By Nicholas Regush Redflagsweekly.com

In this week's edition of redflagsweekly.com's ongoing investigation of Lupron, a prominent surgeon speaks out plainly about what he believes is wrong with Lupron, and, indeed, broadens the scope of issues that touch on the drug's safety and efficacy.

Our approach in publishing these reports is to provide one small slice of the big picture each week, gradually extending the scope of the investigation to include all players - such as more of the women and some of the men who take Lupron for different medical conditions, the manufacturer (Tap Pharmaceuticals, Inc.), the U.S. Food and Drug Administration, the professional medical societies, and advocates and other critics of the drug.

As is the case in any complex medical story, there are many viewpoints and levels of argument and many will be represented in this series. First and foremost, however, redflagsweekly.com has been digging into the bottom line - the science behind Lupron. This will become increasingly apparent as our segments continue.
" They feel their doctors have lied to them and they are angry and disappointed."

This is Dr. David Redwine's assessment of the predicament of some of the patients that end up at his endometriosis treatment program at the 181-bed St. Charles Medical Center in Bend, Oregon.

"Most of them have been on Lupron or other therapies," he told redflagsweekly.com this week in a long phone interview. "The stories I hear from my endometriosis patients is that they were told Lupron would take care of their problems - and it has not."

A "minority" of the several thousand patients he has seen from the US, Canada and Europe have lingering symptoms after taking Lupron, including memory loss, severe joint pain, and emotional upheaval.

But he says that it is difficult to determine any real numbers because "so many women are not getting the proper treatment for endometriosis and are poorly followed by their doctors."

Redwine, an ObGyn, has pioneered several diagnostic and treatment approaches to endometriosis, and uses surgery to remove diseased tissue.

According to Redwine, endometriosis patients, including those on Lupron, get a raw deal in several ways:

• To begin with, patients are sometimes misdiagnosed.
  
• There is inadequate determination if a particular therapy, including Lupron, is
  achieving results.
  
• There is inadequate long-term care and what happens to the patients later is unclear.

"The typical ObGyn gives the drug because it's the easiest thing to do and there is often just not enough time to do much else after diagnosis," Redwine said.

Endometriosis is a condition in which pieces of the lining of the uterus are found in other parts of the body, especially in the pelvic cavity. These pieces of endometrium respond to the menstrual cycle and bleed.

Because the blood cannot escape, it builds up and causes the development of small or large painful cysts.

Lupron, a synthetic hormone-like drug is supposed to temporarily interrupt estrogen output. Hence, a drug-induced menopause.

The goal of treatment is to shrink any lesions produced via endometriosis.

The problem is that there are conditions that mimic the pain of endometriosis, such as fibroid tumors, chronic inflammation, adhesions and cysts.

"There is a lack of studies that use biopsies to ensure that the patients actually have endometriosis," Redwine said. "This makes no sense."

Lack of biopsy control in studies, which sets the tone for everyday diagnosis in the doctor's office, also makes it "extremely difficult to determine whether the lesions have been eradicated. It's not enough to use laparoscopy to view whether lesions have disappeared. This can lead to false conclusions."

And since there is little or no followup of many patients, you have to wonder what happens to them. How many require surgery later? How many have persistent endometriosis? How many have enduring side-effects?

Redwine believes that while Lupron can treat the pain of endometriosis, "albeit temporarily," it has been his experience that Lupron does not treat the disease effectively over time. "It just doesn't do it," he said. "My experience tells me that I'm right."

And he added:

"There are thousands of women from around the world coming to a small town in Oregon. Why?"

Red Flags Weekly February 2, 2002