A Call to Suspend Contaminated Rotavirus Vaccines

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, May 10 /PRNewswire-USNewswire/ -- 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 22nd 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 interests 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.

For more information on vaccine safety, visit www.coalitionforvaccinesafety.org.

Contact:

Lyn Redwood, RN (404) 932-1786

Mary Holland, Esq. (917) 743-3868

coalitionforvaccinesafety@gmail.com

Amanda Peet, Paul Offit, Parasites and Biostitutes

JB has shared the contact information for Ms. Peet's representation.  I took a moment to write to them:

-------- Original Message --------

Subject:	Amanda Peet and Paul Offit
Date:	Wed, 16 Jul 2008 11:48:57 -0400
From:	Ginger Taylor
To:	Stephen.huvane@pmkhbh.com, ekranzler@management360.com

Dear Mr. Huvane and Mr Kranzler,

You may have already gotten word on this, but your client may need a little more back ground on who this doctor that Ms. Peet is taking her cues from, Paul Offit, actually is. 

Paul Offit is a doctor at Children's Hospital of Philadelphia, and is very often seen in vaccine autism stories making claims that vaccines are safe and have no relationship to autism.  But what those stories do not tell the audience is that Paul Offit is a vaccine patent holder and consultant for Merck Pharmaceuticals.  He is a co-creator of the Merck RotaTeq vaccine that is on the CDC's current vaccine schedule.  It is a vaccine that prevents Rota Virus, a benign virus under which subjects experience a miserable day or so of diarrhea and vomiting, and from which you usually gain immunity after having it twice.  The CDC recommends treating it at home with Pedialyte to prevent dehydration.  In third world countries, Rota virus can be a more serious threat to children's health, because death can occur from severe dehydration due to lack of infrastructure, clean water and basic sanitation.  But in the US, it is not a serious health threat to any one with indoor plumbing or within driving distance to a 7-11.

In addition, Paul Offit's RotaTeq can cause a very serious, life threatening condition called intussusception in which the intestine actually folds up, telescoping in on itself.  The FDA has confirmed that RotaTeq killed one child in such a manner this year.  A previous Rota virus vaccine, Rota Shield, was taken off the market for causing the same problem.  And this far, RotaTeq has more reported incidences of intussusception than it predecessor that was removed from the market.  RotaTeq also causes Kawasaki Disease.

Many people, myself included, believe that the vaccine schedule is too aggressive and should be pared down.  If the CDC decides to remove any vaccines from the schedule, surely the first to go will be Paul Offit's vaccine.  Further, if parents do as we are urging, and start evaluating vaccines one at a time to see which are important for a child to have, and which are not really needed, the first one that parents will likely stop buying for their kids will be RotaTeq, and that will effect the sales of his vaccine.

Further, Paul Offit was personally reprimanded by the U.S. Congress, at length, for his ethics problems.  He actually sat on the ACIP, the CDC committee that decides what vaccines go on the US schedule, and voted for RotaShield to be added to the schedule, knowing full well that it would pave the way for his own vaccine, Rotateq to be added and be immediately put into wide spread use as soon as it came to market.  Which is exactly what happened.  Offit should have abstained from any comments or votes on any thing to do with Rota virus because of his conflicts of interest.

Paul Offit is the poster child for medical conflicts of interest.

When you take vaccine advice from him, it is as if you called Merck to ask if their products cause autism.

Finally, Paul Offit makes completely irresponsible and ridiculous statements about vaccine safety.  In Baby talk magazine he was quoted as believing that studies, "theoretically show an infant could handle up to 100,000 vaccines at one time … safely."  I personally wrote to Offit, assuming that of course this was some sort of misprint.  It wasn't.  He replied, "The figure of 100,000 is correct, and probably a little conservative."

We in the autism community cannot understand why this man continues to be taken seriously.  Do people who are interviewing him or taking his advice understand know who this guy is?  Did Ms. Peet know who he really was when she took his council as gospel?  Does she know that his nick name in the autism community is Dr. Proffit, and that Robert F. Kennedy Jr. labeled him a "Biostitute" because his opinions on medicine are for sale?

The only thing that we can think of is that because, he is always merely introduced as a doctor at CHOP, that no one knows the whole story about him.

So now you know.  You should probably encourage your client not to tout her association with this doctor, as the exposure of his back story is getting out there.  "Distancing" might be wise for her at this time.

Ginger Taylor M.S., Parasite
AdventuresInAutism.com

Like Its Predecessor RotaShield, Offit's Rotateq May Be Linked To Intussusception

Potential conflicts of interest: Ginger Taylor is the mother of a child with vaccine induced autism who has gotten to the point where she cringes at hearing the name Paul Offit because of his ridiculously irresponsible overstatements of vaccine safety on media outlet after media outlet while always failing to disclose his conflict of interest that he is a vaccine patent holder on Merck's RotaTeq vaccine. (Did you know that babies can theoretically handle 100,000 vaccines in one sitting? It's true! Paul Offit says so!)

If there is such thing as a science grudge match, this qualifies, as I can't imagine that the authors of this study feel any differently about Offit than I do.

However, let's let the article speak for itself. It finds that like the last rota virus vaccine to be removed from the market, Offit's vaccine may be causing Intussusception, a nasty, life threatening disorder where the intestine actually turns inside out and starts folding in on itself like a a telescope collapses.

Rota Teq is on the CDC's vaccine schedule.

If this bears out, let's hope it is yanked even more quickly than RotaShield was.

RotaTeq vaccine adverse events and policy considerations

David A. Geier, Paul G. King, Lisa K. Sykes, Mark R. Geier

The Institute of Chronic Illnesses, Inc., CoMeD, Inc., The Genetic Centers of America,

Potential conflicts of interest: David A. Geier has been a consultant in vaccine/biologic cases before the no-fault National Vaccine Injury Compensation Program (NVICP) and in civil litigation. Mark R. Geier has been a consultant and expert witness in vaccine/biologic cases before the no-fault NVICP and in civil litigation. Paul G. King and Lisa K. Sykes have no conflicts of interest.

Background: Rotavirus is the leading cause of severe gastroenteritis in children <5 years-old worldwide. On February 3, 2006, the US Food and Drug Administration licensed RotaTeq™ (Merck and Co.), a bioengineered combination of five human-bovine hybridized reassortment rotaviruses. In August of 2006, the Advisory Committee on Immunization Practices recommended RotaTeq for routine vaccination of US infants administered orally at the ages 2, 4, and 6 months. Material/Methods: An evaluation of data reported to VAERS following the fi rst fi ve quarters of post-marketing surveillance of RotaTeq was undertaken. Trends in adverse events reported following RotaTeq and cost effectiveness calculations of RotaTeq in the context of the disease burden of rotavirus in the US were examined. Results: From February 3, 2006 through July 31, 2007, a total of 160 (of the 165 reported) intussusception and 11 (of the 16 reported) Kawasaki disease adverse event reports were identifi ed when RotaTeq was administered or co-administered with other vaccines. Time-trend analyses showed that there were signifi cant increases in the total number of intussusception and Kawasaki disease adverse events entered into VAERS in comparison to previous years. Conclusions: These observations, coupled with limited rotavirus disease burden, cost-effectiveness, and potential contact viral transmission concerns, raise serious questions regarding the use of RotaTeq in the US. Healthcare providers should diligently report adverse events following RotaTeq vaccination to VAERS, and those who have experienced a vaccine-associated adverse event should be made aware that they may be eligible for compensation from the no-fault National Vaccine Injury Compensation Program (NVICP). key words: gastroenteritis • gastrointestinal hemorrhage • rotavirus infection • vaccine adverse event reporting system

Offit's RotaTeq Safety Labeling Updated to Include Cases of Kawasaki Disease

Paul Offit, who believes that it is safe to inject babies with more than "100,000" vaccines at once (I emailed him to make sure he was not being misquoted, and he replied, "The figure of 100,000 is correct, and probably a little conservative."), has his vaccine labeling changed to note that it may cause Kawasaki Disease.

RotaTeq Safety Labeling Updated to Include Cases of Kawasaki Disease
http://www.medscape.com/viewarticle/558530?src=mp
Yael Waknine
Medscape Medical News 2007. © 2007 Medscape


June 19, 2007 — Changes have been made to the adverse reactions and postmarketing sections of the safety labeling for a live, oral, pentavalent rotavirus vaccine (RotaTeq, Merck and Company, Inc); it now includes cases of Kawasaki disease, the US Food and Drug Administration (FDA) told healthcare professionals on Friday.

The poorly understood disease is uncommon in children, is characterized by high fever and blood vessel inflammation, and affects the lymph nodes, skin, mouth, and heart.

During a phase 3 clinical trial, 5 cases of Kawasaki disease were reported among 36,150 infants who received the vaccine, compared with only 1 case among 35,536 who were given placebo, according to an alert sent from MedWatch, the FDA's safety information and adverse event reporting program.

Three other cases have been reported through the Vaccine Adverse Event Reporting System (VAERS) since the vaccine was approved on February 3, 2006. There is no known cause-and-effect relationship between the use of this or any other vaccine and Kawasaki disease, the FDA said, noting that the cases reported to date are not more frequent than what would be expected to occur by coincidence.

Rotavirus vaccine is indicated for the prevention of rotavirus gastroenteritis in infants and children, which is caused by the serotypes G1, G2, G3, and G4, when administered orally as a 3-dose series to infants between the ages of 6 and 32 weeks.

Healthcare professionals are encouraged to report cases of Kawasaki disease and other adverse events potentially associated with the vaccine to VAERS by going online at www.vaers.hhs.gov or calling 1-800-822-7967 for a report form.

Additional information about the use of the vaccine can be obtained by contacting the FDA’s Center for Biologics Evaluation and Research at 1-800-835-4709 or by e-mail at octma@cber.fda.gov.

Offit's Vaccine Up For Approval by FDA

From John Gilmore at ACHAMP:

A vaccine for rotavirus (Rotateq) developed by Merck, the Children's Hospital of Philadelphia and Paul Offit, America's most quoted promoter and apologist for the vaccine industry, will be considered for licensure on December 14 and by the Vaccines and Related Biological Products Advisory Committee of the Center for Biologics Evaluation and Research of the FDA.

Offit and his partners Merck and the Children's Hospital of Philadelphia, first received a patent for a rotavirus vaccine in 1994. Offit later voted to add rotavirus vaccine (a variety from Wyeth not Merck) to the recommended schedule of vaccines when he was a member of the FDA's Advisory Committee of Immunization Practices. Despite his ownership of a rotavirus vaccine patent Offit saw no need to recuse himself from several votes on adding rotavirus to the schedule, which is one of the last steps to inclusion in the mandatory schedules, and a guaranteed market worth billions to a vaccine maker, and comes with complete immunity from lawsuits.

This vaccine was rushed into distribution has quickly shown to cause massive intestinal damage and death in a small but vulnerable subset of children. It was just as quickly removed form the market.

According to the FDA website three of the members of the Committee's members have applied for and received waivers dor potential conflicts of interest

Participation of the public is permitted in this meeting:

Date and Time:
The meeting will be held on December 14, 2005, 9:00 am to 4:30 pm; and on December 15, 2005, 9:00 am to 4:30 pm

Location:
Holiday Inn Select, 8120 Wisconsin Avenue, Bethesda, MD, 20814, 301-652-2000 .

Contact Persons:
Christine Walsh, R.N. or Denise Royster, 301-827-0314, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512391. Please call the Information Line for up-to-date information on this meeting.

Agenda:
On December 14, 2005, the Committee will hear presentations and make recommendations on the safety and efficacy of a Rotavirus Vaccine manufactured by Merck. On December 15, 2005, the Committee will hear presentations and make recommendations on the safety and efficacy of ZOSTAVAX (Zoster Vaccine Live [Oka/Merck] ) manufactured by Merck.

Oral Presentations:
Between approximately 1:15 and 1:45 pm, on December 14, 2005; and 1:30 and 2:00 pm on December 15, 2005, oral presentations from the public will be scheduled. Those desiring to make formal oral presentations should notify the contact person before December 7, 2005.

RotaTeq®
Paul Offit at The Children's Hospital of Philadelphia developed a vaccine based on a bovine strain of rotavirus (WC-3). Merck is currently running Phase III trials of a modified version of his quadravalent reassortant vaccine.

Aiming to avoid the adverse affects that RotaShield® was associated with, the vaccine is based on a bovine strain of rotavirus. The bovine strain was chosen because it replicates less prolifically in the human gastrointestinal tract than the simian strain used for the tetravalent rhesus reassortant vaccine. [1] Each of the five reassortants consists of the genetic backbone of the bovine virus with an inserted gene coding for a different human rotavirus surface protein. The inserted genes were selected to represent a broad range of serotypes in order to elicit protection against a wide variety of strains.

Genes coding for four VP7 proteins and one VP4 protein are included in the reassortants. Human serotypes G1, G2, G3 and G4 are represented by the four VP7 proteins, and serotype P1a is represented by the VP4 protein. [2]

Initial trials of a similar live quadrivalent human-bovine reassortant vaccine demonstrated promising protection against rotavirus infection. [3] Differing from the Merck vaccine only by the exclusion of serotype G4, this vaccine's results likely mirror the protection that RotaTeq® will afford.

The quadrivalent vaccine, which was delivered to vaccinees in three oral doses at 2, 4, and 6 months of age (identical to the Merck vaccine delivery schedule), showed 74.6% efficacy against any rotavirus infection and 100% efficacy against severe rotavirus infection. No increase in diarrhea, vomiting, fever or irritability was reported as compared to the recipients of the placebo.

The immunogenicity of the quadrivalent vaccine was reflected in an increased ratio of rotavirus specific IgA to total IgA as measured in the vaccinee's stool. [3]

Licensure of RotaTeq® by the FDA is predicted for 2005 if Phase III trials are successful.