Interestingly, the AAP may actually have dramatically increased integrity under Dr. David Tayloe, our new president, but someone else violated the first rule of publicity: Don’t complain when some one makes you look a lot better than you really are. Even if he does it on April First!!

Dr. Susan E.Burger is one of the world’s foremost experts on international nutrition and epidemiology who shared with me her submission to the New York Times. The Times did not publish this excellent article and I asked her permission to post it here. Thank you very much, Dr. Burger

JNGMD

Goliath and the Gnats:

The resuscitation of an April fools’ joke that should have been allowed to die.
by Susan E. Burger, MHS, PhD, IBCLC, RLC

Increasingly, professional medical associations are evaluating their ethical standards and setting the bar higher. The American Psychological Association responded to a grassroots effort of their membership base by placing moratorium on psychologists participating in the interrogation of detainees. The International Lactation Consultant Association, of which I am a member, recently decided to stop accepting sponsorship from a company that is no longer complying with the International Code of Marketing of Breast-milk Substitutes. On April 1st, the Journal of the American Medical Association published a proposal for controlling conflicts of interest (and it was NOT a hoax).

As a parent, I would expect a professional medical association that declares itself to be “dedicated to the health of all children” to uphold standards at least as high if not higher than others. Unfortunately, it seems as if the American Academy of Pediatrics (AAP) has become distracted by the urge to protect its reputation through silencing one of its critics, rather than clarifying and improving its ethical standards.

The AAP’s protectionist response was triggered when one of its own members posted on Lactnet, a listserve frequented by members of my profession. The pediatrician in question posted a fake press release from the President of the AAP. It does not take a neonatal surgeon to realize that the prominent display ofApril 1st and the poster’s own name suggests this was an April fools’ joke. Just in case anyone missed these obvious clues, the pediatrician clarified that the press release was a fake within several hours of his original post.

What was the essence of the spoof?

The fake press release stated that the AAP would end the ethical problem of receiving money and sponsorships from the pharmaceutical industry.

It apologized for the AAP’s role in watering down a national breastfeeding campaign and allowing a formula company logo to be printed on the Academy’s book on breastfeeding.

It finished with the assurance that the AAP would seek to comply with the International Code on the Marketing of Breast-milk Substitutes, a code published by the World Health Organization (WHO) and endorsed by the United States.

What is true in the fake press release is that the AAP does receive money and sponsorships from the pharmaceutical and formula industry; it did play a role in watering down the breastfeeding campaign; the front cover of its breastfeeding book is imprinted with a formula company logo; and it does not meet its obligations under the International Code of Marketing of Breast-milk Substitutes. What is not true in the fake press release is that the President of the AAP wrote it, apologized about the conflicts of interest, and made assurances about code compliance.

For a day, the false press release provided mild amusement and sighs of “wouldn’t it be great if this were true”. By the next day, the spoof had leaked into online forums and gone global!

A frequent blogger on issues of breastfeeding advocacy who goes by the username of Lauredhel, investigated the resulting chatter in the blogosphere and concluded, “no one who’s paying attention believes it is real”. Like many an April fools’ joke, this spoof should then have quickly disappeared into obscurity.

Unfortunately, the AAP itself resuscitated the discussion. On April 15th, the moderators of Lactnet posted a letter from Nicole Finitzo, attorney for the AAP, to ensure that members of the listserve understood the AAP’s position on the fake press release. The letter from Ms. Finitzo claimed that the fake press release “contains patent misstatements of fact and misrepresents the AAP’s position, and it is defamatory.” The breastfeeding advocacy blogger, Lauredhel, commented,“I do believe this is the very first time I’ve seen someone accused by a lawyer of defamation for claiming that an organization was more ethical than it actually is.”

Ms Finitzo also demanded of the listserve moderators that, “it will be essential for the original items and all copies on your server, wherever located, to be immediately taken out of circulation immediately.” Since the AAP has over 60,000 members and the Lactnet listserve merely comprises a few thousand members, this heavy-handed letter seems like Goliath swatting at gnats. Unfazed by the demand to remove the original items, the moderators of the listserve offered to post a statement on behalf of the AAP if they wish to further illuminate their stance on financial relationships with industry. The AAP has not yet replied.
I’m hoping that the AAP will come to its senses and realize swatting at gnats is a futile endeavor unlikely to earn anyone’s respect. I think the AAP would earn more respect if they chose to set higher standards to control the conflicts of interests that influence policies for children’s health.

Susan E. Burger, MHS, PhD, IBCLC, RLC

Proud member of the International Lactation Consultant Association, the United States Lactation Consultant Association, and the New York Lactation Consultant Association.

Excellent Follow up at HOYDEN ABOUT TOWN

In June 2000, a group of top government scientists and health officials gathered for a meeting at the isolated Simpsonwood conference center in Norcross, Georgia. Convened by the Centers for Disease Control and Prevention, the meeting was held at this Methodist retreat center, nestled in wooded farmland next to the Chattahoochee River, to ensure complete secrecy. The agency had issued no public announcement of the session — only private invitations to fifty-two attendees. There were high-level officials from the CDC and the Food and Drug Administration, the top vaccine specialist from the World Health Organization in Geneva and representatives of every major vaccine manufacturer, including GlaxoSmithKline, Merck, Wyeth and Aventis Pasteur. All of the scientific data under discussion, CDC officials repeatedly reminded the participants, was strictly “embargoed.” There would be no making photocopies of documents, no taking papers with them when they left.

The federal officials and industry representatives had assembled to discuss a disturbing new study that raised alarming questions about the safety of a host of common childhood vaccines administered to infants and young children. According to a CDC epidemiologist named Tom Verstraeten, who had analyzed the agency’s massive database containing the medical records of 100,000 children, a mercury-based preservative in the vaccines — thimerosal — appeared to be responsible for a dramatic increase in autism and a host of other neurological disorders among children. “I was actually stunned by what I saw,” Verstraeten told those assembled at Simpsonwood, citing the staggering number of earlier studies that indicate a link between thimerosal and speech delays, attention-deficit disorder, hyperactivity and autism. Since 1991, when the CDC and the FDA had recommended that three additional vaccines laced with the preservative be given to extremely young infants — in one case, within hours of birth — the estimated number of cases of autism had increased fifteenfold, from one in every 2,500 children to one in 166 children.

Even for scientists and doctors accustomed to confronting issues of life and death, the findings were frightening. “You can play with this all you want,” Dr. Bill Weil, a consultant for the American Academy of Pediatrics, told the group. The results “are statistically significant.” Dr. Richard Johnston, an immunologist and pediatrician from the University of Colorado whose grandson had been born early on the morning of the meeting’s first day, was even more alarmed. “My gut feeling?” he said. “Forgive this personal comment — I do not want my grandson to get a thimerosal-containing vaccine until we know better what is going on.”

But instead of taking immediate steps to alert the public and rid the vaccine supply of thimerosal, the officials and executives at Simpsonwood spent most of the next two days discussing how to cover up the damaging data. According to transcripts obtained under the Freedom of Information Act, many at the meeting were concerned about how the damaging revelations about thimerosal would affect the vaccine industry’s bottom line. “We are in a bad position from the standpoint of defending any lawsuits,” said Dr. Robert Brent, a pediatrician at the Alfred I. duPont Hospital for Children in Delaware. “This will be a resource to our very busy plaintiff attorneys in this country.” Dr. Bob Chen, head of vaccine safety for the CDC, expressed relief that “given the sensitivity of the information, we have been able to keep it out of the hands of, let’s say, less responsible hands.” Dr. John Clements, vaccines advisor at the World Health Organization, declared that “perhaps this study should not have been done at all.” He added that “the research results have to be handled,” warning that the study “will be taken by others and will be used in other ways beyond the control of this group.”

In fact, the government has proved to be far more adept at handling the damage than at protecting children’s health. The CDC paid the Institute of Medicine to conduct a new study to whitewash the risks of thimerosal, ordering researchers to “rule out” the chemical’s link to autism. It withheld Verstraeten’s findings, even though they had been slated for immediate publication, and told other scientists that his original data had been “lost” and could not be replicated. And to thwart the Freedom of Information Act, it handed its giant database of vaccine records over to a private company, declaring it off-limits to researchers. By the time Verstraeten finally published his study in 2003, he had gone to work for GlaxoSmithKline and reworked his data to bury the link between thimerosal and autism.

Vaccine manufacturers had already begun to phase thimerosal out of injections given to American infants — but they continued to sell off their mercury-based supplies of vaccines until last year. The CDC and FDA gave them a hand, buying up the tainted vaccines for export to developing countries and allowing drug companies to continue using the preservative in some American vaccines — including several pediatric flu shots as well as tetanus boosters routinely given to eleven-year-olds.

The drug companies are also getting help from powerful lawmakers in Washington. Senate Majority Leader Bill Frist, who has received $873,000 in contributions from the pharmaceutical industry, has been working to immunize vaccine makers from liability in 4,200 lawsuits that have been filed by the parents of injured children. On five separate occasions, Frist has tried to seal all of the government’s vaccine-related documents — including the Simpsonwood transcripts — and shield Eli Lilly, the developer of thimerosal, from subpoenas. In 2002, the day after Frist quietly slipped a rider known as the “Eli Lilly Protection Act” into a homeland security bill, the company contributed $10,000 to his campaign and bought 5,000 copies of his book on bioterrorism. The measure was repealed by Congress in 2003 — but earlier this year, Frist slipped another provision into an anti-terrorism bill that would deny compensation to children suffering from vaccine-related brain disorders. “The lawsuits are of such magnitude that they could put vaccine producers out of business and limit our capacity to deal with a biological attack by terrorists,” says Dean Rosen, health policy adviser to Frist.

Even many conservatives are shocked by the government’s effort to cover up the dangers of thimerosal. Rep. Dan Burton, a Republican from Indiana, oversaw a three-year investigation of thimerosal after his grandson was diagnosed with autism. “Thimerosal used as a preservative in vaccines is directly related to the autism epidemic,” his House Government Reform Committee concluded in its final report. “This epidemic in all probability may have been prevented or curtailed had the FDA not been asleep at the switch regarding a lack of safety data regarding injected thimerosal, a known neurotoxin.” The FDA and other public-health agencies failed to act, the committee added, out of “institutional malfeasance for self protection” and “misplaced protectionism of the pharmaceutical industry.”

The story of how government health agencies colluded with Big Pharma to hide the risks of thimerosal from the public is a chilling case study of institutional arrogance, power and greed. I was drawn into the controversy only reluctantly. As an attorney and environmentalist who has spent years working on issues of mercury toxicity, I frequently met mothers of autistic children who were absolutely convinced that their kids had been injured by vaccines. Privately, I was skeptical.

I doubted that autism could be blamed on a single source, and I certainly understood the government’s need to reassure parents that vaccinations are safe; the eradication of deadly childhood diseases depends on it. I tended to agree with skeptics like Rep. Henry Waxman, a Democrat from California, who criticized his colleagues on the House Government Reform Committee for leaping to conclusions about autism and vaccinations. “Why should we scare people about immunization,” Waxman pointed out at one hearing, “until we know the facts?”

It was only after reading the Simpsonwood transcripts, studying the leading scientific research and talking with many of the nation’s pre-eminent authorities on mercury that I became convinced that the link between thimerosal and the epidemic of childhood neurological disorders is real. Five of my own children are members of the Thimerosal Generation — those born between 1989 and 2003 — who received heavy doses of mercury from vaccines. “The elementary grades are overwhelmed with children who have symptoms of neurological or immune-system damage,” Patti White, a school nurse, told the House Government Reform Committee in 1999. “Vaccines are supposed to be making us healthier; however, in twenty-five years of nursing I have never seen so many damaged, sick kids. Something very, very wrong is happening to our children.”
More than 500,000 kids currently suffer from autism, and pediatricians diagnose more than 40,000 new cases every year. The disease was unknown until 1943, when it was identified and diagnosed among eleven children born in the months after thimerosal was first added to baby vaccines in 1931.

Some skeptics dispute that the rise in autism is caused by thimerosal-tainted vaccinations. They argue that the increase is a result of better diagnosis — a theory that seems questionable at best, given that most of the new cases of autism are clustered within a single generation of children. “If the epidemic is truly an artifact of poor diagnosis,” scoffs Dr. Boyd Haley, one of the world’s authorities on mercury toxicity, “then where are all the twenty-year-old autistics?” Other researchers point out that Americans are exposed to a greater cumulative “load” of mercury than ever before, from contaminated fish to dental fillings, and suggest that thimerosal in vaccines may be only part of a much larger problem. It’s a concern that certainly deserves far more attention than it has received — but it overlooks the fact that the mercury concentrations in vaccines dwarf other sources of exposure to our children.

What is most striking is the lengths to which many of the leading detectives have gone to ignore — and cover up — the evidence against thimerosal. From the very beginning, the scientific case against the mercury additive has been overwhelming. The preservative, which is used to stem fungi and bacterial growth in vaccines, contains ethylmercury, a potent neurotoxin. Truckloads of studies have shown that mercury tends to accumulate in the brains of primates and other animals after they are injected with vaccines — and that the developing brains of infants are particularly susceptible. In 1977, a Russian study found that adults exposed to much lower concentrations of ethylmercury than those given to American children still suffered brain damage years later. Russia banned thimerosal from children’s vaccines twenty years ago, and Denmark, Austria, Japan, Great Britain and all the Scandinavian countries have since followed suit.

“You couldn’t even construct a study that shows thimerosal is safe,” says Haley, who heads the chemistry department at the University of Kentucky. “It’s just too darn toxic. If you inject thimerosal into an animal, its brain will sicken. If you apply it to living tissue, the cells die. If you put it in a petri dish, the culture dies. Knowing these things, it would be shocking if one could inject it into an infant without causing damage.”

Internal documents reveal that Eli Lilly, which first developed thimerosal, knew from the start that its product could cause damage — and even death — in both animals and humans. In 1930, the company tested thimerosal by administering it to twenty-two patients with terminal meningitis, all of whom died within weeks of being injected — a fact Lilly didn’t bother to report in its study declaring thimerosal safe. In 1935, researchers at another vaccine manufacturer, Pittman-Moore, warned Lilly that its claims about thimerosal’s safety “did not check with ours.” Half the dogs Pittman injected with thimerosal-based vaccines became sick, leading researchers there to declare the preservative “unsatisfactory as a serum intended for use on dogs.”

In the decades that followed, the evidence against thimerosal continued to mount. During the Second World War, when the Department of Defense used the preservative in vaccines on soldiers, it required Lilly to label it “poison.” In 1967, a study in Applied Microbiology found that thimerosal killed mice when added to injected vaccines. Four years later, Lilly’s own studies discerned that thimerosal was “toxic to tissue cells” in concentrations as low as one part per million — 100 times weaker than the concentration in a typical vaccine. Even so, the company continued to promote thimerosal as “nontoxic” and also incorporated it into topical disinfectants. In 1977, ten babies at a Toronto hospital died when an antiseptic preserved with thimerosal was dabbed onto their umbilical cords.

In 1982, the FDA proposed a ban on over-the-counter products that contained thimerosal, and in 1991 the agency considered banning it from animal vaccines. But tragically, that same year, the CDC recommended that infants be injected with a series of mercury-laced vaccines. Newborns would be vaccinated for hepatitis B within twenty-four hours of birth, and two-month-old infants would be immunized for haemophilus influenzae B and diphtheria-tetanus-pertussis.
The drug industry knew the additional vaccines posed a danger. The same year that the CDC approved the new vaccines, Dr. Maurice Hilleman, one of the fathers of Merck’s vaccine programs, warned the company that six-month-olds who were administered the shots would suffer dangerous exposure to mercury. He recommended that thimerosal be discontinued, “especially when used on infants and children,” noting that the industry knew of nontoxic alternatives. “The best way to go,” he added, “is to switch to dispensing the actual vaccines without adding preservatives.”

For Merck and other drug companies, however, the obstacle was money. Thimerosal enables the pharmaceutical industry to package vaccines in vials that contain multiple doses, which require additional protection because they are more easily contaminated by multiple needle entries. The larger vials cost half as much to produce as smaller, single-dose vials, making it cheaper for international agencies to distribute them to impoverished regions at risk of epidemics. Faced with this “cost consideration,” Merck ignored Hilleman’s warnings, and government officials continued to push more and more thimerosal-based vaccines for children. Before 1989, American preschoolers received eleven vaccinations — for polio, diphtheria-tetanus-pertussis and measles-mumps-rubella. A decade later, thanks to federal recommendations, children were receiving a total of twenty-two immunizations by the time they reached first grade.

As the number of vaccines increased, the rate of autism among children exploded. During the 1990s, 40 million children were injected with thimerosal-based vaccines, receiving unprecedented levels of mercury during a period critical for brain development. Despite the well-documented dangers of thimerosal, it appears that no one bothered to add up the cumulative dose of mercury that children would receive from the mandated vaccines. “What took the FDA so long to do the calculations?” Peter Patriarca, director of viral products for the agency, asked in an e-mail to the CDC in 1999. “Why didn’t CDC and the advisory bodies do these calculations when they rapidly expanded the childhood immunization schedule?”

But by that time, the damage was done. At two months, when the infant brain is still at a critical stage of development, infants routinely received three inoculations that contained a total of 62.5 micrograms of ethylmercury — a level 99 times greater than the EPA’s limit for daily exposure to methylmercury, a related neurotoxin. Although the vaccine industry insists that ethylmercury poses little danger because it breaks down rapidly and is removed by the body, several studies — including one published in April by the National Institutes of Health — suggest that ethylmercury is actually more toxic to developing brains and stays in the brain longer than methylmercury.

Officials responsible for childhood immunizations insist that the additional vaccines were necessary to protect infants from disease and that thimerosal is still essential in developing nations, which, they often claim, cannot afford the single-dose vials that don’t require a preservative. Dr. Paul Offit, one of CDC’s top vaccine advisers, told me, “I think if we really have an influenza pandemic — and certainly we will in the next twenty years, because we always do — there’s no way on God’s earth that we immunize 280 million people with single-dose vials. There has to be multidose vials.”

But while public-health officials may have been well-intentioned, many of those on the CDC advisory committee who backed the additional vaccines had close ties to the industry. Dr. Sam Katz, the committee’s chair, was a paid consultant for most of the major vaccine makers and was part of a team that developed the measles vaccine and brought it to licensure in 1963. Dr. Neal Halsey, another committee member, worked as a researcher for the vaccine companies and received honoraria from Abbott Labs for his research on the hepatitis B vaccine.
Indeed, in the tight circle of scientists who work on vaccines, such conflicts of interest are common. Rep. Burton says that the CDC “routinely allows scientists with blatant conflicts of interest to serve on intellectual advisory committees that make recommendations on new vaccines,” even though they have “interests in the products and companies for which they are supposed to be providing unbiased oversight.” The House Government Reform Committee discovered that four of the eight CDC advisers who approved guidelines for a rotavirus vaccine “had financial ties to the pharmaceutical companies that were developing different versions of the vaccine.”

Offit, who shares a patent on one of the vaccines, acknowledged to me that he “would make money” if his vote eventually leads to a marketable product. But he dismissed my suggestion that a scientist’s direct financial stake in CDC approval might bias his judgment. “It provides no conflict for me,” he insists. “I have simply been informed by the process, not corrupted by it. When I sat around that table, my sole intent was trying to make recommendations that best benefited the children in this country. It’s offensive to say that physicians and public-health people are in the pocket of industry and thus are making decisions that they know are unsafe for children. It’s just not the way it works.”

Other vaccine scientists and regulators gave me similar assurances. Like Offit, they view themselves as enlightened guardians of children’s health, proud of their “partnerships” with pharmaceutical companies, immune to the seductions of personal profit, besieged by irrational activists whose anti-vaccine campaigns are endangering children’s health. They are often resentful of questioning. “Science,” says Offit, “is best left to scientists.”

Still, some government officials were alarmed by the apparent conflicts of interest. In his e-mail to CDC administrators in 1999, Paul Patriarca of the FDA blasted federal regulators for failing to adequately scrutinize the danger posed by the added baby vaccines. “I’m not sure there will be an easy way out of the potential perception that the FDA, CDC and immunization-policy bodies may have been asleep at the switch re: thimerosal until now,” Patriarca wrote. The close ties between regulatory officials and the pharmaceutical industry, he added, “will also raise questions about various advisory bodies regarding aggressive recommendations for use” of thimerosal in child vaccines.

If federal regulators and government scientists failed to grasp the potential risks of thimerosal over the years, no one could claim ignorance after the secret meeting at Simpsonwood. But rather than conduct more studies to test the link to autism and other forms of brain damage, the CDC placed politics over science. The agency turned its database on childhood vaccines — which had been developed largely at taxpayer expense — over to a private agency, America’s Health Insurance Plans, ensuring that it could not be used for additional research. It also instructed the Institute of Medicine, an advisory organization that is part of the National Academy of Sciences, to produce a study debunking the link between thimerosal and brain disorders. The CDC “wants us to declare, well, that these things are pretty safe,” Dr. Marie McCormick, who chaired the IOM’s Immunization Safety Review Committee, told her fellow researchers when they first met in January 2001. “We are not ever going to come down that [autism] is a true side effect” of thimerosal exposure. According to transcripts of the meeting, the committee’s chief staffer, Kathleen Stratton, predicted that the IOM would conclude that the evidence was “inadequate to accept or reject a causal relation” between thimerosal and autism. That, she added, was the result “Walt wants” — a reference to Dr. Walter Orenstein, director of the National Immunization Program for the CDC.
For those who had devoted their lives to promoting vaccination, the revelations about thimerosal threatened to undermine everything they had worked for. “We’ve got a dragon by the tail here,” said Dr. Michael Kaback, another committee member. “The more negative that [our] presentation is, the less likely people are to use vaccination, immunization — and we know what the results of that will be. We are kind of caught in a trap. How we work our way out of the trap, I think is the charge.”

Even in public, federal officials made it clear that their primary goal in studying thimerosal was to dispel doubts about vaccines. “Four current studies are taking place to rule out the proposed link between autism and thimerosal,” Dr. Gordon Douglas, then-director of strategic planning for vaccine research at the National Institutes of Health, assured a Princeton University gathering in May 2001. “In order to undo the harmful effects of research claiming to link the [measles] vaccine to an elevated risk of autism, we need to conduct and publicize additional studies to assure parents of safety.” Douglas formerly served as president of vaccinations for Merck, where he ignored warnings about thimerosal’s risks.

In May of last year, the Institute of Medicine issued its final report. Its conclusion: There is no proven link between autism and thimerosal in vaccines. Rather than reviewing the large body of literature describing the toxicity of thimerosal, the report relied on four disastrously flawed epidemiological studies examining European countries, where children received much smaller doses of thimerosal than American kids. It also cited a new version of the Verstraeten study, published in the journal Pediatrics, that had been reworked to reduce the link between thimerosal and autism. The new study included children too young to have been diagnosed with autism and overlooked others who showed signs of the disease. The IOM declared the case closed and — in a startling position for a scientific body — recommended that no further research be conducted.

The report may have satisfied the CDC, but it convinced no one. Rep. David Weldon, a Republican physician from Florida who serves on the House Government Reform Committee, attacked the Institute of Medicine, saying it relied on a handful of studies that were “fatally flawed” by “poor design” and failed to represent “all the available scientific and medical research.” CDC officials are not interested in an honest search for the truth, Weldon told me, because “an association between vaccines and autism would force them to admit that their policies irreparably damaged thousands of children. Who would want to make that conclusion about themselves?”

Under pressure from Congress and parents, the Institute of Medicine convened another panel to address continuing concerns about the Vaccine Safety Datalink Data Sharing program. In February, the new panel, composed of different scientists, criticized the way the VSD had been used in the Verstraeten study, and urged the CDC to make its vaccine database available to the public.

So far, though, only two scientists have managed to gain access. Dr. Mark Geier, president of the Genetics Center of America, and his son, David, spent a year battling to obtain the medical records from the CDC. Since August 2002, when members of Congress pressured the agency to turn over the data, the Geiers have completed six studies that demonstrate a powerful correlation between thimerosal and neurological damage in children. One study, which compares the cumulative dose of mercury received by children born between 1981 and 1985 with those born between 1990 and 1996, found a “very significant relationship” between autism and vaccines. Another study of educational performance found that kids who received higher doses of thimerosal in vaccines were nearly three times as likely to be diagnosed with autism and more than three times as likely to suffer from speech disorders and mental retardation. Another soon-to-be published study shows that autism rates are in decline following the recent elimination of thimerosal from most vaccines.

As the federal government worked to prevent scientists from studying vaccines, others have stepped in to study the link to autism. In April, reporter Dan Olmsted of UPI undertook one of the more interesting studies himself. Searching for children who had not been exposed to mercury in vaccines — the kind of population that scientists typically use as a “control” in experiments — Olmsted scoured the Amish of Lancaster County, Pennsylvania, who refuse to immunize their infants. Given the national rate of autism, Olmsted calculated that there should be 130 autistics among the Amish. He found only four. One had been exposed to high levels of mercury from a power plant. The other three — including one child adopted from outside the Amish community — had received their vaccines.

At the state level, many officials have also conducted in-depth reviews of thimerosal. While the Institute of Medicine was busy whitewashing the risks, the Iowa legislature was carefully combing through all of the available scientific and biological data. “After three years of review, I became convinced there was sufficient credible research to show a link between mercury and the increased incidences in autism,” says state Sen. Ken Veenstra, a Republican who oversaw the investigation. “The fact that Iowa’s 700 percent increase in autism began in the 1990s, right after more and more vaccines were added to the children’s vaccine schedules, is solid evidence alone.” Last year, Iowa became the first state to ban mercury in vaccines, followed by California. Similar bans are now under consideration in thirty-two other states.

But instead of following suit, the FDA continues to allow manufacturers to include thimerosal in scores of over-the-counter medications as well as steroids and injected collagen. Even more alarming, the government continues to ship vaccines preserved with thimerosal to developing countries — some of which are now experiencing a sudden explosion in autism rates. In China, where the disease was virtually unknown prior to the introduction of thimerosal by U.S. drug manufacturers in 1999, news reports indicate that there are now more than 1.8 million autistics. Although reliable numbers are hard to come by, autistic disorders also appear to be soaring in India, Argentina, Nicaragua and other developing countries that are now using thimerosal-laced vaccines. The World Health Organization continues to insist thimerosal is safe, but it promises to keep the possibility that it is linked to neurological disorders “under review.”

I devoted time to study this issue because I believe that this is a moral crisis that must be addressed. If, as the evidence suggests, our public-health authorities knowingly allowed the pharmaceutical industry to poison an entire generation of American children, their actions arguably constitute one of the biggest scandals in the annals of American medicine. “The CDC is guilty of incompetence and gross negligence,” says Mark Blaxill, vice president of Safe Minds, a nonprofit organization concerned about the role of mercury in medicines. “The damage caused by vaccine exposure is massive. It’s bigger than asbestos, bigger than tobacco, bigger than anything you’ve ever seen.”

It’s hard to calculate the damage to our country — and to the international efforts to eradicate epidemic diseases — if Third World nations come to believe that America’s most heralded foreign-aid initiative is poisoning their children. It’s not difficult to predict how this scenario will be interpreted by America’s enemies abroad. The scientists and researchers — many of them sincere, even idealistic — who are participating in efforts to hide the science on thimerosal claim that they are trying to advance the lofty goal of protecting children in developing nations from disease pandemics. They are badly misguided. Their failure to come clean on thimerosal will come back horribly to haunt our country and the world’s poorest populations.

NOTE: This story has been updated to correct several inaccuracies in the original, published version. As originally reported, American preschoolers received only three vaccinations before 1989, but the article failed to note that they were innoculated a total of eleven times with those vaccines, including boosters. The article also misstated the level of ethylmercury received by infants injected with all their shots by the age of six months. It was 187 micrograms – an amount forty percent, not 187 times, greater than the EPA’s limit for daily exposure to methylmercury. Finally, because of an editing error, the article misstated the contents of the rotavirus vaccine approved by the CDC. It did not contain thimerosal. Salon and Rolling Stone regret the errors.

An earlier version of this story stated that the Institute of Medicine convened a second panel to review the work of the Immunization Safety Review Committee that had found no evidence of a link between thimerosal and autism. In fact, the IOM convened the second panel to address continuing concerns about the Vaccine Safety Datalink Data Sharing program, including those raised by critics of the IOM’s earlier work. But the panel was not charged with reviewing the committee’s findings. The story also inadvertently omitted a word and transposed two sentences in a quote by Dr. John Clements, and incorrectly stated that Dr. Sam Katz held a patent with Merck on the measles vaccine. In fact, Dr. Katz was part of a team that developed the vaccine and brought it to licensure, but he never held the patent. Salon and Rolling Stone regret the errors.

CLARIFICATION: After publication of this story, Salon and Rolling Stone corrected an error that misstated the level of ethylmercury received by infants injected with all their shots by the age of six months. It was 187 micrograms ? an amount forty percent, not 187 times, greater than the EPA’s limit for daily exposure to methylmercury. At the time of the correction, we were aware that the comparison itself was flawed, but as journalists we considered it more appropriate to state the correct figure rather than replace it with another number entirely.

Since that earlier correction, however, it has become clear from responses to the article that the forty-percent number, while accurate, is misleading. It measures the total mercury load an infant received from vaccines during the first six months, calculates the daily average received based on average body weight, and then compares that number to the EPA daily limit. But infants did not receive the vaccines as a ?daily average? ? they received massive doses on a single day, through multiple shots. As the story states, these single-day doses exceeded the EPA limit by as much as 99 times. Based on the misunderstanding, and to avoid further confusion, we have amended the story to eliminate the forty-percent figure.

Correction: The story misattributed a quote to Andy Olson, former legislative counsel to Senator Bill Frist. The comment was made by Dean Rosen, health policy adviser to the senator. Rolling Stone and Salon.com regret the error.

Kennedy Report Sparks Controversy

November 3rd, 2003 was a big day for Alabama emergency room pediatrician, Dr. Carden Johnston. On that date last month, he was installed as the new President of the 66,000 member American Academy of Pediatrics (AAP) at the prestigious organization’s annual meeting in New Orleans. It was also the date that he sparked what has emerged as a major ethical controversy by inadvertently pulling back the curtains on the powerful influence that a particular corporate interest appears to have in shaping AAP policy and action.

“I have to admit that I never imagined that my presidency would start off with such a bang,” Dr. Johnston says, acknowledging the debate now taking place within his organization.

At issue is a letter dated November 3rd that Dr. Johnston sent to Secretary of the Department of Health and Human Services (DHHS), Tommy G. Thompson, officially expressing the AAP’s concern over the “negative approach” of the federal agency’s soon-to-be-released, pro-breastfeeding advertising campaign. What Dr. Johnston didn’t mention in his letter, however, was that he had developed this sudden and seemingly urgent interest in this issue not via a last minute clinical review of the scientific literature, or even after consulting with the AAP’s own recognized lactation science experts.

In fact, his concern came immediately after aggressive, personal lobbying by representatives of one of the AAP’s biggest financial contributors, the $3 billion U.S. infant formula industry. Within days of a New Orleans meeting with worried formula industry reps, Johnston hurled the considerable credibility and persuasive impact of the esteemed American Academy of Pediatrics into an explicit effort to stifle the most ambitious initiative ever undertaken to promote breastfeeding in the United States.

“Some of us within the AAP have long suspected that the infant formula companies had this sort of direct access to AAP leadership,” explains Dr. Lawrence Gartner, a founding member of the Academy of Breastfeeding Medicine and chairman of the AAP’s Professional Section on Breastfeeding. “Dr. Johnston’s actions have revealed the extent of this influence more clearly than anything else I’ve seen. Many doctors within the AAP are very disturbed by this.”

Reflecting the strong opinions of a number of AAP members interviewed in the past week, Dr. Jay Gordon, a pediatrician and best-selling author of several parenting books, says that his opinion on the AAP leadership’s actions in this matter go beyond “disturbed.”

Dr. Gordon reports that, that in his view, the AAP leadership has “weakened and emasculated (the ads) to suit the manufacturers of formula,” and “as a result of their craven disregard for America’s babies and families, more infants will get sick and die each year. I wish that this greedy, immoral, reprehensible act could be met with criminal charges,” explains Gordon.

The ad campaign currently inspiring such passion among the nation’s pediatric health care providers is funded within the DHHS Office on Women’s Health (OWH), and has been in the works since 2000. Officially dubbed the “National Breastfeeding Awareness Campaign,” the creative end of the OWH project has been handled by Raleigh, North Carolina advertising agency McKinney+Silver, while the entire project is overseen by The Ad Council, the private, non-profit organization that produces, distributes, and promotes public service campaigns on behalf of charitable organizations and government agencies.

In 2002, DHHS described the upcoming breastfeeding initiative as a three-year, multimedia social marketing blitz worth as much as $40 million in advertising dollars. It is alleged by a variety of organizations representing lactation consultants, physicians, nurses, midwives, and public health activists that the AAP’s last-minute appeal to DHHS prevented the much-anticipated campaign launch from taking place as scheduled this month. Additionally, it appears that representatives of the infant formula industry – with the benefit of prematurely leaked information about the specifics of the ad campaign- have been quietly lobbying federal and Ad Council officials to change the ads’ content and tone.

According to the AAP’s own Breastfeeding Section, at least one thousand new scientific and medical papers on topics related to breast and bottle feeding have been published in just the past four years. Taken as a whole, this mounting body of research revealsdramatically different health outcomes for populations of breast and formula-fed babies, even when controlling for socioeconomic and other factors. The new ad campaign was designed to reflect this research and to catapult the issue of breastfeeding into the same category of public health concerns as smoking, carseat use, childhood vaccinations, and SIDS prevention.

While critics of Dr. Johnston’s action strongly disagree that the tone of the DHHS ads is “negative,” they concede that the new campaign does offer a fundamentally different way of looking at the breast-bottle issue. They hasten to add, however, that this new approach was completely intentional. According to those medical professionals who played a role in creating the actual content of the new campaign, the ads utilize a market-oriented and evidence-based approach to the issue, relying for the first time on the proven communications strategies that have successfully impacted other public health behaviors in recent years.

According to those who have viewed them, the ads feature catchy slogans meant to become memorable such as “Breastfeed: It’s too important not to,” and “Babies are born to be breastfed.” Some of the ads also use humor to make their points, including TV spots showing a pregnant woman participating in roller derby and riding a mechanical bull. These absurdist images are used to make the point that, just as no woman would take those sorts of risks while pregnant, mothers of infants should avoid the quantifiable risks to their babies’ health that come with not breastfeeding.

“As I understood it, this was to be the first national advertising campaign that focused on the risks of not breastfeeding as opposed to the benefits of choosing to breastfeed,” explains Dr. Audrey Naylor, a San Diego pediatrician and Executive Director ofWellstart International, as well as a member of the AAP’s Breastfeeding Professional Section, and a past consultant to the World Health Organization on infant nutrition issues. “This would definitely mark a significant change in the way this issue would be presented to the general public. It’s a change to promote breastfeeding as a public health issue rather than simply as a personal parenting choice.”

The area of the website of The Ad Council devoted to a brief discussion of the planned DHHS breastfeeding campaign offers a glimpse into this very different, market-oriented way of viewing the issue of breast vs. bottle, stating that, “Babies who are not exclusively breastfed for at least 6 months will be more likely to contract asthma, allergies, and cancer.” In previous breastfeeding promotion campaigns, this statement would have certainly read “Babies who are breastfed will be less likely to contract asthma, allergies, and cancer.”

In a presentation sponsored by the Breastfeeding Task Force of Greater Los Angeles on the planned campaign, McKinney+Silver was quoted as seeking to move from creating awareness to creating conversion with the ads.

“Shift the language from ‘If you breastfeed, your baby will be healthier,’ to ‘If you don’t breastfeed, your baby will be more prone to…,” noted McKinney+Silver in describing the campaign’s approach. The presentation went on to note that, while most American women seemed informed of the benefits of breastfeeding, few seemed aware of the potential consequences of not nursing their babies. “(There is) no perceived disadvantage if you don’t breastfeed. Many think breastfeeding is like supplementing a ‘standard diet’ with vitamins. Formula, by default, is credited with the status of being ‘the standard.’”

In much of the rest of the world, ads for infant formula directed at consumers are verboten in much the same way that television ads for cigarettes and liquor are no longer acceptable in the United States. This global aversion to infant formula advertising is due to the widespread adoption by governments and private industries outside the United States of the World Health Organization’s Code on the Marketing of Breastmilk Substitutes – known as the WHO Code.

In this country, however, there is only minimal adherance to the WHO Code by public or private entities and as a result, advertisements for different brands of infant formula are a ubiquitous part of the U.S. media landscape.

In years past, various individual government agencies, hospitals, and private organizations such as La Leche League International have attempted to counter the advertising sledgehammer wielded by the well-heeled infant formula industry via a patchwork of relatively low-budget, smaller-scale ads focusing on the “the benefits of breastfeeding.” However, the DHHS breastfeeding campaign to which the AAP leadership has now objected was to be the first national effort to utilize high-end, commercial-quality production values to position the “breast is best” public health message to go head-to-head with even the slickest Madison Avenue-produced infant formula ads.

Clearly, this was not a campaign that was going to play well with the infant formula industry, which has until now managed to create a uniquely advantageous situation in which it has positioned itself as the primary spokesman for its chief competitor in the marketplace, breastfeeding. And this new message is assuredly not the one they want projected into public consciousness.

“Ironically, infant formula companies in this country can honestly say they spend more on what they call ‘breastfeeding education’ than any other single entity,” explains Amy Spangler, a nurse and lactation consultant who currently chairs the United States Breastfeeding Committee, an umbrella consortia of health care organizations interested in breastfeeding that was intimately involved in developing the new DHHS campaign. “They also underwrite much of the research into infant feeding issues. The pay-off for them is that they then get to manipulate the message, which is always “Breastfeeding is best, but… There is always a ‘but,’ and breastfeeding is suggested as a type of ‘bonus feature’ for parenting rather than the norm.”

According to a number of sources within the medical community who were included in meetings during the planning process for the breastfeeding campaign, DHHS officials repeatedly stressed to participants that the specific messages of the ads –which were clearly shaping up to be potentially controversial- needed to be “embargoed” until their official release.

Amy Spangler attended several meetings with DHHS and OWH officials to discuss the Breastfeeding Awareness Campaign and she says that federal and Ad Council officials encouraged participants to avoid speaking publicly about the content of the planned ads before their release.

“It was never said specifically that the need for keeping the ads under wraps until release was due to anything having to do with infant formula companies, but I think we would have been naïve to assume that this was not one of the reasons why,” explains Spangler.

Despite the warnings, however, the infant formula industry did apparently gain access to much of the content of the ads, allowing them to begin an intensive and targeted lobbying effort against their release. DHHS officials are reluctant to discuss the circumstances surrounding the premature leak of the ads, saying only that “a small amount” of information about the campaign was accidentally released on The Ad Council website at some point in November. Hipmama.com has learned, however, that DHHS and Ad Council officials voluntarily met with formula industry representatives at several points during the fall, even as pro-breastfeeding stakeholders were being instructed by the same officials to keep mum in order to preserve the integrity of the ad campaign’s message.

Additionally, most or all of the actual ads were shown to dozens of attendees at a North Carolina medical conference in October, something that Office on Women’s Health spokesperson Christina Pearson says the agency didn’t authorize or even know about until after the event.

According to a variety of sources, members of Congress began hearing complaints about the pending ad campaign from infant formula manufacturers as early as the first week of October, but it was at the AAP convention in November that the industry was able to aim what is arguably the biggest weapon in its lobbying arsenal –the clout of the American Academy of Pediatrics – directly at the breastfeeding campaign.

“The reason why the infant formula industry is so successful is because they have managed to manipulate health care providers into providing them with a cloak of credibility,” explains Amy Spangler. “The bottom line here is that the president of (an infant formula company) doesn’t have to send a letter directly to a federal official when he can get the President of the American Academy of Pediatrics to do it for him.”

Public health advocates and many individual physicians, nurses, midwives, and lactation consultants have long criticized the cozy financial ties between infant formula manufacturers and major medical organizations such as the AAP, the American Medical Association, the American Academy of Family Physicians, and the American College of Obstetrics and Gynecology. The infant formula industry – part of the larger pharmaceutical industry lobby – is also recognized as one of the most effective and powerful lobbies on Capitol Hill.

Critics of this relationship between baby doctors and formula makers note that because the U.S. infant formula industry –with sales of $3 billion annually – clearly has a commercial interest in impacting parents’ infant feeding choices, the industry should not play any role in crafting public health messages relating to the industry’s clear competitor in the marketplace, breastfeeding.

“It is simply not appropriate for these companies to have a say in how publicly-funded health education campaigns present breastfeeding issues,” argues Marsha Walker, RN, IBCLC, and Executive Director of the National Alliance for Breastfeeding Advocacy (NABA), a non-profit group promoting breastfeeding. “It would be like inviting a cigarette manufacturer to have a say in the message of a government sponsored anti-smoking campaign.”

OWH spokesperson Christina Pearson disagrees, however, insisting that DHHS has made it clear all along that the agency wanted to hear from “all sides” on the issue.

While it may be reasonably asked what “sides” exist when speaking of a public health campaign promoting a free or low-cost, healthy alternative over another, expensive and less healthy alternative, the AAP leadership decided that their organization was going to take sides. In a phone interview with Hipmama.com on December 3rd, AAP President Dr. Johnston readily admitted that he was approached by representatives of infant formula companies during the annual AAP convention in the first week of November, and asked to attend a “private,” “not on the agenda” meeting to discuss some concerns that the industry had with the planned DHHS breastfeeding campaign. He says that he and the three other members of the American Academy of Pediatrics Executive Committee, Dr. Joe Sanders, Dr. Carol Berkowitz, and Dr. E. Stephen Edwards, immediate past president of the AAP, met for approximately 45 minutes with “two or three” representatives of Ross Products “and maybe one other company” to hear their concerns.

“This was the first I had heard about this planned breastfeeding promotion campaign,” says Dr. Johnston. “Sad, but true. I didn’t know it was in development until after these folks told us about it.”

Dr. Johnston’s account of his interest in and knowledge of the DHHS ad campaign differs from the version reported in the December 4th edition of the New York Times. In a story entitled “Breastfeeding Ads Delayed In Dispute Over Content,” reporter Melody Peterson writes that Dr. Johnston and Dr. Sanders “…said that they had decided to send their letter before (infant formula company) executives expressed their concerns at the Academy’s national conference, held last month in New Orleans.”

In his interview with Hipmama.com, Dr. Johnston said that he became alarmed at the tone and message of the ads after viewing samples shown to him by the infant formula company reps in New Orleans.

“They showed us more than ten but fewer than twenty printouts of something that looked like ads. It was my impression these were copies of some of the ads,” says Dr. Johnston. “A lot of the ads looked fine to me, but I shared their concerns about the negative approach overall. It worried me, as it did them, that parents whose kids got cancer or grew up dumb might feel guilty if they did not breastfeed.”

Dr. Johnston says that he did not find it inappropriate or even remarkable that a commercial interest would have advance advertising copy from a planned multi-million dollar federal public health campaign designed to convince Americans to buy less of their products.

“I never asked them where they got this stuff,” says Dr. Johnston. “I just had the feeling that their relationships within Health and Human Services were better than ours at the Academy. I was actually embarrassed that this was the first time I was being made aware of the problems with this advertising campaign. Of course, they have to be concerned about issues that impact their shareholders.”

Dr. Carol Berkowitz, who will become AAP President in 2004-2005, confirms that she also attended this meeting, however in a phone interview on December 3rd, she told Hipmama.com that the meeting was noted on her personal conference schedule when she arrived in New Orleans.

“The meeting was on my own schedule that they handed me when I arrived,” says Dr. Berkowitz. “I assumed it had been set up in advance at AAP headquarters. I saw nothing remarkable about it; I attended many such meetings while I was there and I’ve been friends with many infant formula representatives for years.”

Dr. Berkowitz says that she too was concerned about the tone of the ads based on what formula industry representatives told her when she met with them at the AAP Convention.

“At the end of the meeting, Dr. Edwards asked what they wanted us to do and they told us that they had just wanted to make us aware of the situation, ” remembers Berkowitz.

Apparently, the AAP leadership’s freshly heightened awareness led to almost immediate action on behalf on the formula industry. In a letter dated November 3rd –- while the AAP convention was still underway in New Orleans and on the very same day he was installed as President — Dr. Johnston signed off on a strongly worded statement to DHHS objecting to the ostensibly still-under-wraps breastfeeding advertising campaign, based solely on what he had been shown and told by infant formula company lobbyists.

In the letter, Johnston notes that it has “come to his attention” that an ad campaign is about to be launched, and that he formed his opinions “after reviewing the Web Page of The Ad Council.” He does not mention that his concern was, in fact, prompted by a private meeting he had just concluded with representatives from the infant formula industry. Dr. Johnston told Hipmama.com that, despite the wording in his letter to Secretary Thompson, he is not certain that he personally viewed The Ad Council webpage before signing the letter, and that he didn’t actually draft the letter himself; staff at AAP offices near Chicago did. But he says that he was comfortable signing his name to it.

“I felt that we needed to send a letter immediately because the people we met with told me that these ads were about to be released,” explains Dr. Johnston. “They conveyed a sense of urgency to me and I shared their concerns. I thought many of our members would be disturbed if these ads were released in that format. I felt we needed to act.”

Meanwhile, members of the U.S. Breastfeeding Committee and other medical professionals with an interest in the DHHS advertising campaign had no idea that the new President of the AAP had taken such an action. Within a week of the AAP convention, however, sympathetic sources within DHHS began contacting interested medical professionals around the country and quietly reporting that “something was up” with the breastfeeding campaign.

“We started hearing from people that the infant formula companies had begun an intense lobbying campaign against the ads within DHHS and other government offices, including Senator Bill Frist’s,” says Marsha Walker of NABA. “They were saying that they were unhappy with ads that told of consequences of not breastfeeding as opposed to stating the benefits.”

By mid-November, Dr. Lawrence Gartner had been alerted by a DHHS staffer to the existence of the Johnston letter sent on behalf of the AAP. Gartner says that he was very disturbed that the AAP’s own Breastfeeding Section had not been consulted or even notified about the contents of Dr. Johnston’s letter to Secretary Thompson, even though he and his colleagues in the AAP’s Breastfeeding Section had also attended the AAP Convention earlier in the month. After investigating the matter, Dr. Gartner felt compelled to send his own letters to Secretary Thompson, as well as to other AAP members.

In his letter to fellow pediatricians across the country, Dr. Gartner wrote that, “ There is every reason to believe that (the infant formula companies) are pulling out all the stops to get this ad campaign buried, or, at least, modified to be less effective… This entire affair is a very serious matter, which raises many questions about the leadership of the AAP and the influence of the formula industry on AAP activities.”

Mardi K. Mountford, Executive Director of the International Formula Council, a trade group representing the interests of infant formula manufacturers takes issue with Dr. Gartner’s assertion that her industry is seeking to discredit or delay the DHHS campaign.

“We strongly encourage mothers to breastfeed if they can, but we don’t believe that women need to be subjected to scare tactics like the ones that are in these ads,” explains Mountford. “Our only interest in reviewing the scientific claims in the ads is that they be accurate so that parents have the information they need to make their own decisions about what’s best for their families”

Mountford’s remarks highlight something that public health advocates have long noted; namely, that the infant formula industry’s tactics in lobbying against initiatives such as FDA regulation of their product, standardization of ingredients in their product, and now, the DHHS breastfeeding campaign are remarkably similar to the strategies employed by tobacco companies in the early years of the anti-smoking public health movement.

According to PRWatch.org, the tobacco industry created what eventually became known as the Council for Tobacco Research(CTR) in 1953, claiming that the organization’s mission was to ”find out whether smoking was dangerous…’” During the 1980s, internal CTR memos revealed that “ the CTR actually worked at “promoting cigarettes and protecting them from these and other attacks,” by “creating doubt about the health charge without actually denying it, and advocating the public’s right to smoke, without actually urging them to take up the practice.” Just as the infant formula industry currently pays for much of the research into breastfeeding in the U.S, for many years the CTR funded most research into tobacco health issues and attempted to insert itself as a “concerned” corporate citizen into the government’s earliest anti-smoking campaigns.

While Dr. Johnston’s letter to DHHS referred only to a “negative tone” in the ads, infant formula industry lobbyists had been contacting DHHS and Ad Council officials since Spring, 2003 and insisting that the specific scientific research upon which some of the language of the ads were based was faulty. OWH spokesperson Christina Pearson confirms that the infant formula industry raised these concerns with DHHS officials, and concedes that the ads have now been modified to remove references to specific statistics that quantify the higher risks for certain diseases. However, she says that this change was in no way the result of pressure from the infant formula industry.

Several sources within the Ad Council, which relies heavily on funding by pharmaceutical companies that also produce infant formula – such as Mead Johnson – claim otherwise. They say that Mead Johnson threatened to pull its millions from The Ad Council’s budget if the references to specific risk numbers were not removed from the ads. The Ad Council declined to comment on this report, instead referring all inquiries to Christina Pearson at OWH, who says her agency can neither confirm or deny this alleged incident.

According to Dr. Gartner, the industry’s complaints about a “negative” tone in the ads, as well as its questioning of the science behind the campaign are just red herrings designed to delay and water down the campaign for as long as possible.

“As far as a negative tone goes, most successful public health campaigns rely heavily on making the public aware of negative consequences of certain behaviors. While it may be a new way to approach breastfeeding promotion, it’s a common advertising device.” says Dr. Gartner. “We don’t tell parents about the ‘benefits’ of carseats. We tell them that studies indicate that if they do not use a carseat, their baby has a greater risk for being injured or killed in an accident. And telling them this has worked. Thousands of lives are saved every year because this message works.”

Dr. Johnston admits that he now regrets not having discussed the letter he sent to Secretary Thompson with his own “breastfeeding experts” within the AAP, including Dr. Gartner. But notification is as far as it should have gone, says Johnson. He stands by his concerns about the ad campaign.

“I rely on the breastfeeding experts to help me learn more about breastfeeding issues, but some of the science behind these breastfeeding claims is shaky. It’s just not solid yet, and you know how some of these breastfeeding enthusiasts can lack objectivity,” noted Dr. Johnston.

When asked whether this lack of scientific objectivity he has observed extends to members of the AAP breastfeeding section, he replied “some, not all.”

Dr. Gartner says that he finds Dr. Johnston’s statement about objectivity among the physicians in the AAP’s Breastfeeding Section “outrageous.”

“I’ve read thousands of scientific papers on breastfeeding and formula feeding in just the past few years and so have my colleagues in the Breastfeeding Section within the AAP,” notes Dr. Gartner. “I challenge Dr. Johnston to discuss the hard science behind this issue with me any time. I would welcome the opportunity. Frankly, I do not believe he is qualified to comment on the research because I doubt he’s read much of it except –it appears – possibly what the infant formula companies have shown him.”

According to many lactation consultants and physicians who have played a consulting role in crafting the DHHS ad campaign, an earlier release date offered by DHHS officials was to be in October, 2003, to correspond with World Breastfeeding Week. That date came and went and participants were next told that the date for the campaign’s official roll-out would December 3rd, to correspond with a meeting of breastfeeding and infant health experts that was scheduled to take place in Washington. In its December 4th edition, the New York Times cited an Ad Council newsletter that named a December, 2003 release date for the campaign.

Christina Pearson of OWH disputes the claim that there has ever been a true release date set for the ads and emphatically denies that any changes have been made to the campaign’s message as a result of pressure from the AAP or infant formula industry representatives.

“The campaign is still on the drawing board and as far as we are concerned it has never come off the drawing board,” explains Pearson. “Anyone who thought we were about to release the ads was simply mistaken. We will continue our review of the message and the content until everyone feels comfortable that we have it right.”

Katie Allison Granju is the author of “Attachment Parenting: Instinctive Care for Your Baby and Young Child” and her essays can be viewed on her website at Loco Parentis.

It is exactly this kind of absurd, exaggerated rhetoric (not from our Peachheader, but from the doctor she’s quoting) that is creating anxiety and fear and making it harder to make an informed intelligent decision.

The possibility of your healthy child “being hooked to a respirator” because of Swine Flu is incredibly small. To imply otherwise is an unintelligent scare tactic.

I am very much aware of children and adults who have suffered severe and even fatal consequences from Swine Flu. You may know someone or, if you’re a health care professional, you may be caring for one of those patients. There is no way to minimize how devastating this is. 70-90% of those patients belonged to high-risk groups, and it was for them that the H1N1 vaccine was created. Media and government misinformation may actually lead to fewer of these high-risk children having access to a vaccine they need as they are moved aside by people with better access to medical care.

I believe I have seen dozens of children with Swine Flu. This H1N1 Influenza is uncomfortable, inconvenient and could certainly even be life-threatening to a very, very small number of people. A doctor implying that it’s actually anextremely dangerous part of this or any other winter is doing a disservice to you and the community. Many other (non-vaccinable) illnesses pose a far greater threat. And even they should not keep you away from your usual life’s schedule. A related worry is that the community’s focus on Swine Flu might lead to a missed diagnosis of other febrile winter illnesses.

The vaccine is not dangerous but will cause harm to a tiny percentage of those who receive it.
(Youtube videos circulating and scary vaccine-reaction stories are not a fair characterization of the facts.)

The illness will also cause harm to a tiny percentage of those who contract it.

Declaring this a “national emergency” while vaccines are not even available to 99% of people was ill-advised to say the least.

I have practiced medicine through the era of polio, HIB meningitis, and much more. I’ve diagnosed two cases of botulism, one case of diphtheria decades ago and cared for patients with tetanus. I have seen hundreds of children and families survive pertussis–with no whooping cough fatalities in thirty years of practice. I have hospitalized children with RSV many winters in a row. For doctors and the government to imply that we have a dangerous pandemic on our hands distorts the entire community’s approach to health care, scares people and, yes, the anxiety provoked is causing more medical problems than the disease itself.

Below is an interesting new article about the European flu shot. An adjuvant is a chemical which “jump starts” or irritates the immune system and causes it to respond to a smaller amount of actual vaccine. This saves money for the manufacturer and also “stretches” the vaccine supply. There may be unintended consequences to creating that much irritation/inflammation in the immune system and in the entire body. The article below addresses this topic. The American H1N1 vaccine does not contain an adjuvant at the present time, but the President’s declaring a “national emergency” may allow the addition of the chemical discussed in the article.

Med Microbiol Immunol. 2009 Oct 23. [Epub ahead of print]

Possible hidden hazards of mass vaccination against new influenza A/H1N1: have the cardiovascular risks been adequately weighed?

Bhakdi S, Lackner K, Doerr HW. Institute of Medical Microbiology and Hygiene, University Medical Center, Augustusplatz, 55101, Mainz, Germany, sbhakdi@uni-mainz.de.

Programs for vaccination against the new influenza A/H1N1 targeting many hundred million citizens in Europe and the USA are to be launched in the fall of this year. The USA is planning to employ a non-adjuvanted vaccine, whereas European nations are opting for inclusion of MF59, the adjuvant contained in an alternative seasonal flu vaccine, or the related adjuvant AS03 that is contained in a recently developed H5N1 vaccine. We draw attention to unappreciated hazards of using adjuvanted vaccine in Europe. Evidence from animal experiments in conjunction with clinical epidemiological data indicates that, quite irrespective of cause, stimulation of the immune system may accelerate atherogenesis. Application of adjuvanted flu vaccines to individuals at risk may therefore aggravate the course of underlying atherosclerotic vessel disease with all the clinical consequences. The same may hold true for other widespread diseases that are propelled by deregulated immune mechanisms. Safety trials conducted to date have not specifically taken these possible side effects into account, and unexpected serious adverse effects thus may follow in the wake of a general vaccination program. A prudent consequence would be to establish careful survey systems alongside with mass application of new adjuvanted vaccines, or to hold mass vaccination in reserve for use only in situations of true need, such as would arise with the emergence of a more virulent new H1N1 virus strain, or to use non-adjuvanted vaccines in individuals who are potentially at risk for adverse side effects.
PMID: 19851782 [PubMed - as supplied by publisher]

http://tinyurl.com/ygzewsb

This is not a discussion of vaccine safety, autism or similar issues. This is a discussion of medical honesty and integrity.

Jay Gordon, MD, FAAP

No lengthy newsletter to read today. Just a couple important medical articles. One from the lay press and one from a serious medical journal.

Please invest 15-20 minutes reading these two articles in full. I’ve given brief summaries of some of their information below.

One article is from a well-respected periodical and the other is from the most respected medical journal (BMJ) in the world and the Cochrane Collaboration which is the “gold standard” in medical information.

We expect H1N1 flu vaccines to arrive in our office in a week or two. I am willing to give them to high risk children. Tamiflu has side effects which give me great pause.

http://www.theatlantic.com/doc/200911/brownlee-h1n1

“Tom Jefferson, a physician based in Rome and the head of the Vaccines Field at the Cochrane Collaboration, a highly respected international network of researchers who appraise medical evidence, says: “For a vaccine to reduce mortality by 50 percent and up to 90 percent in some studies means it has to prevent deaths not just from influenza, but also from falls, fires, heart disease, strokes, and car accidents. That’s not a vaccine, that’s a miracle.”

“Jackson’s findings showed that outside of flu season, the baseline risk of death among people who did not get vaccinated was approximately 60 percent higher than among those who did, lending support to the hypothesis that on average, healthy people chose to get the vaccine, while the “frail elderly” didn’t or couldn’t. In fact, the healthy-user effect explained the entire benefit that other researchers were attributing to flu vaccine, suggesting that the vaccine itself might not reduce mortality at all. Jackson’s papers “are beautiful,” says Lone Simonsen, who is a professor of global health at George Washington University, in Washington, D.C., and an internationally recognized expert in influenza and vaccine epidemiology. “They are classic studies in epidemiology, they are so carefully done.”

“As with vaccines, the scientific evidence for Tamiflu and Relenza is thin at best. In its general-information section, the CDC’s Web site tells readers that antiviral drugs can “make you feel better faster.” True, but not by much. On average, Tamiflu (which accounts for 85 to 90 percent of the flu antiviral-drug market) cuts the duration of flu symptoms by 24hours in otherwise healthy people. In exchange for a slightly shorter bout of illness, as many as one in five people taking Tamiflu will experience nausea and vomiting. About one in five children will have neuropsychiatric side effects, possibly including anxiety and suicidal behavior. In Japan, where Tamiflu is liberally prescribed, the drug may have been responsible for 50 deaths from cardiopulmonary arrest, from 2001 to 2007, according to Rokuro Hama, the chair of the Japan Institute of Pharmacovigilance.”

http://clinicalevidence.bmj.com/ceweb/resources/editors-letter-full.jsp?src=editorsletter_intro

“In summary, evidence presented here points to influenza being a relatively rare cause of [influenza-like illnesses] and a relatively rare disease. It follows that vaccines may not be appropriate preventive interventions for either influenza or ILI.”

Jay Gordon, MD, FAAP

We should have long ago moved beyond trying to scare parents into vaccinating and also moved beyond trying to frighten parents into believing that every child getting a vaccine might end up with autism.

But the middle part of his exposition is devoted to a patient of mine and he commits ethics and HIPAA violations so egregious that the Medical Board must take him to task.

Dr. Parikh is a well-published medical author and blogger and he speaks of a patient he saw as an intern in the year 2000 at Cedars-Sinai Medical Center. (His bio on many sites lets you know that year.) He identifies the parents, their unique profession and their child’s age and illness. This family can be identified by anyone who can use Google.

They have given me permission to respond to the LA Times article.

What he has done is illegal and unethical and violates the family’s and child’s privacy.

He wants to scare parents into listening and is willing to break the rules and violate medical confidentiality to do it.

He even identifies me in his story: “We stuck more needles into her tiny veins, and her doctor performed a spinal tap to make sure she didn’t have bacterial meningitis.” He knows that I’m the only private attending pediatrician who comes to Cedars do spinal taps.

Dr. Parikh then goes on to describe the patient as having whooping cough.

She did not have whooping cough.

Preliminary tests were positive but more definitive tests done later showed that the baby did not have any evidence of exposure to the bacterium that causes whooping cough. This medical writer then goes on to speculate that ” . . .if she had only RSV, then she would have gotten better faster than she did, which is what led us to evaluate her further. But that combination — being very sick and unvaccinated — had led this child to the edge of respiratory failure . . .”

She was sick, required exactly the same care as a fully-vaccinated child and recovered. She’s a healthy happy child.

Again, more efforts to scare than to educate. And a dishonest presentation of the facts. And a serious ethical and legal breach.

Dr. Parikh’s discussion of the Larry King television show omits my presence on the show and mischaracterizes what actually occurred. Watch the episode on YouTube.

This is the second time in a matter of a few weeks that this newspaper has presented old news and inaccurate facts as being real news.

Dr. Paul Offit co-held the patent for a vaccine whose rights recently sold for $182 million. He and his book are cited here and often elsewhere as unbiased sources for information. Dr. Offit is an honest researcher but he should not be quoted as a completely disinterested expert.

Dr. Parikh correctly mentions that pediatricians have long been disdainful and dismissive of those of us who disagree with the routine vaccination schedule. The American Academy of Pediatrics has received millions of dollars from the pharmaceutical industry to support everything from the building of our new headquarters to the coffee and doughnuts at our conferences. The industry sponsors our speakers, spends millions on advertising in our official journals and pays for our lunches and dinners. Dr. David Tayloe, the AAP President, is a good man and I sense that he will soon begin reversing this controversial relationship. But, that money has influenced vaccine approval and recommendations and scheduling for decades.

There is no proof that vaccines can cause autism but the evidence needs further research and investigation. The three “vaccine court” cases this year are easily analogized to the early judicial decisions over cigarettes and lung cancer. Again, the proof’s not there against vaccines, but dismissing the possibility and the evidence based on a few court cases is bad law, bad science and bad medicine.

No one, no one accuses doctors of being ” . . . bent on making profits from vaccines at the expense of children” as Dr. Parikh implies. Drug companies may be motivated very strongly by the profit motive but most of us doctors give vaccines because we truly believe that a child’s personal health and the community’s health benefit because of these shots. And, yes, I give some shots every day. I just don’t give as many of them as are recommended and I vaccinate as late and slowly as I can. Yes, I have considered the public heath implications of this choice. The dangers are grossly over-stated by Dr. Parikh and others.

For the first time in eight years, a child died of HIB bacterial meningitis in Minnesota earlier this year. I responded to a recent LA Times article about vaccines and my first draft included my notes about fatal tree limb accidents: Over 100 people die each year because tree limbs fall on them. The relevance was questioned by my editor (my wife) and therefore omitted. Strange statistically-unlikely things happen. Using them as scary examples in medical articles does not serve the discussion well.

Talk to your doctor but do your own “homework” too. Vaccines are neither unequivocally good nor bad. The way we vaccinate our children now is not as safe as we could make it.

Jay Gordon, MD, Fellow of the American Academy of Pediatrics, FABM, IBCLC Emeritus