Patenting A Little Less Poison

Popular Hormone Therapies Pose Real Health Risks

Question: Why are more effective and safer bio-identical hormone options being overshadowed?

Answer: Pharmaceutical companies can patent synthetic hormone replacement therapies (HRT) but, because the molecular structure of bio-identical hormones is exactly the same as what is produced in the body, bio-identical hormones can not be patented.

“Big drug companies continue to twist and manipulate the idea of hormone replacement to capitalize on a business opportunity,” Dr. C.W. Randolph, Jr. said today. “Despite all the scrutiny synthetic HRT has been under since Women’s Health Initiative (WHI) study was halted in 2002 because of the increased risk of heart attack, stroke, breast and uterine cancer and Alzheimer’s disease, the pharmaceutical industry is now gearing up to launch marketing campaigns for lower dose or different formulation synthetic estrogen-progestin therapies. From my professional point of view, these companies are just trying to make more money by patenting just a little less poison.”

In 2003, only a year after the output of the WHI study found synthetic HRT to have toxic and sometimes lethal side effects, Wyeth-Ayerst Pharmaceuticals won government approval to market lower doses of its synthetic estrogen-progestin combination HRT sold as Prempro. “There are several valid reasons to fear that the pharmaceutical companies marketing efforts to promote synthetic HRT could once again be successful,” Dr. Randolph says in his recently published book, “From Hormone Hell to Hormone Well.”

“First, treating menopause is a big business opportunity. Even after the results of the WHI, the customer has not gone away. Female patients continue to clamor for relief and their doctors still want to help them. Secondly, physicians continue to be confused. They were trained in medical school to prescribe synthetic HRT and, unless they have taken the initiative to educate themselves about bio-identical HRT, they remain ignorant as to its safety and benefits.”

“Most people don’t realize how much a doctor’s prescribing habits are fostered by pharmaceutical dollars. The pharmaceutical industry funds much of the training and research that goes on in medical school. Moreover, the pharmaceutical companies are the primary sponsor for most continuing medical education (CME) meetings for doctors. In addition to their stronghold on physician education, many big drug companies also offer physicians some nice ‘perks,’ such as dinners, fishing trips and sporting event tickets. Credible or questionable”, Dr. Randolph continues, “the dollars the pharmaceutical companies spend gets them the ear of the physician.”

Dr. Randolph, who is both a pharmacist and gynecologist, cites the following studies as enough evidence that no physician should ever prescribe synthetic HRT:

• In 2001, representatives from the National Cancer Institute and the NIH voted 8-1 to add synthetic estrogen to the nation’s list of cancer causing agents.
• The WHI study was abruptly halted in July 2002. The initial findings showed that women taking synthetic combination HRT (e.g.Prempro) had an increased risk of heart disease, breast cancer, stroke and blood clots.
• In May 2003, additional findings were released indicating that women over 65 who were taking synthetic combination HRT (e.g. Prempro) had a heightened risk of dementia, or Alzheimer’s disease.
• In January 2003, the FDA requires that the highest level of warning information in labeling be included with every prescription of synthetic estrogen or estrogen-progestin HRT. The label highlights the increased risks for heart disease, strokes and breast cancer.
• In June 2003, the Journal of the American Medical Association published another study that was a closer analysis of the WHI findings on the correlation between Prempro and breast cancer. The new research affirmed the breast cancer problem, finding a 26 percent increase in the risk of breast cancer for women taking the synthetic HRT formulation.
• Also in 2003, a study appeared in the Journal of the National Cancer Institute in which Swedish researchers reported that women using synthetic estrogen replacement therapy had a 43 percent increased risk of ovarian cancer. The study went on to report that those women on a combination of synthetic estrogen and progestin had a 54 percent increased risk of ovarian cancer.

Why are these synthetic hormones still the most commonly prescribed treatment for the negative symptoms associated with hormone imbalance and menopause? Dr. Randolph believes that some physicians remain legitimately confused by the contradictory evidence in the medical literature and others, unfortunately, continue to prefer to remain in a state of denial.

As long as the pharmaceutical industry has an influence on medical education, physicians will be challenged to seek out information and teach themselves about the options and choices related to synthetic HRT versus bio-identical HRT. The reason: money. Synthetic hormones have a molecular structure that can be patented. Therefore, a pharmaceutical company with that owns the patent for a form of synthetic HRT has the potential to generate a huge profit margin if enough market share is captured. In contrast, bio-identical hormones have exactly the same molecular structure as the ones produced by the human ovaries. Since the molecular structure is exactly the same as that found in nature, bio-identical hormones can not be patented.

Dr. Randolph concludes with this advice for his peers: “It really comes down to business dollars versus patient care. The good news is that patients may soon have more power than the pharmaceutical industry. There are 38 million women entering menopause this year and I can assure you that none of them want to suffer from symptoms of hormone imbalance. They do want their doctors to help them find safe and effective alternatives to synthetic HRT. More and more female patients are doing their own research and, once they educate themselves as to their options, they are demanding that their doctors to look past the pharmaceutical representatives in their offices and look into the scientific data supporting bio-identical HRT.”

“If doctors want to do the right thing and keep their patients’ loyalty, they need to get their heads out of the pharmaceutical companies’ pockets. They need to return to their role as patient advocates. They need to take the initiative to read all the medical evidence; e.g. the studies that incriminate synthetic HRT as well as the ones that support bio-identical HRT. More women will be better off once more doctors find their brains, review the literature and, then, decide for themselves what type of HRT they feel is best for their patients’.

Sincerely,

C.W. Randolph, Jr., M.D., R.Ph.
Author: From Hormone Hell To Hormone Well
www.HormoneWell.com

Dr. Randolph is celebrated as a physician champion of natural medicine and women’s health, as well as a pioneer in the realms of personalized medicine and natural hormone therapies. As a trained pharmacist and Board Certified practicing gynecologist, Dr. Randolph has treated thousands of women suffering from the symptoms of hormone imbalance. He’s built a sound foundation of clinical evidence to support the safety and efficacy of treating patients with human-identical hormones (e.g. estrogens, progesterone, testosterone) vs. synthetic hormone replacement therapies (HRT).