CBS News says that bioidenticals are no safer than other h ormone-replacement therapy. This is incorrect; they are actually safer.
Recently, CBS News did an interview with Dr. Christina Matera entitled, "Bioidenticals no safer than other hormone-replacement therapy."
Although Dr Matera managed to get some of the information right, much of it is misinformation and drug-company propaganda.
Above Image: Dr Christina Matera courtesy of CBS News (1)
"Dr. Cristina Matera, a reproductive endocrinologist at New York-Presbyterian Hospital/Columbia University Medical Center, warned that patients should be aware of the risks that come with using products that are compounded and not FDA approved"... One of the main concerns is that the amount of each hormone used is not monitored. When treatments like these are produced in a compounding pharmacy, the final product is not FDA regulated. Compounding pharmacies themselves aren't subjected to the same quality standards as other medical production facilities that are regulated by the FDA."The Issue of FDA Regulation of Compounded Formulations.
Compounding pharmacies are heavily regulated at the state level. Not at the federal level. That is as it should be.
Compounded medications have never been under the jurisdiction of the FDA and are not subject to FDA approval simply because they are made to order and are not manufactured. To make a statement that FDA approval gives you a better or safer product is simply false. 20% of FDA-approved products are later banned or given a black-box warning. Where is the higher level of safety for these "FDA-Approved" products?
Another point that Dr Matera ignores is that every time she orders intravenous antibiotics at the hospital pharmacy for one of her hospitalized patients, these are all compounded formulations falling outside of FDA jurisdiction. The hospital pharmacy is a compounding pharmacy. Will Dr Matera stop ordering IV antibiotics and abolish the hospital pharmacy? Of course not. Compounding is here to stay.The Video Interview
In the video interview, Dr Matera said a few things right. Her definition of "bioidentical hormones" as the exact chemical structure as the estrogen and progesterone hormones made by the ovary is correct. This is OK.Compounded Products -- The Hatchet Job Again
Mr. Lapook, the CBS journalist, brings up a study in 2001 in which one-third of compounded products failed analysis. The study did not specifically state which pharmacies were sampled or how the analysis was conducted. Was this a hatchet job? Was this a drug industry-sponsored study to destroy the competition? Perhaps.
I would agree there may be some variation in quality, and differences from one pharmacy to another in terms of quality control and service. That is why we use only the highest quality pharmacies that specialize in women's hormones.A False Statement -- Serves As Drug-Industry Propaganda
To state there are greater risks when using compounded medications compared to manufactured hormone patches (which are FDA approved) is simply false and serves as drug-company propaganda to drive customers away from the competition.
Adjusting Dosage Based on Symptoms
Dr. Lapook brings up testing to monitor and adjust hormone dosage, and Dr. Matera replies that hormone dosage should be based on symptoms that we are trying to treat, not reliance on testing. This is correct and this is the way we adjust dosage in our office as well. Dosage is adjusted as needed for full relief of menopausal symptoms.