Tuesday, July 19, 2005

CDC Media Briefing on Vaccines & Child Health

Posted by Craig Westover | 5:47 PM |  

The political battle shaping up over whether or not the mercury preservative Thimerosal used in childhood vaccines is a cause of autism heated up today as the CDC held a press conference in Washington DC to tout vaccine safety just one day before a capitol rally -- “Power of Truth” -- intended to draw national attention to the theory that mercury in childhood vaccines can and has caused autism in thousands of children.

In a press release from rally sponsors characterized the press conference as “a secret press conference” and “an invitation-only meeting” It criticized the CDC for not notifying anyone from 13 organizations involved in the rally of the press conference and not inviting any of the national autism groups to speak, nor share any copies of what will be presented with these groups.” Well, to set the record straight, I was sent an announcement this morning from the Department of Health and Human Services with a call in number. Dan Olmstead, a UPI reporter who has written in support of the position that there is a connection between thimerosal and autism was in attendance -- so the characterization of secret is a little unfair.

I make this point, first because like Olmstead, I find the hypothesis of a connection very convincing and to call a Washington D.C. press conference “secret,“ especially when people like Olmstead and myself who have been critical of government on this issue are included on the list damages the credibility of those making what I believe is the stronger argument. Further, the irony is that any thinking reporter who listened to the press conference should come away with more doubts about the government’s position than he or she had going in. If the arguments presented at the press conference were the best that government agencies could muster, if I were a DC reporter, I’d be out to the rally tomorrow to hear what the other side had to say.

Indeed, one of the first questions asked by a reporter, who obviously had some background on the issue, was to the effect of “Why are we here today. I’m hearing no new information. Are we here because of the parents rally at the capitol tomorrow?”

The answer is obiously yes, but Dr. Julie Gerberding clumsily ducked it with condescending comments about providing information on vaccine safety, without even acknowledging the rally.

The thimerosal issue is out in the open now. It may not be a popular position with the organizations sponsoring the rally, but while releasing anger at the government might feel good, the high ground of reasoned argument is what will ultimately win the day.

As noted, I listened in via teleconference. Questions were only taken from reporters in attendance. Participants were --

Dr. Julie Gerberding, Director, Centers for Disease Control & Prevention

Dr. Duane Alexander, Director, National Institute of Child Health Development, of the National Institutes of Health

Dr. Murray M. Lumpkin, Acting Deputy Commissioner for International and Special Programs, Food and Drug Administration

Dr. Eileen Ouellette, president-elect, American Academy of Pediatrics

Dr. Robert M. Wah, member of the Board of Trustees, American Medical Association

Dr. Peter Hotez, father of a child with autism and medical researcher

Dr. Gerberding of the CDC gave pretty much a mom and apple pie presentation of dedicated government officials. We all have one purpose, she noted, and that is a firm commitment to protecting health of children in our country and the world. She defined the purpose of the press conference as talking about vaccine safety and some of the steps being taken to ensure safety. Also to look at new research into autism.

She made comments like we know the issue is near and dear to the hearts parents. But, she stressed, the issue is not just Thimerosal. The focus is vaccine safety. The job of government is to help people feel safe. It has the responsible to speak out to assure people about vaccine safety, which is what the press conference was for.

Gerberding acknowledged that autism is heart-wrenching, and presents special challenges, which everyone on the panel wanted to prevent. Parents want answers and the agencies represented have a collective responsibility to help find those answers.

She stressed that we don’t know what causes autism today. We don’t have a complete scope learning, of early signs, of detection and treatment. She emphasized that we have a long way to go to understand the current status of autism and what it means.

In what was probably the most significant comment she made, Gerberding seemed to back off the 1 in 166 number saying that it came from a relatively small sample. More studies are needed to to get a true picture of the prevalence of autism. Expected to have a better grasp next year. My take is the CDC might be moving to a “What epidemic?” strategy.

Gerberding then addressed the heart of the matter by saying that some people say thimerosal is a cause in some children. She repeated the mantra that studies have looked at thousands of children with autism, and the preponderance of evidence shows no connection between vaccines and autism. She noted that she can’t say with 100 percent certainty -- science can never say never or prove a negative. However, the preponderance of evidence doesn’t prove a link. She says the CDC has been looking hard for such a link and more studies are underway.

She also noted it’s important to keep an open mind. She noted that scientists have a responsibility to look at all hypothesis and base decisions on the best available science, not on fear. What is clear is that children live better because of vaccines. Gerberding cited statistics of how many people came down with polio at the height of its epidemic, measles, rubella and the like. She noted that these viruses haven’ gone away. They exist in other parts of world, and we are just one traveler away from an outbreak. There was a measles this year in Midwest. We must continue to vaccinate our children until diseases disappear throughout the world, and that is far away.

An editorial aside here -- Gerberding’s theme here was echoed by the other speakers. Specfically, she made a point of all the good vaccines have accomplished and that the risk associated with vaccines does not outweigh the clear benefits. Here implications was that to question vaccine safety is to favor not vaccinating children. This is a bit of a disingenuous argument on both fronts. In the latter case, the majority of people questioning vaccine safety are not anti vaccines nor do they want people not to vaccinate their children. What they want are safe vaccines. To Gerberding’s first point, equating the damage caused by thimerosal to adverse vaccine reactions is apples to oranges. The risk of an adverse reaction of a vaccine is a rare and random event that cannot be foreseen -- an unknown allergic reaction and the like. Damage caused by thimerosal is preventable and is neither rare nor random. It is this kind of reasoning that makes people like myself question government science on this issue.

Gerberding goes on pointing out that technology has advanced. We can produce vaccines without thimerosal, with the exception of some flu vaccines. She emphasized that thimerosal is a preservative and needs to be used in significant amounts to be effective. We can package vaccines in single dose vials, without thimerosal, which is more expensive, but it’s worth it to ease parents minds. Government agencies and the pharmaceutical industry have worked to get thimerosal out of vaccines, but it is still used in the manufacturing process. Some trace amounts remain in vaccines but well below the preservative level -- anyone with common sense, would recognize that these trace amounts are not a health issue.

She repeated -- We know the benefits of vaccine. We’re committed to safe vaccines. The predominance of evidence says there is no risk.

My colleagues spent a lot of time listening to parents. Their voices are strong and caring voices, dismayed about children, want to know how to treat their children and prevent others from suffering. The one message we’ve taken is the government agencies must do more -- what are most important research steps -- how can you screen and treat autism -- lots of questions and lots of factors to review. If we learn more might be able to generate more robust hypothesis. That takes time. In the meantime we have to rely on the science we have, which indicates that vaccines save lives and protects our children

Dr. Alexander of the NIH was the first Gerberding echo on the theme that vaccines have done a lot of good and help children. Worst thing a parent can do is forego vaccines. The danger of disease is far worse. He said we hear parents and are listening to their concerns. (At this point it was clear he was reading a prepared statement.) He said the NIH is committed to research. He cited the IOM review and five studies to dismiss the thimerosal claim.

At this point, Alexander gave a detailed rundown of all the research being done by the NIH on autism -- detailed in the sense of inputs, the money and facilities and the technology being employed. He did not mention the context of the studies or any findings or results that have already been achieved. Some reporter ought to have asked about that -- one did during the question and answer period.

Dr. Lumpkin of the FDA expressed he was glad to be participating in the press conference as a parent, pediatrician and a member of the scientific community. Vaccination, he said, is one of mainstays of therapies to try to improve the human conditions. There are still devastating diseases in parts of the world.. As we look to future, as we look at diseases, vaccination provides hope for the future. But vaccination is only as good as those willing to take it. Major concern and goal is parents to have confidence in immunization. Extremely important for children and the community. Here he echoed the theme -- look at the benefits of vaccinations, look at the data, stringent scientific data, and the benefits outweigh the dangers.

To help parents to reduce environmental exposure to mercury, the FDA began working in 1999 to remove mercury from vaccines. Between 1999 -- 2001 all vaccines on the recommend list except flu contain no thimerosal except trace amounts less than one microgram. As soon as manufacturing issues are resolved, flue vaccines will be thimerosal free as well. Flu vaccine that became routine in 2004, there is a thimerosal-free version. We working to increase capacity -- we’ll get there.

Another editorial note. Removing thimerosal from the manufacturing process of flue vaccines might be a manufacturing problem, but it is a problem that was brought about by government interference in the market. During the early 90s as part of the Vaccine for Children program, the CDC was given buying authority for over 70 percent of all vaccines purchased in the united States. Consequently, government set the price and the price set had so slim a profit margin that all but two suppliers dropped out of the flu vaccine market, one reason for the shortage this past year. Low profit margins on flu vaccine is one reason manufacturing implementation has not kept up with production technology -- it’s just too expensive given government controlled profit margins. Another example of good intentions with unintended consequences.

Alexander reiterated the day’s theme -- the FDA is very concerned that people have confidence in products they use including vaccines. Dealing with a healthy child, we have shown that we can create a more healthy life for child. Looking at science to make vaccines even safer than they are now.

Dr. Ouellette off the AAP read her statement. She noted that pediatricians care about their patients. She did have a good line -- 23 percent of population are children, but they are 100 percent of our future. She then went into the history of pediatrics to reinforce the vaccine-good theme. She related how pediatricians spent the early years of the specialty taking care of devastating childhood diseases. Vaccines have made those diseases disappear from this county. When children don’t vaccine, diseases reappear. Pediatricians are concerned when parents don’t vaccinate their children. Pediatricians are parents and they vaccinate their children. Recommendations based on science led us to many benefits including immunization.

Organizations have reviewed literature and do not believe in a causation theory (vaccines and autism).. Evidence does not point to vaccines. Pediatricians are committed to services and the latest information. The AAP offers guidelines to physicians and publishes article in the Journal of Pediatrics. She’d like to see more government funds for autism research. She directed reporters to the AAP web site for more information.

She stressed we want parents to know immunizations are safe and save lives and urged parents to discuss immunization peditriicans. She understand importance of listening to parents. Working together can improve child health.

Editorial comment -- had I been able to ask a question, I’d have asked her what happens if a pediatrician decides it is less of a risk to delay vaccinations until a child is older and has more fully developed immune and neurological systems and weighs a little more. That was a question that didn’t get asked.

Dr. Wah of the American Medical Association was their to lend his support. He added little to what was already said, recapping the history of diseases that had be virtually wiped out in this country by vaccinations. He noted that it would be wrong to blame vaccines for autism.

Another question that was not asked -- virtually all the speakers raised the point that thimerosal was removed from vaccines in this country, but none addressed the potential problems of thimerosal for children in countries overseas where multi-dos vials are still being shipped. Does that give anyone in government pause?

Dr. Hotez a vaccine researcher from George Washington University gave the best presentation both emotionally and in context. The fact that he has an autistic daughter gives him emotional credibility. That he works first hand with devastating disease around the world gives him professional credibility.

He talked about the cruelty of autism and the financial and emotional impact it’s had on his family. Nonetheless, he is confident that his daughter’s autism has nothing to do with her vaccinations. Knowing what he knows today, he would still have her take the full compliment of vaccinations.

He then talked about characteristics -- head and brain size, patterns of heredity -- that distinguish autistic kids form normal kids that have nothing to do with mercury. He cited Minamata as the source for some of his comparisons.

Editorial note -- Having been following this issue for some time now, I see a pattern -- I fall into at times as well -- of using the catch all “autism” when writing about this issue. In fact, there are some distinctions.

First, I don’t think it’s correct to say that all autism is caused by mercury. Indeed, there is regressive autism, in which a child develops normally and then suddenly regresses, and other forms of autism where a child doesn’t seem “right” from birth. Indeed, Hotez daughter might not have autism because of her vaccinations, but that doesn’t rule out the hypothesis that due to genetic make-up, a significant number of children will be more susceptible to to mercury than others.

A second point is that when people claim that mercury causes “autism,” what they are really claiming is that mercury poisoning in children produces the same or nearly the same set of symptoms as “autism.” In fact, they may not be the same thing.

Hotez also cited the IOM report as evidence. He left reporters with two thoughts (nice wrap-up).

1) He has seen children suffer horrible from diseases that have been wiped out in this country because of vaccines. This would be a terrible consequence of not vaccinating children in this country.

2) He does not want to see an unfounded emphasis on vaccines detract from the real needs of families with autistic children -- structured activities for children when not in school, access to psychiatric medicines and doctors who know how to administer them correctly, more involvement fby insurance companies to cover cost, more government research. He said we need a war on autism, not a war on vaccines.”

Question and Answers --

A Washington DC reporter asked about the California DDS statistics, Her second question was very pointed. She noted that there seemed to be nothing new presented at the press conference. What is the purpose of this meeting? Is it response to rally tomorrow?

Dr. Gerberding took the question and noted that the California data is bouncing around. She compared to stock market, (a bad analogy) and referred the reporter to a CDC researcher following that data.

There was a pause before the reporter asked for a follow-up on the second question about the rally. Gerberding committed the classic PR error of appearing reluctant to address the question and then denying the obvious that of course it was timed to the rally. Instead she concocted some answer about this was an opportunity to gather resources in one place to present the information.

Again, I understand the anger some parents have over this issue, but the government people do not have science on their side. They do not have a story. It is better to let them shoot themselves in the foot, as Gerberding did, than to be perceived, through wild conspiracy stories about a “secret press conference,” to be shooting them in the head.

There was a question from a UPI reporter (not Olmstead) about how an individual, not a community should decide whether or not to vaccinate a child, noting not much risk in not vaccinating an individual child in this country.

I believe it was Dr. Ouellette who took the answer (not sure). She pointed out it only takes a small number of non-vaccinating parents to create conditions for an outbreak. She went with a civic duty rationale for vaccination. It’s the right thing to do.

Another editorial comment -- rather than focus on conspiracy theory, a better approach is taking these people at their word and looking at the consequences. Does Dr. Ouellette really believe that it is okay to put 166 couples in a room, each holding their newborn and tell them that all their children are healthy, but after today, one of them will suffer autistic symptoms? That’s an extremely callous and arrogant position. But that is the position she is taking. I don’t think many people would find it acceptable.

I had a hard time picking up the next question, but it was a good one -- is any money being put into clinical studies, not just epidemiological studies.

I couldn’t pick up who answered, but he noted that doing a prospective study of thimerosal and vaccines was impossible because there are no vaccine with thimerosal in use in this country. Retrospective studies are difficult (and yet that is what the IOM study is). He noted that other studies on brain development and environmental influences are being conducted.

Again, imagine if that question had be asked by someone on the plausibility side of the issue. There is an abundance of hard science providing evidence that supports, but more importantly does not refute the plausibility the hypothesis that mercury in vaccines is connected to autism. This is another major distinction between government science and the independent research being done on vaccine issue. The government keeps coming back to the same epidemiological studies -- without ever addressing the flaws in those studies. The other side keeps pushing the boundaries of existing science. And for them, each new study is a risk. If on contradictory piece of hard science evidence is found that does not fit with the mercury poisoning hypothesis, the theory loses a lot if not all credibility. That’s what science is and does, and thant’s not what the government is doing.

I could not pick up the next question, but Dan Olmstead of the UPI followed with this zinger -- Have you looked at autism in a never-vaccinated population and if not, why not?

Olmstead has written an excellent series of articles looking for the “autistic Amish.” If the government’s contention is correct, the rate of autism among the Amish, who do not vaccinate their children, should be roughly the same 1 in 166 found in the general population. That is not the case. The only cases of autism Olmstead found were foreign children adopted by an Amish couple. The children were vaccinated before coming to this country.

Dr. Gerberding took the question with obvious reluctance, clearly hoping no one knew where Olmstead was coming from. She noted that vaccination is at a high level and it’s hard to find such a population that doesn‘t vaccinate and difficult to do an accurate, emphasis on accurate -- study. The problem is that genetics of a group -- “like the “Amish” --might influence the study, making a conclusion difficult. Good science takes time.

The final question was about speeding up thimerosal-free flu vaccine production.

Dr. lumkin took the answer, basically reiterating that delays were a manufacturing issue -- the capacity to produce single dose units. Companies are working on this -- as soon as they ready, the FDA will inspect. It’s a manufacturing issue hard to provide a timetable.

Reflecting on the press conference, if I were a new reporter to this issue, after this press conference I’d be very curious about the issue. Good reporters can detect BS and that was not difficult to do. Dr. Hotez was the only speaker that really offered a sense of credibility.

I wish there had been more time for questions -- and that reporters on the phone could have asked questions -- but I can understand why there wasn’t. Certainly the CDC et al can be criticized for not fully exploring the issue with the press and involving people from the autism groups in town for the rally, but that’s a bad strategy. Simple, honest refutation of what was said at the conference is the best response. The government was not impressive.

Update: From an email I received from Dan Olmstead of UPI with his impression of the atmosphere of the press conference.

Thanks for the mention. I think you did a real service by summarizing the event and offering comment where you felt it was needed. You were right on the mark. I have to say, I've never been to a press conference, or whatever it was, where the press was made to feel like such an imposition. Interesting, eh? Also, I've never seen a situation where those on the conference call weren't allowed to ask questions.
Olmstead's comments on the press conference can be found here.

Update: Gardiner Harris of the New York Times, who was in Minnesota to cover committee hearings on Minnesota's thimersoal legislation, which did not make it out of committee, writes about the press conference here. USA Today checks in here.

An NBC Nightly News report on the press conference and the "Power of Truth" rally can be found here. NBC has been criticized by Autism organizations for misreporting and presenting more favorable coverage of the position that there is no link between vaccines and autism. Although I think this piece is fairly balanced -- with one little dig at the end that leaves the impression this issue is about compensation for parents -- it points out the perception problem facing parent-champions of the theory that mercury in vaccines can cause autism. Comparisons come down to who are you going to believe -- A government scientist with a PHD, a board-certified pediatrician, or a housewife from New Jersey. That comparison is misleading. I've worked with many such parents in researching this topic, and they are drawing their knowledge from studies done at not only reputable, but prestigious research centers around the country. They have done their homework. They understand the science. They can make the connections to autism. The straw man set up by the media -- parents are simply hysterical and looking for someone to blame for the happenstance of their child’s autism -- is disingenuous. Newcomers to this issue -- new parents or parents to be with questions about vaccine safety should look at the science itself, not just at those purporting its veracity.