June 2008

Quote Machine

1) Mr. Offit is the mainstream media's favorite quote machine in the vaccine-autism debate. In fact, he is more than often the only quote in every article on the topic and seems to have immediate access to the Op-Ed pages of the New York Times, Boston Globe, and Wall Street Journal.

2) A Google search of "Paul Offit & Vaccines" reveals 47,800 separate hits.

Conflict

1) In testimony before Congress on April 6, 2000, Mr. Offit stated, "In addition, I have been in collaboration with Merck and Co. on the development of a rotavirus vaccine since 1992."

2) In speaking to a journalist, Mr. Offit stated, "I am a co-holder of a patent for a (rotavirus) vaccine. If this vaccine were to become a routinely recommended vaccine, I would make money off of that."

3) In the New England Journal of Medicine, it was stated at the end of an article by Dr. Offit, "Dr. Offit reports being a co-inventor and co-holder of a patent on the rotavirus vaccine RotaTeq, from which he and his institution receive royalties, as well as serving on a scientific advisory board for Merck."

4) The Committee on Government Reform of the U.S. Congress reported that "Dr. Offit shares the patent on the Rotavirus vaccine in development by Merck and received a $350,000 grant from Merck for Rotavirus vaccine development. Also, he acts as a consultant to Merck."

Congressional Reprimand

1) In August 2000, the Committee on Government Reform of the US Congress issued a highly critical document called Conflict of Interest in Vaccine Policy Making. Dr. Offit was reprimanded by Congress and his actions were a primary focus of the report.

2) The report focused on the introduction of the Rotavirus vaccine called Rotashield in the late 1990s. The report stated, "A little more than one year after the "RotaShield" rotavirus vaccine was licensed by the Food and Drug Administration as a safe and effective vaccine, it was removed from the market due to adverse events. More than 100 cases of severe bowel obstruction, or intussusception, were reported in children who had received the vaccine."

3) The report singled Dr. Offit out for questionable voting as a member of the Advisory Committee ("ACIP") affiliated with CDC that adds new vaccines to the vaccine schedule. The report stated, "Dr. Offit began his tenure on ACIP in October of 1998. Out of four votes pertaining to the ACIP's rotavirus statement, he voted yes three times, including voting for the inclusion of the rotavirus vaccine in the VFC program. Dr. Offit abstained from voting on the ACIP's rescission of the recommendation of the rotavirus vaccine for routine use."

Death & Damage From Paul Offit's Rotavirus Vaccine

1) In 2006, Dr. Offit's vaccine, Rotateq, was added to the CDC's recommended schedule.

2) In May 2008, it was reported that, "Later in 2007, the Centers for Disease Control and Prevention reported that there were 117 confirmed cases of intussusception among recipients of Rotateq between March 2006 and June 2007." This is more cases of bowel obstruction than the vaccine the FDA recalled from the market, Rotashield.

Also, in 2008 it was reported that, "The U.S. Food and Drug Administration approved an update to the product label for Merck & Co.'s Rotateq vaccine to include the report of a death of a recipient due to an intestinal obstruction."

July 07, 2008

DR. RENEE JENKINS: CHANNELING PAUL OFFIT'S BULLSHIT

By J.B. Handley

Renee Jenkins, the President of the American Academy of Pediatrics, is helping her organization rocket ahead of the CDC in becoming parent enemy number one for our community. In a month when Julie Gerberding conceded that the entire foundation of the CDC's position that vaccines do not cause autism -- the Verstraeten Study -- had major weaknesses, the AAP seems hell-bent on defending the CDC's Recommended Vaccine Schedule at all costs.

Moreover, we are seeing the AAP's new media strategy, forged through the formation of the "Immunization Alliance"--a front group for parties with a vested interest in promoting vaccines -- which is likely to not only backfire, but also put the AAP in the middle of the line of fire for parent activism.

For those of you who have been enjoying your summer, here's a little background:

- In the July 2008 issue of Pediatrics, a trade magazine published by the AAP, the Editor in Chief of the AAP wrote an article detailing the newly formed "Immunization Alliance" and its plans for combating declining immunization rates. Breathtaking in its dismissiveness of parent concerns, it's no surprise to read that Dr. Paul Offit is a key architect of this alliance and that the groups forming it are almost exclusively fronts for the CDC, AAP, or Big Pharma. Here's an excerpt:

"Underscoring the need for compelling vaccine messages is the No. 1 ranked resolution from the 2008 Annual Leadership Forum, calling for the Academy to lead a coalition that will develop a media campaign on the value of immunizations that can be marketed to parents, added Dr. Jenkins.

The group agreed that communication strategies must appeal to parents who are Internet and media savvy, and go beyond presentation of the science by engaging consumers on an emotional level. There was acknowledgment among attendees that messages from anti-vaccine groups' helped erode public confidence in immunizations through their use of celebrities to deliver heartrending first-hand accounts."

(Editor's Note: Please find the full text of the article below, which has not previously been available online -- an AoA exclusive!)

- Julie Deardorff, a writer for the Chicago Tribune, challenged the AAP's new attitude in an excellent blog post that you can read HERE, where she noted:

"The American Academy of Pediatrics is growing so concerned about the climbing rate of vaccine exemptions--and the possible affect on community health--that it recently formed a group called the "Immunization Alliance" to address the growing refusal of some parents to vaccinate...But here's a problem the AAP missed: The sheer number of recommended and mandated vaccines is freaking parents out. And new combo shots that contain a stew of four or five different vaccines aren't going to help matters."

- On July 3rd (what is it about the AAP and the day before the fourth of July?) Renee Jenkins responded to Julie Deardorff's post with a statement that clearly reflects the new plans of this "Immunization Alliance" to go after critics in a more aggressive manner. An excerpt from the full text of Dr. Jenkins statement which you can read below includes the following:

"Deardorff parrots the misleading pseudoscience of the most strident anti-vaccine Web sites and the scare tactics of celebrity-funded ad campaigns. In quoting the number of vaccines children receive today compared to 1982, Deardorff takes the extra step to write the numbers in boldfaced type, suggesting she believes these numbers alone should give parents pause about immunizing their children."

Dr. Jenkins goes on to explain that, "today's vaccines are safer than any in history. Current vaccines are more refined than older versions, so children receive fewer immune-challenging antigens overall even though they get a larger number of immunizations."

She also tries to scare parents by noting, "It's true that doctors recommend more vaccines for children today than they did two decades ago. The number of vaccines has increased because new vaccines have been developed to prevent more diseases. That is a good thing. That means children will not have to suffer devastating diseases such as Hib meningitis, which once killed 600 children a year and left thousands more with deafness, seizures and mental retardation. The vaccine available today has wiped out 98 percent of these cases."

While I wasn't in the room for the first meeting of the "Immunization Alliance", I know that Dr. Paul Offit was. In fact, he is cited specifically in the AAP article in Pediatrics and his picture even appears in the article. Having studied his media approach quite closely over the years, his fingerprints are all over this new strategy of the AAP's. Imagine Offit in a room with a bunch of self-conscious Doctors who have never dealt with the media with his smugness and track record of media experience. (Read more in Paul Offit: Quote Machine For Hire HERE.) It's no surprise that he would have heavy influence over this new approach and that many of Dr. Jenkins comments paraphrase things Offit has said in the past.

From my perspective, there are five major problems with the AAP's new approach:

1. You can't defend the assertions

The "fewer antigens" argument has been a Paul Offit special for years. Not only is this argument confusing for parents to understand, it also means nothing. Offit's claim is based exclusively on the removal of an older Pertussis vaccine (which was causing many problems) decades ago.

What parents see clearly is how many more vaccines they are getting. When Dr. Jenkins says that today's vaccines are "safer than any in history" there is simply no evidence and no study to back this up. Moreover, the combination risk of so many vaccines administered simultaneously has simply never been studied, so the AAP has no way to respond to this concern.

I sincerely hope they keep making this "less Antigen" argument, it is a real loser.

2. The news is making them look very stupid

With the Hannah Poling case, Dr. Bernadine Healy's recent comments, the potential for an Omnibus decision going our way, Julie Gerberding retreating, the IOM revisiting the "environment's" role in autism, and the case reports of children falling into autism after vaccines continuing to roll in, the AAP's position is looking chronically old and inconsistent with the reality many parents see. It's starting to remind me of that great spokesperson for Saddam Hussein who kept telling the press how the Iraqi Army was winning the war.

3. They don't know who their "enemy" is

The AAP believes the decline in immunization rates is due to "anti-vaccine groups" and "celebrities" as if Jenny and a few websites are the only problem. What they fail to realize is that the message of groups like Generation Rescue would fall flat if there weren't tens of thousands of parents who agreed with it. 8,000 people don't march on Washington because of Jenny McCarthy and a few websites, they march on Washington because they know what happened to their child. If parents weren't hearing our message corroborated in their own communities, there wouldn't be an impact.

4. They are not dealing honestly with parent concerns

If you have no safety studies verifying the issue of combination risk of so many vaccines, defending the schedule in its current form will backfire on you. If your best defense is to cite the 600 deaths a year from HIB now being prevented, parents will compare this to the 1 in 150 risk or higher of autism and make their own conclusions. By not acknowledging that the risk-reward of vaccines is potentially wildly out of balance, parents will not listen to you.

5. Offit is a time bomb

When the face of the public vaccine initiative -- which Offit very much is as a Google search of "Paul Offit & Vaccines" reveals 47,800 separate hits -- happens to be both a patent holder of a vaccine that may well get pulled from the market due to adverse events and a guy who was admonished by the US Congress for his conflicts, you are dealing with a slippery slope.

Consider:

"In 2006, Dr. Offit's vaccine, Rotateq, was added to the CDC's recommended schedule. In May 2008, it was reported that, "Later in 2007, the Centers for Disease Control and Prevention reported that there were 117 confirmed cases of intussusception among recipients of Rotateq between March 2006 and June 2007." This is more cases of bowel obstruction than the vaccine the FDA recalled from the market, Rotashield. Also, in 2008 it was reported that, "The U.S. Food and Drug Administration approved an update to the product label for Merck & Co.'s Rotateq vaccine to include the report of a death of a recipient due to an intestinal obstruction."

And:

"In August 2000, the Committee on Government Reform of the US Congress issued a highly critical document called Conflict of Interest in Vaccine Policy Making. Dr. Offit was reprimanded by Congress and his actions were a primary focus of the report. The report focused on the introduction of the Rotavirus vaccine called Rotashield in the late 1990s. The report stated, "A little more than one year after the "RotaShield" rotavirus vaccine was licensed by the Food and Drug Administration as a safe and effective vaccine, it was removed from the market due to adverse events. More than 100 cases of severe bowel obstruction, or intussusception, were reported in children who had received the vaccine."

The report singled Dr. Offit out for questionable voting as a member of the Advisory Committee ("ACIP") affiliated with CDC that adds new vaccines to the vaccine schedule. The report stated, "Dr. Offit began his tenure on ACIP in October of 1998. Out of four votes pertaining to the ACIP's rotavirus statement, he voted yes three times, including voting for the inclusion of the rotavirus vaccine in the VFC program. Dr. Offit abstained from voting on the ACIP's rescission of the recommendation of the rotavirus vaccine for routine use."

The AAP's new approach will not only fail, but it puts them front and center for criticism and action from our community. As people who are supposed to be defending our kids, I had much higher hopes for how the AAP would deal with the vaccine-autism issue.

Using "Bullshit" is not going to work, particularly the kind Paul Offit has been spewing for years.

J.B. Handley is Editor at Large for Age of Autism and Co-Founder of Generation Rescue.

APPENDIX

AAP Article from July Issue of Pediatrics:

Immunization Alliance to develop compelling messages for parents
Anne Hegland
Editor in Chief

With pediatricians facing an increasing number of parents who question the safety of vaccines, representatives from organizations with a shared interest in advancing children's health met May 30 to compare notes and develop strategies to help recapture public trust in childhood immunizations.

The newly formed Immunization Alliance, representing 15 groups, agreed that together they must work on short-and long-term solutions before falling immunization rates lead to further outbreaks of once-common and sometimes deadly vaccine-preventable childhood diseases. Fresh in everyone's mind were the measles outbreaks in nine states earlier this year.

Framing the challenges

Paul Offit, M.D., FAAP, director of the Vaccine Education Center at Children's Hospital of Philadelphia, identified some of the factors contributing to the increase in vaccine refusal and the need for quick action:

- parents who have never experienced or seen vaccine-preventable diseases; - media and Internet reports that are unbalanced; - decreased trust in the government and health care providers; - an increasing number of states allowing philosophical exemptions; and - parent-to-parent spread of misinformation.

Dr. Offit pointed out that the majority of vaccine refusals stem from parents' fears, with only 10% of refusals associated with parents who strongly oppose vaccines.

"We need to work on public messaging around vaccines -- the benefit of vaccines -- and to have the right messenger delivering those messages," said AAP President and meeting co-facilitator Renée R. Jenkins, M.D., FAAP.

Underscoring the need for compelling vaccine messages is the No. 1 ranked resolution from the 2008 Annual Leadership Forum, calling for the Academy to lead a coalition that will develop a media campaign on the value of immunizations that can be marketed to parents, added Dr. Jenkins.

The group agreed that communication strategies must appeal to parents who are Internet and media savvy, and go beyond presentation of the science by engaging consumers on an emotional level. There was acknowledgement among attendees that messages from anti-vaccine groups' helped erode public confidence in immunizations through their use of celebrities to deliver heartrending first-hand accounts.

"The greatest challenge is getting these messages out in a timely fashion. We've got August coming up, which is a big month for kids going to the pediatrician for back-to-school visits and for immunizations," said Dr. Jenkins.

At press time, Alliance members were prioritizing strategies to be shared with communication experts who will help craft messages promoting the value of immunizations.

Messages for pediatricians

Meeting co-facilitator Margaret Fisher, M.D., FAAP, chair of the AAP Section on Infectious Diseases, said the Alliance's efforts also are an effort to help pediatricians in practice, whose messages have not always been understood by parents.

"We're all about what's best for children, and what we're trying to do is find a way to re-establish our trust with the public. We want to help provide our members with the messages and the method that can regain that trust and make it easier for them on a day-to-day basis.

"The public has lost trust in medicine in general -- not in their individual pediatricians," Dr. Fisher added.

The Immunization Alliance meeting was supported by the Tomorrows Children Endowment of the AAP.

Immunization Alliance

The following groups are represented on the Immunization Alliance: - American Academy of Family Physicians - American Academy of Pediatrics - American College of Obstetricians and Gynecologists - American Medical Association - American Public Health Association - Association of State and Territorial Health Officials - Easter Seals - Every Child By Two - Immunization Action Coalition - March of Dimes Foundation - National Foundation for Infectious Diseases - National Vaccine Program - Parents of Kids with Infectious Diseases (PKIDS) - Rotary International - Voices for Vaccines

AAP Response to Julie Deardorff:

New vaccines are preventing more diseases

The American Academy of Pediatrics is disappointed that a premier newspaper like the Chicago Tribune would publish such a one-sided, fear-mongering report as columnist Julie Deardorff's June 27 blog post, "The AAP gets tough on vaccine dissenters.

Deardorff parrots the misleading pseudoscience of the most strident anti-vaccine Web sites and the scare tactics of celebrity-funded ad campaigns. In quoting the number of vaccines children receive today compared to 1982, Deardorff takes the extra step to write the numbers in boldfaced type, suggesting she believes these numbers alone should give parents pause about immunizing their children.

The fact is, today's vaccines are safer than any in history. Current vaccines are more refined than older versions, so children receive fewer immune-challenging antigens overall even though they get a larger number of immunizations.

It's true that doctors recommend more vaccines for children today than they did two decades ago. The number of vaccines has increased because new vaccines have been developed to prevent more diseases. That is a good thing. That means children will not have to suffer devastating diseases such as Hib meningitis, which once killed 600 children a year and left thousands more with deafness, seizures and mental retardation. The vaccine available today has wiped out 98 percent of these cases.

Deardorff is less than fair in her depiction of how the American Academy of Pediatrics is responding to parents with questions about vaccines. Pediatricians spend many hours in their day counseling parents about the safety and importance of immunization and answering their specific questions. Pediatricians want to provide parents with accurate information; our job is made all the harder by misleading reports like this one.

By J.B. Handley

Dear Carla Johnson:

I found your article "Fringe Autism Treatment Could Get Federal Study" today on a potential federal study on chelation treatment for autism to be extremely one-sided and at times quite condescending of parents of children with autism. As a reporter for the Associated Press, we look to you to give us a fair and balanced view of the medical issues we face. As the parent of a child with autism, I was dismayed to consider how your report might be received by parents new to this debate who are drowning in the range of treatment options for their disabled children.

It's worth repeating the first two sentences of your article for some perspective:

"Pressured by desperate parents, government researchers are pushing to test an unproven treatment on autistic children, a move some scientists see as an unethical experiment in voodoo medicine. The treatment removes heavy metals from the body and is based on the fringe theory that mercury in vaccines triggers autism -- a theory never proved and rejected by mainstream science."

We parents have grown very tired of being referred to as "desperate" by journalists.

Do you really think the NIH fund studies because parents are desperate? No, they fund studies because compelling anecdotal evidence leads them to believe that more work should be done to see if the anecdotes can be extrapolated to a broader conclusion to benefit more kids. This is how science progresses.

Why do you need to belittle it and call it "voodoo" medicine? Also, how can the "theory never proved" as you say be proven without doing studies? You can't criticize that no studies have been done while a study is trying to be done! And, who is the "mainstream science" you refer to that has rejected this theory? I have never seen a document from "Mainstream Science" rejecting chelation therapy for autism. Isn't the NIH about as mainstream as it gets and aren't they the ones considering funding the study?

If your personal bias weren't obvious enough in the way you wrote your article, I was even more dismayed to read your quote from Paul Offit, the Vaccine Industry's well-funded spokesperson.

Quoting Paul Offit on an article on autism treatment is like quoting the Marlboro Man about a compelling treatment for lung cancer! Not only does Mr. Offit have zero expertise in the area of autism treatment -- he has never treated a single child with autism and his specialty is infectious diseases -- but also Mr. Offit is a paid spokesperson for Merck, he's a vaccine patent holder on a vaccine currently in our recommended schedule, and he has been reprimanded by the US Congress for his conflicts when serving on a Vaccine Advisory Committee.

Worse, not one of Mr. Offit's conflicts are mentioned by you in the article. Googling "Paul Offit and Autism" leads to more than 47,000 hits, which leads me to believe you were on deadline and chose the lazy way out to get a quote from the Vaccine Industry's most reliable quote machine.

Unlike Dr. Offit, Dr. Insel of the NIH should be commended for listening to parents and pushing science to move faster. To date, neither the AAP nor the CDC nor Dr. Offit have any explanation for a crippling epidemic that is fast approaching 1 in every 100 children.

With deep disappointment,

JB Handley
Co-Founder
Generation Rescue
Father to Jamison, Age 5

You can email your comments to the AP: info@ap.org

JB Handley is co-founder of Generation Rescue and Editor At Large for Age of Autism.