LadyRdhd
08-02-2002, 08:32 PM
4 months ago, I volunteered to be in a HRT study, comparing the products Prempro and Femhrt for side affects. There is no placebo, subjects are given two pills to take, but don't know which they are taking. Of course, after the news about the big study (Woman's Health Initiative) on Prempro being stopped, I thought my study would be stopped, too, but it has not.
Instead, we subjects were sent a copy of "new verbiage" and disclosures from the manufacturer updating and correcting the risks of HRT found in the WHI study. We will be asked to sign a release, stating that we are aware of these risks.
I was told that our study was not being cancelled, because it "only studies the drugs for 9 months, and the other study was stopped because of conditions that developed after 5 years." At first blush, this sounded reasonable. My concern is this: the new verbiage is misleading and not accurate according to the information from the Journal of American Medical Assoc., which states that in the study that was stopped, the increase in Coronary Heart Disease (CHD) occured DURING THE FIRST YEAR, not after 5 years! Also women who have only one of the 6 risk factors for CHD should not take HRT. We were NOT screened for coronary heart disease risk at all before this study (I actually have 3 of the risk factors), AND the new disclosure does not say a word about the incident stroke, heart attack, and coronary thrombosis increasing in the first year.
I feel someone is trying to mislead by not informing the participants accurately and by not screening the participants more carefully for CHD risk. I am well-informed, but the other 499 women in this study may not be. Does anyone know to who's attention can I bring these concerns? I tried to talk to the PHD in charge of this study in my area, but my words fell on deaf ears.
I believe this to be a matter of serious concern. If women are willing to be a guinea pig, they should be given ALL the facts, and they should be properly screened, to avoid jeopardizing their health.
Instead, we subjects were sent a copy of "new verbiage" and disclosures from the manufacturer updating and correcting the risks of HRT found in the WHI study. We will be asked to sign a release, stating that we are aware of these risks.
I was told that our study was not being cancelled, because it "only studies the drugs for 9 months, and the other study was stopped because of conditions that developed after 5 years." At first blush, this sounded reasonable. My concern is this: the new verbiage is misleading and not accurate according to the information from the Journal of American Medical Assoc., which states that in the study that was stopped, the increase in Coronary Heart Disease (CHD) occured DURING THE FIRST YEAR, not after 5 years! Also women who have only one of the 6 risk factors for CHD should not take HRT. We were NOT screened for coronary heart disease risk at all before this study (I actually have 3 of the risk factors), AND the new disclosure does not say a word about the incident stroke, heart attack, and coronary thrombosis increasing in the first year.
I feel someone is trying to mislead by not informing the participants accurately and by not screening the participants more carefully for CHD risk. I am well-informed, but the other 499 women in this study may not be. Does anyone know to who's attention can I bring these concerns? I tried to talk to the PHD in charge of this study in my area, but my words fell on deaf ears.
I believe this to be a matter of serious concern. If women are willing to be a guinea pig, they should be given ALL the facts, and they should be properly screened, to avoid jeopardizing their health.
Sponsor
AllyMcBeal
08-02-2002, 10:14 PM
How about talking with your personal healthcare provider??
What you are saying though, only proves to me that the results of the WHI study are most likely inaccurate too as I feel those women were not properly screened either prior to the study. Some may have already had CHD or may have even had strong histories of the disease in their families. The same for the breast cancer link.
Good luck in getting the answers you seek.
Ally
What you are saying though, only proves to me that the results of the WHI study are most likely inaccurate too as I feel those women were not properly screened either prior to the study. Some may have already had CHD or may have even had strong histories of the disease in their families. The same for the breast cancer link.
Good luck in getting the answers you seek.
Ally
LadyRdhd
08-05-2002, 02:36 AM
Thank you for your suggestion, Ally. You are right, I should speak with my physician. He might be able to suggest a venue in which I can alert someone of my concerns. One might hope there is a watchdog that protects the safety of people who volunteer for clinical trials.
I felt safe when I became a "lab rat" for this study because my doctor urged me to start HRT for my symptoms of menopause, and his clinic told me about this study. Both Prempro and FemHRT had been on the market for years. The research Dr., herself, was using Prempro. Imagine my shock when I read the findings of the Woman's Health Initiative Study, only to discover that the reasearchers in my study had given me innacurate and misleading information in the form of their new "disclosure," which came straight from the manufacturer. Their screening proceedure completely overlooked Coronary Heart Disease risk factors, a practice which lead to heart attacks and even deaths of women volunteers within the first year of the WHI study. At the very least, women who volunteer for these studies deserve truthful, complete, and accurate information, so they can make an informed decision about becoming involved.
I felt safe when I became a "lab rat" for this study because my doctor urged me to start HRT for my symptoms of menopause, and his clinic told me about this study. Both Prempro and FemHRT had been on the market for years. The research Dr., herself, was using Prempro. Imagine my shock when I read the findings of the Woman's Health Initiative Study, only to discover that the reasearchers in my study had given me innacurate and misleading information in the form of their new "disclosure," which came straight from the manufacturer. Their screening proceedure completely overlooked Coronary Heart Disease risk factors, a practice which lead to heart attacks and even deaths of women volunteers within the first year of the WHI study. At the very least, women who volunteer for these studies deserve truthful, complete, and accurate information, so they can make an informed decision about becoming involved.
bjg
08-05-2002, 04:18 PM
you might try calling the federal drug administration
medwatch ...1-800-fda-1088
medwatch ...1-800-fda-1088
drs
08-06-2002, 01:34 AM
I have been following this thread, and I have always felt that there are many things we are not told as far as meds. go.
My goal has always been what I could find naturally if I could to help myself, I do discuss this with my doctor though. I do have to take synthroid, and I take a hormone too. After my total hysterectomy 6yrs ago.
This year I've finally found very close natural substitute for the hormone therapy. It's called tri-est. Very low dose of the horse pee kinds of hormone pills. ISN'T THAT GROSS!
But it true. The tri-est only has 10% estrodial, 10% estrogen, and 80% estroil. Which is the plant based one. I feel almost normal again.
But I hear you as far as being outraged....I am too. Do what you have to do and keep us informed on your responses and progress, would you? We'll be here cheering you on.
Diana :wave:
My goal has always been what I could find naturally if I could to help myself, I do discuss this with my doctor though. I do have to take synthroid, and I take a hormone too. After my total hysterectomy 6yrs ago.
This year I've finally found very close natural substitute for the hormone therapy. It's called tri-est. Very low dose of the horse pee kinds of hormone pills. ISN'T THAT GROSS!
But it true. The tri-est only has 10% estrodial, 10% estrogen, and 80% estroil. Which is the plant based one. I feel almost normal again.
But I hear you as far as being outraged....I am too. Do what you have to do and keep us informed on your responses and progress, would you? We'll be here cheering you on.
Diana :wave: