Living With Endometriosis

Endometriosis not predicted by hormone effect
Internal Medicine News, Feb 1, 2008 by Miriam E. Tucker

WASHINGTON — Response to hormonal therapy does not accurately predict whether a patient has endometriosis, Dr. Todd R. Jenkins reported at the annual meeting of the AAGL.

Laparoscopy has long been considered the standard for diagnosing endometriosis. However, a 1999 paper by Dr. Frank W. Ling called into question the necessity for doing laparoscopy in women with chronic pelvic pain (Obstet. Gynecol. 1999;93:51-8). The findings of that study, which was sponsored in part by depot leuprolide manufacturer TAP Holdings Inc., suggested instead that a diagnostic algorithm plus a reduction in symptoms with a 3-month trial of depot leuprolide could non-invasively identify those women for whom endometriosis was the cause of pain.

“Our clinical impression has been that many women who failed to respond to hormonal treatment did, in fact, have endometriosis. Unfortunately, many women have been told that they did not have endometriosis since they did not respond to hormonal treatment,” said Dr. Jenkins, director of the division of women’s reproductive health care in the department of obstetrics and gynecology at the University of Alabama at Birmingham.

In a retrospective study conducted by Dr. Jenkins and his then-associates at the Chattanooga (Tenn.) Women’s Laser Center, chart reviews identified 486 patients at the private endometriosis referral center who had undergone laparoscopy for chronic pelvic pain and who had received at least 3 months of preoperative hormonal therapy. Of those, a total of 105 met the study criteria, which included complete information regarding response to treatment and less than 3 months between completion of hormonal therapy and the laparoscopy.

The hormonal treatments were oral contraceptive pills in 80% of the patients and gonadotropin-releasing hormone (GnRH) agonists in 20%. Response to the hormones, defined as either partial or complete symptom relief, was achieved in 46% (48), while 54% (57) had no relief of symptoms. Endometriosis was identified subjectively during laparoscopy in 84% (88) of the women, and a pathological diagnosis was made in 67% (70). These findings confirm those of Dr. Ling and others that endometriosis is present in approximately 80%-85% of women with well-defined chronic pelvic pain, Dr. Jenkins noted.

There was no significant difference in the rate of endometriosis between all hormonal therapy responders and nonresponders, either by subjective impression or pathological diagnosis. Subjective diagnoses of endometriosis were made for 85% of responders (41/48) and 81% of nonresponders (46/57), and pathological diagnoses in 65% (31/48) and 68% (39/57), respectively. Endometriosis rates also did not differ between the 35 responders and 48 nonresponders to oral contraceptives specifically.

Differences were significant for those who took GnRH agonists: Subjective diagnoses of endometriosis were made in 100% (9/9) of responders, compared with just 50% (4/8) of nonresponders, and pathological diagnoses in 89% (8/9) of responders vs. 25% (2/8) of nonresponders. However, the number of cases was too small to be conclusive, he said.

Response to hormonal therapy also did not predict the diagnosis of endometriosis at any specific location except for the anterior bladder wall peritoneum (70% of responders vs. 30% of nonresponders), but only 10 patients had endometriosis at that site. The same was found for pathologically confirmed diagnoses: Only endometriosis of the anterior peritoneum was statistically more likely among responders than nonresponders (85% vs. 15%), and again, the data were limited because the numbers were very small, Dr. Jenkins added.

He noted that these findings should not be interpreted to mean that a trial of GnRH agonists isn’t a good idea, since they were found to be the most effective hormonal treatment for the relief of symptoms. “We do not disagree with a trial of empiric therapy in patients with chronic pelvic pain. But no judgment should be made regarding the diagnosis of endometriosis based on the response to hormonal therapy without a laparoscopic evaluation. A laparoscopic diagnosis is still the gold standard.”

BY MIRIAM E. TUCKER

Senior Writer
COPYRIGHT 2008 International Medical News Group
COPYRIGHT 2008 Gale, Cengage Learning

Part II: Overpriced poison?
Posted: Nov 2, 2009 03:53 PM
Updated: Nov 2, 2009 06:22 PM

28-year-old Rachelle Fenner finds it hard some days to just get out of bed.

“Right now, my face is numb, my shoulders are numb, I feel dizzy, I just don’t ever feel good.”

“It’s horrible,” says 30-year-old Mary Orseno. “It’s debilitating. I can’t work full-time. I suffer quite a bit. I can’t play with my son the way I used to be able to play with my son.”

The stories told by Rachelle Fenner and Mary Orseno echo those of young women across the country.

Women whose doctors have prescribed Lupron for Endometriosis: a medical condition that causes pelvic pain, irregular bleeding and possible infertility.

“After I took the Lupron,” Mary recalls, “I started having more and more things go wrong.”

Mary’s been off Lupron for nearly five years.

“I was told that those things should go away after stopping taking the Lupron and for awhile they did but then came back worse.”

Dr. Rachel McConnell didn’t treat Mary, but she does prescribe Lupron for some of her Endometriosis patients.

“One of the biggest side effects I’ve always been concerned about has been Osteoporosis or Osteopenia developing, so I’m very limited. I limit the use of that medication. If a patient has used it once then I pretty much do not want them to use it again.”

Osteoporosis is a known side effect, but the seriousness has been downplayed according to a lawsuit that was filed in Clark County District Court but is now a federal case.

It centers on a woman who took Lupron when she was just 17.

By age 20, she’d developed bone loss so severe that she’s been diagnosed as totally and permanently disabled.

Lupron is made by Illinois-based Abbot Labs. They wouldn’t give us anyone to talk to on camera, but did provide a statement.

It says: “Lupron has had more than two decades of clinical experience and is an important treatment option for patients with advanced prostate cancer and endometriosis. Both the benefits and risks of therapy are well known and clearly outlined in the label for consideration by physicians before recommending treatment.”

But medical records filed with the lawsuit document other serious side effects that aren’t on Lupron’s label, like back and neck pain, severely debilitating bone loss, and thyroid disorder.

Endometriosis expert Dr. David Redwine doesn’t use Lupron because he says its risks far outweigh the benefit of temporary pelvic pain relief.

“One of the disturbing things is that some of these side effects seem to be long-lasting in women. Even women who have been off Lupron for months or years.”

In a document Abbott filed in the federal case, the manufacturer says: “Lupron is neither defective nor unreasonably dangerous when properly prepared and accompanied by proper warnings and instructions for use.”

But Dr. John Gueriguian, who spent 20 years reviewing drugs for the FDA, disputes that.

In an expert opinion he submitted for the federal lawsuit, he says the manufacturer “intentionally suppressed knowledge about the real danger associated with the use of Lupron… misleading both prescribers and patients.”

He says their studies are inadequate and they’ve “failed to put warnings in the Lupron labeling about known adverse events which were reported to FDA and known throughout the medical community.”

“I really wish the FDA would take a harder look at that,” Mary says. “Something needs to be done. And I don’t know if they’re ignoring it or they’re just not realizing it but I think they really need to take a harder look at Lupron itself.”

The FDA has more than 12,000 adverse events from Lupron patients on file right now, including more than 1100 deaths.

Most are men taking Lupron for advanced prostate cancer, and as a result of our inquiry, the FDA is evaluating Lupron’s safety as a prostate cancer treatment.

But women are dying too and we wanted to know who’s looking out for them.

We wanted to ask the FDA how many reports it takes before the government takes action?

Contact 13 sent numerous e-mails and made repeated phone calls to ask why they keep the data if they don’t use it or it doesn’t trigger something?

When does a red flag go up?

They haven’t answered any of those questions.

But they say they continue to monitor patient complaints, and if they see potential for a widespread problem, the agency will take action as needed.

“I think the FDA is just as much a victim of Big Pharma marketing as consumers are,” says Dr. Redwine.

Unless and until Congress or the FDA does something, consumers feel like they’ve got little help and even less hope.

“Pack your bags and run,” says Derrick Fenner.

We spoke to his wife, Rachelle, at the beginning of this story.

“If your doctor says the word Lupron, get up and walk out. It’s not worth it! It’s just not worth it,” he says.

Abbot Labs says everything about Lupron, from design through marketing, complied with federal law.

But here’s a little perspective for you.

According to Dr. Gueriguian–the former FDA medical officer–the pharmaceutical industry is responsible for performing all studies needed to develop a new drug.

So FDA approval is based on information provided by the drug company.

The manufacturer is also largely responsible for pre- and post-marketing safety and contents of their labeling.

FDA acknowledges the agency rarely takes a drug off the market without the approval of its manufacturer.

Many thanks to Melissa Ralston, moderator of the Goddesses of Endometriosis email list, for finding this hair-raising story.

Overpriced Poison?
Posted: Oct 30, 2009 04:15 PM
Updated: Nov 1, 2009 11:56 PM

Doctors and a drug company may be getting rich at the expense of patients and taxpayers. Devastating side effects kept secret and ineffective government oversight.

It sounds like a movie script, but it’s playing out in reality.

Contact 13 Chief Investigator Darcy Spears talked to women in Las Vegas and across the country who are begging federal authorities to investigate and recall what they say is nothing short of overpriced poison.

“I have pain in my chest and in my ribs, the bone pain,” says 28-year-old Rachelle Fenner.

“I have severe pain in my neck and shoulder,” echoes 30-year-old Mary Orseno.

Rachelle can’t feel her shoulders or her face. Mary often can’t feel hot and cold.

Rachelle’s eyes go blurry.

Mary says, “There are some days I just burst into tears just thinking about getting out of bed.”

Both women were prescribed the same drug, Lupron Depot, for the same reason endometriosis–a medical condition in women that causes pelvic pain, irregular bleeding and possible infertility.

Rachelle recalls a couple weeks she got the shot, “I swelled up like I was five months pregnant.”

She’s been off the drug for months.

“It’s taken a lot from us,” says her husband, Derrick, with tears sliding down his face. “It really has. Every day’s a fight. You just don’t know.”

Mary took it almost five years ago.

“I could do normal things like play with my son and go out and go for a walk and go for a bike ride and all of that is just nearly impossible at this point to do those things,” she says.

Like millions of women across the country, Mary and Rachelle were told their pain would go away if they took this highly toxic cancer drug.

“Is there ever a day when you say, you know what, getting rid of the pain was worth it?” Darcy Spears asked.

“No,” Rachelle answers emphatically.

She and Mary both say they’d gladly take it all back.

“I would have lived with the endometriosis pain. That pain compared to the pain that I experience every day is nothing,” Mary said.

Lupron was originally approved in the 1980s to help men with advanced prostate cancer live longer.

But it doesn’t work for dying men, and it has significant side effects.

That’s according to two recent studies published in the Journal of the American Medical Association.

In 1990 the FDA approved it as a pain reliever for women with endometriosis.

But it’s so toxic, it’s not recommended for more than 12 months in a lifetime.

Renowned endometriosis experts like Dr. David Redwine steer clear of it altogether.

“Lupron does not make endometriosis go away so the cure rate with Lupron is zero,” Redwine explains. “So if you take the rate of essentially 100-percent side effects and compare that with a zero percent cure rate, I think it’s clear that the risks and side effects far outweigh the benefits.”

Entire websites are devoted to those who call themselves Lupron victims.

There’s a petition to Congress and letters to the FDA demanding a recall.

And an ongoing federal lawsuit filed here in Las Vegas centers on a woman who took Lupron when she was just 17 years old.

By the age of 20, she’d developed severe bone loss and has been medically diagnosed as totally and permanently disabled.

Still, many doctors keep prescribing it, citing medical studies as support.

“I would choose Lupron as a treatment for endometriosis because there’s been very good clinical studies that show that patients respond to the drug,” says Dr. Rachel McConnell of Nevada Fertility C.A.R.E.S.

“These articles come out like wolves in sheep’s clothing,” counters Dr. Redwine. “They are cloaked in what appears to be science and in many respects the results sound too good to be true.”

In some cases, they are.

The U.S. Department of Health and Human Services issued a scientific misconduct finding against a former Harvard Medical School professor who falsified and fabricated 80-percent of the data in his pro-Lupron studies.

But Dr. McConnell says she wouldn’t use Lupron if she felt there was too much risk.

“There’s a certain group of patients for whom I think it is worth it.”

Lupron is manufactured by Illinois-based Abbott Laboratories–formerly Takeda Abbott Pharmaceuticals, called TAP.

In 2001, TAP pled guilty to civil and criminal misconduct over Lupron.

They agreed to the then-largest healthcare fraud fine in history–$875 million dollars.

The U.S. Department of Justice found TAP bribed doctors to prescribe Lupron.

In addition to cash and trips, the doctors would get Lupron for free and then bill Medicare or Medicaid at $500 per dose.

Redwine says, “Doctors have been trained by medical journal articles favoring Lupron, they have been trained by listening to speakers hired by Lupron to speak at major national and international medical meetings.”

No one from Abbott Labs would go on camera.

They provided a statement saying: “Lupron has had more than two decades of clinical experience and is an important treatment option for patients with advanced prostate cancer and endometriosis. Both the benefits and risks of therapy are well known and clearly outlined in the label for consideration by physicians before recommending treatment.”

But some serious side effects reported by patients aren’t on the label.

“I’m assuming that no one ever told you that this drug can cause an immune disorder or attack your thyroid or your nervous system?” Spears asked Mary Orseno.

“No,” Mary says. “Never told, never warned. I read pretty thoroughly through the package insert before I ever took it and none of that was in there.”

She says she was only counseled about the menopause-like side-effects and the possibility of Osteoporosis.

Both Mary and the Fenners feel there’s only one answer.

“In my opinion, it’s too dangerous to be on the market,” says Mary.

“I think it’s pretty hostile stuff, what it does to the human body,” says Derrick Fenner, recalling what his wife endures on a daily basis. “I would be happy to see it off the market.”

Abbott’s rap sheet with the federal government doesn’t stop with Lupron.

Just last year, the FDA sent them a warning letter about an HIV drug they make.

FDA cites numerous violations of federal law in Abbott’s promotional materials, which “minimize the serious risks of the drug while overstating its efficacy and including unsubstantiated claims.”

Back on June 30, 2009, I posted an article informing you that the FDA had just voted to remove prescription acetaminophen combination drugs, such as Percocet, Vicodin and Tylenol 3 from the market.

Check out more in this PDF from The Pain Foundation.

The petition has already closed, but you might still be able to get your word in via Regulations.gov. Refer to docket FDA-2009-N-0138-0001.

To anyone who uses Vicodin, Percoset, Darvocet, Lortab, and any meds that contain Acetaminophen, read this!
This has been in the news before, when a group originally petitioned the FDA, but the FDA has now voted. The ban could be real and official very soon.

Excerpt:
“If the combination products are eliminated, the acetaminophen and the other ingredients could be prescribed separately. In effect, patients would take two pills instead of one, and be more aware of the acetaminophen they are consuming.”

I currently take Tylenol 3 and Motrin for endometriosis pain each month. Last year, my liver enzymes were high, and I had to go off of Tylenol for three months until my liver stabilised again. I’ve tried codeine directly without any Tylenol in it, because my GYN is so against the use of Tylenol. But I have bad side effects to codeine. Mixing it with Tylenol seems to work better for me. See my growing list of medications I’ve tried to fight the pain.

So this whole advisory vote is a bit unnerving for me. I need to find alternate working choices for medication, and fast.

FDA panel: Lower maximum daily dose of Tylenol
By MATTHEW PERRONE, The Associated Press
7:51 p.m. June 30, 2009

ADELPHI, Md. — Government experts called for sweeping safety restrictions Tuesday on the most widely used painkiller, including reducing the maximum dose of Tylenol and eliminating prescription drugs such as Vicodin and Percocet.

The Food and Drug Administration assembled 37 experts to recommend ways to reduce deadly overdoses with acetaminophen, which is the leading cause of liver failure in the U.S. and sends 56,000 people to the emergency room annually. About 200 die each year.

“We’re here because there are inadvertent overdoses with this drug that are fatal and this is the one opportunity we have to do something that will have a big impact,” said Dr. Judith Kramer of Duke University Medical Center.

But over-the-counter cold medicines – such as Nyquil and Theraflu – that combine other drugs with acetaminophen can stay on the market, the panel said, rejecting a proposal to take them off store shelves.

The FDA is not required to follow the advice of its panels, though it usually does. The agency gave no indication when it would act on the recommendations.

In a series of votes Tuesday, the panel recommended 21-16 to lower the current maximum daily dose of over-the-counter acetaminophen from 4 grams, or eight pills of a medication such as Extra Strength Tylenol. They did not specify how much it should be lowered.

The panel also endorsed limiting the maximum single dose of the drug to 650 milligrams. That would be down from the 1,000-milligram dose, or two tablets of Extra Strength Tylenol.

A majority of panelists also said the 1,000-milligram dose should only be available by prescription.

The industry group that represents Johnson & Johnson, Wyeth and other companies defended the current dosing that appears on over-the-counter products.

“I think it’s a very useful dose and one that is needed for treating chronic pain, such as people with chronic osteoarthritis,” said Linda Suydam, president of the Consumer Healthcare Products Association.

The experts narrowly ruled that prescription drugs that combine acetaminophen with other painkilling ingredients should be eliminated. They cited FDA data indicating that 60 percent of acetaminophen-related deaths are related to prescription products.

But some on the panel opposed a sweeping withdraw of products that are widely used to control severe, chronic pain. Prescription acetaminophen combination drugs were prescribed 200 million times last year, according to the FDA.

“To make this shift without very clear understanding of the implications on the management of pain would be a huge mistake,” said Dr. Robert Kerns of Yale University.

If the drugs stay on the market, they should carry a black box warning, the most serious safety label available, the panel decided.

“If we don’t eliminate the combination products we should at least lower the levels of acetaminophen contained in those medicines,” said Sandra Kewder, FDA’s deputy director for new drugs, summarizing the panel’s vote.

Percocet and similar treatments combine acetaminophen with more powerful pain relieving narcotics, such as oxycodone.

If the combination products are eliminated, the acetaminophen and the other ingredients could be prescribed separately. In effect, patients would take two pills instead of one, and be more aware of the acetaminophen they are consuming.

Vicodin is marketed by Abbott Laboratories, while Percocet is marketed by Endo Pharmaceuticals. Both painkillers also are available in cheaper generic versions.

“The panel recommending banning Vicodin and Percocet seems a little draconian,” said Les Funtleyder, an analyst for Miller Tabak & Co.

Drug companies avoided the most damaging potential outcome with the defeat of proposal to pull NyQuil and other over-the-counter cold and cough medicines that combine acetaminophen with other drugs.

These drugs can be dangerous when taken with Tylenol or other drugs containing acetaminophen, according to the FDA, but cause only 10 percent of acetaminophen-related deaths.

“I don’t think we should be advocating a solution to a problem that really is not there,” said Dr. Osemwota Omoigui, of the Los Angeles pain clinic.

A recall of combination cold medicines would have cost manufacturers hundreds of millions of dollars in revenue. Total sales of all acetaminophen drugs reached $2.6 billion last year, with 80 percent of the market comprised of over-the-counter products, according to IMS Health, a health care analysis firm.

“The acetaminophen people dodged a bullet,” said Erik Gordon, a University of Michigan business professor who studies the biomedical industry.

Even with the lower daily dosage recommendation, consumers will likely keep taking as many pills as they think they need to ease their pain, Gordon said.

Analyst Steve Brozak of WBB Securities said the panel votes were a “shot across the bow” of the pharmaceutical industry.

“This basically puts more government oversight into something that heretofore has been less than present,” Brozak said.

Women Predisposed To Endometriosis By Birth - Scientists
Monday, January 19, 2009 at 12:36:18 PM

Scientists from Northwestern University’s Feinberg School of Medicine have found vital clues that may help explain the cause of endometriosis.

Endometriosis is a chronic disease characterized by infertility and chronic pelvic pain during intercourse.

The study, led by Serdar Bulun, M.D., George H. Gardner Professor of Clinical Gynecology at Northwestern University’s Feinberg School of Medicine, have discovered key epigenetic abnormalities in endometriosis and identified existing chemicals that now help treat it.

These abnormalities result from epigenetic defects that occur very early on during embryonic development and may be the result of early exposure to environmental toxins.

One of the abnormalities he discovered is the presence of the enzyme aromatase - which produces estrogen - in endometriosis, the diseased tissue that exists on pelvic organs and mimics the uterine lining.

As a result, women with endometriosis have excessive estrogen in this abnormal tissue found on surfaces of pelvic organs such as the ovaries.

Bulun found the protein SF1 that produces aromatase, which is supposed to be shut down, is active in endometriosis.

“Estrogen is like fuel for fire in endometriosis. “It triggers the endometriosis and makes it grow fast,” Bulun said.

Bulun launched clinical trials in testing aromatase inhibitors currently used in breast cancer treatment - for women with endometriosis.

The drug blocks estrogen formation and secondarily improves progesterone responsiveness.

“We came up with a new treatment of choice for post-menopausal women with endometriosis,” Bulun said. Moreover, treatment with an aromatase inhibitor is a very good option for premenopausal women with endometriosis not responding to existing treatments, he said.

Another molecular abnormality Bulun found is that women with endometriosis have a progesterone receptor that is inappropriately turned off.

In the absence of appropriate progesterone action, endometriosis tissue remains inflamed and continues to grow.

“This may be a disease that women are born with. Perhaps when a baby girl is born, it has already been determined that she is predisposed to have endometriosis,” Bulun said.

“Maybe research can now be directed toward the fetal origins of the disease and raise the awareness of how the disease develops,” he added.

I want to know what the other epigenetic abnormalities are, because apparently endometriosis experts have known about aromatase for awhile (see article in 2004 and in 2007).
I also want to know WHICH environmental toxins are suspected in early formation of endometriosis in utero.

A search of the web produced another article on these latest findings, and was kind enough to cite where this info came from: The New England Journal Of Medicine - which costs money to subscribe to.

I just registered for a 21-day free trial to get the contents of the article, to see what the other epigenetic abnormalities are, as well as whether any environmental toxins were listed as suspects in early formation of endometriosis in utero.

The full article gives some examples.

“…Endometriosis can be the result of diverse anatomical or biochemical aberrations of uterine function. For example, endometriosis commonly develops in young women with vaginal obstruction of outflow, possibly because of large quantities of backwashed menstrual tissue that has become implanted on pelvic organs. In contrast, endometriosis can also involve mechanisms that are independent of anatomical abnormalities; for example, the incidence of endometriosis is increased in women who were exposed in utero to environmental toxins or potent estrogens such as diethylstilbestrol.3.”

Edit: The New England Journal of Medicine and the author of the Endometriosis research paper posted there have graciously given full access to that research paper - click here. I did not find out anything new regarding epigenetic (inheritable) abnormalities, and the only example noted regarding environmental toxins was that of Diethylstilbestrol (DES). However, the article is well worth reading, and the author also goes into detail regarding treatment options using GnRH agonists and aromatase for pain relief.

Chinese Herb May Help Treat Cancer
Posted on Tuesday, November 25, 2008
Herbal Remedy May Help Combat Endometriosis and Cancer

The Chinese herb Prunella vulgaris (PV) may prove an effective treatment for women with endometriosis and certain types of cancer because of its anti-estrogen properties, according to research published in the November 5 issue of the journal, Biology of Reproduction.

Although the female hormone, estrogen is crucial to reproduction, it can have some negative side effects, fueling the abnormal cell growth that occurs in diseases such as endometriosis and cancer. To treat these diseases, doctors have turned to tamoxifen and other anti-estrogen medications, but these drugs can have significant side effects.

In their search for an alternative to anti-estrogen medications, researchers in Greenville, South Carolina focused their attention on several possible herbal remedies. “We had 20 herbs in the lab that included Prunella vulgaris,” says Bruce Lessey, MD, PhD, vice chair of Research, and director of Reproductive Endocrinology and Infertility at Greenville Hospital System. PV is found in Europe and Asia and is often used to treat painful periods. “There had been one study previously suggesting that a related herb, Prunella stica, had anti-estrogen properties. So we screened the herbs, and this one really jumped out.”

When Dr. Lessey and his colleagues tested the herb on endometrial cancer cells, they discovered that it significantly reduced the cancer cells’ growth. In mice implanted with human endometriosis, PV also reduced the number of abnormal endometrial tissue growths. The herb was just as potent as a synthetic anti-estrogen drug used in the study. The only side effect researchers have noted in ongoing human studies of PV has been an increase in headaches in some women.

There were concerns that, because of its anti-estrogen properties, PV might negatively impact fertility. Yet PV had virtually no effect on the fertility of female mice tested in the study. In fact, the researchers say the herb might actually improve the odds of conception in women who are struggling with infertility due to endometriosis, because it blocks the harmful actions of estrogen that can interfere with embryo attachment and implantation.

The benefits and low risks of PV make it a promising therapy for diseases like endometriosis and cancer. “My interest in the herb is the fact that we can block the action of estrogen and do it in a way that has very few side effects,” Dr. Lessey says. “So this might be beneficial as an adjunct treatment for patients who have had breast cancer or endometrial cancer to help prevent a recurrence.”

“I think PV will find a place, because women will accept it because it’s herbal and therefore natural, and probably they’ll have greater access to it,” he adds. PV, also known as ‘Self Heal,’ is readily available in health food stores as a dried herb that can be made into a tea.

Upcoming studies will help clarify what role PV might have in treating endometriosis and cancer. “It really does not seem to be at all harmful, and because it seems to be a potent anti-estrogen, it deserves future research,” Dr. Lessey says.

If you are interested in using PV you should consult with your healthcare provider.

Source:
Collins NH, Lessey EC, DuSell CD, McDonnell Dp, Fowler L, Palomino WA, Illera MJ, YuX, Mo B, Houwing AM, Lessey BA. Characterization of anti-estrogenic activity of the Chinese Herb, Prunella vulgaris, using In Vitro and In Vivo (Mouse Xenograft) Models. Biol Reprod. 2008 Nov 5. [Epub ahead of print]

Scarring caused by surgical gel spray
Women are being hurt by a surgical treatment
LANE NICHOLS - The Dominion Post | Monday, 11 February 2008

A surgical gel - containing a drug untested on humans - has caused excruciating internal scarring in dozens of women that could lead to infertility, claims a leading gynaecologist.

Many of the endometriosis patients have already forked out thousands of dollars for repeat surgery. Some are now pursuing compensation from ACC.

Endometriosis is a condition where abnormal growths develop in pelvic organs, causing inflammatory reactions leading to scarring and pain. It affects millions of women worldwide.

Though some gynaecologists have stopped using the anti-scarring gel because of concerns about its safety and effectiveness, others still use the treatment, Wellington specialist Hanifa Koya said.

Medsafe, the Government agency that approves medicines, has told the American manufacturer to add additional precautions to the instruction pamphlet. But it maintains the product is safe, and refuses to ban its sale without conclusive evidence of harm - even though the gel is considered high risk under proposed legislation.

Dr Koya - who first raised concerns in December 2005 - was disillusioned at the response of health agencies, which she claimed had let Confluent SprayGel be used internally on thousands of Kiwi women since about 2002 without adequate clinical testing or ongoing monitoring of its effects.

She had spoken out because of concern for her patients and to highlight the need for immediate law changes to protect people.

“Confluent SprayGel is a product sprayed inside human beings and contains a section 29 drug (methylene blue) which has not been tested on human beings, and this product was allowed to be used … [with] no quality assurance in terms of monitoring,” she wrote to Medsafe in December.

“It’s quite amazing - we’re using it inside human beings,” she told The Dominion Post. “I would have expected … that they would have said, `Let’s put this product on hold or start asking some questions’, but that didn’t happen.”

Dr Koya began using the gel in October 2002, but stopped in April 2006 after her rate of repeat laparoscopies - keyhole operations - jumped from less than 2 per cent to around 10 per cent.

Women who would usually have made swift recoveries developed severe pain or discomfort after their initial operations. Dozens of the many hundred women she treated with the gel needed repeat surgery to remove scarring - which could cause infertility - even though their endometriosis had not returned. “It’s only where I’ve sprayed the SprayGel. It’s like sheets of scarring which I’ve never seen in my practice.”

Dr Koya said she had not repeated any laparoscopies since using an alternative product.

She complained to American manufacturer Confluent Surgical and has written repeatedly to MedSafe and the Health Ministry asking them to investigate, but felt her concerns had been ignored.

New Zealand distributor Covidien Tyco did not return calls.

Medsafe interim manager Stewart Jessamine said SprayGel was classed as a device under the Medicines Act, not a medicine. No clinical assessment was required before its sale, though manufacturers had to ensure the device was safe. Medical practitioners had the ultimate responsibility for its use on patients.

After a review, it it concluded the gel was safe “when used as intended”.

There had been no other complaints and there were no plans to restrict its supply, it said.

DESIGNED TO HELP HEALING

What is Confluent SprayGel?

• Marketed as a synthetic, absorbable barrier to prevent tissue sticking together and forming scarring after abdominal pelvic surgery.

• A gel-based product containing methylene blue – a dye substance which is added to make it visible.
• Medsafe says methylene blue is already used widely in humans but is not approved for general supply as a medicine.
• The gel is in clinical trials in the United States but not approved for sale there.
• Approved for use in Australia and Europe.
• Sprayed on internal tissue. Usually absorbed within a week then excreted.
• Distributed in New Zealand till last month by Intermed Medical but now by Covidien Tyco.