reproductive health
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The Toxic Devil Inside Of Me
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How A Defective Medical – Device Turned Her Life Upside Down
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Digging Deep Into The United States ‘Top 10 Big Pharma Corporations’ United States Government and the U.S. Healthcare Industry.
Unleashing Research data dating back to 2013…
Provided to the Obama Administration
BY: Daughter Of Vietnam Veteran
2018 Prior Political Candidate
Homeless Women’s Advocate
Humanitarian Consultant
Contact Email: consumer2savlives@gmail.com
Blog: http://www.consumer2savlives.wordpress.com
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CABIRI Big Pharma Research – Reproductive Health
BAYER PHARMACEUTICALS WARNING LETTER
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration Silver Spring, MD 20993
“FDA Warning Letter To Bayer”
Fadwa Almanakly, Pharm.D.
Associate Director, Advertising and Promotions
Bayer HealthCare Pharmaceuticals Inc.
6 West Belt Wayne, NJ 07470-6806
RE: NDA 21-225 Mirena® (levonorgestrel-releasing intrauterine system) MACMIS # 18166
Dear Dr. Almanakly:
The Division of Drug Marketing, Advertising, and Communications (DDMAC) has reviewed a script for a live consumer-directed program (program) entitled “Mirena Simple Style Statements Program” (150-74-0002-09) for Mirena® (levonorgestrel-releasing intrauterine system) (Mirena), submitted by Bayer HealthCare Pharmaceuticals Inc. (Bayer) under cover of Form FDA-2253.
The program overstates the efficacy of Mirena, presents unsubstantiated claims, minimizes the risks of using Mirena, and includes false or misleading presentations regarding Mirena. Thus, the program misbrands the drug in violation of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 352(n), and FDA’s implementing regulations. See 21 CFR 202.1(e)(3)(i), (e)(5) & (e)(6)(i).
Background According to the DESCRIPTION section of its FDA-approved product labeling (PI),1 “Mirena® (levonorgestrel-releasing intrauterine system) consists of a T-shaped polyethylene frame (Tbody) with a steroid reservoir (hormone elastomer core) around the vertical stem.” The steroid reservoir contains the progestogen levonorgestrel, which is secreted slowly into the uterus over time upon the insertion of Mirena by a trained healthcare provider. According to the INDICATIONS AND USAGE section of its PI, Mirena is approved for the following indication: Mirena is indicated for intrauterine contraception for up to 5 years.
Thereafter, if continued contraception is desired, the system should be replaced. Mirena is recommended for women who have had at least one child. The PI for Mirena also includes numerous contraindications, including “[u]ntreated acute cervicitis or vaginitis, including bacterial vaginosis or other lower genital tract infections until infection is controlled,” and “[c]onditions associated with increased susceptibility to pelvic infections.”
1 The most current version of the FDA-approved PI as of the dissemination date indicated on Form FDA-2253 was the July 21, 2008, version, and that is the version referred to in this letter. We note that the PI for Mirena was updated on October 1, 2009. Fadwa Almanakly, Pharm.D.
Page 2
Bayer HealthCare Pharmaceuticals Inc. NDA 21-225 / MACMIS 18166 The use of Mirena is associated with a number of risks, including warnings regarding the increased risk of pelvic inflammatory disease (PID), ovarian cysts, and irregular bleeding and amenorrhea.
Additional warnings include the risk of Mirena embedding in, perforating, or being expelled from the uterus, as well as the increased risk of ectopic pregnancy, and the risks to an intrauterine pregnancy that occurs with Mirena in place. Should a woman become pregnant while using Mirena, serious risks include pregnancy loss and a permanent loss of fertility. In addition to the warnings noted above, the PI details the common adverse reactions that were observed during the clinical trials for Mirena.
According to the PI, “Very common adverse reactions” (>10% of clinical trial patients) included “uterine/vaginal bleeding (including spotting, irregular bleeding, heavy bleeding, oligomenorrhea and amenorrhea), and ovarian cysts.” Adverse reactions that were reported by 5% or more of clinical trial patients include, among others, abdominal/pelvic pain, nausea, headache, nervousness, back pain, weight increase, breast pain/tenderness, acne, decreased libido, and depressed mood. The PI also includes precautions that patients should be counseled that Mirena does not protect against HIV infection (AIDS) or other sexually transmitted diseases, and that patients should be instructed to check that the threads attached to Mirena are still in place after each menstrual period, as there is no contraceptive protection if Mirena is displaced or expelled.
Additionally, in regards to patient follow-up following the insertion of Mirena, the DOSAGE AND ADMINISTRATION, Patient Follow-up section of the PI states (in pertinent part): • Patients should be reexamined and evaluated 4 to 12 weeks after insertion and once a year thereafter, or more frequently if clinically indicated. Overstatement of Efficacy/Unsubstantiated Claims Promotional materials are misleading if they represent or suggest that a drug is more effective than has been demonstrated by substantial evidence or substantial clinical experience.
The Mirena program is a live presentation designed for a consumer audience of “busy moms.” The program is presented in a consumer’s home or other private setting (e.g. private restaurant party) by a representative from Mom Central (a social networking internet site) and a nurse practitioner (Ms. Barb Dehn).2 The script of this program submitted to FDA includes an introduction from the Mom Central representative, a presentation given by Ms. Dehn regarding the use of Mirena, and a “post-party” questionnaire for the audience. The script includes the following statements to be delivered by the Mom Central representative (emphasis added):
• “This party was brought to you by Mom Central in partnership with Bayer HealthCare Pharmaceuticals’ Mirena which may help couples keep life simple!” 2 The Mirena program submitted to FDA also references a presentation given by a fashion stylist (Ms. Angela Hastings) that immediately follows Ms. Dehn’s presentation regarding the use of Mirena. The script of Ms. Hastings’ presentation regarding fashion tips was not submitted to FDA.
Fadwa Almanakly, Pharm.D.
Page 3
Bayer HealthCare Pharmaceuticals Inc. NDA 21-225 / MACMIS 18166 • “Barb Dehn is a practicing Women’s Health Nurse Practitioner, award-winning author and nationally recognized health expert from San Francisco. Barb is going to kick things off with a discussion about romamance and how to find simple ways to reconnect with our partners.” The script also includes the following statements to be delivered by Ms. Dehn (emphasis added): •
“. . . And, let’s face it, when we feel good about the way we’re put together, we feel better about approaching the romance in our lives.” • “What we’re here to talk about today – is how to find those simple ways to reconnect with ourselves and our partners.” Following the introduction of the program, the script states that “Barb [Dehn] will begin presentation with an icebreaker – an interactive Q&A – which will touch upon issues such as busy schedules, barriers to intimacy and contraception” (emphasis added). The “icebreaker” questions include the following (in pertinent part; emphasis added): • “How many of you feel so busy that you often can’t find time to take care of yourself? And do you think this impacts your level of intimacy?”
• “Do you ever feel so overwhelmed by your schedule that intimacy is much more of a “to do” on a list than a desire?” • “If you didn’t have to worry about contraception, do you think you would be more likely to be intimate with your partner?”
• “Do you think if you didn’t have to worry about taking your birth control everyday, it would help you be more intimate?” Immediately following the “icebreaker” questions, the script for Ms. Dehn states (emphasis added):
• “So you mentioned that convenience and reliability are among the most important benefits of your birth control method. One strategy that I recommend for busy couples is choosing a birth control method that allows for spontaneous intimacy and which you don’t have to think about every day, such as the intrauterine contraceptive Mirena®.”
The above statements clearly indicate that the use of Mirena instead of other means of contraception will result in increased levels of intimacy, romance, and by implication, emotional satisfaction. These claims misleadingly overstate the proven efficacy of Mirena. Mirena has been proven to be an effective intrauterine contraceptive device. While we note that Mirena does not involve a daily routine and is not a barrier method of contraception, FDA is not aware of any evidence that suggests that women using Mirena for birth control experience an increase in reconnection, romance, or intimacy with their partners. Claims that state or suggest such quality of life outcomes, such as those described above, must be Fadwa Almanakly, Pharm.D.
Page 4
Bayer HealthCare Pharmaceuticals Inc. NDA 21-225 / MACMIS 18166 supported by substantial evidence, as demonstrated through adequate and well-controlled trials using validated patient assessment instruments to measure the outcomes of interest. If you do, in fact, have data to support these claims, you should submit them to FDA for review. We note that, according to the Mirena PI, at least 5% of clinical trial patients reported decreased libido as a side effect of Mirena use. Patients also experienced abdominal/pelvic pain, nausea, headache, nervousness, and depressed mood, which could adversely affect a woman’s feelings relating to romance or intimacy. The script also includes the following statements, to be presented by Ms. Dehn (emphasis added):
• “But what this party is really about is looking at the whole picture and figuring out steps to take to simplify your lifestyle while still looking and feeling great. One of those ways is finding a birth control that is compatible with your busy lifestyle.” The above statement goes beyond the suggestion of increased intimacy to suggest that Mirena can help patients “look and feel great.
” Again, FDA is not aware of any evidence suggesting that women who are using Mirena for birth control look great or feel great. Patients using Mirena may experience various side effects, such as irregular bleeding, ovarian cysts, back pain, weight increase, breast pain/tenderness, and acne, in addition to the side effects indicated above. The experience of these side effects can prevent patients from “looking and feeling great.” Such claims of improved patient-reported outcomes must be supported by substantial evidence, as demonstrated through adequate and well-controlled trials using validated instruments to measure these outcomes of interest.
If you do, in fact, have data to support these claims, you should submit them to FDA for review. Omission and Minimization of Risk Information Promotional materials are misleading if they fail to reveal material facts in light of the representations made by the materials or with respect to consequences that may result from the use of the drug as recommended or suggested by the materials. The script includes the following risk presentation, to be presented by Ms. Dehn (emphasis in original):
• Only you and your healthcare professional can decide if Mirena is right for you. Mirena does not protect against HIV or STDs. Candidates for Mirena have had a child, and do not have certain cancers or acute pelvic inflammatory disease. In rare cases, perforation or embedment may occur. Mirena may become completely or partially dislodged. In the uncommon event you think you’re pregnant, contact your healthcare professional without delay.
Ovarian cysts may occur and typically disappear. Changes in bleeding are common in the first few months followed by shorter, lighter periods. Periods, however, may remain irregular. The risk presentation omits the contraindications regarding untreated lower genital tract infections and conditions associated with increased susceptibility to pelvic infections, and does not adequately convey that should a woman become pregnant while using Mirena, she may lose her baby or her fertility. Fadwa Almanakly, Pharm.D.
Page 5
Bayer HealthCare Pharmaceuticals Inc. NDA 21-225 / MACMIS 18166
We refer you to the December 17, 2008, advisory letter from DDMAC to Bayer, regarding the promotion of Mirena. This advisory letter includes a change of opinion regarding the risk presentation for Mirena. The letter states (in pertinent part, emphasis added): Because this constitutes a change in our position, you will be provided a reasonable period of time to revise any Mirena promotional materials currently in use that omit this important risk information.
Accordingly, the revisions should be completed within 90 days of receipt of this letter or at the next production of new promotional materials, whichever comes first. The promotional program at issue here was newly developed, and as stated on the Form FDA-2253 accompanying the materials, it was disseminated on February 28, 2009, after the change of opinion letter was issued.
We also refer you to your January 5, 2009, response to the change of opinion letter, stating that you intend to comply with our request. Additionally, the script minimizes the risks associated with Mirena. Specifically, the “looking and feeling great” statement referenced above, in the context of the program as a whole, minimizes the risks associated with the use of Mirena.
As stated in the Background section above, the PI for Mirena includes “very common” (experienced by >10% of clinical trial patients) adverse reactions, in addition to other serious warnings, precautions, and safety issues associated with the use of Mirena. The suggestion that Mirena will help patients “feel great” minimizes the side effects that patients may experience as a result of using the drug. False/Misleading Statements The script includes the following statements to be presented by Ms. Dehn (emphasis added):
• “. . . Mirena has no daily, weekly, or monthly routines to comply with as compared to the negatives associated with other birth control methods.” The above claim that Mirena has “no . . . monthly routines” directly contradicts information contained in Mirena’s PI.
According to PRECAUTIONS, Continuation and Removal section (repeated in the DOSAGE AND ADMINISTRATION, Patient Follow-up section) of the PI for Mirena, “[Patients should be] reexamine[d] and evaluate[d] . . . 4 to 12 weeks after insertion and once a year thereafter, or more frequently if clinically indicated.”
The PRECAUTIONS, Patient Counseling Information section of the PI also states that patients should check that the threads attached to Mirena are in place after each menstrual cycle (thus on a monthly basis), to ensure that Mirena has not become displaced or expelled, which would result in a loss of contraceptive efficacy. Therefore, the claim that there is no “monthly routine to comply with” is a false statement.
We note that the script includes instructions to check the Mirena threads monthly in a separate part of the presentation; however, this does not correct the false statement highlighted above. Fadwa Almanakly, Pharm.D.
Page 6 Bayer HealthCare Pharmaceuticals Inc. NDA 21-225 / MACMIS 18166 Conclusion and Requested Action For the reasons discussed above, the program is misleading in violation of the Act, 21 U.S.C. 352(n), and FDA implementing regulations.
See 21 CFR 202.1(e)(3)(i), (e)(5) & (e)(6)(i). DDMAC requests that Bayer immediately cease the dissemination of violative promotional materials for Mirena such as those described above.
Please submit a written response to this letter on or before January 14, 2010, stating whether you intend to comply with this request, listing all promotional materials (with the 2253 submission date) for Mirena that contain violations such as those described above, and explaining your plan for discontinuing use of such violative materials.
Please direct your response to me at the Food and Drug Administration, Center for Drug Evaluation and Research, Division of Drug Marketing, Advertising, and Communications, 5901-B Ammendale Road, Beltsville, MD 20705-1266; facsimile at 301-847-8444. In all future correspondence regarding this matter, please refer to MACMIS # 18166 in addition to the NDA number for Mirena. We remind you that only written communications are considered official.
The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for Mirena comply with each applicable requirement of the Act and FDA implementing regulations. Sincerely, {See appended electronic signature page} Carrie Newcomer for Cynthia Collins, Ph.D. Regulatory Review Officer Division of Drug Marketing, Advertising, and Communications
Sincerely,
Carrie Newcomer for Cynthia Collins,
Ph.D. Regulatory Review Officer Division of Drug Marketing, Advertising, and Communications
“CandyK’s Communication Outreach”
Dec 9, 2018
DRUGINFO@fda.hhs.gov
Thank you for contacting the Division of Drug Information (DDI). This message is an automatic acknowledgment of your inquiry.
Dec 9, 2018
Automatische Antwort: Mirena Claim
Thank you very much for your email. I’m not in the office until Monday, December 10th. During this time, I have no access to my emails. In case of emergency, you will reach my colleague Ms. Heber,mailto:kerstin.heber@bayer.com
Date: Thu, Mar 6, 2014
Subject: Incident #01980MMJ-42104CCO
To: <complaint@jointcommission.org HYPERLINK “”>
Oct. 21st, 2014
Your Comment Submitted on Regulations.gov (ID: CMS-2014-0115-0002)
Jan. 23, 2015
@aclufl.org
Legal Director – American Civil Liberties Union of Florida
Hello Candace-
I got your voicemail yesterday, but had a filing due in court. I just sent you an email copying Jeff Weinberger so I hope the two of you will follow up. I’m supposed to be in Palm Beach on Wed., Feb. 4, for a meeting at noon. However, if you have time that morning, I could probably get there by 10 a.m. and meet you someplace convenient. Please let me know if that works for you
Jan, 28th, 2015
Hello Candace-
Are you available to meet next Wed. at 10 a.m.? My meeting is at 11:30 a.m. and then I have to head back to Miami, but we can talk about this and the homeless rights work you’ve been doing then. If that time works, just let me know where you’d like to meet
Apr 10, 2014
Ellen Malcolm, National Partnership
Dear Candance,I’m the chairwoman for the National Partnership’s board of directors, and tomorrow I plan to mention you at our semi-annual meeting. Yes, you.
Apr 15, 2014
Balboa Press – jstogsdill@balboapress.com
I want to help you tell your story
To get started publishing right away or to discuss your options. I look forward to speaking with you again soon.
Mar 6, 2014
PATIENTSAFETY-L@LISTSERV.NPSF.ORG
LISTSERV@listserv.npsf.org
May 7, 2015
Cecile Richards, Planned Parenthood – NO Response
pponline@ppfa.org
Jul 23, 2014 – Planned Parenthood – No Response
Lisa.Murano@ppsoflo.org
Tue, Jul 31, 2018
CDER DRUG INFO <DRUGINFO@fda.hhs.gov>
druginfo@fda.hhs.gov
Incident #01980MMJ-42104CCO – Reporting to MedWatch
Division of Drug Information – Center for Drug Evaluation and Research
Thank you for writing to DICE@fda.hhs.gov. Your inquiry was forwarded to the Division of Drug Information in the FDA’s Center for Drug Evaluation and Research for a response.
Stay Tuned: Episode 7 – More Adverse Complications Continued
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New Kindle Vella: E-Book Episodes – The Unknown Hidden Devil Living Inside Of Me…All women must read…
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The Internal Death: New Episodes & Medical Research On ‘Kindle Vella’
Are U.S. women’s organizations credible
Are the United States women’s organizations credible and helping women?
Women’s organizations are supposed to be there to uplift, support and help women! So are they truly helping Women?
In some ways Yes, and more ways No! Many women in the United States ‘Reproductive Health” is being altered and has become extremely deadly for many U.S. women! Cancer is spreading rapidly in U.S. women and should not to be taken lightly! Why isn’t anyone doing anything to help U.S. women, does a international country need to step in to save the lives of American women?
The current Hobby Lobby and Abortion Issue’s are just the icing on the cake there’s many more attacks against women brewing behind closed doors, “going unrecognized!”
Astonishingly, although many of these ‘Women’s’ organizations receive public and federal funding, although there hasn’t been one organization or government entity, reaching out to help women in the United States who’s ‘Reproductive Health’ has been impacted in some form or fashion!
Why is that? Do they care? Everyone knows a woman’s reproductive system is part of a woman’s internal organs, and if severely impacted this could cause woman to die, become medically ill, and/or internally diseased.
Involuntary attacks
Women in America are being targeted in every facet imaginable! When it comes to ‘Women’s’ lives, female run organizations, leaders of America and world leaders should surely step up to help women, who’s health is being impacted or has been impacted! Unsupported illnesses and deaths are occurring, is this unimportant?
U.S. families reproductive health is involuntarily being destroyed by Americas corrupt Healthcare system, drugs and products! How is this ethically fair to women in America!
Women are the main back bones of many families! Few realize, if you destroy a mothers health you destroy their children! These children now have a sick or deceased mother, who they can no longer look up to for support and guidance, some may become homeless due to no father being present. A mother ill or deceased puts a huge burden onto family households, siblings, grandparents, government programs and society.
Also, did anyone not bother to think that U.S. women’s reproductive health personal traumatic stories could help sway laws, and protect millions of other women around the world! Or are they politically keeping these stories private, fearing backlash by the female population?
It’s been hard to figure out the past 3yrs. why women led organizations, government healthcare agencies, doctors, lawyers, hospitals, healthcare agencies, and women leaders have mysteriously chose to ignore the many stories being communicated by U.S. women speaking out about there personal ‘Reproductive Health” trauma’s in America!
Do Women’s Life’s Matter
Do their stories and lives not matter? If this is the case many women in America need to re-think who really has there back! Do these organizations, leaders, agencies truly deserve our support in the U.S.?
Women speaking up like myself, and lawsuits being filed by thousands of women, will help change laws and bring awareness to other women around the world! Women matter in the world, and we all need to start acting like we matter or men will continue treating us like we are less deserving!
So why wouldn’t Women leaders want to help and ask women questions about there ‘Reproductive Health trauma’s, and that ‘s if there still alive, many have unfortunately died due to reproductive health complications?
Does the credibility of Women’s organizations hold true? If they aren’t even reaching out or acknowledging the same women they vouched to help protect in America, and throughout the world, What is their true purpose?
At this case and point this is not the case! There seems to be a broken link behind Women’s organizations whom are supposed to be there helping support American women who’s reproductive health or health in general has been compromised or currently being altered!
So why aren’t these top women led organizations and leaders not assisting U.S. women crying out for help?
Well one things for sure at least other U.S. women including myself care enough to speak out about there personal trauma’s, to help alert and protect millions of other women?
Women In America Demand Support From U.S. Women Led Organizations & Leaders
It’s time to start speaking out against ‘Women organizations and leaders’ who aren’t supporting or helping the women they vouched to help protect! Supporting women calls for much more besides “Political Bureaucracy,” and it’s called, “Women’s Health” which is attached to a human life! Which do you think would be more important?
As the owner of CABIRI, and a U.S. woman with reproductive health trauma’s. I’ve personally experienced and dealt with many shortcomings of all these women led organizations and leaders in the past 3yrs. speaking with various organizations, leaders, and agencies, whom all chose to ignore many U.S. women’s voices in America experiencing reproductive health trauma’s due to healthcare corruption!
In my opinion and anyone with common knowledge, knows some businesses are portraying and professing to help fight for and support women, although when it comes to reality it’s a “Tall Tale!”
** Women of America please think about this when you vote!**
Ask yourself, who’s really sincere and cares about you and your families well-being
Thank you for reading and please help CABIRI, spread the word, helping us protect women of the United States from devious planned out attacks via greed, power and corruption!
CABIRI,
Consumer Advocacy For America
CABIRI Quote’s:
The root of money is evil – Evil is the root of money – Money is the root of all evil
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International FGM vs American FGM
American Women’s Voices Don’t Matter & Won’t Be Heard! Ya Gotta Be a Foreign citizen!
“2 Similar stories although very different outcomes! International vs America”
US surgeon who campaigned against potentially dangerous device receives legal threat
America, the United States Federal Government doesn’t acknowledge American women’s voices! From personal experience they’ve blatantly refused, to hear about life-threatening ‘Reproductive Health‘ concerns coming from their own American people! Thousands of American women, Healthcare Whistle-blowers, Doctors, and some Scientist have been effortlessly reporting about the numerous attacks against Women’s ‘Reproductive Health’ in the United States. Which coincides with ‘FGM’ it’s merely the same subject!
So why in the world won’t the U.S. Government, HHS, FDA, CDC or any other Healthcare agency not acknowledge the thousands of American Women’s numerous ‘Cries For Help! My behind the scenes ‘FGM’ similar ‘Reproductive Health’ trauma prompted me to warn all ‘Women’! I’ve been warning women and the public since the start of my “Social Media” business, October 2013. Which No U.S. Government, Healthcare agency or any organization, cared enough to “listen to numerous American victims” about the current Reproductive Health ‘FGM’ crisis that’s been looming in the United States. It took a ‘Foreign Woman,’ with the assistance of a ‘Foreign country’ to acknowledge, Oh, Yes by the way the United States women ‘Reproductive Health is at risk, and we need to as to ask the United States to launch a investigation!”
Are you serious America, “2yrs. reporting about the ‘Reproductive Health – FGM’ crisis in America,” and no response from any leading American official, until a ‘Foreign country and citizen gets involved!’ Which truly shows how much the U.S. Government really cares about the voices, of “American Women or the people of the United States! Why did it take another country and Female citizen, to acknowledge American Womens Reproductive Health is in jeopardy?
A African woman from ‘Gambia’ now in America, experienced ‘FGM’ in her country and spoke out about her personal ‘FGM’ attack in her country ‘Africa,’ and her attacks within the United States! Ironically, and Thankfully the African woman’s ‘FGM’ personal experience from ‘Zambia’ was recognized, gaining more than 221,000 signatures, support from London, U.S. Government, United Nations, Guardian News, and a organization based in the U.K. by the name of Equality Now @http://www.equalitynow.org/! If you are a American Woman you get no response or support!
Gambia- Change.org Petition: My name is Jaha Dukureh and I am 24 years old. As an infant growing up in Gambia, I experienced Female Genital Mutilation. It took away a part of my femininity, my ownership to my body. Some girls, including my half-sister who died from complications from being cut, even lose their lives.
As a American citizen woman that’s been impacted by the ‘FGM’ in America this very disturbing and upsetting. The alert about American Womens, Reproductive FGM Health attacks had to be communicated by foreign citizen to acknowledge there was problem in America! Women of America have been communicating the same issue! Why did it take a ‘African’ Woman from another country to speak out about ‘FGM’ in America to other foreign countries. The serious attacks against ‘Womens Reproductive Health,’ inside the United States is impacting millions of American women, “altering lives and causing death’s?”
CABIRI’s owner Candance Camper a American citizen ‘FGM’ victim, put in years of due diligence, and research into Americas Healthcare industry, all the hard work and reporting wasn’t acknowledged at all by the United States Government, since I wasn’t a ‘FGM’ victim from Africa! Wow! The numerous Reproductive Health article’s published, emails, phone calls made to top officials, and my business website was set up by CABIRI, back in December 2013, explaining the reproductive health attacks against women via Americas new International Pharmaceutical Industry was developed to warn all American Women!
It’s amazing that, I’m a Black/White/Indian American born woman who’d experienced FGM in my own country, and my own U.S. Government, medical leaders and numerous healthcare leaders chose to ignore me completely, leaving me lifeless with no support, with lingering medical issue’s no doctor, pathologist or hospital can explain! The only thing I personally heard from numerous American leaders the few who did reply was, Oh, were sorry that happened to you! There was one report done about my personal story @ Lawsuitsandsettlements.com a Canadian Medical Lawsuit website.
Thankfully a African woman from, ‘Zambia’ reported the same issue occurring in her country, and luckily she’s now residing in America because she realized there’s a FGM problem in the United States! Now she has international support to help “All Women,” who aren’t getting any help or support from the U.S. Government. Myself and many others have been speaking out about “Womens Reproductive Health ‘FGM’ attacks,” against all U.S. women, who are being ignored and going unprotected against these current attacks in America!
View all below articles then ask yourself if this ethically correct in the United States!
(Jaha Dukureh – Gambia Petition and Published Articles)
End Female Genital Mutilation in the US – Commission a prevalence report on women impacted and girls at risk – https://www.change.org/p/end-fgm-now-protect-girls-from-getting-cut-and-support-victims-of-female-genital-mutilation-in-the-usa (PLEASE SIGN)
Petition Victory: At a summit on FGM and child marriage in London, the Obama administration announced it would conduct a major study into FGM to establish how many women are living with the consequences of FGM in the United States and how many girls are at risk. Not only that, but the administration said they would create a preliminary working group on FGM, with a mission of measuring the extent of FGM in the United States and coming up with concrete plans to tackle it.
US to conduct major study into female genital mutilation
Activists hail study, which will assess how many US women are at risk, as ‘a great success for everyone who has fought for this’ Cathy Russell, the US ambassador for global women’s issues, confirmed that the study would be carried out by the US Department of Health and Human Services. Speaking to the Guardian at a major summit on FGM and child marriage in London, Russell praised the event for highlighting the issue. “This summit is important because it brings together government, civil society and activists who care and have been working on this issue,” she said.
FGM is carried out in 29 countries, and Unicef has estimated that more than 130 million women are living with the consequences, which include heavy bleeding, infections, infertility and death during childbirth. At least 228,000 American women and girls in the US are at risk of the practice, according to previous research from the African Women’s Health Center of the Brigham and Women’s Hospital, but the true number is thought to be much higher.
CABIRI Published Reproductive Health Articles – Ignored with few responses
American Woman’s Published FGM Article’s – Doesn’t include numerous emails, phone calls
“President Barack Obama: Demand Investigations Into United States Corrupt Healthcare Systems And Institutions“http://www.change.org/p/president-barack-obama-demand-investigations-into-united-states-corrupt-healthcare-systems-and-institutions – Includes You Tube Video! (PLEASE SIGN)
URGENT MESSAGE! Big Pharma Discriminating & Sterilizing WOMEN – EUGENICS – https://consumer2savlives.wordpress.com/2014/03/28/urgent-message-big-pharma-discriminating-sterilizing-women-eugenics/
Special Report! All Women In Cancer DANGER! – https://consumer2savlives.wordpress.com/2014/04/26/special-report-all-women-in-cancer-danger/
American Women – ‘FGM’ via Big Pharma – https://consumer2savlives.wordpress.com/2014/05/18/american-women-fgm-via-big-pharma/
URGENT WOMEN!! Lead Developer Of HPV Vaccines Comes Clean, Warns Parents & Young Girls It’s All A Giant Deadly Scam – Attack On Women – https://consumer2savlives.wordpress.com/2014/04/09/urgent-women-lead-developer-of-hpv-vaccines-comes-clean-warns-parents-young-girls-its-all-a-giant-deadly-scam-attack-on-women/
Deadly Birth Control Corruption In America by Germany – https://consumer2savlives.wordpress.com/2014/07/11/deadly-birth-control-corruption-in-america-by-germany/
Corruption in the FDA = Bayer Pharmaceuticals = Animal Products – GMO Products – PYRAMID SCHEMES – https://consumer2savlives.wordpress.com/2014/03/13/corruption-in-the-fda-bayer-pharmaceuticals-animal-products-gmo-products-pyramid-schemes/
HEALTH ALERT! FDA proposes program for faster approval of medical devices – Americas Nightmare – https://consumer2savlives.wordpress.com/2014/04/22/health-alert-fda-proposes-program-for-faster-approval-of-medical-devices-americas-nightmare/
Please Read! Women Reproductive Health Alert – https://consumer2savlives.wordpress.com/2014/07/14/please-read-women-reproductive-health-alert/
DANGER!! EUGENICS THEORY: WOMEN BEING UNKNOWINGLY STERILIZED – BY REPRODUCTIVE HEALTH – https://consumer2savlives.wordpress.com/2014/03/10/danger-eugenics-theory-women-being-unknowingly-sterilized-by-reproductive-health-2/
Special Alert!! Women Taking Deadly Birth Control Toxins – https://consumer2savlives.wordpress.com/2014/04/29/special-alert-women-taking-deadly-birth-control-toxins/
Americas Big Pharma Chemistry Projects – https://consumer2savlives.wordpress.com/2014/05/09/americas-big-pharma-chemistry-projects-2/
View another American woman’s FGM Cancer petition: (PLEASE SIGN)
Health Alert: Many Women Have Died Unnecessarily Because Dangerous Cancers of the Uterus and Ovaries Are Being Spread using MORCELLATORS. Stop MORCELLATION in Minimally Invasive Gynecological Surgery. http://www.change.org/p/women-s-health-alert-deadly-cancers-of-the-uterus-spread-by-gynecologists-stop-morcellating-the-uterus-in-minimally-invasive-and-robot-assisted-hysterectomy?tk=FnoH-7T_4mx7cNLqueYbiW1qGxUDW268LZxYO_j2-FY&utm_source=petition_update&utm_medium=email&utm_campaign=petition_update_email
Once everyone has read this please tell all U.S. Government Officials to start ‘Listening’ to what American Citizens are reporting, Government leaders have no idea what’s occurring in the ‘Real World!’ It’s sad other international countries had to step in and save ‘American Women!’
This is a major problem for all United States Women! Every American Woman has to stand up and start “Demanding” to be heard in the United States to protect our health and lives! Millions of Womens lives are in danger, please pass this along and support both ‘American based FGM and Gambia, U.K., ‘FGM’ petitions please take a few minutes to save millions of ‘Women’ by signing petitions: (links below) Gambia and 2 American Women Change.org petitions.
I hope many read this story and see the problem American Women are facing! Our own U.S. Government is ignoring our cries for help! If your a foreign citizen they will help you! What are American Citizens to do about the communication barrier with the U.S. Government! Lives are at stake and top leaders and corporations in the U.S. care nothing about helping their own country people, until they get caught by another international country, which at that point the U.S. will act on the crisis to not look bad, not wanting to be held accountable for Women’s lives in America who will be harmed, or discreetly killed! All women please help save our lives it’s important we stand together and support one another like we’ve never done before, believe it or not we do have a ‘Reproductive Health problem in America!
Video’s
– Brutal Female Genital Mutilation Happening to American Girls
Please pass along and continue to follow and support CABIRI, helping save millions of lives!
Candance Camper
Founder/Owner – CABIRI – http://www.consumer2savlives.com
Email: http://www.consumer2savlives@gmail.com
Consumer Advocacy For America – Saving Lives
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Florida Governor Against Women
America, as being a Florida resident and a woman, the below article should run chills up every woman’s spine! When the below information was communicated by, “Florida’s Upcoming Governor Charlie Christ” campaign organizers, this was a nostalgic moment as a women! Couldn’t believe it! Mr. Rick Scott of Florida, is has the nerve to want to tell “Women” what to do with their bodies!
Read Below America, see what this “Man” in power position feels he can do to human beings!
Rick Scott signed (anti-choice bills) that opened the door to (government interference) between a (woman and her doctor) — and then threw a party at the governor’s mansion to celebrate their passage. He also vetoed $1.5 million from the state’s budget for rape crisis prevention centers.
Link: http://www.charliecrist.com/community/women-for-charlie
Rick Scott wants to take us back to the days when women were charged more for health insurance, just for being women. If Scott has his way, basic pieces of women’s health and well-being – like affordable contraception, cancer screenings, and preventive care – will cost more.
America, this is a tragedy someone like this “Man-Another-Human-Being,” has the audacity, to pass bills concerning “Women’s Reproductive Health, and Well-Being! Are you really joking!
Everyone please realize, ‘Men’ are not “Women” and have no clue what their bodies need or endure on a daily basis! So how can any “Man” have a ‘say so about’ what a woman needs medically! Ask, any man has he given “Child Birth,” or does he know what it feels like, or does he know what a ‘Woman’s body feels like as the ‘Fetus’ is growing inside of him? How can “Men make decisions for Women?” Here’s another fantastic question for “Men” have you ever had a “Menstrual Cycle?” So how in the world can you make a decision for a woman, when you have no idea what she medically needs or how she truly feels, when bodily changes are occurring!
This is the craziest misconstrued thing ever! Men have no clue about “Women,” Mentally, Physically or Medically, so why is “Society” allowing men to pass laws, make toxic pharmaceutical products for women’s bodies, when they have “No Clue” about women at all! Believe that every “Woman’s” body make-up is different and unique, in many nationalities, what may apply to one woman, may not apply to the next woman and it varies by race and culture! America, are men saying they know about every woman’s body on earth and are for certain about women’s internal organs and what they need?
Women of America, and all over the world, this has to “Stop!” There is no way reasonably possible, for a man to be telling women what there body needs! Also, has anyone really stopped to think, “Why is it all about women, Why is the world so focused on Women?” Are men Inferior or God’s leaders in the world! Why isn’t society, targeting men, and all of their draw backs! What about their Mental, Physical and Medical issue’s! Do you see anyone telling men, what they can do with their bodies, or passing legislative bills?
America, how fair is it really, for men to make crucial life-altering body ‘Medical’ decisions, for Women when they have no clue about women? The body and gene make up is totally different, so how would a man know what’s best for a woman’s body? Also another point to be made, didn’t men get birthed by a “Woman” their Mothers? Guess it’s fair to say “All men know what there own Mother body needs!
Think about this America, including men, ask yourselves some of the above questions! The conclusion should be a valid point that has been made and addressed, this should not be occurring! Only women, should be making decisions about “Women’s Reproductive Health,” Not Men such as; Florida’s Governor Rick Scott! Maybe this is why there are so many “Homeless Women and Children in Florida! America, everyone should see some men have no respect for women, which many forget their mothers are included in the equation!
CABIRI,
Consumer Business Research
Website: http://www.consumer2savlives.com
Email: http://www.consumer2savlives@gmail.com
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American Women – ‘FGM’ via Big Pharma
All Women Please Read Full Article, Protect Your Health!
America, in reading the below petiton from Change.Org concerning, Female Gentile Mutilation in America, and CABIRI’s article, this should hopefully open ‘All American womens eyes’! It’s important for them to the realize we have a huge “Reproductive Health Issue in America” Please read all ‘FGM’ article’s and view video, all “Women need to know this, it’ll help save millions of lives!” Now get this, American Women, the same “FGM” concerns, are coming from a American woman and an Inernational younger woman, from Gambia, realize these are two women from different parts of the world, who do not know one another, although standing up for other women, and speaking out about the same exact issue’s of “Reproductive Health, life-threatening and life-alterimg trauma’s in America!” Which is seriously impacting millions of American and International Women!
This should help put everything in prespective for you, about ‘Sterilization’ against American and International women young and old. CABIRI, has been communicating and warning all women of America for quite some time, trying to let fellow ‘American’ women know “FGM” or “Reproductive Health” attacks are occuring right here in the United States and “Be Aware!”
Now, a wonderful young lady, from Gambia has come forward by the name of Jaha Dukureh, who was brought to America for an arranged marriage, (Which is also very interestesing – America allows arranged marriages for young international girls?) Jaha, gives her personal “FGM” detailed occurrence, of what personally happened to her when coming to the United States! This is very sad and disturbing, young women from 3rd world countries are experiencing torture in their countries, only to come, to the United States and experience the same type of “FGM” toture!
The humiliating part about all of this, is if these girls don’t agree to the terms in the U.S. they are unknowingly, privately sent to other countries, to be forced into getting the mutilation procedure done, which is horrfic! So Ameica, this means, international women are enduring the same “FGM nightmare, as American, women. United States women are experiencing unknown private attacks against their “Reproductive Health, them or their “Doctor” wouldn’t seeing coming, it may be privately manifesting inside your body!
Please realize by the time you figure out there’s a problem with your body, it may be too late, and the Cancer or disease has advanced to a uncontrollable level, due to fact it’s been brewing inside your body for years! Women and young girls, may of had a prior procedure done, taken birth control or hormone pills, which caused irreversable deadly side-effects.
Women, you may have also received a medical device, mesh, ring, patch etc., that may be currently releasing harmful chemical toxins inside your body, although you’ve discontinued taking the prodcut, or you thought you were healed from a previous procedure, only to find out years later, your internal organs are infected, cancer, diseased, and now you have, ‘No other choice’ to get all, or part of your Reproductive Hormones” surgically removed in order to survive or rid your body of a disease. This is occurring in America, and please realize many younger women will never be able to enjoy “Motherhood” if their Reproductive Organs are being altered at a young age, which is very disappointing, inhumane, and unfair, to the ‘Next generational women of the world!’
Women, please note that your previous or current “Reproductive Health,” decisions may one day come back to haunt you, or your daughters one day! Every woman should now see, that “FGM” is right here in America! It’s sad and alarming, to see this is occuring in the United States, many “Women” especially, Younger women, are in the dark!
It’s very important for CABIRI, and courageous foreign women such as Jaha Durukeh, to speak out about these life-altering issues to save millions of women lives in America, and all over the world! Whom have no idea this is happening to them. Mothers, who have daughters, should truly be concerned, about this occurring in America.
America, let’s get down to, who could casue “FGM” damage in America! There’s a few obvious sources; Doctors; Americas top International Pharmaceutical Corporations; and Third world foreign American citizens, who are practicing their country rituals of “FGM” on younger girls, right here in America! Did anyone stop to think of why womens bodies are being harmed and tainted with in America? Why are many women getting Cancer unexpectedly? There’s a recent report which shows a suprising increase of “Cancer looming in America!”
Health professionals in all facets, whom are agreeing to market, utilize and distribute these toxic products, are all just as guilty of “FGM!” These are young innocent vicitms “Reproductive Health,” they are playing with, and is not fair to these young girls or women for that matter! Womens lives in America are being strategically altered, by birth control toxins, medical-device chemical toxins – perforations – embedments and device relocation, which could be considered forms of “FGM,” including Radiologic mammorgram testing equipment, Laporscopic – Hysteroscopic digital procedures, and other equipment that’s medically harming millions of women.
This should be very disturbing to all women around the world, women are being attacked in every inhumane aspect there is, women have no justice, or much needed, or deserved respect in the world! Which is very shocking, due to fact, that if it weren’t for women “Birthing” and raising their sons and daughters in the world, there wouldn’t be a world, now would there! This article and petition should enlighten and alert all ‘Women’ about the “Real FGM Truth,” so you can protect yourselves. All women must stop holding back and help protect one another, no matter what nationality, we all must stand up for the younger generation of women who don’t know any better, and can’t protect themselves from the “FGM” predators! Please sign petition, and continue to support CABIRI, in helping save lives!
Please pass along and note; The tactics to control the population is a form of ‘Eugenics Theory!’ Pharmaceutical and International Country Ritual culprits are controlling the worlds population by altering millions of womens “Reproductive Health, which can cause death!” These predators are scientifically finding many ways to harm women all around the world, and must be stopped, all women must get involved, to protect their own lives against these culprits! Tell the powers at be ‘Women’ and ‘Young innocent girls,’ aren’t pawns to “Depopulate The World!” This is totally unfair, unjust, and inhumane!
American women have been trying to report ‘FGM’! It’s a shame it’s taken an International woman to tell her personal story about what she’d experienced in the United States for American women to now listen. Foreign women should’nt have to speak out in order for American women to re-act! American womens “Reproductive Health’s has been on attack for quite some time, and sadly women in America, didn’t hear the “Cry” of many American women young and old, who were communicating or experiencing some form of “FGM” or awful attacks against their Reproductive Health! Please take a look at some “FGM” related links below, of what’s been occurring right here in the United States! Another point to be made, why is Womens Health such a big issue, there’s no need to worry about abortion issue’s, when women are already being altered by “FGM” – Sterilization and diseased with cancer or having stroke’s!
A Huge Thanks to Jaha Dukureh and other “FGM” courageous international women for standing up for all women and ‘Saving milions of women and young female lives in America!’
Please see Americas Numerous related “FGM” Links against Women:
Petition:
https://www.change.org/petitions/end-fgm-now-protect-girls-from-getting-cut-and-support-victims-of-female-genital-mutilation-in-the-usa?utm_source=action_alert&utm_medium=email&utm_campaign=62280&alert_id=IqpSUjElmn_2rdHY4ZbPvmWRX542m300xIugZZH%2BxFHbHPwYfJ7akg%3D
$14 million awarded in lawsuit linking birth control pill Yasmin to stroke -http://www.foxnews.com/health/2014/04/21/14-million-awarded-in-lawsuit-linking-birth-control-pill-yasmin-to-stroke/
Lawsuits pile up over popular birth control pill – http://articles.chicagotribune.com/2013-09-15/health/ct-met-birth-control-risks-20130915_1_drospirenone-clots-pills
Lawsuits Over NuvaRing Birth Control Problems
– See more at: http://www.youhavealawyer.com/nuvaring/#sthash.ool9ThuF.dpuf
Lawsuits Over NuvaRing Birth Control Problems- See more at: http://www.youhavealawyer.com/nuvaring/#sthash.ool9ThuF.dpuf
Safe Hand For Girls Website: http://www.safehandsforgirls.org/
GRISWOLD v. CONNECTICUT
http://www.oyez.org/cases/1960-1969/1964/1964_496
NuvaRing Class Action Lawsuit
Cosmopolitan: Article:
http://www.cosmopolitan.com/celebrity/news/female-genital-mutilation-united-states
NuvaRing Class Action Lawsuits:
http://www.drugnews.net/nuvaring/class-action-lawsuit
Depo – Pevera Breast Cancer Lawsuit:
http://www.altmanllp.com/depo-provera-lawsuits.html
Depo-Pevera Osteoporosis Lawsuit:
http://www.bigclassaction.com/lawsuit /depo_provera_contraceptive_osteoporosis_class_action.php
Norplant Nightmare: An American Victim of Family Planning
http://www.pop.org/content/norplant-nightmare-an-american-victim-of-family-planning-529
Mirena – IUD Lawsuits – http://www.drugwatch.com/mirena/lawsuit/
Mirena Iud Lawsuits Climb, as Filings in State and Litigations surpass 1800 Cases – http://www.digitaljournal.com/pr/1924787
Skyla IUD Lawsuit – http://www.skylaiudlawsuit.com/
Another class action lawsuit against Ortho Erva Makers
http://www.lawyersandsettlements.com/articles/ortho_evra/ortho_evra_lawsuit-00259.html#.U3hQnyg3eMA
Sryker and FDA Issue Class I Recall of OASYS Midline Occiput Plate:
Safyral Birth Control: http://www.lawyersandsettlements.com/lawsuit/safyral-side-effects-lawsuit.html#.U3hTRCg3eMA
Paxil Birth Defects, PPHN and Birth Defects:
http://www.lawyersandsettlements.com/lawsuit/paxil_birth_defects.html#.U3hUMSg3eMA
Advil Ibuprofen – Stevens Johnson Syndrome
http://www.lawyersandsettlements.com/lawsuit/advil.html#.U3hUsCg3eMA
Patent infringement lawsuit over breast cancer testing genes
http://www.thedp.com/article/2014/02/myriad-settlement-gene-by-gene-
Prempro Hormone Therapy Amplifies Breast Cancer Risks
http://www.nytimes.com/2010/10/20/health/20hormone.html?_r=0
Court Find Prempro Causes Cancer, but FDA still promotes It
http://www.anh-usa.org/fda-promotes-cancer-causing-prempro/
West Linn woman’s lawsuit claiming breast cancer from Novo Nordisk drug
http://www.oregonlive.com/west-linn/index.ssf/2013/10/west_linn_womans_lawsuit_claim.html
FDA Warns Epidural Corticosteroid Injection Assoicated with Serious Neurologic Problems
http://www.bigclassaction.com/lawsuit/fda-warns-epidural-corticosteroid-injection.php
Diethylstilbestrol – Synthetic Hormone (DES – Cancer)
http://www.lawyersandsettlements.com/lawsuit/diethylstilbestrol
Cervical Cancer Lawsuit: Misread PAP Smear Results in
http://www.lubinandmeyer.com/…/cervical–cancer
Failure to Diagnosis Cervical cancer
http://www.floridalawsuits.com/PersonalInjury/MedicalMalpractice/FailuretoDiagnoseCervicalCancer.aspx
Fibroid Surgery Lawsuit:
http://sssfirm.com/products-liability/fibroid-surgery-lawsuits/?gclid=CL-Cv6v4tL4CFTAV7Aodoh4Aig
Hormone Replacement Therapy Litigation:
http://www.wdolaw.com/CM/Custom/HormoneReplacementTherapyLitigation.asp
Breast Cancer Misdiagnosis and Mammography Errors
http://www.levylaw.com/breast-cancer-misdiagnosis.php
Transvaginal Mesh Lawsuits: http://www.drugwatch.com/transvaginal-mesh/lawsuit.php
Feds sued for Secrets on HPV Vaccine Deaths – http://www.wnd.com/2013/03/feds-sued-for-secrets-on-hpv-vaccine-deaths/
Gardisil Lawsuit Vicitms:
Wisconsin sisters 19 & 20 yrs. say HPV vaccine caused ovaries to stop producing eggs
“FGM” Video: https://www.youtube.com/embed/6FWNHfw2MwY
Mirena IUD Birth Control Leads to Injuries in Women Lawsuits
My Mirena Warning to You: https://www.youtube.com/watch?v=y1t0RN1VCaI
America, now you can see there is a tidbit of disturbing similarities between “FGM” and Womens’ Reproductive Health!
Please pass along and help save Women in America and across the world!
Consumer Advocacy Business Industry Research & Investigations (CABIRI) 
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