Vaccination Profiteers Gang up in US Supreme Court

The American Academy of Pediatrics announced the submission of an amicus brief to the US Supreme Court on July 30, 2010, “joined by 21 partnering health organizations,” in the vaccine injury case of Bruesewitz v Wyeth, to support the powerful vaccine maker against a lone family.

Oral arguments in the case took place on October 12, 2010, but a final decision won’t be known for months. The most recent drug injury preemption case decided by the Court was also against Wyeth and the ruling came down in favor of plaintiff, Diane Levine.

The Court took the Bruesewitz case to determine whether 18-year-old Hannah, disabled by injuries she received from Wyeth’s diphtheria, tetanus and pertussis (DPT) vaccine at 6-months-old in 1992, has the right to bring a lawsuit against Wyeth after the Vaccine Court, set up by the 1986 National Childhood Vaccine Injury Act, refused compensation even though she will require life-long care and her vaccine was traced to a lot that had 65 adverse reactions including two deaths, 39 emergency room visits, and 6 hospitalizations.

After compensation was denied, the family filed suit against Wyeth in Pennsylvania and argued that the vaccine Hannah received was defectively designed and had a known safer vaccine been used her injuries could have been avoided.

Wyeth filed for summary judgment and the lower court dismissed the case holding that the 1986 vaccine law preempted all design defect claims. In March 2009, the Third Circuit Court of Appeals affirmed the ruling and the family filed a petition for review in the Supreme Court.

“Amici—all of whom support the routine vaccination of children against a host of vaccine-preventable infectious diseases—urge this Court to affirm the judgment of the Third Circuit below,” the brief filed by the 22 groups states.

The term “host” inadequately describes the number of “routine” shots kids get today, along with the increased risk of injury. Before 1986, children’s vaccines included diphtheria, tetanus, pertussis, measles, mumps, rubella and inactivated poliovirus. Since the Vaccine Injury Act was passed, nine new vaccines have been added, including hepatitis B, rotavirus, haemophilus influenzae type b, pneumococcal, influenza, varicella, hepatitis A, meningococcal, human papillomavirus (for girls), or an additional 46 doses for girls and 43 for boys, the CDC’s 2009 Recommended Immunization Schedule shows.

Amici Anything But Impartial

JB Handley, co-founder of Generation Rescue, as well as co-founder and contributor to Age of Autism, says whenever he meets pediatricians he asks what percentage of their revenue comes from vaccine administration. “The number always astounds me,” he said on Age of Autism. “The answers I get are that anywhere from 50-80% of their revenue comes from giving vaccines.”

In addition to their individual income from giving shots, Wyeth is now owned by Pfizer and over the past few years, the grant reports of the two companies show millions of dollars pouring into the American Academy of Pediatrics and many of the “partnering health organizations” that signed off on the brief.

For instance, Pfizer 2009 report lists two grants to the Academy totaling $56,000 and Wyeth donated $630,000 to benefit the group in 2009. Wyeth also gave the Academy $345,919 in 2008. The group received $524,080 from Pfizer in the first two quarters of 2010 alone.

In 2009, the Academy presented the “President’s Certificate for Outstanding Service” award to Dr Paul Offit, whose least offensive nickname, of many, is “Dr Proffit.”

Offit was also called the “poster child” for the term “biostitute,” by Robert Kennedy Jr at a green vaccine rally in Washington in 2008, for making himself the spokesperson for the vaccine industry and pretending to be an independent scientist without disclosing his ties to and the millions of dollars he’s made off the vaccine industry.

“The AAP is honoring Dr. Offit in recognition of his ongoing commitment to promote immunization,” the Academy’s October 16, 2009 announcement stated, without mentioning the financial windfalls he received due to his “commitment to promote immunization.”

On December 9, 2009, a report on Offit was published on Age of Autism with the headline, “Counting Offit’s Millions: More on How Merck’s Rotateq Vaccine Made Paul Offit Wealthy,” by Dan Olmsted and Mark Blaxill, authors of the new book, “Age of Autism: Mercury Medicine and A Manmade Epidemic.”

The report points out that Paul Offit, “vaccine entrepreneur and public health spokesperson, has earned approximately $10 million in income from Rotateq® royalties through 2009 and stands to earn a total of between $13-35 million over the life of his rotavirus vaccine patents.”

The analysis by Blaxill and Olmsted found that Offit’s future royalty income is tied to the vaccine’s future sales in the US and international markets, which gives him a strong financial stake in both the specific success of the rotavirus vaccine category and the global reputation of vaccines in general.

The American Academy of Family Physicians also signed off on the amicus brief. This group, along with its state chapters and Foundation, received a combined total of more than $5 million from Pfizer in 2009, and another $856,772 from Wyeth. In the first half of 2010, Pfizer gave the Family Physician groups $1,334,165.

Another signer, the American Medical Association, received grants worth $751,500 from Pfizer and a $5,000 grant from Wyeth in 2009. The Association received $447,400 from Pfizer in the first two quarters of 2010.

Several other members of the group that ganged up on Hannah in the brief also received plenty from the vaccine makers. Pfizer gave $55,000 to the National Foundation for Infectious Diseases in 2009, and Wyeth gave $45,000. In 2008, the Foundation received $2,153,500 Wyeth, and Pfizer gave it $58,500 in the first half of 2010.

In 2009, the Infectious Diseases Society of America received $15,000 from Wyeth and $65,000 in 2008.

The American Public Health Association received three grants totaling $200,000 from Pfizer in 2009.

The March of Dimes and its Foundation combined got $4,500 from Wyeth in both 2008 and 2009. Pfizer gave the groups $14,500 in the first half of 2010.

In 2009, Wyeth gave the National Association of Pediatric Nurse Practitioners Foundation four grants totaling $175,150 and three worth $70,000 in 2008.

Parents of Kids with Infectious Diseases received $75,000 from Wyeth in 2009.

The Immunization Action Coalition was paid $95,000 by Wyeth in 2009 and $136,743 in 2008.

Every Child By Two received nearly a million dollars, or $950,000, from Wyeth in 2009, and $350,000 in 2008.

In the August 4, 2008 report, “Every Child By Two: A Front Group for Wyeth,” JB Handley points out that Craig Engesser, an employee of Wyeth with a title of Senior Director, Professional Affairs, was on the Board of Every Child By Two for as far back as he could track. In fact, Engesser had even served as the group’s treasurer.

Handley also noted that Paul Offit had recently joined the group’s Board.

For the year 2006, Handley found IRS filings showed Wyeth gave Every Child By Two $350,769 and page 23 of the filing read: “Wyeth Vaccine: Ensure all children from birth to Age 2 are fully immunized.”

The National Healthy Mothers, Healthy Babies Coalition received $200,000 from Pfizer in 2009, and Wyeth gave the Georgia chapter $500 in 2008. Other corporate sponsors listed on the group’s website in 2009 included Merck, GlaxoSmithKline, Johnson & Johnson and Sanofi-Pasteur.

Amici for Hannah

Amicus briefs were also submitted in support of the Bruesewitz family in September 2009 and June 2010, by attorneys from the state of New York, Mary Holland and Robert Krakow, on behalf of the National Vaccine Information Center and its cofounders, parent advocates who helped draft the 1986 legislation, the New Jersey Coalition for Vaccine Choice, No Mercury, Truth About Gardasil, Age of Autism, National Autism Association, Autism One, SafeMinds, Autism United, US Autism and Asperger Association, Talk About Curing Autism, Generation Rescue, and the Elizabeth Birt Center for Autism Law and Advocacy.

It would require too much space to list every organization, but all together more than 25 signed off on the briefs - none of which receive money from vaccine makers. Basically the question to be answered by the Supreme Court is: Does § 22(b)(1) preclude all vaccine design-defect claims even if the vaccine’s side effects were avoidable?

“The legislative history suggests that all the stakeholders – Congress, parents, manufacturers and physicians – understood that victims preserved the right to take design defect claims to court,” the June brief says. “Respondent and its amici appear to be trying to achieve through the judiciary what they failed to obtain through Congress.”

In fact, the brief includes several statements made at the time the Act was passed that suggest that Congress recognized that victims, who duly filed for compensation in the Vaccine Program, could take design defect claims to court under Section 22(b).

For instance, when presenting the Act to the full House of Representatives for a vote, Rep Henry Waxman, the chief sponsor of the Act, stated that civil claims for “inadequately researched” vaccines would be preserved under Section 22. Waxman’s description of this claim, that a vaccine’s design did not take adequate account of avoidable safety risks, would likely be a design defect, the brief notes.

“Furthermore, the Committee explicitly rejected the opportunity to create a broad exemption for all design defect claims when it considered the Act,” it says. “Proposals were considered by the Committee that would have explicitly preempted all design defect claims, but the final version did not contain those provisions.”

“By rejecting language that would have barred all design defect claims,” the attorneys wrote, “Congress showed its intent to permit courts to decide on a case-by-case which side effects were genuinely ‘unavoidable.’”

“The Act and its legislative history simply do not make sense without the understanding that the tort system remains an available alternative for such cases,” the brief says. “And Congress’ intent to keep the courthouse doors open is even more important today than it was in 1986.”

“The significance of the Bruesewitz case relates to all vaccine injury – it goes to the heart of whether Vaccine Court is fulfilling the role Congress set for it, and whether it is possible to challenge the design safety of a vaccine in any court in the United States,” Holland explained in a March 10, 2010 commentary on Age of Autism.

“For the autism community, the case could not be more central,” she says, “it will determine whether the 5,000 petitioners in the Omnibus Autism Proceeding can continue their claims in state and federal courts if Vaccine Court ultimately dismisses their claims.”

Right about now, paranoia in the vaccine industry is no doubt running at an all time high since the announcement of the first award in a vaccine-autism case in September 2010 for another girl named Hannah, with $1.5 million to start and $500,000 a year for life to pay for her care. “Those familiar with the case believe the compensation could easily amount to $20 million over the child's lifetime,” CBS News reported on September 10, 2010.

Hannah was “described as normal, happy and precocious in her first 18 months,” until “she was vaccinated against nine diseases in one doctor's visit,” in July 2000, CBS said.

A government study titled, “The Prevalence of Parent-Reported Diagnosis of Autism Spectrum Disorder among Children in the United States, 2007,” evaluated the number of children in the US who currently had an Autism Spectrum Disorder diagnosis in 2007, based on data from a national Survey of Children's Health, and found that 1 in 91 children between the ages of 3 and 17 carried an ASD diagnosis.

”Even more alarming, for the subset of children between ages 6 and 14 immunized during the 1990's the prevalence is actually 1 in 71 children with an autism diagnosis,” Age of Autism reported.

”This age group represents children in the U.S. with the highest exposure to thimerosal, the mercury preservative routinely used until CDC, AAP and industry recommended its removal “as soon as possible” from all childhood vaccines,” AoA explained.

It’s obvious that parents no longer trust claims by the government and drug companies about harmless vaccines. On October 17, 2010, in the Huffington Post, Kim Stagliano, managing editor of AoA and author of the new book, “All I Can Handle I’m No Mother Teresa,” reported that a new study from CS Mott Children’s Hospital found 89% of parents think vaccine safety is the most important topic in medical research today.

“That makes sense, since the American pediatric vaccine schedule now includes 48 vaccinations before the age of six,” Stagliano says. “Parents are facing vaccination choice issues at every pediatric visit.”

Fictional Fear Factors

In the brief filed by the groups with all the money from Wyeth and Pfizer, when warning that vaccine makers might flee the market if they have to face the threat of lawsuits and unpredictable litigation costs, they argue that the number of vaccine makers has not greatly increased since 1986 and refer to the “precarious state of the vaccine industry.”

“The preemption of all design defect claims is critical to Congress’s objective of stabilizing the vaccine market and safeguarding the Nation’s vaccine supply,” they claim.

First of all, the vaccine industry is not in dire financial straights, in fact far from it. On June 11, 2009, Kalorama Information issued a press release for the vaccine sales forecast in a market analysis report with the headline, “New Report Forecasts More Than Doubling of Vaccine Sales by 2013.”

“Few areas of pharmaceuticals have seen the fast-moving developments in the marketplace that the vaccine market has,” Kalorama noted. The press release described 2008 as another “stellar year for the world vaccine market,” in which sales “grew 21.5% since 2007 to reach $19.2 billion.”

A year earlier, Kalorama reported that stronger than anticipated revenues for flu vaccines and the “surprising commercial success” of Merck's Gardasil had led to $16.3 billion in vaccine sales in 2007, “an increase of 38% over 2006 sales of $11.7 billion.”

However: “Vaccine manufacturers face many challenges in bringing new vaccines to market,” the amicus brief points out, with a note to: “See Paul A. Offit, Why Are Pharmaceutical Companies Gradually Abandoning Vaccines?, 24 Health Affairs 622, 623-629 (2005).”

The brief goes on to complain about how much the cost of developing vaccines has increased. “Between 1991 and 2003, for instance, costs for research and development, post licensure clinical studies, and production process improvements grew from $231 million to $802 million,” it said, citing Stanley A Plotkin, et al, Vaccines 38 (5th ed 2008). Plotkin was a co-inventor with Offit on the Rotateq vaccine.

But in any event, the high prices charged for vaccines today wipe out those costs in record time. For instance, Rotateq runs close to $200 for a 3 dose series and when you multiply that by the CDC’s calculation of more than 4 million babies born each year in the US, annual sales come to over $800 million in this country alone. Wyeth’s pneumococcal vaccine “makes $2 billion a year in sales,” according to a July 25, 2008 report by CBS News.

About a year ago, Dr Proffit was shilling for vaccine makers in the October 18, 2009 “Wall Street Journal,” by claiming infants should get 2 regular flu and 2 swine flu vaccines, without mentioning that all 4 contained the mercury-based preservative, thimerosal. “Children ages six months to nine years who have never received a flu vaccine before are recommended to receive two doses of both the H1N1 and seasonal-flu vaccine about a month apart,” Offit said.

With the headline, “Most flu shots contain mercury, but few know it,” on November 13, 2007, the Milwaukee Journal Sentinel reported that when using the standards set for methyl mercury consumption, a 22-pound baby getting the flu shot “would get more than 25 times the amount of mercury considered safe.”

In the WSJ article, Offit was identified only as “chief of infectious disease” at the Children's Hospital of Philadelphia, when in fact he holds a “$1.5 million dollar research chair at Children's Hospital, funded by Merck,” according to CBS News.

That bit of advice from Offit in the WSJ could potentially drum up over 4,000,000 new customers every year for shot givers and vaccine makers in the US for flu vaccines alone. Last year, the September 14, 2009 Los Angeles Times reported that physician offices usually “charge about $25 to $75 for the seasonal shot, including administration fees.”

“If you are immunizing a child for the first time, the child may need two shots,” the Times said. “Ask the healthcare professional giving the shot if you will have to pay two fees.”

For the sake of simplicity, let’s say doctors threw in both seasonal flu shots for one fee of $75. The total amount made from vaccinating 4,000,000 babies would be $300 million.

The Times said the H1N1 shot would be free, although doctor's offices and clinics may charge an administrative fee. But the swine flu shots were in no way free. Tax payers paid vaccine makers a fortune as a result of the pig flu hoax. However, for the sake of non-argument, let’s say the shot givers only charged $10 per infant to give each of the two swine flu vaccines. They would still make $80 million.

Will Health Care Workers Revolt?

The fact that health care workers have an aversion to flu vaccines is likely the best testament to the lack of benefits and potential harms associated with vaccines including the inability to sue for compensation if injured. It only stands to reason that if vaccines worked so great this group would be the first in line to get them.

But a new policy statement by the American Academy of Pediatrics, in a paper in the October, 2010 issue of their official journal, “Pediatrics,” gives notice of plan to force health care workers to get flu vaccines with the heading, “Recommendation for Mandatory Influenza Immunization of All Health Care Personnel.”

The Academy claims that “despite the efforts of many organizations to improve influenza immunization rates with the use of voluntary campaigns, influenza coverage among health care personnel remains unacceptably low.”

Mandatory influenza immunization for all health care personnel is “ethically justified, necessary and long overdue to ensure patient safety,” the group said in a statement.

“The influenza vaccine is safe, effective, and cost-effective, so health care organizations must work to assuage common fears and misconceptions about the influenza virus and the vaccine,” the Academy claims.

Their paper reports that in January 2010, the CDC estimated the percentage of health care personnel who received vaccines was only 61.9% for seasonal flu, 37.1% for swine flu, and only 37.1% received both the seasonal and swine flu vaccines.

However, it’s not like the industry is suffering from a lack of flu shot customers even when health care workers refuse to get them. In 2009 alone, multi-national corporations took home profits of $2.8 billion in influenza vaccine sales, according to an October 2010 report by Barbara Loe Fisher, co-founder of the National Vaccine Information Center.

By comparison, since the Vaccine Injury Act was passed roughly 25 years ago, the vaccine court has paid out less than $2 billion. Of the more than 13,550 petitions filed covering all vaccines, compensation for injuries was only awarded in about 2,500 cases.

Of course the estimates in the paper, if true at all, would have come from the same CDC that was run for years by Julie Gerberding and has put out the trumped up claim year after year that 36,000 people in the US die of the flu annually, with the death number never changing even when vaccination rates greatly increase.

In a December 21, 2009 Pharmalot Blog, Ed Silverman reported that Gerberding, “who until this year was the director of the US Center for Disease Control and Prevention, was named president of Merck’s vaccine division.”

As the former “top dog” at the CDC, she “has plenty of experience overseeing the selection of recommended immunizations,” FiercePharma noted on December 22, 2009.

“Autism activists, particularly those who believe vaccines are a primary cause of regressive autism, are often derided for conspiratorial comments about the CDC and Big Pharma,” JB Handley pointed out on the Pharmalot blog.

“This one is making us look more sane every day,” he said.

On October 7, 2010, Barbara Loe Fisher reported that doctors at Children’s Hospital of Philadelphia (Dr Proffit’s Kingdom), are ordering all employees to get a flu shot every year or be sent home for two weeks without pay to “think about it.”

“Anyone, who still refuses to get a flu shot after that, is fired,” she wrote. And that goes for not just doctors and nurses, she says, but every person who has anything to do with the health care facility, including students, volunteers, and contract workers.

“An exception could be made if the doctors in charge approve a “medical exemption” to vaccination, which, today,” Fisher warns, “is about as hard to get as a job.”

Evelyn Pringle

(Evelyn Pringle is a columnist for Scoop International and an investigative journalist and researcher focused on exposing corruption in government and corporate America)

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