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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

CABIRI Business Services

American Medical Rehabilitation Fund – For Unexpected Medical Trauma’s (AMRF)

American Medical Rehabilitation Fund

 For Unanticipated Medical Trauma’s

 

 American citizens are suddenly becoming ill and losing there entire life’s history due to major unforeseen medical trauma’s caused by faulty drugs, medical device and/or tainted products.

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CABIRI, is seeking investors to help establish an American Medical Rehabilitation Fund for victims of unexpected life-threatening medical trauma’s that has altered, their households and families lives.

 The fund will be established for individuals who have pending lawsuits and are having difficulties maintaining their households while undergoing rehabilitation and additional surgery’s while awaiting their pending lawsuits to be resolved.

 Many employers will only disburse sick pay for previous time worked, leaving many individuals and their families struggling to cover living expenses such as; food, utilities, mortgage, child care, car payments, medications or any other pertinent family household living expenses that has to be paid while they are in recovery.  

 AMRF, is imperative for many individuals who are suffering from unforeseen major medical side-effects and surgery’s due too life-threatening faulty drugs or medical devices. Many individuals are losing their entire lives while their cases are tied up in Multi-Jurisdiction or Supreme Court proceedings. What would you do if your life was on track and all of sudden you became severely medically ill, from deadly side-effects that had left you incapacitated and unable to maintain your job, household or lifestyle for over 9 months?   

 “Hypothetically speaking,” let’s say you’ve recently been told you have a severe deadly disease,  and/or you need several surgeries’ to correct a current medical trauma, your presently experiencing from a faulty drug or medical device, and you may have to be out of work for a period of 9 months or more recuperating, and under continuous doctor’s care?  

 How would you cover your living expenses for 9 months?

 Would your employer hold your position open while you go back and forth to the Doctor 2 and 3 times a week?

 Would you’re your employer hold your job for you if your hospitalized on 4 separate occasions resulting in 1 to 2 week stays?

 Can your family members cover your living expenses while you’re incapacitated for 9 months?

 Do you have enough sick time saved up to be compensated while you are out of work for a period of 9 month extended sick leave?

 Can your spouse or family members cover your mortgage or rent for 9 months?  

 

Do you have family members you can move in with or take care of you while recuperating from several major surgeries?

 

Do you have anyone who can care for your children and daycare expenses?

 

Do you have income to purchase food for your family?

 

Do you have income to purchase additional medical costs not covered by your insurance?

 

How would you provide transportation for your family if you can’t keep up with your car insurance and car payments over a 9 month period of time?

 Will you borrow money or receive a loan that you do not know when you can pay back do to your health status and rebuilding your life?

 These are very important questions every family should ask themselves the above scenario’s could be you or any of your family members; mother, daughter, father, or your elderly parents on a fixed income. Ask yourselves, what if I was in a predicament as such, what would I do? How would I survive?  Could your immediate family and friends help care for you and your children for a 9 month period of time or more?

 Will your attorney help you from going into debt and stop bill collectors from calling, while your lawsuit is being resolved and you are still in recuperation mode.

 Will you be able too rebuild your entire life again, from an unforeseen severe medical illness that has left you lifeless, homeless and unable to provide for yourself or your family?    

 What if you called around for assistance to be told by many agencies, churches and other establishments there are no funds available at this time, or the limited help provided isn’t enough to cover basic household expenses?

 If you had trouble answering any of the above questions, please join CABIRI, in our new quest and help Invest and contribute to the “American Medical Rehabilitation Fund,” that will be there to help cover expenses for individuals who are faced with severe unforeseen life-threatening major medical problems, that are beyond their control and require extensive lengthy medical rehabilitation and constant doctor care.  

 The American Medical Rehabilitation Fund (AMRF), will help many suffering families who are facing severe medical financial dilemma’s such as these in America, and have no where to turn for temporary financial assistance, while they are in recuperating stages and under doctors care. In addition, AMRF will help fund individuals trying to rebuild their lives once again from being medically incapacitated for a period of 4 months or more. The fund will also reach out and assist Veterans and their families who are in need of additional assistance due to unexpected injuries caused by war, impacting their families and children’s lives. AMRF will continually assist American citizens who have recent unexpected life-threatening major illnesses and their cases are currently in litigation. The other portion of the funding will assist individuals with major medical rehabilitation for a period of 6 months, helping them maintain their medically interrupted households so they can heal accurately without the stress of worrying about their households and how bills will be maintained while they are in rehabilitation and recovery stages.     

 The new AMRF fund, was established for a young lady who recently lost her and her children’s entire life in a recent storage unit sale, she was forced to rent after undergoing 9 months of extensive life-threatening medical traumas from a medical device that was not foreseen for a period of 6yrs. The young lady has lost her home, vehicle, and her children’s personal belongings, family memorabilia, along with displacement of her children, and her two pets.

 The sudden unforeseen life-threatening medical debacle impacted her entire family and has left her in a very distraught trying situation, now having to somehow pull herself out of this medical nightmare after receiving a hysterectomy towards the end of 2013. The medical trauma has turned the young lady and her two children’s, and family’s worlds upside down in a split second from 2012-2013 and currently 2014.    

 How is this young lady able to rebuild her life from scratch from losing her life for 9 months, and awaiting a pending lawsuit that can take several years to resolve? In the meantime, her employer has let her go, her unemployment benefits have run out, and she’s having trouble finding employment due to the length of time she’s been out of work, potential employers question her about why she’s been out of work for such a long period of time, she told them due to medical reasons, this throws up a red flag to the employer who does not want to hire someone who’s recently had severe medical problems, that has left them out of work for  a period of 9 months. What is this young lady to do? She has to start rebuilding her and her children’s lives somehow. She’s borrowed from all her friends and family members while ill and now the well has run dry, and she has no other means to provide for her or her children to start rebuilding their lives.

 This is a very sad trying situation for this particular young lady, especially when she’s used to being the bread winner, providing for her family and helping others. She’s currently facing displacement and frustration do to no help from local tapped out organizations with no funding.

This young lady needs urgent help getting her life back on track from falling suddenly ill from a faulty medical product she had no clue would alter her life in such a drastic way. Prior to her medical trauma the young lady was a very active, healthy, hardworking upper-level business professional.      

 CABIRI, is asking help from all American citizens to contribute to the newly established American Medical Rehabilitation Fund (AMRF), for victims such as the young lady mentioned above and any other American families who may be in need of additional assistance, whom are facing life-threatening medical trauma’s and rehabilitation from horrific unforeseen medical illnesses from faulty drugs or medical devices. The fund can help many families who need urgent assistance preventing families from spiraling out of control, and help individuals get their lives back on track from being continuously deathly ill for a period of 3 months or more.  

 A sudden unforeseen life-threatening medical dilemma is not the fault of the individual, and isn’t fair to them. Why should someone have to endure losing their life history, and become displaced all due to a major medical nightmare, then turn around and endure trying too rebuild a entire new life with no resources? This is not moral, fair or humane in this day and age and American citizens should have a funding source who can assist with helping individuals and their families stay, or get back up on their feet after sudden severe medical dilemma’s that have occurred that were out of their control.

 The doctors, pharmaceutical corporations and lawyers continue on with their  daily lives with their families, while the infected patient and their family’s lives have been destroyed by their faulty drugs, medical devices, and products. Is this fair in America? All of the top three business professionals have profited from the patient and moved on to their next culprits. Is this fair to the patient? Please climb aboard and help these families and contribute to AMRF, American Medical Rehabilitation Fund! AMRF would be no different than Hospice who keeps individuals comfortable for a certain length of time.  

 CABIRI

Consumer Advocacy Business Industry Research and Investigations

If anyone would like to donate to the young lady who remained Anonymous due to her current medical litigation case.

Please go to:  consumer2savlies.com FOR AMRF Donations’

Thank you for helping rebuild lives from unexpected life altering medical issue’s! 

CABIRI Business Services

America’s Interpol International Connections

INTERPOL vs U.S. PHARMACEUTICAL

United States Interpol Agency has numerous international sponsors, by which many sponsors are top pharmaceutical & biotech companies in the United States. Not only does American’s have to worry about the NSA, the U.S. government and citizens should be concerned with the U.S. Interpol police agency, who’s international connections run deep! In early 2013 the Pharmaceutical Industry Initiative to Combat Crime signed an agreement with 29 of the world’s largest pharmaceutical companies, giving the U.S. Interpol agency funding in Euro dollars over a 3yr, period of time which enables these international corporations to take more control over the United States pharmaceutical markets and the U.S. Interpol agency.

Interpol’s so called agreement, is to prevent pharmaceutical crime and counterfeiting for branded and generic drugs in the United States to combat crime, which many of these top U.S. pharmaceutical companies are providing the world and American citizens with many of the same tainted toxic drugs they are combating. How can you combat crime when your the culprit’s doing the crime?

The top U.S. pharmaceutical companies and U.S. National Interpol agency, other sneaky objective’s is to dismantle organized crime networks, expand training and building opportunities with their newly formed U.S. partnership. Top U.S. pharmaceutical companies are providing funding for their own criminal activities, inflicting harm all over the world and U.S. population impacting numerous lives.These pharmaceutical companies efforts are in vein, when these international pharmaceutical companies and U.S. Interpol agency has the majority controlling interest in combating crime, one could say the relationship between the United States Interpol and International U.S. pharmaceutical companies would be a contradictory partnership.  

Mr. Snowdens reports of United States illegal activities should be re-focused, on his counter partners International criminal activities against the United States and how they’ve illegally infiltrated top U.S. governmental agencies and businesses by financing their own efforts to take control over the United States, which many Americans may not know the majority of international funding comes from American citizens, over a long period of time via international U.S. based business operations.  

America not only has severe problems with the U.S. NSA, there are major issue’s within the United States Interpol agency the world’s largest police monitoring agency, whom are working directly with U.S. international pharmaceutical markets.

Known Interpol U.S. Pharmaceutical Sponsors

Abbott, Almirall, Amgen, Astellas Pharma, AstraZeneca, Bayer AG, Boehringer Ingelheim, Celgene, Chugai Pharmaceutical Co., Daiichi Sankyo, Dainippon Sumitomo Pharma, Eisai Co., GlaxoSmithKline, Lilly, Lundbeck, Menarini SA, Merck & Co., Merck KGaA, Novartis, Novo Nordisk, Otsuka Pharmaceuticals, Pfizer, Roche, Sanofi, Shionogi  & Co., Takeda Chemical Industries, UCB

Image

CABIRI,

Support: Consumer Advocacy Business Industry Research and Investigations 

Press Releases:

 http://www.briefingwire.com/pr/united-states-international-economic-warfare-whos-really-in-control-america

http://www.briefingwire.com/pr/pharmaceutical-vs-agriculture

http://www.briefingwire.com/pr/snowden-is-wrong-united-states-has-been-spied-on-for-decades

Email: consumer2savlives@gmail,com

Website: consumer2savlives.com

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CABIRI Business Services

Consumer Advocacy Business Industry Research & Investigations – CABIRI

 PHARMACEUTICAL VS. AGRICULTURE

Industry: Pharmaceutical & Agriculture News
Business: Bayer AG – Monsanto

Business information this week will be advertised freely, all information after December 20th, 2013 will be based upon consumer request. The format will be a power point news presentation for easy viewing and convenience to review important business investigations & research news pertaining to the specific corporation or industry request. Information is for consumer corporation business knowledge operating in the United States and Abroad!

                                   

Current Highlight – Germany Agricultural and Pharmaceutical Business Industry Connection

 Many government agencies has somehow missed the boat, by not overseeing mergers and business purchases made by corporations and private businesses. With no governmental monitoring there are several international business industry owners who seem to be “Keeping it in the family!”

  Many consumers may not know that U.S. German Bayer AG (Holding Company) entered a series of cross-licensing agreements with Monsanto in the early part of 2013.  This would make Monsanto a German based business not American! With the cross-licensing agreement Bayer AG (Headquartered in Germany), Limited company Bayer Crop Science will acquire the business aspects of Monsanto and it’s subsidiary a independent German family owned business, KWS SAAT AG.  See Below Diagram

 

Global Business Industry Impact

Monsanto – Global Industry Impacts

 

Industries: Chemical, Agriculture, Biotechnology

 

Controlling Markets:

Crops, Laundry Detergents, Pesticides, GM Food, Insecticides, GM Seeds, Led (light emitting diodes), DDT, Agent Orange, Synthetic Fibers, Herbicides, Bt Cotton (India), Cotton (Acquired by Bayer AG. U.S.) Gm Plants, Sulfuric Acid, Polyurethanes, Acetic Acid, AstroTurf, rBGH (Bovine Growth Hormone),  Nucleus Herds, & Industrial Bio-Testing, Plant Biotechnology, Pig Genetics, Semen, Nuclear Weapons, Various Pharmaceutical Drugs (Celebrex – L-dopa),Chiral Compounds, Polychlorinated biphenyls (PCBs), RoundUp Ready Alfalfa (RRA), Bollgard I Cotton and Many more not listed

  

Monsanto Sold Markets:

Animal Genetics Sold – (2009) U.S. (Privately Held) Newsham Genetics  – Swine Genetics

Subsidiary of: Group Grimaude (France) – Multispecies Genetics Supplier largest in North America

Cotton Division Sold – (2009) Partner Bayer Crop Science –  (Subgroup of Bayer AG of Germany)

  

SUBSIDIARIES & AFFILIATE’S

Partnerships – Mergers & Affiliations

 

Major Corporations & Privately Owned Businesses

Newsham Genetics – UK & U.S.

Grimaud, Bucolica Bv ( Netherlands financial group holds majority interest in Newsham)

Rattle Row Seghers – European formerly know as; Seghers Genectics NV – (Belgium)

RA – SE Genetics & Elita Ltd. – Ukraine 

D & F Afxentiou – Belgium

Syngenta – Switzerland

Many international business partners: Europe, India, China, Ukraine, Belgium, Switzerland & Canada

 

United States & Global Affiliations

BASF – Dow – Dupont – Mobay – Mound Laboratories – Cargill Seeds – NutraSweet

Pfizer – Americot – Climate Corp. – Seminis – De Ruiter Seeds – Dutch – Hoescht AG

I.G. Farben – Bayer Ag – Bayer Cropscience – Aventis – Solutia Inc., Asgrow

Agracetus – Calgene – Pharmacia – UpJohn – Emergent Genetics, Unilever,

Nexgen – Delta & Pine Ltd – Genetec – Dekalb Genetics, Climate Corp., Phytogen and

Holden Foundation. Numerous GMO patents held by BAYER, BASF & MONSANTO!

Financial Reports can be requested – Cash Value Paid at 3 to 4x’s FMV for many businesses!

  

Business Issue’s & Concerns

Farming Suicides – False Advertising

Anti – Trust – Generally Modified Corn, Soy Beans, Beets, Wheat, Potato, etc.,

Environmental Damage – Global Protest

Chemical Waste Leakages – Contamination

Patent Violations (Terminator, Patent Swaps) & Lawsuits- Dioxin & Toxic Chemical Spills

Unauthorized Genetically Modified Organisms – Pollution

Deregulations – Various Drug Health Risks

Scientific Misconduct and Fraud – Highly Toxic Fungicides – Maxium or Thirum

Seed Piracy – Crop Failures – Seed Production Child Labor (India)

False Advertising – Bee Killings ( Pesticides-Herbicides) 

Various U.S. & Top High Profile Political Agents & Agencies Monsanto Supporters

Defending Farmer Lawsuits against U.S. Farmers for GM Seeds

 

Bayer Crop science GM Patents: Maize, wheat, rice, barley, soy, cotton, sugar beet, rape, potatoes, tobacco, tomatoes, grapes – the list of transgenic plants & Many more not listed

 

Monsanto Global Concerns: – United States, Argentina, Canada, Brazil, India, China, Europe, Haiti, Australia, and Spain

 

In 2008, the International Assessment of Agricultural Science and Technology for Development (IAASTD), initiated by the United Nations and the World Bank warned that research and dissemination of knowledge is being restricted by the increasing registration of patents. Especially in developing countries this would prevent locally adapted agricultural practices contributing to food security and economic sustainability.

 

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The United States Medical Board does not accept international degree’s, although the government allows international business owners with green cards to run billion dollar U.S. corporation. The top U.S. Big Pharma and Biotech corporations are run by other countries along with many other business & corporations in the United States!

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