MARCH 29, 2018
A Matter of Right and Wrong: The CDC’s Troubling Lack of Research Ethics
By Brian S. Hooker, Science Advisor, Focus for Health and Board Member, World Mercury Project
Documents obtained by the Freedom of Information Act indicate that Centers for Disease Control (CDC) officials gave preferential treatment to the Danish grantees (including Dr. Poul Thorsen) at Aarhus University, and took no apparent action to evaluate the veracity of any of the study data when theft of over $1 million of grant money by Thorsen was made known. Furthermore, in 2009, when CDC officials including Dr. Coleen Boyle (Director of the National Center for Birth Defects and Development Disabilities [NCBDDD]), Marshalyn Yeargin-Allsopp (Chief of the Developmental Disabilities Branch), Joanne Wojcik (Public Health Analyst, Developmental Disabilities Branch), and Diana Schendel (former CDC NCBDDD senior epidemiologist) became aware that Thorsen failed to obtain legally required ethics permissions for the autism bio and genetic data projects, these CDC employees worked with the Danish grantees to hide this fact.
…studies were conducted and results published without legally-required ethics clearances.
These officials have never made public that both the validity of childhood autism in the Danish Psychiatric Central Register (Lauritsen et al. 2010 Journal of Autism and Developmental Disorders) and the population-based study of measles, mumps, and rubella vaccination and autism (Madsen et al. 2002 New England Journal of Medicine) studies were conducted and results published without legally-required ethics clearances. They knew that the psychiatric registry records were reviewed without required permissions, a serious ethical violation.
On the 30th of November 2009, Coleen Boyle, Diana Schendel, Joanne Wojcik, and Marshalyn Yeargin-Allsopp, along with Danish grantees, failed to report this serious ethical violation in previously published research, as well as a study near publication. They sought to cover their tracks on their failure to ensure Poul Thorsen had obtained all the needed ethical approvals for autism bio and genetic studies. Two studies were published in which legally required ethical permissions were apparently never applied for and granted, according to their notes. When repeatedly asked to provide them, Thorsen did not.
These acts were a clear violation of both ethical and legal standards.
It appears that the biggest concern the CDC-Danish collaborators had at that point was getting ethical coverage for Diana Schendel’s paper on autism and inflammatory markers that was about to be published. They decided to extend the permissions obtained by another researcher (Dr. Rikke Maimburg from Aarhus) to Schendel’s work because Maimburg had been approved in 2000 for an unrelated study entitled ‘Obstetric factors and autism’. Their thinking was that since Diana’s study used mothers’ obstetric files, the 2000 Ethics Committee approval could be extended to her study (even though the committee never reviewed Schendel’s study design.) However, permissions for child records, which were also reviewed, were never obtained. These acts were a clear violation of both ethical and legal standards.
Thorsen, the principle investigator for the granted CDC funds, failed to provide evidence after the fact that he had obtained ethical committee permissions for his research on bio and genetic markers and autism. The team eventually determined no requests had ever been submitted. By all appearances, they found that studies related to the two papers, one previously published, were done without legally-required ethical approval. The two papers in question are:
- A population-based study of measles, mumps, and rubella vaccination and autism. Madsen KM, Hviid A, Vestergaard M, Schendel D, Wohlfahrt J, Thorsen P, Olsen J, Melbye M., 2002, New England Journal of Medicine 347:1477
- Validity of childhood autism in the Danish Psychiatric Central Register: findings from a cohort sample born 1990-1999. Lauritsen MB, Jørgensen M, Madsen KM, Lemcke S, Toft S, Grove J, Schendel DE, Thorsen P., 2010, Journal of Autism and Developmental Disorders 40:139
…the seminal Denmark study on the MMR and autism, used to “debunk” the vaccine-autism hypothesis both in the Institute of Medicine’s 2004 report “Vaccines and Autism” as well as in the National Vaccine Injury Compensation Program’s Omnibus Autism Proceedings, is an illegal study.
Notes from the Nov. 30, 2009 phone call between the CDC officials and Danish grantees include:
We have not been able to find a permission from ethical committee that covers both bio and genetic markers and autism. As far as we understand only one paper has been published using these data and Diana will soon be submiting (sic) another. Apart from the letter from the EC in our region (attached) we have not been able to locate the permission for abstraction of the psychiatric records, and it is likely that it does not exist.
Dr. Coleen Boyle, current Director of NCBDDD at CDC, should have shut this grant down immediately upon being informed that ethical clearances were not in place. She should have immediately contacted the Department of Health and Human Services Office of Research Integrity as well as the Office of Inspector General. Funding should have been discontinued. She should have led the charge to have these papers retracted. There should have been, at a minimum, a press release from the CDC to inform the public. Instead, Dr. Boyle along with Dr. Marshalyn Yeargin-Allsopp, Joanne Wojcik and Dr. Diana Schendel worked with their Danish Grantees to ‘fix it’ and retrospectively apply ethics approvals. Their next call on 14 December 2009 closed the case on Poul providing information to Aarhus.
Poul Thorsen’s reply from the Dec. 14, 2009 conference call was:
“As I have stated before to Carsten and Erik, I have not been able to locate the ethical approval for the autism pilot study. I recommend that new approvals are requested just as stated in the notes from the last conference call.”
Not only is this egregious behavior for government officials, but it also points to poor grant management by CDC staff. The CDC staff responsible for this multimillion dollar grant, starting with Diana Schendel, should have had copies of all the legally required ethics permissions in hand before the Danish grantees were allowed to get started, and before the first US taxpayer dollar was sent to Denmark.
Also, most notable is the fact that the seminal Denmark study on the MMR and autism, used to “debunk” the vaccine-autism hypothesis both in the Institute of Medicine’s 2004 report “Vaccines and Autism” as well as in the National Vaccine Injury Compensation Program’s Omnibus Autism Proceedings, is an illegal study. Without proper ethics approval, it should have never been published and indeed should be retracted from the New England Journal of Medicine.
This is one of two studies that the CDC has completed regarding the MMR vaccine and autism. Of course, the other study was completed by DeStefano et al. (2004 Pediatrics 113:259) and showed a statistically significant relationship between MMR timing and the incidence of autism, specifically in boys, despite the fact that the authors erroneously dismissed the relationship as evidence that individuals with autism had to get early vaccines to enroll in special education programs.
How can the CDC be trusted with stewarding vaccine safety for the U.S. if this is an example of how ethics are regarded within their ranks? Unfortunately, this is just one of many instances of research fraud and malfeasance within the CDC. CDC officials in the Immunization Safety Office and the Developmental Disabilities Branch have repeatedly omitted data and manipulated statistical results to deny any relationship between vaccines and neurodevelopmental disorders. These same officials have covered up the embezzlement of Federal funds by CDC grantee, Dr. Poul Thorsen as well as the romantic relationship between Thorsen and his CDC grant supervisor, Dr. Diana Schendel. As described by Robert F. Kennedy, Jr.,
this agency is truly “a cesspool of corruption” and should be disqualified from protecting the health of our children.
And this institution has led the charge on all things Lyme/MSIDS related.
For more on the CDC and corruption: https://madisonarealymesupportgroup.com/2016/11/29/spider-attacks-cdc/
CDC Corruption with Lyme: https://madisonarealymesupportgroup.com/2017/09/25/speaking-of-fake-science-fifty-seven-million-anti-trust-lawsuit-against-cdc-lyme-tests/ An anti-trust law suit of $57 million is being prepared against the CDC. They are accused of deliberately suppressing the use of an accurate DNA direct diagnostics for Lyme disease.
https://madisonarealymesupportgroup.com/2017/12/13/suppression-of-microscopy-for-lyme-diagnostics-professor-laane/ After publishing the 2013 article ‘A simple method for the detection of live Borrelia spirochetes in human blood using classical microscopy techniques’, professor Laane was invited to give a lecture at the 2014 Norvect conference in Oslo. I was present at that conference and still remember how nervous he was. The reason was that several medical professors complained to his university. He was threatened with losing his job, if he would speak at the conference. In fact, he did not literally speak – as you can see in the movie below – but used performing arts to show the slides of the spirochetes. Professor Laane was fired anyway and his laboratory was closed down.
https://madisonarealymesupportgroup.com/2017/10/06/remembering-dr-masters-the-rebel-for-lyme-patients-who-took-on-the-cdc-single-handedly/ Masters went over the charts with a fine tooth comb and found huge CDC errors. Another contentious point was the arbitrary cut off date imposed by the CDC which did not pick up serious late-stage symptoms. Another was the CDC’s rejection of many positive blood tests performed in its own lab, as well as other lab work showing “motile spirochetes” in nearly 5% of lone star nymphs. Long story short, after numerous revisions, Masters could never sign onto the bastardized study. The CDC had purposely tossed out data and manipulated the results.
The CDC essentially tried blackmailing Masters into signing off on the study before they would let him see the final draft. Refusing the bait, he published a letter of objection in the Journal of Infectious Diseases as well as an article of his own in Missouri Medicine which showed Missouri patients met the CDC surveillance definition for LD and growing evidence that lone star ticks were infected with an unidentified spirochete causing identical symptoms of LD in patients. When the CDC study came out they unbelievably attributed the rashes they labeled STARI to an allergy to tick saliva! In the acknowledgment section of the paper where dozens of folks were thanked, they completely omitted the man who made it all possible – Dr. Ed Masters. RIP – we will never forget you.
https://madisonarealymesupportgroup.com/2018/01/31/when-als-is-lyme-letter-to-tbi-working-group/ The racketeering scheme to downplay the severity of Lyme disease as identified in the RICO lawsuit should be addressed and documented by the TBD Working Group and not ignored as if this crime does not exist otherwise it will be business as usual at the Centers for Disease Control and we’ll have another thirty years of failure to properly diagnose, treat and control this life-altering infection.
https://madisonarealymesupportgroup.com/2017/12/09/25303/ 10 points – Suing the Architects of Lyme Policy as Task Force Meets to Review it
https://madisonarealymesupportgroup.com/2017/09/07/20268/ (complete convoluted history about Lymerix found in this link) In 2012, when the CDC revised the official case number of new Lyme disease infections per year from 30,000 to over 300,000 new Lyme––overnight, those of us in the know understood that they were getting the public ready to accept this upcoming vaccine with open arms and a sense of relief. In other words, scare the public just enough to make them open to wanting this product without causing mass panic nationwide or worldwide. And without having to explain their denial to date.
https://madisonarealymesupportgroup.com/2017/07/01/pbs-lyme-vaccine/ Did you know that the LYMERIX vaccine caused 640 emergency room visits, 34 life threatening reactions, 77 hospitalizations, 198 disabilities, and 6 deaths? In a vile cesspool of conflicts of interest are university patent holders, drug companies, and the FDA itself as another patent holder. It generated 40 million dollars before it was yanked. (2008, Drymon)