Pfizer got double good news Wednesday after the FDA approved Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), the company's 13-valent pneumococcal conjugate vaccine. It is the updated version of Prevnar and protects against six additional strains of bacteria.
The same day, the CDC's Advisory Committee on Immunization Practices (ACIP) recommended the use of Prevnar 13 for healthy children between the ages of 2 and 59 months. ACIP also recommended that children who have started their immunization series with Prevnar should complete the series by switching to Prevnar 13 at any point in the schedule.
Prevnar 13 is indicated for active immunization of children 6 weeks through 5 years of age for the prevention of invasive disease--including sepsis, bloodstream infections and meningitis--caused by 13 Streptococcus pneumoniae.
The L.A. Times notes that Prevnar was the world's top-selling vaccine in 2008 with sales of $2.7 billion and was considered a key product in Pfizer's decision to purchase its rival Wyeth. And Matthew Herper of Forbes' health blog predicts that the vaccine could be Pfizer's top seller after Lipitor loses patent protection.
Pfizer expects to start selling Prevnar 13 in the U.S. during the first quarter. Already approved for infants and young children in 38 other countries, Prevnar 13 is also being studied in global Phase III clinical trials in adults, with regulatory submissions expected later in the year, according to a Pfizer statement. Earlier this year, the company said that Prevnar 13 sales in adults older than 50 could account for $1.5 billion in sales.
Pfizer's stock jumped 1.5 percent to $17.94 yesterday following the approval, according the Financial Times.
Thursday, February 25, 2010
The Coalition for Vaccine Safety Calls for Congressional Hearings on Federal Agencies' Failure to Provide Adequate Safety Research
WASHINGTON, Feb 24, 2010 /PRNewswire via COMTEX/ ----CASE NOT CLOSED ON GOVERNMENT VACCINE SAFETY CLAIMS
In a letter to the Chairmen and Ranking Members of House and Senate Committees charged with oversight of the Department of Health and Human Services (HHS), the Coalition for Vaccine Safety (CVS) is calling for hearings to investigate HHS, the Centers for Disease Control (CDC) and other government agencies for failure to fully address issues of vaccine safety as intended by the Mandate for Safer Vaccines in the 1986 National Childhood Vaccine Injury Compensation Act.
With the federal government claiming "case closed" on possible damage to children caused by compulsory vaccines, too much evidence exists and too many unanswered questions remain, according to the letter. Key concerns are: insufficient and flawed data knowingly and willing used by government entities to reach conclusions that science dictates simply cannot be reached; conflicts of interest of individuals and government agencies involved in vaccine safety research; and ignored statements from experts regarding the un-answered question of a link between thimerosal (mercury) in vaccines and autism.
"The question has not been answered." (former Chairman of the National Institute of Health (NIH) Dr. Bernadine Healy)
"[T]here's been grossly insufficient investment in research on the safety of immunization." (former head of the American Academy of Pediatrics, Dr. Louis Cooper)
"Yet the study had significant weaknesses and they knew it." (former Congressman David Weldon, MD, R-FL in reference to a CDC study regarding thimerosal and autism)
"[T]he committee cannot rule out, based on the epidemiological evidence, the possibility that vaccines contribute to autism in some small subset or very unusual circumstances." (The Institute of Medicine's (IOM) 2004 report on thimerosal and autism)
The Coalition for Vaccine Safety urges Congress to view the claims of HHS and the Centers for Disease Control (CDC) that vaccines are safe with a jaundiced eye. The existing evidence on vaccine safety is grossly insufficient and fails to meet the requirements of public confidence. In fact, significant evidence points to suppression of science that could prove or disprove vaccine safety. This suppression may be due to potential liability and financial conflicts of interest involving individuals and organizations responsible for scientific studies and vaccine safety policies. Furthermore, "HHS has blatantly disregarded laws passed by Congress requiring it to properly and thoroughly study vaccine safety," reads the letter.
The letter also notes pending National Vaccine Injury Compensation Program decisions at stake, "An important additional reason for Congress to act now is that the Court of Federal Claims is likely to release its Omnibus Autism Proceeding 'test cases' on the possible link between the mercury-containing preservative thimerosal and autism soon. Suppression of science or significant conflicts of interest contaminating the research that undergirds the Court's determinations creates an urgent need for Congress to act."
In light of the growing number of questions and concerns regarding vaccine safety, it is imperative that the U.S. government rely on the best, most thorough and rigorous science possible. The Department of Health and Human Services is legally and ethically bound to do everything reasonably possible to ensure the safety of vaccines.
The letter can be found at http://www.coaltionforvaccinesafety.org Recipients are:
Senator Tom Harkin (D-IA), Chairman, Senate Health, Education, Labor and Pensions Committee, Senator Michael Enzi (R-WY), Ranking Member, Cong. Frank Pallone (D-NJ) Chairman, Health Subcommittee of the House Energy and Commerce Committee and Cong. Nathan Deal (R-GA), Ranking Member.
For more information, contact Cheri Jacobus at (202) 547-7358 firstname.lastname@example.org
or Pamela Felice at 404-394-2857 email@example.com
SOURCE Coalition for Vaccine SafetyCopyright (C) 2010 PR Newswire. All rights reserved
H1N1 Flu Is a False Pandemic, Health Expert Claims
Monday, January 11, 2010
A leading health expert said the swine flu scare was a "false pandemic" led by drug companies that stood to make billions from vaccines, The Sun reported Monday.
Wolfgang Wodarg, head of health at the Council of Europe
, claimed major firms organized a "campaign of panic" to put pressure on the World Health Organization (WHO) to declare a pandemic.
He believes it is "one of the greatest medicine scandals of the century," and he has called for an inquiry.
An emergency debate on the issue will be held by the Council of Europe later this month.
The Council of Europe covers 47 European countries and seeks to develop common and democratic principles between the nations.
Wodarg said, "It's just a normal kind of flu. It does not cause a tenth of deaths caused by the classic seasonal flu
"The great campaign of panic we have seen provided a golden opportunity for representatives from labs who knew they would hit the jackpot in the case of a pandemic being declared.
"We want to clarify everything that brought about this massive operation of disinformation. We want to know who made decisions, on the basis of what evidence, and precisely how the influence of the pharmaceutical
industry came to bear on the decision-making."
He added: "A group of people in the WHO is associated very closely with the pharmaceutical industry."
The WHO recently reaffirmed its stance that the pandemic is not over. However, the number of swine flu deaths is dramatically lower than expected.
In an interview with France's L'Humanite Sunday, Wodarg also raised concerns about swine flu vaccines.
"The vaccines were developed too quickly. Some ingredients were insufficiently tested," he said.
"But there is worse to come. The vaccine developed by Novartis was produced in a bioreactor from cancerous cells
, a technique that had never been used until now.
"This was not necessary. It has also led to a considerable mismanagement of public money.
"The time has come at last for us to make demands on governments. The purpose of the inquiry is to prevent more false alarms of this type in the future."
"We must make sure people can rely on the analysis and the expertise of national and international public institutions. The latter are now discredited, because millions of people have been vaccinated with products with inherent possible health risks."
FDA selects pandemic H1N1 for 2010-11 seasonal flu vaccine
Robert Roos News Editor
Feb 22, 2010 (CIDRAP News) %u2013 The US Food and Drug Administration's (FDA's) vaccines committee voted today to follow the World Health Organization's advice and fold the pandemic H1N1 influenza vaccine into the seasonal flu vaccine for next season.
The FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously to recommend that the pandemic virus become the influenza A/H1N1 component of the 2010-11 vaccine, according to FDA spokeswoman Shelly Burgess. Barring major surprises, that means there will be just one flu vaccine next fall instead of the two vaccines%u2014pandemic and seasonal%u2014that were made for the current flu season.
The committee also went along with the WHO's recommendation last week to switch the A/H3N2 component of the trivalent (three-strain) vaccine from the Brisbane strain to a 2009 Perth strain, Burgess reported.
In addition, the VRBPAC voted to keep the influenza B strain used in the 2009-10 vaccine, a 2008 Brisbane strain, as the WHO had advised, she said.
The WHO and FDA normally pick flu strains for the Northern Hemisphere in February because it takes months to develop vaccine viruses based on the circulating strains, grow large quantities of them in chicken eggs, and formulate them into vaccines. Most flu vaccines are still produced by the decades-old egg-based method.
The committee recommendation comes as pandemic H1N1 cases continue to decline and seasonal flu strains are scarce in much of the Northern Hemisphere, though some type B activity has been reported in China. Pandemic flu strains typically continue to be predominant in the first few years after their emergence, experts say.
The strains chosen by the FDA panel today, according to Burgess, are:
- For the H1N1 component, an A/California7/2009-like virus (the pandemic strain), which replaces A/Brisbane/59/2007
- For H3N2, an A/Perth/16/2009-like virus (an example is A/Wisconsin/15/2009), which replaces A/Brisbane/10/2007
- For type B, a Brisbane/60/2008-like strain (the same as last year)
These are the same three strains the WHO picked last September for the 2010 Southern Hemisphere flu season, which typically begins in May.
CLS Ltd., an Australian vaccine company, is currently producing trivalent vaccine for the Southern Hemisphere's season. Bill Cracknell, who is director of the company's influenza operations and attended the VRBPAC meeting, said today that CSL hasn't had any major production glitches but that yields of the three flu strains have not been great.
"It's been less than spectacular," he told CIDRAP News, but added that he doesn't expect problems making the vaccine for the Northern Hemisphere season.
Cracknell said CSL is using a Wisconsin strain, part of the Perth family, for the H3N2 component, but will switch to another related strain for Northern Hemisphere production in the hope of getting better yields.
He said the VRBPAC meeting brought no surprises. "I guess the whole meeting proceeded really as you would've expected it to, coming out of a season in which one strain knocked everything else's socks off," he commented.
Dr. Nancy Cox, director of the Centers for Disease Control and Prevention's Influenza Division, told the committee that the previous H1N1 strain "most likely poses a low risk in the forthcoming Northern Hemisphere season," according to a Bloomberg News report published today.
The WHO announced its flu vaccine recommendation Feb 18, after a 4-day meeting of experts from the agency's collaborating laboratories and national regulatory authorities. The VRBPAC routinely follows the WHO advice on the strains to put in the vaccine.
Feb 18 CIDRAP News story "WHO picks pandemic strain for next seasonal flu vaccine"
Sep 23, 2009, CIDRAP News story "WHO picks novel H1N1 for 2010 southern hemisphere flu vaccine"
PRESS RELEASE CONTACTS:
For Immed. Release Mark R. Geier, MD, PhD, FACMG, FACE
February 15, 2010 Founder & Medical Director
Tel. : 301-989-0548
as well as the opening of new treatment clinics in both Florida and Kentucky.
ASD Centers, LLC is committed to providing each patient with an exceptional level of care and attention.
At the ASD Centers, LLC we are proud to be physician owned and operated.
Our dedicated staff works together as a team to provide high-quality comprehensive care.
Our compassionate and understanding doctors take pride in paying close attention to each patient's needs.
ASD Centers is committed to:
a. Listening to the concerns of the parents of those who are not competent and/or unable to speak for each person we treat as well those patients who are able speak for themselves,
b. Clinically assessing and then addressing each of our patient's clinically identified medical issues and
c. Helping those who have a diagnosis of an autism spectrum, or related disorders, to recover from the underlying medical issues that produce the clinical symptoms of the diagnosed medical conditions for which we have clinically sound therapies.
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If, after visiting our NEW web site, you have any questions, you MAY call the main office or the clinic nearest to you, or email or FAX the main office. Hopefully, the information provided here as well as that provided on the web site MAY help you to know how we MAY be of help to your children and/or yourself.
Respectfully, Paul G. King, PhD
http://www.dr-king.com Director, Genetic Consultants of New Jersey
and CoMeD Science Advisor +++++++++++++++++++++++++++++++++++++++++++
We invite all people, families and organizations committed to protecting these fundamental rights to stand with us in downtown Chicago on May 26, 2010 at our inaugural rally, and to work with us after the event to support grassroots advocacy, education, and leadership in defense of our personal %u2013 individual, legal, moral, religious, civil, and human -- rights.
Wednesday, May 26, 2010
3:00 p.m. %u2013 5:00 p.m.
Grant Park, Downtown Chicago
J. B. Handley: Show Me The Monkeys!
By J.B. Handley
Do you remember that scene where Indiana Jones tosses the date up in the air, expecting to catch it in his mouth?
Suddenly, Indy is saved at the last second by Sallah who points at the dead monkey on the floor.
Why did every audience member intuitively get the connection? %u2018Cause what%u2019s bad for a monkey is probably bad for us.
Show me the monkeys.
If a scientist were dropped into the autism controversy with no previous understanding of anything, here is what they would be presented with:
- A dramatic increase in the number of kids with autism, creating a need to find an environmental, rather than genetic, cause.
- A vaccine schedule that has grown dramatically during a time when the autism rate has grown dramatically, representing something (vaccines) nearly every child is exposed to from their environment.
- The knowledge that vaccines do, with certainty, cause brain damage in a certain subset of kids. As Jim Moody has pointed out, it%u2019s certain that vaccines cause brain damage, we just need to know how many kids have been damaged.
- The fact that tens of thousands of parents have reported that heir child regressed into autism after vaccination. People like Andy Wakefield never created this connection. He, like many other honest doctors and scientists, simply reacted to the dizzying number of parental reports. He listened to parents.
Show me the monkeys.Thinking again about these scientists who are learning about the autism epidemic for the first time and presuming they are agnostic to the political risks of questioning the Godliness of vaccines, they would find themselves in quite a pickle for one very simple reason:
If in fact vaccines seemed like a good place to start to assess a fairly obvious risk from the environment, a risk that was known to cause brain damage and that many parents were pointing to as a cause of their child%u2019s regression, than it would really be hard to know where the hell to start because we give so many vaccines at once.
Show me the monkeys.People forget how many vaccines we actually do give in a very short period of time so sometimes it just bears repeating the obvious, even though I%u2019m certain I%u2019m boring some of you in doing so, so here%u2019s just the first 6 months of most American newborns:
Day 1 of life: Hepatitis B
2 month visit: Hepatitis B, Rotavirus, DTP, Hib, Pneumococcal, Polio
4 month visit: Hepatitis B, Rotavirus, DTP, Hib, Pneumococcal, Polio
6 month visit: Hepatitis B, Rotavirus, DTP, Hib, Pneumococcal, Polio, Flu
Something like, we started out with really good intentions to save kids lives, but didn%u2019t realize that something with a tiny risk of brain injury when given singularly, may in fact see that risk grow geometrically when given in combination, so that the risk of brain injury is no longer a risk so much as simply an expected side effect.
Something like that. Show me the monkeys.
So these scientists, looking at this whole mess for the first time and all these vaccines and all these parent reports and the fact that vaccines are most certainly known to cause brain injury would realize that there simply had to be some way somehow to isolate some population somewhere who had not yet actually been exposed to all these vaccines that are given to most children so early in life.
What these scientists would be left with, I am wholly certain, is that there are three relatively easy and obvious paths for how you would go about trying to figure out if all these tens of thousands of parent reports were actually telling you something, or if all these parents were just sort of making it up to get better services:
- Find a group of kids who never received any vaccines and compare their rates of all the things you suspect the vaccine schedule may be causing to kids who got all their vaccines. See if there are any differences that are significant, statistically speaking.
- Take a group of kids whose parents claim regression after vaccination and see if there is anything materially different about their bodies from a group of normally developing children who didn%u2019t regress after vaccination.
- Start from scratch with an animal model, thereby bypassing potential ethical issues of not having children vaccinated, and see what happens to a group of animals vaccinated like our kids compared to a group of animals getting no vaccines.
I think Andy Wakefield is the only doctor on the planet who has attempted to do both the second and third ones, and no one has yet done the first one, even though Dan Olmsted has been writing about it for five years or so.
Show me the monkeys.
One of the many interesting aspects of this whole autism-vaccine debate is how many times it seems that the issue is presented in a very binary fashion: a kid who gets vaccinated has a risk of autism or nothing. I%u2019m preaching to the choir when I tell you that if in fact autism is a byproduct of too many vaccines, than it is most certainly the tiny tip of a very, very large iceberg. An iceberg named ADHD, speech delay, learning disability, asthma, food allergy, and many, many more.
If, in fact, autism is just a tiny tip of the iceberg, than it is very likely that these poor little monkeys who were given our vaccines are messed up in many, many ways.
Show me the monkeys.
Let me say something to clear my conscience: I love animals and I hate animal testing. I feel terrible writing about these monkeys because the truth is that they were all sacrificed at the end of this study. It breaks my heart open to think about how these monkeys had to live their lives and I do think it is both cruel and inhumane to experiment on animals. We are all God%u2019s creatures.
The only thing I can say in defense of the sacrifice of these poor monkeys is that I have a very strong feeling their deaths will not be in vain. I have this strong feeling these monkeys will in fact save and improve the lives of many, many thousands of kids, if not millions. These monkeys have made a huge contribution to the planet%u2019s life, and I am very grateful for them.
Show me the monkeys.
If you were alive last week, you may have heard the gravedancer%u2019s ball, tapdancing all over town. Ding dong, Andy%u2019s dead, and so is his stupid theory and movement, yippee! They were everywhere, and they were gleeful.
They were also driving web traffic to Generation Rescue's website to new, unprecedented levels, bigger than we have ever seen.
The most downloaded page? Alternative vaccine schedules.
Show me the monkeys.
On Friday, you could almost hear the collective gasp of the gravedancers when Jenny & Jim%u2019s statement about the monkey study hit the wires. Did you notice the %u201Ctheir theory is dead%u201D articles slowed to a trickle?
It was amazing how many journalists I talked to on Friday, journalists who had been told by their editors to write something about this whole Wakefield thing. I referred them all to the statement.
It wasn%u2019t what they were expecting to hear. They wanted to talk about the death of a theory and we talked instead about monkeys. How were they supposed to know unvaccinated children had never been looked at?
Do you know how many of those reporters from Friday have actually written an article as of today?
Show me the monkeys.
The other side is playing defense again. My favorite argument so far?
%u201CThere is no animal model for autism.%u201D
Right, O.K. Well, is there an animal model for being completely and utterly messed up, both in terms of neurological and immunological function?
Show me the monkeys.
Yes, the expected drumbeat has begun.
%u201CDon%u2019t trust anything that guy Wakefield publishes, it%u2019s all lies!%u201D
%u201CHe probably poisoned those poor monkeys, with something other than vaccines I mean!%u201D
In fact, some yahoo apparently protested to Neurotoxicology, the journal with the courage to publish the first phase of the unvaccinated monkey study, letting them have it for even considering publishing something with Andy%u2019s fingerprints on it. This yahoo claims that he wrote:
%u201CIt has been reported that your journal has or will soon publish a paper cowritten by Andrew Wakefield, against whom there are well-substantiated charges of fraud. If so, you have breached professional ethics, and unless you retract immediately, I feel it is the duty of all professionals to boycott your magazine and all others in the Elsevier line. I would welcome any explanations or clarifications you have to offer.%u201D
The editor of Neurotoxicology apparently responded to said yahoo with the following response:
%u201CAs Editor of Neurotoxicology this is to inform you that the referenced manuscript has been subjected to rigorous independent peer review according to our journal standards. If you have issues with the science in the paper please submit them to me as a Letter to the Editor which will undergo peer review and will be subject to publication if deemed acceptable.%u201D
For those of you who don%u2019t speak %u201CScientist%u201D, the response from the Editor of Neurotoxicology actually reads:
Show me the monkeys, and let the world decide.
J.B. Handley is Co-Founder of Generation Rescue.
Saturday, February 20, 2010
Visit and sign this petition complaint against the UK General Medical Council (GMC) judgment (28 January 2010)
Target: General Medical Council (GMC) in United Kingdom (UK)
Sponsored by: Jaquelyn McCandless, M.D.
Dr. Andrew J. Wakefield's findings of gastrointestinal pathologies in a subgroup of children with autism are very important. His persecution by the GMC is akin to the persecution of Semmelweis.
Vaccine promoters keep citing their "science" in claiming that H1N1 vaccines are safe and effective. NaturalNews and the CWC ask one simple question: Where is this science?
The $10,000 reward will be issued to anyone who can produce scientific evidence meeting the following criteria:
%u2022 A scientific paper, published in a peer-reviewed medical journal, describing the results of a minimum of two Phase III trials structured as randomized, placebo-controlled scientific clinical trials of an FDA-approved H1N1 vaccine currently in distribution, carried out on a minimum of 1,000 people (for statistical significance) for a duration of at least 90 days. The inclusion criteria for both clinical trials must be properly randomized so that the participants are representative of the entire U.S. population and not merely a desired sub-group selected to skew the research outcome. Inclusion criteria must be provided to NaturalNews for verification.
%u2022 At the same time, the vaccine must be scientifically demonstrated to be effective at reducing H1N1 swine flu infections. Scientifically speaking, it must be demonstrated to reduce the death rate from H1N1 infections by a minimum of 50 percent (relative numbers, not absolute, since so few die from H1N1 in the first place). In other words, if 100,000 people get infected with H1N1 and 100 might normally die, the study must show that fewer than 50 vaccinated people die. This would equate to a 50 percent reduction in mortality from swine flu. If the vaccine is less than 50 percent effective, then it doesn't really offer much benefit for such a mild flu with extremely low fatality rates.
%u2022 Because vaccine promoters describe the vaccine as "safe enough for children and expectant mothers" and because vaccine promoters insist that there are absolutely no risks of long-term side effects, the study must demonstrate that the vaccine causes no statistically significant increase in side effects of any kind for a minimum of one year following the vaccine injection. You might think this is impossible to produce since the vaccine hasn't even existed for one year and couldn't have possibly been tested to see whether it produces neurological side effects in the one-year timeframe. That is exactly my point.
%u2022 Finally, due to widespread corruption and dishonesty in clinical trials that are funded by drug companies, these clinical trials must not be funded in whole or in part with drug company money. Funding for the studies must come from truly independent sources such as a government institution or a university with no financial ties to the vaccine manufacturer.
This is not a satire story or a parody. This $10,000 reward for scientific proof of the H1N1 vaccine safety and effectiveness is being offered in all seriousness. The offer is valid through March 31, 2010.
If proof of the H1N1 vaccine safety and effectiveness is produced in accordance with the reasonable requirements published here, NaturalNews will publish a public apology regarding our condemnation of H1N1 vaccines and issue a $10,000 check to the winner of the reward within five business days. (Per IRS regulations, we may require proper income reporting details from the reward recipient if they reside in the U.S. or are a U.S. citizen).
Tuesday, February 9, 2010
withLAWRENCE B. PALEVSKY, MDCome hear the renowned board certified pediatrician and sought-after lecturer, present his research on the safety and efficacy of vaccinesand offer his experience on using a holistic approach to child care.Bring your questions!Wednesday February 24th6.30pm to 9.30pm George Washington LoungeWest Side YMCA5 West 63rd StreetNew York, NY 10023To buy a ticket to this lecture and to learn more about Dr. Palevsky go tohttp://www.drpalevs ky.com/events. asp or call 917 617 6149$35 per person ($60 for couples from the same household)Early reservations are advised.In this workshop, you will hear discussions on vaccine science:Ø What is current vaccine science and who is funding it and doing it? Ø How do vaccines work, and have they done, and do they do what we're told they do?Ø What role do vaccine ingredients play when injected into infants and children?Ø What do the ingredients do to our children once they're injected? Ø Do vaccines contribute to the development of chronic illnesses in children?Ø How do our children get into school if they're not vaccinated?Ø How does the immune system work in babies and children? Attendees will hear some of the answers to these questions, along with the research that questions whether vaccines are safe and effective, and whether the scientific process is even at work to prove the answers to these questions. Attendees will also be asked to look at the issues that drive us to make the decisions we make, many of which come to us through fear, bullying, uncertainty, and a lack of knowledge, and to perhaps think alternatively about how illnesses occur and disappear.
AN EDUCATIONAL OPPORTUNITY FOR PARENTS AND PRACTITIONERS