In London, the Sunday Times is reporting that "When the new vaccine for swine flu arrives in Britain, regulators said this weekend, it could be approved for use in just five days."
No word yet on how long the trials for the H1N1 shots will last in the US.
I have spoken to an official at the Maine health department who is reporting that the vaccine delivered here will be one that comes in multidose vials, therefore will be a mercury containing vaccine.
Last week, HHS secretary Kathleen Sebelius said that HHS was "anticipating a voluntary" H1N1 vaccine program this fall, which leaves room for the possibility that HHS could change their minds and make it mandatory.
I would encourage everyone to keep an eye on this story as it develops, as hastily manufactured, tested and delivered vaccines that are not held up to the same scrutiny that is standard during FDA licensure certainly would have a greater potential for adverse reactions when introduced to the general public.
Swine flu vaccine to be cleared after five-day trial
July 12, 2009 The Sunday Times
byJon Ungoed-Thomas
The path of a popular medicine from the laboratory to the chemist or doctor’s surgery can involve years of clinical trials on a select group of patients.
When the new vaccine for swine flu arrives in Britain, regulators said this weekend, it could be approved for use in just five days.
Regulators at the European Medicines Agency (EMEA) said the fast-tracked procedure has involved clinical trials of a “mock-up” vaccine similar to the one that will be used for the biggest mass vaccination programme in generations. It will be introduced into the general population while regulators continue to carry out simultaneous clinical trials.
However, regulators said fast-tracking would not be at the expense of patient safety. “The vaccines are authorised with a detailed risk management plan,” the EMEA said. “There is quite a body of evidence regarding safety on the trials of the mock-up, and the actual vaccine could be assessed in five days.”
The UK government has ordered enough vaccine to cover the entire population. GPs are being told to prepare for a nationwide vaccination campaign.
Dr Peter Holden, the British Medical Association’s lead negotiator on swine flu, who has been attending Department of Health meetings on the outbreak, said GPs’ surgeries were prepared for one of the biggest vaccination campaigns in almost 50 years.
He said although swine flu was not causing serious illness in patients, health officials were eager to start a mass vaccination campaign, starting first on priority groups. First, the jabs would reduce the chances of a shortage of hospital beds because of people suffering from swine flu. Second, it would reduce the effect on the economy by ensuring workers were protected from the virus.
“The high-risk groups will be done at GPs’ surgeries. People are still making decisions over this, but we want to get cracking before we get a second wave, which is traditionally far more virulent.”
Holden said it was likely the elderly would be given their seasonal flu jab as well as the swine flu vaccination. The new vaccine is likely to require two doses.
Details of the inoculation plans emerged after the death of a patient, reportedly a middle-aged man, at a hospital in the Basildon area of Essex. The victim had no underlying health problems, but officials say there is no evidence the swine flu virus had mutated into a more dangerous strain.
Holden said it would be the biggest campaign in response to an outbreak since mass vaccination against smallpox in 1962. He said surgeries would be aiming to inoculate about 30 people an hour in a “military-style operation”.
The Department of Health said it had still not finalised which groups would be vaccinated first, but children, frontline health workers, people with underlying illnesses and the elderly are likely to take priority.
The European Commission is also identifying population groups which it believes should get priority. It is keen to ensure that countries such as the UK, which had ordered supplies of the vaccine in advance, do not cause inequities in treatment elsewhere in Europe.
It warned health ministers in a note circulated last month that if the vaccines were more readily available in some countries it could cause “vaccine tourism/shopping in other member states”.
About 15 people have died of swine flu in Britain, but most of those infected get only mild symptoms. According to the latest figures from the Health Protection Agency, the UK has had 9,718 confirmed cases of the disease.
They will soon claim that the benefits of the omega 3s found in fish are worth the mercury poisoning.
Apparently they have not heard that you can get cheated fish oil in a little pill which gives pregnant women all the bennies of fish oil with out all the brain damagie effects of mercury.
Robert F. Kennedy, Jr., in his comments last summer at the Green our Vaccines rally talked about the phenomenon of agencies being captured by the industries that they are supposed to be regulating. I think that once we find out exactly how this report came to be, this will turn out to be a huge, glaring example of this destructive trend. I will be surprised if we don't find Big Tuna's fin prints all over this thing.
FDA Draft Report Urges Consumption of Fish, Despite Mercury Contamination
By Lyndsey Layton
Washington Post Staff Writer
Friday, December 12, 2008; Page A07
The Food and Drug Administration is urging the government to amend its advisory that women and children should limit how much fish they eat, saying that the benefits of seafood outweigh the health risks and that most people should eat more fish, even if it contains mercury.
If approved by the White House, the FDA's position would reverse the government's current policy that certain groups -- women of childbearing years, pregnant women, nursing mothers, infants and children -- can be harmed by the mercury in fish and should limit their consumption.
The FDA's recommendations have alarmed scientists at the Environmental Protection Agency, who in internal memos criticized them as "scientifically flawed and inadequate" and said they fell short of the "scientific rigor routinely demonstrated by EPA."
The FDA sent its draft report, a copy of which was obtained by The Washington Post, to the White House Office of Management and Budget as part of the FDA's effort to update the existing health advisory. The report argued that nutrients in fish, including omega-3 fatty acids, selenium and other minerals could boost a child's IQ by three points.
The greatest benefits, the FDA report said, would come from eating more than 12 ounces of fish a week, which is the current limit advised for pregnant women, women of childbearing age, nursing mothers and young children.
FDA spokesman Michael Herndon declined to discuss the draft report. "As a science-based regulatory agency we periodically and routinely review and analyze scientific evidence about health effects of FDA-regulated products," he wrote in an e-mail. "We do not comment on draft reports that are undergoing internal review."
Benjamin H. Grumbles, the EPA's assistant administrator for water, said, "EPA is working closely with other agencies in the scientific review of this report to better understand the risks and benefits of fish consumption."
The FDA and the EPA both play a role in protecting the public from mercury contamination. The EPA investigates and regulates mercury and other contaminants in recreationally caught fish, while the FDA regulates mercury in seafood sold in markets and restaurants. States rely on the federal agencies in issuing their own advisories.
In 2004, the two agencies issued their first joint advisory, suggesting that women of childbearing age, pregnant women, nursing mothers, infants and children stop eating four species of fish considered especially high in mercury: swordfish, shark, tilefish and king mackerel. At the same time, the government advised limiting consumption of other mercury-contaminated fish.
Mercury can damage the neurological development of fetuses and infants. Recent studies have suggested that mercury may also pose a health risk for adults, including an increased risk of cardiovascular disease.
The two agencies are supposed to work together to regularly review the advisory, but EPA sources said the FDA went ahead with its own proposal earlier this year, not consulting the EPA until the document was nearly finished.
The Environmental Working Group, an advocacy organization, wrote yesterday to EPA Administrator Stephen L. Johnson and urged him to fight the FDA's recommendations.
"This is an astonishing, irresponsible document," said Richard Wiles, the environmental group's executive director. "It's a commentary on how low FDA has sunk as an agency. It was once a fierce protector of America's health, and now it's nothing more than a patsy for polluters."
Kathryn Mahaffey, who was the EPA's top mercury scientist until she left the agency in August to become a lecturer at George Washington University School of Public Health, said the FDA used an "oversimplified approach" that could increase the public's exposure to mercury.
But Gavin Gibbons, a spokesman for the National Fisheries Institute, applauded the FDA's efforts. "This is a science-based approach," he said. "And you start to see a picture emerge that shows the clear benefits of eating seafood outweigh the risks of a trace amount of mercury in fish."
This is actually recycling an old story from June, but I am gonna run it again anyway because the point needs to be made loudly.
Again... props to Amy and Angela of Mom's Against Mercury for forcing the FDA to do its job.
FDA Reluctantly Admits Mercury Fillings Have Neurotoxic Effects on Children
David Gutierrez Natural News
Wednesday, Dec 03, 2008
For the first time, the FDA has issued a warning that the mercury contained in silver dental fillings may pose neurological risks to children and pregnant women.
"Dental amalgams contain mercury, which may have neurotoxic effects on the nervous systems of developing children and fetuses," reads a statement that has been added to the agency's Web site. "Pregnant women and persons who may have a health condition that makes them more sensitive to mercury exposure, including individuals with existing high levels of mercury bioburden, should not avoid seeking dental care, but should discuss options with their health practitioner."
The warning was one of the conditions that the FDA agreed to in settling a lawsuit filed by several consumer health groups.
"Gone, gone, gone are all of FDA's claims that no science exists that amalgam is unsafe," said Charles Brown, a lawyer for Consumers for Dental Choice, one of the plaintiffs.
"It's a watershed moment," said Michael Bender of the Mercury Policy Project, another plaintiff.
Mercury is a well-known neurotoxin that can cause cognitive and developmental problems, especially in fetuses and children. It can also cause brain and kidney damage in adults.
So-called dental amalgams, or fillings made with a mix of mercury and other metals, have been used since the 1800s. Although it is known that small amounts of mercury are vaporized (and can be inhaled) when the fillings are used to chew food, and though Canada, France and Sweden have all placed restrictions on the use of mercury fillings, the FDA has always insisted that amalgams are safe.
Dental amalgams are considered medical devices, regulated by the FDA.
Even the FDA's new warning stops short of admitting that dental amalgams are dangerous for the general population. Instead, it focuses on the same population that has already been warned to limit mercury exposure by consuming less seafood: children and pregnant women. The FDA says it does not recommend that those who already have mercury fillings get them removed.
Millions of people have received amalgam fillings, although their popularity has dropped off in recent years. Currently, only 30 percent of dental fillings contain mercury - the rest are tooth-colored resin composites made from glass, cement and porcelain. These alternative fillings are more expensive and less durable than amalgam, however.
In 2002, the FDA began a regulatory review of amalgam that was expected to be complete within a few years. In 2006, with the review still incomplete, an independent FDA advisory panel of doctors and dentists rejected the agency's position that there is no reason for concern about the use of amalgam. While the panel agreed that the majority of people receiving such fillings would not be harmed, panel members expressed concern for the health of certain sensitive populations, including children under the age of six.
The panel recommended that the FDA conduct further studies on the risks to children from dental amalgam, and that it consider a policy of informed consent for children and pregnant: that is, warning those groups of the risks associated with the fillings before installing them.
Part of the lawsuit centered on the FDA's failure to respond to these recommendations in a timely fashion.
"This is your classic failure to act," federal judge Ellen Segal Huvelle told the agency.
As part of the lawsuit settlement, the FDA must reach a final decision on the regulation of amalgam by July 28, 2009.
"This court settlement signals the death knell for mercury fillings," Brown predicted.
But J.P. Morgan Securities analyst Ipsita Smolinski disagreed, saying that the FDA is unlikely to ban amalgam entirely
"We do believe that the agency will ask for the label to indicate that mercury is an ingredient in the filling, and that special populations should be exempt from such fillings, such as: nursing women, pregnant women, young children, and immunocompromised individuals," Smolinski said.
When the FDA discovered melamine in U.S. infant formula products, it made a conscious decision to withhold that information from the public. Instead, it called a teleconference with the infant formula manufacturers to warn them about its findings!
The truth about the melamine only became public after the Associated Press filed a Freedom of Information Act request, demanding the test results from the FDA. Absent that request, this whole issue would have continued to remain an FDA secret.
In the aftermath of that decision, the FDA is now under intense fire for once again betraying the public trust and acting to protect the interests of corporations rather than the people. Congress, public health groups and consumer advocate (like me) are blasting the FDA for utterly disregarding public safety and catering (once again) to the financial interests of the companies it regulates...
It is with deep sadness that I inform the autism community that we have lost another hero. Dr. Frank Engley passed away last night. It is no exaggeration to say that Dr.Engley was the very first scientist to raise the alarm of the dangers of thimerosal with his landmark paper. This last year infused him with a sense of purpose and determination to alert the world that the use of thimerosal must be stopped. He was deeply saddened that the FDA never followed through with his recommendations on eliminating thimerosal from all human biologicals. It was my honor and privilege to know this incredible man. I will miss his brilliance and sense of humor. You are my hero Dr. Engley.
Linda Weinmaster
Vice President
No Mercury
Trustee; Alan D. Clark Research Foundation
From Anne Dachel:
The efforts of Dr. Engley to prevent this disaster will be a lasting
tribute to him. We need to remind the public of his early findings:
"Doctor Frank Engley a researcher and microbiologist who served on boards with the Centers for Disease Control, the FDA, and EPA throughout the 70s and 80s.
"I am afraid they have a tremendous amount of pressure being brought to bear by the medical profession, by the pediatricians, by congress, and by industry, and so they are under pressure&and someday they will have to live with the fact with what they said is wrong," Dr. Frank Engley.
Dr. Engley says the FDA knew about the dangers of thimerosal back in the 70s and 80s, when he served on its boards.
"Industries did not comment. They thought it was just generally going away. And it practically did. They came out with another report. The FDA about eight years later, and about 1998." Dr. Engley said.
"I would say to you, the FDA is partly to blame for the mecuricals still being on the market all that length of time. If they would have followed through with our 1982 report, vaccines would have been freed of thimerosal and all this autism as they tell me would not have occurred. But as it is, it all occurred," said Dr. Engley."
“Monsanto should not have to vouchsafe for the safety of biotech food, our interest is in selling as much as possible. Assuring its safety is the FDA’s job.”
Phil Angell
Director of Corporate Communication – Monsanto
New York Times, Oct. 25, 1998
"Monsanto came to Arthur Anderson to look at how they wanted to position themselves, and they asked them, 'where do you want to be with Monsanto in 20 or 30 years?' And the answer was, 'We want to control the global food supply".
- Kirk Azevedo, former Monsanto employee
If you eat food, you need to watch this documentary:
The World According to Monsanto (updated: found a working source for the film)
I have never understood what the big complaints about genetically modified foods were all about. If you can breed a plant to be resistant to bugs or more fruitful, if you can get a cow to give more milk, why would that be a bad thing? People have been cross breeding plans for thousands of years. I assumed that bioengineered foods would be tested like crazy by the FDA, not allowed into the food supply if they were problematic and would be labeled as GMOs (genetically modified organisms) in the grocery store, because in this country we have to have full disclosure in the packaging of our food.
I figured that when they did come on the market, I would just avoid them for a few years to make sure that there were not problems en mass. You don’t buy a new model car the first year on the market, you don’t take a new vaccine (Gardasil) or medication as soon as it is introduced, and you don’t eat stuff that has ingredients that have not had a safety history of at least a few years, right?
On March 11th this documentary on Monsanto’s business practices and their introduction of GMOs into the food supply aired on French television. Apparently we have all been eating genetically modified foods for a decade or so. 70% of the items at the grocery store contain GM foods. They are not labeled as such, and, as I was with vaccines, apparently I was very naive about the FDA’s regulatory process.
Instead of testing GMO foods for safety, the FDA decided that they were similar enough to the original food product to just be considered equivalent to the original food product, and GMOs do not even have to go through as stringent a regulatory process as a new food dye or preservative.
As with vaccines, the FDA does not do any testing of their own, but just reviews the company’s safety studies; but just taking the word of a company that already has a history of very serious abuses of the public, like the PCB poisoning in Anniston, Alabama that Monsanto was responsible for, is monumentally foolish. Internal Monsanto documents showed that the contamination in Anniston was so serious that fish put in the local waters died in THREE AND A HALF MINUTES, but Monsanto decided to continue what they were doing because, "…we can’t afford to loose one dollar".
Watch the documentary to see what happened to the poor, black population of Anniston. (If this was done in a town full of white people with money, you probably would have heard about it long before now. We tend to draw more attention when we complain that our kids are being poisoned).
As with vaccines, the Monsanto GMO safety studies turn out to be junk, that actually claim the opposite of what a well designed study might find. (If you don’t want to find a problem, only look where you know you won’t find it!) The parallels to Verstraeten, Denmark and Fombonne and the like are obvious to anyone in our community.
This is a two hour documentary, so pick a night this week, grab your spouse and watch it. This is really important.
I lost track of how many whistle blowers, previously highly respected scientists, were fired and had their reputations trashed for reporting that their findings showed that Monsanto’s GMO products were not safe or reported the million dollar bribes that Monsanto was offering to regulators. Researchers found they caused problems in cell division, which is step one in the development of cancer, and that the bodies of animals reacted to the GMO food as a foreign substance to be attacked, stimulating the immune system. (Does this set off any alarms for anyone? More on this in my follow up post.)
I also lost track of how many cotton farmers in India had committed suicide because of Monsanto’s take over of the industry. Was it 600 last year and then another 600 so far this year? Monsanto sells the seed, which are marketed as growing plants that are resistant to a certain problematic bug, at very high prices, but it apparently doesn’t even protect against the bug, and often take on a blight and dies. Farmers, rather than being faced with the shame of loosing everything, are killing themselves by the hundreds.
And because Monsanto has flooded the market with their seeds, it is apparently next to impossible for the farmers to get a hold of regular seeds any more.
Which leads us to the craziest thing about this whole story. That Monsanto had patented seeds (how did the supreme court decide that was legal?), and by flooding the market, gotten rid of other seeds (if they are not being grown and re harvested every year, plant lines die out, and in about a decade, Monsanto has come to own like 90% of the world's seeds. Farmers using these seeds cannot save the Monsanto owned seeds from a previous crop and replant. They have to re buy them every year from Monsanto, and the corporation is suing local farmers suspected of resowing seed. Even when they haven't and can prove they bought the seed. Apparently Monsanto is now the Stalin of the Farm Belt infiltrating local farming communities, showing up incognito at local meetings and encouraging farmers to report on each other.
If a truck driving by your land accidentally drops a seed and it grows on your property, Monsanto can sue you. And apparently is suing people for seeds that have blown on to their land and taken root. Farmers are giving up fighting these law suits, that drag on for years, because they can't afford protracted legal battles, and just paying Monsanto a settlement.
Additionally, Monsanto is patenting regular seeds, seeds that have been around forever, so that they can just put them in a vault and not let anyone use them.
So Monsanto is basically poised to own food. All food. It is like something out of a movie, but apparently Monsanto is more clever than Hollywood, because not even the X-Files came up with a conspiracy plot to own all the food in the world.
Oh and by the way their food may cause cancer and autoimmune disorders.
I can’t even explain all the problems that this documentary brings to light in the US, the UK, Canada, Mexico, Argentina and India. Monsanto declined to be interviewed for the documentary and has not commented on it, but their web site assures us that they are working ethically.
For anyone who criticizes the autism community for their mistrust of the federal regulators, big pharma and the revolving door between the two where one day someone is working for the government on vaccine safety, the next they are a high paid pharma employee and next year they are back in government regulation (or even doing both at the same time), this documentary shows in living color that our mistrust is not only founded, but probably not distrustful enough.
This story is our story. Replace Merck for Monsanto, replace FDA/CDC for the FDA and replace vaccine for food, and this is what parents like me have been bitching about.
Our kids are getting sick, and when we look into how the sausage that is being injected into our kids is made, this is the junk we are finding.
Our sick babies are the canaries in the coal mine of this toxic world. It is long past time for us all to wake up and realize that we might have been wise to listen to those crazy, drama club drop out hippies screaming about FrankenFoods in the 1990’s. They might have been crazy and dramatic, but they might not have been wrong.
UPDATE: In the mean time... if you want more information, check out Mercola's post on the subject.
ANOTHER UPDATE: If you have Netfix, go watch the 2004 documentary "The Future of Food". It serves as a prequel to this documentary.
Interestingly, one man is featured in both films. He is one of the fired researchers in The World According to Monsanto, but was still employed during The Future of Food. He was a professor at Berkley. Berkley for petes sake! When Berkley starts firing professors for standing up to corrupt multinationals for the sake of indigenous foods and rural farmers who grow them, that is pretty much a sign of the end times.
ANOTHER UPDATE: Here is a 2007 Documentary called Genetically Modified Organisms - Unnatural Selection:
It's a Monsanto UPDATE weekend:
Monsanto is currently applying to patent pigs.
You heard me right, they want to own all pigs.
Last year they applied for a patent on a gene that is found in pigs. A pre-existing gene that has always been in pigs and that Monsanto had absolutely nothing to do with, and if it is granted, they will own almost all pigs everywhere. If this is legal, then anyone with enough money and hubris can walk into the patent office and claim the rights to a gene sequence in any living thing, whether they created it or not, and they could become the legal property of said entity and anyone using them must pay a licensing fee to the patent holder.
Further, if two pigs get the natural urge to get funky and do what pigs do and they make a little piglet, the pigs will have violated Monsanto's patent because only Monsanto would be allowed to say who can make little piglets and how. Said owner of the two pigs could then be sued by Monsanto. And we know that Monsanto LOVES to sue farmers. They have threatened thousands of farmers with lawsuits, sued hundreds and reaped millions in settlements. They have a $10 million budget and a staff of 75 devoted solely to prosecuting farmers.
They have already done it with seeds, now they have moved on to livestock. Where exactly does that end? If they patent a gene that is in my kidney, do I have to pay them every time I go pee pee?
Watch this 2007 German documentary.
I wish there were not so much info out there to UPDATE with:
Monsanto bullies Fox News into pulling a Bovine Growth Hormone story and Fox fires the journalists because they would not change the story to conform to Monsanto's demands:
More UPDATEed milk information:
UPDATE:
Monsanto GMO's and food allergies, toxic foods (new toxins never seen before) and inadequate and missing testing.
Two weeks ago I took a break from blogging to spend time with family who came to visit. Last week was a work catch up week, and I have only begun to catch up with all that has happened in the autism world while I was gone.
As I have been reading, I am seeing things that are surprising me. It is freaking me out a little.
Something has changed around the Cedillo Trial.
I have been following autism news for three years and I have never seen the kind of stories/events that are surfacing.
Dave Weldon and Carolyn Maloney have introduced bipartisan legislation, the Mercury Free Vaccines Act of 2007. Autism Speaks has uncharacteristically decided to back it and oppose AB 16 in Sacramento that would mandate that the State of California automatically adopt any vaccine that the CDC puts on the schedule (and pushed the HPV vaccine). They have never taken a stance on vaccines before. AS is also listing mercury research that was funded by CAN before the merger on their web site, but someone who spends a lot of time on the site said they didn't remember every seeing this page there before. (Anyone know if this is new, or remember seeing it in the past?)
AS has also stepped into the insurance coverage legislation in PA and announced legislative efforts on their web site.
The CDC issued a response to Verstraeten/VSD on their web site with lots of references to thimerosal studies. (I haven't had a chance to read it yet), but how long has it been there? It is not dated and David Kirby, who is a guy who keeps track of these things, didn't even know it was there until a few days ago.
The Autism Research Institute is now being backed by the giant Autism Society of America, which is now teaming up with Easter Seals who will now make Autism their priority.
Over the last three years, my blog has been visited occasionally by CDC and NIH and a few other government agencies. These visits were few and far between, and always interesting to me when they happened. But now, ramping up with increasing frequency since about April, my blog has been regularly visited by The Powers that Be CDC, NIH, FDA, EPA, HHS, the House and the Senate, The Department of Justice (who are the governments "defendants" in the Cedillo Trial), The Department of Veterans Affairs, The US Forestry Service, The Naval Research Laboratory, Lawrence Livermore Laboratory, The US Census Bureau, dozens of foreign, state and local governments, a slew of Canadian government agencies, dozens of medical centers/health organizations/universities/dental schools including CHOP (Paul Offit's hospital), Johns Hopkins, The Cleavland Clinic, our pharma friends at Johnson & Johnson and Glaxo Smith Klein, Immunize.org, media corporations Tribune and Gannett, The World Health Organization and even one visit from the Nuclear Regulatory Commission
Apparently the Department of Justice is curious to know when and if the Evidence of Harm movie will be coming out.
Here is my blog traffic graph for the last three years.
2005 - nice little blog with decent traffic. 2006 - took a break from blogging for most of the year. 2007 - Started to write again. Feb/March stats broke but I didn't notice. April was Autism Awareness Month (Damn that is a lot of awareness). May - residual autism awareness?? June - suddenly I am twice as fascinating as I have ever been on my best month! July - on track to have 8,000 visitors despite the fact that I have been on vacation most of the time.
As much as I would love to believe that it is my brilliance that people are coming for, it is probably a safer bet that more people (and more people in positions of power to do something) are awakening to the reality that autism is preventable and treatable and are taking valuable time out of their day to investigate for themselves.
Last month I said that the tide had turned. I think I might have been righter than I thought I was and that the tide might start moving faster than I had anticipated.
Even if I had 40 hours a week to sort all this stuff out, I don't think I could do a decent job. I am just going to start posting references to stories with out much comment just so I can get as much out as possible.
Whereas you needed to be 550lbs to safely take the mercury laden flu shot with 25 mikes of merc according to the EPA, now you must weigh 1100 lbs to safely take the bird flu shot. Oh... and you need two doses 28 days apart.
How is this making vaccines safer?
If bird flu comes, just don't go outside.
Update: I seem to remember some bad movie from the 70's where people caught a horrible disease from a bird and locked themselves in a clinic and created an vaccine but in the end the vaccine killed them and everyone else ended up being fine. Does anyone remember this movie?
A vaccine for rotavirus (Rotateq) developed by Merck, the Children's Hospital of Philadelphia and Paul Offit, America's most quoted promoter and apologist for the vaccine industry, will be considered for licensure on December 14 and by the Vaccines and Related Biological Products Advisory Committee of the Center for Biologics Evaluation and Research of the FDA.
Offit and his partners Merck and the Children's Hospital of Philadelphia, first received a patent for a rotavirus vaccine in 1994. Offit later voted to add rotavirus vaccine (a variety from Wyeth not Merck) to the recommended schedule of vaccines when he was a member of the FDA's Advisory Committee of Immunization Practices. Despite his ownership of a rotavirus vaccine patent Offit saw no need to recuse himself from several votes on adding rotavirus to the schedule, which is one of the last steps to inclusion in the mandatory schedules, and a guaranteed market worth billions to a vaccine maker, and comes with complete immunity from lawsuits.
This vaccine was rushed into distribution has quickly shown to cause massive intestinal damage and death in a small but vulnerable subset of children. It was just as quickly removed form the market.
According to the FDA website three of the members of the Committee's members have applied for and received waivers dor potential conflicts of interest
Participation of the public is permitted in this meeting:
Date and Time:
The meeting will be held on December 14, 2005, 9:00 am to 4:30 pm; and on December 15, 2005, 9:00 am to 4:30 pm
Contact Persons:
Christine Walsh, R.N. or Denise Royster, 301-827-0314, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512391. Please call the Information Line for up-to-date information on this meeting.
Agenda:
On December 14, 2005, the Committee will hear presentations and make recommendations on the safety and efficacy of a Rotavirus Vaccine manufactured by Merck. On December 15, 2005, the Committee will hear presentations and make recommendations on the safety and efficacy of ZOSTAVAX (Zoster Vaccine Live [Oka/Merck] ) manufactured by Merck.
Oral Presentations:
Between approximately 1:15 and 1:45 pm, on December 14, 2005; and 1:30 and 2:00 pm on December 15, 2005, oral presentations from the public will be scheduled. Those desiring to make formal oral presentations should notify the contact person before December 7, 2005.
RotaTeq® Paul Offit at The Children's Hospital of Philadelphia developed a vaccine based on a bovine strain of rotavirus (WC-3). Merck is currently running Phase III trials of a modified version of his quadravalent reassortant vaccine.
Aiming to avoid the adverse affects that RotaShield® was associated with, the vaccine is based on a bovine strain of rotavirus. The bovine strain was chosen because it replicates less prolifically in the human gastrointestinal tract than the simian strain used for the tetravalent rhesus reassortant vaccine. [1] Each of the five reassortants consists of the genetic backbone of the bovine virus with an inserted gene coding for a different human rotavirus surface protein. The inserted genes were selected to represent a broad range of serotypes in order to elicit protection against a wide variety of strains.
Genes coding for four VP7 proteins and one VP4 protein are included in the reassortants. Human serotypes G1, G2, G3 and G4 are represented by the four VP7 proteins, and serotype P1a is represented by the VP4 protein. [2]
Initial trials of a similar live quadrivalent human-bovine reassortant vaccine demonstrated promising protection against rotavirus infection. [3] Differing from the Merck vaccine only by the exclusion of serotype G4, this vaccine's results likely mirror the protection that RotaTeq® will afford.
The quadrivalent vaccine, which was delivered to vaccinees in three oral doses at 2, 4, and 6 months of age (identical to the Merck vaccine delivery schedule), showed 74.6% efficacy against any rotavirus infection and 100% efficacy against severe rotavirus infection. No increase in diarrhea, vomiting, fever or irritability was reported as compared to the recipients of the placebo.
The immunogenicity of the quadrivalent vaccine was reflected in an increased ratio of rotavirus specific IgA to total IgA as measured in the vaccinee's stool. [3]
Licensure of RotaTeq® by the FDA is predicted for 2005 if Phase III trials are successful.
The following is a summary of the history of thimerosal. It is not a complete list, as there is much more information out there and many more details to the information that I have included, but it hits the high points and gives a good frame of reference for where the discussion of the safety of this product and its relationship to autism and neurodevelopmental disorders should begin.
History of Thimerosal and Autism
Invented in the 1920’s by Eli Lilly, thimerosal is 49.6% ethlymercury by weight, a neurotoxin known to be more than a hundreds times more lethal to tissue than lead.
Eli Lilly’s safety testing of the product consists of a 1930 study of 22 patients dieing from mengiococcal meningitis in an Indiana hospital. Patients are injected with the solutions and followed until their death, which is within days. Because the patients die of meningitis, they are declared to show no adverse reaction to thimerosal and the product is declared safe for use. Thimerosal is subsequently introduced for use in vaccines and in over the counter remedies as a preservative to kill bacteria in the product.
When the FDA is created, Thimerosal is grandfathered in and is not subjected to any additional safety testing. The 1930 study remains the only safety testing done on the substance even after being in use for over 75 years.
Through FOIA requests and documents acquired as a part of discovery process in lawsuits against Lilly, it is clear that they have been warned about, and have been aware of the dangers of the product since at least 1947.
The use of thimerosal in teething powders for infants leads to a fatal out break of Acrodynia, or “Pink’s Disease”, a form of mercury poisoning. This illness has many symptoms in common with Autism. The link to mercury powders was found in the 1940's and by the 1950's Pink's disease was disappearing.
In 1963 Eli Lilly was forwarded an article that read in part: "There is another point of practical significance: does the parenteral injection of thimerosal - containing fluids cause disturbances in thimerosal-sensitive patients?" "It is known that persons that are contact sensitive to a drug may tolerate the same medications internally, but it seems advisable to use a preservative other than thimerosal for injections in thimerosal-sensitive people."
On August 17, 1967 the Medical/Science department requests that the claim "non-toxic" on thimerosal labels be deleted in next printing run. Two weeks later the label is changed to "non-irritating to body tissues," and the phrase non-toxic omitted.
In 1972 The British Medical Journal reports case of skin burns resulting from the chemical interaction of thimerosal and aluminum. "Mercury is known to act as a catalyst and to cause aluminum to oxidize rapidly, with the production of heat." The manufacturers who supply us with thimerosal have been informed." [Thimerosal is being used in vaccines which also contain aluminum].
In the 1970’s six newborns at one hospital die as a result of having a thimerosal containing antiseptic wiped on their wounds.
In 1982 the FDA reviews the use of thimerosal. Their statement reads in part: “At the cellular level, thimerosal has been found to be more toxic for human epithelial cells in vitro than mercuric chloride, mercuric nitrate, and merbromim (mercurichrom). "It was found to be 35.3 times more toxic for embryonic chick heart tissue than for staphylococcus areus." [a pathogen that the thimerosal is intended to kill]. A 1950 study showed that thimerosal was no better than water in protecting mice from potential fatal streptococcal infection." "The Panel concludes that thimerosal is not safe for over the counter topical use because of its potential for cell damage if applied to broken skin and its allergy potential. It is not effective as a topical antimicrobial because its bacteriastatic action can be reversed." Additional language added to some Lilly labels: "As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product." The FDA orders the withdrawal of over the counter, thimerosal containing products within a 6 month period. It does not order removal from vaccines, but recommends that the issue be studied and that the incidence of neurological problems in unvaccinated populations like the Amish be compared to the vaccinated population. [22 years later no such study has yet been done. On July 19, 2005 Dr. Julie Gerberding, head of the CDC says that such a study would be difficult to undertake because of genetic confounders. This seems contrary to the scientific process because if indeed such a study is done and it is found that the Amish have a lower incidence of neurodevelopmental disorders, the next step would be to undertake genetic studies to see if their genes differ dramatically from the general population and if their differences can help us locate the genetic component of autism. In addition studies designed to see if the small number of vaccinated Amish differ in their risk for NDDs to the larger Amish population would offer information about increased risk from thimerosal.]
In the 1930’s the average child only received three vaccines in their young life. Many vaccines are added to the schedule over the years, with an increase in the 1980’s and with 3 vaccines added to the schedule in 1991 alone. The current vaccine schedule calls for 31 vaccines in the first 18 months of life, 48 with full flu vaccination by 72 months of life.
A Merck internal memo is obtained during discovery discloses that in 1991 a Merck researcher added up the amount of mercury that is in the new vaccine schedule and sounded an alarm at the company that children who are vaccinated according to it would receive amounts of mercury far and above that considered to be safe by the EPA. Merck takes no action in regard to the information.
During the 1990’s, autism rates begin to rise dramatically. Parents complain to the health authorities that they believe that their children’s developmental disorders are related to their vaccines.
In 1998, a researcher at the CDC does the same math that Merck did 7 years previously. She finds that children are getting as much as 125 times the EPA limit of mercury for their weight. The EPA limit is based on the ingestion of methlymercury in food by a healthy adult. Because 90% of ingested mercury is excreted in the digestive track and never enters the blood stream, so even the EPA limit may be drastically lacking considering that thimerosal is injected directly into the blood stream and is not subject to the bodies natural defenses against toxic poisoning.
In 1999, the CDC and the American Association of Pediatrics issue a joint statement saying that although they find no “evidence of harm” from the mercury exposure that children are getting in their vaccines, they are calling on vaccine manufacturers to remove it from vaccines on a voluntary basis as a precautionary measure because “some children may” get more than the EPA limit for mercury at their 6 month visits. Manufactures begin the process in 1999, but do not remove it from all vaccines.
No legal ban on thimerosal is issued.
No recall of the mercury laden vaccines is issued and companies continue to sell lots already manufactured. Some of these vaccines containing full doses of thimerosal have been found in doctors’ offices, by parents who request to read package inserts, with expiration dates as late as 2007.
No independent or government testing of vaccines is done to confirm that thimerosal has been removed. FDA denies parents request that they set up a system to verify manufacturers claims of low dose or thimerosal free vaccines.
No statement is issued to pediatricians to alert them to the symptoms of mercury poisoning.
No recommendation is made to pediatricians to screen children who suffered the onset neurological impairment after vaccination for mercury toxicity.
Vaccines with 25mcg of thimerosal are still shipped to developing countries Most flu shots still contain a full dose of thimerosal as of this writing in 2007. (The EPA estimates that a person must weigh 550 lbs. to safely tolerate this amount of mercury.)
In November of 1999, the CDC commissions one of its new employees, a Belgian named Thomas Verstraten, to study the Vaccine Safety Datalink to find the risk of autism and other NDDs in relation to thimerosal exposure. Verstraten’s first draft of the study finds a relative risk above 7 for children who receive the highest dose of thimerosal to develop autism. In simple terms, such children have a more than a 600% higher chance of developing autism than children who don’t receive any thimerosal. (A relative risk of 2 is sufficient proof in U.S. courts to find for vaccine injury) Verstraten and other scientists at the CDC spend 4 years trying to change the study so that the relationship between the preservative and NDD’s is significantly reduced or eliminated. The Center for Disease Control will later describe these changes to the study as “improvements”. When the study is published in 2003, it concludes that “no consistent significant associations are found between thimerosal containing vaccines and neurodevelopmental outcomes.” By this time Thomas Verstraten, who is listed as a CDC employee on the study, has been an employee of GlaxoSmithKlein (a defendant in thimerosal law suits) for more than 2 years.
In November of 2000, despite being born almost two months prematurely and despite the assurance of my pediatrician that thimerosal had been removed from vaccines, my son Webster is injected with a DTaP vaccine that was 74.5 times the EPA limit for mercury exposure for his weight, just two weeks past his due date. He will go on to develop verbal apraxia and sensory integration disorder.
In 2001 Bernard et. al. publish their hypothesis: Autism: A Novel Form of Mercury Poisoning. It reads in part: “Exposure to mercury can cause immune, sensory, neurological, motor, and behavioral dysfunctions similar to traits defining or associated with autism, and the similarities extend to neuroanatomy, neurotransmitters, and biochemistry. Thimerosal, a preservative added to many vaccines, has become a major source of mercury in children who, within their first two years, may have received a quantity of mercury that exceeds safety guidelines. A review of medical literature and US government data suggests that: (i) many cases of idiopathic autism are induced by early mercury exposure from thimerosal; (ii) this type of autism represents an unrecognized mercurial syndrome; and (iii) genetic and non-genetic factors establish a predisposition whereby thimerosal’s adverse effects occur only in some children.”
In 2001 the Institute of Medicine is commissioned by the CDC to undertake a comprehensive review of all research into the thimerosal/autism connection. At their first meeting, Dr Stratton, head of the commission, when discussing what the process and product of the working group would be states that, “We said this before you got here, and I think we said this yesterday, the point of no return, the line we will not cross in public policy is to pull the vaccine, change the schedule. We could say it is time to revisit this, but we would never recommend that level. Even recommending research is recommendations for policy. We wouldn’t say compensate, we wouldn’t say pull the vaccine, we wouldn’t say stop the program”. When the transcript of the meeting is made public through a FOIA request, many interpret this to mean that no matter what they find, they will not publicly say that there is any link between the thimerosal and autism. Dr. Harvey Fineberg, head of the IOM, states that this is an incorrect interpretation of the comments, but will not offer any alternate interpretation of what else they could mean.
In 2001 Verstraten presents a version of his study to the IOM. He begins his presentation by telling the panel that as of 8 am that morning, he had become an employee of Glaxo Smith Klein. Despite the conflict of interest and the drastic changes made over the course of the study, the IOM will rely heavily on the study in making their determination. Dr. Verstraten returns to Belgium and except for a letter published in Pediatrics, little is heard from him again.
In March of 2002 my son Chandler, who was born one month early, is injected with Hepatitis B vaccine containing a “trace amount” of thimerosal (currently still on the schedule), despite the fact that he has no risk factors for Hepatitis B, and he is still two weeks from reaching his due date. Within days he develops fevers and uncontrollable crying that lasts for three months and bowel problems that persist for two years until he is placed on the GFCF diet. He will go on to be diagnosed with both Autism and mercury poisoning at age 2. I later discover that the “trace amount” of thimerosal is still just over the EPA limit of mercury for his weight.
In 2003 the Verstraten Study is published in Pediatrics with no mention of the conflict of interest of the lead researcher. Later a private contractor would testify before congress that he was ordered to destroy the original data sets used in the 1999 version of the study that found the dramatic link between thimerosal and autism in the interest of “patient confidentiality”. The entire Vaccine Safety Datalink is eventually moved to an offshore private company and can no longer be accessed by FOIA request.
In February of 2004, the IOM rushes to hold public hearings where researchers on both sides of the issues present their studies. The meeting is considered to be a “draw” between the two sides by many of those in attendance. A link is neither proved nor disproved, but new research in to the mechanism of how mercury can trigger autism and NDDs in a genetically vulnerable sub population is presented, along with case studies of successful treatment of autistic symptoms based on the new research.
In May of the same year, the IOM issues their final conclusion on the link between Thimerosal and NDDs. They state that, “the body of epidemiological evidence favors rejection of a causal relationship between thimerosal-containing vaccines and autism. The committee further finds that potential biological mechanisms for vaccine-induced autism that have been generated to date are theoretical only.” They then go on to take the unusual step of recommending that research into a link between the two be abandoned and funds be spent on other lines of inquiry. The conclusion relies heavily on Verstraten and several other epidemiological studies that are considered to implement fatally flawed methods and to be riddled with conflict of interest by members of the autism community. Parent groups are enraged. The IOM panel disbands.
Later that year, Thomas Verstraten publishes a letter in Pediatrics in response to those who criticize his study and his conflict of interest. His letter does not address the substance of the charges made against the study and the changes that were made to it over it’s 4 year evolution, but instead says that continuing the debate the validity of the 1999 study would be a “waste of scientific energy and not to the benefit of the safety of US children or of all the children world wide that have the privilege of being vaccinated.” He goes on to say that any suggestion of impropriety on the part of himself, the CDC or GSK is an insult and accuses his critics of having “pitiable attitudes”.
In July of 2005, in the face of continuing criticism of the IOM findings, the head of the IOM, Dr. Harvey Fineberg, issues a letter stating that Dr. Stratton’s 2001 comments that they would not say “pull the vaccine” or “change the schedule” were taken out of context and did not suggest that the IOM decision was compromised. Dr. Fineberg has not, despite requests, offered an alternative interpretation of what her comments meant in context.
In March of 2005, Author David Kirby released his book, “Evidence of Harm - Mercury in Vaccines and the Autism Epidemic: A Medical Controversy” detailing the history of thimerosal in vaccines and its relationship to autism.
In April of 2005 the CDC posts a notice on their web site stating that they were in the process of reviewing “Evidence of Harm” and would be responding to the book.
In June of 2005 Robert F. Kennedy Jr. echoed the information found in the book and charged the CDC and Eli Lilly of malfeasance in covering up evidence of a causal effect between thimerosal and autism in an article published in Rolling Stone and Salon.com. It is entitled “Deadly Immunity: Robert F. Kennedy Jr. investigates the government cover-up of a mercury/autism scandal”.
July 19, 2005. The CDC holds a press conference to: “communicate the importance of infants and children receiving their recommended vaccinations on time, and reassure parents that vaccines are safe. The renewed attention to the potential causal link between thimerosal, a vaccine preservative, and autism will also be addressed during the press conference.” Vaccine safety groups are not informed of the press conference nor invited. The conference presents no new information and does not answer important questions raised in Evidence of Harm or Deadly Immunity about the conduct of the CDC the IOM or the reliability of the research that continues to be used to show no link between thimerosal and autism.
As of this writing June 26, 2007 the CDC has yet to issue its response to “Evidence of Harm” or to “Deadly Immunity”.
In June of 2007 the first vaccinated v. unvaccinated study is finally done... by parents. Generation Rescue funded a survey using the CDC's techniques for determining incidence of a disorder and found that vaccinated children are two and a half times more likely to have a neurodevelopmental disorder. CDC spokesman Curtis Allen said, "We look forward to learning more about the survey," . If the CDC responds to the survey this paper will be updated to reflect their response.
On June 25, 2007 Congresswoman Carolyn Maloney (D-NY) introduced the "Comprehensive Comparative Study of Vaccinated and Unvaccinated Populations Act of 2007" (H.R. 2832), legislation that would require the National Institutes of Health (NIH) to conduct a comprehensive comparative study of vaccinated and unvaccinated populations. Her stated purpose is to resolve the controversy about the possible link between autism and mercury or other vaccine components.
