I am beside myself…

Bend Doctor Responds to License Threat
Tami Sawyer’s Former Physician May File Appeal
By Barney Lerten, KTVZ.COM
POSTED: 5:13 pm PDT October 29, 2010
UPDATED: 4:22 pm PDT October 30, 2010

BEND, Ore. — A Bend gynecologist facing state Medical Baord disciplinary action over involvement with now-indicted real estate broker (and former patient) Tami Sawyer said Saturday his license is still valid and he’ll be back to work Monday.

Dr. David Redwine, who won a still-unpaid, hefty judgment against a company run by Tami and Kevin Sawyer, faces possible suspension or revocation of his medical license over state findings of “unprofessional or dishonorable conduct” and “gross or repeated acts of negligence” involving Tami Sawyer.

“The board has not diminished my license at all. I’ll be seeing patients Monday and I’m scheduled to operate Tuesday,” said Redwine, who has less than two weeks to seek an appeal hearing or face as-yet undetermined consequences that could range from revocation or suspension of his license to practice medicine, to a fine or reprimand.

Redwine told KTVZ.COM he is out of town visiting family and “will be talking with my attorney about filing an appeal hearing.”

The physician said he could not speak to the issues until he discusses matters further with his attorney, but added, “We need to let the process take its course.”

The Oregon Medical Board issued a complaint and notice of proposed disciplinary action Oct. 21 against Redwine, a physician and surgeon specializing in endometriosis and gynecology.

The state’s findings come nearly a year after Tami Sawyer filed a malpractice lawsuit against him, accusing him of a consensual sexual relationship with her when she was a patient and improperly prescribing medicines to her and her family members.

The state findings detail much of the same claims, showing that Redwine disputes Sawyer’s claim of how long the relationship lasted.

Sawyer claimed this week that no judge in the area would hear the malpractice case and had recused themselves.

Last week, Tami and Kevin Sawyer were indicted on 21 federal charges of fraud, conspiracy and money-laundering charges. They are due for arraignment in Eugene Nov. 8.

Tami Sawyer agreed in March 2009 to a judgment on behalf of their company, Starboard LLC, in a lawsuit filed by Redwine and wife Laurie against the Sawyers’ company, Starboard LLC, for more than $800,000 invested in the company that they never got back.

Sawyer almost went to jail on contempt of court charges a year ago, for refusing to divulge details of the company’s finances, but the Oregon Court of Appeals stayed that order, saying she was likely to prevail on appeal. The judgment has not been paid.

The state Medical Board complaint says Redwine first provided obstetric and gynecological care for Sawyer, identified as “Patient A,” in the late 1980s and they also began business transactions in the late ‘90s, including Redwine making loans to Sawyer for real estate investments.

According to Sawyer, the two “entered into a sexual relationship beginning in 1999 and culminating in the fall of 2007,” the complaint said, while Redwine recalled “a shorter time span” of “a sporadic sexual relationship beginning in late 2004 and extended into 2005.”

The state complaint says Redwine “wrote various prescriptions” for the patient between 2004 and 2007, and also “wrote occasional prescriptions for (Sawyer’s) family members at her request, without the benefit of conducting an examination or maintaining a chart.”

In 2005, the complaint says Redwine “performed a breast examination on (Sawyer) in a social setting that was witnessed by a family member and friend.” It says Redwine terminated their doctor-patient relationship in an April 2008 letter.

Greta Matus, an investigator with the Oregon Medical Board, said Friday the nature of the disciplinary action against Redwine has not been decided. If Redwine does not seek a contested case hearing, the complaint said that will result in a dfault order by the board as it “deems appropriate.”

Sawyer told KTVZ.COM on Friday, “It’s very sad it’s come to this.”

“Why David’s attorney … deposed me about David and (my) past relationship is still a mystery to me,” she wrote.

“He had to know that when all of my attorneys read it, there would be further investigation surrounding that fact,” Sawyer said.

“Lives and careers have been ruined,” she added. “It’s just incredibly sad to me.”

I just want to scream, “How dare you be rotten like so many others out there! You were supposed to be one of the good ones!”

There just aren’t enough good endometriosis surgeons out there as it is, and he is ranked as one of the rock stars out there. I have recommended him for years. To fall from grace like that – who loses? The patients lose.

No one has (yet) accused him of butchery like some of the other former rock star surgeons out there have been accused, but his disciplinary action is still a tragedy because he used very poor judgement while emotionally and sexually involved with a patient, and emotionally involved with her family.

Even if his medical license does not get revoked, I will never see him now, and I will not recommend him.

You ought to be ashamed of yourself, Mr. Redwine. I am heartbroken.

You have got to be kidding me. I just learned that the drug Thalidomide, which I thought was banned in the 1970s, is still prescribed for illnesses. I learned further that there’s been an ongoing study since 2006 of Thalidomide treatments in women with endometriosis.

Thalidomide. The drug which is known to have a side effects list a mile long, including neuropathy in people taking the drug, and severe birth defects in children born to parents taking the drug. The drug which comes with the following warning, “you should know that thalidomide is present in your blood and body fluids. Anyone who may come into contact with these fluids should wear gloves or wash any exposed areas of skin with soap and water.”
Does that mean that people taking Thalidomide should not be working? I’m a school teacher with stage III endometriosis and ovarian endometrioma – I’m your perfect candidate for treatment, but I work with children – wouldn’t they be at risk? Therefore people on this treatment are likely treated as patients – homebound – isolated from the general population, like those with Hepatitis C – unable to share eating utensils and bathrooms, right?

Thalidomide. The drug with such known side effects as “uncontrollable shaking of a part of the body”, “seizures”, and “nerve damage that can be severe and permanent. This damage may occur any time during or after your treatment”.

The first wind I got of Thalidomide being used to treat endometriosis was when I checked my Google News Alerts today and found the article titled, Health News: A pill to treat endometriosis:
By DAILY MAIL REPORTER
Last updated at 1:41 AM on 21st July 2010

“The controversial drug thalidomide is being used to treat endometriosis in a new trial.
Previous smaller studies have shown eight out of ten women went into remission after treatment.
The drug is thought to work by stopping new blood vessels growing.
Endometriosis is a condition where cells that usually line the womb are found elsewhere in the body, such as in the ovaries.
These cells behave in the same way as womb cells, so every month they grow and shed as a bleed. This leads to pain and swelling. It may also cause fertility problems.
The new treatment focuses on a side-effect of thalidomide – blocking the growth of new blood vessels. As endometriosis requires a blood supply in order for the cells to implant and grow, the theory is that thalidomide prevents any new development.
During the U.S. trial, women will take the drug daily for 14 to 16 weeks, and will be followed up six months later.”

I then googled “thalidomide endometriosis” and found the following:

Open Label of Thalidomide in Treatment of Women With Chronic Pelvic Pain Associated With Endometriosis
Summary:
Patients will undergo a standard history and physical examination detailing objective clinical exam findings performed by one of the co-investigators. The research coordinator will obtain baseline values for intensity of pain, quality of life, and coping strategies. Baseline serum levels inflammatory markers will then be measured. Over the course of 12 weeks Thalidomide will be titrated as tolerated to achieve a minimum of a 30% reduction of pain on VAS from week 2.

Start Date: October 2006
Projected Completion Date: February 2010
Status: Recruiting
Phase of Study: Phase 4
Study Type: Interventional
Study Design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Information Provided By: University of North Carolina, Chapel Hill
Oversight Provided By: United States: Food and Drug Administration
Sponsors:
Celgene Corporation
University of North Carolina, Chapel Hill

Health Issues Studied:
Endometriosis

Study Interventions:
Drug: Thalidomide

Description:

Study Eligibility Requirements
Genders Eligible for Study: Female
Ages Eligible for Study: 18 Years – N/A
Does Study Accept Healthy Volunteers: No

Inclusion Criteria:
1. Age > 18 years

2. Histologically/laparoscopically confirmed endometriosis

3. Chronic pelvic pain defined as non-menstrual pain for at least two weeks in the
previous month for at least 6 months

4. VAS of 6 or more at baseline

5. Failure, completion or intolerance of standard treatment modalities (oral
contraceptive therapy, danazol, Depo-Provera, Depo-Lupron)

6. Patients must give written informed consent.

7. Patients must be willing and able to comply with the FDA-mandated S.T.E.P.S.
program.

Exclusion Criteria:

1. Pregnant and/or lactating female

2. Users of other angiogenesis inhibitors

3. Current use of Rifampin, rifabutin, barbiturates, glucocorticoids, phenytoin,
carbamazepine, chlorpromazine, reserpine, penicillin derivatives, or St. Johns Wart
in user of oral contraceptive therapy

4. Use of aromatase inhibitors, Etanercept (Enbrel), GnRH agonists (Depo-Lupron), and
Danazol within the past 3 months

5. Use of norethindrone acetate (Aygestin) in the prior month

6. Seizure disorder

7. Hepatitis, or any active infection (upper respiratory infection, PID, etc)

8. History of thromboembolic disease.

9. Baseline neutropenia (ANC < 1000/mm3) 10. Any severe physical or metal illness that would interfere with the completion of the protocol 11. Illicit drug or alcohol abuse Study Contacts
Primary Contact Information:
Name: Denniz Zolnoun, MD, MPH
Phone: 919 966 9189
Email: zolnound@med.unc.edu

Study Locations:
UNC Chapel Hill
Chapel Hill, North Carolina 27599 United States

University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599 United States

In 2008, the following research was published:
Mechanistic and Therapeutic Implications of Angiogenesis in Endometriosis
Robert N. Taylor, MD, PhD, Jie Yu, MD, MSc, Paulo B. Torres, MD, Aimee C. Schickedanz, MD, John K. Park, MD, MSc, Michael D. Mueller, MD, and Neil Sidell, PhD
Department of Gynecology and Obstetrics, Human Uterine Biology Program, Emory University School of Medicine, Atlanta, Georgia
Address correspondence to: Robert N. Taylor, MD, PhD, Woodruff Memorial Building 4217, Department of Gynecology and Obstetrics, Emory University School of Medicine, Atlanta, Georgia 30322. Email: robert.n.taylor@emory.edu

Published in final edited form as:
Reprod Sci. 2009 February; 16(2): 140–146.
Published online 2008 November 11. doi: 10.1177/1933719108324893.

“…At the present time, the authors are aware of only 1 clinical trial of an antiangiogenic agent for the treatment of pain associated with ovarian endometrioma. In an abstract presented at the 2002 meeting of the ASRM (Seattle), Scarpellini et al59 reported that 8 of 10 women with stage IV endometriosis achieved remission of pain and resolution of ovarian cysts following a 6-month course of combined goserelin (GnRH analog) and thalidomide (300 mg/d). In some women, the symptom relief persisted following discontinuation of the GnRH analog while the patients received only thalidomide therapy. These promising pilot findings are well supported by a series of studies examining antiangiogenesis in preclinical models of endometriosis. Thalidomide was shown to inhibit IL-8, an angiogenic cytokine, in endometriotic stromal cells via interference with the transcription factor NF-κB.6.”

“…Future therapeutic strategies to target VEGF have the potential to block the establishment or progressive growth and invasion of endometriotic lesions. However, we must not ignore the likely teratogenic* actions of these same antiangiogenic drugs and cotreatment with effective contraceptives is prudent in reproductive-age women.”

*te·rat·o·gen
–noun Biology .
a drug or other substance capable of interfering with the development of a fetus, causing birth defects.

This study was reupped in December, 2009, and was supposed to have been completed in January or February 2010, which is why we’re now reading about it in mainstream media like The Daily Mail, UK.

Based upon the last Clinical Trial news in December, 2009, it looks like only 14 women enrolled in this program. That’s an embarrassingly small sample of women. If the researchers are backed by huge Pharma and the FDA, this will pass as legitimate and be marketed to women, if it is not already being done.

And so a whole new generation of women and their offspring will be wrecked by Thalidomide.

Wonderful.

I must note that once again, not only is the treatment worse than the disease itself, but we are still being used as guinea pigs.
Not only do endometriosis patients treated with Thalidomide have to watch where their precious bodily fluids end up, for fear of poisoning others with the toxic Thalidomide, but those women who embark on this treatment must understand that they can NEVER have children, EVER, after putting Thalidomide into their bodies. You KNOW that is not going to get communicated properly.

Why, in the 21st century, must we still be experimented on, just because we are female?

There truly is no hope for humankind.

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.”

I love how this article is titled the GOOD NEWS about endo after menopause. I have placed in bold-text the direct contradictions with this woman’s so-called “good news”.

The Good News About Endometriosis After Menopause
Wednesday, 28 February 2007
Shelley Ross

Menopause is a time of life that most women dread, but if you’re an endometriosis sufferer, menopause may be the break you’ve been waiting for. Why? Menopause is a normal part of aging that every woman experiences. It is the time when estrogen levels drop and the ovaries no longer produce eggs. As a result, a woman no longer has a menstruation cycle due to the natural cessation of ovarian function. Menopause is the end of a woman’s reproductive cycle.

Menopause usually occurs naturally for most women when they are in their late 40’s or early 50’s. However, some women may be pushed suddenly into menopause at any age if they have their ovaries removed, or take certain types of chemotherapies for cancer treatment.

Although menopause has its own host of unpleasant symptoms, it has been known to have one positive side effect for endometriosis sufferers — It often puts an end to painful endometriosis symptoms.

To help you fully understand the positive influence menopause has on endometriosis, the following are some answers to common questions regarding the issue:

How does menopause improve endometriosis symptoms?

The hormone estrogen is no longer produced during menopause. Estrogen is what stimulates endometriosis growth. Thus, most women no longer feel pain, as the endometrial tissue no longer grows or breaks down because the menses cycle has ceased.

Does menopause cure endometriosis?

No, you need to understand that menopause does not cure endometriosis. However, for most women, it seems to put it in an eternal state of sleep. Nevertheless, symptoms of endometriosis can still occur at any time, even though for most women not taking hormone replacement therapy this is rare.

Can endometriosis symptoms still occur after menopause?

Yes. For some women, especially those who have a severe case of endometriosis and experienced strong symptoms prior to the stop of their cycle, endometriosis can still persist after menopause, especially if a woman has scar tissue. Often the reason why endometriosis persists is due to hormone replacement therapy that provides the body with estrogen, which is taken by women to help with menopausal symptoms.

Is hormone therapy necessary for menopause?

No. However, some women who go through menopause take hormone replacement therapy to help prevent and treat osteoporosis. Estrogen plays an important role in building and maintaining strong and healthy bones. Lack of estrogen causes cells that build bone to become less active, which increases the risk of bone loss.

Aside from keeping bones healthy, estrogen also plays a big role in keeping the vagina moist, helping it to guard against infection. Thus, many women take estrogen hormone replacement therapy for these reasons. Unfortunately, estrogen stimulates the growth of endometrial implants, which can lead to a recurrence in painful symptoms.

There are different ways you can help treat your menopausal symptoms caused by lack of estrogen without dramatically increasing your risk of reactivating endometriosis symptoms. Talk to your doctor about your condition. He or she may be able to provide you with treatment that limits the amount of estrogen you give back to your body, or they may be able to prescribe creams or other treatments to help with vaginal dryness and other menopausal symptoms.

ATTENTION! Please sign the petition to stop the FDA from further restrictions on pain medication.

Thank you.

F.D.A. to Place New Limits on Prescriptions of Narcotics
By GARDINER HARRIS
Published: February 9, 2009

WASHINGTON — Many doctors may lose their ability to prescribe 24 popular narcotics as part of a new effort to reduce the deaths and injuries that result from these medicines’ inappropriate use, federal drug officials announced Monday.

A new control program will result in further restrictions on the prescribing, dispensing and distribution of extended-release opioids like OxyContin, fentanyl patches, methadone tablets and some morphine tablets.

These products are classified as Schedule II narcotics and already are restricted according to rules jointly administered by the Food and Drug Administration and the Drug Enforcement Agency. But the current restrictions have failed to “fully meet the goals we want to achieve,” said Dr. John K. Jenkins, director of the F.D.A.’s new drug center.

“What we’re talking about is putting in place a program to try to ensure that physicians prescribing these products are properly trained in their safe use, and that only those physicians are prescribing those products,” Dr. Jenkins said in a news conference on Monday. “This is going to be a massive program.”

Hundreds of patients die and thousands are injured every year in the United States because they were inappropriately prescribed drugs like OxyContin or Duragesic or they took the medicines when they should not have or in ways that made the drugs dangerous. The agency has issued increasingly urgent warnings about the risks, but the toll has only worsened in recent years.

The blame for this is shared among doctors who prescribe poorly, patients who pay little attention to instructions or get access to the medicines inappropriately, and companies that have marketed their products illegally.

The F.D.A. this year will hold meetings with manufacturers, patient and consumer advocates, and the public to ask for advice on how to carry out the new control program, officials announced. The first meeting will be on March 3, and no immediate changes in access to the drugs is planned.
(A complete list of the drugs is at www.fda.gov/cder.)

But many doctors prescribe the drugs far too cavalierly, Dr. Jenkins said. The F.D.A. has received reports of patients’ being prescribed such medicines to treat something as simple as a sprained ankle, he said. In such patients, the medicines can be dangerous.

Part of the problem is marketing. Several reports, for instance, have suggested that Purdue Pharma, the maker of OxyContin, helped fuel widespread abuse of the drug by aggressively promoting it to general practitioners not skilled in either pain treatment or in recognizing drug abuse.

The company has denied such a connection, but a holding company connected with Purdue and three top Purdue executives pleaded guilty last year to criminal charges that the company had misled doctors and patients by claiming for five years that OxyContin was less prone to abuse because it was a long-acting narcotic.

Doctors are also to blame. A common reason for disciplinary actions at state medical boards is the use of narcotics in patients who show clear signs of addiction or for whom the drugs are obviously inappropriate.

The F.D.A. generally avoids interfering with the practice of medicine because doctor behavior is governed by state medical boards. Instead, the agency usually tries to provide doctors with the best and most current information, and then allows them to decide how to use it.

Most of the drugs withdrawn over the last 20 years, however, were taken off the market because doctors continued to use the medicines in ways that the F.D.A. warned against.

For decades, the agency’s armory in these battles held only a popgun and a cannon — the popgun being the issuance of widely ignored warnings; the cannon being its ability to force a medicine’s withdrawal. But a law passed in 2007 gave the agency a new, intermediate weapon — Risk Evaluation and Mitigation Strategies. Known as REMS, these programs allow the agency to place strong restrictions on the distribution of certain drugs.

State to review limited coverage, caps in student health plans
Regulations will be overhauled
By Kay Lazar
Globe Staff / December 21, 2008

State regulations that require college students to have health insurance but allow insurers to substantially limit coverage – potentially exposing seriously ill students and their families to enormous medical bills – will be overhauled, according to a top state official.

The Division of Health Care Finance and Policy is conducting a “soup to nuts” review because of mounting concerns that the limited coverage allowed by the 20-year-old rules has not kept pace with rising healthcare costs and has been inconsistent with the state’s recent overhaul of the health insurance system, said Commissioner Sarah Iselin.

Most of those 77,800 covered by the student health program have plans that cap payments at $50,000 a year per injury or illness. That limit can be easily exceeded by cancer treatments or one hospitalization after a serious accident. Iselin said her agency, which regulates student health plans, is considering whether to mandate more generous benefits.

Another 225,000 college students have declined the student health insurance program, meaning they are choosing instead to be covered by their parents’ plan or some other private plan. A 1988 state law mandates that all part- and full-time students have health coverage.

The problem of limited student health insurance is hardly unique to Massachusetts. New York’s attorney general launched a probe last month into such insurance plans, reportedly focused on the adequacy of the disclosure of policy terms and costs to students. More than half of the student health plans studied nationwide capped the maximum benefits paid for an injury or illness at $30,000, according to an investigation earlier this year by the Government Accountability Office, an arm of Congress.

In Massachusetts, the contrast between student policies and other healthcare policies is stark; the capped coverage allowed for students fails to meet the minimum standards set for other plans as part of the state’s 2006 near-universal health law.

“To say it’s OK for you to receive substandard care because you made a choice to be a student, that is offensive,” said Heather Knauer, a 23-year-old Tufts University senior.

Knauer said her parents have already refinanced their house to pay her sister’s medical bills. Knauer’s sister, a college student in New York, had a school health plan with a $25,000 cap. So when it came to her own treatment, Knauer recently made a pragmatic choice: She is skipping the $400 monthly injections advised by her doctor to treat her endometriosis. Instead she is opting for a much less expensive hormone treatment with harsher side effects – she is losing her hair – so she won’t exceed the $1,500 yearly cap on prescription drugs in the health program from Tufts University.

“I am stuck,” she said, “between a rock and a hard place.”

Insurers say the college policies, with premiums that typically cost students $2,000 or less a year, are as comprehensive as possible given the need to keep the price tag affordable. It is, they say, a balancing act.

School administrators, meanwhile, say they, too, face a tough choice in juggling costs versus quality when negotiating these plans with insurance companies. “It’s really a challenge to find benefit levels that are affordable,” said Michelle Bowdler, senior director of health and wellness services at Tufts. She said the university’s plan raised its overall coverage cap from $50,000 to $100,000 about three years ago because Tufts officials thought $50,000 wasn’t enough.

Word of the state’s planned overhaul comes as college students lobby for better health coverage. Knauer is one of several students who recently met with Iselin’s division and asked, among other things, for data about how many students have faced medical bills beyond what their policies covered – something officials were unable to provide, Iselin acknowledged.

Iselin said her division would probably start requiring schools to track that number and to submit health plans for review before the start of each school year; now the policies arrive in November, three months after they begin.

Students are also faulting the state for allowing insurers to impose limits in other areas. Many cap prescription drug benefits at $1,500 yearly and limit outpatient services.

As part of taking a “really hard look” at the student health plans, Iselin hired an actuarial company this fall to study the financial impact on students if regulators required insurers to provide more generous benefits. The data are due in February.

“The challenge is to strike a balance, to ensure the adequacy of these benefits . . . with the affordability,” she said. “We may find that increasing [benefits] may not, in fact, turn out to be hugely expensive.”

That is what the students hope to see. “These plans are downright pathetic,” said Aaron Marden, a Tufts senior who founded the Student Health Organizing Coalition this fall. The Tufts coalition is planning to form chapters on other campuses.

Marden said he and other coalition leaders who met last month with Iselin’s office were not told about the state’s plan to overhaul regulations, nor asked to join an 11-member advisory group appointed by Iselin.

Marden said his coalition presented regulators with a list of questions and requests for data including whether insurers are applying a reasonable percentage of profits toward students’ medical services. A recent Business Week investigation of student health plans nationwide found the plans to be unusually lucrative for insurers.

Iselin acknowledged that her division lacks that information and said it would probably require schools or the insurers to start reporting it as early as July.

“I would like to see, at the very least, large, large warnings, for colleges to have to say that before you sign up for this plan, this may not be appropriate,” said Mark Wiranowski, 37, of Jamaica Plain, who was covered under his wife’s Simmons College plan, capped at $50,000, when a boulder crushed his leg while he was hiking last year in the Rockies. His medical bills were nearly $400,000. Through state and other financial aid, Wiranowski said he eventually got all but $10,000 covered.

“I was unprepared for how enormous medical bills can be and how woefully inadequate the student health plan was, and I was too busy to do the research,” he said. “I am fortunate I was not bankrupt.”

Alternative procedures to hysterectomies
Friday, December 05, 2008 | 7:17 PM
By Dr. Jay Adlersberg

NEW YORK (WABC) — One in every four women has to deal with an often difficult gynecological problem like fibroids and endometriosis. One option is to manage the disease with a hysterectomy. But there are other easier options that many women may not be hearing about, even though there is a law that says they should be informed.

New York State passed a law 17 years ago mandating doctors to provide women with a state issued pamphlet outlining alternatives to hysterectomy. New York is one of 3 states in the country with that requirement. But there are questions as to whether women are getting adequate information about their choices of treatment.

In our area, one out of every 7 women over the age of 18 has had surgery to remove her uterus. That’s 600 thousand procedures each year, a total that has not changed in a decade. The procedure can be life saving if there is cancer. But 90 percent of the time the reason is gynecological with problems like fibroids, endometriosis or abnormally heavy bleeding. So the solution becomes removal of the uterus and sometimes the ovaries and cervix as well. It is a major surgery with a long recovery and possibly long term effects.

“In New York State there is a brochure that is supposed to be handed out to every woman to whom the doctor recommends a hysterectomy” says journalist Peg Rosen. She writes about hysterectomies in this months issue of “MORE” magazine. Rosen says the law to make the brochure about alternatives available to women has been ignored, and she had to use the freedom of information act to find it out. Rosen also says that fewer than 20 of the four thousand practices in the entire state of New York had requested the alternatives brochure.

Dr. Jaques Moritz is a respected obstetrician gynecologist with decades of experience, and performs many minimally invasive gynecological procedures. “It’s a shame that someone like myself who does a lot of these minimally invasive procedures doesn’t know that there is a pamphlet that I’m supposed to be giving to these patients. So somewhere, the good idea didn’t get followed up.”

Peg Rosen says she “interviewed women who told me that when they did mention alternatives, their doctor’s became annoyed.”

Dr. Moritz feels doctors might not mention alternatives because they themselves do not know how to do some of the newer procedures like a laparoscopic hysterectomy or endometrial ablation. He says it’s up to the woman herself to get, “a second opinion. I’ve been saying it over and over, you gotta do it.”

Sandra Hernandez had a minimally invasive procedure to deal with a gynecological problem and says, “it’s important to know all of your different options before going in and saying, ok just give me a hysterectomy.”

The health department does have the brochure on line for downloading, but it hasn’t been updated in 10 years. Women need to have complete informed consent before deciding to undergo a hysterectomy. Do careful research in order to find good alternatives, and remember, in some cases a hysterectomy might still be the best option. But get a second opinion from someone who does other procedures.

ON THE NET:

http://www.hersfoundation.org/index.html

http://www.fda.gov/fdac/features/2001/601_tech.html

http://www.acog.org/publications/patient_education/bp140.cfm

More alternatives to non-cancer related abdominal hysterectomies might include:

Laparascopic hysterectomy — also known as peephole surgery

Endometrial ablation – treats the lining of the uterus.

Uterine artery embolization — arteries to the uterus are blocked.

Myomectomy — abdominal surgery to remove fibroid tumors, but preserves the uterus.

Judge asked to lower award
Government questioning future costs
Saturday, Dec. 13, 2008
BY JIM SUHR – Associated Press

EAST ST. LOUIS — The U.S. government is asking a federal judge to trim an $8.6 million judgment over an Air Force base doctor’s mistreatment of a case of flesh-eating bacteria that cost a woman use of an arm.

Federal prosecutors this week asked federal Magistrate Judge Philip Frazier to reconsider his ruling favoring Jean Phillips, an Air Force captain’s former wife, who the judge concluded was left with a right arm that’s been “withered, lifeless and useless” since 2002.

Frazier, after an August bench trial, found that Dr. Dan MacAlpine was stationed at Scott Air Force Base just east of St. Louis when he failed to notice or heed Phillips’ rash on her right arm in 2002, assuming she was an addict looking for prescription drugs. MacAlpine told her to go home and take Motrin, a popular over-the-counter pain medication.

But the rash turned out to be necrotizing fasciitis, commonly known as flesh-eating bacteria, that Frazier says eventually cost Phillips use of her right arm.

“This is a sad story,” Frazier wrote in his 13-page ruling Nov. 25. With a useless arm that causes her continuous, extreme pain and likely hooked on prescription drugs, the judge added, the now-divorced Phillips “faces the future with no reason to be optimistic that things will improve.”

Frazier awarded $2.5 million each for future pain and suffering and for future disability, as well as $1.5 million for past pain and suffering. The judge also said Phillips should get $500,000 apiece for past disability and disfigurement, $495,169 for past and future lost earnings, $421,581 for past medical costs and $215,040 for future ones.

Frazier credited the government for $110,748 in medical services already rendered.

“Granted, there are more dramatic injuries out there involving multiple amputations and the like,” Frazier wrote. “But (Phillips’) situation is about as bad as it gets when one considers the impact on her work and personal life.”

The judge acknowledged Phillips’ life already “was on a downward arc” when she contracted the flesh-eating bacteria, noting she had poor health including issues with abnormal uterine tissue growth called endometriosis, hypothyroidism, insomnia, headaches and anxiety. Frazier said she also had emotional troubles and perhaps drug addiction.

But “she had one other thing that she does not have today. She had a chance,” the judge wrote. “The cruel reality is that her life would probably improve if the arm were taken” — amputated to make way for a prosthetic arm she actually could use.

In its motion Wednesday, the U.S. government, which operates Scott Air Force Base through the Defense Department, asked Frazier to lower the damages he assessed for Phillips’ past and future medical expenses and her lost wages. Those damages total $1,131,790.

According to the government, Phillips’ future medical expenses beyond 10 years from now required speculation, perhaps making her eligible for $48,000 — not $215,040 as Frazier ruled. And “there is simply no evidence in the record that (Phillips) was willing or able to work even prior to her necrotizing fasciitis,” Wednesday’s motion read in questioning the woman’s eligibility for lost earnings.

Phillips’ attorney, Thomas Keefe Jr., was out of the office Friday and unavailable until next week, according to his office, which declined to disclose where Phillips now lives. A published telephone listing could not be found.

MacAlpine now lives in Iowa, where a woman who answered his home telephone Friday said the 39-year-old doctor had no comment. The AP left a message.

Randy Massey, a spokesman for Southern Illinois’ U.S. attorney’s office representing the federal government in the case, declined comment Friday.