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Some states are passing laws to expand the powers of public health authorities to force people to submit to mass immunizations: for example, Pennsylvania House Bill 492 and Massachusetts (WorldNetDaily 10/12/09).
But public health campaigns to get everybody immunized against both seasonal influenza and swine flu (novel H1N1) are running into opposition. (more…)
Public health officials are gearing up for a mass swine flu (H1N1) immunization campaign, first targeting children, pregnant women, and medical workers.
The U.S. government has purchased 195 million doses of swine flu vaccine, and contracted for 120 million doses of adjuvants to stretch the vaccine supply. The production process in eggs is yielding two to four times less viral antigen from H1N1 flu than from seasonal strains. (more…)
Based on records obtained under a May 2007 Freedom of Information Act (FOIA) request, Judicial Watch has summarized the approval process, side effects, safety concerns, and marketing practices related to the human papillomavirus (HPV) vaccine Gardasil. It calls these a “large-scale public health experiment.”
One of the most startling findings is 78 cases of outbreaks of warts following the vaccine in women already infected without knowing it. Besides genital warts, some patients experienced massive outbreaks on the face, hands, or feet, sometimes caused by strains not included in the vaccine.
Additionally, the vaccine could increase the incidence of CIN 2/3 (cervical endothelial neoplasia in moderate stage) in women who had persistent infection with “vaccine-relevant” HPV strains at baseline. A chart in a report of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) showed an efficacy rate of –44.6% (that’s a minus sign) in subjects already exposed to “relevant HPV types.”
On June 25, 2008, the FDA denied Merck’s application to expand marketing of Gardasil to women aged 27 through 45. The FDA refused Judicial Watch’s request for a copy of the letter to Merck, stating that it may be available under FOIA.
Merck also failed to win approval to expand the vaccine to more strains and has reportedly dropped plans to do so.
Most tests with Gardasil were done against an adjuvant-containing “placebo,” rather than a nonreactive saline base, possibly making the vaccine seem safer than it actually is.
In its report to the FDA, Merck noted that “it is not known whether Gardasil can cause fetal harm when administered to a pregnant woman.” It reported that 27% of pregnant women experienced an adverse reaction upon receiving the vaccine, and the Vaccine Adverse Event Reporting System (VAERS) contains 45 cases of spontaneous abortion following Gardasil.
A pre-condition for fast-tracking Gardasil was a requirement for a safety surveillance study, which will not be complete until June, 2009. Nonetheless, intensive marketing continues.
A total of 8,864 VAERS reports have been filed, including 38 of Guillain-Barre syndrome and 18 deaths, 11 occurring within one week of receiving the vaccine. Association, of course, does not prove causality.
The entire Judicial Report is available.
Mandating HPV vaccine is a matter of the public good vs. private rights, states Alexandra M. Stewart, J.D., who worked under contract from Merck with the George Washington University Medical Center to study Medicaid coverage for HPV vaccine. The intimate mode of transmission is “a distinction without a meaningful difference”; therefore, legal precedents justifying mandates should apply to Gardasil, she writes (N Engl J Med 2007;356:1998-1999).
In an article that appeared in MedScape on July 26, and was quickly taken off the website, Diane Harper, M.D., a principal chief investigator in clinical HPV trials, was quoted as saying, “The side effects that have been reported are real and they cannot be brushed aside.” She suggested that physicians not vaccinate patients with personal or family histories of the more serious complications, which have included neurologic disorders, thromboembolism, and autoimmune conditions.
“The cause of recent complications remains a mystery and it is difficult to know whether they are linked to vaccines,” the article stated.
Two physicians, a cardiologist and a rheumatologist, say they regret their decision to immunize their 17-year-old daughter and will not encourage his younger daughters to receive the vaccine. After being vaccinated, their eldest went from being a healthy athlete to a chronically ill patient. He worries that other girls may be struggling with immune damage, feeling achy and unwell, but going undiagnosed and unreported.
Gynecologist Christiane Northrup, M.D., appearing on the Oprah Winfrey Show, told viewers that she wouldn’t advocate vaccinating her daughters, and that medical dollars were better spent elsewhere.
The FDA and CDC issued a joint statement reassuring the public and physicians of the vaccine’s safety.
MedScape was accused of “germ theory denialism” (apparently for suggesting that it might be fruitful to investigate how most patients successfully fight off HPV) and “antivaccination myths.” It was also criticized for having the “chutzpah” to run a poll on how physicians were reacting to the reports about adverse events and the FDA/CDC advisory, and the poll has apparently been pulled also.
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In what was called a “thunderclap in the vaccine industry,” French authorities have opened a formal investigation concerning a hepatitis B vaccination campaign by GlaxoSmithKline and Sanofi Pasteur in the 1990s. It is alleged that the companies failed to fully disclose neurologic side effects. Another investigation opened by Judge Marie-Odile Bertella-Geffroy concerns the death (“manslaughter”) of a 28-year-old woman from multiple sclerosis, allegedly connected to the vaccine (Le Figaro 1/31/08).
From 1994 to 1998, almost two-thirds of the French population and almost all newborn babies were vaccinated against hepatitis B, but the campaign was temporarily suspended because of concerns about side effects.
Some 30 plaintiffs, including the families of five patients who died after the vaccination, have launched civil actions (Reuters 1/1/08).
A British case-controlled analysis showed an odds ratio of 3.1 (95% CI 1.5-6.3) for first symptoms of multiple sclerosis in recipients of recombinant hepatitis B vaccine compared to controls. Two previous French studies had shown a RR of about 1.5. Other studies showed a nonsignificant increase or null findings, especially when date of diagnosis rather than date of first symptoms was used (Neurology 2004;63:838-842).
According to attorney Clifford Miller, “British doctors administering hepatitis B vaccine to infants could face criminal prosecution if fully informed consent is not obtained. Civil prosecution for damages is possible over 21 years later if the injured survive as adults” (UK Press Association Newswire/Romeike, September 2005).
The hepatitis B vaccine has been considered “one of the safest vaccines ever produced” (Neurology, op. cit.). On the other hand, French medical expert Marc Girard has said that “for a preventive measure, hepatitis B is remarkable for the frequency, variety and severity of complications from its use” (Romeike, op.cit.)
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Although an attorney representing the federal government said that it “has not conceded that vaccines cause autism,” Associated Press headlines read that “officials concede vaccines’ link to illness like autism” (AP 3/6/08). Petitioner Hannah Joling, now 9 years old, received 5 vaccines at once in 2000. According to a document that AP obtained from the U.S. Department of Health and Human Services, this aggravated an underlying mitochondrial disorder, causing metabolic dysfunction manifesting as worsened brain function with features of autistic spectrum disorder.
The document drew no conclusions as to the role of thimerosal. The government has previously denied any link at all between vaccine components and autism.
A Portuguese study suggested that 7% of autistic children might have a mitochondrial disorder, compared to 0.02% in the whole population.
Stories are conflicting about the time of onset of Hannah’s symptoms. Some state that she had suggestive symptoms at age 3 months; others that she was developing normally until the vaccines were given at 19 months. Her father Jon Poling, M.D., Ph.D., a neurologist, and mother, who is a lawyer and nurse, contend that the vaccines were also responsible for their daughter’s mitochondrial disorder (Kent Heckenlively, Age of Autism 3/5/08).
The family has filed a request with the court to unseal the documents on the case. A spokesman for the U.S. Department of Justice, which represents the government in all cases, refused to grant interviews or to explain to the Atlanta Journal-Constitution why it isn’t releasing the records (Alison Young, Atlanta Journal-Constitution 3/6/08).
The 5,000 families seeking compensation for autism or other developmental disorders they blame on vaccines are encouraged by the decision, the first of its type. However, each case needs to be proved on its own merits, and the decision is so narrowly worded that it may not be a helpful precedent.
Whatever the cause, the number of children receiving Supplemental Social Security Income (SSI) for disability has more than tripled in 20 years. In 1960, only 1.8% of U.S. children or adolescents were said by their parents to have a limitation of activity due to a health condition of more than 3 months’ duration; this rate had increased to more than 7% by 2004. Conditions include obesity, asthma (which has doubled since the 1980s), and attention-deficit/hyperactivity disorder (ADHD, affecting some 6% of schoolchildren).
Potential causative factors, according to JAMA, include maternal smoking (although its prevalence has decreased), poverty (which is stable), and “fast foods.” The only suggested role for the large increase in the number of vaccines is that less or less normal stimulation of the immune system, owing to less exposure to viral infections in early childhood, could cause greater susceptibility to allergens (JM Perrin, et al., JAMA 6/27/07).
There is also a significant increase in both type 1 and type 2 diabetes mellitus in children, at least partly attributed to obesity (RB Lipton, JAMA 6/26/07). Some wonder whether this too could have a link to vaccines. Hemophilus immunization has been associated with autoantibodies to islet cells. A Danish study recently showed an attributable risk of 2.3/100 (2.3%) of type 1 diabetes from hemophilus immunization in siblings of insulin-dependent diabetic children (JB Classen, Open Ped Med J 2/25/08).
Establishing the role of vaccines in any chronic, disabling condition could open floodgates of demand for compensation. And this single case of compensation for autism is making public health officials and pediatricians worry that parents will skip vaccinations.
A CDC panel voted unanimously to recommend influenza vaccine annually for all school-age children (WorldNetDaily 2/28/08). New Jersey officials have told parents that their babies can’t attend day care without their flu shot. Most influenza vaccine contains thimerosal.
Two other vaccine-court cases testing the alleged connection between thimerosal and autism go to trial in May.
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