Dr. Russell Blaylock on Who Created Orthodox Medicine

Dr. Russell Blaylock, Faked Medical Data, Top Stories, Undue Influence, Vaccine Propaganda

Dr. Russell Blaylock on Who Created Orthodox Medicine

No Comments 16 March 2010

“Who Created Orthodox Medicine?”

Dr. Russell Blaylock:

“Who created orthodox medicine? Where did that come from?”

“Well, it actually came from the Rockefeller Foundation back in 1901.”

“The Rockefellers at the time . . . because of the Standard Oil scandals, no one wanted to be called a Rockefeller.

“Everybody hated all the Rockefellers. And so his friend, Reverend Gates, went to John D. Rockefeller, Sr. and told him, he said, “Well, here’s a way we can repair your reputation.” And he gave him a good example. He said, “There was this man who everybody hated . . . and he started giving money out for all sorts of philanthropic enterprises, and soon people forgot all of the bad things.” . . .

“So the first thing, because Gates’ father was a physician, and John D. Rockefeller’s father was a quack snake-oil salesmen, he said, “Let’s form the Rockefeller Institute of Medical Research.” And so they created this in 1901. . . .”

“Rockefeller owned what was called the drug trust: that’s the major drug manufacturing firms all over the world: Merck Pharmaceuticals, Lederle, all of these . . . pharmaceutical companies . . .”

“And of course, the aim was to remove all nutrition, references to nutritional type treatments, from the medical schools. They closed down half the medical schools in the United States. There were 165 medical schools at the time. . . . Then he had his anointed medical schools, which he poured his money into, appointed the professors from his own stock of professors. And so they created an educational system that taught the things that he wanted taught. And therefore every professor that came out of those programs taught the same thing.”

  1. http://russellblaylockmd.com
  2. The Regimentation in Medicine and the Death of Creativity
  3. Flexner Report (http://www.carnegiefoundation.org/sites/default/files/elibrary/Carnegie_Flexner_Report.pdf)
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Ex-Pfizer Worker Cites Genetically Engineered Virus In Lawsuit Over Firing

General, Vaccine Development

Ex-Pfizer Worker Cites Genetically Engineered Virus In Lawsuit Over Firing

No Comments 16 March 2010

By EDMUND H. MAHONY

The Hartford Courant

March 14, 2010

Medical experts will be watching closely Monday when a scientist who says she has been intermittently paralyzed by a virus designed at the Pfizer laboratory where she worked in Groton opens a much anticipated trial that could raise questions about safety practices in the dynamic field of genetic engineering.

Organizations involved in workplace safety and responsible genetic research already have seized on the federal lawsuit by molecular biologist Becky McClain as an example of what they claim is evidence that risks caused by cutting-edge genetic manipulation have outstripped more slowly evolving government regulation of laboratories.

McClain, of Deep River, suspects she was inadvertently exposed, through work by a former Pfizer colleague in 2002 or 2003, to an engineered form of the lentivirus, a virus similar to the one that can lead to acquired immune deficiency syndrome, or AIDS. Medical experts working for McClain believe the virus has affected the way her body channels potassium, leading to a condition that causes complete paralysis as many as 12 times a month.

“If a worker in a plant as sophisticated as Pfizer is becoming infected with a genetically engineered virus, then I think the potential is everywhere,” said Jeremy Gruber, president of the Council for Responsible Genetics, a public interest group created to explore the implications of genetic technologies.

“Genetically engineered viruses are commonly worked on at your average university,” Gruber said. “The public has a right to know what regulations are in place and what regulations are required to fix an industrywide issue. We need to have a conversation about this. Ms. McClain’s attempt to do that has been hampered at every turn, by the courts and by regulators.”

Pfizer disputes all of McClain’s claims and says it fired her in 2005 because she refused to come to work. The global pharmaceuticals manufacturer, with research labs in southeastern Connecticut, defends its safety practices and denies that McClain’s physical disability is related to exposure at its Groton lab. The company says she did not link her disability to workplace exposure until after she was fired.

As a molecular biologist, McClain studied cells on a molecular level, manipulating genetic codes in an effort to develop vaccines. During the period at issue in the suit, McClain worked in Pfizer’s Human Health Embryonic Stem Cells Technologies, Genomic and Proteomic Sciences and Exploratory Medicinal Sciences Group.

Hostile Exchanges

The sharp disagreement between McClain and her former employer mirrors a half-dozen or so years of hostile litigation leading to Monday’s jury trial in Hartford before U.S. District Judge Vanessa L. Bryant. McClain will argue that she was wrongfully dismissed and is entitled to unspecified damages. In the run-up, Pfizer attacked McClain’s legal claims, and she questioned the company’s corporate integrity.

On the advice of her lawyers, McClain would not discuss her suit last week. Neither would her lawyers, nor those representing Pfizer.

But McClain has claimed in her suit and in earlier public statements that she was fired after experiencing symptoms of illness and after complaining to the U.S. Occupational Safety and Health Administration about safety in her Pfizer lab.

OSHA dismissed McClain’s complaint. In a decision published after McClain’s termination, the agency criticized her for refusing to return to work in spite of “Pfizer’s substantial efforts” to address her concerns. In a speech last year to a labor safety group in California, McClain said she was told by an OSHA investigator that the federal agency’s legal authority has not kept pace with developments in sophisticated medical research.

A series of angry, pretrial exchanges developed over McClain’s efforts to compel Pfizer to give her precise information about the DNA sequencing of the engineered lentivirus she suspects infected her. Pfizer says it responded to all of McClain’s requests, in accordance with the law. Her advocates called Pfizer’s assertion preposterous and claimed the company has not produced — perhaps because it is subject to trademark — the sequencing data that could enable scientists to engineer a genetic cure.

Over the course of pretrial argument, the number and breadth of McClain’s legal claims against Pfizer have been reduced from eight to two. Last month, Bryant dismissed the most significant of the eight claims: that willful and wanton misconduct by Pfizer resulted in lax laboratory procedures. McClain claimed laxity contributed to her exposure.

McClain’s advocates point to language in Bryant’s ruling that suggests the misconduct allegation was dismissed, at least in part, because state law requires such claims to be resolved by state workers’ compensation rules. But Pfizer says Bryant’s ruling is another vindication of its assertion that no evidence exists to support McClain’s contention that she was infected by a viral exposure at Pfizer.

“We have thoroughly investigated Ms. McClain’s claims and our investigation concluded that her workplace was safe and that she was not infected by any virologic materials while she was employed by Pfizer,” company spokeswoman Elizabeth Power said.

Bryant’s ruling means the trial will move forward under McClain’s two remaining claims, both of which involve free speech protection. She says Pfizer fired her in violation of Connecticut’s whistle-blower law after she raised questions about Pfizer lab safety to OSHA. And she claims her dismissal also was in retaliation for questions she raised in discussion with Pfizer colleagues about safety practices. In addition to performing her research duties, McClain served on a lab safety committee for at least part of the nine years she was employed by Pfizer.

Medical Evidence

Pfizer has taken the position that Bryant’s ruling in March means no evidence will be admitted at the trial concerning McClain’s health or her claim that it was destroyed by bad lab procedures. McClain’s advocates, again, disagree. Because McClain is suing under a whistle-blower claim, they believe she will be allowed to present evidence about why she figuratively blew the whistle. If her health and safety are the reasons, they say, the judge could allow jurors to hear evidence in those areas.

In her suit, McClain says that Pfizer hired her in 1995 and that, in 2000, she became involved in human cellular research associated with vaccine development. She later learned, the suit says, that colleagues in her lab were working with infectious, genetically engineered viruses, including the lentivirus she suspects causes what her physician calls “acute intermittent paralysis.”

The suit describes lab events that McClain suggests could have infected her.

The first involved the possible malfunction of a “laminar hood,” a system designed to contain materials being subjected to scientific manipulation and to purify the air circulating around the materials. She said the hood began emitting a noxious odor at the same time she and several colleagues developed symptoms of illness, including nausea.

McClain said in the suit that, as a member of the lab safety committee, she reported the apparent hood malfunction. Judge Bryant said in a preliminary ruling that Pfizer took “various steps” to fix the hood and ultimately replaced it, twice.

Pfizer contends that the hood problem was resolved eight months after McClain reported it. But a long e-mail message by one of McClain’s supervisors and the OSHA review corroborate McClain’s contention that the problem persisted for a year. Before it was corrected, several people suffered from headaches, vomiting and nausea, including at least one member of the crew that cleaned the lab after work.

About two months after the hood problem was resolved, McClain says in the suit, she learned from a colleague that he was working “next to” her on “dangerous lentivirus material and embryonic stem cells.” The work was being done on an open lab bench, unprotected by a biological containment system, the suit says, even though lentivirus work should have been done only under a protective “biological hood.”

“I was shocked and appalled to find he had been using lentivirus materials on an open lab bench without biocontainment where I performed my office work (e.g. without gloves) in October 2003,” McClain wrote in a legal filing.

On another occasion, she says, she encountered an unidentified experimental set-up consisting of cell cultures on her laboratory bench, but she cannot recall whether she touched it.

Pfizer has responded that any lentivirus studied in lab areas where McClain was present was not derived from a human infectious virus and was not infectious because it lacked genes for replication.

McClain says in the suit that she repeatedly raised laboratory safety issues following the hood malfunction, despite a warning from a supervisor that doing so could jeopardize her employment. She said she began suffering from “fatigue, suspicion of multiple sclerosis, joint pain, and numbness in her face as well as sleep difficulties” and took a medical leave in February 2004. She was fired about 11 months later.

The suit contends the dismissal was retaliation for her complaints about safety. In a speech a year ago, McClain asserted that some of the safety deficiencies she has criticized are the product of poor lab design — design that is nonetheless acceptable under OSHA rules.

Pfizer contends that McClain’s dismissal was not related to her concern about safety. Rather, the company says, she was terminated for refusing to report back to work after the company made her repeated offers, including alternative employment opportunities, some in laboratories other than the one about which she had complained. Pfizer claims McClain was told in advance of her termination that she would be fired if she didn’t return to work.

Even though jurors are unlikely to hear arguments that McClain’s potassium disorder and related transient paralysis are attributable to exposure to an engineered virus, a network of laboratory safety advocates already is using the case as a rallying point. A group from San Francisco has planned a press conference outside the Hartford courthouse on Main Street at 12:15 p.m. Monday.

They say OSHA’s inability to stay abreast of developments in sophisticated, molecular research techniques — as well as law protecting the confidentiality of proprietary discoveries — has neutralized the agency’s ability to act as an effective regulator.

“This case shows a major flaw for workers in the biotech industry who have to prove where they got injured in order to receive workers’ compensation,” said Steve Zeltzer, one of the organizers.

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Merck to Build New Vaccine Plant With IBM, GM, UPMC and Battelle

Medical Cartel, Top Stories, Vaccine Development

Merck to Build New Vaccine Plant With IBM, GM, UPMC and Battelle

No Comments 11 March 2010

Press Release

CONTACT: Wendy Zellner
PHONE: (412) 586-9777
E-MAIL: ZellnerWL@upmc.edu
Battelle, IBM, Merck Join UPMC’s Effort to Produce Vaccines to
Protect Public Health
21st Century Biodefense Offers Innovative Solution to President Obama’s Call for
Improved Response to Bioterrorism and Infectious Diseases

PITTSBURGH, March 11 – Building on its extensive efforts to establish a flexible vaccine development and production facility to strengthen the nation’s biosecurity, UPMC announced today that it has been joined by Battelle, IBM and Merck & Co. Inc. in this first-of-its-kind initiative. These industry and non-profit leaders are supporting UPMC and GE Healthcare in pursuing the construction of this facility, which UPMC proposes to operate in a unique partnership with the federal government.

“With this powerful coalition of partners, we will finally address a critical gap in the nation’s defenses against bioterrorism and infectious diseases,” said Robert J. Cindrich, UPMC’s chief legal counsel and chairman of the initiative, known as 21st Century Biodefense (21CB). “Through this collaboration, we are poised to deliver the urgently needed advances in vaccine development and manufacturing as recently called for by President Obama in his State of the Union address.”

Battelle, the world’s largest, independent research and development organization, has agreed to provide comprehensive pre-clinical research and development services, including infectious disease model development and product safety and efficacy evaluations in a Good Laboratory Practice (GLP) environment. These services will support the licensure of new vaccines and therapeutics by the U.S. Food and Drug Administration. Battelle also will provide project management support and senior leadership to 21CB’s advisory board. “We are committed to solving the most critical problems in human health and stand ready to be a full partner in this impressive public-private initiative,” said John Wade, vice president for Battelle.

IBM will provide innovative information technology, such as IBM’s new POWER7 systems, to create the infrastructure that will support 21CB manufacturing processes and operations. This infrastructure will be able to handle extreme volumes of data and scale quickly to adapt to changing demand. “IBM brings leading technology to 21CB, as well as access to teams of life sciences researchers at each of our eight research labs around the world,” said Dan Pelino, general manager, IBM Healthcare and Life Sciences. “We’re pleased to bring our deep skills and pharmaceutical industry consulting expertise to support 21CB and its important mission.”

Merck, a global pharmaceutical company, has agreed to provide drug-development and bioprocess counsel as part of a planned consortium of other biopharmaceutical companies. Merck also will provide senior leadership to 21CB’s advisory board and training for facility staff when 21CB begins operations. “As a global company with a long history of dedication to public health, Merck is pleased to share its technical expertise with 21CB in this innovative approach to enhancing our nation’s biodefense capabilities,” said Diana Lanchoney, executive director, Merck Research Laboratories. These new 21CB partners join GE Healthcare, which announced in October 2009 that it would provide manufacturing design and development expertise, as well as production equipment, consumables, and manufacturing processes for 21CB. GE Healthcare’s leadership in bioprocessing and its innovative disposable manufacturing technologies will enable 21CB to rapidly and flexibly produce vaccines for the U.S. government’s dynamic biosecurity needs. The new facility would be designed to produce multiple vaccines simultaneously and would have the ability to quickly switch production from one vaccine to another to respond in a crisis.

In his State of the Union address on Jan. 27, President Obama announced a new initiative to respond faster and more effectively to bioterrorism and infectious diseases. The Administration said it plans to pursue “a business model that leverages market forces and reduces risk to attract pharmaceutical and biotechnology industry collaboration with the U.S. government.” Department of Health and Human Services Secretary Kathleen Sebelius has launched a comprehensive review of the nation’s public health countermeasure enterprise with the goal of providing “a modernized countermeasure production process where we have more promising discoveries, more advanced development, more robust manufacturing, better stockpiling, and more advanced distribution practices. In other words, we want to create a system that can respond to any threat at any time.”

With the expectation that the government will allocate money for this public health priority, UPMC and its partners plan to compete for the funds to build a vaccine facility. Through 21CB, UPMC would share in the necessary private funding and own and operate the facility under the direction of the federal government as a public-private partnership, thus ensuring that the plant focuses on national health priorities. The initiative would create 1,000 jobs directly and up to 6,000 indirectly, while increasing the nation’s pool of scientists and engineers.
# # #
About 21st Century Biodefense (21CB) 21CB is a non-profit corporation established by UPMC in 2009 to build, own and operate a facility for the development and manufacture of biologic drugs and vaccines to protect against bioterrorism and certain naturally occurring disease threats. The targeted drugs and vaccines have limited commercial markets, thus spawning the need for this new and innovative solution. 21CB has created a coalition of private interests to work with the U.S. government in helping it meet its responsibilities in the area of biodefense. 21CB would act in a public-private partnership with the U.S. government to bring to bear the expertise and resources necessary to meet the nation’s pressing need for medical countermeasures and therapeutics to combat bioterrorism, while fortifying and expanding the nation’s bio-industrial base.

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Henrietta Lacks, HeLa Cells, and Cell Culture Contamination

Vaccine Development, Vaccine Snafus

Henrietta Lacks, HeLa Cells, and Cell Culture Contamination

No Comments 10 March 2010

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Brendan P. Lucey, MD, Walter A. Nelson-Rees, PhD, and Grover M. Hutchins, MDFrom the Department of Neurology, Michael O’Callaghan Federal Hospital, Nellis Air Force Base, Nevada (Dr Lucey); and the Department of Pathology, Johns Hopkins Hospital, Baltimore, Maryland (Dr Hutchins).

Abstract

Henrietta Lacks died in 1951 of an aggressive adenocarcinoma of the cervix. A tissue biopsy obtained for diagnostic evaluation yielded additional tissue for Dr George O. Gey’s tissue culture laboratory at Johns Hopkins (Baltimore, Maryland). The cancer cells, now called HeLa cells, grew rapidly in cell culture and became the first human cell line. HeLa cells were used by researchers around the world. However, 20 years after Henrietta Lacks’ death, mounting evidence suggested that HeLa cells contaminated and overgrew other cell lines. Cultures, supposedly of tissues such as breast cancer or mouse, proved to be HeLa cells. We describe the history behind the development of HeLa cells, including the first published description of Ms Lacks’ autopsy, and the cell culture contamination that resulted. The debate over cell culture contamination began in the 1970s and was not harmonious. Ultimately, the problem was not resolved and it continues today. Finally, we discuss the philosophical implications of the immortal HeLa cell line.

Accepted: March 6, 2009

Deceased. Dr Nelson-Rees, retired, contributed significantly to the manuscript before his death.

Reprints: Brendan P. Lucey, MD, Department of Neurology, Michael O’Callaghan Federal Hospital, Nellis Air Force Base, 1400 N Las Vegas Blvd, Nevada 89191 (brendanlucey@hotmail.com).

HENRIETTA LACKS

On February 1, 1951, a 30-year-old woman named Henrietta Lacks presented to the Johns Hopkins Gynecology Clinic in Baltimore, Maryland, for symptoms of spotting between her menstrual periods. Her last menstrual period had been on January 4, 1951.1 Although the results of her general examination were unremarkable, examination of the cervix revealed a raised, smooth, glistening, and purple lesion less than 2.54 cm (1 inch) in size.2 The lesion was confined to the cervix and appeared different from other carcinomas of the cervix seen by the treating physician. It was later noted in the autopsy report3 by Ella Oppenheimer, MD, that “1 year before death the patient delivered a normal infant and 6 weeks later her cervix was said to be normal. Three months later she presented herself to the clinic with a 2–3 cm cervical tumor.” Results of tests for sexually transmitted diseases were negative and a biopsy of the cervix was performed. Four pieces of tissue from the biopsy were sent to the pathology department and “epidermoid carcinoma, cervix uteri, spinal cell type” was diagnosed with definite invasion of the stroma (Figure 1).1

During the next several months, the patient received 4800 mg-h of radium and 11500 R (roentgen) of deep x-ray.3 Treatment failed to prevent spread of the cancer, however, and it extended relatively rapidly to both parametria. On August 8, 1951, she developed severe abdominal pain and was admitted to The Johns Hopkins Hospital (Baltimore, Maryland). Her pain became progressively more severe and intractable. Because of failure to void urine, ureteral catheterization was unsuccessfully attempted several times and the serum level of nonprotein nitrogen rose to from 120 to 150 mg/dL (reference range, 25-50 mg/dL). Diathermy therapy was tried without positive effect. Henrietta Lacks died at 12:15 am on October 4, 1951.3

THE AUTOPSY

Ms Lacks’ autopsy was performed at 10:30 am on the same day as her death. Examination of the body revealed a “well-developed, thin, colored female [with] deeply pigmented skin over the lower abdomen such as seen after x-ray treatment.”3 The peritoneal cavity contained a small amount of yellowish fluid and approximately 1 L of fluid was found in the pleural cavity, but the pericardium was devoid of fluid. The lungs were noted to have bibasilar lobar pneumonia with cheesy material in the bronchi. The mucosa of the bronchi was blood stained. The cranial cavity and neck organs were not examined because permission was not granted.

Small, white, and firm nodules were observed throughout both the thoracic and abdominal cavities, including the surfaces of the peritoneum, the entire length of the intestines, and the surface of the liver. Furthermore, both the pleural surface and the superior surface of the diaphragm (right side more than the left side) were covered with nodules, as were the lung, liver parenchyma, and the pericardium. The nodules varied slightly in size, measuring from 8 mm in diameter on the peritoneal surface to 1 cm in the lung parenchyma. However, the largest mesenteric lymph node infiltrated with tumor was 6 cm in length. Small tumor nodules, 3 mm in diameter, were seen in each adrenal gland. At the apex of the right ventricle, a tumor nodule approximately 1 cm in diameter protruded into the lumen. Relatively little necrosis was seen in any of the nodules.

A large subcapsular hematoma was present at the superior pole of the right kidney and a tumor nodule had grown into the capsule. Bilaterally, the ureters, calyces, and pelves were markedly dilated, consistent with severe hydronephrosis. The left ureter was involved in a mass of tumor just inside the brim of the pelvis, while a tumor mass near the posterior wall of the bladder entangled the right ureter. The bladder itself was adherent to the anterior abdominal wall. Many small nodules were seen on the bladder mucosa, and the external surface was nearly a solid mass of tumor.

The right ureter was dilated within 4 cm of the bladder, where the dilatation ceased abruptly. At this level, the circumference of the ureter was 14 mm; distally, the right ureter had been left intact and a probe passed with some difficulty down to the bladder. The probe could not be passed through the left ureter to the bladder, although both ureteral openings appeared patent from within the bladder. Closer examination revealed that the left ureter was dilated to the bladder wall, at which point a mass of tumor on the external surface caused the obstruction. The bladder was partially surrounded by nodular masses of tumor that penetrated the bladder wall, particularly in the trigone area. The bladder was not especially dilated. Tumor was seen infiltrating the wall of the vagina and friable masses of tumor replaced the cervix. The uterus was approximately normal in size and covered with tumor nodules, while the fallopian tubes and ovaries were obliterated by clusters of tumor nodules. A mass of tumor surrounded the iliac veins, and the area of the right iliac vein appeared to have tumor entering its lumen. Focal uremic diphtheritic colitis was also noted.

HeLa CELLS

Henrietta Lacks’ cervical biopsy supplied tissue to the pathology department for clinical evaluation and to the Tissue Culture Laboratory in the Department of Surgery at The Johns Hopkins Hospital for research purposes. In 1951, George Gey, MD, was director of the laboratory and had already spent many years at Johns Hopkins as a student and faculty member. Prominent scientists at Johns Hopkins, such as Ross Harrison, MD, PhD, and Warren Lewis, MD, made important contributions to the history of tissue culture.4,5 Dr Gey and his wife and chief collaborator, Margaret Gey, RN, continued in this tradition and began working on tissue culture in association with Dr Lewis in 1922. Dr Gey’s work grew to encompass in vitro investigations related to endocrinology, cancer, and virology in addition to intracellular and membrane cytology.4 However, his greatest scientific contribution was due to Henrietta Lacks.

While Henrietta Lacks was treated at Johns Hopkins, Dr Gey was attempting to fulfill ambitious goals for the Tissue Culture Laboratory, that is, “the isolation and maintenance of normal and malignant or otherwise diseased tissues as temporary or stable organoids or as derived cell strains.”6 Toward this purpose, Dr Gey and his colleagues collected tissue from surgical procedures throughout the hospital.7 Approximately 30 specimens of cervical cancer had been sent to the laboratory of Dr Gey by the time Ms Lacks presented to the gynecology clinic.2 An investigator in the laboratory, Mary Kubicek (Figure 2), placed cells obtained from the biopsy specimen of Henrietta Lacks into culture by using the roller-tube technique; the cells grew robustly, contrary to the results with previous specimens, becoming the first human cancer cell line immortalized in tissue culture. The cells were named “HeLa” after the initial 2 letters of Henrietta Lacks’ first and last names. She would not be credited as the originator of the cell line for many years, and HeLa cells were misinterpreted as originating with “Harriet Lane” or “Helen Lane” for years.7,8

Previous efforts to grow either normal cervical epithelium or cervical carcinoma in culture proved elusive9; however, efforts to grow cells from the aggressive adenocarcinoma of the cervix that had affected Henrietta Lacks were successful. Twenty years later, reexamination of the histopathology slides from Ms Lacks’ surgical biopsy and autopsy led to a revision of the initial diagnosis, with the finding that the patient had a very aggressive adenocarcinoma of the cervix.9 The cervical carcinoma was clearly very malignant and the patient had a rapid clinical deterioration. Although the concept of rapidly progressive cervical carcinoma has been questioned,10 this case history would suggest otherwise. Recently, HeLa cells have been shown to contain human papillomavirus (HPV) 18 DNA11 and HPV18-positive HeLa cells have been linked to changes in microRNA expression.12 Since HPV18 has been associated with very aggressive adenocarcinomas, this finding may explain why Dr Gey was surprised by the prolific growth of HeLa cells in culture. Routine Papanicolaou smear screening may not detect rapidly progressive cervical carcinomas; the new HPV vaccine holds the promise of preventing these tumors.

Gey and colleagues13 published data with HeLa cells in 1952, reporting the “evaluation in vitro of the growth potential of normal, early intra-epithelial, and invasive carcinoma from a series of cases of cervical carcinoma.” Only 1 strain of cervical carcinoma cells was established in “continuous roller-tube cultures for almost a year,” which grew in a medium of chicken plasma, bovine embryo extract, and human placental cord serum: HeLa.13 Dr Gey’s roller-tube technique for tissue culture was another significant scientific contribution and was used by John Enders, PhD, and colleagues in their work cultivating poliomyelitis virus in nonnervous system tissue.4 Perhaps less well known in the history of poliomyelitis research is that Dr Gey successfully propagated poliomyelitis viruses in HeLa cell culture.14

TISSUE CULTURE CONTAMINATION

George Gey was generous with requests for HeLa cells. Since HeLa cells were a robust, immortal cell line, easily propagated over generations in culture, Dr Gey supplied samples to scientists in the United States and internationally who were interested in studying the first established human cancer cell line. HeLa cells proliferated in cultures around the world and, as the years passed, evidence accumulated that HeLa cells had contaminated other cell lines. Interspecies cross-contamination with HeLa, easier to detect than intraspecies contamination, was described in the early 1960s.15,16

Several years later, in 1967, intraspecies contamination of cell lines became more readily detectable through the work of Stanley Gartler, PhD.17 He described apparent HeLa cell contamination of 19 other human cell lines by using a technique of isoenzyme analysis of glucose-6-phosphate dehydrogenase (G6PD) and phosphoglucomutase (PGM) electrophoretic polymorphisms; all cell lines had the same G6PD type A and PGM type 1 phenotypes.18 The G6PD type A variant is sex-linked and found at an increased frequency in the African American population. The phosphoglucomutase gene is autosomal and has 3 common variants. The likelihood of all cell lines having these 2 isoenzyme variants was low, and several of the tested cell lines were known to be from whites. Gartler18 noted that “with the continued expansion of cell culture technology, it is almost certain that both interspecific and intraspecific contamination will occur.” He hypothesized that the G6PD subtype could have changed because of multiple divisions in culture, but he later demonstrated the stability of isoenzymes in cell culture lines over time.19

Methods for identifying cell lines were not limited to isoenzyme phenotypes. Karyotyping and chromosome band analysis were added to the arsenal of techniques available. Chromosome band analysis involved limited trypsin digestion of histone proteins followed by Giemsa staining20; controlled exposure of nucleoproteins to trypsin resulted in their partial removal and revealed Giemsa-stained bands. The technique was time-consuming but reliable in experienced hands. Thus, in the early 1970s, the state of the art for HeLa cell identification included presence of G6PD type A, lack of a Y chromosome, and identification of a specific pattern of banded-marker chromosomes21; these 3 three findings were thought sufficient to define a cell line as HeLa.

In 1974, 5 cell lines—reportedly of human lineage and infected with animal viruses—were sent to the United States from the Soviet Union. All of the cell lines were revealed to be HeLa in origin.22 In a story previously detailed,7 the realization that HeLa cells had contaminated cultures so far afield led to a reappraisal of tissue culture stocks by the American Type Culture Collection (ATCC; Manassas, Virginia) and the Cell Culture Laboratory at the Naval Biosciences Laboratory (Oakland, California).21–27 For instance, a follow-up study to the proper identification of the Soviet Union cell lines implicated HeLa cells as contaminants of several other cell lines.23 The ATCC found that 27 of 56 cell lines had G6PD type A variant.24 Further analysis revealed that several of these cell lines possessed some, but not all, HeLa markers. It was hypothesized that these variations could represent somatic cell hybridization between the original cell line and the contaminating HeLa cells.

During the previous quarter century, Dr Gey’s samples of HeLa cells had multiplied in laboratories throughout the world, as they were transferred from researcher to researcher and across international borders. Several hypotheses were offered for HeLa cells’ remarkable growth beyond what might be expected of a very aggressive cervical adenocarcinoma. As the first human cancer cell line, and a potent cell at baseline, it had been selected to survive in culture after countless passages, cell divisions, and viral infections. In the battle for reproduction, HeLa was best selected to outcompete other cell lines and eventually overgrew other cultures it invaded. Another possible explanation was that cell lines often came from outside laboratories. Prior to their deposition in tissue culture collection banks, the cell lines had been subjected to variable laboratory techniques. Furthermore, these laboratories undoubtedly possessed other cell lines such as the ubiquitous HeLa. Since HeLa cell contamination has been reported from air droplets,28 poor laboratory technique would suffice to rapidly contaminate other cell lines, which would then be passed on to subsequent laboratories.24,29

CELL CULTURE CONTROVERSY

The debate over cell culture contamination was not always harmonious.7,30 Contaminated cell lines went far beyond HeLa cells. In one study, human breast cancer cell lines were found to have both intraspecies and interspecies contamination. Other cell lines reported to be human cells were actually derived from hamster, rat, mouse, mongoose, or mink; gibbon cells were actually human cells; horse cells were dog cells.25 In total, 41 of 253 cell lines (16%) were not what they had been purported to be. Years of research and numerous academic careers were built on the presumed identity of various cell lines, and clarifying incorrect data required repudiating previously reported results.31 Alternative explanations for HeLa cell contamination were offered in some instances.32

Unfortunately, the impact of cell culture contamination extended far beyond the relatively narrow field of cytobiology and the researchers studying cell lines. For example, radiobiologists investigating the relation of radiation doses to cell death in human kidney cells were surprised to discover that the cells they thought were derived from human kidney were actually HeLa.26 Controversy erupted regarding the interpretation of their results: how did irradiating malignant cells translate to normal cells when evaluating cell death?33 The debate even ensnared Jonas Salk, MD, who stated at a conference in October 1978 that he had injected study subjects, enrolled in a vaccine trial, with HeLa cells that had contaminated his cultures7; however, any mention of HeLa failed to find its way into his published remarks regarding the “‘theoretical’ possibility of transmitting a neoplasia-inducing factor.”34

HeLa CELLS AND CELL CULTURE CONTAMINATION TODAY

Despite the passing of nearly 50 years since the problem first surfaced of HeLa cell contamination of tissue cultures and despite the explosive advances in molecular biology, cell culture contamination remains an important issue for the scientific community.35–38 The problem extends far beyond HeLa cells, although they remain a culprit.38 In one study, 45 of 252 human cell lines (18%) supplied by 27 of 93 originators (29%) were contaminated.39 Most of the contaminants were intraspecies cells, suggesting improved detection of interspecies contamination, but still concerning. New techniques, such as amplification of minisatellite-region DNA40 and short tandem repeat profiling,41 which are faster and more precise than older techniques such as chromosome banding, have not been widely adopted in a standardized, universal fashion. Fortunately, there was recently a call to action on preventing contaminated cell lines.42

CONCLUSION

Philosophically, we wonder if Henrietta Lacks has achieved a kind of corporeal immortality through her eponymous cell line. Sir William Osler, MD, delivering the Ingersoll Lectureship titled “Science and Immortality” at Harvard University, Boston, Massachusetts, in 1904 pondered new lessons from modern embryology and how they may impact the meaning of death. Although he obviously knew nothing of cell lines or DNA, he could marvel that “the individual is nothing more than the transient off-shoot of a germ plasm, which has an unbroken continuity from generation to generation, from age to age … ‘the individual organism is transient, but its embryonic substance, which produces the mortal tissues, preserves itself imperishable, everlasting, and constant.’43

It is impossible to know what Dr Osler would have thought about immortal HeLa cells. Has Henrietta Lacks’ “germ plasm” or “embryonic substance” (her DNA) provided her with an unbroken, unaltered chain to the present day so that we can claim that HeLa cells are Henrietta Lacks? Or, has her DNA evolved into a new entity—Helacyton gartleri has been suggested44—after countless cell culture passages, viral infections, and other cell line contaminants? Although the question of whether or not such a new species has evolved in the cell cultures of laboratories around the world is difficult to answer, as molecular biology continues to expand the frontiers of our knowledge at breathtaking speed, this question may need to be answered to fully comprehend both the findings of experiments performed on HeLa cells and the ethical implications of creating what may be regarded as a new organism.

References
1. Surgical Biopsy Number 92498. Baltimore, MD: Department of Pathology, The Johns Hopkins Hospital; 1951.
2. Jones, H. W. Record of the first physician to see Henrietta Lacks at the Johns Hopkins Hospital: history of the beginning of the HeLa cell line. Am J Obstet Gynecol 1997. 176:227S–228S.
3. Autopsy Protocol 23260. Baltimore, MD: Autopsy Records of The Johns Hopkins Hospital; 1951.
4. Harvey, A. M. Johns Hopkins—the birthplace of tissue culture: the story of Ross G. Harrison, Warren H. Lewis, and George O. Gey. Johns Hopkins Med J Suppl. 1976:114–123.
5. Bang, F. B. History of tissue culture at Johns Hopkins. Bull Hist Med 1977. 51:516–537.
6. Gey, G. O. Some Aspects of the Constitution and Behavior of Normal and Malignant Cells in Continuous Culture. New York, NY: Academic Press; 1955. The Harvey Lectures, Series L, 1954–1955..
7. Gold, M. A Conspiracy of Cells: One Woman’s Immortal Legacy and the Medical Scandal It Caused. Albany, NY: State University of New York Press; 1986.
8. Culliton, B. J. HeLa cells: contaminating cultures around the world. Science 1974. 184:1058–1059.
9. Jones, H. W. , V. A. McKusick , P. S. Harper , and K. D. Wuu . George Otto Gey: the HeLa cell and a reappraisal of its origin. Obstet Gynecol 1971. 38 (6):945–949.
10. Schwartz, P. E. , O. Hadjimichael , D. M. Lowell , M. J. Merino , and D. Janerich . Rapidly progressive cervical cancer: the Connecticut experience. Am J Obstet Gynecol 1996. 175:1105–1109.
11. Meissner, J. D. Nucleotide sequences and further characterization of human papillomavirus DNA present in the CaSki, SiHa, and HeLa cervical carcinoma cell lines. J Gen Virol 1999. 80:1725–1733.
12. Martinez, I. , A. S. Gardiner , K. F. Board , F. A. Monzon , R. P. Edwards , and S. A. Khan . Human papillomavirus type 16 reduces the expression of microRNA-218 in cervical carcinoma cells. Oncogene 2008. 27:2575–2582.
13. Gey, G. O. , W. D. Coffman , and M. T. Kubicek . Tissue culture studies of the proliferative capacity of cervical carcinoma and normal epithelium. Cancer Res 1952. 12:264–265.
14. Scherer, W. F. , J. T. Syverton , and G. O. Gey . Studies on the propagation in vitro of poliomyelitis viruses. J Exp Med 1953. 97:695–710.
15. Defendi, V. , R. E. Billingham , W. K. Silvers , and P. Moorhead . Immunological and karyological criteria for identification of cell lines. J Natl Cancer Inst 1960. 25:359–385.
16. Brand, K. G. and J. T. Syverton . Results of species-specific hemagglutination tests on “transformed,” nontransformed, and primary cell cultures. J Natl Cancer Inst 1962. 28:147–157.
17. Gartler, S. M. Genetic markers as tracers in cell culture. In: Westfall BB, ed. Second Decennial Review Conference on Cell Tissue and Organ Culture. Washington, DC: US Government Printing Office; 1967:167–195. National Cancer Institute Monograph No. 26..
18. Gartler, S. M. Apparent HeLa cell contamination of human heteroploid cell lines. Nature 1968. 217:750–751.
19. Auersperg, N. and S. M. Gartler . Isoenzyme stability in human heteroploid cell lines. Exp Cell Res 1970. 61:465–467.
20. Wang, H. C. and S. Fedoroff . Karyology of cells in culture: trypsin technique to reveal G-bands. In: Kruse PF Jr, Patterson MK Jr, eds. Tissue Culture Methods and Applications. New York, NY: Academic Press; 1973:782–787.
21. Nelson-Rees, W. A. and R. R. Flandermeyer . HeLa cultures defined. Science 1976. 191:96–98.
22. Nelson-Rees, W. A. , V. M. Zhdanov , P. K. Hawthorne , and R. R. Flandermeyer . HeLa-like marker chromosomes and type-A variant glucose-6-phosphate dehydrogenase isoenzyme in human cell cultures producing Mason-Pfizer monkey virus-like particles. J Natl Cancer Inst 1974. 53:751–757.
23. Nelson-Rees, W. A. , R. R. Flandermeyer , and P. K. Hawthorne . Banded marker chromosomes as indicators of intraspecies cellular contamination. Science 1974. 184:1093–1096.
24. Lavappa, K. S. , M. L. Macy , and J. E. Shannon . Examination of ATCC stocks for HeLa marker chromosomes in human cell lines. Nature 1976. 259:211–213.
25. Nelson-Rees, W. A. and R. R. Flandermeyer . Inter- and intraspecies contamination of human breast tumor cell lines HBC and BrCa5 and other cell cultures. Science 1977. 195:1343–1344.
26. Nelson-Rees, W. A. , R. R. Flandermeyer , and D. W. Daniels . T-1 cells are HeLa and not of normal human kidney origin. Science 1980. 209:719–720.
27. Nelson-Rees, W. A. , D. W. Daniels , and R. R. Flandermeyer . Cross-contamination of cells in culture. Science 1981. 212:446–452.
28. Coriell, L. Detection and Elimination of Contaminating Organisms. Bethesda, MD: US Department of Health, Education and Welfare; 1962. National Cancer Institute Monograph No. 7..
29. Grimwade, S. HeLa takes over. Nature 1976. 259:172.
30. Chatterjee, R. Cases of mistaken identity. Science 2007. 315:928–931.
31. Nelson-Rees, W. A. , R. A. Akeson , and R. Cailleau . Lung organ-specific antigens on cells with HeLa marker chromosomes. J Natl Cancer Inst 1978. 60 (6):1205–1207.
32. Pathak, S. , M. J. Siciliano , R. Cailleau , C. L. Wiseman , and T. C. Hsu . A human breast adenocarcinoma with chromosome and isoenzyme markers similar to those of the HeLa line. J Natl Cancer Inst 1979. 62 (2):263–271.
33. Broad, W. J. The case of the unmentioned malignancy. Science 1980. 210:1229–1230.
34. Salk, J. The spector of malignancy and criteria for cell lines as substrates for vaccines. In: Petricciani JC, Hopps HE, Chapple P, eds. Cell Substrates and Their Use in the Production of Vaccines and Other Biologicals. New York, NY: Plenum Press; 1979:107–113.
35. Stacey, G. N. , J. R. W. Masters , R. J. Hay , H. G. Drexler , R. A. F. MacLeod , and R. I. Freshney . Cell contamination leads to inaccurate data: we must take action now. Nature 2000. 403:356.
36. Masters, J. R. HeLa cells 50 years on: the good, the bad and the ugly. Nat Rev Cancer 2002. 2:315–319.
37. Nardone, R. M. Eradication of cross-contaminated cell lines: a call for action. Cell Biol Toxicol 2007. 23 (6):367–372.
38. Lucey, D. J. , M. A. Walsh , and R. Costello . Imposter cell lines. Laryngoscope 2006. 116:161–162.
39. MacLeod, R. A. F. , W. G. Dirks , Y. Matsuo , M. Kaufmann , H. Milch , and H. G. Drexler . Widespread intraspecies cross-contamination of human tumor cell lines arising at source. Int J Cancer 1999. 83:555–563.
40. Silva, L. M. , H. Montes de Oca , C. R. Diniz , and C. L. Fortes-Dias . Fingerprinting of cell lines by directed amplication of minisatellite-region DNA (DAMD). Braz J Med Biol Res 2001. 34:1405–1410.
41. Masters, J. R. , J. A. Thomson , and B. Daly-Burns . et al. Short tandem repeat profiling provides an international reference standard for human cell lines. PNAS 2001. 98 (14):8012–8017.
42. Lacroix, M. Persistent use of “false” cell lines. Int J Cancer 2008. 122:1–4.
43. Osler, W. Science and Immortality: The Ingersoll Lecture, 1904. New York, NY: Arno Press; 1977.
44. Van Valen, L. M. and V. C. Maiorana . HeLa, a new microbial species. Evol Theor Rev 1991. 10 (1):71–74.
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SEBELIUS: HHS document EXTENDING THE PANDEMIC to 2012

H1N1, Influenza, Top Stories, Undue Influence, Vaccine Laws

SEBELIUS: HHS document EXTENDING THE PANDEMIC to 2012

No Comments 08 March 2010

.
.
.

*Special thanks goes to Eileen D. for bringing this to our attention.

See bolded Excerpt such as:

Therefore, pursuant to section 319F-3(b) of the Act, I have determined there is a credible risk that the spread of pandemic influenza A viruses and those with pandemic potential and resulting disease does or could constitute a public health emergency.

…and extends through February 28, 2012.

Section 319F-3(a)(4)(A) confers immunity to manufacturers and distributors of the Covered Countermeasure, regardless of the defined population.

…and amended on September 28, 2009 to provide targeted liability protections for pandemic countermeasures to enhance distribution


100226 Sec HHS Sebelius Pandemic Influenza Vaccines Amendment

[Federal Register: March 5, 2010 (Volume 75, Number 43)]
[Notices]
[Page 10268-10272]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05mr10-76]

=======================================================================
———————————————————————–

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

Pandemic Influenza Vaccines–Amendment

Authority:  42 U.S.C. 247d-6d.

ACTION: Notice of amendment to the September 28, 2009 Republished
Declaration under the Public Readiness and Emergency Preparedness Act.

———————————————————————–

SUMMARY: Amendment to declaration issued on September 28, 2009 (74 FR
51153) pursuant to section 319F-3 of the Public Health Service Act
(“the Act”)

[[Page 10269]]

(42 U.S.C. 247d-6d) to revise covered countermeasures and extend
effective date and republication of the declaration to reflect the
declaration in its entirety, as amended.

DATES: The amendment of the republished declaration issued on September
28, 2009 is effective as of March 1, 2010.

FOR FURTHER INFORMATION CONTACT: Nicole Lurie, MD, MSPH, Assistant
Secretary for Preparedness and Response, Office of the Secretary,
Department of Health and Human Services, 200 Independence Avenue, SW.,
Washington, DC 20201, Telephone               (202) 205-2882         (202) 205-2882 (this is not a toll-free
number).
HHS Secretary’s Amendment to the September 28, 2009 Republished
Declaration for the Use of the Public Readiness and Emergency
Preparedness Act for H5N1, H2, H6, H7, H9 and 2009-H1N1 Vaccines:
Whereas there are or may be multiple animal influenza A viruses,
circulating in wild birds and/or domestic animals that cause, or have
significant potential to cause, sporadic human infections or have
mutated to cause pandemics in humans;
Whereas, these viruses may evolve into virus strains capable of
causing a pandemic of human influenza because these viruses may cause
infection in and spread among humans and because humans have little or
no immunity to these viruses;
Whereas, one such virus is the 2009 H1N1 Influenza Virus;
Whereas, vaccination may be effective to protect persons from the
threat of pandemic influenza;
Whereas, Secretary Michael O. Leavitt issued a Declaration for the
Use of the Public Readiness and Emergency Preparedness Act dated
January 26, 2007 (“Original Declaration”), as amended on November 30,
2007 and October 17, 2008 with respect to certain avian influenza
viruses;
Whereas, I amended the declaration on June 15, 2009 with respect to
2009 H1N1 influenza virus and on September 28, 2009 to provide targeted
liability protections for pandemic countermeasures to enhance
distribution and to add provisions consistent with other declarations,
and republished the declaration each time in its entirety;
Whereas, the September 28, 2009 declaration extended through
February 28, 2010 for vaccines against influenza virus strains named in
the Declaration other than 2009 H1N1 influenza vaccine;
Whereas, modifications are necessary to revise covered
countermeasures and to extend the effective date of the Declaration;
Whereas, the findings I made in the declaration issued on September
28, 2009 continue to apply;
Whereas, in accordance with section 319F-3(b)(6) of the Act (42
U.S.C. 247d-6d(b)), I have considered the desirability of encouraging
the design, development, clinical testing or investigation,
manufacturing, labeling, distribution, formulation, packaging,
marketing, promotion, sale, purchase, donation, dispensing,
prescribing, administration, licensing, and use of additional covered
countermeasures with respect to the category of disease and population
described in sections II and IV of the September 28, 2009 Republished
Declaration, as hereby amended, and have found it desirable to
encourage such activities for these additional covered countermeasures,
and;
Whereas, to encourage the design, development, clinical testing or
investigation, manufacturing and product formulation, labeling,
distribution, packaging, marketing, promotion, sale, purchase,
donation, dispensing, prescribing, administration, licensing, and use
of medical countermeasures with respect to the category of disease and
population described in sections II and IV of the September 28, 2009
Republished Declaration, as hereby amended, it is advisable, in
accordance with section 319F-3(a) and (b) of the Act, to provide
immunity from liability for covered persons, as that term is defined at
section 319F-3(i)(2) of the Act, and to include as such covered persons
other qualified persons as I have identified in section VI of the
September 28, 2009 Republished Declaration, as amended;
Therefore, pursuant to section 319F-3(b) of the Act, I have
determined that there is a credible risk that the spread of influenza A
viruses with pandemic potential and resulting disease could in the
future constitute a public health emergency and that spread of one of
these viruses (2009 H1N1 Influenza) has caused a disease that
constitutes a public health emergency.
In order to extend the scope of covered countermeasures and to
extend the effective date of the Declaration, the September 28, 2009
Republished Declaration, is hereby amended as follows:
In the title, delete “for H5N1, H2, H6, H7, H9 and 2009 H1N1
Vaccines” and replace with “for Vaccines Against Pandemic Influenza A
Viruses and Those with Pandemic Potential”.
In the recitals, delete the first through the fourth “whereas”
clauses, and insert two new recitals as follows:
Whereas there are or may be multiple animal influenza A viruses
circulating in wild birds and/or domestic animals that cause, or have
significant potential to cause, sporadic human infections or have
mutated to cause pandemics in humans;
Whereas, these viruses may evolve or have evolved into virus
strains capable of causing a pandemic of human influenza because these
viruses may cause infection in, and spread among, humans and because
humans have little or no immunity to these viruses;
In the sixth “whereas” clause, insert “October 1, 2009, and
December 28, 2009” after “July 24, 2009”.
In the “therefore” clause, delete “avian influenza viruses and
resulting disease could in the future constitute a public health
emergency, and that 2009 H1N1 influenza constitutes a public health
emergency” and replace with: “pandemic influenza A viruses and those
with pandemic potential and resulting disease does or could constitute
a public health emergency”.
In section I, first paragraph, delete “the pandemic
countermeasures influenza A H5N1, H2, H6, H7, H9, and 2009 H1N1
vaccines” each time it appears and replace with “vaccines against
pandemic influenza A viruses with pandemic potential”.
In section I, at the end of the second sentence, replace “IX”
with “X”.
In section II, delete “the virus with (1) highly pathogenic avian
influenza A (H5N1, H2, H6, H7, or H9) virus; or (2) 2009 H1N1
influenza” and replace with “animal and/or human influenza A viruses
against which most humans do not have immunity, except those included
in seasonal influenza vaccines and/or covered under the National
Vaccine Injury Compensation Program, that are circulating in wild birds
and/or domestic animals causing or having significant potential to
cause sporadic human infections or have mutated to cause pandemics in
humans”.
In section III, first paragraph, delete in its entirety and replace
with: “The effective period of time of this Declaration commenced as
described in the September 28, 2009 Republished Declaration, and
extends through February 28, 2012.
In section III, second paragraph, delete “; except that with
respect to 2009 H1N1 influenza vaccine, the effective period commences
on June 15, 2009 and extends through March 31, 2013” and replace with
“through February 28, 2012.”
In section III, add to the end of the section as a new paragraph:
“With respect to any covered countermeasure subsequently covered under
the

[[Page 10270]]

National Vaccine Injury Compensation Program, the effective time period
expires immediately upon such coverage.”
In section VIII, insert “and use” after “administration in the
first sentence, delete “the Act’s” from the second sentence and
replace with “this”, and delete “Countermeasure” from the second
sentence and replace with “Countermeasures”.
In section IX, add to the end of the first sentence: “; and
amended on September 28, 2009 to provide targeted liability protections
for pandemic countermeasures to enhance distribution and to add
provisions consistent with other declarations and republished in its
entirety.”
In section X, after the fifth paragraph, insert a new definition as
follows:
Pandemic influenza A viruses and those with pandemic potential:
Animal and/or human influenza A viruses, except those included in
seasonal influenza vaccines and/or covered under the National Vaccine
Injury Compensation Program, that are circulating in wild birds and/or
domestic animals, that cause, or have significant potential to cause,
sporadic or ongoing human infections, or historically have caused
pandemics in humans, or have mutated to cause pandemics in humans, and
for which the majority of the population is immunologically na[iuml]ve.
In Appendix I, title and item 32, add “H7,” after “H6”.
Throughout, insert “National” before “Vaccine Injury
Compensation Fund”.
All other provisions of the June 15, 2009 Republished Declaration
remain in full force.
Republication of HHS Secretary’s September 28, 2009 Republished
Declaration, as Amended, for the Use of the Public Readiness and
Emergency Preparedness Act for Vaccines Against Pandemic Influenza A
Viruses and Those with Pandemic Potential.
To the extent any term of the September 28 Republished Declaration,
as hereby amended, is inconsistent with any provision of this
Republished Declaration, the terms of this Republished Declaration are
controlling.
Whereas there are or may be multiple animal influenza A viruses
circulating in wild birds and/or domestic animals that cause, or have
significant potential to cause, sporadic human infections or have
mutated to cause pandemics in humans;
Whereas, these viruses may evolve or have evolved into virus
strains capable of causing a pandemic of human influenza because these
viruses may cause infection in, and spread among, humans and because
humans have little immunity to these viruses;
Whereas, on April 26, 2009, Acting Secretary Charles E. Johnson
determined under section 319 of the Public Health Service Act, (42
U.S.C. 247d), that a public health emergency exists nationwide
involving the Swine Influenza A virus that affects or has significant
potential to affect the national security (now called “2009-H1N1
influenza”);
Whereas, on July 24, 2009, October 1, 2009, and December 28, 2009 I
renewed the determination by the Acting Secretary that a public health
emergency exists nationwide involving the Swine influenza A virus (now
called “2009-H1N1 influenza virus”);
Whereas, vaccination may be effective to protect persons from the
threat of pandemic influenza;
Whereas, the possibility of governmental program planners obtaining
stockpiles from private sector entities except through voluntary means
such as commercial sale, donation, or deployment would undermine
national preparedness efforts and should be discouraged as provided for
in section 319F-3(b)(2)(E) of the Public Health Service Act (42 U.S.C.
247d-6d(b)) (“the Act”);
Whereas, immunity under section 319F-3(a) of the Act should be
available to governmental program planners for distributions of Covered
Countermeasures obtained voluntarily, such as by (1) donation; (2)
commercial sale; (3) deployment of Covered Countermeasures from Federal
stockpiles; or (4) deployment of donated, purchased, or otherwise
voluntarily obtained Covered Countermeasures from State, local, or
private stockpiles;
Whereas, the extent of immunity under section 319F-3(a) of the Act
afforded to a governmental program planner that obtains Covered
Countermeasures except through voluntary means is not intended to
affect the extent of immunity afforded other covered persons with
respect to such covered countermeasures;
Whereas, to encourage the design, development, clinical testing or
investigation, manufacturing and product formulation, labeling,
distribution, packaging, marketing, promotion, sale, purchase,
donation, dispensing, prescribing, administration, licensing, and use
of medical countermeasures with respect to the category of disease and
population described in section II and IV it is advisable, in
accordance with section 319F-3(a) and (b) of the Act, to provide
immunity from liability for covered persons, as that term is defined at
section 319F-3(i)(2) of the Act, and to include as such covered persons
such other qualified persons as I have identified in section VI;
Whereas, in accordance with section 319F-3(b)(6) of the Public
Health Service Act (42 U.S.C. 247d-6d(b)) (“the Act”), I have
considered the desirability of encouraging the design, development,
clinical testing or investigation, manufacturing and product
formulation, labeling, distribution, packaging, marketing, promotion,
sale, purchase, donation, dispensing, prescribing, administration,
licensing, and use of medical countermeasures with respect to the
category of disease and population described in sections II and IV
below, and have found it desirable to encourage such activities for the
Covered Countermeasures;
Therefore, pursuant to section 319F-3(b) of the Act, I have
determined there is a credible risk that the spread of pandemic
influenza A viruses and those with pandemic potential and resulting
disease does or could constitute a public health emergency.

I. Covered Countermeasures (as Required by Section 319F-3(b)(1) of the
Act)

Covered Countermeasures are defined at section 319F-3(i) of the
Act.
At this time, and in accordance with the provisions contained
herein, I am recommending the manufacture, testing, development,
distribution, dispensing; and, with respect to the category of disease
and population described in sections II and IV, below, the
administration and usage of vaccines against influenza A viruses with
pandemic potential and any associated adjuvants. The immunity specified
in section 319F-3(a) of the Act shall only be in effect with respect
to: (1) Present or future Federal contracts, cooperative agreements,
grants, interagency agreements, or memoranda of understanding for
vaccines against pandemic influenza A viruses with pandemic potential
used and administered in accordance with this declaration, and (2)
activities authorized in accordance with the public health and medical
response of the Authority Having Jurisdiction to prescribe, administer,
deliver, distribute or dispense the pandemic countermeasures following
a declaration of an emergency, as defined in section X below. In
accordance with section 319F-3(b)(2)(E) of the Act, for governmental
program planners, the immunity specified in section 319F-3(a) of the
Act shall be in effect to the extent they obtain Covered
Countermeasures through voluntary

[[Page 10271]]

means of distribution, such as (1) donation; (2) commercial sale; (3)
deployment of Covered Countermeasures from Federal stockpiles; or (4)
deployment of donated, purchased, or otherwise voluntarily obtained
Covered Countermeasures from State, local, or private stockpiles. For
all other covered persons, including other program planners, the
immunity specified in section 319F-3(a) of the Act shall, in accordance
with section 319F-3(b)(2)(E) of the Act, be in effect pursuant to any
means of distribution.
This Declaration shall subsequently refer to the countermeasures
identified above as Covered Countermeasures.
This Declaration shall apply to all Covered Countermeasures
administered or used during the effective time period of the
Declaration.

II. Category of Disease (as Required by Section 319F-3(b)(2)(A) of the
Act)

The category of disease for which I am recommending the
administration or use of the Covered Countermeasures is the threat of
or actual human influenza that results from the infection of humans
following exposure to animal and/or human influenza A viruses, against
which most humans do not have immunity, except those included in
seasonal influenza vaccines and/or covered under the National Vaccine
Injury Compensation Program, that are circulating in wild birds and/or
domestic animals causing or have significant potential to cause
sporadic human infections or have mutated to cause pandemics in humans.

III. Effective Time Period (as Required by Section 319F-3(b)(2)(B) of
the Act)

The effective period of time of this Declaration commenced as
described in the September 28, 2009 Republished Declaration and extends
through February 28, 2012.
With respect to Covered Countermeasures administered and used in
accordance with the public health and medical response of the Authority
Having Jurisdiction, the effective period of time of this Declaration
commences on the date of a declaration of an emergency and lasts
through and includes the final day that the emergency declaration is in
effect including any extensions thereof through February 28, 2012.
With respect to any covered countermeasure subsequently covered
under the National Vaccine Injury Compensation Program, the effective
time period expires immediately upon such coverage
.

IV. Population (as Required by Section 319F-3(b)(2)(C) of the Act)

Section 319F-3(a)(4)(A) confers immunity to manufacturers and
distributors of the Covered Countermeasure, regardless of the defined
population.
Section 319F-3(a)(3)(C)(i) confers immunity to covered persons who
could be program planners or qualified persons with respect to the
Covered Countermeasure only if a member of the population specified in
the Declaration administers or uses the Covered Countermeasure and is
in or connected to the geographic location specified in this
Declaration, or the program planner or qualified person reasonably
could have believed that these conditions were met.
The populations specified in this Declaration are the following:
(1) All persons who use a Covered Countermeasure or to whom such a
Covered Countermeasure is administered as an Investigational New Drug
in a human clinical trial conducted directly by the Federal Government,
or pursuant to a contract, grant or cooperative agreement with the
Federal Government; (2) all persons who use a Covered Countermeasure or
to whom such a Countermeasure is administered in a pre-pandemic phase,
as defined below; and/or (3) all persons who use a Covered
Countermeasure, or to whom such a Covered Countermeasure is
administered in a pandemic phase, as defined below.

V. Geographic Area (as Required by Section 319F-3(b)(2)(D) of the Act)

Section 319F-3(a) applies to the administration and use of a
Covered Countermeasure without geographic limitation.

VI. Other Qualified Persons (as Required by Section 319F-3(i)(8)(B) of
the Act)

With regard to the administration or use of a Covered
Countermeasure, Section 319F-3(i)(8)(A) of the Act defines the term
“qualified person” as a licensed individual who is authorized to
prescribe, administer, or dispense the countermeasure under the law of
the State in which such Covered Countermeasure was prescribed,
administered or dispensed. Additional persons who are qualified persons
pursuant to section 319F-3(i)(8)(B) are the following: (1) Any person
authorized in accordance with the public health and medical emergency
response of the Authority Having Jurisdiction to prescribe, administer,
deliver, distribute or dispense Covered Countermeasures, and their
officials, agents, employees, contractors and volunteers, following a
declaration of an emergency, and (2) Any person authorized to
prescribe, administer, or dispense Covered Countermeasures or who is
otherwise authorized under an Emergency Use Authorization.

VII. Additional Time Periods of Coverage After Expiration of
Declaration (as Required by Section 319F-3(b)(3)(B) of the Act)

A. I have determined that, upon expiration of the applicable time
period specified in Section III above, an additional twelve (12) months
is a reasonable period to allow for the manufacturer to arrange for
disposition of the Covered Countermeasure, including the return of such
product to the manufacturer, and for covered persons to take such other
actions as are appropriate to limit the administration or use of the
Covered Countermeasure, and the liability protection of section 319F-
3(a) of the Act shall extend for that period.
B. The Federal Government shall purchase the entire production of
Covered Countermeasures under the contracts specifically listed by
contract number in section I for the stockpile under section 319F-2 of
the Act, and shall be subject to the time-period extension of section
319F-3(b)(3)(C). Production under future contracts for the same vaccine
will also be subject to the time-period extension of section 319F-
3(b)(3)(C).

VIII. Compensation Fund

In addition to conferring immunity to manufacturers, distributors,
and administrators of the Covered Countermeasures, the Act provides
benefits to certain individuals who sustain a covered injury as the
direct result of the administration or use of the Covered
Countermeasure. The Countermeasures Injury Compensation Program (CICP)
within the Health Resources and Services Administration (HRSA)
administers this compensation program. Information about the CICP is
available at               1-888-275-4772         1-888-275-4772 or http://www.hrsa.gov/countermeasurescomp/
default.htm
<http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html\
&log=linklog&to=http://www.hrsa.gov/countermeasurescomp/default.htm> .

IX. Amendments

The Declaration for the Use of the Public Readiness and Emergency
Preparedness Act for H5N1 was published on January 26, 2007; amended on
November 30, 2007 to add H7 and H9 vaccines; amended on October 17,
2008 to add H2 and H6 vaccines; amended on June 15, 2009 to add 2009
H1N1 vaccines and

[[Page 10272]]

republished in its entirety; and amended on September 28, 2009 to
provide targeted liability protections for pandemic countermeasures to
enhance distribution and to add provisions consistent with other
declarations and republished in its entirety. This Declaration
incorporates all amendments prior to the date of its publication in the
Federal Register. Any future amendment to this Declaration will be
published in the Federal Register, pursuant to section 319F-2(b)(4) of
the Act.

X. Definitions

For the purpose of this Declaration, including any claim for loss
brought in accordance with section 319F-3 of the PHS Act against any
covered persons defined in the Act or this Declaration, the following
definitions will be used:
Administration of a Covered Countermeasure: As used in section
319F-3(a)(2)(B) of the Act includes, but is not limited to, public and
private delivery, distribution, and dispensing activities relating to
physical administration of the countermeasures to recipients,
management and operation of delivery systems, and management and
operation of distribution and dispensing locations.
Authority Having Jurisdiction: Means the public agency or its
delegate that has legal responsibility and authority for responding to
an incident, based on political or geographical (e.g., city, county,
Tribal, State, or Federal boundary lines) or functional (e.g., law
enforcement, public health) range or sphere of authority.
Covered Persons: As defined at section 319F-3(i)(2) of the Act,
include the United States, manufacturers, distributors, program
planners, and qualified persons. The terms “manufacturer,”
“distributor,” “program planner,” and “qualified person” are
further defined at sections 319F-3(i)(3), (4), (6), and (8) of the Act.
Declaration of Emergency: A declaration by any authorized local,
regional, State, or Federal official of an emergency specific to events
that indicate an immediate need to administer and use pandemic
countermeasures, with the exception of a Federal declaration in support
of an emergency use authorization under section 564 of the FDCA unless
such declaration specifies otherwise.
Pandemic influenza A viruses and those with pandemic potential:
Animal and/or human influenza A viruses, except those included in
seasonal influenza vaccines and/or covered under the National Vaccine
Injury Compensation Program
, that are circulating in wild birds and/or
domestic animals, that cause, or have significant potential to cause,
sporadic or ongoing human infections, or historically have caused
pandemics in humans, or have mutated to cause pandemics in humans, and
for which the majority of the population is immunologically na[iuml]ve.
Pandemic Phase: The following stages, as defined in the National
Strategy for Pandemic Influenza: Implementation Plan (Homeland Security
Council, May 2006): (4) First Human Case in North America; and (5)
Spread Throughout United States.
Pre-pandemic Phase: The following stages, as defined in the
National Strategy for Pandemic Influenza: Implementation Plan (Homeland
Security Council, May 2006): (0) New Domestic Animal Outbreak in At-
Risk Country; (1) Suspected Human Outbreak Overseas; (2) Confirmed
Human Outbreak Overseas; and (3) Widespread Human Outbreaks in Multiple
Locations Overseas.

Dated: February 26, 2010.
Kathleen Sebelius,
Secretary.

APPENDIX

I. List of U.S. Government Contracts–Covered H5N1, H2, H6, H7, H9, and
2009-H1N1 Vaccine Contracts

1. HHSN266200400031C
2. HHSN266200400032C
3. HHSN266200300039C
4. HHSN266200400045C
5. HHSN266200205459C
6. HHSN266200205460C
7. HHSN266200205461C
8. HHSN266200205462C
9. HHSN266200205463C
10. HHSN266200205464C
11. HHSN266200205465C
12. HHSN266199905357C
13. HHSN266200300068C
14. HHSN266200005413C
15. HHSO100200600021C (formerly 200200409981)
16. HHSO100200500004C
17. HHSO100200500005I
18. HHSO100200700026I
19. HHSO100200700027I
20. HHSO100200700028I
21. HHSO100200600010C
22. HHSO100200600011C
23. HHSO100200600012C
24. HHSO100200600013C
25. HHSO100200600014C
26. HHSO100200600022C (formerly 200200511758)
27. HHSO100200600023C (formerly 200200410431)
28. CRADA No. AI-0155 NIAID/MedImmune
29. HHSO100200700029C
30. HHSO100200700030C
31. HHSO100200700031C
32. All present, completed and future Government H5N1, H2, H6, H7,
H9, and 2009-H1N1 vaccine contracts not otherwise listed.

[FR Doc. 2010-4644 Filed 3-4-10; 8:45 am]
BILLING CODE P

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Gardasil Primer: Doctors & vaccine injured families speak out

Gardasil, HPV, Top Stories, Vaccine Snafus, Video

Gardasil Primer: Doctors & vaccine injured families speak out

No Comments 03 March 2010

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Activists: Uzbekistan orders forced sterilizations

Top Stories, Undue Influence, Vaccine Propaganda, Vaccine Snafus

Activists: Uzbekistan orders forced sterilizations

No Comments 02 March 2010

Yahoo News

MOSCOW – An independent think-tank and a rights group in Uzbekistan claim that authorities have instructed health workers to surgically sterilize women as part of a government campaign to reduce the birth rate in the authoritarian ex-Soviet nation.

The Expert Working Group claimed Tuesday that a Health Ministry decree has ordered doctors to conduct hysterectomies on tens of thousands of women in the Central Asian nation.

The Najot rights group reported “numerous” cases of forced sterilization in maternity hospitals where doctors allegedly sterilize women without their consent.

Uzbek health officials did not answer repeated phone calls seeking comment.

A human right activist who made similar allegations in 2005 was jailed for alleged anti-government actions.

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Victims of Vaccine Injury Silenced

Undue Influence, Vaccine Propaganda, Video

Victims of Vaccine Injury Silenced

No Comments 02 March 2010

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Bill Gates: Use Vaccines To Lower Population

By Author, Undue Influence, Vaccine Development, Vaccine Propaganda

Bill Gates: Use Vaccines To Lower Population

Comments Off 02 March 2010

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Paul Joseph Watson
Prison Planet.com
Monday, March 1, 2010

Microsoft founder Bill Gates told a recent TED conference, an organization which is sponsored by one of the largest toxic waste polluters on the planet, that vaccines need to be used to reduce world population figures in order to solve global warming and lower CO2 emissions.

Stating that the global population was heading towards 9 billion, Gates said, “If we do a really great job on new vaccines, health care, reproductive health services (abortion), we could lower that by perhaps 10 or 15 per cent.”

Quite how an improvement in health care and vaccines that supposedly save lives would lead to a lowering in global population is an oxymoron, unless Gates is referring to vaccines that sterilize people, which is precisely the same method advocated in White House science advisor John P. Holdren’s 1977 textbook Ecoscience, which calls for a dictatorial “planetary regime” to enforce draconian measures of population reduction via all manner of oppressive techniques, including sterilization.

“I’m not sure what the nothing-to-see-here explanation is for Bill Gates’ theory that “new vaccines” can help lower the population of the world,” points out the Cryptogon blog, “But I thought about the incidents from the 1990s where the World Health Organization was providing a “tetanus vaccine” to poor girls and women (and just poor girls and women) that contained human chorionic gonadotrophin (hCG). For those who don’t want to delve into that, in short, it was a World Health Organization experiment; a test of a vaccine against pregnancy.”

After presenting an equation that included the number of people on the planet and CO2 emissions, Gates said, “Probably one of these numbers is going to get pretty near to zero.”

Later in the presentation, Gates mentions picking a vaccine, “which is something I love,” that would be used to lower global CO2 emissions.

He also advocates pouring more money into the global warming scam by way of the United Nations, as well as a “CO2 tax” and cap and trade, while making it clear that the developed world would have to reduce its living standards by cutting back on essential services that generate CO2.

Gates said that a 20 per cent reduction in CO2 emissions was necessary by 2020, a 50 per cent reduction by 2050, and ultimately that there had to be zero CO2 emissions globally, a measure that would completely reverse hundreds of years of technological progress and return man to the agrarian age, all in the name of preventing an alleged miniscule temperature increase that has been proven to be based on fraudulent data models in light of the Climategate scandal.

One of Gates’ proposals for reducing CO2 emissions is the use of biofuels, which as a new report highlights, has resulted in millions of acres of forests being destroyed, which ultimately means a net increase in CO2 emissions from biofuels when compared to fossil fuels, not to mention the massive devastation caused to wildlife.

As we have documented, a CO2 reduction of 50-80 per cent, not to mention 100 per cent, would inflict a new great depression in the United States, reducing GDP by 6.9 percent – a figure comparable with the economic meltdown of 1929 and 1930.

Additionally, the “post-industrial revolution” being proposed by Gates and his ilk would lead to massive job losses.

The implementation of so-called “green jobs” in other countries has devastated economies and cost millions of jobs. As the Seattle Times reported back in June, Spain’s staggering unemployment rate of over 18 per cent was partly down to massive job losses as a result of attempts to replace existing industry with wind farms and other forms of alternative energy.

In a so-called “green economy,” “Each new job entails the loss of 2.2 other jobs that are either lost or not created in other industries because of the political allocation — sub-optimum in terms of economic efficiency — of capital,” states the report.

The fact that Gates would be so open in his call to use vaccines to lower global population (without a word as to the human rights considerations), probably has a lot to do with the audience attending his speech.

The TED organization admits that it is elitist, “in a good way,” and charges a whopping $6,000 dollars membership fee which must be paid by conference attendees. TED also charges nearly $1,000 just for its live conference web stream. The organization’s sponsors include IBM and military-industrial complex kingpin General Electric, which has a notorious history of environmental misdeeds, being ranked fourth-largest corporate producer of air pollution in the United States, with more than 4.4 million pounds per year (2,000 Tonnes) of toxic chemicals released into the air. GE is also a major contributor to the toxic waste problem, rendering its sponsorship of an organization that claims to be seeking solutions to environmental problems completely hypocritical.

Watch Gates’ speech below.

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Vaccine Teams Dispatched to Inject the Unsuspecting

Medical Cartel, Top Stories, Undue Influence

Vaccine Teams Dispatched to Inject the Unsuspecting

No Comments 01 March 2010

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Seeing POD People? It’s No Sci-Fi Film

By ARIEL KAMINER
NYTimes
3/1/10

PODs are the sleeper cells of public health, assuming a different shape and observing different local mores each time a crisis emerges. When hepatitis A was diagnosed in a bartender at the Manhattan nightclub Socialista two years ago, POD people were on hand to vaccinate patrons, including some guests at Ashton Kutcher’s birthday party. In the case of a bioterrorism attack, they might turn up in your neighborhood dispensing anthrax antidote. On Feb. 18, they were in Anshe Sfard Hall in the Borough Park section of Brooklyn, rolling up the sleeves of Hasidic Jews. That’s a long way from Ashton Kutcher.

I entered the hall on the left, with the other women; men entered on the right. With stacks of gold-braided chairs in the corner and a divider to keep the sexes apart, the Anshe Sfard POD — short for Point of Distribution — could have been the day-before photo of an Orthodox wedding. Instead, it was the front line against one of the city’s more surprising outbreaks in years.

It started last year, when some children at a Jewish summer camp in the Catskills came down with mumps, one of those childhood diseases that were supposed to have been consigned to history. They brought it back home to the Hasidic enclaves in Borough Park, Crown Heights and Williamsburg. By last month, there were more than 900 cases, and more adults were getting sick.

Time to activate the PODs.

Mumps is not generally fatal, though it is painful and can cause deafness or infertility. In neighborhoods where families might have a dozen children, and young men spend long days together in yeshivas or synagogues, it spreads fast. But business was slow at Anshe Sfard, so Sheila Palevsky and Elissa Levine, two of the sharp, funny members of the POD team, were keeping each other amused with tales of former postings.

Hasidic Jews may be more inclined to visit their own doctors than to discuss bodily functions with strangers. (“When did you last go to the mikvah?” Ms. Levine asked while taking my medical history, referring to the ritual bath that many observant Jewish women visit after menstruating. I thought the euphemism was very sweet.) As for the antivaccine movement, its echoes are rare in these parts, but they ring out with a strong local accent. “Jews trust the Almighty, not vaccines,” one commenter wrote on the site of The Yeshiva World, an online newspaper, in a mix of Hebrew and English. On a Crown Heights Web site, someone else wrote, “I wish that folks would have as much faith and confidence in God as they do in doctors and scientists.”

But there is another reason things look different here: This outbreak has written a new chapter in epidemiological history.

The standard prescription is two doses of the M.M.R. (measles, mumps, rubella) vaccine in childhood. That’s what most of the patients in Brooklyn had gotten, and it didn’t help them. Which has led medical professionals to reconsider some long-held notions about mumps in particular and communicable diseases in general.

“People that have measurable antibodies to mumps, which I was always taught meant you were immune, we found are getting the disease,” said Dr. Edward Chapnick, director of infectious diseases at Maimonides Medical Center. “And two vaccines, which we always thought had a very high effectiveness at preventing this, turns out to have a 75 to 80 percent effectiveness.”

The Department of Health still recommends two shots, but many doctors in the area — including Dr. Eli Rosen, a pediatrician who said he had treated 200 to 300 mumps cases so far — now favor three vaccinations, as do other private doctors in the area. “It appears that two vaccines are not effective in the vast majority of cases,” Dr. Rosen said. “Is this going to be a pattern we’ll see as we go out in vaccine years?” And, he added, would other vaccines also lose their effectiveness over time?

As a child I probably got my two M.M.R. shots, but who remembers. Everyone I spoke to assured me that so long as I wasn’t pregnant and did not have an immune disorder, there was no downside to an extra shot. But what’s the chance I would really need it? I don’t hang out in Brooklyn yeshivas.

In a city where people live so close to one another, it’s baffling that an outbreak could stay confined to a specific population, even an insular population. But that’s the paradox of city life, on an epidemiological scale: We are simultaneously a teeming megalopolis and a collection of little villages (or offices or apartment buildings), each with its own public health profile.

Still, a cluster of cases has already been documented in Orthodox and Hasidic neighborhoods of Westchester County. Unless that outbreak is halted, entropy will eventually win out.

So at the Quality Health Center in Williamsburg, which has reported hundreds of suspected cases, I decided to roll my sleeve up. Turns out it’s not just a fear of needles that makes little kids cry; the shot really did smart.

To distract me, Dov Landa, a physician assistant, shared the story of a 40-year-old Hasidic woman who had brought her large family in the day before. When it was her turn to get vaccinated, Mr. Landa, following protocol, asked if she was pregnant. The woman laughed. “I haven’t been pregnant in 10 years,” she said. He tested her anyway, just to be sure. And so it was that he got to tell her the happy news. Mazel tov.

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