Thursday, November 17, 2011

Drugs for unmet needs may soon get faster FDA approval

A new FDA proposal with drug companies might help more people with meningioma and cancer get Mifeprex like I do in a FDA investigational clinical trial.

This proposal might prevent deaths like the tragic story of the real Norma Rae, Crystal Lee Sutton, a union activist who died after a two year struggle with meningioma. There is still no standard chemo for meningioma so insurance companies do not have to pay for any drug therapy for this disease. They delayed paying for any other type of brain cancer therapy for two months. She had already had brain surgery two years in a row which probably used up some type of annual insurance cap on her treatment costs.

Tuesday, November 8, 2011

Mifepristone for Meningioma 2004 and 2006 research reports

MY dear Meningimates,

My main goal is to replace fear with confidence and enough medical knowledge to help the doctors of my dear meningimates, male and female, who want to try a safe effective drug therapy to possibly block low grade meningioma regrowth that has no risks of permanent brain injury or blood clots. I also want women to know it works safely to control and shrink uterine fibroids 50 % without the risks of major abdominal surgery.

This detailed longterm use research report of Mifepristone for two female meningioma patients below came out in 2004 and I have a similarly located left sphenoid recurrent meningioma tumor affecting my vision in one eye and in 2004 I had already had two craniotomies in 1986 and 2000 and I did not want the recommended six weeks of five days a week standard brain IMRT radiation, as if my non malignant low grade 2 brain tumor condition was real brain cancer.

My tumor had been stable for three years before in a similar US 1992 NCI SWOG 9005 trial of mifepristone for meningioma by Doctor Steven Grunberg I was in from 1996-1999 and during that time I had no new tumor symptoms or bad side effects. Dr Grunberg published another clinical trial report in 2006 below that says it also helped some male meningioma patients.

So I wanted to take this drug again, just like these two ladies above . I generally felt better while I was on the drug and I already had a total hysterectomy in 1992 for fibroids so I did not see any risk to me of endometrial hyperplasia like one lady had in this report and three in the other.

I was able to start taking this drug again in Feb 2005 after a delay of one year to complete all the FDA and IRB legal paper work to get my own individual clinical drug trial of mifepristone for meningioma. And Dr Grunberg published his additional PUB MED report below in 2006.

• Long-term administration of mifepristone (RU486): clinical tolerance ...
by SM Grunberg - 2006 - Cited by 47 - Related articles
2006 Dec;24(8):727-33. ... Grunberg SM, Weiss MH, Russell CA, Spitz IM, Ahmadi J, Sadun A, Sitruk-Ware R. Division of Hematology/Oncology, University of Vermont College of Medicine, Burlington, Vermont, USA. ...

Please feel free to take these reports to your own doctor. One of our m readers recently told me that three different doctors all told her there was an increased risk of blood clots with Mifepristone. Baloney!! None of these patients had any problem with blood clots and neither do I after taking this safe medication for six years the second time.

I have recently read it may be true of YAZ or other new drugs used for birth control, but generic Mifepristone (brand name Mifeprex the Early Option Pill) is not the same as these newer drugs. I believe all the scary possible side effects we hear about when good old Mifepistone is used as the first part of an early medical abortion are actually from the other drug usually/sometimes? given during a regular first trimester medical abortion. Certainly not when low dose Mifepristone alone is used for daily or emergency birth control. The small daily dose I take does not cause any bleeding problems, in fact I have read in the research below where very low daily dose Mifepristone fights anemia and stops uterine blood loss completely and safely when it is used to treat fibroids.

• Rochester Study Rolls Out RU-486 to Treat Uterine Fibroids - News ... › NewsroomCached - Similar
Rochester Study Rolls Out RU-486 to Treat Uterine Fibroids. December 06, 2006. Low doses of the drug mifepristone shrink uterine fibroid tumors and greatly ...
• Pathology Study Tracks Uterine Changes with Mifepristone - News ... › NewsroomCached
Mar 7, 2011 – URMC Research Confirms Possible Use of Drug for Painful ...
Show more results from

• Pathology study tracks uterine changes with mifepristone
Mar 7, 2011 – Rochester Study Rolls Out RU-486 To Treat Uterine Fibroids (Dec. 7, 2006) — Low doses of the drug mifepristone shrink uterine fibroid tumors ...
These extra pathology study reports showed no pre cancerous changes to the uterus with low dose Mifepristone use.

I think her three doctors are all wrong about blood clots too with old generic Mifepristone because of this FDA report I googled last week.

The CBS Evening News (10/27, story 9, 0:30, Pelley) reported, "The FDA is raising serious questions tonight about the safety of a popular birth control pill. It says the pill, called Yaz [drospirenone and ethinyl estradiol], puts women at a 75% greater risk of blood clots than older forms of birth control."
The AP (10/28) reports the FDA says "several new birth control drugs, including the Bayer pill Yaz, appear to increase the risk of dangerous blood clots more than older medications." Study results released by the FDA "reviewed the medical history of more than 800,000 American women taking different forms of birth control between 2001 and 2007."
In a separate story, the AP (10/28) reports the FDA also saw "higher complications in women using ethinyl estradiol and norelgestromin [Ortho Evra] patch from Johnson & Johnson and ethinyl estradiol and etonogestrel [Nuvaring] vaginal ring from Merck & Co. Inc." Recent studies show "differing conclusions on the risks of newer birth control pills." For example, "two studies published in 2007...did not find any difference in blood clotting between the two comparable groups."
MedPage Today (10/28, Gever) also reports, "Compared with hormonal contraceptives with relatively low estrogen doses, norelgestromin/ethinyl estradiol transdermal patch and etonogestrel/estradiol vaginal ring products were both associated with increased risk for venous thromboembolism (VTE), as were birth control pills containing drospirenone," according to the retrospective database analysis.
HealthDay (10/28) reports, "For now, the FDA is not advising that most women switch to another form of contraception." The FDA said, "If your birth control pill contains drospirenone, do not stop taking it without first talking to your health care professional." But "contact your health care professional immediately if you develop any symptoms of blood clots."
Bloomberg News (10/28, Bettelheim, Kresge) reports on study findings in Denmark published in the British Medical Journal this week, which found that "users of oral contraceptives with desogestrel, gestodene, or drospirenone were at least at twice the risk of venous thromboembolism compared with users of oral contraceptives with levonorgestrel."

We live in a free country with basic human rights for all people, therefore I want the US Congress to get out and stay out of private doctor/patient relationships. I want Congress to stop passing laws dictating to our well qualified medical doctors what FDA approved safe old generic drug they can not prescribe for their own patients to treat and improve their quality of life for rare chronic conditions.

Please ask them to stop procrastinating, ask them to read the Amendment to Medicare Part D for Drug Parity in HR 1055, then co sponsor it to get a bill in the Senate and pass HR 1055 in both houses in 2011.

And I hope you will read about HR 1055 and use my congressional zip code widget in the left sidebar to find your members of congress and tell them whether or not you want to have the freedom and right to the safest medical care from your qualified and well informed doctors without political and legal interference by others in your personal health care decisions.

GBYAY Anne McGinnis Breen
See my ponytail bouncing and my smiley face winking at you? &;>)

Please scroll all the way down to my first two blog entries for my list of 28 questions to ask your medical team about brain tumor treatments plus my personal meningioma alternative drug therapy RU486 Mifepristone
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Keep you faith, cherish your reason, treasure your mind and hold to your own good not afraid!