[*quote*]
Consumer Health Digest #24-03
January 21, 2024
Consumer Health Digest is a free weekly e-mail newsletter edited by William M. London, Ed.D., M.P.H.
http://www.calstatela.edu/faculty/william-m-london, with help from Stephen Barrett, M.D
http://www.quackwatch.org/10Bio/bio.html., It summarizes scientific reports; legislative developments; enforcement actions; other news items; Web site evaluations; recommended and nonrecommended books; research tips; and other information relevant to consumer protection and consumer decision-making. The Digest’s primary focus is on health, but occasionally it includes non-health scams and practical tips. Items posted to this archive may be updated when relevant information becomes available. To subscribe, click here
http://lists.quackwatch.org/mailman/listinfo/chd_lists.quackwatch.org###
Midwife faces unprecedented fine for substituting homeopathic pellets for children’s vaccinesThe New York State Department of Health has issued a $300,000 penalty as part of a Stipulation and Order
https://cdn.centerforinquiry.org/wp-content/uploads/sites/33/2024/01/21180325/breen_order.pdfsigned by Jeanette Breen, a licensed midwife who operated Baldwin Midwifery in Nassau County. The agreement notes she created false records of 12,449 immunizations for about 1,500 school-aged children located throughout the state.
[State health department issues unprecedented $300k penalty to midwife for falsifying vaccine records
https://www.health.ny.gov/press/releases/2024/2024-01-17_baldwin_midwifery.htm. New York State Department of Health press release. Jan 17, 2024]
Breen’s scheme began at the start of the 2019–2020 school year, just three months after the state eliminated non-medical exemptions for required school immunizations. Breen supplied a “Real Immunity Homeoprophylaxis Program,” a series of oral pellets marketed by an out-of-state homeopath
https://quackwatch.org/homeopathy/as an alternative to vaccination. The pellets were not authorized by the U.S. Food and Drug Administration (FDA), or approved by the Centers for Disease Control and Prevention (CDC) or the Health Department as an immunizing agent against any disease.
As part of the settlement, Breen has paid $150,000 of the $300,000 monetary penalty. The remainder is suspended contingent upon her achieving and maintaining full compliance with the Public Health Law, associated regulations, and all terms in the Stipulation and Order. These terms include:
being permanently denied access to the New York State Immunization Information System (NYSIIS) directly or through anyone acting on her behalf
permanently refraining from administering any immunization that must be reported to NYSIIS
not participating in any scheme or attempting to misrepresent any individual as having received immunization the individual, in fact, has not received
being prohibited from using Department of Health Immunization Record and Signature Cards and any similar documents generally intended to record immunization
including a clear disclaimer with any information provided to patients by Bree—regarding Real Immunity or any other product or treatment alleged to effect immunity—as to the nature of the product and the fact that it is not recognized by the government as an alternative to standard vaccination
The immunization records of affected children have been voided. Before they can return to school, they must be fully up to date with age-appropriate immunizations or be in the process of receiving their missing vaccinations. The immunizations that were part of the scheme included diphtheria, tetanus toxoid-containing and pertussis vaccine (DTaP or Tdap); hepatitis B vaccine; measles, mumps and rubella vaccine; polio vaccine; varicella (chickenpox) vaccine; meningococcal conjugate vaccine or booster doses; and the Haemophilus influenzae type b conjugate vaccine (Hib) and pneumococcal conjugate vaccine (PCV) required for daycare and pre-k only. Although not required for school enrollment and attendance, the scheme also included vaccines for influenza and hepatitis A.
###
Retraction Watch highlights new tactics being used to publish fake scientific papersFrederick Joelving, an editor for Retraction Watch
https://retractionwatch.com/, has described how paper mills operate to exploit “the growing pressure on scientists worldwide to amass publications even if they lack resources to undertake quality research.” These mills generate “possibly tens or even hundreds of thousands of articles every year
https://www.nature.com/articles/d41586-023-03464-x” that contain made-up data, are plagiarized, or are of low quality. Their preferred targets are open-access journals to which authors pay to have their articles considered for publication. In addition to selling papers to prospective authors and influencing manuscript reviewers, paper mills have exploited the lax vetting processes for hiring open-access journal editors and guest editors of special issues of the journals. They plant their own editors, who in some cases employ made-up identities rather than their own. They also pitch special issues to journal editors, get their own agents placed on editorial boards of journals, and attempt to bribe journal editors to publish papers. While some journal publishers have recently made significant efforts to retract fraudulent papers, it remains a challenge for editors to safeguard their journals against the efforts of paper mills.
[Joelving F. Paper trail
https://www.science.org/content/article/paper-mills-bribing-editors-scholarly-journals-science-investigation-finds. Science, Jan 18, 2024]
###
FDA authorizes Florida to initiate process for importing certain drugs from Canada.The FDA has authorized
https://www.fda.gov/media/175237/download?attachment Florida’s Agency for Health Care Administration’s drug importation program under section 804 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
https://www.fda.gov/about-fda/reports/importation-program-under-section-804-fdc-act.
[FDA authorizes Florida’s drug importation program
https://www.fda.gov/news-events/press-announcements/fda-authorizes-floridas-drug-importation-program. FDA news release, Jan 5, 2024]
This is the first step on the pathway toward Florida facilitating importation of certain prescription drugs from Canada. The imported products are called Section 804 Importation Program, or SIP, drugs. Through this pathway, the FDA can authorize proposals from states or Indian tribes to import certain prescription drugs from Canada if the process will significantly reduce the cost to American consumers without imposing additional risk to public health and safety. President Biden’s Executive Order on Promoting Competition in the American Economy directed the FDA to work with states and Indian tribes on these plans. Florida’s plan is authorized for two years from the date the FDA is notified of the first shipment of SIP drugs to be imported. Before these can be imported, Florida’s Agency for Health Care Administration must:
submit additional drug-specific information for the FDA’s review and approval
ensure the drugs Florida seeks to import have been tested for, among other things, authenticity and compliance with the FDA-approved drugs’ specifications and standards
relabel the drugs to be consistent with the FDA-approved labeling
submit a quarterly report to the FDA that includes information about the imported drugs, cost savings and any potential safety and quality issues
==================
Stephen Barrett, M.D.
Consumer Advocate
7 Birchtree Circle
Chapel Hill, NC 27517
Telephone: (919) 533-6009
http://www.quackwatch.org (health fraud and quackery)
[*/quote*]
Author
Topic: Midwife faces unprecedented fine for substituting homeopathic pellets for childr (Read 65 times)