Showing posts with label Sanofi. Show all posts
Showing posts with label Sanofi. Show all posts

August 1, 2008

Drugs.com Lists "Autism" as Known Adverse Reaction to DTaP Vaccine Tripedia

In Drugs.com's "A to Z Drug Facts" section the entry on Diphtheria / Tetanus Toxoids / Acellular Pertussis Vaccine contains the following Central Nervous System Adverse reactions for Sanofi Pasteur's Tripedia:

"Tripedia
Drowsiness (29%); irritability (25%); anorexia (10%); fussiness (6%); autism, convulsion, encephalopathy, grand mal convulsion, hypotonia, neuropathy, somnolence (postmarketing)."

Hats off to Drugs.com for actually providing informed consent to consumers. To my knowledge they are the first to do it.

HT: Allison Chapman

July 18, 2007

Congress Votes on Banning Mercury From Vaccines

[Update: Make sure you check the bottom to see why ECBT's stance is BS. Also my letter to Mrs. Carter calling her attention to the mercury issue]

Every Child by Two is urging their membership to call congress and oppose this amendment that would make vaccines safer. Here is everything you need to know about Every Child By Two:

Officers:

Kirsten Thistle
Treasurer
Senior Vice-President, APCO Worldwide
(APCO is the PR Agency for: Johnson & Johnson, International Federation of Pharmaceutical Manufacturers' Associations, Novartis Pharmaceuticals – Glivec, Immunex Corporation - Novantrone, The Vaccine Fund, STERIS Corporation and the list goes on)

Board Members:

Craig Engesser
Senior Director, Professional Affairs
Wyeth Pharmaceuticals

Paul Offit, MD
Chief, Section of Immunologic and Infectious Diseases
The Children’s Hospital of Philadelphia

Ex-Officio Members:

Anne Schuchat, MD
Director, CDC/National Center for Respiratory and Infectious Diseases


I called their offices and they said that they receive unrestricted grants from pharmaceutical companies.

It is difficult for me to believe that the former first lady Rosalynn Carter, who founded Every Child By Two, understands the dire conflict of interest here. She is a mental health advocate, and advocates for caretakers like us.

I think I will write her a letter too.

Call your Congressman and support the ban on mercury in vaccines.

From A-CHAMP:

Congressional Vote on Mercury Ban Expected

Contact Your Member of Congress ASAP!!!

Take Action!
This past Wednesday, July 11, the House Committee on Appropriations adopted by voice vote an amendment that prevents federal dollars from being used to provide flu vaccines, that contain mercury as a preservative, to children under three years of age. This amendment, offered by Rep. Dave Weldon (R-FL) was based on legislation that he has introduced with Rep. Carolyn Maloney (D-NY) to completely ban mercury from all vaccines. This bill will come to the floor of the House of Representatives on July 17.

Action You Must Take Today!
You need to e-mail of fax write your member of Congress today.
You may use our automated system to send an email by Clicking Here.

If you want to call or fax your Congressman and don’t know who your Member of Congress is you can find out by Clicking Here or going to http://capwiz.com/a-champ/directory/congdir.tt Your Congressman's contact information can be found there.

E-mail your Member of the House of Representatives AND CALL their office (Congressional Switchboard 202-224-3121 can also get you to your Congressman by phone).

Here is suggested text for a letter if you wish to send a fax or a manual email. The text is also in our pre-written email if you wish to use our automated system:
I am writing you to urge that you vote against any amendment that removes from the FY 2008 House Labor/HHS Appropriation bill the provision that bans mercury (thimerosal) from childhood flu vaccines. I am very concerned that an amendment may be offered on the House floor when this bill is considered that would strip this important provision from the House bill. As my representative, I urge you to vote against any amendment that would leave babies exposed to mercury-laced flu vaccines.

There is no other way to put this - It is just a stupid practice to be injecting babies at 6, 7, 12 and 24 months with the neurotoxin mercury particularly at such a critical stage of neurodevelopment. The House Appropriations Committee agreed overwhelmingly that injecting children with mercury is a bad idea when they adopted an amendment on July 11 offered by Rep. Dave Weldon - a physician.

The developed world other than the United States has essentially banned mercury from all of their childhood vaccines, including the flu vaccine. But, the USA continues to use mercury as a preservative in millions of doses of the flu vaccine given to children. Seven years ago, in 1999, the following concensus was reached by the US's leading public health agencies: “[The] Public Health Service, the American Academy of Pediatrics, and vaccine manufacturers agree that thimerosal-containing vaccines should be removed as soon as possible. Similar conclusions were reached this year in a meeting attended by European regulatory agencies, the European vaccine manufacturers, and the US FDA which examined the use of thimerosal-containing vaccines produced or sold in European countries.”

That was in 1999. In October 2004 the House Appropriations Committee held a hearing on the need to remove mercury as a preservative from childhood flu vaccines. Now, three years later virtually no action has been taken by the CDC, AAP or vaccine makers to eliminate mercury preservative from childhood flu vaccines. The time to end this madness is long overdue.

I appreciate in advance your vote against any amendment that would weaken the Weldon provision that protects babies from exposure of babies to this dangerous neurotoxin. I will be reviewing the record vote on this issue should an amendment be offered to strip this provision.

Thank you for protecting our babies.

Message Brought To You By A-CHAMP
Advocates for Children's Health Affected by Mercury Poisoning
See Our Action Alerts. Click the TAKE ACTION! button


Update: So ECBT says they oppose removing the mercury because, "Sanofi (the only company licensed to supply [flu] vaccine to this age group) has reported that they do not have enough capacity to meet this demand".

Except that Sanofi just announced the opening of their new FLU VACCINE FACILITY! (And yes of course Paul Offit is quoted in the article. Silly of you to even ask.)

New Pa. vaccine plant poised for pandemics
By Karl Stark
Philadelphia Inquirer

SWIFTWATER, Pa. - Here in the former honeymoon capital known as the Pocono Mountains sits a near-windowless building that everyone will know about when the next pandemic flu hits.

Just down the road from a Caesars resort with its heart-shaped pools lies the country's only comprehensive flu-vaccine plant. Drugmaker Sanofi-Aventis announced yesterday that it had finished construction of a $150 million building here that would double its production of vaccine for seasonal or pandemic flu, since both are made nearly the same way.

The highly computerized plant now awaiting final government approval won't be pumping out vaccine until late next year. But the drugmaker invited Health and Human Services Secretary Mike Leavitt and the media for a rare peek yesterday at a critical facility before its life-saving balm begins flowing.

Leavitt called the plant critical to the health of the country and the world. "We do know that pandemics happen, and that we will see a pandemic, and that we need to be prepared," he said.

The plant looks like a high-tech hospital on perpetual security alert. No merely curious visitors can enter when it's working. Its 200 production workers - all vaccinated for the flu - will be gowned, gloved and masked.

A few workers went through the motions yesterday, entering rooms through special air locks that help keep the virus in and the contaminants out, and pantomiming production steps as a special filtration system purified the air.

Yet, amid the warren of stainless-steel tubes and vats, the plant will still make vaccine the old-fashioned way: with chicken eggs.

They have incubated flu vaccine reliably since 1935. And the plant will need 600,000 eggs a day at full capacity. Sanofi buys what it needs and more from dedicated egg suppliers, to assure an ample supply.

Sanofi senior vice president Wayne Pisano, who oversees vaccine sales, described the process as tried-and-true, and said the emerging cell-culture-based method has not been perfected for making the millions of doses needed.

Leavitt said the federal government was trying to change that by spending $1 billion over the next five years to improve cell-based technology and to increase U.S. vaccine production. The United States has amassed pre-pandemic vaccine for six million people, along with 50 million doses of antiviral medicines. "Obviously, that's not enough," Leavitt said.

While media attention on flu has receded, Leavitt noted that the flu virus was continuing to change and threaten people. An especially dangerous form, called H5N1, has infected 318 people worldwide and killed nearly 200 since 2003. The world has averaged three flu pandemics a century, the last striking in 1968 and 1969. Sooner or
later, another one will occur, Leavitt said.

The federal government is continuing to prepare. Last month, Sanofi announced a $77.4 million contract from the government to retrofit a second flu factory at the Swiftwater site. The firm, which will also spend $25 million of its own funds, would be able to make 150 million doses a year by 2010, tripling its current production, when all ongoing upgrades are done.

Sanofi, the world's biggest vaccine-maker, isn't the only company in the game. GlaxoSmithKline P.L.C., which has a U.S. headquarters in Philadelphia, is rehabbing a 90-acre former vaccine plant in Marietta, Lancaster County, to make flu and other vaccines. The firm has received a $274 million federal contract to develop the cell-
culture method and to ramp up manufacturing there. Swiss drugmaker Novartis AG is also building a vaccine plant in Holly Springs, N.C. But both projects are years away from production.

Kimberly Elliott, deputy director of Trust for America's Health, a public-health-advocacy group, said the U.S. effort still lags in key aras, such as how to detect the disease quickly and how to handle the large numbers of sick patients in a pandemic. "Most hospitals are already overcrowded," she said. "Hardly any state is doing well on this, including Pennsylvania and New Jersey."

Experts hope that vaccines will provide a lot of protection. And yesterday at the plant, workers were showing how they would be made.

In one room, a mechanical needle will inject virus into the eggs, which will be left to incubate for two or three days.

Workers shine special lights onto the eggs to make sure they are intact. The process is known as "candling" because it was originally done by candlelight.

A mechanical knife then cuts off the top of eggs, and a machine flips 36 at a time, pouring their fluid into a vat. The virus is killed, and then the fluid is run through a centrifuge and purified several times.

"We're still stuck with eggs," noted Paul A. Offit, the chief of the division of infectious diseases at Children's Hospital of Philadelphia and author of Vaccinated: One Man's Quest to Defeat the World's Deadliest Diseases.

"I would like to think," he added, that "the fear of the pandemic will enable us to upgrade our flu technology."


My Letter to Mrs. Carter:

Dear Ms. Carter,

I am a Johns Hopkins educated marriage and family therapist and the mother of a 5 year old boy diagnosed with autism and mercury poisoning. At only two weeks of age he was given a Hepatitis B vaccine that contained what is described at "trace" amounts of mercury, after which he developed colic and unexplained fevers that lasted for three months, and bowel problems that persisted for five years. At age two, when he was diagnosed with autism, we tested him and found that he had mercury poisoning. In researching his vaccinations to see if that could be the source, we found that the hep B vaccine that he had just after he was born, the one that is currently on the vaccine schedule, although considered to contain "low dose" or "trace" of mercury, actually exceeded the EPA's safety limits for a person of his weight.

Further research on the EPA's safety limits showed me that they were not based on any research on the safety of injected mercury, and that in fact the only safety study on the mercury containing preservative thimersoal was done in the 1920's on 22 patients who were dieing of meningitis. The study found that there were no long term side effects, because all the participants died with in days of injection. Thimerosal was then put into vaccines, and grandfathered in to the FDA at its inception, with out any further safety testing. That study remains the only safety testing on thimerosal.

For the last three years I have been reading the research on vaccine safety. I was heartbroken to find that the hep B vaccine that my son initially reacted to (eventually loosing speech and eye contact the 4th time he was given the shot at 18 months of age) was given inadequate safety testing as well. Children who got the shot were only followed for three days, a woefully inadequate amount of time to see if the vaccine resulted in immune or neurological changes.

I have also read and analyzed for myself several of the large epidemiological studies that the medical establishment puts forth as proof that thimerosal in vaccines are safe and has no relationship to autism or other developmental disorders. I find that these studies do not measure what they purport to measure and that because of their very narrow inclusion criteria, they cannot be used to determine whether or not thimerosal containing vaccines are safe for my two sons.

Because of our family's experience, I began writing (I maintain a blog at http://adventuresinautism.com) and advocating for adequate research and vaccine safety. This week the bipartisan Mercury Free Vaccines Act of 2007 will be voted on, and your organization, Every Child By Two, is opposing it. I am writing to you to ask you to change your stance and support the complete removal of mercury from vaccines.

Mercury is one of the most potent neurotoxins on the planet and there can be no justification for injecting it into full grown adults much less newborns babies. It is hundreds of times more lethal to humans than lead, yet the medical establishment, who stands firm and united in their assertion that no amount of lead is safe, maintains the nonsensical assertion that there is "no evidence of harm" in injecting a "trace amount" of mercury directly into the blood stream of a developing child, and therefore should be allowed to stay in vaccines.

As I have read the emerging research on the relationship between mercury and neurodevelopmental disorders like autism, and seen the dramatic improvements in my own son as we chelate the metal out of his body, I am convinced that there is a link between mercury in vaccines and autism. But if you are not, would it still not be prudent to remove mercury from vaccines as quickly and completely as we can?

The Every Child By Two's stance is that the effort should be struck down because, "Sanofi (the only company licensed to supply [flu] vaccine to this age group) has reported that they do not have enough capacity to meet this demand". This seems a woefully inadequate justification. Mercury should continue to be injected into small children and pregnant women so that fewer people get the flu for one season?

I read on the web site that you began your vaccination efforts after a measles outbreak killed 150 people. According to the CDC, autism now effects 1 in 150 people. The evidence that vaccines and autism are related are growing every day, as are the number of children who are making a full recovery and loosing their autism diagnosis when they are treated with emerging interventions, like chelation and diet, that are based on the vaccine/autism theory.

Because of mainstream medicine's reluctance to see the possibility that autism is an iatrogenic disorder, confidence in the vaccine program as a whole is at risk. I am one of a growing number of parents who has ceased vaccinating their children all together because I can no longer trust the medical establishment to be honest with me about the risks and benefits to my children's health. I believe complete and verifiable removal of all mercury from all vaccines will be the only thing to prevent further erosion in the program.

If I might be so bold, in my eyes, there is an irony in your work. You advocate strongly for those diagnosed with mental disabilities, like my son, and for caregivers, like me; but your stance on mercury in vaccines has unintentionally served to put us in those positions. Your love and your heart for those of us suffering and struggling with illness is so clear. Please use the better part of caution and support the immediate and complete removal of mercury from vaccines.

If I can be of any further assistance to you in examining this issue further, I would be happy to make my self available in any way I can.

Sincerely,
Ginger Taylor
Chandler's Mother

February 11, 2006

The Age of Autism: Doctors for mercury

The Age of Autism: Doctors for mercury
By DAN OLMSTED
UPI Senior Editor

WASHINGTON, Feb. 9 (UPI) -- As doctors and health authorities fight state bans on mercury in vaccines and keep giving it to kids and pregnant women, one fact stands out: their certainty.

The image of pediatricians and public officials as valiant defenders of mercury takes a bit of getting used to, given their longstanding efforts to keep the toxic element out of our food, our bodies and the environment.

No reasonable person -- let alone health professional -- would advocate keeping mercury in childhood vaccines unless they were absolutely certain it was an exception to this lethal legacy.

That's especially so because vaccines can be made without the mercury preservative, called thimerosal. You can take it out and still protect the health of American children through vaccination, and if you had a shred of doubt about its safety, surely you would.

If you keep it in, you had better be right.

But what is the real degree of certainty that thimerosal is safe? Is it absolute? Beyond a reasonable doubt? A preponderance of the evidence -- the lesser standard that applies in civil cases but not when someone's freedom (or life) is at stake?

Here's the kind of thing that makes doctors -- most of whom have no more ability than you or I to investigate the safety of vaccines for themselves -- feel so certain. It's a paper titled "Vaccine Safety Controversies and the Future of Vaccination Programs," and it appears in the November 2005 issue of The Pediatric Infectious Disease Journal.

The authors are from the U.S. Centers for Disease Control and Prevention, which recommends the childhood immunization schedule; the United Nations World Health Organization, which oversees the vaccination of tens of millions of people worldwide every year, and several big universities. The report was supported by "unrestricted grants from GlaxoSmithKline Biologicals, Sanofi Pasteur MSD, several universities and other institutions."

"Thimerosal has been used for (more than) 60 years in infant vaccines and in other applications and has not been associated with adverse health effects in the general population, except when persons have been exposed to amounts many orders of magnitude greater than found in vaccines or pharmaceuticals," the authors write.

That's a ringing endorsement of safety (whether it's supported by the data is an issue I'll address in upcoming columns). But keep reading: "It should also be borne in mind that the risks of thimerosal-containing vaccines to the fetus, premature infant and low-weight infant have insufficiently been studied."

Whoa. "Insufficiently studied" -- after more than 60 years of giving thimerosal to pregnant women and babies of every size and shape? Nonetheless, the CDC recommends flu shots for pregnant women and 6-to-23-months-olds and won't recommend thimerosal-free versions. As a result, most flu shots still contain mercury.

Another new study is condescendingly titled, "When science is not enough -- a risk/benefit profile of thimerosal-containing vaccines," by Australians C. John Clements and Peter B. McIntyre in the journal Expert Opinion on Drug Safety:

"Thimerosal is safe as a vaccine preservative, and should continue to be used in settings where accessibility and cost require that multi-dose vials of vaccine are available."

Clements advises the WHO on vaccine policy; McIntyre is director of Australia's National Center for Immunization Research and Surveillance of Vaccine-Preventable Diseases.

"The overwhelming weight of scientific opinion rejects the hypothesis that neurodevelopmental abnormalities are causally related to the use of thimerosal in vaccines," they point out.

This is the kind of ammunition public health officials and the American Academy of Pediatrics are firing back at proponents of mercury bans --"overwhelming" evidence that thimerosal is safe. In Illinois, the state AAP vigorously opposed the ban.

"Though well intended, these bills do not advance public health and could inadvertently diminish our state's efforts at fighting influenza," the AAP said. "Though it is a mercury-containing compound, thimerosal does not pass from the bloodstream into the brain to any significant degree."

The state legislators listened politely to that dubious assertion -- and voted to limit thimerosal in childhood vaccines anyway. But that was not the last word.

As reported by R. L. Nave in the Illinois Times last month: "Citing cost concerns and a potential shortfall for the upcoming flu season, the Illinois Department of Public Health filed for a 12-month exemption to the Mercury-Free Vaccine Act, passed last summer to limit the use of vaccines containing mercury. However, child-health-care advocates who lobbied for the bill's passage are upset by what they believe was a premeditated attempt by IDPH to circumvent state law."

This is what you call chutzpah -- public health authorities thwarting the express will of the people, certain that flu shots will save humanity and mercury never hurt anybody. Does the governor never fire anyone?

Almost lost in this crossfire is the simple fact that in 1999, these selfsame health authorities -- the CDC, the Public Health Service, the pediatricians, the family physicians -- urged drug companies to remove thimerosal from childhood immunizations in the United States as soon as possible.

Most childhood vaccines -- in the United States, not overseas -- are now thimerosal-free. But that's hardly a blanket reassurance, because most flu shots do contain thimerosal.

Yet the CDC is still studying whether thimerosal causes autism.

"We do agree the preponderance of evidence to date suggests there is no association between thimerosal and autism," CDC spokesman Glen Nowak told us last month. But he said CDC Director Dr. Julie Gerberding is committed to exploring all possibilities until the cause or causes of the disorder are identified.

"Dr. Gerberding has made it clear the CDC has not ruled out anything as possible causes of autism, including thimerosal," Nowak said. "Science is a dynamic process. We have continued to fund studies to look at the role, if any, of thimerosal."

Given these caveats, what would you do? Well, there are two maxims of medicine that might apply. "First, do no harm," is the obvious one.

The second, related concept is the precautionary principle which, according to wikipedia.org, "is the idea that if the consequences of an action are unknown, but are judged to have some potential for major or irreversible negative consequences, then it is better to avoid that action."

So: Vaccines don't need mercury. Even government experts acknowledge some possible risks -- to the fetus, for example -- are insufficiently studied 60 years on. A link to autism has not been ruled out. They're continuing to investigate, as they should.

But the doctors and their public and private allies are battling state by state to stop mercury bans, and the CDC won't recommend a thimerosal-free flu shot for kids and pregnant woman. There's a phrase for this approach:

Bombs away.