News came today that an appeals court has upheld a jury’s finding last year that Wyeth’s hormone-replacement drugs helped cause an Arkansas woman’s breast cancer. At stake was $27 million in actual damages, an amount that was upheld by the three-judge panel.
The appeals court said “the evidence presented could allow a jury to find or infer that Wyeth was guilty of malicious conduct.” According to the news report, Pfizer’s lawyers argued that the plaintiff received ample warning about the cancer risks tied to the company’s Prempro and Premarin drugs and chose to continue using them.
The ruling comes a week after a Philadelphia jury ordered Wyeth to pay an undisclosed amount of punitive damages to an Illinois woman who developed breast cancer after taking Prempro. Six million women have taken Wyeth’s hormone therapy drugs for severe menopause symptoms and there are more than 9,000 lawsuits against the company. The menopause drugs are still on the market and many physicians continue to recommend and prescribe them to their patients.You can read the court’s summary of the case here.
Editor’s note: Earlier this month, I wrote about a webinar on Bioidentical Hormone Therapy, that was “supported” by Ascend Therapeutics, makers of an FDA-approved topical estrogen gel that competes with compounded hormone products. There’s a companion magazine, “The Buzz on Bioidenticals,” that is available free online and in doctors’ offices and it, too, is “supported” by Ascend. The publication repeatedly cautions women against using compounding pharmacies and, in an article called “Why You Should Avoid Compounded Hormone Therapy” the writers suggest that doing so poses a risk to our health.
In the interest of fairness and to contribute to a balanced discussion that will help you make an informed decision about using compounded, bio-identical hormones, I contacted Christine Givant (pictured below), a pharmacist and founder of La Vita Compounding Pharmacy, in San Diego, to ask her to respond to some statements made in the “Buzz on Bioidenticals” publication.
Wendy: First, explain what a compounding pharmacy does and why a woman on hormone therapy would choose to have her hormones “compounded.” What does that mean exactly?
Christine: A compounding pharmacy serves many vital purposes. To begin with, it allows the physician the opportunity to customize therapy to a patient’s individual needs. For example, Ascend Therapeutics offers a hormone product that comes in one strength, one dosage form, and one delivery device. Well, that will work for some women, but not all. A compounding pharmacy would be able to make it in the exact strength your physician determines you need and put it in a variety of dosage forms depending on your lifestyle (i.e gel, cream, suppository, lozenge, capsule, sub-lingual drop). A compounding pharmacy could also combine a daily hormone regimen into one cream, which could result in increased compliance and a lower cost to the patient. [click to continue...]
You should be aware that both the webinar and the magazine are supported “by an educational grant” from Ascend Therapeutics, which makes EstroGel, an FDA appproved estrogen gel that competes with the Vivelle-Dot estrogen patch as well as hormone products formulated by compounding pharmacies. That explains the repetitive advice you’ll find throughout the magazine against using compounded hormone products (i.e. “you don’t need to go to a compounding pharmacy to obtain bioidentical hormone therapy” and “there is no need to risk using a compounding pharmacy.”)
As I’ve written here before, the debate continues over the safety of bio-identical hormones, the reliability of saliva tests and the safety and consistency of compounding pharmacies. It’s hard to evaluate claims when the information we receive is “sponsored” by an interested party. All I can say is read and listen to everything, ask questions and know the source.
Some women are just plain lucky. They sail through Menopause without a minute of discomfort. I put them in the same category as super-models. They’re freaks of nature. The fact is that most menopausal women experience hot flashes and/or night sweats and they can range from mildly disruptive to downright debilitating. Hormone therapy will help with the hot flashes (vasomotor symptoms as they are called), but current guidelines recommend that it be taken at the lowest effective dose for the shortest period of time. So, in making the decision to take HT, wouldn’t it be a lot easier if women knew how long their hot flashes would last? [click to continue...]
If TV commercials for pharmaceuticals are a true reflection of what ails our population, then I have to conclude that a good percentage of people – men and women – suffer from Gerd, often called acid reflux or heartburn. It has been commonly believed that lifestyle factors such as BMI (body mass index), diet, smoking status, alcohol consumption and the use of certain medications are the culprits. But recent research has shown that if a post-menopausal women is complaining of Gerd-like symptoms, it’s very possible that her use of hormone therapies, or raloxifene (prescribed for osteoporosis prevention) or even over-the-counter soy estrogen products are to blame. [click to continue...]
Your claims of brain fog, senior moments, or whatever you want to call the small but frequent memory lapses you experience during the menopause transition are real, according to the findings of a new study just published in Neurology journal.
Researchers spent four years investigating the effects of the menopause transition and hormone use on three areas of cognitive function; processing speed, verbal memory and working memory. They concluded that mid-life women, particularly those in the late-perimenopause stage (they haven’t have a period in three to 11 months) were not able to learn as well as they had during pre-menopause. The good news is that their test scores eventually improved and rebounded to pre-menopause levels once they hit post-menopause (no period for 12 months), indicating that “menopause related cognitive difficulties may be time-limited.” [click to continue...]
Last month, while attending the Scripps Conference on Natural Supplements, I met Dr. Tieraona Low Dog, whose presentation on Botanicals and Women’s Health drew a packed house of medical professionals eager to learn more about complementary and alternative medicine. And who better to learn it from than Dr. Low Dog, who was a highly respected herbalist before receiving her medical degree. Naturally, I was interested in what she would recommend for women who want to go through menopause “naturally.” That is – without the use of hormones. I think you’ll be surprised at her response as I was during our one hour conversation: [click to continue...]
I recently attended The Scripps Conference on Natural Supplements in beautiful La Jolla, CA where I listened to a presentation on bio-identical hormone therapy in menopause by Dr. Steven Brody, a gynecologist and assistant clinical professor at UC San Diego School of Medicine.
Dr. Brody’s time slot coincided with another, equally compelling presentation on “Chocolate and Tea: A Scientific Overview and Tasting Demonstration.” It was a tough call, I admit, yet he drew a full house of mostly female physicians and nurses. And when the hour was up, no one would let him go. His discussion continued outside the presentation room, as a sea of women, notebooks in hand, peppered him with more questions. He was still holding court at lunch the next day as more conference attendees (perhaps the ones who chose chocolate over his presentation) pulled up their chairs to join him at his table. Despite all the research, articles, FDA actions, dueling press releases and Oprah shows, there is still a lot of confusion about bio-identical hormones, and an urgent need for unbiased information.
In Dr. Brody’s opinion, conjugated hormones – namely Premarin, which consists of about six different conjugated estrogens derived from the urine of pregnant mares, is “one of the worst offenders for woman’s health in the last 50-100 years. It’s natural for horses, not for women,” he said. [click to continue...]
Melinda Beck’s “Health Journal” column in today’s Wall Street Journal focuses on “The 7 Things You Should Know About Hormones.“ She tries to clarify the debate over bio-identical hormone replacement therapy by offering 7 facts about bio-identicals, some of which are, well, debatable such as: don’t trust saliva tests, and hormones from compounding pharmacies aren’t safer than conventional HRT. I don’t know if those statements are true, but I do know that there is still principled debate on both sides. [click to continue...]
It was refreshing to hear an open, frank discussion about Menopause, hormones and hot flashes on national TV – and on the most popular talk show for women to boot. It was downright historic! And long overdue. As Oprah put it, it’s about time that “the veil of shame” around menopause was lifted and that we should “get a conversation started about it.”
Only someone like Oprah, with a worldwide platform, could pull this off, so I thank her profusely! Hopefully, her initiative will begin an “oral tradition” of sharing information about Menopause with our friends and daughters so that women can take control of their own lives and, as she put it, “demand to feel better!” [click to continue...]
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Christine: A compounding pharmacy serves many vital purposes. To begin with, it allows the physician the opportunity to customize therapy to a patient’s individual needs. For example, Ascend Therapeutics offers a hormone product that comes in one strength, one dosage form, and one delivery device. Well, that will work for some women, but not all. A compounding pharmacy would be able to make it in the exact strength your physician determines you need and put it in a variety of dosage forms depending on your lifestyle (i.e gel, cream, suppository, lozenge, capsule, sub-lingual drop). A compounding pharmacy could also combine a daily hormone regimen into one cream, which could result in increased compliance and a lower cost to the patient. 
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