CDC FUNDING , A CONFLICT OF INTEREST ‘ COLLABORATE WITH DRUG MANUFACTURERS’RESEARCHERS
LATEST RESEARCH I HAVE FOUND ON CDC WHICH MAY INTEREST MANY OF YOU- Carol Sakey WakeUpNZ
OUTSIDE GIFTS: CDC has delegated authority from the Assistant Secretary for Health, HHS, to accept outside gifts. Specifically, Section 231 of the Public Health Service Act (42 USC 238) authorizes acceptance of unconditional and conditional gifts “…for the benefit of the Public Health Service or for the carrying out of any of its functions.” https://www.cdc.gov/partners/gift-funding.html In the spring of 2016, CDC’s ACD made seven recommendationspdf icon pdf icon[PDF – 285 KB] for ethical considerations with CDC’s public-private partnerships. These recommendations focused on how CDC engages the private sector and reaffirm CDC’s commitment to the American people. The workgroup found it necessary to understand the complexity of relationships with private partners. This included both direct relationships between the agency and outside organizations from multiple sectors including private, NGO, philanthropic and business sectors. Additionally, CDC has a unique and somewhat complex relationship with the CDC Foundation, an organization established by Congress for the sole intent of facilitating public private partnerships with CDC. Further background on these relationships and the Legislative framework for CDC public private partnerships can be found in Appendix B. Ethical_Considerations_for_Public_Private_Partnerships_Recommendations_to_ACD.pdf (cdc.gov) https://journals.asm.org/doi/10.1128/jcm.00134-06?permanently=true 2007
EXPERIMENTAL EVALUATION OF THE FLU CHIP DIAGNOSTIC MICRO-ARRAY FOR INFLUENZA VIRUS SURVEILLANCE: By using a new algorithm (22, 29) developed in our laboratory for sequence selection and described in the companion paper (22), a low-density microarray (the FluChip-55 microarray) was designed to use a relatively small set of capture and label sequences (n = 55) for analysis of the subtypes of three important influenza A viruses and some influenza B viruses. The results from a thorough blind study involving 72 samples provided by the Centers for Disease Control and Prevention (CDC) are described herein. The samples contained RNA from influenza viruses recently isolated from several species, including human, avian, equine, and swine species. Additionally, nine patient samples that had previously been shown to be positive for influenza virus were tested on the microarray. The total cost per assay, including the chips and all reagents used during printing, amplification, and hybridization, is less than $20. The unique aspects of this work include the microarray design and sequence selection, the use of target RNA rather than DNA, the broad range and large number of viruses used to test the microarray, and the implementation of a novel and highly effective visual identification methodology.
THE FLU CHIP AND CDC: The CDC provided 72 samples for a blind study of the FluChip-55 microarray. The sample set was later revealed to contain three negative controls: two water samples and one sample that contained bovine serum albumin. An independent negative sample (water) was added to the sample set in the University of Colorado laboratory for control purposes. The viral isolates provided represented samples from human, avian, equine, and swine species. The original samples were acquired by a range of techniques, including from throat swabs, nasopharyngeal swabs, or tracheal aspirates or by bronchoalveolar lavage. The viruses were propagated in either embryonated eggs or MDCK cells (15). Genomic RNA was extracted directly from allantoic fluid or cell culture supernatant with an RNeasy kit (QIAGEN, Valencia, CA). The virus type and subtype were predetermined at the CDC by sequencing of the hemagglutinin and neuraminidase genes and by traditional serological techniques.
CAPTURING B Y ALGORITHM: A new algorithm for the mining of large databases to identify regions of genetic conservation for highly mutable viruses such as influenza virus was recently developed in our laboratory; the algorithm is fully described in the companion paper (22). Sets of capture and label sequences that were anticipated to be capable of discriminating between different influenza virus types and subtypes were selected, spotted in an easily visualized microarray format (Fig. 1), and evaluated. Specifically, the 55 capture-label pairs were chosen to enable identification of influenza A virus M, HA1, HA3, HA5, NA1, and NA2 genes and influenza B virus M, NP, and HA genes, thereby covering the two most common influenza A viruses currently circulating in the human population as well as the avian A/H5N1 virus that is of great concern throughout the world. The entire set of capture and label sequences is shown in Table 1.
Future directions. In subsequent efforts the FluChip microarray will be expanded to cover a larger number of important influenza virus strains, such as the avian H7N3 (34), H7N7 (3, 12, 14), and H9N2 (4, 19, 26) virus strains. Novel viruses transmissible from species to species, such as the equine influenza virus H3N8 (6), which was recently found in canines, will also be addressed. S
ACKNOWLDGEMENTS: This CDC Collaboration Article on the FluChip concluded with aknowledging funding from National Institute of Allergy and Infectious Diseases (NIH) Grant Number Uo1 AI056528-03. Thanking InDevR, LLC for use of its Genetix microarrayer and particularly thanking Linda Kuck for spotting the microarrays and her helpful discussions in array design and layout. Thanking Rebessa Garten at the Centre for Disease Control (CDC) for her assistance with the database organization and selection of conserved regions targeting influenza virus. Also thanking Patricia Young of the Colorado Dept of Public Health and Environment for providing patient samples.
A LITENY OF UNTRUTHS: Despite the claim that “CDC does not accept commercial support,” this agency does indeed have financial ties to industry organizations, through their government-charted foundation. Congress has created foundations for many government organizations, including the Food and Drug Administration (FDA), National Institutes of Health (NIH), and Centers for Disease Control and Prevention (CDC), to supplement the agencies’ funding for specific projects and encourage more public-private partnerships.
FINANCIAL CONFLICTS: https://lowninstitute.org/cdc-disclaimers-hide-financial-conflicts-of-interest/ Since the CDC Foundation was created in 1995, hundreds of corporations have contributed to public health programs, for a total of $161 million in donations. Many of these contributions could be seen as conflicts of interest–for example, a $193,000 donation from Roche, the maker of antiviral drug Tamiflu, to fund a CDC flu prevention campaign. Despite the significant funding the CDC receives from industry via its foundation, few were aware of these conflicts until Jeanne Lenzer called attention to the foundation in The BMJ a few years ago. Recently, the CDC accepted $3.4 million from Pfizer for the prevention of Cryptococcal disease, $1 million from Merck & Co. pharmaceutical company for a program on preventing maternal mortality, and $750,000 from Biogen for a program on screening newborns for spinal muscular atrophy, the petition states
FALSE DISCLAIMERS: The petitioners ask that CDC should stop publishing the false disclaimers, remove the disclaimers from their website and resources, and issue corrections to retroactively disclose financial relationships with industry. “It’s time for the CDC to be truthful with health professionals and all Americans, and to stop denying that it takes corporate money,” said Gary Ruskin, co-director of U.S. Right to Know, in STAT. “The CDC is violating the public trust by misleading us in this way.”
CORPORATIONS AND PUBLIC HEATH: Many in the health community believe corporate ties are undermining the authority of the hugely influential public health agency. Many people in and out of the medical community were shocked to read in an article published earlier this year in the medical journal the BMJ that the U.S. Centers for Disease Control and Prevention (CDC) takes funding from industry. As Jeanne Lenzer, an independent reporter and associate editor at the BMJ, pointed out in that article, pharmaceutical and other types of companies can — and do — fund CDC projects by giving money to the CDC Foundation, a nonprofit organization created by Congress in the mid-1990s to “connect CDC to the private sector to advance public health.” And that has raised some serious conflict-of-interest concerns. For example, to help pay for its new “Take 3” flu-prevention campaign, the CDC, via its foundation, accepted a $193,000 donation from Roche, the company that makes the antiviral drug Tamiflu, Lenzer reported last February.
THE MEDICAL COMMUNITY WERE SHOCKED: Many people in and out of the medical community were shocked to read in an article published earlier this year in the medical journal the BMJ that the U.S. Centers for Disease Control and Prevention (CDC) takes funding from industry. As Jeanne Lenzer, an independent reporter and associate editor at the BMJ, pointed out in that article, pharmaceutical and other types of companies can — and do — fund CDC projects by giving money to the CDC Foundation, a nonprofit organization created by Congress in the mid-1990s to “connect CDC to the private sector to advance public health.” And that has raised some serious conflict-of-interest concerns.
THE CDC AND ITS DONATIONS: For example, to help pay for its new “Take 3” flu-prevention campaign, the CDC, via its foundation, accepted a $193,000 donation from Roche, the company that makes the antiviral drug Tamiflu, Lenzer reported last February. One of the central tenets of the “Take 3” campaign is the recommendation that people take an antiviral drug like Tamiflu if they develop symptoms of the flu. That advice, however, is highly controversial. Indeed, another government agency, the Food and Drug Administration (FDA), says that the clinical trial data it has reviewed does not support the claim that Tamiflu saves lives or reduces hospitalizations, including among the elderly.
ADDITIONAL CONFLICTS: Earlier this month, Lenzer wrote again for the BMJ on CDC’s industry funding. In that article, she offers two additional examples of how controversial decisions recently made by the CDC are associated with that funding. One involves the CDC’s recommendation that everyone born between 1945 and 1965 be screened for the hepatitis C virus. As Lenzer details in her article, the science behind such widespread screening has been challenged. She also describes how industry’s connections with the CDC raise questions about why that screening recommendation was made:
FINANCIAL TIES TO DRUG MANUFACTURERS: In 2010, the CDC, in conjunction with the CDC Foundation, formed the Viral Hepatitis Action Coalition, which supports research and promotes expanded testing and treatment of hepatitis C in the United States and globally. Industry has donated over $26m to the coalition through the CDC Foundation since 2010. Corporate members of the coalition include Abbott Laboratories, AbbVie, Gilead, Janssen, Merck, OraSure Technologies, Quest Diagnostics, and Siemens — each of which produces products to test for or treat hepatitis C infection. Conflict of interest forms filed by the 34 members of the external working group that wrote and reviewed the new CDC recommendation in 2012 show that nine had financial ties to the manufacturers.
TIES TO THE SUGAR INDUSTRY: The CDC has also accepted $1.7 million from the sugar industry to fund a series of studies involving an epidemic of chronic kidney diseases among agricultural workers in Central America, particularly among young men working in the sugar fields. The epidemic has killed more than 20,000 workers over the past two decades. As Lenzer notes, researchers have cited two interrelated factors as the most likely explanation for the epidemic: dangerous pesticides and difficult working conditions. When the men cut sugar under a hot, tropical sun, they get dehydrated, which may leave them more susceptible to the kidney damage caused by chemical toxins.
INDUSTRY BIAS: “Industry funding undermines trust and introduces a bias in the presentation of results and treatment recommendations that is deplorable for a government agency,” he said. “If the allegations of industry funding and influence are true, we will have to look very carefully at recommendations we are following now and those made in the future by the CDC.”- Dr. Neil Calman, president and chief executive of the Institute of Family Health, a large New York-based community health center network