement declaring their intent to crack down on "unscrupulous marketers who use the Internet to prey on the sickest and most vulnerable consumers." But for every shark-cartilage manufacturer penalized for making cancer-curing claims, someone else pops up with spit from worker bees that wards off aging.
Karen Tannert, chief pharmacist with the Texas Department of State Health Services, says the marketers of colloidal silver are among the worst violators of labeling laws.
"The product's basically fraudulent from the word go," she says. "However, because of the loopholes in the laws, it can be marketed still as a dietary supplement, and they take advantage of that."
Tannert says hucksters play with people's health by distracting them from treatment that might actually work.
"Who is being affected through omission?" she asks. "That's really one of the big problems with a lot of these fraudulent products, is that people want to take care of their own treatment, their own therapy, so they don't seek, you know, the truly effective stuff How can you measure the harm because somebody postponed seeking chemotherapy for six months? How do you measure that?"
Hotze has gone to great lengths to sell his line of bioidentical hormones, which he trademarked under the name BellaFem. While Hotze's Web site doesn't directly list the sources of these hormones, the site repeatedly mentions soybeans and wild yams.
Bioidentical hormones for the most part are sold as dietary supplements. But Hotze prescribes them to his patients, who purchase them from his in-house pharmacy.
BellaFem's claims were criticized in a 2004 issue of The Women's Health Activist, the journal of the National Women's Health Network. Under a headline reading "BellaFem: Fulla False Claims," the brief article stated that "no hormone has been proven to be completely safe," adding that "All of the research done so far shows that natural hormones carry the same risks (including increased risk of breast and endometrial cancer) as synthetic hormones. Research has shown that natural hormones are beneficial only for the treatment of hot flashes and vaginal dryness." (The Washington, D.C.-based advocacy group does not receive funding from pharmaceutical companies.)
Under the 1997 FDA Modernization Act, compounded drugs were not subject to approval standards as long as pharmacists did not advertise them. But the U.S. Supreme Court overturned that part of the act in 2002, stating it violated pharmacists' First Amendment rights. In Texas, Senator Kyle Janek introduced a bill to reflect the court's ruling. With the green light to hawk BellaFem online, Hotze created an organization called the American Academy of Biologically Identical Hormone Therapy.
For a $1,000 membership, "wellness" facilities get access to the BellaFem line and are allowed to use Hotze's ad copy on their Web sites. Shortly after the Houston Presscalled the Houston members of the Biologically Identical Hormone Therapy group, the academy's Web site was shut down. The only physician who replied, Susan Hardwick-Smith, stated in an e-mail that "we have no particular relationship with [Hotze's pharmacy], although we use them frequently." She also stated that natural hormone replacement is "an excellent way to treat menopausal and premenopausal symptoms for some women."
With more and more doctors prescribing the BellaFem line, Hotze would need more pharmacy technicians to prepare orders. More techs means more pharmacists, since Texas law requires a ratio of one pharmacist to three techs. Janek once again took care of that by pushing through legislation that changed the ratio to one-to-five in pharmacies that dispense no more than 20 different prescription drugs. Hotze's pharmacy appears to be the only one in the state affected by the law, according to Gay Dodson of the Texas Board of Pharmacy.
The risky nature of mainstream hormone replacement therapy has made it easier for some manufacturers to sell their bioidentical products. Although no studies exist to verify Hotze's claims that his products are safer, an infamous study by the Women's Health Initiative went a long way to show the substantial risks in mainstream therapy.
In 2002 the Women's Health Initiative terminated the study of a popular hormone replacement when incidence of breast cancer in the study group reached a preset safety limit. The 10,000 women taking an estrogen-progestin combination had higher incidences of breast cancer, stroke, coronary heart disease and blood clots than those taking a placebo.
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