Wednesday, January 7, 2009

What is Paul Offit's Problem?

By Anne Dachel
I had to ask myself why Dr. Paul Offit, nationally-known vaccine expert, would consider The Vaccine Book, by Dr. Robert Sears to be so dangerous that he'd put out a whole piece about it in the January 2009 issue of Pediatrics. It's especially curious, since Sears' book came out well over a year ago.

Offit's article, The Problem With Dr Bob's Alternative Vaccine Schedule, (HERE) led to a response from Dr. Sears (HERE) that is running on his website. I hope readers will take the time to read both pieces to understand first-hand what was said by each of the doctors. Offit's overall message is that Sears is fueling fears over vaccine safety by allowing parents to choose alternative vaccine schedules for their children. Offit wrote, "Sears' book is unique. Unlike typical antivaccine books, he offers a middle ground, allowing parents to act on their fears without completely abandoning vaccines. Unfortunately, Sears sounds many anti-vaccine messages." Offit devoted the Pediatrics article to describing the ways in which Sears' book is undermining the vaccine program and endangering children's health.

In his response, Sears stated, "I believe that Dr. Offit has misconstrued the book's overall message by selectively extracting various phrases and sentences that discuss anti-vaccine ideas and worries parents have and portraying those ideas as my own." In another place he said, "I believe that Dr. Offit has greatly misrepresented the overall message of the book as being 'anti-vaccine." I read through many of the things Sears has written and looked hard for his "anti-vaccine messages." I have to agree with him when he says he's clearly not attacking the vaccine program. Sears stated, "It is my belief that many families go unvaccinated simply because they aren't offered a more gradual option."

Sears doesn't enter the controversy siding with parents. For example, he cited the studies that debunk a link between the MMR and autism, and added that "My initial worries about the MMR and intestinal inflammation are probably unfounded." Sears has called for studies on the effects of aluminum, noting, "I've been searching and searching for human infant studies that determine what a safe level of injected aluminum is, including looking at all the studies used in the article quoted by Dr. Offit, and I can't find a single one." Sears avoids the argument over mercury in vaccines and autism by saying, "It has been removed from virtually all vaccines, so you really don't have to spend hours researching whether or not it is harmful." I couldn't find big issues of controversy in what Dr. Sears has written about vaccines. He said in his response, "If my book had been portrayed correctly , we would find very little to debate about." Sears is not criticizing the CDC or vaccines in general. He's simply asking for flexibility in dealing with parents who are worried about vaccine side effects. He's definitely pro vaccine.

According to Offit, even a little break from rigid adherence to the mandated schedule is dangerous. It gives parents the idea that there might be serious side effects that could be avoided by changing the schedule. And, judging by the tens of thousands of copies of Sears' book that have been sold, lots of parents are having second thoughts about blindly accepting the one-size-fits-all-kids vaccine schedule. Two things in Sears' response to Offit Pediatrics article got my immediate attention. Sears noted that lots of parents worry about the cozy relationship between the vaccine makers and the medical community, especially those in charge of safety. Sears wrote, "In medical school we are taught to at least briefly raise an eyebrow at research funded by a pharmaceutical company, instead of simply taking it for granted."

A bit later, Sears said, "As for the issue regarding parents' trust in the vaccine manufacturers, that trust was severely shaken when it was revealed in the Los Angeles Times on February 8, 2005, that way back in 1991 a researcher at Merck sent a memo to the president of Merck's vaccine division stating that they had just realized that the cumulative amount of mercury in vaccines given to infants by six months of age was about 87 times the safety limits set by the FDA. And that information was not revealed to the public until 8 years later."

Sears said he continues to put his faith in the vaccine makers but he added that "I find it surprising that any doctors can fault a parent for not completely trusting Merck after that, or the FDA and CDC departments that were supposed to be overseeing this type of issue." Offit doesn't worry about conflicts of interest however. In his new book, Autism False Prophets: Bad Science, Risky Medicine, and the Search for a Cure, the fact that Eli Lilly tested thimerosal on 22 adult patients who had meningitis is noted. Offit wrote, "Lilly scientists gave thimerosal to doctors to treat the infection. It didn't work." The deaths of the patients from meningitis also prevented any possibility of studying the long term side effects and it meant there was no way to determine how safe thimerosal would be for babies and children.

The fact is that the manufacturer's testing was the only recorded study on thimerosal before it was used regularly in vaccines that I've ever heard about. Offit wrote, "Although thimerosal didn't treat meningitis, doctors found that it was safe. Adults injected with 2 million micrograms of thimerosal didn't suffer symptoms of mercury poisoning; the amount was 10,000 times greater than the FDA later found babies had received in vaccines." (p. 63 Autism's False Prophets) Simpsonwood, the meeting of scientists, federal health officials, and pharmaceutical company representatives in 2000 at the Methodist Retreat Center in Norcross, GA was also talked about in Offit's book.

The initial findings by Dr. Thomas Verstraeten showed a relationship between the increase in mercury-containing vaccines and developmental problems. Offit wrote, "With the exception of autism, children who had received mercury in vaccines were more likely to have a variety of neurological problems." (p. 91 AFP) Offit continued, "Tom Verstraeten presented his data. He started with autism, concluding that the relationship between the amount of mercury in vaccines and and the risk of developing the disorder was 'not statistically significant.' ...He showed that children who had received mercury in vaccines were more likely to have tics, attention deficit disorder, and speech and language delays. ...If Verstraeten's preliminary data were right, vaccine makers public health officials, and doctors had inadvertently poisoned a generation of children." (p. 92 AFP) Not to worry, according to Offit.

By 2003, "Verstraeten had gone back to the medical records to verify the computer diagnoses,... Verstraeten found that his preliminary data had been misleading: mercury in vaccines did not cause harm. He concluded, 'No consistent significant associations were found between thimerosal-containing vaccines and neurodevelopmental outcomes.' " (p. 93 AFP) Offit noted that many charges have been leveled against Verstraeten for his about-face over mercury's side effects, plus there's the fact that by 2003, Verstraeten had gone to work for GlaxoSmithKine.

It's obvious too that Offit doesn't raise an eyebrow at connections between researchers and drug companies as Sears told us he should. Other medical experts have also published their opinions of Offit's Pediatrics article on Dr. Sears. (HERE) Dr. Jon Poling, father of Hannah Poling whose case in federal vaccine court gained national attention in 2008 when it was conceded that the vaccines she received were linked to her autism, also responded: "As a physician, scientist, and father of a vaccine-injured child, I have many issues with Offit and Moser's critique of Dr. Sears vaccine book, particularly its authoritarian tone and content. Offit is certainly entitled to his opinion, but it must be recognized as that.

We must stick to the science and recognize the open questions with regards to vaccine safety." Poling gave a detailed summary of the possible errors in the claim that epidemiological studies have disproved any association between vaccines and autism. He also said, "As a Neurologist that saw his normally developing daughter regress into autism before turning 2 years old, co-incident with immunization, I obviously have an inherently different bias than Offit, the wealthy vaccine inventor and patent holder." Poling ended his letter by saying, "As physicians we took an oath to 'first do no harm' to our individual patients. Dr. Sears offers a pro-vaccine individualized approach to childhood immunization that acknowledges the risks, benefits, and uncertainties of this medical intervention.

Dr. Sears should be applauded for his efforts to provide safe vaccination alternatives to his patients, given the void of randomized controlled trials to support continued growth of the current CDC/AAP schedule. "Rather than personal attacks, let's turn to science to provide the answers. The enormous public benefit of vaccination cannot be used to stifle open discourse on critical vaccine safety issues. One size does not fit all."

Where have we heard the statement, "One size does not fit all" with regard to vaccines? It was announced on April 03, 2008 in a commentary on CNN: A view from the CDC, (HERE) "Although some may call it a "one size fits all" approach, the recommended vaccine schedule is flexible, and it does account for instances when a child should not receive a recommended vaccine or when a recommended vaccine should be delayed."

Four days later, on April 7, the phrase again appeared in an article (HERE) by Anne Schuchat MD, assistant surgeon general at the U.S. Public Health Service and director at the CDC's National Center for Immunization and Respiratory Diseases.It was also said by a top doctor, Bernadine Healy, former head of the National Institutes of Health (HERE) on CBS News.
"Healy says the argument need not be framed in those terms (vaccinate or don't vaccinate). Instead, she says, we should vaccinate, but work to do it in the safest manner possible based on what we know and what we can find out.

"That's what the parents of autistic children have told me as well. If we can screen children to see which ones might be more susceptible to vaccine side effects, and vaccinate them on a more personalized schedule that is safer for them, why wouldn't we? If it's safer for all children to have their vaccinations spread out, why wouldn't we? Healy says it's called 'personalized medicine' and is being done in virtually all areas of medicine today with the exception of vaccines. Yet the government continues to frame the conversation in all-or-nothing, 'one-size-fits-all' terms." Healy challenged the credibility of the CDC and admonished officials for refusing to investigate a susceptible subgroup of children who are unable to eliminate the toxins in vaccines.

This admission that there hasn't been enough research and that epidemiological studies are not proof is a major step toward public recognition about what's happened to our children. Healy said that officials have been too quick to dismiss a link between vaccines and autism without ever studying the group that got sick. There never have been studies done on the kids that developed symptoms of autism within a few weeks of being vaccinated. She furthermore pointed out that the Institute of Medicine which produced the cumulative study on vaccines and autism in 2004 refused to 'pursue susceptibility groups.'

In other words, they didn't want to find any evidence that linked vaccines to autism. She left us with the haunting statement: 'The question has not been answered.'In the December 11, 2008 issue of U.S. News and World Report, A Government Call for Vaccine Research, (HERE) Dr. Healy again called for more research into vaccine safety. It would seem that yet another top doctor is calling for flexibility when it comes to the vaccine schedule and for additional studies on safety. Will Paul Offit be writing a scathing critique of Bernadine Healy for her very vocal challenge to the mandated vaccine program in next month's Pediatrics?

Dr. Lawrence Rosen, another well-known physician in the vaccine debate, added his letter in response to the Offit's article. Rosen practices in northern New Jersey and consults at Hackensack University Medical Center. His remarks sounded a lot like what Bob Sears had said. Regarding parents wanting changes in the vaccine schedule, Rosen wrote, "Would it be better that they seek non pediatric primary care in support of no vaccination or would it better for me to tolerate their concerns and 'allow' them to vaccinate flexibly? What is the 'right thing' to do? This is what many of us struggle with."As I become more involved in the AAP at a leadership level, I become more and more aware of the divide between pediatricians. What I fear is that we as a profession and the AAP as an institution may be discouraging honest and open dialogue about one of the most important public health issues of our times. I find it highly unusual that a fellow AAP pediatrician is roundly criticized in Pediatrics (the flagship journal of the AAP) without a chance to address the claims. Perhaps some at the AAP find his book that threatening. Is fear of information the direction we want to support? Should we not be using this as an opportunity for discussion? "Whether we want to admit it or not, public trust in the immunization program and in pediatricians in general is eroding.

And while we can debate whether aluminum and mercury in vaccines is the same or different as what we eat/drink/breathe (my personal bias is that we should reduce all exposures when possible), we must all agree that the only way to save the U.S. vaccine program - and trust in our profession by the families who need us most - is to encourage public conversation in a non judgmental manner. And it has to start here, with us." Offit's critique was also the focus of an article in U.S. News on December 29.

In Flexible Approach to Vaccinations Comes Under Fire (HERE) reporter Deborah Kotz, who also spoke with Dr. Sears, described Offit's piece as "an attack on doctors who take a flexible approach to vaccinations." Kotz wrote, "Unfortunately, instead of allowing a pro-and-con debate about the benefits and drawbacks of pediatricians working with parents who wish to have some flexibility, the Pediatrics journal editors chose to feature just one side of this debate. The authors of the special article take a firm stand against allowing any deviation from the current vaccine schedule, arguing that in offering a middle ground, Sears is sending 'antivaccine messages.'"What's worse, the lead author, Paul Offit, who heads the vaccine education center at the Children's Hospital of Philadelphia, clearly has a conflict of interest. He's one of the patent holders of RotaTeq, a vaccine against rotavirus that's on the AAP's vaccine schedule. That means he stands to lose money if parents shun RotaTeq."Kotz said Offit's piece was "a special article that quite frankly shocked me for its one-sided treatment of a very important issue with regard to vaccinations."

Kotz also wrote that Offit didn't respond to her request to be interviewed. That seems incredible to me, since Offit's name appears in articles on vaccine safety more often than any other doctor. It's hard to imagine that he'd skip an opportunity to be covered by U.S. News.There seems to be a lot of holes in Offit's claim that the science is in on vaccines and a possible link to autism. Clearly, there is a lack of safety studies and research looking into the kids who regressed following vaccinations.

Barbara Loe Fisher from the National Vaccine Information Center (HERE) has also voiced her concerns about the lack of science to back the claim of no link: "There has never been a large, prospective scientific study to scientifically evaluate the long term effect on brain and immune function of giving children in America the CDC recommended 69 doses of 16 vaccines (for girls) and 66 doses of 15 vaccines (for boys) from the day of birth to age 18, including injecting children under age six with 48 doses of 14 vaccines and administering eight or more vaccines on the same day as the CDC schedule allows. Any long term study that evaluates the safety and effectiveness of this kind of vaccination schedule should also compare the health of children, who receive all the CDC recommended vaccines on schedule, with children, who receive fewer or no vaccines at all, to evaluate the long term health differences between the children. This is the only way a true scientific comparison can be made to determine whether the recommended CDC schedule leads to better or poorer health outcomes for most children and whether there are certain groups of children, perhaps those with genetic or other biological high risk factors, for whom vaccination is much more likely to result in permanent brain and immune system dysfunction." Dr. Sears isn't a lone maverick in his call for a flexible schedule.

Another well-known pediatrician, Dr Jay Gordon, was On Larry King Live (HERE) raising serious questions about vaccine safety. On his website (HERE), he states, "I am very much opposed to the routine vaccination schedule in the U.S. There are too many vaccines given too early in a child's life and not enough information given to parents."Vaccines have side effects. There can be rare severe problems, common minor problems and constant speculation about hidden problems. Vaccine proponents who deny side effects are not being honest with you, either."My strongest recommendation to you and anyone else considering alternatives to the standard vaccine regimen is to become very well informed and discuss these issues long and hard with your doctor. A doc who won't hold these discussions is too busy and you may need to move on to another."

Offit has tried to portray parents' fears about vaccine safety as something irrational. At the beginning of his article on Sears, Offit wrote, "Many parents are hesitant about vaccinating their children. Vaccine hesitancy can be explained in part by a lack of trust in those who make vaccine recommendations; a suspicion of profit motive driven by pharmaceutical companies; misinformation on the Internet; failure to appreciate the seriousness of vaccine-preventable diseases, given their low rates; and constant stories in the media claiming that vaccines cause a variety of illnesses, ranging from allergies to autism.

Most recently, with the addition of several new vaccines to the infant vaccine schedule, some parents have become concerned that children receive too many vaccines too early."Offit leaves out a very important reason why parents are frightened over vaccines. There is an epidemic of autism out here in the real world that no one can reasonably explain. I don't care where you are, if you bring up autism, someone will start talking about a family member or neighbor with a child who is autistic. Stories are everywhere about normally developing children who regressed into autism following vaccinations. I've yet to hear a plausible explanation for why children suddenly lose learned skills like talking, making eye contact, and being potty-trained.

In Offit's world, there hasn't been any increase in autism, only greater awareness and an expanded spectrum of autism. Even though many parents, scientists and doctors directly link the autism explosion to the dramatic increase in the number of vaccines in the mandated schedule, Offit sees no connection. In Autism's False Prophets, Offit wrote, "Two phenomena likely account for the increase. First, the definition of autism has broadened to include children with milder, more subtle symptoms. During the time of Leo Kranner and Bruno Bettelheim, children with mild symptoms of autism may have been described as 'quirky' or 'different' or 'unusual' but not autistic.

Today, these children are more likely to be diagnosed with autism spectrum disorder or Asperger's Syndrome or pervasive developmental delay. Second, in the past children with severe symptoms of autism were often considered mentally retarded. Today, as the number of children with severe autism has increased, the number with mental retardation has decreased." (p. 3-4 AFP)(Strangely, Offit included statements in the book that seemed to say the opposite. On page 109, he wrote, ":Finally, in January 2008, Robert Schechter and Judy Grether from California's Department of Public Health took a closer look at the rate of autism from 1995--six years before thimerosal had been removed from vaccines--to 2007, six years after it had been removed. They found what everybody else had found: the rates of autism continued to increase." It seems that when it's convenient, the autism increase is real. When it's implicates vaccines, it isn't.)

In his book, Offit stated that, "The first clue to the cause of autism is that it's genetic." (p. 218 AFP) He talked about possible environmental triggers, but they don't include vaccines. The basis of Offit's view of autism is that children are born with the disorder and that it hasn't really increased. Everything in Offit's scenario depends on this claim, but that simply isn't what's happening in America. I don't have to go back more than a couple of days to find news stories describing the dramatic impact of autism that can't be explained with Offit's theory of an expanded spectrum.

December 31, 2008--Edmond, OK. (HERE) "Autism is a quiet epidemic growing at a rate of 10-17 percent per year, according to the U.S. Department of Education. Eighty percent of these children are under the age of 14."January 2, 2009--Columbia, SC (HERE) "The number of students diagnosed with autism in South Carolina's public schools has more than doubled in the past five years, creating more challenges in programming and staffing for education officials. The state Department of Education counted 2,685 students in 2007, up from 1,283 students in 2003, with autism as their leading disorder."January 2, 2009-- Maryland, Health report gives mixed results (HERE), "The number of children diagnosed with autism in the local school system more than doubled in only four years, according to the 2008 Community Health Assessment, a report released by Calvert County charities and government agencies." January 3, 2009--Marin, CA (HERE) "The number of autistic students in Marin has doubled in the past seven years, from 76 in 2001 to 152 in 2008." This is only part of the autism crisis. Soon the focus will be on providing for the upcoming generation of adults with autism who aren't there now.

On December 16, the Chicago Tribune ran the story, Autism study: Fears for the Future (HERE) which described the dire prospects for autistic adults based on an Easter Seals study. Easter Seals looked at the situation of "adults" --individuals between 19 and 30--and found that the majority are living at home and unemployed. Parents have very real fears about what will happen when they're no longer able to care for their children. Insurance doesn't pay for the therapy these people need and the financial burden is huge. Wendy Murphy, director of therapeutic schools for Easter Seals Metropolitan Chicago was quoted in the article: 'We are always talking about the need for adult services. We always say that there's a crisis, that there's nothing for our students to do when they graduate.

There just aren't any supports out there to help people with autism live independently.'The experts like Paul Offit who devote themselves to denying that autism is a crisis with very real environmental causes sound absurd when we read these stories. If autism has always been around like this, why isn't there even one study that could find the mislabeled autistic adults at rates even approaching what we see in our children? Offit claims that they're out there somewhere, but he never has to prove it. It will be the autism price tag that will finally expose the truth.

Each affected child represents an estimated cost of 3 to 5 million dollars for lifetime care and it'll be the taxpayers who are left with the massive bill for this disaster. The public is going to demand answers and there will be plenty of parents who will blame the vaccines their children received and the proof will be everywhere.Paul Offit and the AAP should understand one thing: this issue isn't going to be swept away with one damning article in Pediatrics. The autism epidemic is very real and parents will continue to be scared of what vaccines may do to their children. Good doctors will be listening to them.

Anne Dachel is Media Editor of Age of Autism.

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