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Uterine Fibroid Embolization
SCVIR Changes Name to SIR
UAE Clinical Trial
NIH Rejection of Clinical Trial
Strong Medicine
Cutting Edge Medical Report: Uterine Fibroids
Endometrial Ablation
Female Reconstructive Surgery
Clinical Trials/Research

UAE Clinical Trial


UPDATE 1/30/2002

Boston Scientific Announces Completion of Investigational Arm of Uterine Artery Embolization Trial

So often we wonder about the influences that the pharmaceutical industry has on the studies that get done in this nation and sometimes we come away quite skeptical over the outcome of such studies. I'm quite certain that similar skepticism will no doubt come from the gynecology camp once the following study is complete:

Boston Scientific Announces Clinical Trial on Uterine Artery Embolization
Procedure studied as possible alternative to hysterectomy and myomectomy

With 2 rejections from the NICHD regarding clinical trials that would collect information on Uterine Artery Embolization and Myomectomy for the treatment of uterine fibroids under his belt, along with condescending and derogatory commentary regarding the need for women to have any other treatment option available to them when hysterectomy is "the definitive cure" coming from the NICHD funding decision-making panel, is it any wonder that Dr. Scott Goodwin would choose to move on and work with device manufacturers to get a clinical trial underway?

Content of last rejection letter:
NIH Rejection of Clinical Trial

Read Critique #3 in this summary rejection statement very carefully. I particularly liked this statement:

"It is not clear to this reviewer that the question to be addressed
is of significant importance to justify this study.

A study completely funded by a pharmaceutical isn't the study that I would have preferred. But, from my perspective, I think we simply have to thank Boston Scientific for choosing to pick this up and doing this study. Yes, I know they'll stand to financially benefit from this in the long run. So what? Without a clinical trial of some sort, we'll never make any headway with insurance providers covering uterine artery embolization in this nation and we'll also never make any headway in determining the efficacy of alternative treatments for uterine fibroids. Besides, the financial benefits from performing ~600,000 hysterectomies every year in the U.S. are quite evident to us all in terms of gynecologists bickering over their insurance provider payout and refusing to refer women for UAE due to income loss. Not to mention all the medical devices and drugs used during the performance of a hysterectomy and the filled hospital beds these numbers represent. Oh, and let us not forget the high price of hormone replacement therapy for that 60% of the hysterectomy population who have their ovaries prophylactically removed at the same time and the 20% of the remaining 40% of the women keeping their ovaries who experience ovarian failure as a result of their hysterectomy....

We all would have preferred an NIH funded study to keep this entire discussion of financial gain from study outcome off the table. Unfortunately, that just didn't happen. The researchers tried to go the NIH route first -- but were resolutely rebuffed in lieu of the overbearing, out-dated, patriarchal thinking that hysterectomies are all that women need for their uterine fibroids. After all, women who might want to explore medical alternatives allowing them to keep their body parts are simply silly, aren't they?

Shame on the NICHD. With a $15 million dollar matching grant from the Gates Foundation awarded just last year " improve the health of women and children throughout the world..." it would seem to me that fibroid trials would be high on their list.

Gates Foundation and NIH Fund Global Network for Women and Children's Health Research

Fibroids are rampant in African nations and hysterectomy surgery clogs the hospitals. Heaven help us but my guess would be that the morbidity stats are much higher there from hysterectomies than in the U.S. (Of course, according to one of the most recent studies released just last December, perioperative morbidity alone for hysterectomy in the U.S. is running about 40%. Not exactly a statistic that sells me on this treatment option as the "definitive cure.")

Last year at the Feminist Majority Foundation conference there were several medical delegates from African nations present who gave me their business cards and asked about getting UAE in their hospitals. What could I tell them? I'm not a physician. I'm not even a medical researcher. I just disseminate information and try to educate the public. But these doctors wanted to know how they could learn more about UAE to bring it to their countries. Every week I note that this website has many visitors from the continent of Africa. Actually, the statistics tracker for this website show visitors from every continent. I can even say that I've seen Antarctica show up in the statistics once. (Yes, there are people stationed in Antarctica in need of medical care.) And, if you think Chinese women don't have fibroids, well, you'd be wrong. I often receive website visitors from China -- including visitors from China's Ministry of Education.

The point is, funds coming from the Gates Foundation are supposed to benefit the "global" community. The health of the female reproductive system of women all over the world is in serious trouble. The presence of tumors of the uterus is reaching epidemic proportions and even though perhaps only 25% of all women with fibroids today present with symptoms requiring treatment, who's to say it won't be 50% by 2010 or 100% by 2020? And since uterine fibroids seem to impact African Americans at a higher rate than Caucasians, just what is the prevalence of this disease today in African nations? (I couldn't find the statistics -- if you know them, could you share?) In the U.S., beyond heart disease, I can't think of research that would impact more women than uterine fibroids research. And, I would warrant a guess that cutting down the number of hysterectomies performed would have an impact on even heart disease statistics.

Yet, here's what the NICHD has in mind in terms of funding opportunities:

NICHD Funding Opportunities

I'm not impressed. In fact, I'm a bit nauseous. $15 million dollars matched by the Gates Foundation and this is the best they could do? Mind you, I do recognize that I'm quite prejudiced in this regard and absolutely apologize to those researchers who might have an interest in one of the areas the NICHD is choosing to fund. But, I'm simply tired of uterine fibroids being so desperately ignored by the NIH. Continuing to ignore this issue from either a U.S. or global perspective is ludicrous. We need to know what causes these tumors and how to prevent them. For women who already have them in their bodies, we need to know more about alternative treatment options associated with reduced morbidity statistics beyond hysterectomy.

Overall, I just want to know the answer to one question: Why is convincing the NIH to fund this type of research so difficult? I lied. I have lots of questions. Like, why has there never been a prospective clinical trial of myomectomy funded? Why is efficacy of UAE or myomectomy deemed an "unimportant" research question? How much longer must women be forced to tolerate a treatment solution (hysterectomy) that they don't want simply because researchers and funders refuse to look any further? Is there someone out there who can answer my questions?

In the meanwhile, thank you Boston Scientific for stepping up to the plate of uterine fibroids research. Simply, thank you.

Uterine Fibroid Embolization

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This page last updated Wednesday, April 10, 2002