Your voices: menopause, hormones and the FDA
by Tucson Citizen on Jun. 09, 2008, under OpinionAgency compounding woman’s health woes
Re: the May 20 column (“Giffords takes bad step by opposing FDA hormone ruling”) by Anne T. Denogean:
When the government agency responsible for guarding our health embarks on a course with opposite effects, I am left angry, bewildered and filled with questions.
The Food and Drug Administration is going after the local Reed’s Compounding Pharmacy, which provides valuable health care to our community.
I will no longer be able to fill my doctor’s prescription for the hormone estriol, which I have been taking for four years with positive effects.
The custom-blended hormone (BHRT) replacement is vital to my health.
Wyeth, which manufactures a competing drug, is a party to the FDA action against estriol even though it sells that same drug in European markets.
Only here, where it has a higher-priced competitive drug, does Wyeth seem concerned about the sale of estriol.
It is as though greed has overcome good sense and sound medicine.
Reed’s is a responsible local pharmacy and does not make “false and misleading” claims for the drug. It has never made any claims to me.
The shop dutifully fills my prescription, and our relationship ought not to be messed with. It is unfair to them, to me and to other women who need what the store offers.
The FDA action has been so excessive and outrageous that Congress has taken action to prevent its inevitable and deleterious effects.
I am pleased that our Rep. Gabrielle Giffords has been one of the leaders in this crucial (for my health) action.
CAROLYN MOSER
Bioidentical hormones have benefited many
My wife and I were stunned by Anne T. Denogean’s May 20 column disparaging bioidentical hormones.
She expressed disappointment that some members of Congress, including Rep. Gabrielle Giffords, are challenging the FDA’s decision to go after compounding pharmacies that sell these products.
The Food and Drug Administration is being pushed by Wyeth Pharmaceuticals, which controls the market for horse-urine derived hormones, to close out the competition whose bioidentical hormones are derived from plants.
Although Wyeth’s version has been proven to carry potential side effects (increased risks of heart disease, etc.), bioidentical may show different results, but medical testing is too cost-prohibitive.
Although any pharmacy should use caution describing the benefits of a drug or supplement, some women claim that bioidentical hormones have helped them with bone, joint and emotional health issues, in addition to providing some relief from hot flashes (a percentage of women suffer from hot flashes for years beyond menopause) and have even helped some to get adequate sleep.
Allowing Wyeth to essentially eliminate this personal health option from women is heavy-handed over-regulation.
We hope Ms. Denogean will reconsider her stance and support Rep. Giffords’ correct position on this important health choice.
JON F. AND GRIER HAWTHORNE-BUCK
Unsafe in U.S., estriol touted as safe abroad
Re: “Giffords takes bad step by opposing FDA hormone ruling,” the May 20 column by Anne T. Denogean:
As a user of tri-est, a bioidentical hormone that is 80 percent estriol, 10 percent estrone and 10 percent estradiol, I read this column with great dismay.
Her column does not represent scientific facts.
Premarin, made from pregnant mares’ urine, was shown through research to be unsafe. Estriol, made from soy and yams, has been consistently shown through research to be safe.
Before taking bioidentical hormones that match mine (and all women’s natural hormones including yours!) on a cellular level, I did quite a bit of reading on the research.
Wyeth, which claims estriol is unsafe and told the FDA so, is marketing estriol as being safe in Europe!
Millions of women failed by other therapies take bioidentical hormones prescribed by their doctors. My doctor prescribes my treatment to prevent osteoporosis, which runs in my family. My osteopenia recently has been reversed without side effects.
The FDA has no business telling doctors what to prescribe for their patients, especially when the prescribed ingredient has been proven to be safe and the absence of this substance in women’s prescriptions would cause a loss of quality of life for millions of women.
JOAN BRUNDAGE
BHRT offers relief, not bad reaction drugs do
I wrote to Rep. Gabrielle Giffords about my concerns in removing BHRT from the market.
I applaud her for listening to the many women who have actually taken the compound and have excellent results.
I have taken Wyeth’s Prempro and other hormone replacement patches, pills, etc.
I had adverse reactions to these drugs and was not able to function.
I am a widowed single parent of teenage twins and the sole breadwinner of the family.
I have been on BHRT for the past four years and don’t know what I would do if I were forced to stop taking my replacement therapy.
I was placed into surgical menopause four years ago unexpectedly. I don’t have low hormones – I have no hormones.
I believe the decision for a woman to take BHRT should remain with her physician and her.
The FDA can’t make a blanket decision of all women without taking all information from each patient into consideration before making a decision that affects thousands of women.
DANNETTE SCHULTZ
FDA doesn’t always put patient welfare 1st
I am writing about the column in which Anne Denogean complained about Gabrielle Gifford’s attempt to preserve yet another of our rights that the FDA wants to appropriate for themselves.
Ms. Denogean would do the people of Tucson a real service if she would write about some of the many examples of the FDA taking the part of pharmaceutical manufacturers while disregarding the welfare of the population.
If she does not know where to find this information, I will be happy to show her some good places to start.
ALLEN LARSON
No suitable alternative to ease her symptoms
I was dismayed to see the column criticizing Gabrielle Giffords’ challenge of the FDA’s ban on estriol use.
Wyeth seems to be pressuring the FDA to act in an area where its market share is being hurt.
I have depended for years on bioidentical hormones containing estriol. I wouldn’t use anything if those hormones were unavailable.
I consider myself a highly informed consumer on this issue and would never use something overly risky.
My physician, Karen Addis, prescribes this for me. She said the risk was small and the drug worth taking to relieve symptoms.
PAMELA D. HAYS
Effort to ensure option earns Giffords thanks
I found Ms. Denogean’s column on bioidentical hormones to be very biased in the information provided.
I take bioidentical hormone replacement therapy and am grateful for this option.
I am not comfortable taking synthetic hormones or hormones derived from mare’s urine.
My hormone replacement therapy is designed specifically for me. It contains more than just estriol and has made a real difference in my life.
Nothing was “false and misleading” in my conversations with my doctor and pharmacist regarding this product, and I have periodic blood tests to monitor how the BHRT is regulating my hormone levels.
I do not want the FDA to take away this option, and I am thankful to U.S. Rep. Gabrielle Giffords for supporting my rights.
CECILIA LASPISA