GallagherBarbara Ellington, Senior Gleaner Writer
THE 15TH annual North American Menopause Society (NAMS) conference took place in Washington D.C., from October 5 to 10. Over 1,500 doctors, nurses, pharmaceutical companies and medical practitioners representing 45 countries were in attendance. Making it all happen was Dr. Christopher Gallagher, Professor of Medicine in the Department of Metabolism, Creighton University, Omaha, Nebraska..
The conference was sponsored by Eli Lilly and Company, Merck and Company Inc., Solvay Pharmaceuticals Inc. and Wyeth Pharmaceutical.
As chairman of the 2004 conference planning committee and the NAMS 2004 Scientific Committee, Dr. Gallagher and his team selected at this year's theme: Individualised Care at Menopause. Carrying heavy workload, Dr. Gallagher, formerly from England exudes a warm personality the stuff that a great bedside manner is made of. With a speciality in osteoporosis he divides his time among patients, research and a hectic international travel schedule. He spoke to Outlook about NAMS, the controversial Women's Health Initiative (WHI) study and clarified some of the issues that exist about menopause.
B.E: How long you have been involved with NAMS and the International Menopause Society (IMS)?
CG: I was one of the original members at the inception. I had known Professor Wulf Utian, NAMS Executive Director and Honorary Founding President, some 10 years before coming aboard. But earlier in my career I had been interested in osteoporosis research and we had set up the world's first menopause clinic in England in the '70s. At our first meeting there were only 14 people.
I was interested in osteoporosis research because I wanted to know how to treat bone loss without menopausal women having long-term symptoms. We were using 50 micrograms of estrodial and now we know the required dose is five but we had no idea we were using 10 times the required amount.
B.E: Were there any adverse effects on users?
CG: I don't think so but we found we can use lower and lower doses and be just as effective. Then in the '70s Americans were turned on to oestrogen but because no one knew the correct doses to give, women began to have cancer of the uterus. This led to a drop in interest in oestrogen but it gradually returned.
BE: Explain in a nutshell the controversial WHI study why was it done and why were the findings so negatively presented to the public?
CG: The WHI study was started by Dr. Bernadine Healy, a cardiologist appointed head of the National Institute of Health (NIH) in 1986. The NIH does all the medical research in the country but Dr. Healy soon discovered that although lots had been done on men, there was no research on women so she started planning for this study in 1988 to test whether oestrogen would help prevent heart disease. She also wanted to evaluate the safety of oestrogen because this had not been done before.
There were problems because like others before them (research team), they didn't know what dose of oestrogen to use so they picked .625 prempro with a group of 25,000 women in the hormone arm and 125,0000 women in the observational study. None of the findings in the latter group has yet been published but will start to emerge soon. There were three groups: placebo, prempro (premel in Jamaica) and oestrogen only.
Three years into this into the trials, a previous study came out showing that women who were on unopposed oestrogen showed an increase in uterine cancer so it was decided it would be unethical to continue this arm of the WHI study so they discontinued doing it for women who had their uteruses in place.
Meanwhile, there s a group of 10 people comprising the Data Safety and Monitoring Board (DSMB), who meet every six months and are shown the results of whatever trials are done. After five and a half years, they found a small increase in the risk of breast cancer, so the trials were stopped two years earlier than the eight originally planned for.
BE: What about heart disease, did anything unusual show up?
CG: The problem is that in the original trial, they published all the information for the entire group of women among whom the youngest were 50 and the oldest 79; the data showed that the oestrogen did not prevent heart attacks.
BE: Isn't that a case of damned if you do and damned if you don't? If women produce oestrogen naturally, wouldn't they be at risk of heart attack later in life? And if it is administered to them in the menopause years when they no longer produce it, aren't they also at risk?
CG: Right. The reasons they wanted to do the trial were (one) women don't have heart attacks before the menopause, they usually get one 10 years later than men and (two) if you had an early menopause say at age 30, you'd have an increased risk of earlier heart attack, so that was another reason for the trial.
B.E.: I see. I remember the controversy some years ago when many women in Jamaica refused to take oestrogen, was that the reason?
C.G: The problem with the findings as it was presented to the public, was that the study included women between age 50-80 and the argument by many was that you can't study prevention of heart disease in someone who's 70. They already have it. We should be studying 50 year-olds and they didn't have enough of those so we got the wrong answer to the wrong question.
As a result of that trial, a private millionaire in Phoenix, Arizona is now financing an oestrogen-heart attack study in eight centres with 5,000 women aged 50 and who are going into menopause because the NIH is not going to do another one (For more information on the new study go to: (the website, kronos.com). In the original study, the results for each of the three groups showed that all the risks were in women aged 65 and over.
B.E.: Is there any way to undo the damage done?
C.G: The media were sent the wrong information and in a negative fashion and the result was that they were responsible for propagating he fear. The second trial showed that oestrogen use was shown to reduce the risk of breast cancer by 23 per cent but that was never reported.
B.E.: How long should menopausal women remain on hormone therapy?
C.G.: It can be for the long term but needs annual review. If the individual woman is at a high risk for osteoporosis, it should be used for symptoms at the lowest possible dose for the shortest time possible. Remember also that the study did not include women with hot flashes or it would have changed the balance of risk versus benefit.
The researchers felt that if women with symptoms were put on placebos, they'd be lost from the trials. The average woman takes ooestrogen for less than three years before the WHI study, so they were never on long-term use. So, the media thing was much ado about nothing. The Food and Drug Administration (FDA) says ooestrogen should be given for as short a time as possible but the decision should be left to the woman.
B.E.: In your Nebraska practice, who are your main patients and given your hectic schedule, how much time do you have for patient care?
CG: I treat primarily persons with osteoporosis but I see menopausal women too. I devote 30 per cent of my time to patients and the rest to a lot of research, administrative work and travel.
B.E: What is your next big challenge?
C.G.: There are many but I just completed a study on soy that did not reveal anything harmful or earth-shattering.
B.E.: In Jamaica, our men have a saying that "soy kills the boy" in other words it negatively affects their libido. Is there any scientific basis for that?
C.G.: No, there is no information to support that, it's all make-believe; the latest scientific research with soy does not show much. Soy comes from various sourcesand sales are very high here in America.
B.E.: Where does oestrogen come from?
C.G: Soy has some natural oestrogens, some come from plants like the Mexican wild yam. It goes through a 12-step process and all natural oestrogens are actually synthesized. Some comes from the red leaf clover and some from animals too.
B.E.: In your 15-year association with NAMS/IMS, what have you been (one) most satisfied with and (two) most disappointed with?
C.G.: I am happy that the society grows year by year and has become more scientific with better presentations that help menopause practitioners. It is important in helping doctors who want to know they're doing the right thing. I am not unhappy with anything because you build medicine by doing research and advancing the knowledge step by step. Some people expect perfection immediately. The WHI study cost US$600 million and will go on for another five years so it will reach at least US$1billion when it ends but people expect too much too soon.
B.E.: As chair of the planning committee, how difficult was it to put this conference all together? You had 1,500 delegates from 45 countries. How do you get such eminent presenters?
C.G: It was a challenge because you can only go to certain hotels with accommodation for large exhibit space and conference rooms. We usually have to book space several years in advance, in fact we have bookings through to the 2010 meeting and work is already far advanced on next year's conference. We look carefully at evaluation forms to see what people want and it is important that we meet goals and maintain high standards.
It's a complicated process, you have to cash in the chips and presenters get their ravel and other out-of-pocket expenses. Doctors who attend, get 23 of the 40-50 hours credit required annually by the Continuing Medical Education Council. They leave feeling very stimulated.
Funding and membership
NAMS is a non-profit organization funded through membership fees, grants, consumer use of their website on the Internet and several other philanthropic sources. Anyone can become a member and gain access to a vast amount of material on the subject. NAMS meets annually but the international body meets every three years.
Jamaica was represented at the conference by Drs. Verna Brooks-McKenzie, Venice Bernard-Wright and Fay Whitbourne.
