Nancy Lee
(xxx) xxx-xxxx
Appeal to Intergroup for
Uterine Artery Embolization

What they say

Foundation Health Systems, Inc.
“Position Statement: Uterine Artery Embolization for Treatment of Fibroids”
Dated 10/08/98, with lines for approval signatures from Dr. Dale Berkbigler and Jacqueline Sandvik. My copy is not signed.

Section “II. Introduction”, wih my responses:

FHS: “Transcatheter arterial embolization is an established and effective pelvic angiographic technique used to control acute and chronic pelvic bleeding for a variety of diagnoses outside the field of obstetrics and gynecology.”

My response: Interventional radiologists have been embolizing uterine arteries to control acute bleeding of the uterus for the last 15 years. I am not sure how this falls outside the field of obstetrics and gynecology, since acute uterine bleeding is most likely to accompany childbirth. To quote from The Society of CV and Interventional Radiology Website (http://www.scvir.org/fibroid/index.htm):

”While embolization to treat uterine fibroids has been performed for more than six years, embolization of arteries in the uterus is not new. The procedure has been used successfully by interventional radiologists in uterine arteries for more than 20 years to treat heavy bleeding after childbirth. Today, fibroid embolization is being performed at hospitals and medical centers across the country, in Canada and around the world. As of the end of 1998, about 1,500 to 2,000 fibroid embolization procedures had been done world-wide.” (NRL note: I believe this number is now closer to 2,500.)

My response: Researchers do not postulate that blood deprivation will shrink fibroids; our experience is way past that point. Rather, current medical evidence demonstrates that blood deprivation shrinks fibroids. Likewise, researchers do not postulate that blood deprivation of fibroids decreases bleeding and “possibly” pain; rather, current medical evidence demonstrates that, for an average 89% of patients, UAE produces significant or total symptomatic relief. To quote again from The Society of CV and Interventional Radiology (SCVIR) Website:

“The results of studies that have been published or presented at scientific meetings report that 78 percent to 94 percent of women who have the procedure experience significant or total relief of pain and other symptoms, with the large majority of patients considerably improved. The procedure has been successful even when multiple fibroids are involved ... The expected average reduction in the volume (size) of the fibroids is 50 percent after three months, with a reduction in the overall size of the uterus of about 40 percent.”

Additionally: At the age of 47, childbearing is not the major issue for me, though I’m loathe to allow an insurance company to make that decision for me. However, to set the record straight, I’ll include another quote from the SCVIR:

“The majority of patients who have fibroid embolization are finished with childbearing and few women have tried to subsequently become pregnant, making fertility difficult to study. More than a dozen pregnancies have been reported, however, and patients who have had uterine arteries embolized for other reasons, such as bleeding after childbirth, have successfully become pregnant.”

My response: A body of evidence based on experience with 2,500 patients is not a small sample. And if long-term follow-up means more than 10 years, it’s a moot point in terms of my treatment. I am nearly 48 years old and menopause will manage my fibroid problem soon enough, if necessary. Six years’ durability has been proven, and six years’ durability is all that I require.

My response, objetive: The procedure in general is quite well-defined. Here is a description from the SCVIR Website:

“Known medically as uterine artery embolization, this is a fundamentally new approach to the treatment of fibroids that blocks the arteries that supply blood to the fibroids. It is a minimally invasive procedure, which means it requires only a tiny nick in the skin, and is performed while the patient is conscious but sedated — drowsy and feeling no pain.

“Fibroid embolization is usually done in a hospital by an interventional radiologist, a physician who is specially trained to perform this and other minimally invasive procedures.

“The interventional radiologist makes a small nick in the skin (less than one-quarter of an inch) at the crease at the top of the leg to access the femoral artery, and inserts a tiny tube (catheter) into the artery. Local anesthesia is used so the needle puncture is not painful. The interventional radiologist steers the catheter through the artery to the uterus using X-ray imaging (fluoroscopy) to guide the catheter's progress. The catheter is moved into the uterine artery at a point where it divides into the multiple vessels supplying blood to the fibroids.

“An arteriogram (a series of images taken while radiographic dye is injection) is performed to provide a road map of the blood supply to the uterus and fibroids.

“The interventional radiologist slowly injects tiny plastic (polyvinyl alcohol or PVA) or gelatin sponge particles the size of grains of sand into the vessels. The particles flow to the fibroids first, wedge in the vessels and cannot travel to other parts of the body. Over several minutes, the arteries are slowly blocked. The embolization is continued until there is nearly complete blockage of the blood flow in the vessel.

“The procedure is then repeated on the other side so the blood supply is blocked in both the right and left uterine arteries. Some physicians block both uterine arteries from a single puncture site, while others puncture the femoral artery at the top of both legs. After the embolization, another arteriogram is performed to confirm the results. The skin puncture where the catheter was inserted is cleaned and covered with a bandage.

“As a result of the restricted blood flow, the tumor (or tumors) begin to shrink.

“Fibroid embolization usually requires a hospital stay of one night, although some women do go home the same day. About six to eight hours of bed rest is typical after the procedure. Pain-killing medications and drugs that control swelling typically are prescribed following the procedure to combat cramping, which is a common side effect. Fever also is an occasional side effect, and is usually treated with acetaminophen. Total recovery generally takes one to two weeks, but can take longer. “

My response, subjetive: The statements about angiographic technique and particle size comprise possibly the most ludicrous aspect of FHS’s position statement. I am stunned that anyone in a medical field might seriously state that such procedures cannot be executed while we wait for something like particle sizes to be “standardized”! (Incidentally, the PVA particles measure 500 - 700 microns.) Medicine, science, thought, technology - all develop by progressive improvement and refinement. If medicine had always been governed by limits as restrictive as those stated, we would never have used GoreTex to govern tissue replacement, never discovered and used penicillin, never realized that bacteria are involved in infection, never quit believing that someone’s curse must have made us sick. The ignorant self-righteousness of this statement would strike me as funny (one imagines John Cleese haughtily declaiming “I cannot stanch your wound until the bandage size is standardized”) if it weren’t the cause of six months of pain and discomfort for me, not to mention distraction from my work and family.

As far as the angiographic technique is concerned, what do they think these doctors do fo a living? This is their specialty. This is what they do, usually in the living heart, for gosh sake. I have been unable to determine the medical qualifications and specialty of Dr. Dale Berkbigler, the FHS Executive Vice President of Medical Affairs and Chief Medical officer who signed - or rather, did not sign - FHS’s Position Statement on Uterine Artery Embolization, mostly because he was replaced in April 1999 by Dr. Ross Henderson. I do know that he spent the last 14 years managing Qual-Med and then Foundation Health’s interests, earning multimillions of dollars, rather than practicing medicine. From a Business Wire news releasedated April 29, 1999 (http://www.businesswire.com/webbox/bw.042899/1128837.htm) :

“Dr. Henderson succeeds Dale Berkbigler, M.D. Dr. Berkbigler, 50, served as CMO since FHS' creation on April 1, 1997. Prior to this, Dr. Berkbigler served in several executive positions with FHS predecessor companies since 1985.”

In a Families USA Foundation press release included in a California nurse’s organization Website (http://califnurses.org/cna/fusa.html) and dated September 18, 1998, we find that Dr. Berkbigler was among the HMO executives who received the 25 largest unexercised stock-option packages in 1997:

“Dale Berkbigler, Executive Vice President, Foundation Health Systems, Inc.: $3,687,463”

The other non-signee, Jaccqueline Sandvik, FHS’s Director of Medical Policy, is a Registered Nurse. One must seriously question how well their qualifications compare to those of the interventional radiologists who perform this procedure.

My response: FHS neglects to define “durability” here. Myomectomy has a 20-30% fibroid recurrence rate in 3 years, yet Intergroup (FHS) covers this procedure. In comparison, UAE to date has shown no regrowth of existing fibroids or growth of new fibroids. According to the SCVIR Website:

“It is not yet known if the fibroids can re-grow, however no recurrences have occurred in women who have been followed for up to six years.”

My response: And here is the key. Although it has been clearly demonstrated that UAE is a safe and effective treatment for fibroids, is more durable than myomectomy and has both lower complication risk and faster recovery than any of the surgical procedures available, Intergroup - or rather, FHS - is concerned that I might subsequently need a hysterectomy. Indeed, it appears that there’s a 5 - 10% chance that, post-UAE, I might need further medical intervention of some kind. Two or three patients out of 500 treated by Dr. Worthington-Kirsch of Philadelphia have needed a hysteroscopic resection of a submucosal fibroid that could not be expelled. To the best of my knowledge, none of the 500 have needed a hysterectomy. In other practices, a few patients have had subsequent hysterectomies.

When balanced against the risks of major surgery and the 40% post-operative complication rate of hysterectomy, it is clear whose interests FHS has close at heart. They’d rather I had an organ removed unwillingly than take the very small risk, relatively, of paying for later surgery. This is rather like cutting my leg off rather than seeing whether antibiotics will heal an infection first, because if the antibiotics don’t work, they might have to pay for a leg removal anyway. If they were to say that antibiotics were only invented 7 years ago and there’s not a sufficient sample to prove efficacy, I’d have to ask “And whose fault is that?”