Source: http://adventuresinautism.blogspot.com/2015/03/
Timestamp: 2019-04-18 10:58:35+00:00

Document:
MaineHealth Remains Completely Unaccountable for False Vaccine Claims. So I Wrote a Bill.
In our last installment of, "Ginger goes bitchcakes about all the Pharma lies being proffered in Maine," we learned that Cassandra Grantham of MaineHealth had lied about vaccine safety, claiming that there were several vaxxed/unvaxxed studies and they all showed no increased autism rates in vaccinated kids. Research that is as imaginary as the Power Puff Girls.
I called her out on it and she only dug a deeper hole, and then said she would not talk to me anymore.
So four months ago I decided to go on the fools errand of actually filing complaints against MaineHealth to get the false claims retracted and the company held accountable, just to prove that no one gives a damn... Wanna know what happened?
TL;DR: I filed complaints with every private, public, state and federal authority that might have oversight and no one gives a damn.
... and the ONLY response I received was from FDA who said they didn't have jurisdiction. No one is manning the gate.
So in short... there you have it. In Maine you can make ANY CLAIM YOU WANT ABOUT VACCINES and no one will do anything about it. Precedent set.
Below are all the letters, for your edification.
So I wrote a bill to try to put a band-aid on the disaster that is the current vaccine program and a very conscientious State Representative, Beth O'Connor, has introduced it into the Maine Legislature. I revived the Maine Coalition for Vaccine Choice and we are coming together to try to... do something... fix this... a bit... but honestly, until the 1986 act is repealed, our kids are going to continue to get sick and die and remain untreated at the hands of this screwed up program and all we will be able to do is stem the tide and keep our rights to opt out of it.
Robert F. Kennedy, Jr is going to come to Maine on May 11th and help us get these legislators to understand how badly the vaccine program is broken and that parents need to retain the rights to choose. Perhaps it will get enough people to understand the real problem that they will not put up with the corruption any more. Cross fingers.
I would like to file a complaint against MaineHealth for making fraudulent statements concerning one of their product lines.
MaineHealth, both on the VaxMaineKids.org web site and during an interview on MPBN on December 1, have made false vaccine safety claims. I have contacted VaxMaineKids, MaineHealth and MPBN to ask for a retraction and correction of the false marketing messages that they are issuing to the public, but none of the organizations will properly address the issue.
During an email exchange last summer with Cassandra Grantham, Program Director of Child Health at MaineHealth, initiated by Ms. Grantham after I had written about her work, I corrected the misinformation, sending VaxMaineKids a list with dozens of studies that link vaccines and autism. http://www.scribd.com/doc/220807175/86-Research-Papers-Supporting-the-Vaccine-Autism-Link Ms. Grantham failed to correct the false claims on the MaineHealth web site, and wrote that she was no longer interested in discussing the matter any further with me.
Ms. Grantham, representing Maine Health, made further false claims on December 1st on MPBN's Maine Calling, when she claimed that there were multiple studies compairing populations of unvaccinated children to children fully vaccinated according to the CDC schedule that have found no increased risk in autism among fully vaccinated children.
In fact, no such research exists, as testified to by Dr. Coleen Boyle, Director of CDC's National Center on Birth Defects and Developmental Disabilities during the House Oversight & Government Reform Committee hearing 1 in 88 Children: A Look Into the Federal Response to Rising Rates of Autism on November 29, 2012. In response to a question whether or not autism risk had been studied in vaccinated v. unvaccinated children Dr. Boyle stated, "We have not studied vaccinated v. unvaccinated."
I wrote to Ms. Grantham to ask that she cite her sources or retract her false claim. In her response, she referred to three publications as sources for her information, none of which referenced a vaccinated. v. unvaccinated autism study. In fact, one of her references, a 2013 report by the Institute of Medicine on the current US vaccine program, addressed the lack vaccinated v. unvaccinated research as a whole, and specifically in regard to autism and other developmental disabilities, and notes that parents and the public have been asking for this research for some time. The IOM report recommends against performing such research, because, although they admit it can be accomplished and would be informative, it would also be costly, time consuming and difficult.
Ms. Grantham actually replied to me with information that confirms my allegations against her false claim by MaineHealth.
I have further contacted several staff members at MaineHealth to ask for a retraction and for clarification of their stance on a public policy. I have received no reply.
Further, I have contacted both Maine Calling hosts and producers, as well as MPBN management, to ask for a retraction of these fraudulent claims, but none have replied.
I have attached the email chains below.
As MaineHealth is receiving both insurance payments and tax dollars for delivering vaccines, I believe it may be under the purview of the Bureau of Insurance to exercise authority over the false claims being made to the public about product line that MaineHealth is providing to the public.
Further, it is imperative that the State of Maine provide oversight in this matter, as the federal 1986 National Childhood Injury Act has removed the rights of families to sue corporations like MaineHealth when members are harmed or killed by a vaccine. The result of this blanket liability protection which has been in place for decades is that physicians, medical care providers, health corporations and even government agencies routinely put out false safety and efficacy information, because there is no mechanism by which the public may directly hold them accountable for fraudulent claims. The public's right to take these entities into a civil court, force them testify under oath, have judgments rendered by a jury and have remedies be enforced by a judge has been removed. As a result, misinformation can be circulated by both malicious and merely uninformed parties, including doctors providing recommendations to patients in their offices. Bad faith parties and organizations who wish to make outright fraudulent claims are free to do so with out fear of legal reprisal from their customers, even if the worst possible outcome happens and the vaccination that was delivered under false information and/or coercion results in the death of a child.
This complaint does not represent the total number of false statements made by Ms. Grantham and MaineHealth, but is a short complaint on the easily corrected fraud currently taking place. In light of their refusal to correct even these extremely obvious false statements, I believe that a full accounting of their vaccine safety claims is appropriate.
Further, Ms. Grantham in her professional, role has been quoted in the Portland Press Herald as advocating the elimination of the philosophical vaccine exemption in Maine. This would remove the right of children to a free and appropriate education if their parents did not choose to vaccinated as the state requests. As vaccines are legally classified by the federal government as “Unavoidably Unsafe” (which means they cannot be made safe for their intended use) and can result in serious diseases, disorders, disability, brain damage and death, it a civil rights matter that parents and individuals be free to exercise their right to informed consent, and to reject one or more vaccines ones self or ones child. It is also a civil rights matter that children be allowed equal access to a free and appropriate public education with out being impeded by discriminatory policies. In their actions in the last 6 months, I assert that MaineHealth has demonstrated a willingness commit fraud in order to achieve their goal of removing either families right to medical informed consent or the right to a public education for their children to increase vaccine sales.
In no other area of medicine are these types of false claims on pharmaceutical products allowed. I hope that The Bureau of Insurance will take this matter seriously and exercise their authority here to protect Maine consumers against false vaccine safety claims.
Thank you for listening to MPBN’s Maine Calling Show – it is great to know that we have reached such a wide audience with important vaccine messages. I want to clarify that I do not represent any product line or company other than MaineHealth, which is a health system which supports on-time childhood immunizations. I have never been paid by or consulted for a pharmaceutical or medical intervention company or agency. Please see below for MaineHealth’s official statement regarding childhood immunizations.
No reply from MPBN as of this filing.
Letter also forwarded to patientrelations@mmc.org, no response as of this filing.
Ms. Grantham, representing Maine Health, made further false claims on December 1st on MPBN's Maine Calling, when she claimed that there were multiple studies comparing populations of unvaccinated children to children fully vaccinated according to the CDC schedule that have found no increased risk in autism among fully vaccinated children.
In fact, no such research exists, as testified to by Dr. Colleen Boyle, Director of CDC's National Center on Birth Defects and Developmental Disabilities during the House Oversight & Government Reform Committee hearing 1 in 88 Children: A Look Into the Federal Response to Rising Rates of Autism on November 29, 2012. In response to a question whether or not autism risk had been studied in vaccinated v. unvaccinated children Dr. Boyle stated, "We have not studied vaccinated v. unvaccinated."
I wrote to Ms. Grantham to ask that she cite her sources or retract her false claim. In her response, she referred to three publications as sources for her information, none of which referenced a vaccinated v.. unvaccinated autism study. In fact, one of her references, a 2013 report by the Institute of Medicine on the current US vaccine program, addressed the lack vaccinated v. unvaccinated research as a whole, and specifically in regard to autism and other developmental disabilities, and notes that parents and the public have been asking for this research for some time. The IOM report recommends against performing such research, because, although they admit it can be accomplished and would be informative, it would also be costly, time consuming and difficult.
Further, it is imperative that the State of Maine provide oversight in this matter, as the federal 1986 National Childhood Vaccine Injury Act has removed the rights of families to sue corporations like MaineHealth when members are harmed or killed by a vaccine. The result of this blanket liability protection which has been in place for decades is that physicians, medical care providers, health corporations and even government agencies routinely put out false safety and efficacy information, because there is no mechanism by which the public may directly hold them accountable for fraudulent claims. The public's right to take these entities into a civil court, force them to testify under oath, have judgments rendered by a jury and have remedies be enforced by a judge has been removed. As a result, misinformation can be circulated by both malicious and merely uninformed parties, including doctors providing recommendations to patients in their offices. Bad faith parties and organizations who wish to make outright fraudulent claims are free to do so without fear of legal reprisal from their customers, even if the worst possible outcome happens and the vaccination that was delivered under false information or coercion results in the death of a child.
This complaint does not represent the total number of false statements made by Ms. Grantham and MaineHealth but is a short complaint on the easily corrected fraud currently taking place. In light of their refusal to correct even these extremely obvious false statements, I believe that a full accounting of their vaccine safety claims is appropriate.
Further, Ms. Grantham in her professional, role has been quoted in the Portland Press Herald as advocating the elimination of the philosophical vaccine exemption in Maine. This would remove the right of children to a free and appropriate education if their parents did not choose to vaccinate as the state requests. As vaccines are legally classified by the federal government as “Unavoidably Unsafe” (which means they cannot be made safe for their intended use) and can result in serious diseases, disorders, disability, brain damage and death, it a civil rights matter that parents and individuals be free to exercise their right to informed consent, and to reject one or more vaccines for one’s self or one’s child. It is also a civil rights matter that children be allowed equal access to a free and appropriate public education without being impeded by discriminatory policies. In their actions in the last 6 months, I assert that MaineHealth has demonstrated a willingness commit fraud in order to achieve their goal of removing either families’ rights to medical informed consent or the right to a public education for their children to increase vaccine sales.
In no other area of medicine are these types of false claims on pharmaceutical products tolerated. I hope that Maine DHHS will take this matter seriously and exercise its authority here to protect Maine consumers against false vaccine safety claims.
In no other area of medicine are these types of false claims on pharmaceutical products tolerated. I hope that the Maine Immunization Program will take this matter seriously and perform its duty in this case to protect Maine consumers against false vaccine safety claims.
I would like to file a complaint against MaineHealth, which I believe is a member of the Maine Immunization Coalition and whose web site, VaxMaineKids.org is supported by your coalition, for making fraudulent statements concerning one of their product lines.
It is imperative that vaccine promotional programs are accurate in their claims, as the federal 1986 National Childhood Vaccine Injury Act has removed the rights of families to sue corporations like MaineHealth when members are harmed or killed by a vaccine. The result of this blanket liability protection which has been in place for decades is that physicians, medical care providers, health corporations and even government agencies routinely put out false safety and efficacy information, because there is no mechanism by which the public may directly hold them accountable for fraudulent claims. The public's right to take these entities into a civil court, force them to testify under oath, have judgments rendered by a jury and have remedies be enforced by a judge has been removed. As a result, misinformation can be circulated by both malicious and merely uninformed parties, including doctors providing recommendations to patients in their offices. Bad faith parties and organizations who wish to make outright fraudulent claims are free to do so without fear of legal reprisal from their customers, even if the worst possible outcome happens and the vaccination that was delivered under false information or coercion results in the death of a child.
I would hope that the Maine Immunization Coalition's work to increase vaccine uptake rates would not include offering disinformation to the public to obtain their consent to vaccinate, and that you will correct your member's false safety claims, insisting they retract these fraudulent statements, which only further erode trust in the vaccine program you are promoting.
Thank you for your inquiry to the Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER). CBER, one of seven centers within FDA, is responsible for the regulation of biologically-derived products, including blood intended for transfusion, blood components and derivatives, vaccines and allergenic extracts, and cell, tissue and gene therapy products.
We appreciate your concerns and please know that ensuring the safety and effectiveness of vaccines is one of FDA’s top priorities. Unfortunately, we will be unable to assist you with your complaint against MaineHealth. FDA regulates the manufacturing of biological products including vaccines; however, the Agency does not regulate the general practices for home health care, healthcare systems, pharmacies, hospitals, or physicians.
If you should have any other questions or concerns regarding this subject, please feel free to contact a representative from FDA's Consumer Affairs Branch within CBER at ocod@fda.hhs.gov.
This communication is consistent with 21 CFR 10.85 (k) and constitutes an informal communication that represents my best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.
I know that the FDA has gone after several companies for making false claims, on supplements especially, and inappropriate use. What department or departments of the FDA are responsible for those oversight actions?
Thank you for your follow-up inquiry.
All vaccines are required to include a true statement of information in brief summary relating to side effects, contraindications, and effectiveness in accordance with Title 21 of the Code of Federal Regulations, Part 202.1(e)(1). A copy of the regulation is available at: http://edocket.access.gpo.gov/cfr_2014/aprqtr/pdf/21cfr202.1.pdf. Information on FDA’s surveillance of advertising practices is also available on CBER’s website at: http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ComplianceActivities/Enforcement/UntitledLetters/UCM091551.
factors that contribute to medication errors, such as unclear label abbreviations, acronyms, dose designations, and error prone label and packaging design. Additional information on advertising and promotional labeling is available on the CBER website at: http://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/Advertising LabelingPromotionalMaterials/ucm164120.htm and http://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/Advertising LabelingPromotionalMaterials/ucm117616.htm.
Federal regulations specify what can and cannot be included in the advertising and marketing of prescription drug products. This information can be found in Title 21 of the Code of Federal Regulations (CFR) Section 202.1 (http://edocket.access.gpo.gov/cfr_2014/aprqtr/pdf/21cfr202.1.pdf) and 203 (http://www.access.gpo.gov/nara/cfr/waisidx_08/21cfr203_08.html). In addition to FDA regulations, the Federal Trade Commission (FTC) has requirements for advertisements of health products targeting consumers. You may wish to contact the FTC for more information on their regulations (http://www.ftc.gov/ftc/contact.shtm).
It is important to note that FDA regulations apply to advertising and promotion by or on behalf of the drug product manufacturer. FDA does not have jurisdiction over the statements of other persons. For accurate information, we suggest that consumers refer to FDA’s website and the FDA approved labeling for drug products.
This is very helpful. I will review what you have send and will be back in touch if I have more questions.
Bold in letter from Ms. Burkhoff above is mine: FDA does not have jurisdiction over the statements of other persons.
During an email exchange last summer with Cassandra Grantham, Program Director of Child Health at MaineHealth, initiated by Ms. Grantham after I had written about her work, I corrected the misinformation, sending VaxMaineKids a list with dozens of studies that link vaccines and autism. (http://www.scribd.com/doc/220807175/86-Research-Papers-Supporting-the-Vaccine-Autism-Link) Ms. Grantham failed to correct the false claims on the MaineHealth web site, and wrote that she was no longer interested in discussing the matter any further with me.
Ms. Grantham, representing MaineHealth, made further false claims on December 1st on MPBN's Maine Calling, when she claimed that there were multiple studies comparing populations of unvaccinated children to children fully vaccinated according to the CDC schedule that have found no increased risk in autism among fully vaccinated children.
I have contacted several staff members at MaineHealth to ask for a retraction and for clarification of their stance on a public policy. I have received no reply.
It is imperative that the FDA provide oversight in this matter, as the federal 1986 National Childhood Vaccine Injury Act has removed the rights of families to sue corporations like MaineHealth when members are harmed or killed by a vaccine. The result of this blanket liability protection which has been in place for decades is that physicians, medical care providers, health corporations and even government agencies routinely put out false safety and efficacy information, because there is no mechanism by which the public may directly hold them accountable for fraudulent claims. The public's right to take these entities into a civil court, force them to testify under oath, have judgments rendered by a jury and have remedies be enforced by a judge has been removed. As a result, misinformation can be circulated by both malicious and merely uninformed parties, including doctors providing recommendations to patients in their offices. Bad faith parties and organizations who wish to make outright fraudulent claims are free to do so without fear of legal reprisal from their customers, even if the worst possible outcome happens and the vaccination that was delivered under false information or coercion results in the death of a child.
Further, Ms. Grantham in her professional, role has been quoted in the Portland Press Herald as advocating the elimination of the philosophical vaccine exemption in Maine. This would remove the rights of children to a free and appropriate education if their parents did not choose to vaccinate as the state requests. As vaccines are legally classified by the federal government as “Unavoidably Unsafe” (which means they cannot be made safe for their intended use) and can result in serious diseases, disorders, disability, brain damage and death, it a civil rights matter that parents and individuals be free to exercise their right to informed consent, and to reject one or more vaccines for one’s self or one’s child. It is also a civil rights matter that children be allowed equal access to a free and appropriate public education without being impeded by discriminatory policies. In their actions in the last 6 months, I assert that MaineHealth has demonstrated a willingness commit fraud in order to achieve their goal of removing either families’ rights to medical informed consent or the right to a public education for their children to increase vaccine sales.
In no other area of medicine are these types of false claims on pharmaceutical products tolerated. I hope that the FDA will take this matter seriously and exercise its authority here to protect consumers against false vaccine safety claims.
MaineHealth, both on their VaxMaineKids.org web site and during an interview on Maine Public Broadcasting (MPBN) on December 1, have made false vaccine safety claims. I have contacted VaxMaineKids, MaineHealth and MPBN to ask for a retraction and correction of the false marketing messages that they are issuing to the public, but none of the organizations will properly address the issue.
During an email exchange with Cassandra Grantham, Program Director of Child Health at MaineHealth, initiated by Ms. Grantham after I had written about her work, I corrected the misinformation, sending VaxMaineKids a list with dozens of studies that link vaccines and autism. http://www.scribd.com/doc/220807175/86-Research-Papers-Supporting-the-Vaccine-Autism-Link Ms. Grantham failed to correct the false claims on the MaineHealth web site.
In fact, no such research exists, as testified to by Dr. Colleen Boyle, Director of CDC's National Center on Birth Defects and Developmental Disabilities during the House Oversight & Government Reform Committee hearing, 1 in 88 Children: A Look Into the Federal Response to Rising Rates of Autism on November 29, 2012. In response to a question whether or not autism risk had been studied in vaccinated v. unvaccinated children Dr. Boyle stated, "We have not studied vaccinated v. unvaccinated."
I wrote to Ms. Grantham to ask that she cite her sources or retract her false claim. In her response, she referred to three publications as sources for her information, none of which referenced such a study. In fact, one of her references, a 2013 report by the Institute of Medicine on the current US vaccine program, addressed the lack vaccinated v. unvaccinated research in regard to autism, and notes that parents and the public have been asking for this research for some time.
It is imperative that the FTC provide oversight in this matter, as the federal 1986 National Childhood Vaccine Injury Act has removed the rights of families to sue corporations like MaineHealth when members are harmed or killed by a vaccine.
Ms. Grantham, in her professional, role has been quoted in the Portland Press Herald as advocating the elimination of the philosophical vaccine exemption in Maine. This would remove the right of children to a free and appropriate education if their parents did not choose to vaccinate as the state requests. I assert that MaineHealth has demonstrated a willingness commit fraud in order to achieve their goal of removing either families’ rights to medical informed consent or the right to a public education for their children to increase vaccine sales.
So doctors... feel free to claim that vaccines are made of rainbows and unicorn tears if you think you patients will believe you... cause no one cares if you lie.

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