Thalidomide being used to treat endometriosis?

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.