Menopause Therapy Sparks Controversy

Opinion Split Over Safety Of Synthetic Hormones, Bioidenticals

(CBS)  Fifty-two-year old Glennis runs her house with brisk efficiency, but there was a time when her days were spent in a mind-numbing fog.

"I found myself very irritable, very tearful, everything would make me cry," Glennis explains.

Yes, it was menopause, CBS Evening News anchor Katie Couric reports.

"I was deteriorating into this old, nasty lady," she says, laughing. "I'd feel like I was outside my body looking at myself and my behavior and saying, 'Eww, do you have to be that way?'"

Glennis started taking synthetic hormones, but stopped when the study four years ago warned of the risks. Some experts believe the study was misinterpreted and that low levels of hormones taken over a short period of time are safe.

But many skeptical women turned to something called bioidenticals. These products, derived from soy and yam extracts, are structurally identical to those hormones found in a woman's body, but they are not approved by the FDA.

Dr. Erika Schwartz, author of four books about menopause, is an advocate for bioidenticals, prescribing them to others and herself.

"I have seen people get their sex drive back. I've seen women get rid of their hot flashes, their night sweats, re-capturing their ability to sleep," Dr. Schwartz says.

But critics say there's virtually no difference between bioidenticals and their synthetic counterparts. And now, doctors are concerned that a new bestseller by former actress Suzanne Somers is creating more hype and more confusion.

"These people are claiming that these are natural, that they don't increase the risk of breast cancer, That's absolute nonsense," says Dr. Wulf Utian, executive director of the North American Menopause Society. "They carry exactly the same risks and exactly the same potential benefits as the commercial products."

Critics also say the compounding pharmacies mixing the bioidenticals aren't regulated enough.

"If they're getting something that's mixed in the backroom of a pharmacy, then they're not certain what they're getting," Dr. Utian says.

But the issue, says Dr. Schwartz, isn't about safety. It's about dollars and cents. Since bioidenticals are found in nature and can't be patented, Schwartz says that drug companies have no financial incentive to study them.

"I have no doubt that it's about profit," Dr. Schwartz says, adding that she wants a long-term study on these plant-derived hormones. For now, these women say the relief they're getting from bioidenticals today is worth whatever they may face in the future.

"I'm more worried about the risks if I don't take this," Glennis says.

"It's really just about maybe the second half of your life and being able to get through that feeling as good as you possibly can," says Stacy Pear, another patient.

[brianprather]

Anyone interested in pursuing BHRT (Bio-Identicals) should visit www.savemymedicine.org. This website is dedicated to preserving patient access to Bio-Identical Hormones, as well as other compounded medications. There are forces (Drug Companies, Pharma, Insurance Companies, etc.) who are trying desperately to block women%u2019s access to these hormones. Why? Corporate greed. Bio-Identicals are cutting into the profit margins of the Drug Companies, who provide kickbacks to the insurance companies that cover their synthetic hormones. www.savemymedicine.org. Let your voice be heard. Protect your access to Bio-Identical Hormones.

[brianprather]

It is very interesting that NAMS would be opposed to Bio-Identicals, since the majority of their financial contributions comes from Wyeth (maker of Premarin) and the drug industry in general. "They carry exactly the same risks and exactly the same potential benefits as the commercial products." Dr. Utian should know that hormones with differing chemical structures will react differently, and carry different safety profiles. Not enough studies have been performed on Bio-Identicals to guarantee their safety. Equally, no studies have been done to show that Bio-Identicals are more dangerous than their synthetic counterparts. Therefore, Dr. Utian%u2019s comparison of synthetic hormones to Bio-Identical Hormones is not only unscientific, but also irresponsible, inflammatory & unsubstantiated. Equally irresponsible was the hypothetical question posed by Ms. Couric. She somehow infers that Doctors who prescribing Bio-Identicals are putting their patients at risk. Premarin & other synthetic hormones have been shown in scientific tests to be dangerous & carcinogenic, yet they are still widely used today. Apparently that is perfectly fine.

Gather the facts & make your own educated decision. And if you decide that you want to have the option to pursue Bio-Identicals, go to www.savemymedicine.org to preserve access to Bio-Identical Hormones & other compounded medications.

[hym8nts]

As a compounding pharmacist, I am deeply offended by the picture painted by Dr. Utian. My husband and I are pharmacists who own a compounding-only pharmacy and have installed one of the most advanced cleanroom facilities to not only ensure the safety of the patient and those who make the medications, but also the quality of the environment in which all the compounding takes place. We underwent extensive training and are highly regulated by the USP *notably 795 and 797 * which clearly defines the legal parameters in which non-sterile and sterile products are prepared, stored, and dispensed. In addition to the USP, we are regulated by state and federal laws, individual state Boards of Pharmacy and agencies responsible for medical quality assurance. We are still, at the end of the day, very highly trained PROFESSIONALS. Everything we make is from the finest raw ingredients available and is legally held to a much smaller margin of error than the larger manufacturers. I wonder how many of the big drug companies lose sleep at night knowing that "what we do" is still centered around patient care and not dictated by shares of stock. Money and Power corrupt. Patient Care suffers. We take this very seriously and will continue to fight for our rights to provide quality patient care. Fear and Ignorance should never be allowable tactics used to determine therapeutic outcomes. Heather Wilson Rutkowski, RPh. (Professional Compounding Services in Destin, FL)

[drishman-2009]

Where does Dr. Utian get his information? Bioidentical estradiol is most definately FDA approved. It comes in commercial preparations in pills, patches (Vivelle Dot) as well as compounded creams. Bioidentical progesterone is commercially available Prometrium or can be compounded. One arm of the more recent PEPI trial used Premarin combined with bioidentical progesterone as opposed to medroxyprogesterone (found in PremPro) and there was no increase in breast cancer. In addition, it has been noted in several studies that oral estrogens increase CRP which is a cardiovascular risk factor and probably accouts for the minute increase in strokes noted in the WHI. Transdermal estrogens(patches and creams) do not increase CRP. Besides, do you want to take estrogen derived from horse urine which has over 30 different estrogens most of which are not even found in the human body? Or, wouldyou prefer to take what occurs naturally in your body? Another question, who funds NAMS?

[drishman-2009]

Where does Dr. Utian get his information? Bioidentical estradiol is most definately FDA approved. It comes in commercial preparations in pills, patches (Vivelle Dot) as well as compounded creams. Bioidentical progesterone is commercially available Prometrium or can be compounded. One arm of the more recent PEPI trial used Premarin combined with bioidentical progesterone as opposed to medroxyprogesterone (found in PremPro) and there was no increase in breast cancer. In addition, it has been noted in several studies that oral estrogens increase CRP which is a cardiovascular risk factor and probably accouts for the minute increase in strokes noted in the WHI. Transdermal estrogens(patches and creams) do not increase CRP. Besides, do you want to take estrogen derived from horse urine which has over 30 different estrogens most of which are not even found in the human body? Or, wouldyou prefer to take what occurs naturally in your body? Another question, who funds NAMS?

[indiana127]

I have been on BHRT for five years now. It was the best decision I ever made for my health. I have plenty of energy, sleep well, *** drive is excellent, my mind works well, and I'm not an irritated, ****** menopausal woman. I recommend them to any woman with hormonal problems, menopausal or not.

BTW, there are studies on bio-identical hormones. Just go to www.salivatest.com and read, read, read!

I know what I'm talking about, because I work for a compounding pharmacy and wouldn't encourage women to look into BHRT if I weren't convinced of it myself. All of our patients are monitored by taking saliva tests at periodic intervels. How many women on synthetic hormones are ever monitored by blood or saliva tests by their doctors? Virtually none! Talk about unsafe. With Premarin, every woman was supposed to fall into four different dosage categories, while bio-identical hormone replacement therapy is tailored just for your body chemistry.

These media reports are barely scratching the surface regarding the amazing benefits of bio-identical hormones. While Wyeth and other pharmaceutical companies have been busy killing women for the past fifty years by their patented drugs, bio-identicals are now giving women their lives back. And Dr. Susan Love's caution to take them only for 3-5 years is pure bunk, right from the mouths of the pharmaceutical companies (the quote she was echoing refers to their new line of milder HRT, mostly still synthetics).

[fgarcia571]

Dear Katie:

My doctor recommended a complete hysterectomy at the age of 46 due to endometriosis. Needless to say the after effects of this operation were terrible. I went into instant menopause and I have a heart condition so I could not take the hormones that doctors were prescribing.

I was recommended bioidentical hormones. These hormones have saved my life -- I am currently 50 and I don't know what I will do if they stop making them. My gyn, endocrinologist and cardiologist check me every six months and prescribes my hormones accordingly. Please read "the Wisdom of Menopause" by Dr. Christianne Northrup, "What doctors don't tell you about menopause" by Dr. John Lee. These doctors tell you that doctors and pharmaceutical companies are losing money and are pushing for legislation. I know you are a superb advocate for women's rights and have always risen to the occasion of presenting the facts on any subject. I speak for the thousands of women in this country that need safer and better medicines to deal with menopause, pms and other women hormonal imbalances. God bless you.

[robinm9]

Katie: I've always respected you as a journalist--until now. Why did you NOT report that in the interview you did with the president of the North American Menopause Society that this organization receives funding from Wyeth - the same pharmaceutical company which manufactures the synthetic hormone Premarin (PREgnant MARE uriINe - yes that's where the name comes from!). Katie - whether you intentionally left out this information or neglected to research it, you let all of your viewers down. In addition, why didn't you get someone from Wyeth on your show and ask THEM if they feel badly about all the cancer and other health problems their product has ALREADY caused? I doubt they do because they are still selling their product despite studies that show it's dangerous. Not only that, they have filed a consumer complaint with the FDA to stop the manufacture of bioidentical hormones! I have a suggestion, Katie, do a story on whether anyone at the FDA has received gifts, money, or trips from anyone in the pharmaceutical industry. I'd be very interested in an expose on that issue. Oh wait, aren't the pharmaceutical companies big advertisers for our network tv stations? Guess a story like that won't happen anytime soon. So much for objective reporting in America! Sign me disgusted and disappointed!

[bhrtman]

I just wanted to add my perspective. As a compounding pharmacist specializing in BHRT, I want to thank all of the women who have given positive testimonies regarding this therapy. The reason I got into BHRT was a personal issue that was resolved amazingly through BHRT. There is no better way than patient testimony to spread the word on this treatment option. I always tell patients to use common sense, and also to "follow the dollar". It's amazing there are certain drug companies that want us to stop making BHRT for patients because they say they are concerned about patient safety. I encourage all users of compounded medications to visit www.savemymedicine.org to learn more about current issues in pharmacy compounding. On a personal note, there is no greater feeling than getting a phone call from a patient saying "you saved my life and my marriage". Wow.....I sleep very well at night.
Regards,
Glenn

[lww11]

I am 59 years old and had a complete hysterectomy 12 years ago and spent 12 years in hell. I went from being a mild mannered, easy going person to being a grouchy irritated witch most of the time. I went from having a very satisfying *** life to no drive at all. For 12 years I never slept over 2-3 hours without waking up. I gained 50 pounds without changing anything about my diet or exercise. I started going to a new doctor this summer who gets the connection between aging and hormones and she put me on bioidentical gel hormones and for the first time in 12 years I slept all night. It's amazing how much better your brain works when you get uninterrupted sleep.
Don't tell me they don't work better than synthetic drugs. My insurance won't cover the hormones but I'll pay for them anyway but it's sad that people who can't afford them won't get them because of drug companies and insurance companies. I know the difference now and I won't go back to a one for all pill that doesn't work for me.