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Supporting organizations support the overall mission and intent of CVS, but press releases are only endorsed by those organizations that have individually signed on and do not necessarily reflect the views or endorsement of all CVS members.

Contact: Mary Holland, Esq., (212) 998-6212
(917) 743-3868
coalitionforvaccinesafety@gmail.com 
Robert Krakow, Esq.
(917) 763-0063
rkrakow@krakowlawfirm.com

Court Protects Vaccine Manufacturers, Not Injured Children
Supreme Court Decides Bruesewitz v. Wyeth 6-2, Foreclosing Civil Lawsuits for Vaccine Design Defect

New York, NY Feb.22 / The Coalition for Vaccine Safety (CVS) condemns the decision of the U.S. Supreme Court in Bruesewitz v. Wyeth to preempt all vaccine design defect lawsuits in state and federal civil court. Quoting Justice Sotomayor’s dissent, the majority “imposes its own bare policy preference over the considered judgment of Congress.” In the dissent, which Justice Ginsburg joined, Justice Sotomayor argues that the majority misreads the text, misconstrues the Act’s legislative history, and “disturbs the careful balance Congress struck between compensating vaccine-injured children and stabilizing the childhood vaccine market.”

The actual circumstances in Bruesewitz v. Wyeth illustrate why the Supreme Court’s decision is misguided. Hannah Bruesewitz, hours after a diphtheria-pertussis-tetanus vaccine, developed catastrophic brain injury and a lifelong seizure disorder. The only plausible explanation for the harm to Hannah was her vaccine. Indeed, many other children were injured by the same vaccine lot, yet the Vaccine Injury Compensation Program, the only court where Hannah could bring her claim, denied compensation after years of litigation. Now the Supreme Court tells Hannah and her family that there is no courtroom in the country in which she can obtain justice and compensation for the years of care ahead that she needs.

The majority’s true intent appears to be to prevent several thousand tort cases claiming a link between vaccines and autism from reaching civil court to assert that a dangerous vaccine design, using mercury as a preservative, was defective. Sotomayor writes that this concern, to shield manufacturers from litigation, “appears to underlie the majority and concurring opinions in this case.”

According to vaccine safety advocate Louise Kuo Habakus, “The Court is telling parents that they’re on their own. Parents know that 4 out of 5 cases of vaccine injury do not get compensation in the misnamed Vaccine Injury Compensation Program. The Supreme Court has slammed the courthouse doors shut.” Because the federal government recommends 70 doses of 16 “unavoidably unsafe” vaccines, and states compel 30-45 doses for school attendance, this issue affects all children.

CVS calls for Congressional hearings and action to amend the 1986 National Childhood Vaccine Injury Act to reinstate the right to sue for vaccine design defect in civil court.

For more information on Bruesewitz v. Wyeth, click here for the Supreme Court decision.

Organizations supporting the Coalition for Vaccine Safety:

Age of Autism (www.ageofautism.com)
Autism One (www.autismone.com)
Autism Action Network (www.autismactioncoalition.org)
Center for Personal Rights (www.centerforpersonalrights.org)
The Coalition for Safe Minds (www.safeminds.org)
Elizabeth Birt Center for Autism Law and Advocacy (www.ebcala.org)
Generation Rescue (www.generationrescue.org)
National Autism Association (www.nationalautismassociation.org)
National Autism Association New York Metro Chapter (www.naanyc.org)
Talk About Curing Autism (www.talkaboutcuringautism.org)
Unlocking Autism (www.unlockingautism.org)

3-Part Investigative Series on Merck's Gardasil(R) Highlights Government Conflicts of Interest in Vaccine Development, Approval and Safety Surveillance

The Coalition for Vaccine Safety (CVS) calls for independent vaccine safety agency and Congressional hearings on government's lax record on safety issues

WASHINGTON, May 19/ A three-part investigative series on Merck’s cervical cancer vaccine, Gardasil(R), highlights serious conflicts of interest across agencies of the Department of Health and Human Services (DHHS) in the development, approval and safety surveillance of vaccines. The series, by Mark Blaxill, Editor-at-Large for the internet newspaper Age of Autism and a Director of SafeMinds, was posted on the newspaper's site on May 12-13 http://www.ageofautism.com/mark_blaxill.  It preceded the announcement on May 14 that FDA, a DHHS agency, is allowing use of rotavirus vaccines despite their contamination with viral particles from pigs. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm212149.htm

Blaxill's investigation found an unprecedented vaccine “public-private partnership” between drug companies and DHHS's National Institutes of Health (NIH). NIH researchers developed key technology underpinning cervical cancer vaccines. The technology was patented and licensed to pharmaceutical giants Merck and GlaxoSmithKline through the NIH Office of Technology Transfer (OTT). When new products invented at NIH clear the regulatory hurdles at FDA and reach market, OTT shares in the profits and distributes them back to NIH and its staff inventors.

Despite clinical trials lacking a true placebo, FDA approved it for use. The CDC's vaccine advisory committee then recommended Gardasil for universal use by girls. The FDA and CDC jointly conduct the surveillance to decide whether the NIH-invented Gardasil is safe once licensed. Dr. Julie Gerberding served as the Director of the CDC when it approved Gardasil. She is now the president of Merck Vaccines. According to Blaxill, this situation creates “an unprecedented web of conflict, one in which the same departments that are tasked with regulating the health and safety of medical products are also profiting from them.”

There have been hundreds of claims of injury or death from Gardasil. Some of these claims are now reaching the Court of Federal Claims, where vaccine injured petitioners are required to bring claims. Here too there are serious potential conflicts of interest as DHHS jointly administers the Vaccine Injury Compensation Program and is also the defendant against the claims of vaccine injury instead of the vaccine manufacturer Merck.

“DHHS has chosen to minimize other safety issues like mercury and viral contamination in vaccines,” stated Mary Holland of CVS. “We need a stronger vaccine safety oversight agency which is independent of DHHS.” CVS calls on Congress, as it has in recent letters, to hold hearings to investigate the agencies responsible for the national vaccine program. These federal agencies have failed to comply with the terms of the 1986 Vaccine Injury Compensation Act (VICA) to provide critical vaccine safety science.

CVS is an alliance of organizations dedicated to vaccine safety representing over 75,000 families.
For more information on vaccine safety, visit www.coalitionforvaccinesafety.org. 

Coalition for Vaccine Safety (CVS) Calls on FDA Commissioner to Immediately Suspend All Contaminated Rotavirus Vaccines

FDA Expert Advisory Panel Fails to Follow Safety-First Agenda for Childhood Vaccines Containing DNA from Pig Viruses

Washington, DC – On Friday, the Food and Drug Administration (FDA) convened a panel of experts to review recent findings that rotavirus vaccines given to infants in the U.S., Rotateq, produced by Merck Pharmaceuticals and Rotarix produced by GlaxoSmithKline, are contaminated with DNA from pig viruses PCV1 and PCV2.  On March 22^nd  the FDA Commissioner asked doctors to suspend use of the Rotarix vaccine due to the contamination.  Upon additional testing, Rotateq was also found to be contaminated.

At the meeting, the experts acknowledged that the PCV2 virus is known to cause a wasting disease in pigs, similar in type to the AIDS virus in humans. While acknowledging that the entire short and long term risks from the porcine circoviruses PCV1 and PCV2 are as yet unknown, the advisory panel decided that ‘the benefits of the vaccine trump its risks.’ By contrast, health authorities in Hong Kong ordered an immediate recall of Merck Rotateq despite the U.S. panel’s recommendation to keep the vaccine on the market.

Shocked at the advisory panel’s recommendations for the health and safety of American children, the Coalition for Vaccine Safety (CVS) calls on FDA Commissioner Hamburg to re-assess the panel’s hastily-considered risk-benefit analysis and suspend the use of both rotavirus vaccines.  Steering Committee member Mary Holland said, “ How can you say the benefits outweigh the risks when you don't know what the risks are?"  A safety first agenda demands suspension of the vaccines immediately while the short and long term risks are studied, especially since rotavirus is a relatively benign and treatable gastrointestinal disease that is rarely fatal in the United States.    

The risks from PCV1 and PCV2 are real and potentially testable by analyzing lymphoid tissues, which is where the human immunodeficiency virus hides during its latency period.  Immediate independent analysis should be done on children and primates who have received these vaccines before another child receives the rotavirus vaccine.  According to CVS member Lyn Redwood, RN, “It is impossible for parents to give free and informed consent to a vaccine containing pig virus DNA when their risks are unknown.  To continue to administer these vaccines given the impossibility of informed consent is unethical.”

The FDA expert panel’s failure to urge suspension of contaminated vaccines underscores the need for immediate Congressional hearings on vaccine safety.  The apparent conflicts of interest in the U.S. vaccine program are illustrated by the fact that the Director of the Centers for Disease Control and Prevention (CDC) until January 2009, Dr. Julie Gerberding, is now the President of Merck Vaccines. In 2007, under her stewardship, 97% of CDC outside experts failed to complete their conflict of interest disclosure forms as required by law. The lack of direct corporate accountability for vaccine products, codified by the 1986 Childhood Vaccine Injury Compensation Act, further complicates conflicts of interest in the national vaccine program.

CVS is an alliance of organizations dedicated to vaccine safety representing over 75,000 families.  In recent letters 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 called for hearings to investigate HHS, CDC and other government agencies.  These federal agencies have failed to comply with the terms of the 1986 Vaccine Injury Compensation Act (VICA) by not providing critical vaccine safety science.

Further Information:  Biohazard potential for live viral vaccines containing naked or free nucleic acids from contaminating (adventitious) viruses.

Special Masters Protect Vaccine Program and Deny Justice to Vaccine-Injured Children

Mercury-Autism Link Not Found Because of Government Policy, not Science

Washington, DC – The Coalition for Vaccine Safety (CVS) believes that the Special Masters of the Court of Federal Claims wrongly decided that thimerosal-containing vaccines (TCVs) do not cause autism.  The Special Masters appear to have based their decisions on the government policy to protect the vaccine program rather than to fulfill their role to do justice by vaccine-injured children.   In these three ‘test case’ decisions in the Omnibus Autism Proceeding, petitioners William Mead, Jordan King and Colin Dwyer developed normally through the first year of life and then regressed into autism.  They presented thousands of pages of scientific documentation and testimony.  Their evidence showed that thimerosal, a mercury-laden vaccine preservative, more likely than not contributed to their autism. 

"The deck is stacked against families in Vaccine Court.  Government attorneys defend a government program, using government-funded science, before government judges.  Where’s the justice in that?" asked Rebecca Estepp, a CVS steering committee member and mother of a petitioner in the Omnibus Autism Proceeding.

It is universally accepted that mercury is a neurotoxin and can damage the developing brain and the immune system.  All three boys’ health improved through medical interventions to reduce mercury toxicity and immune dysfunction.  Nonetheless, the Special Masters concluded that petitioners failed to meet their burden of proof, even though Health and Human Services (HHS), the respondent in the proceeding, offered no alternative explanation other than genetic predisposition.  The Special Masters appear to be following a misguided government policy that if they acknowledge a mercury-autism link, parents will stop vaccinating their children.

The breaking story of fraud at the Centers for Disease Control and Prevention (CDC) involving Dr. Poul Thorsen, a leading member of a Danish research group that wrote studies supporting the CDC’s claims that there is no mercury-autism link, casts further doubt on the Special Masters’ decisions. The emerging evidence of Dr. Thorsen’s embezzlement of $2 million, falsehoods about his employment, and serious questions about his research throw into question the validity of the science at the heart of HHS’s claim of no mercury-autism link.

The Coalition for Vaccine Safety (CVS) is an alliance of organizations dedicated to vaccine safety representing over 75,000 families.  In recent letters 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 called for hearings to investigate HHS, the CDC and other government agencies.  Those federal agencies have failed to comply with the terms of the 1986 Vaccine Injury Compensation Act (VICA).  Specifically they have failed to provide critical vaccine safety science, including from the taxpayer-funded Vaccine Safety Datalink, on thimerosal, autism and other neurodevelopmental disabilities.

The Special Masters’ Omnibus Autism Proceeding decisions and revelations about Dr. Thorsen’s actions only strengthen the Coalition’s resolve in calling for immediate Congressional action to investigate vaccine safety – an issue that potentially affects every person in the country.

“We are confident that the truth will win out.  We hope that Congress will intervene in what is clearly a miscarriage of justice to vaccine-injured children,” said Jim Moody, an attorney and CVS steering committee member.

For more information on the Omnibus Autism Proceeding and vaccine safety, visit www.coalitionforvaccinesafety.org.

THE COALITION FOR VACCINE SAFETY CALLS FOR CONGRESSIONAL HEARINGS ON FEDERAL AGENCIES’ FAILURE TO PROVIDE ADEQUATE SAFETY RESEARCH

CASE NOT CLOSED ON GOVERNMENT VACCINE SAFETY CLAIMS

WASHINGTON, DC – 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 adverse neurological outcomes)

“[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.coalitionforvaccinesafety.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 Pamela Felice at 404-934-0777 pamelafelice@coalitionforvaccinesafety.org or Cheri Jacobus at (202) 547-7358 or cherijacobus@aol.com