Gold salts and d-penicillamine both act as chelators, helping the body to excrete heavy metals. Funny how Big Pharma has no interest in producing these therapies for patients with autism and/or rheumatoid arthritis.
I went to college at a time and place where, in the name of academic freedom and not riling up the students any further, one could avoid almost any unpleasant subject -- by which I mean the whole of math and science. So my understanding of the complexities of biology, neurology and statistics is seriously restricted. I tend to rely on logic and an English major's reading of scientific papers as my tools -- along with a few people whose knowledge and fair-mindedness I have learned to trust.
I'm sure it won't be long before that paragraph comes back to "haunt" me -- just like the idea of doing my own natural history of autism from scratch. Here's how one person described that: "I exchanged correspondence with Dan Olmsted when he started his autism series. In response to my citation of various materials for him to look at, he told me that he wanted instead to take a fresh look at things, and not be influenced by ideas that others had before him. In other words, he prefers to draw his conclusions in a vacuum, without doing any research."
Well, that's interesting -- taking a fresh look is the equivalent of "drawing conclusions in a vacuum, without doing any research." I suppose it could be, but what clearly unifies much criticism of independent-minded autism investigation is the idea that people with -- sniff, sniff -- simply no standing are venturing into areas that were previously the province of self-ordained "experts." Yeah, experts like the ones who maintained for decades that parents made their kids autistic. Now that the experts say it's genetic -- well, they must be right this time ... they couldn't have screwed up twice in a row, could they?
Compared to them, parents, activists, maverick journalists, advocates -- people who communicate and share information on the newfangled World Wide Webs, for God's sake -- are the know-nothings of the autism universe.
What their nervous condescension really conceals is the yawning gap in autism research that allows an unlettered yahoo (no B.S., M.S., Ph.D.) like me to drive a big ol' truck right through it. For instance, the quote above was in reference to my report that the first autism case in the medical literature -- Donald T. -- recovered markedly after getting gold salts treatment for an entirely different ailment (or perhaps not so entirely different): juvenile rheumatoid arthritis. The "experts" at the time chalked up his recovery to the kindly farm family he had been sent to live with -- get the picture? bad parents! -- but Donald's brother told me in 2005 that the medical treatment is what made the difference. So even though the "parents-did-it" idea had long been discredited, it succeeded for decades in submerging the fact that a biomedical treatment helped the first child to recover.
But information wants to be free -- so says one of the better slogans of our age. And once actual facts -- as opposed to mere speculation masquerading as expertise -- are loosed upon the world, there is no getting them back in the multi-dose vial. So it goes with gold salts and Donald T., and before long I came upon a study that seemed pertinent. Here's what I wrote two years ago:
"A published scientific paper suggests gold salts -- the treatment that may have prompted improvement in the first child ever diagnosed with autism -- can affect mental conditions. "'Although there is very little modern research on these applications for gold, historically one notable use of gold was as a 'nervine,' a substance that could revitalize people suffering from nervous conditions, a term we would today call neurological and psychiatric disorders, such as epilepsy and depression,' according to the paper, 'Gold and its relationship to neurological/glandular conditions.'
"The paper appeared in 2002 in the International Journal of Neuroscience, co-authored by four researchers at the Meridian Institute, a Virginia-based non-profit group. It is online HERE.
"'Neither the causes of the disorders nor the mechanism of gold is known, yet there are reports pointing to a possible involvement of naturally-occurring gold in the nervous and glandular systems, and evidence from historical sources of a possible efficacy of gold in therapy for neurological disorders,' write authors Douglas G. Richards, David L. McMillin, Eric A. Mein and Carl D. Nelson."
I thought that was kind of interesting -- maybe a clue worth pursuing in light of Donald's treatment. If it's useful information, does it really have to be peer-reviewed to be pertinent? Right after I wrote about Donald, University of Kentucky Chemistry Professor Boyd Haley decided to do a little experiment. I wrote about this two years ago, Dec. 23, 2005:
"In a striking follow-up to our reporting on the first child diagnosed with autism -- and his improvement after treatment with gold salts -- a chemistry professor says lab tests show the compound can 'reverse the binding' of mercury to molecules.
"'This does lend support to the possible removal of mercury from biological proteins in individuals treated with gold salts,' Haley said. "The potential significance: Donald T. -- Case 1 among children diagnosed with autism in the 1930s -- showed marked improvement in his autistic symptoms after being treated with gold salts for an attack of juvenile rheumatoid arthritis. That's according to his brother, who we interviewed earlier this year in the small Mississippi town where he and Donald, now 72, still live.
"One theory of autism -- strongly dismissed by federal health authorities and mainstream medical groups -- is that the disorder is primarily caused by a mercury preservative called thimerosal that was used in vaccines beginning in the 1930s. Some parents and researchers who believe autism is, in essence, mercury poisoning are using treatments designed to remove mercury from the body or offset its neurological effects.
"Haley is among a minority of scientists who holds this view, and after reading about Donald's improvement he set out to test whether gold salts have any effect on mercury. "You follow your nose in research, and when I saw that I thought, yes, this is a possibility," said Haley. In the test tube, anyway, the effect was pretty dramatic: The gold pulled the mercury off the enzyme in 30 minutes flat.
Another rare researcher whose nose twitched was Mady Hornig. I wrote about that, too:
"A Columbia University scientist plans to test whether gold salts improve the functioning of autistic mice -- a step toward finding whether they could help children with autism. Dr. Mady Hornig of Columbia's Mailman School of Public Health will give the compound to mice that have been bred to be susceptible to thimerosal, a mercury-based preservative in children's immunizations until recently."
First, though, she needed the grant money. As far as I know, neither the medical establishment nor cash-stuffed Autism Speaks has seen fit to fund this project, which would require less than $100K (that's lunch money for AS). Genes are where the glamour and grants are.
But gold salts just won't go away. People keep reading about their effect and making connections that appear to elude the established experts. Age of Autism's Kent Heckenlively recently wrote:
"Scientists at the Duke University Medical Center, led by Dr. David Pisetsky, chief of the division of Rheumatology and Immunology recently tested the mechanism by which gold salts may treat inflammatory disorders.
"The researchers were aware that the HMGB1 molecule provokes inflammation in the body and is associated with arthritis. The scientists at Duke stimulated mouse and human cells to produce HMGB1 then treated them with gold salts. The researchers found that the gold salts interfered with the activity of interferon beta and nitric oxide, leading to a significant decrease in HMGB1 over time. This was consistent with reports that gold salts were effective in treating arthritis, but took several months for the full effects to become apparent.
"Researchers in Korea and Italy have reported that HMGB1 is released in great quantities following an ischemic injury and induces neuro-inflammation in the brain. In the body HMGB1 generally acts as a cytokine, promoting inflammation.
"Many autism researchers have noted the signs of neuro-inflammation in the brain as well as other signs of inflammation in the body. Our medical field is full of specialists, but few who can put the pieces together and look at the entire body.
"Donald T. had severe arthritis as well as autism and apparently recovered after treatment with gold salts. Researchers at Duke may have now uncovered an explanation for that event. Wouldn't it be ironic if parents who have had their bank accounts emptied by the necessity of caring for their autistic children found that gold really did (help)?"
Well, "ironic" is one word for it -- "grotesque" would also work.
Just this week I got an e-mail from a reader named Martin Cowen: "Hi Dan. The Wall Street Journal today, 12-18-07, page D-1, has a story about this lead poisoning treatment. Of interest to you, I think, will be the fact, stated in the article, that the treatment was originally for rheumatoid arthritis. As you have reported, Autism case number 1 was treated for rheumatoid arthritis with gold salts. Maybe there is a connection between autism and rheumatoid arthritis?"
Lo and behold, the article says that this lead-chelating drug, called d-penicillamine, was originally only for "rheumatoid arthritis and adults with a rare genetic disorder." But years of off-label use showed it could also lower blood lead levels, the article said. So I went to Wikipedia (can't you just hear the "experts" hyperventilating?) and looked up the drug. One use is for "Wilson's disease, a rare genetic disorder of copper metabolism ... (the drug) relies on its binding to accumulated copper and elimination through urine."
I sent this off to my AOA colleague Mark Blaxill, and in a few minutes he fired back a 2007 scientific study that looked at thimerosal and mercury in mice brains and showed "d-penicillamine as a chelator decreased the mercury contents in the cerebrum." So here's a drug that likes to lap up mercury in the brain, escort lead out of the bloodstream, help people with a metals efflux disorder get rid of copper, and kick the dickens out of rheumatoid arthritis, all at the same time. Not only that -- the scientist profiled has come up with a nice grape flavored d-penicillamine so kids will drink it. He just can't get any pharmaceutical company to make it.
So here we are back to chelators, metals, mercury, rheumatoid arthritis, autism and inflammation -- back to Case 1, with links and cross-currents that seem to get more interesting all the time, at least to laymen like me and my correspondents. That's why I'm still talking about gold salts and reading about HMGB1 and citing that 2007 study on d-penicillamine by Minami et al from the Journal of Environmental Toxicity and Pharmacology titled "Effects of lipopolysaccharide and chelator on mercury content in the cerebrum of thimerosal-administered mice."
I don't even know what lipopolysaccharides are, but I wish someone who did would order up a big, blind, double-placebo thing to figure all this out. Until then, I'm afraid, we're going to have to take a page from Pogo. We have met the experts, and they are us. -- Dan Olmsted is Editor of Age of Autism.
June 28, 2007 -- Scientists report reversing symptoms of fragile X syndrome, a common genetic cause of autism and mental retardation, in lab tests on mice.
The findings may eventually lead to the development of drugs for fragile X syndrome and perhaps for autism, according to the researchers.
"Our study suggests that inhibiting a certain enzyme in the brain could be an effective therapy for countering the debilitating symptoms of FXS (fragile X syndrome) in children, and possibly in autistic kids as well," says researcher Mansuo Hayashi, PhD, in a Massachusetts Institute of Technology (MIT) news release.
Hayashi worked on the study while at MIT. She now works at Merck Research Laboratories in Boston.
The study appears in the online edition of Proceedings of the National Academy of Sciences.
What Is Fragile X Syndrome?
The National Institutes of Health defines fragile X syndrome as a genetic condition that causes a range of developmental problems including learning disabilities and mental retardation.
Fragile X syndrome is the most commonly inherited form of mental retardation and autism, note Hayashi and colleagues.
They studied mice born with fragile X syndrome. Those mice were hyperactive, had displayed repetitive behaviors, and lacked the normal anxiety of mice when put in an open area.
The scientists blocked a brain enzyme called PAK in the fragile X mice. That reduced fragile X symptoms.
That tactic hasn't been tested in people. But there are chemicals known to inhibit PAK.
"Our findings warrant testing of these inhibitors in FXS animal models with a hope of an eventual development of an FXS drug," write Hayashi and colleagues.
Well, as Merck's lawyers would say, the 11 deaths are linked to Gardasil, but unless God tells you it's true, you don't know for certain exactly why these women died. After all, it could have been the world's biggest coincidence.
Another eight deaths in just the past few months are being connected to Gardasil, Merck & Co.'s vaccine that targets the sexually transmitted human papillomavirus and is being considered by many states as mandatory for all schoolgirls, according to documents released by Judicial Watch.
There also have been another 1,824 adverse reactions to the drug, bringing the "known total" of such problems to 3,461, according to the public interest group that investigates and prosecutes government corruption.
"In light of this information, it is disturbing that state and local governments might mandate in any way this vaccine for young girls," said Tom Fitton, the group's president. "These adverse reactions reports suggest the vaccine not only causes serious side effects, but might even be fatal."
The dispute primarily has been over proposed state and other governmental requirements that schoolgirls be vaccinated against an infection transmitted only by sexual contact.
The target of the vaccine is cervical cancer, since studies show that those who have HPV have a higher chance of later developing cervical cancer. However, opponents note that such cancers develop most often in older women, while the plan is to require girls as young as 11 or 12 years old to be inoculated. They cite the lack of evidence that the vaccine would have an impact later in life.
Judicial Watch said it obtained documents from the U.S. Food and Drug Administration under the Freedom of Information Act detailing the new 1,824 cases.
Those cases include as many as eight deaths related to the vaccine, on top of the three deaths reported earlier among 1,637 earlier reports of adverse effects.
Among the new information Judicial Watch found:
"Information has been received … concerning a 17 year old female who in June 2007 … was vaccinated with a first dose of Gardasil … During the evening of the same day, the patient was found unconscious (lifeless) by the mother. Resuscitation was performed by the emergency physician but was unsuccessful. The patient subsequently died."
"Information has been received … concerning a 12 year old female with a history of aortic and mitral valve insufficiency … who on 01-MAR-2007 was vaccinated IM into the left arm with a first does of Gardasil … On 01-MAR-2007 the patient presented to the ED with ventricular tachycardia and died."
"Initial and follow-up information has been received from a physician concerning an 'otherwise healthy' 13 year old female who was vaccinated with her first and second doses of Gardasil. Subsequently, the patient experienced … paralysis from the chest down, lesions of the optic nerve…At the time of the report, the patient had not recovered."
The flood of adverse reactions during 2007 reported to the FDA through the Vaccine Adverse Event Reporting System, included 347 serious reactions.
"Of the 77 women who received the vaccine while pregnant, 33 experienced side effects ranging from spontaneous abortion to fetal abnormities. Other serious side effects continue to be reported including, paralysis, Bells Palsy, Guillain-Barre Syndrome, and seizures," Judicial Watch said.
And these numbers may not even include all the cases, Judicial Watch said. It filed a lawsuit this week against the FDA for failing to fully respond to its requests for information involving the vaccine.
Specifically Judicial Watch wanted access to correspondence between Merck and the FDA regarding the vaccine, communications between the FDA and GlaxoSmithKline, which is working on a similar vaccine, called Cervarix, and reports by consumers, health professionals and others regarding problems with the HPV vaccine.
When the organization's investigation into the HPV vaccine issue arose, and the first reports starting coming in, Fitton described it as "a catalog of horrors."
One earlier report, No. 275438-1, describes the reaction as coronary artery thrombosis, sudden cardiac death. "Given Gardasil vaccine dose #1 3/12/07. Collapsed and died on 3/26/07… Echocardiogram revealed very enlarged right ventricle, small left ventricle as well as large blood clots within both the right atrium & right ventricle."
Another report noted that the woman was vaccinated and "died of a blood clot 8 hours after getting the Gardasil vaccine."
Officials with the Abstinence Clearinghouse noted in a position paper that groups including the Texas Medical Association, the AmericanAcademy of Pediatrics, the Association of American Physicians and Surgeons, and the AmericanAcademy of Environmental Medicine have come out publicly against mandatory vaccination.
"The reasoning of these medical associations is clear. They are not opposed to medical progress, and certainly support all efforts to combat life-threatening diseases. The problem, as these organizations see it, lies in the fact that the drug only went through three and a half years of testing, leaving the medical community somewhat in the dark as to what serious adverse effects might result in the long term," the group said.
"Along with the potential of serious adverse effects is the question of efficacy. There is evidence that after approximately four years, the vaccine's potency significantly declines. The long-term value of the vaccine has yet to be determined; if it wears off within six years, will girls and women need to repeat the battery of injections they originally received?" the organization wondered.
Michigan was the first state to introduce a plan to require the vaccine to be given to young girls, but the proposal failed. Ohio also considered a failed plan in 2006.
Then in 2007, after Merck's aggressive lobbying campaign and contributions to Women in Government, lawmakers in at least 39 states and the District of Columbia worked on sponsoring such plans.
Even moderate exercise helps ward off dementia, study shows
-- Robert Preidt
WEDNESDAY, Dec. 19 (HealthDay News) -- In people age 65 and older, simply walking regularly or engaging in other moderate exercise can reduce dementia risk, a new Italian study finds.
Vascular dementia is the second most common form of dementia after Alzheimer's disease.
This four-year study included 749 women and men over age 65 who had no memory problems at the start of the study. Researchers monitored the participants' weekly physical activity levels such as walking and climbing stairs, and moderate activities such as house and yard work, gardening and light carpentry.
By the end of the study, 54 of the participants had developed Alzheimer's disease and 27 had developed vascular dementia.
The findings are published in the Dec. 19 issue of the journal Neurology.
The top one-third of people who exerted the most energy walking were 27 percent less likely to develop vascular dementia than those in the bottom third, the study found. People who exerted the most energy in moderate activities were 29 percent less likely to develop vascular dementia, and those who were in the top one-third for total physical activity had a 24 percent reduced risk compared to those in the bottom third.
"Our findings show moderate physical activity, such as walking, and all physical activities combined lowered the risk of vascular dementia in the elderly independent of several sociodemographic, genetic and medical factors," study author Dr. Giovanni Ravaglia, of the University Hospital S. Orsola Malpighi in Bologna, said in a prepared statement.
"It's important to note that an easy-to-perform moderate activity like walking provided the same cognitive benefits as other, more demanding activities," Ravaglia noted.
More research is needed to determine how physical activity may help protect against vascular dementia, the study suggested.
The American Academy of Family Physicians has more about dementia.
Ever wonder why the laws are what they are? Check out these campaign donors (and keep in mind that these are just federal donations) and see if they draw a picture for you...
Count the number of pharmaceutical companies whose US headquarters are in New Jersey. Then ask yourself if there is a causal relationship between Big Pharma being HQ'd in NJ and NJ's vaccination laws.
Just for kicks, here are the campaign contributions of a few pharmas for the 2007-2008 campaign season, as of the end of 2007: Wyeth Good Government Fund - $534,382; Johnson & Johnson Political Action Committee - $487,847; Roche Inc. Good Government Fund - $202,217; Schering-Plough Corporation Better Government Fund - $154,349. Those four donors are in the top 11 donors in the state, and J&J and Roche are #2 and #3.
Avoiding vaccines will be difficult Monday, December 17, 2007
By ELISE YOUNG STAFF WRITER
Parents who oppose New Jersey's new mandatory vaccines have two options -- a medical or religious waiver -- to keep their children in public preschools and day cares starting in September.
But some who have exemptions for other mandatory vaccinations say they were tough to get.
At times, they say, authorities questioned their faith or demanded more documentation from their pediatricians. Others found that when school officials rejected their requests, they were forced to compromise their suspicion that preservatives in some vaccines can cause autism, a neurological disorder with no known cause or cure.
In all, New Jersey will require four new immunizations -- two for kids under 5 and two for sixth-graders. Mercury and thimerosal, the suspect preservatives, are used in some influenza, meningitis and DPT, or diphtheria/pertussis/tetanus, vaccines.
The federal Centers for Disease Control and Prevention says there is no proven link between autism and the preservatives.
That's not good enough for some New Jersey parents, who say they are taking no chances in the state with the country's highest rate of autism. One in 94 children here is on the autism spectrum, with behavioral and communication problems ranging from barely noticeable to completely debilitating.
"I'm considering home-schooling," said Stella Crispo of Little Falls. Her 20-month-old son -- a typical, healthy child -- has had some vaccinations, but not a recommended pneumonia shot.
"It's scary," Crispo said. "I can't imagine having all these vaccines at one time."
Parents say they have concerns beyond autism. Last week, for instance, Merck recalled 1.2 million doses of children's HIB, a flu and meningitis vaccine, because of possible bacterial contamination. Federal officials said the recall was a precaution and that the drugs did not pose a health threat.
The new vaccination routine was approved by Health Commissioner Fred Jacobs on Friday. It will take effect Sept. 1. Those without the vaccinations will be barred from public schools.
Children ages 8 weeks to 4 years, 9 months will need bacterial (pneumococcal) pneumonia immunizations. Starting at 6 months, they also will need the influenza vaccine. Sixth-graders will be required to have meningitis and DPT boosters.
New Jersey is the first state mandating such immunizations for kids in public preschools and certified day-care centers. Supporters call the rules a groundbreaking step in disease control, with the potential to prevent thousands of serious illnesses, even deaths. The shots, they say, protect not only the recipients, but also their families, teachers, playmates, neighbors -- in short, anyone inside or outside the home.
Critics unconvinced
The anti-vaccination movement says it won't submit so easily. It maintains that no amount of the heavy metal mercury and related preservatives in these vaccines is safe, despite assurances from pharmaceutical companies.
Jonathan Brown of Old Tappan, the retired father of a 12-year-old with autism, said his son became impaired shortly after his first round of immunizations. The boy won't be lining up for the meningitis and DPT boosters.
"My wife wrote to legislators and said that if we have to go to jail over it, fine. It'll be the first respite care we've had in 12 years," Brown said. "If we think for even the slightest bit of a moment that there's a possibility that vaccinations are the root cause of autism, why aggravate people? Why would I ever do vaccinations again?"
New Jersey is not among the 18 states that permit "conscientious exemptions," which allow parents to claim moral or philosophical reasons for not vaccinating. Assemblywoman Charlotte Vandervalk, R-Hillsdale, has tried to win passage of such a law for four years.
"There's no way they will look at it in lame duck," Vandervalk said last week, referring to the post-election legislative session. "Nobody takes it seriously. People don't understand how tragically this affects individual families."
Dr. Lawrence D. Rosen, a Hackensack pediatrician, said that in general, immunizations are a good idea. But he has deep reservations about the preservatives in question, and he doesn't agree with the state's latest mandate.
"It does not take into account individual choice or individual medical issues," Rosen said.
Andy Schlafly, general counsel to the Association of American Physicians and Surgeons, said its members oppose the new rules in New Jersey.
"It's unfortunate to think that one size can fit all," Schlafly said. "There are children who are susceptible to adverse effects. And it's not easy to get a doctor to sign a waiver."
Many seek waivers
Sue Collins, co-founder of the New Jersey Alliance for Informed Choice in Vaccination, said she has received hundreds of e-mails since last week, when the state Public Health Council recommended the compulsory vaccinations. Many expressed interest in the religious exemptions.
"It's not supposed to be challenged," Collins said of the waivers. "But there are more than enough instances in which it doesn't happen the way it's supposed to."
Mary Hernandez of River Edge has a medical waiver for her 9-year-old son with autism, because tests showed he has great sensitivity to vaccines. But she ran into trouble with a religious waiver for her 7-year-old daughter.
"The one school had no problem with it, but then we transferred," Hernandez said. "Whatever kind of audit the state or county does, they questioned it at the new school. They wanted to know why did I initially allow her to get vaccines and why was it now against my beliefs. I said that initially I didn't realize there could be harm involved. And it's against my religious beliefs to harm my child. And they accepted it."
One North Jersey mother -- who asked not to be identified for fear that her family would be ostracized -- said she had religious waivers for her children. But then officials overseeing their Roman Catholic parochial school rejected her claim, saying it wasn't in line with the church's tenets.
"What it came down to was making a choice between the potential health of my children -- with immediate and long-term consequences -- versus their moral and spiritual development," the mother said. "I sold out. The school gave us 12 months to get caught up on the vaccine schedule. I've been taking my kids to get one vaccine a month."
Many activists who oppose immunization say there is a link between autism and the preservatives thimerosal and mercury. The federal government says it has found no evidence to support that claim. For more information:
• The Institute for Vaccine Safety, part of the Johns Hopkins Bloomberg School of Public Health, maintains a list of vaccine ingredients, including thimerosal and mercury: vaccinesafety.edu
• The Food and Drug Administration links to studies about neurological effects: ww.fda.gov/cber/ vaccine/ thimerosal.htm
• The Centers for Disease Control and Prevention publishes vaccine fact sheets, including benefits and risks: immunize.org/vis/
• The National Vaccination Information Center focuses on public education and informed consent: nvic.org
* * *
Vaccine exemptions
Roughly 2,200 New Jersey children have vaccination waivers: 1,644 for religious reasons and 611 for medical reasons, according to 2005-06 figures. Parents seeking exemptions must submit them to their children's public school nurses. The records are subject to review by state health officials.
Medical waiver: Requires signature of medical doctor. Must cite a specific risk, such as a history of allergic reaction.
Religious waiver: Needs statement from parent attesting that vaccination violates a tenet of his or her religion. Does not require reference to a particular religion. Not valid for general philosophical or moral beliefs.
Sources: State Department of Health and Senior Services; New JerseyStateSchool Nurses Association
In February of 1976, the Centers for Disease Control (CDC) investigated and confirmed that an influenza outbreak at Fort Dix had been caused by the swine-type influenza A virus. Subsequently, the Department of Health, Education and Welfare, as well as numerous medical experts, became concerned that a major flu epidemic was imminent for the coming fall. Fear of influenza deaths in numbers similar to the 1918 flu epidemic led to a recommendation that the federal government vaccinate all Americans. When insurance companies refused to provide coverage to the vaccine manufacturers, the government agreed to accept liability for claims of adverse events (Neustadt). This obstacle having been cleared, the National Influenza Immunization Program (NIIP) officially started in October of 1976. The number of vaccinations given each week increased rapidly from less than one million in early October to more than four million in the later weeks of the month, and reached a peak of more than six million doses a week by the middle of November 1976 (Marks). The NIIP was unique in the annals of epidemiology: an organized surveillance effort was in place from the very beginning, and over forty million people were vaccinated during the short time the NIIP was in effect. However, on December 16, 1976 the NIIP was suspended following reports from more than ten states of Guillain-Barré syndrome (GBS) in vaccinees. By January of 1977, more than 500 cases of GBS had been reported, with 25 deaths (Langmuir, 1979). Millions of dollars in lawsuits and many years later, we present in this paper a summary of the epidemiologic evidence of the possible causal association between influenza A/New Jersey/76 vaccine and GBS.
GBS is a relatively uncommon neurologic disorder characterized by an acute or subacute onset of polyneuritis. The predominant symptom is weakness, mainly of the extremities, although in more severe cases respiratory muscles may be involved (Hogg). The acute flaccid paralysis of GBS is typically symmetrical and may progress for periods as long as ten days. Spontaneous remission is common, and recovery usually occurs within three months of the time of peak illness (Safranek). Case series show that males are more frequently affected than females, there may be an increase with age, and the disorder is often associated with a preceding infection such as a non-specific upper respiratory or gastrointestinal infection (Hogg). The exact cause of GBS remains unknown. Historically, GBS was proposed to be due to a primary viral infection. However, the more recent prevailing hypothesis is that GBS represents an immunopathological reaction triggered by recent exposure to an exogenous agent. Although physicians can readily diagnose typical cases, criteria for delimiting the syndrome’s diagnostic boundaries have been controversial (Schonberger, 1981). In fact, diagnostic criteria would prove to be a common criticism of the published studies, and the rarity of the illness led to arguments over the appropriate background rate to use in epidemiologic reports.
Before vaccine administration began, a nationwide surveillance system was established to evaluate illnesses that were temporally associated with influenza vaccination. No previous mass immunization campaign had included a similar prospective surveillance network. This passive reporting system was centrally coordinated by the CDC, and all state and territorial health departments were required to participate. A registration consent form had to be signed by all vaccinees. This form allowed health departments to verify the date, type, manufacturer and lot number of vaccines involved in reaction reports. A report form covering basic epidemiologic information was distributed, and any illness serious enough to cause hospitalization had to be telephoned in to the CDC. In addition, some states sent letters to non-neurologist practitioners, surveyed hospitals and conducted a repeat survey of neurologists after the middle of January 1977 (Schonberger, 1979).
Using data taken from the August 1977 public release of the nationally collected surveillance data, Alexander Langmuir presented a preliminary report in 1979 on the possible relationship between the swine flu vaccine and GBS. Concurrently with the vaccine-associated cases of GBS, more than 500 other cases among unvaccinated persons in the population were collected through a network of collaborating neurologists and practicing physicians, organized on an emergency basis throughout all fifty states. Langmuir calculated the average incidence rate in unvaccinated cases for an eleven-week period (October 9 to December 18). This rate, 0.185 cases per million person-weeks, was used to determine the expected weekly numbers.
Unlike with the peak seen in the vaccinated population, the relative constancy of weekly incidence rates in the unvaccinated group throughout the eleven week period conformed to the general impression of most neurologists and epidemiologists that GBS was an endemic disease with little seasonal fluctuation. The incidence of unvaccinated cases declined after December 18, which Langmuir believed was unlikely to be due to under-reporting of cases. Instead, it was during December that the awareness of a possible association between the vaccine and GBS led to the end of the NIIP, and it would have seemed reasonable to expect an even prompter diagnosis than during the period before the relationship was suspected.
Based on the weekly numbers of vaccinations, a comparison of observed with expected cases showed that the relative risk of acquiring GBS during the six weeks after vaccination was about ten times the endemic expectation. No marked differences were observed in incidence by age or geographical distribution. Langmuir was careful to state that much of the available epidemiologic information about GBS was based on data from hospital records and therefore was difficult to interpret because of the lack of accurate estimates of the populations from which the cases were drawn. However, previous studies had shown the incidence rate of GBS to be about 1 case per 100,000 population per year, similar to Langmuir’s calculated baseline incidence.
Very little difference in clinical features was found between the unvaccinated and vaccinated cases. Visits to a neurologist, lower neuron signs and respiratory impairment were similar, and the case fatality rates were almost identical. However, the rate of acute illness in the month preceding GBS onset was much higher among the unvaccinated cases than the vaccinated cases (59% versus 30%, respectively). Langmuir concluded from these data that the swine influenza vaccine distributed in the U.S. during the fall of 1976 contained a "trigger element" which resulted in the development of clinically recognized GBS in 1 in 100,000 recipients of the vaccine.
Also in 1979, Schonberger and his collaborators at the CDC presented an additional analysis of the national surveillance data of cases with an onset between October 1, 1976 and January 31, 1977. In order to be accepted as a case by the CDC, GBS cases had to have been diagnosed by a physician and to have objective evidence of muscle involvement, and suspected cases reported directly to the CDC had to be validated by the state health department. State epidemiologists were sent a brief survey in April 1977 to help assess possible differences in case ascertainment after December 18 due to a sharp decrease nationally in reported cases after that week. A total of 1,098 cases were reported to the CDC during the four months under investigation.
Estimates of the civilian population by state and age (as of July 1, 1976) were obtained from the Census Bureau, and the number of vaccinations was provided by the CDC-NIIP surveillance center. For each state, both weekly and monthly reports of total vaccines administered by age group and vaccine type were gathered. Only data for cases reported on or before the end of January were analyzed, as this was when intensified surveillance for GBS ended. There were four different manufacturers of both monovalent and bivalent vaccine, and an estimated proportion of each vaccine type given in each state was calculated by an inventory of the amounts distributed and remaining at the end of the campaign.
Vaccinations increased from the beginning of the program in October, reaching a peak in mid-November, and declining thereafter (Appendix A, Figure 1A). The incidence of GBS in vaccinated adults (over age 17) rose rapidly through late October and November to reach a peak during the week of December 18. As vaccinations abruptly ended, there was a sudden drop among vaccinated individuals, from more than 70 cases to 22 (Appendix A, Figure 1B). The incidence in unvaccinated persons remained relatively constant, ranging from 28 to 45 cases each week from early October to the middle of December, then declined to half its previous level after the December 18 moratorium (Appendix A, Figure 1C). Using the population estimates, the expected attack rate for adults over 17 was calculated to be 0.22 cases per million person-weeks. It was found that 71% of vaccinated cases with known intervals became ill within four weeks after vaccination, 52% in the second and third weeks after vaccination (Appendix B). The relative risk in the adult population for the six weeks following vaccination was 7.6, although a statistically significant association was seen as long as ten weeks after vaccination. For these ten weeks, the attributable risk was just under 1 case per 100,000 vaccinations.
Schonberger, et al. indicated that one of the weaknesses of the study was the poorly defined clinical boundaries of GBS from the national surveillance data and the lack of medical record review for validation. The authors concluded, however, that their results of markedly increased attack rates in vaccine recipients showed strong support for an etiologic link. The average incidence rate of the unvaccinated (0.79 cases per million people per month) fell within the range of previously reported rates in U.S. cities and other countries (0.5 to 1.6 cases per million per month). In addition, the nonrandom distribution of intervals between vaccine and GBS onset and the markedly lower proportion of acute illness preceding GBS onset in vaccinated cases provided further evidence of an etiologic link. Normally, over 50% of GBS cases are preceded by a respiratory or gastrointestinal illness; in this study, only 33% of vaccinated cases reported having an acute illness within four weeks of onset.
In the following years, lawsuits stemming from the NIIP led to a 1981 court order that the CDC release the data used by Langmuir and Schonberger, et al. in the above studies. A computerized summary was submitted for each reported case. At this time, Langmuir and his colleagues formed a panel to re-evaluate the data. Their intent was to answer the question of how long after vaccination any possible causal effect had continued as well as to re-examine the overall association, due to criticism of methodological issues like the clinical classification of cases.
The panel first examined information on cases for completeness of data. Of the 1,098 cases originally used by Schonberger, et al., only 154 were excluded due to insufficient data or being under age 18. The cases were reviewed for extent of motor involvement and clinical characteristics, then grouped according to severity. Information regarding the vaccination status was deliberately omitted in the process of classifying the cases. The panel immediately found problems with misinterpretations by those who reported the data to the CDC, as well as errors of recording or coding and failures to complete forms. The panel initially considered the adoption of more stringent diagnostic criteria, which would have excluded more than 25% of cases otherwise having clinical features believed to be characteristic. However, the panel only had access to information released by the CDC and from public records. The basic files remained impounded at the CDC, so the investigators were unable to verify records, check inconsistencies or investigate apparent typographical errors or possible miscodings. Thus, the panel chose to accept the original classifications of all 1,098 cases in recognition of the limited data available and the fact that more information was probably available to the CDC reviewers than had been released by the court order.
The panel had access to two distinct data sources which contained the numbers of vaccinations performed. The first was the weekly and monthly reports collected routinely by the NIIP, comprised of the total counts accumulated in the NIIP centers in each state. This was the data used by Schonberger, et al. and Langmuir in 1979. However, some lag or under-reporting was unavoidable in early stages of the program, while there was compensatory over-reporting during the six months after the program ended, as delayed reports came in. Because no adjustments had been made to account for these problems, the panel chose to use data from the Health Interview Survey (HIS) conducted by the National Center for Health Statistics. The HIS data was presumably relatively free of the reporting lags because interviewers were collecting current information each week.
Establishing the baseline incidence rate proved to be difficult. The authors were wary of previous reports, most of which consisted of a collection of cases observed by one or a group of neurologists in which the population from which the cases had been drawn was unknown. The few population-based studies to date had reported rates which were not corrected for adults 18 years of age and older or classified by severity of motor involvement. The 1979 studies by Schonberger, et al. and Langmuir cited these reports because at the time they were considered the best available. However, the panel had greater confidence in the diagnostic criteria used by the Mayo Clinic and cited unpublished data from Kurland and Beghi in Olmsted County, Minnesota as one possible source for baseline rates (the Olmsted County study in its published format will be discussed below). Another population-based study which the panel felt was applicable to their evaluation was that reported by Breman and Hayner out of Michigan. The Michigan study was published simultaneously with this panel’s findings and will also be discussed below.
Langmuir’s panel graphed vaccinated cases by numbers of days since vaccination. The incidence curve for cases with extensive paralysis was skewed to the right. This pattern, characteristic of point source epidemics, was identical to that seen in the previous studies, including Schonberger, et al. (see Appendix B). The lognormal curve suggested a causal relationship between disease and vaccine. Cases with limited motor involvement showed no such pattern, implying that this group included a substantial proportion of cases which were unrelated to the vaccine. The panel decided to use two separate baseline rates of GBS to compare observed with expected cases. Data from the Michigan and Minnesota studies were combined: 0.275 cases per million person-weeks was used as a "high" background estimate. A "low" estimate of 0.14 cases per million person-weeks was calculated from the mean rate in unvaccinated cases. Looking at the first six weeks following vaccination, the relative risk for severe cases was 39.6 using the higher baseline estimate and 7.75 when using the lower baseline estimate. Using the lower baseline rate also showed that the risk extended to eight weeks after vaccination, slightly less than Schonberger, et al.’s estimate of an elevated risk up to ten weeks.
Soon after the publication of this study, Nathan Mantel released strong criticisms of both Schonberger, et al.’s original study and the panel’s conclusions. Mantel felt that the analyses of Schonberger, et al. were done at the expense of bringing out effects somewhat late after vaccination. Although the authors found that the period of increased risk lasted for approximately nine or ten weeks after vaccination, they did not look for later increases in risk in any effective manner. The study only examined GBS cases with onsets up to January 31, 1977. But for thirteen-week delays, for example, the vaccination would have had to have been in the month of October 1976, a time during which much of the vaccination program was still at a low level. Also, a case with an onset in mid-January was unlikely to be diagnosed and reported until February. Therefore, because data for establishing long delay effects were limited, Mantel felt that some people may have been unfairly denied compensation if their onset of GBS occurred after ten weeks post-vaccination.
Mantel also criticized Langmuir and his panel’s study, as they had trouble establishing reliable baseline rates for GBS. Both estimates were subject to scrutiny, as the "high" Michigan-Minnesota rate was based on cases gleaned from active and thorough surveillance and so was undoubtedly too high to be reasonably compared with the rate found in vaccinated cases. The "low" estimate from the unvaccinated cases was based on data which was collected at the same time and by the same surveillance program, and which was approximately half as large as the high estimate. Although under-reporting of unvaccinated cases was certainly probable as Mantel states, the finding of large relative risks using both baseline rates seems to lend more credibility to the panel’s findings.
As noted above, one of the baseline rates cited by the panel came as a result of a study by Breman, et al. in Michigan (1984). As part of the national surveillance program of 1976 and 1977, a system was established in Michigan to detect GBS cases with an onset from July 1, 1976 to June 30, 1977. The purpose of the investigation was to determine GBS frequency over the one-year period, to describe its epidemiology in terms of demographic variables and seasonality, and to determine any association with the A/NJ vaccine. Cases had to be diagnosed by a physician, meet a strict list of criteria, and receive confirmation from the primary care physician and/or consulting neurologist. Classifiers were not blinded, but were told not to consider vaccine status when confirming cases. Between December 20, 1976 and June 30, 1977, over 300 possible cases were screened, but over half were excluded because they did not meet diagnostic criteria, leaving a total of 132 confirmed cases for study.
The incidence of GBS in unvaccinated individuals was found to be about twice the rate for the nation. This finding points to the fact that the Michigan case reporting system was very aggressive and probably detected most, if not all, cases in the state. Using this baseline rate, Breman, et al. found that the incidence rates of GBS among vaccinees in the weeks before vaccination and in the seven or more weeks after vaccination were much lower than during the first six weeks post-vaccination. The risk attributable to the vaccine for adults 18 or older with an onset within six weeks of vaccination was 11.7 cases per million vaccinees. No differences in attack rates were found by sex, season or vaccine manufacturer. Breman, et al. concluded that immunization clearly led to an increased risk of GBS, but the risk period was only for six weeks post-vaccination, similar to a number of the earlier studies. The authors did not posit a biological mechanism for this occurrence, but did note that the unvaccinated population had a slightly increased incidence with age. They thought this might indicate that a prior sensitization was needed to trigger an autoimmune response, but did not extend any theories as to how the vaccine might be responsible.
In addition to Breman’s Michigan study, Marks, et al. (1980) performed a study in Ohio using statewide instead of national data. To ascertain cases, neurologists were called by telephone and asked to check their records for all cases of GBS with an onset since October 1, 1976, and to continue to notify the health department of cases with an onset before January 31, 1977. The authors defined a case as a person with a diagnosis of GBS and with physical evidence of bilateral, but not necessarily symmetrical, lower-motor neuron weakness with acute onset.
Marks, et al. found 54 reported cases of GBS, with 32 giving a history of vaccination against influenza. The cases in vaccine recipients tended to cluster in the two months from late October to late December, while no such clustering was seen in unvaccinated cases. In the vaccinated cases, the length of time between receiving the vaccine and the onset of GBS showed a pronounced peak two to three weeks after vaccination, a finding in line with previous studies. The authors calculated an attributable risk of 80.5%. As in the Michigan study, this Ohio investigation used both active surveillance to find cases and clear diagnostic criteria. Although the authors failed to report the response rate of the contacted health professionals, this study supported the CDC’s initial findings.
Soon after these studies were performed, Beghi, et al. (with Kurland, 1985) published their findings of the epidemiologic and clinical features of GBS in Olmsted County, Minnesota from 1935 to 1980. The authors felt that the validity of prior studies was questionable due to the general confusion over diagnostic criteria and the lack of rigorous case ascertainment. The aim of their study, therefore, was to present an updated evaluation of GBS using more rigid diagnostic criteria, to assess incidences and trends of the vaccine, and to estimate the expected number of GBS cases at time of vaccination. The health care of Olmsted County was documented in a centralized index at the Mayo Clinic. Population rates were computed using time-weighted averages for each of the census years. Complete ascertainment of suspected and diagnosed cases was accomplished by having neurologists review the medical records of all residents under strict criteria.
Beghi, et al. determined that the mean annual incidence was 1.7 per 100,000 population. An acute illness prior to onset was present in 65% of cases. Age-adjusted rates were higher for males (2.3) than for females (1.2), and the rate increased with age, from 0.81 for under 18 years of age to 3.2 for those aged 60 years and older. The overall incidence rate for individuals aged 18 and older was 2.1 per 100,000 population, or 0.4 per million person-weeks. This rate was almost twice that reported by Schonberger, et al. from the national data. Because of this difference in rates and the fact that ascertainment and reporting of unvaccinated cases may have been less intense and complete than among vaccinated, the authors speculated there might not be a true association between the vaccine and GBS. They cited the CDC’s inadequate diagnostic criteria as a problem as well as the lack of any finding of an increased occurrence of GBS during earlier vaccine programs. They also did not uncover any cases of GBS in their county during the swine flu vaccine program. Using the Olmsted County baseline rate, they did show that nationally, there were more cases than expected during the six weeks after vaccination, but did not feel that any argument had been made for a causative association.
Ellsworth Alvord was quick to criticize Beghi, et al.’s assertions. They had compared rates in vaccinated cases taken from national surveillance data in 1976-1977 to background rates taken from a Minnesota county with high quality medical records during a 45-year period. Alvord felt that this comparison was inappropriate, and likened it to comparing "apples and oranges." Beghi, et al. did not find any cases of GBS in their county during the swine flu vaccine program, but Alvord pointed out that they also did not state in their report that there were only approximately 60,000 people in the county. Even if everyone had been vaccinated, the incidence of GBS due to vaccination had been previously calculated at only 1 per 100,000 million people and therefore, only 0.6 excess cases would have been found. The authors should not have been surprised at their lack of reported cases.
Beghi and Kurland immediately replied, stating their comparison was not a case of apples and oranges, but of how many "rotten apples" there were in the cases accepted by the CDC. They agreed that because only 39,000 people in the county received the vaccine, it was not surprising that there were no reported GBS cases during that time. But they argued that Olmsted County rates of rare and uncommon diseases were often higher than that for other areas that did not have such high quality records-linkage, thereby suggesting that they should have found at least one case. This argument, however, certainly offered no additional evidence to refute Alvord’s criticism.
Several of the studies examined possible differences between the four different manufacturers, the 47 lots of vaccine and the type of vaccine itself. Langmuir, Schonberger, Marks and Breman’s studies concluded there were no differences in the outcome whether the vaccine was monovalent or bivalent or whole versus split-virus. No single manufacturer’s vaccine had a significantly higher rate of GBS when compared with the other three manufacturers combined, and no study could show any explainable difference in lot-specific attack rates. Although two studies found that the rate in recipients of one lot was somewhat higher than that for recipients of the other lots of vaccine, it was high in only one of the many states where that lot had been distributed. This finding was most likely a chance association related to random variation.
One methodological criticism of a number of the studies was that the CDC did not establish clear diagnostic criteria for GBS. Records were abstracted by health workers with varying qualifications, no review of clinical records and no systematic follow-up of cases occurred, and no standardized neurologic assessment of the medical records was ever performed. Because there was no method of validating the cases, it was not possible to determine if any bias existed due to differential or non-differential misclassification. As several of the authors used their own diagnostic criteria in their investigations, comparisons of studies is more complicated. The Ohio and Michigan studies were performed with very clear diagnostic criteria, and the fact that their outcomes supported the earlier studies helps to discount fears that this flaw would cause a major bias in the findings.
When trying to establish that a positive association is also a causal relationship, it is important to examine clinical differences between exposed and unexposed cases. Both Schonberger, et al. and Langmuir (1979) found one statistically significant difference between vaccinated and unvaccinated cases, which was the higher proportion in the latter group who had experienced an acute illness during the four weeks preceding onset of GBS. Schonberger, et al. found that prior acute illness had occurred in 61.8% of unvaccinated individuals versus 32.8% of those who were vaccinated, while Langmuir’s data was similar, with rates of 59.3% versus 30.2%, respectively. This difference between vaccinated and unvaccinated cases indicates that the cause of GBS in those vaccinated was different than what was normally seen, and thus a new influence was most likely responsible for the increased incidence of GBS.
Establishing a plausible biological mechanism is also important when assessing causation. But for GBS, the evidence for specific etiologic factors is scanty and conflicting. The syndrome is thought to be an autoimmune reaction, but there is not enough known about the disease to be able to pinpoint the exact cause. Experimental allergic neuritis has been induced by intradermal injections in rabbits, and in humans there is an association between allergic encephalomyelitis and polyneuritis and killed rabies vaccine, with similar latent periods between vaccination and GBS onset as reported here (Langmuir, others). However, no clear connection has been made between these experimental results and the swine flu vaccine-GBS relationship. In the epidemic of GBS, the "trigger element" could have been a component of the Fort Dix strain of swine influenza virus used for making the vaccine, possibly the residual myelin protein of chick embryo origin which might have been retained in the vaccine though all its stages of manufacture and purification. Previous and future non-swine flu vaccine campaigns did not lead to increased cases of GBS, giving credence to this hypothesis. It is not clear whether this question will ever be answered.
Despite the lack of a definitive biological explanation for the association between the swine flu vaccine and GBS, there is strong evidence for a causal relationship. In the multiple studies performed immediately following the discontinuation of the NIIP as well as in those done almost a decade later, and using at least three distinct sources of data, there were consistent findings of increased numbers of GBS cases during the six weeks following vaccination. A peak onset at two to three weeks post-vaccination was clearly shown. Study after study reported an excess risk of GBS of approximately 1 in 100,000 vaccinees. An additional finding consistent in most of the studies was the much lower rate of prior acute illness in vaccinated cases. Although the 1976 NIIP was short-lived, it was a unique time in our nation’s public health history. It included several elements that allowed for the discovery and analysis of the association between the swine flu vaccine and GBS: (1) massive amounts of vaccine were administered in a short time, with a great deal of attendant publicity surrounding the deaths and other negative reactions; (2) written informed consent was required for administration of the vaccine in the public sector, which allowed for accurate reporting of total doses administered; and (3) the passive surveillance system succeeded as an early warning system, such that a large-scale active investigation began when only seven GBS cases had been reported nationwide. Taken together, the most important results from the investigations and the NIIP may be not only that more research is needed to determine the etiology of autoimmune reactions, thereby enabling a stronger argument for a causal relationship to be made, but also that a well-organized surveillance effort is an invaluable tool in the advancement of epidemiology.
References
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Benenson AS (ed.). Control of Communicable Diseases Manual, Sixteenth Edition. Washington DC: American Public Health Association, 1995.
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Greenstreet R. Adjustment of rates of Guillain-Barré syndrome among recipients of swine flu vaccine, 1976-77. J R Soc Med 1983;76(7):620-21.
Greenstreet RL. Estimation of the probability that Guillain-Barré syndrome was caused by the swine flu vaccine: US experience (1976-77). Med Sci Law 1984;24(1):61-67.
Hogg JE, Kobrin DE, Schoenberg BS. The Guillain-Barré syndrome epidemiologic and clinical features. J Chronic Dis 1979;32(3):227-31.
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Neustadt RE, Fineburg HV. Swine Flu Affair - Decision-Making on a Slippery Disease. Cambridge: John F. Kennedy School of Government, 1978.
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Safranek TJ, Lawrence DN, Kurland LT, et al. Reassessment of the association between Guillain-Barré syndrome and receipt of swine influenza vaccine in 1976-1977: results of a two-state study. Am J Epidemiol 1991;133(9):940-51.
Schonberger LB, Bregman DJ, Sullivan-Bolyai JZ, et al. Guillain-Barré syndrome following vaccination in the National Influenza Immunization Program, United States, 1976-1977. Am J Epidemiol 1979;110(2):105-23.
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Most sexually active women have gotten HPV and cleared it up on their own. Others who have HPV but don't have lesions are actually at a greater risk of developing lesions when they get the Gardasil vaccine. Still others plan to practice abstinence or safe sex and don't need the vaccine. Basically, it's just Merck trying to make a buck by conning parents of teenage girls.
(NewsTarget) For the last several years, HPV vaccines have been marketed to the public and mandated in compulsory injections for young girls in several states based on the idea that they prevent cervical cancer. Now, NewsTarget has obtained documents from the FDA and other sources (see below) which reveal that the FDA has been well aware for several years that Human Papilloma Virus (HPV) has no direct link to cervical cancer.
NewsTarget has also learned that HPV vaccines have been proven to be flatly worthless in clearing the HPV virus from women who have already been exposed to HPV (which includes most sexually active women), calling into question the scientific justification of mandatory "vaccinate everyone" policies.
Furthermore, this story reveals evidence that the vaccine currently being administered for HPV -- Gardasil -- may increase the risk of precancerous cervical lesions by an alarming 44.6 percent in some women. The vaccine, it turns out, may be far more dangerous to the health of women than doing nothing at all.
If true, this information reveals details of an enormous public health fraud being perpetrated on the American people, involving FDA officials, Big Pharma promoters, and even the governors of states like Texas. The health and safety of tens of millions of young girls is at stake here, and what this NewsTarget investigative report reveals is that HPV vaccinations may not only be medically useless; they may also be harmful to the health of the young girls receiving them.
Read the whole thing (follow the link). Basically, if you've already had unprotected sex, you probably already had HPV and cleared it up on your own. If you didn't, it would be better to follow safe sex practices (or abstain) than to get the vaccine, which carries a risk of paralysis and death. If you have HPV but don't have lesions (which you wouldn't even know about), the vaccine can actually cause precancerous lesions to occur. Nice job, Merck. Nice dishonest ad campaign, too.
NewsTarget) For the last several years, HPV vaccines have been marketed to the public and mandated in compulsory injections for young girls in several states based on the idea that they prevent cervical cancer. Now, NewsTarget has obtained documents from the FDA and other sources (see below) which reveal that the FDA has been well aware for several years that Human Papilloma Virus (HPV) has no direct link to cervical cancer.
NewsTarget has also learned that HPV vaccines have been proven to be flatly worthless in clearing the HPV virus from women who have already been exposed to HPV (which includes most sexually active women), calling into question the scientific justification of mandatory "vaccinate everyone" policies.
Furthermore, this story reveals evidence that the vaccine currently being administered for HPV -- Gardasil -- may increase the risk of precancerous cervical lesions by an alarming 44.6 percent in some women. The vaccine, it turns out, may be far more dangerous to the health of women than doing nothing at all.
If true, this information reveals details of an enormous public health fraud being perpetrated on the American people, involving FDA officials, Big Pharma promoters, and even the governors of states like Texas. The health and safety of tens of millions of young girls is at stake here, and what this NewsTarget investigative report reveals is that HPV vaccinations may not only be medically useless; they may also be harmful to the health of the young girls receiving them.
The trouble with the MMR vaccine (and all vaccines) is that the immunity conferred wears off. Then you have problems like what's going on in Canada: adults are coming down with the mumps, so Canada is vaccinated adults to protect them against these new outbreaks. Unfortunately, far more than expected of these adults are having serious allergic reactions to the vaccine, so Canada has stopped vaccinating. Maybe (and call me crazy here) Canada should have let nature run its course and let people get these childhood ailments as children, so they could get real lifetime immunity against diseases that are far more harmful to adults.
* * *
Date: Wed Dec 12, 2007 7:55 am ((PST))
THE CANADIAN PRESS Alberta halts most mumps vaccinations due to serious allergic reactions 30 minutes ago
EDMONTON - Alberta has suspended a provincewide campaign to vaccinate young people against the mumps after five people suffered serious allergic reactions for reasons that are still unknown.
Dr. Karen Grimsrud, acting chief medical officer of health, said Tuesday about 62,800 people between the ages of 17 and 26 have been vaccinated across the province since the program began in November.
Only two to five serious reactions are expected in one million vaccinations, said Grimsrud.
"Obviously, our level of concern was great, and this is above what we would expect to be a normal rate of anaphylaxis in MMR (measles-mumps- rubella)," she said after the decision to suspend the program was made in conjunction with Health Canada.
Anaphylaxis is a serious reaction that can cause wheezing, swelling of the throat and collapse. All five people, who all had a history of allergic reactions, were treated immediately and have fully recovered.
Grimsrud stressed that most of these reactions would happen immediately and at most 24 hours after the vaccine, so the tens of thousands of people who have recently been vaccinated are safe.
Millions of doses of the vaccine have been administered in Canada since 1988, and there have been only 21 reports of anaphylaxis following immunization.
Alberta officials have been in contact with federal health officials since the first three cases were reported Nov. 26. When the fifth case came to light Monday, they decided to act.
All five cases came from one lot of vaccine, but two other lots were also produced from the same bulk products. Alberta had purchased about 200,000 of the 250,000 doses from the three lots made by MerckFrosst Canada, and it was decided to suspend the use of all of those vaccines, severely limiting the supply in the province.
They've warned other provinces that may have bought the other 50,000 not to use those lots.
"Health Canada will be conducting an investigation into the root cause of this particular serious allergic reaction to MMR vaccine, it's highly unusual," she said. "It will be important to know what the source or the reason is behind those reactions."
The mass vaccination program for students and staff in post-secondary institutions started in November after a flurry of cases were reported in Lethbridge and Calgary.
Grimsrud said it's hoped enough people have been vaccinated to date to stop the spread of the virus. There have been 157 cases of the mumps in the province since September.
Grimsrud said it is interesting to note that none of the young children who received the vaccine from the same affected lot have had a reaction.
"It is unusual because it's in young adults, and is there something unique about that age group that would lead us to some information as to what the root cause is," she said. "Until we know why we're having problems, we won't be able to purchase large quantities of vaccine."
The province is still conducting vaccinations for one-year-old children from unaffected lots, said Grimsrud. But all vaccinations for young adults and children in kindergarten have been suspended in order to conserve the doses.
Other provinces have also been contacted to ask for extra doses to tide the province over until health officials can find a new supplier, said Grimsrud.
"Regional health authorities are going to vary in their ability to continue their one-year-old program, because they vary in supply of the vaccine," she said.
Some health regions may have to suspend even the vaccinations in young children for a day or two, or even a week, until temporary vaccines can be found, she said.
The province still hopes to re-launch vaccinations for young adults in the new year, but will only be able to do that when a safe supply has been found.
So here's the deal: Merck contaminated ONE MILLION DOSES of Hib, and won't tell parents whether the contamination is bacterial, viral, or what. "Hib" is the vaccine against Haemophilus influenza type b, which is a flu bacteria that can cause bacterial meningitis. Unfortunately, the increased incidence of Hib is probably due to the overuse of antibiotics like ampicillin. Big Pharma gets you coming *and* going. It's too bad they can't tell you exactly what they accidentally put in your kids' Hib vaccines.
Tests showed a sterilization problem at plant that makes Hib vaccine
The Associated Press
updated 7:11 p.m. ET,Wed., Dec. 12, 2007
ATLANTA - More than a million doses of a common vaccine given to babies as young as two months was being recalled Wednesday because of contamination risks, but the top U.S. health official said it was not a health threat.
The recall is for 1.2 million doses of the vaccine for Hib, which protects against meningitis, pneumonia and other serious infections, and a combination vaccine for Hib and hepatitis B. The vaccine is recommended for all children under 5 and is usually given in a three-shot series, starting at two months.
Drug maker Merck & Co., which announced the recall after testing showed a sterilization problem in a Pennsylvania factory, said concerned parents should contact their child’s doctor.
“The potential for contamination of any individual vaccine is low,” said Merck spokeswoman Kelley Dougherty.
Dr. Julie Gerberding, head of the Centers for Disease Control and Prevention, echoed that in a news conference.
“This is not a health threat in the short run, but it is an inconvenience,” she said.
Merck produces about half of the nation’s annual supply of 14 million doses of Hib vaccine.
Production line closed for 9 months Barbara Kuter, executive director of pediatric medical affairs for Merck, told The Associated Press that because of the contamination, the company’s production line has been shut down for at least nine months.
“Manufacture of vaccines is pretty complicated, and we have to basically make some changes in the process,” then get approval from the Food and Drug Administration before resuming production and shipments, Kuter said. Merck hopes to restart production in the fourth quarter of 2008, she said.
“It’s likely that there’s going to be a shortage of this product,” Kuter said, adding that the impact on the public is unclear because the other company making the vaccines may be able to produce more.
Health officials said they already are talking about prioritizing shots for American Indian and Alaska Native children, who are considered at higher risk for Hib-caused illnesses, said Dr. Anne Schuchat, director of the CDC’s National Center for Immunization and Respiratory Diseases.
Health officials said they did not know how many of the 1.2 million doses were administered to children.
The recalled doses are considered potent, so children who got vaccine from the recalled lots will not have to be revaccinated, Schuchat said.
Parents will probably be concerned, CDC officials acknowledged. Should the vaccine later prove contaminated, health officials believe most children will experience, at worst, a skin irritation around the vaccination site. Problems could be worse for children with compromised immune systems.
Such problems would have appeared within one week of the vaccination, Schuchat said, adding that there has been no reports suggesting vaccine contamination so far.
Risk for infection Dougherty could not immediately say whether the contamination seen at the factory involves a virus or bacteria. She said if someone were vaccinated with a contaminated shot, “There is a risk they could develop an infection.” But she did not provide more details.
The recall is likely to heighten a debate over childhood vaccines and their safety and whether too many are required. Some parents are distrustful and suspect some vaccines of being linked to autism, although scientific studies have not shown such a connection.
This week, New Jersey took a controversial step toward becoming the first state to require flu shots for preschoolers after a health advisory board backed new vaccine requirements over opposition from parents.
Merck, based in Whitehouse Station, N.J., is one of the few drug makers that produces a significant number of vaccines.
While the company took a black eye with its September 2004 withdrawal of the painkiller Vioxx due to increased risk of heart attacks and strokes, the company has been performing well recently. On Tuesday, it gave an upbeat assessment in its annual briefing for analysts.
Five weeks ago, Merck reached a deal to settle up to 50,000 Vioxx lawsuits for $4.85 billion, an amount expected to save the company millions in trial costs.
Its stock price has more than recovered from its post-Vioxx slump, a two-year-old restructuring plan is going well and profits are up. For example, Merck posted a 62 percent increase in its third-quarter profit as revenues jumped by double digits.
The company also has had an impressive seven new products approved for U.S. sale in the last two years, including three vaccines: RotaTeq, to prevent an intestinal virus that is the top cause of early childhood diarrhea; Zostavax to prevent shingles, and Gardasil, to block the virus that causes cervical cancer.
Copyright 2007 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
Monsanto sells both chemical herbicide Roundup and corn that's genetically modified to resist Roundup. They're like arms dealers, only worse, because they poison the vast American public silently. Between 60% and 70% of food in grocery stores in the US contains GMOs, mostly from Monsanto. Thanks, US government, for telling them they don't have to label their products. (More details here: http://www.businessweek.com/magazine/content/07_51/b4063034300400.htm?campaign_id=rss_daily). The big myth is that genetically modified crops help hungry nations, which Friends of the Earth International calls BS on (below). Hungry people aren't hungry because of lower crop yields. They're hungry because of dictators, lack of access to healthcare, lack of education, and other related factors. Don't believe the hype--buy organic and eat healthy.
KUALA LUMPUR (MALAYSIA), LAGOS (NIGERIA), BRUSSELS (BELGIUM), January 8, 2007 - A new report released on January 9 shows that genetically modified (GM) crops have failed to address the main challenges facing farmers around the world, and more than 70% of large scale GM planting is still limited to two countries (U.S. and Argentina).
The new report, 'Who Benefits from GMcrops? An analysis ofthe global performance of genetically modified (GM) crops 1996-2006' [1] also notes that the 'second generation' GM farm crops with attractive 'traits' long promised by the industry has failed to appear.
"No GM crop on the market today offers benefits to the consumer in terms of quality or price, and to date these crops have done nothing to alleviate hunger or poverty in Africa or elsewhere," said in Nigeria Nnimmo Bassey ofFriendsoftheEarth Africa.
"The great majority ofGMcrops cultivated today are used as high-priced animal feed to supply rich nations with meat," he added.
According to the report, GMcrops commercialized today have on the whole increased rather than decreased pesticide use, and do not yield more than conventional varieties. The environment has not benefited from them, and GMcrops will become increasingly unsustainable over the medium to long term.
TheFriendsoftheEarthInternational report launch coincides with the annual release ofthe "Global Status of Commercialized Biotech" report ofthe industry-sponsored International Service for the Acquisition of Agri-biotech Applications (ISAAA) which promotes GMcrops as a key solution to hunger and poverty. TheGMcrops industry continues to misleadingly claim that GMcrops play a role in solving world hunger.
2006 A BAD YEAR FOR GMCROPS
In 2006 the US Department of Agriculture, a chief proponent ofGMcrops, for the first time acknowledged that GM crop yields are not greater than those of conventional crops, and a compelling number of studies by independent scientists demonstrate that GM crop yields are lower than, or at best equivalent to, yields from non-GM varieties.
In 2006 a European Union-wide survey of public views reconfirmed the European public's opposition to GM food.
In 2006 the rice food supply on four continents was contaminated with an illegal GM rice supposedly field-tested only until 2001, proving once again the inability or unwillingness ofthe biotech industry to control its products.
In the last decade cotton production has declined in the majority of countries that have adopted GM cotton, including Mexico, Argentina, Colombia, South Africa and Australia, and significant drops in GM cotton production specifically are forecast in 2006 for South Africa and Mexico.
As of December 2006 only four crops (maize, cotton, soy and canola) with only two traits (herbicide tolerance and insect resistance) were widely cultivated by the world's biggest producer ofGMcrops, the United States, despite the fact that it approved 71 distinct biotech 'events' for commercial use so far.
FOR MORE INFORMATION CONTACT:
In Africa: Nnimmo Bassey, FriendsoftheEarth Africa, Tel: +234 8037274395 (mobile) or +234 52602680 (office)
In Asia: Nizam Mahshar, FriendsoftheEarth Malaysia, Tel: +60194777755
In Europe: Adrian Bebb, FriendsoftheEarth Europe, Tel +4916094901163
In South America: Karen Nansen, FriendsoftheEarth Uruguay, Tel: +598 99 524 003
I know it's not health-related, but this is a great analysis of a really crappy thing the government is about to do to those of us who didn't over-borrow and lie about our income. Great--now it'll cost even MORE for me to buy some overpriced house hours away from where I really want to live. Remind me again why I voted Republican in the last election.
The Bush administration intends to fix the subprime credit mess by keeping people who weren't creditworthy in debt longer and rendering signed contracts meaningless.
In a pair of moves that might once have seemed too cynical even for Washington, it looks like policymakers have decided the cure for a crisis created by too much cheap credit offered too long is very simple: Extend the terms, encourage more borrowing and have someone else foot the bill.
It's the financial equivalent of the hair-of-the-dog "cure" for a hangover: a big interest-rate cut from the Federal Reserve next week and, as just announced by President Bush, a massive bailout plan for distressed mortgage holders.
Have we completely lost our common sense? Is it really desirable to provide easier money to people and companies that got into trouble by abusing their access to money in the first place? And is it really a good idea both to cancel mortgage bondholders' contracts for the sake of an adjustable-mortgage-rate freeze and to provide a couple of years of grace for stressed-out home borrowers who are likely to eventually default anyway?
I don't think so. It's as if the Federal Reserve and U.S. Treasury believe the best way to treat heroin addicts is through long-term, government-supplied crack. To be sure, lower interest rates and a mortgage-rate freeze might ease borrowers' pain temporarily, but they do nothing to solve causes or habits -- and without a doubt launch a new cycle of abuse and dependence.
Building bad habits
Unfortunately, this is pretty much the history of U.S. economics in the past decade. We call ourselves a free economy but repeatedly let the government intervene to make sure that no one who votes gets seriously hurt. As a result, individuals who make bad choices -- from Gulf Coast residents who build homes in the path of hurricanes to low-income citizens who take out expensive loans for overpriced real estate -- are rescued time after time in well-intentioned but misguided programs such as the one the Bush administration has cooked up for foreclosure-facing mortgage holders and their lenders.
What has to irk you is the disparity between who wins when things are going well and who loses when things go sour.
When banks make a lot of money, after all, they suck down the profits by giving their executives and boards outrageous pay packages worth tens of millions of dollars, justifying their actions under the rubric of entrepreneurship. And when the opposite happens? They beg taxpayers for a handout.
Veteran observer Satyajit Das has disdainfully called the financial industry's attempt to patch over its problems with taxpayer funds the "socialization of losses." It's an approach that may sound good to politicians in an election year yet is not only morally bankrupt but will also merely delay the ugly final reckoning for companies, individuals and policymakers alike.
Video on MSN Money
Bush reveals mortgage plan President Bush announces an agreement with the mortgage industry that will freeze rates on hundreds of thousands of subprime mortgages.
Postponing the undeniable anguish involved in making participants own up to debt-fueled losses is exactly why it took Japan more than a decade to shake off the bursting of its own credit bubble back in 1990. Interest rates were cut essentially to zero, but because moribund banks and real-estate tycoons were given government stipends, they drew funds and attention away from more-productive uses, and the country entered a recession that haunts Japan to this day.
Broken promises
The program proposed by U.S. Treasury Secretary Hank Paulson -- hammered out in round-robin meetings with mortgage lenders and borrowers' representatives in the past few weeks -- would freeze interest payments on hundreds of thousands of adjustable-rate mortgages for three to five years.
That sounds nice, but here's the catch: Rising interest rates were contractually promised to the mortgage lenders, which then passed along that promise to companies that bought the loans as part of asset-backed securities and associated derivatives.
Though the rate freeze would be awesome to a mortgage holder in Muncie, Ind., who wants to get out of his adjustable-rate obligation, it sounds terrible to a pension-fund manager in Munich who isn't getting the income stream he paid for, as well as to the mortgage-servicing company that won't be getting its own piece of the future income stream.
The breaking of these obligations will not be free. Foreign investors will demand a higher "risk premium" to invest in U.S. real estate, which will make it more expensive for future mortgage seekers to get loans. And they are bound to sue to get the payments they thought they were owed, which will drive up mortgage banks' expenses.
Moreover, the courts and bureaucrats will be tied up for years in a struggle to define exactly who deserves loan forgiveness. People who are making payments on time will naturally demand to get something out of the deal -- why should they essentially suffer for being responsible? As the cost of the bailout goes up, there's little doubt that state and federal governments will float bonds to pay the refinancing fees and, of course, interest payments on those obligations will be paid by all citizens.
Economist Martin Feldstein, a former Reagan administration official, told Bloomberg that among other problems, the plan would forever change foreigners' perceptions of U.S. investments. "What are they going to think about investing in American securities in the future if the government can say, 'Well, you thought these were the interest rates and the contract, but we're going to roll that back now, and you'll just have to settle for less'?" Feldstein asked.
Dr. Frankenstein's debt monster
When you start working your way though the ramifications, you may begin to understand why I called the great de-leveraging of America a very big, very long-range problem in this column back in September -- not something that can be ignored or wished away. Debt that was created, distributed, leveraged and re-leveraged by a factor of up to 30-to-1 over the past 10 years by financial Dr. Frankensteins has wormed its way into every corner of our lives and will alter the way we do business in ways we are only beginning to understand.
Indeed, everywhere you look now is evidence that the subprime-debt crisis is morphing and expanding like a creature in a horror movie. Just this week, we learned from hearings in Congress that strapped credit card companies such as Capital One Financial (COF, news, msgs) and Bank of America (BAC, news, msgs) had begun to soak customers by jacking up interest rates on balances for the slightest changes in their credit profiles.
If you so much as apply for a new credit card, according to testimony gathered at the hearing, your current card provider can boost your rates as high as 30% per year. This is not the kind of fee-generation method that card companies would normally like to pursue, but they have been pushed in this direction by losses elsewhere on their balance sheets.
In another morph, individuals scrambling to pay rising mortgage rates on houses that are declining in value are also punking out on their auto loans, student loans and home-equity lines of credit. According to a Lehman Bros. survey, 4.5% of auto loans issued in 2006 to well-qualified borrowers were 30 or more days delinquent through the end of September, up a whopping 3% from the previous month. Lehman said that was the largest single-month delinquency leap in eight years and that auto-loan delinquency rates are now the highest in a decade. Meanwhile, 12% of subprime auto borrowers are delinquent on their 2006 loans, according to Lehman Bros., which is the most since 2002.
Video on MSN Money
Bush reveals mortgage plan President Bush announces an agreement with the mortgage industry that will freeze rates on hundreds of thousands of subprime mortgages.
Any solution that attempts to solve these issues by cutting rates further to allow people to borrow more will only drag out the effects. It will also force solvent taxpayers to foot the bill for their less responsible siblings and neighbors, a divide that will cause political strife we haven't yet begun to fathom. All of this may ultimately work out in the fullness of time, because Americans are forgiving and generous people. But in the meantime, financial stocks are likely to continue to suffer, so continue to avoid them even as they fitfully rally over the next weeks. They are likely headed much, much lower, as their fundamental value recedes with their profitability.
Fine print
Read more about methadone treatments here. . . . Capital One, focused on credit cards and auto loans, is likely to be an ongoing loser on the subprime front. Learn more about the company here. . . .
Read all about Treasury Secretary Hank Paulson here. Did you know Paulson's passion in life outside work is bird-watching?
At the time of publication, Jon Markman did not own or control shares of companies mentioned in this column.
This has been in the news again recently, because the FDA still denies that the amount of Bisphenol A in baby formula cans is harmful. Check out the table (below), and see for yourself. Even if I weren't breastfeeding, I wouldn't expose my baby girl to the increased risk of, for example, breast cancer. Nice job, FDA, for looking the other way.
Bisphenol A was first synthesized by A.P. Dianin in 1891.[1][2] Bisphenol A was investigated in the 1930s during the search for synthetic estrogens. At that time, another synthetic compound, diethylstilbestrol, was determined to be more powerful than estrogen itself, so bisphenol A was not used as a synthetic estrogen.
Polycarbonates are widely used in many consumer products, including sunglasses, CDs, water and food containers, and shatter-resistant baby bottles. Some polymers used in dental fillings also contain bisphenol A, while epoxy resins containing bisphenol A are popular coatings for the inside of cans used for canning food.
Health risks
Bisphenol A is known to be an estrogen receptor agonist, which can activate estrogen receptors, leading to similar physiological effects as the body's own estrogens.[3] The first evidence of the estrogenicity of bisphenol A came from experiments in the 1930s in which it was fed to ovariectomized rats.[4][5] Some hormone disrupting effects in studies on animals and human cancer cells have been shown to occur at levels as low as 2-5 ppb (parts per billion). It has been claimed that these effects lead to health problems such as, in men, lowered sperm count and infertile sperm. Recent studies have confirmed that bisphenol A exposure during development has carcinogenic effects and produce precursors of breast cancer.[6] Bisphenol A has been shown to have developmental toxicity, carcinogenic effects, and possible neurotoxicity.[7][8] Recent studies suggest it may also be linked to obesity by triggering fat-cell activity.[9]
Various environmental groups have claimed that exposure to bisphenol A from polycarbonate-containing consumer products poses a potential human health risk. However, government regulatory agencies in Europe, Japan, and the United States have all concluded that normal use of these products is harmless.[10] However peer reviewed publications have appeared pointing out flaws within the chemical industry funded studies that report bisphenol A safety.[11] In 2006, Canadian regulators selected bisphenol A as one of 200 substances deserving of thorough safety assessments after preliminary studies found it to be 'inherently toxic'; the chemical had not previously been studied by them in depth, having been accepted under grandfather clauses when stricter regulations were passed in the 1980s. The research will begin in May 2007, and take some time to complete.[12] The city of San Francisco, California, banned the sale of baby bottles and other products for young children containing bisphenol A in June 2006, effective December 2006, and was, at the time, the only jurisdiction in the world to outright forbid the substance.[13] The ban was never enforced, and in May 2007 the city repealed the ban.
In January 2006, the German Federal Institute for Risk Assessment announced that polycarbonate baby bottles are safe, stating that published research is "difficult to interpret and [is] occasionally contradictory".[14] A subsequent study by the European Union’s Food Safety Authority reached a similar conclusion, and sharply criticized the methodology used in many of the low-dose exposure studies on rodents.[15]
Bisphenol A has been known to leach from the plastic lining of canned foods and, to a lesser degree, polycarbonate plastics that are cleaned with harsh detergents or used to contain acidic or high-temperature liquids.[16] Infants fed with liquid infant formula have among the highest exposures of anyone eating canned foods. Infants fed canned formula with polycarbonate bottles can consume quantities of bisphenol A up to 13 µg/kg/day.[17] The chemical is found in most people that live in developed countries at low concentrations. Debate continues on what is the safe limit of this compound. Within the United States, an exposure of up to 50 µg/kg/day (50 ppb) is considered safe - satisfying a thousandfold margin of safety[12] - by the United States Environmental Protection Agency.[18]
Dose (µg/kg/day)
Effects (measured in studies of laboratory animals)
^ EWG, 2007. "Many studies confirm BPA's low-dose toxicity across a diverse range of toxic effects," Environmental Working Group Report: A Survey of Bisphenol A in U.S. Canned Foods. Accessed November 4th, 2007 at http://www.ewg.org/node/20941.
^ Fox, J.E., J. Gulledge, E. Engelhaupt, M.E. Burrow & J.A. McLachlan (2007). "Pesticides reduce symbiotic efficiency of nitrogen-fixing rhizobia and host plants". Proc. Nat. Acad. Sci.104: 10282-7.
Now it's proven: organic food is better for you! In addition, supporting organic farmers means that you're supporting people who don't pour poison into the environment (the groundwater, the food supply, etc.). Time to buy some Horizon milk and eggs, some Applegate Farms cold cuts, some Pure Farms bacon, and some Earth's Best baby food. Do it for your family, and for yourself.
It seems like every day someone emails me another news story about the hidden dangers of plastic.
I usually stop whatever I'm doing to read it, more convinced with every each new study and infertile rat that we're doomed to extinction by plastic. When I'm done I usually look up to find my one year-old daughter trying to stuff something plastic into her mouth, despite the variety of brightly colored non-toxic wood toys lying around her on the floor.
So I was happy to read something good this morning about something that plays a big part in my life —they've proven that organic milk is better for you! All the money I've been spending on the stuff — and it's up to $15 dollars a day because I'm pregnant and it really helps my heartburn — is worth it. The same goes for organic food.
For the past seven years, the organic food lobby in England has been trying to get the Food StandardsAgency (FSA) to change their claim that organic food isn't safer or healthier. And now, after a 4-year, 12million pound, European Union-funded investigation led by Newcastle University that shows organic foods have far more nutritional value, they may soon get their way. The study isn't over yet and the results will be published over the next year, but the hope is that the FSA will change its claim that "the balance of current scientific evidence does not support" the idea that organic food is more nutritious than conventional.
The Quality Low Input Food project, the biggest of its kind, took a 725-acre farm in north-east England, grew conventional produce (like cabbage, lettuce, potatoes and what) next to organic produce, and compared the results.
The biggest contrast was found for milk. The study found that levels of antioxidants in milk from organic cattle were between 50% and 80% higher than conventional milk (60% to 80% more nutrients in the summer than conventional milk, and 50% to 60% more in the winter). Organic milk also has higher levels of vitamin E, and 60 percent more antioxidants and desirable fatty acids. Antioxidants help with a healthy circulatory system and help keep cancer and heart disease away.
Other highlights:
Fruit and vegetables contain up to 40% more nutrients if they are grown without chemical fertilizers and pesticides.
Up to 40% more antioxidants could be found in organic fruit and vegetables than in those conventionally farmed.
Potatoes, kiwi fruit and carrots were among the organic produce found to be higher in vitamin C.
Higher levels of minerals and antioxidants were found in organically- farmed lettuce, spinach and cabbage. Organic spinach and cabbage have more minerals.
Organic produce also had higher levels of iron and zinc, vital nutrients lacking in many people's diets.
Organic cheese can have up to twice as many nutrients than conventional varieties.
Organic tomatoes, wheat, potatoes, cabbage, onions and wheat have 20 to 40 per cent more antioxidants than conventional fruit and vegetables.
Deirdre Dolan and Alexandra Zissu are the authors of The Complete Organic Pregnancy. They write the Ask an Organic Mom blog for The Daily Green.com, where they answer your questions about how to raise a toxin-free baby.
Here's a great posting by the mom from the autism community whose brother is finally waking up to the fact that the CDC is closing its eyes to all the research that could be done about the harmful effects of vaccines. Something to ask yourself as you think about the pros and cons of vaccination is why the average American's life expectancy today is only marginally higher than it was in 1776. We've traded recoverable diseases like the measles for far more tragic ones, and we've polluted our bodies (and our environment) with mercury, aluminum, formaldehyde...
It’s awkward when you have a doctor in the family, isn’t it? If you’re like me, you struggle deciding with what to ask him/her, if anything, and how often. And if you’re like me and have a child with Autism, you struggle with how much you really need their help and approval, even though it is not likely you will get it.
So you can imagine my surprise when our family doctor called with an urgent question.
"Hey, what's the name of that practice in Chicago you said has 30,000 patients and virtually no Asthma or Autism?"
It's my younger brother. Again.
He's a board certified podiatric surgeon married to another board certified podiatric surgeon. They just had an adorable baby girl 4 months ago that they have yet to vaccinate.
"Home First," I replied. "I take your niece there, remember?"
"And no one is studying them you said?"
"Nope. Not that I know of."
"Why not? Hasn't anyone published this? Hasn't this been on the news? I mean almost no Autism, and no one's interested?"
"Well, I told you Dan Olmsted has written about it. But no major agencies like the CDC have done anything with it."
"But that doesn't make any sense. I mean, that's the perfect place to look. The kids aren't Amish, so you can't make a "founders gene" claim. They're all different ethnicities and live in the 3rd largest city in the U.S. Even if you just took a sample and had 10 physicians all agree on their diagnosis, you'd get a good picture of what was going on. I mean it's just data collection and analyzation. It's not hard to do."
"I know, Chris," I shake my head having had this conversation over a year ago. "I don't know what it will take for you to believe me. It's not a hard study to do. It's just that no one wants to do it. No one wants those answers."
And so he continued, his frustration growing ever more palpable. This is now the fourth phone call I have received from him in a matter of 2 weeks regarding vaccines. The previous one was a tirade about aluminum.
"Jul, I really only ever hear you talk about mercury, but did you ever think about aluminum? Did you know that the amount of aluminum acceptable for an adult male is 25 micrograms per day, and that at one well-visit, an infant gets 1200? Do you know what would happen to me if I mainlined anything into someone at almost 50 times the established safety amount, let alone a baby? I'd lose my license!"
Even though we have always been close, we never talk this much. And even though I have been battling to recover my daughter for 3 years now, he has been of very little scientific or medical help.
Instead, he and my sister-in-law (whose mother is a nurse, father is a doctor, and has 3 sisters who are either a pediatrician, dentist or med student) have always been quietly supportive of my position and my protocol regarding Autism. They have never openly criticized me, although I always suspected behind closed doors they thought I jumped off the Desperate Mom Bridge into the Sea of Conspiracy.
"I gotta be honest with you, Jul," he says. "I've always trusted and supported you. It's never been that I didn't believe there was some truth to what you were telling me. I just always believed that you weren't looking at the other side objectively. I believed there was something out there that refuted your theory that would put this all to rest so that I could vaccinate and be at peace with it."
"So I've been looking for something to tell me you're wrong, to tell me that vaccines are safe and necessary in the manner that we administer them now," he pauses.
"And I can't find it."
There's a brief silence, as I don't really know how to respond. I'm offended, annoyed and thrilled at the same time.
" 'Show me the study!', I keep saying. It doesn't exist. All I can find is that we need herd immunity, so just do it. In fact, the only real science I'm finding is being done on the side of why vaccines are likely involved in a lot more than Autism. And by the way, did you know that pertussis was actually already down by 83% before the vaccine was even created?"
Now, my brother is one of the smartest people I have ever met. He graduated at the top of any class he has ever been a part. He is wickedly handsome and charming and looks exactly like Prince William, I swear. And he loves science. But right now, I could smack him upside the head as he regurgitates what I have been saying to him for years.
"You know what really bothers me about all of this?" he asks without waiting for my reply.
"It's that good research always shows you that more research is necessary. It should simply point you in a closer direction. And with vaccines, it's the opposite. It's as if they don't want to do any research."
"And another thing," he added.
"We have a saying as surgeons: 'You're not doing surgery if you have no complications.' It reminds us medicine is imperfect. There are always problems. We're always learning. The way we did bunions 20 years ago changed because our complication rate was too high. We had to adjust. No one is learning from the vaccine complications because they aren't even acknowledging what they are."
On the other side of the phone, I am half-smiling, half-smirking. I wouldn't be human if I didn't feel vindicated, but I am also proud of him. He is who I hoped he was, and I am confident he will be a powerful physician-advocate for our children shortly. But I am also hurt and angry at him for not helping me during the last 3 years. I am frustrated that it took him having a baby of his own to finally get involved and take me seriously.
As he goes on about how his pediatrician-sister-in-law is giving them a hard time for not vaccinating, I marvel at how much he already has in his arsenal to challenge her. He believes strongly there is no possible way any pediatrician is reading what he has read objectively. I am hopeful he will help change that, starting with his wife's sister.
Most of all though, I am relieved. I am relieved he thought enough of my daughter's experience to at least investigate for his own child's benefit. My niece is the most healthy, beautiful little girl I have seen since my own, and the thought of her possibly going through what her cousin has in spite of everything I have tried to tell them is too much to bear.
He ends the phone call disillusioned and sad. I end it with a challenge.
"Three weeks ago, I started reading just to modify our vaccine schedule like you suggested. I waited until she was 4 months old and was all set to get the ball rolling. But today, I sit here dumb-founded. I can't just modify her vaccine schedule. You might be able to get mercury-free vaccines, but you can't get them aluminum-free. And I wasn't going to give her any of the live virus vaccines anyway, so now I simply can't give her any. It goes against everything in me as a scientist, father, and physician."
And then he finishes, "I tell you, I would rather she got Polio than Autism. At least her mind would be in tact. At least she could talk to me, experience life with me. No offense, but some of the stories you send me about these kids? Well, if they were horses, they'd be put down just to ease their misery. What parent can watch that, or live with that? What child deserves that? And I'm supposed to just trust that vaccinating her won't do that, even though at every opportunity the CDC has to prove me wrong, they do nothing of the sort? How can they possibly expect me to take that chance?"
"I don't know, little brother, but they do," I conclude.
"Now tell me what you're going to do about it."
Julie Obradovic is a High School Spanish Teacher in the suburbs of Chicago where she lives with her husband and 3 beautiful children, one of whom is recovered from Autism. She is a member of the NAA, a Rescue Angel, and founder of the Southwest Suburban Biomedical Support Group. Last year she threw the First Annual Evening for ACE, a benefit that raised several thousand dollars for the Autism Center for Enlightenment, Dr. Anju Usman's not-for-profit organization.
Just like your mama always told you, "Cover your mouth and nose when you cough and sneeze, and wash your hands!"
Maybe it's time for the American public to regard drug manufacturers as similar to companies that make candy bars--rather than missionaries, which seems to be the way people think of Big Pharma today. Roche, Merck, et al--they don't exist to help you, out of the goodness of their hearts. They exist to make money by convincing you that you need to buy their products. Think twice before you do.
Masks, gloves also more effective in stopping pandemic spread, study finds
Reuters
updated 11:41 a.m. ET,Wed., Nov. 28, 2007
HONG KONG - Physical barriers, such as regular handwashing and wearing masks, gloves and gowns, may be more effective than drugs to prevent the spread of respiratory viruses such as influenza and SARS, a study has found.
The findings, published in the British Medical Journal, came as Britain announced it was doubling its stockpile of antiviral medicines in preparation for any future flu pandemic.
Trawling through 51 studies, the researchers found that simple, low-cost physical measures should be given higher priority in national pandemic contingency plans.
"Mounting evidence suggests that the use of vaccines and antiviral drugs will be insufficient to interrupt the spread of influenza," they wrote in the report.
The 51 studies compared any intervention to prevent animal-to-human or human-to-human transmission of respiratory viruses, such as isolation, quarantine, social distancing, barriers, personal protection and hygiene, to doing nothing or to other types of intervention. They excluded vaccines and antiviral drugs.
They found that handwashing and wearing masks, gloves and gowns were effective individually in preventing the spread of respiratory viruses, and were even more effective when combined.
"This systematic review of available research does provide some important insights ... There is therefore a clear mandate to carry out further large trials to evaluate the best combinations," the international team of scientists wrote.
Another study, published in the Cochrane Library journal last month, found handwashing with just soap and water to be a simple and effective way to curb the spread of respiratory viruses, from everyday cold viruses to deadly pandemic strains.
Researchers have long warned that the world is due for another pandemic but they cannot say which strain will strike. The H5N1 avian flu virus that has killed more than 200 people globally since 2003 is considered a prime suspect.
(c) Reuters 2007. All rights reserved. Republication or redistribution of Reuters content, including by caching, framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters and the Reuters sphere logo are registered trademarks and trademarks of the Reuters group of companies around the world.
Tamiflu and Relenza linked to abnormal behavior in some patients
MSNBC News Services
updated 6:00 p.m. ET,Fri., Nov. 23, 2007
WASHINGTON - Government health regulators recommended adding label precautions about neurological problems seen in children who have taken flu drugs made by Roche and GlaxoSmithKline.
The Food and Drug Administration on Friday released its safety review of Roche’s Tamiflu and Glaxo’s Relenza. Next week, an outside group of pediatric experts is scheduled to review the safety of several such drugs when used in children.
FDA began reviewing Tamiflu’s safety in 2005 after receiving reports of children experiencing neurological problems, including hallucinations and convulsions.
Twenty-five patients under age 21 have died while taking the drug, most of them in Japan. Five deaths resulted from children “falling from windows or balconies or running into traffic.”
There have been no child deaths connected with Relenza, but regulators said children taking the drug have shown similar neurological problems.
While FDA said it isn’t clear whether the problems are directly related to the drugs, it recommends adding language about the possible side effects to labeling for physicians who prescribe Tamiflu and Relenza.
In documents prepared for the meeting next week and posted on the FDA's Web site, agency staff recommended that Tamiflu's label be strengthened to note: "In some cases, these behaviors resulted in serious injuries, including death, in adult and pediatric patients."
The FDA staff also reviewed Relenza, a drug in the same class as Tamiflu, recommending its label be changed to note "reports of hallucinations, delirium and abnormal behavior" observed in some patients taking the drug.
The current Relenza label has no label warning related to psychiatric events.
The FDA staff said the evidence is "conflicting" as to whether the events are medication-related, a manifestation of disease or a combination of the two.
Japan probe Tamiflu has been more widely used in Japan than in the United States, and there is some evidence that the Japanese are more vigilant about reporting side effects, the FDA has said.
Tamiflu, known generically as oseltamivir, is a pill, while Relenza, generically zanamivir, is inhaled.
A Roche spokesman said no causal relationship between Tamiflu and these psychiatric events has been proven.
"Roche has extensively investigated the issue and is conducting ongoing clinical and nonclinical studies. Roche takes all adverse events reports very seriously," spokesman Terence Hurley said in a statement.
Besides being a drug side effect, the agency said the behaviors alternately could result from an unusual strain of flu or a rare genetic reaction to the drug.
About 48 million people have taken Tamiflu worldwide, including 21 million children, since approval in 1999, he said.
A Glaxo spokeswoman said a review of premarketing and post-approval trial data showed no worrying safety signals on patients taking Relenza. The drug is a not a major revenue-generator for UK-based Glaxo.
FDA staff based its recommendations on a review of nearly 600 cases of neuropsychiatric events reported by patients on Tamiflu and 115 cases of such events by patients taking Relenza.
The FDA staff will present the advice to the advisory panel of experts meeting on Tuesday, November 27. The agency typically takes the advice of these panels but is not bound by them. Japan in March warned against prescribing Tamiflu to those ages 10 to 19 as more than 100 people, mostly young, showed signs of abnormal behavior after taking the drug.
Earlier this year, Japan broadened its probe of Tamiflu to look at flu drugs Relenza and amantadine, after reports of abnormal behavior among young patients.
FDA staff reviewed recent side effect reports on amantadine and rimantadine, another flu drug in amantadine's class, but recommended no label changes. Amantadine already has a strong warning about suicide attempts and an increase in seizures seen in patients on the drug, while rimantadine notes seizure-like activity and hallucinations.
Tamiflu was having lackluster sales as a drug to prevent and treat seasonal flu but got a second life when it was the first drug to show real efficacy in treating and preventing bird flu.
The Associated Press and Reuters contributed to this report
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