For Immediate Release: Contact: Jaillene Erickson, (202) 225-3671 or (202)-549-2933
May 18, 2004 Jaillene.Erickson@mail.house.gov
Weldon Calls IOM Conclusions Premature and Hastily Drawn
Rep. Dave Weldon, M.D. (FL) Issued The Following Statement
Today's report is premature, perhaps perilously reliant on epidemiology, based on preliminary incomplete information, and may ultimately be repudiated. This report will not deter me from my commitment to seeing that this is fully investigated, nor will it put to rest the concerns of parents who believe their children were harmed by mercury-containing vaccines or the MMR vaccine.
Unfortunately, this report will lead many clinicians to believe that thimerosal is safe and there is no problem with the MMR; however, it will do nothing to allay the concerns of thousands of parents of autistic children. It will only drag the IOM under the cloud of controversy that has currently engulfed CDC. This concern is what lead me earlier this year to request that Dr. Julie Gerberding delay this meeting and report.
In 2001 the IOM stated that it is "unclear whether ethylmercury [from vaccines] passes readily through the blood-brain barrier…" The IOM recommended several biological and clinical studies to answer this question and whether this mercury could cause developmental problems. These studies were in large part never done. Yet IOM chose to ignore the need for this research and instead has focused its analysis on the data available today, most of which is statistical, but there is much more research that needs to be done before it can definitively be said that thimerosal does not contribute to NDDs. Even today, the IOM cannot tell you with any degree of certainty what happens to ethylmercury once injected into an infant. Does it go to the brain? Does is cause developmental problems?
The IOM's scope of investigation was severely narrowed for this review. In 2001 the IOM considered thimerosal's relationship with nuerodevelopmental disorders as a whole, but here they only consider Autism. This raises suspicions that this IOM exercise might be more about drawing pre-designed conclusions aimed at restoring public confidence in vaccines rather than conducting a complete and thorough inquiry into whether or not thimerosal might cause neurodevelopmental disorders. Dr. Thomas Verstraeten, the author of one of the studies upon which the IOM relies, recently stated in
an April 2004 letter to Ped iatrics: "The bottom line is and has always been the same: an association between thimerosal and neurological outcomes could neither be confirmed nor refuted, and therefore, more study is required." It was after this study was published that the IOM scope was narrowed.
Unfortunately, the epidemiology studies that the IOM bases its findings on are not immune from conflicts or controversy. Many of the authors have conflicts of interest including funding from vaccine manufactures, employment by manufacturers, or conflicts in that they implemented vaccine
policies that are now being investigated. Furthermore, the studies were designed to examine entire populations and would miss subgroups of genetically susceptible populations. Much like the infamous 1989 study by The National Institute of Child and Human Development (NICHD) which missed the link between folic acid deficiencies and neural tube defects, the epidemiology studies reviewed by the IOM in drawing today's findings, could easily have missed a link between thimerosal and NDDs. The IOM report is based on studies examining populations in the United Kingdom, Denmark, Sweden and the United States - all of whom have different vaccines, vaccine policies, and mercury exposures. Study results are only as reliable as the design of such studies. Relying on these studies to draw conclusions is shaky ground.
The IOM is not immune to error and has been forced to reverse itself before, most recently reversing a long-standing finding that chronic lymphocytic leukemia (CLL) was not due to Agent Orange exposures. A similar reversal is a very real possibility here.
With regard to the MMR vaccine, the IOM review of this matter is totally premature; the NIH is only now attempting to duplicate the work of Dr. Andrew Wakefield. Half of Dr. Wakefield's work has been demonstrated to be correct. Attempting to draw "conclusions" at this time is counterproductive. Statistical studies of this matter are of little benefit, only a clinical pathological study will lay this issue to rest. Lastly, I am also troubled by the lack of liability or accountability by these decision-makers should they be proved wrong. I want more than just a "sorry" from them should their conclusions be found erroneous a few years down the road. Too many lives are at stake.
The Age of Autism: 'The first casualty'
By DAN OLMSTED
UPI Senior Editor
WASHINGTON, June 27 (UPI) -- The only medical doctor in the U.S. House of Representatives delivered a harsh judgment this week on public health authorities whose job is making sure vaccinations are as safe as humanly possible.
"Federal agencies charged with overseeing vaccine safety research have failed," said Rep. David Weldon, R-Fla. "They have failed to provide sufficient resources for vaccine safety research. They have failed to fund extramural research. And, they have failed to free themselves from conflicts of interest that serve to undermine confidence in the safety of vaccines.
"The American public deserves better, and increasingly parents and the public at large are demanding better."
Weldon concentrated his fire on the Centers for Disease Control and Prevention, which recommends the childhood immunization schedule through its Advisory Committee on Immunization Practices -- and has conducted numerous studies that find no association between vaccines and serious health problems, particularly autism.
But Weldon said the federal government in total has failed to do its job.
"Several issues relating to vaccine safety have persisted for years. The response from public health authorities has been largely defensive from the outset, and the studies plagued by conflicts of interest."
It should be noted the CDC stands behind its research and that last year it separated its Immunization Safety Office from the National Immunization Program. Weldon says that's simply not enough to ensure impartial, aggressive investigation.
Weldon introduced a bill -- co-sponsored by Rep. Carolyn Maloney, D-N.Y. -- that would create a new agency of vaccine safety that reports to the secretary of health and human services; require research to be independent of any vaccine-related decisions; and establish an 18-member advisory committee to create a vaccine research agenda. At least one-third of the committee would be made up of people with vaccine injuries or a vaccine-injured child.
Given the realities of the legislative calendar, Weldon told me, he's hoping to build support and hold hearings this fall on the measure and re-introduce it in the new Congress that convenes in January.
Weldon's approach is wide-ranging. For one thing, he's not putting all his eggs in the mercury-equals-autism basket, so to speak -- he's not asking for more research solely to determine whether the mercury-based preservative thimerosal triggered a huge rise in autism diagnoses in the 1990s.
While that question has been the focus of attention -- and properly so, given the government's own decision to phase out thimerosal from routine childhood immunizations beginning in 1999 -- there is the prospect that other vaccine ingredients, and other side effects, may be insidiously at work.
"There are unresolved questions about the MMR (measles-mumps-rubella) vaccine that arose in 1998 that should be fully investigated," Weldon said.
Indeed, this column recently reported on a cluster of cases in Olympia, Wash., that suggest a possible risk of autism from getting MMR and chickenpox shots too close together in a susceptible subset of children.
One of the children diagnosed with autism was in a clinical trial of a new vaccine combining all four of those live-virus vaccines, including 10 times as much chickenpox component as the standalone chickenpox vaccine. The manufacturer, Merck & Co., acknowledged that case -- and another from a similar trial in Olympia involving an experimental chickenpox vaccine given at the same time as the MMR -- was not reported to the FDA until March.
That was the same month we first inquired about the cases -- and six months after the new vaccine, called ProQuad, was approved by the FDA for all children 12 months to 12 years old.
Merck, like other vaccine manufacturers, mainstream medical groups and public health authorities, says there is no association between vaccines and autism. Weldon's bill would put that assertion to the test -- without the conflicts he says make such assurances suspect.
Beyond autism, a range of concerns are "out there" about the childhood immunization schedule, which has expanded greatly over the past two decades and now includes a Hepatitis B shot on the day of birth and the prospect of more combinations and components in coming years.
Few argue against the basic premise of mass vaccination against deadly diseases. The legitimate public-policy question is whether the authorities have gotten the details wrong -- vaccinating too soon against too many illnesses, not all of them life-threatening or likely to afflict children, and undertaking too little independent surveillance of possible unintended consequences.
From that perspective, it was hard to ignore the convergence of events at the Capitol Thursday morning -- as Weldon spoke, members were awaiting the arrival of the Iraqi prime minister, Nouri al-Maliki, to address a joint session.
In the new book "Fiasco" about the Iraq war by Washington Post Pentagon Correspondent Thomas E. Ricks, the failure of public officials to properly gauge the real risks and potential rewards of the invasion are laid out in devastating detail.
"None of this was inevitable," Ricks writes. "It was made possible only through the intellectual acrobatics of simultaneously 'worst-casing' the threat presented by Iraq and 'best-casing' the subsequent cost and difficulty of occupying the country."
That made me go back and dig out a paper titled "From Safety Last To Children First," by Mark Blaxill of the group SafeMinds and Barbara Loe Fisher, president of the National Vaccine Information Center. It was submitted to a CDC panel on vaccine safety in 2004.
"The obvious concern is that benefits may be overstated and that risks will be suppressed," they wrote in terms that eerily echo Ricks'. And they made the war analogy explicit, citing "a mission of fighting a 'war on disease' that disregards the secondary and tertiary consequences of war and views innocent children as inevitable consequences."
"The language of conflict -- the 'war on disease,' 'combating the causes of epidemics,' 'fighting emerging infections' -- is closely connected to the language of military power and, of course, 'Disease Control.' History teaches us that when government officials are determined to fight a war, any war, truth can be the first casualty."
It would be ironic if the same patterns that led to a foreign policy "fiasco" were at work in domestic health policy. Weldon's bill is a first step toward finding out -- and making sure, if that did happen, it gets fixed before more casualties pile up.
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