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Senate Passes Plastic Chemical Ban
In 2005, a group of toxicologists published a study suggesting that mothers whose urine contained high levels of an important component of plastics were more likely to have male babies with subtly feminized genitals. This, the first research showing human effects from a group of chemicals known as phthalates, infuriated the plastics industry, stirred an active controversy among toxicologists and kick-started U.S. legislators into taking steps to ban the substance.
Illustration by: Matt Mahurin
On Thursday, with at least eight states contemplating a phthalate ban similar to one California passed last year, the U.S. Senate, while overhauling the Consumer Products Safety Commission, included an amendment to ban phthalates from all children’s toys and products. Hundreds of thousands of tons of phthalates are produced each year and put in plastics used for everything from shower curtains to baby bottle nipples, to make them soft and pliable.
If the amendment, added by Sen. Diane Feinstein (D-Calif.), survives conference committee and is signed by President George W. Bush, Americans will have the same protection that citizens of the European Union have had since 1999, when the EU parliament responded to studies that suggested phthalates might cause harm to baby boys. Since Europe banned the substances from toys, they’ve been joined by countries like China, Romania and Mexico–not usually regarded as ground breakers in public health. How is it that the United States, which used to set the gold standard for public health regulation, has fallen so far behind?
Research done in the 1990s showed that female rats fed phthalates gave birth to male pups with defective genitals. It was such a reproducible effect in the laboratory that scientists started calling it “phthalate syndrome.” Babies and toddlers suck on plastic toys all the time, so there was concern that ingesting too many phthalates could affect testosterone or other male hormones. Little data, until recently, showed human harm, however. So why did Europe act, while U.S. regulators stayed mum?
The answer, as investigative reporter Mark Schapiro ably points out in his new book Exposed, is that Europe has embraced the “precautionary principle,” the idea that when evidence of harm reaches a certain threshold, it’s best to take action to protect people when there’s doubt about safety. In the United States, however, the operating principle is that we shouldn’t act without definitive evidence.
There’s a wide area of gray between precaution and inaction. But over the past 20 years, the U.S. government has installed a number of barriers to regulation. A combination of industry pressure and the intellectual tutelage of skeptical risk analysts like former Harvard professor John Graham, a top Office of Management and Budget official until 2007, has put the brakes on.
Whereas the Environmental Protection Agency, the Food and Drug Administration and other U.S. agencies led the way to cleaner and safer food, water, air and medicines through the early 1980s, EU regulators now hold the baton, Schapiro notes.
There are considerable ironies here. It was the EPA and the National Institutes of Health that funded research by Rochester University’s Shanna Swan and colleagues that first turned up a diminished “anogenital distance” in male infants with prenatal phthalate exposure. Another key alarm-bell ringer in phthalate research is L. Earl Gray, an EPA scientist. And the European Union based its ban largely on this U.S. government-funded research.
Then, when state legislators decided to take action to ban or control phthalates, they turned to the European Union for guidance. “The EU’s leadership on this issue has already led China to reevaluate what exposures they want for their citizens. Why wouldn’t we want to do the same thing?” asks State Sen. Virginia Lyons {D-Vt.), who is sponsoring legislation there to ban phthalates from toys, cribs and other items that kids chew on.
China now makes phthalate-free toys for Europe, Japan and many other countries — even for its own market. Yet some manufacturers continue to make phthalate-containing toys in China for shipment to the United States. “Why would we want to be the dumping ground for the leftovers?” asks Lyons. “It just doesn’t make sense.”
Some toxicologists contacted by The Washington Independent said they weren’t as worried about phthalates as scientists like Swan and Gray. Though an apparently safe replacement for phthalates is being used in the European Union, some scientists questioned whether the changeover was risk-free and worth the extra expense to U.S. manufacturers. In addition, they noted that even in infants, the most frequent exposure to phthalates comes through food and air, not toys.
“The public is harmed when lawmakers proscribe the use of a product that has been proved safe and useful,” Dr. Henry I. Miller, a former FDA regulator who is now a fellow at Stanford University’s conservative Hoover Institute, wrote in The Los Angeles Times recently. “Simply put, Feinstein’s bill represents bad science, bad law and disregard for the public interest.”
But this ball clearly has momentum. Already, manufacturers have removed the riskiest phthalates from milk bottle nipples and sucky-plugs that babies have in their mouths many hours at a time. Retailers like Toys “R” Us and Target have eliminated phthalates from baby-changing tables and toys voluntarily.
To stress the need for a law that would require removal of phthalates, Feinstein introduced her amendment in the Senate last Tuesday while holding up a photograph of her communications director’s 8-month-old son. The baby was sucking on a plastic book titled “Hello Bee, Hello Me.” Some time later, her staff took the book to a laboratory for testing.
It was loaded with phthalates.
The Autism-Vaccine Connection: Reopened Can of Worms
At a news conference in Atlanta on Thursday (which I haven’t seen, but read accounts of), the Atlanta parents of 9-year-old Hannah Poling revealed that in November, the vaccine court conceded their claim that vaccines caused her autism-like symptoms. At first glance, this case seems to contradict the scientific consensus that vaccines don’t cause autism. Anti-vaccine groups are howling with glee about it. The decision requires some explanation, and it will take a bit of space.
The vaccine court, to back up, is part of the U.S. Court of Federal Claims. Congress set it up in 1988 amid a wave of costly lawsuits over the whole-cell pertussis vaccine, which has since been replaced. The idea of the court is to provide timely compensation to kids demonstrably injured by vaccines. If you want to sue a drug company for a vaccine reaction, you have to come here first. The court protects the drug companies from runaway juries, which helps keep litigation from driving pharma out of the not-terribly-profitable vaccine business.
Illustration by: Matt Mahurin
People don’t sue in vaccine court–they file claims, which the government can contest, or concede. In this peculiar little institution, Department of Justice lawyers represent the defendant, which is the Department of Health and Human Services. Special masters–administrative judges schooled in vaccine matters–rule on the cases.
Over the past decade, nearly 5,000 claims from parents with kids on the autism spectrum have flooded the court. To deal with these numbers, the court set up an Omnibus proceeding, similar to those established to deal with asbestosis claims. The court has been planning to run nine test cases out of the bunch. These test cases, which deal with various theories of how the vaccines might have caused autism, would then be used to resolve the thousands of other cases.
The first three test cases have been heard but not yet adjudicated. Poling was to have been one of the next test cases, but her lawyers withdrew the claim and settled on the side. It is extremely important to understand why they did this, because it gives an indication of how typical Poling’s case is among the population of autistic kids with claims before the government.
It seems that Poling’s case was withdrawn because it’s very unusual, and therefore wouldn’t be a good test case. Poling developed normally at first, her parents say, then suffered seizures and “autism-like symptoms” after getting five vaccinations when she was 19 months old. Some time later, doctors discovered that she had a mitochondrial disorder, a condition that occurs in about 1 in 4,000 kids and can bring about a range of problems.
Poling’s symptoms started with a 102-degree fever a couple days after the shots. This may point to the live, attenuated viruses in the measles-mumps-rubella (MMR) or chickenpox vaccines she received as possible triggers of the reaction. Although this may be the first time that compensation for autism-like symptoms has been awarded by the court, encephalopathy–brain disease–is a rare, but recognized adverse event linked to the MMR shot. The court recognizes such cases, and compensates the children, a few times a year.
If this is the correct scenario, then we could assume Poling is an outlier whose case has nothing to do with the bulk of autism. Epidemiological studies have demonstrated (see Laura’s post earlier today) without a doubt that the increased diagnosis of autism is not linked to thimerosal in vaccines or to the MMR shot, the two factors at play in the autism Omnibus.
That said, children with autism or autistic syndromes may have somewhat higher rates of mitochondrial disorders. These underlying conditions are more likely to be triggered by garden-variety infections than by vaccines. Yet there may be additional kids in the autism Omnibus who fit into this category. Whether the course of their problems fit as neatly as Poling’s did remains to be seen.
In the past, the court has ruled in dozens of cases of a rare genetic disorder called tuberous sclerosis complex (TSC). Like mitochondrial disorders, this is a condition that often doesn’t manifest itself until a child is several months to a few years old. Many parents of TSC children who suffered reactions and subsequent brain disorders following administration of the whole-cell pertussis vaccine–known as DTP–took them to the vaccine court in the 1980s and 1990s. Generally, they lost. The court determined that the underlying condition would have crippled the child regardless of the reaction to the DTP. But in some cases, they won. Incidentally, a small but significant portion of TSS children have “autistic-like symptoms.”
To wrap up, this is probably an isolated case, but we won’t know for a while. Clearly, though, the anti-vaccine forces, bolstered by the glitter of people like Jenny McCarthy and the wealth of donors like investment banker JB Handley, are going to play it for all they can.
Independence of CDC Scientists in Question
CDC Director Julie Gerberding testifies about a vaccine recall before Congress, November 2007. (Associated Press)
Over the past four years, the office at the Centers for Disease Control that is responsible for vaccine safety has undergone numerous leadership changes, internal conflicts and a flight of senior scientists.
Some departing scientists and outside experts have charged that senior CDC officials are failing to give the office the independence it requires to investigate possible harm from vaccines. The accusations have come at a time when the number of routine childhood shots is swelling — preschoolers now get 10 separate types of shots in most states, double the number in 2000. New vaccines are being administered to teenagers as well. In the latest addition to the vaccine schedule, a CDC panel on Wednesday recommended that all children up to 18 years of age receive yearly flu vaccination.
Illustration by: Matt Mahurin
The bitterness and disputes at the Immunization Safety Office, moreover, are par for the course at the CDC under the leadership of Dr. Julie Gerberding, who took over in 2002 after handling the agency’s response to the anthrax mailings.
In more than a dozen interviews, senior CDC scientists complained that Gerberding has driven away the agency’s best scientists while embittering many of its 7,000 employees. She implemented a sweeping reorganization that centralized control and boosted public relations efforts while introducing expensive, often unworkable new management techniques. The officials charge that the once-independent CDC has been brought under tighter political control from the White House.
In 2005, five of the agency’s last six directors charged in an unprecedented letter that Gerberding’s management and politicization of the agency were harming CDC’s unparalleled international reputation in the field of public health. Daily complaints on a venting website provide a window into a dispirited, demoralized workforce.
A half-dozen senior scientists told The Washington Independent that they now spend roughly a third of their time on administrative tasks that previously took up no more than 10 percent. In the view of many, Gerberding took a functioning, vibrant agency and subjected it to a needless purges and restructuring. In some cases, scientists who champion unpopular positions, like non-abstinence forms of birth control, have been muzzled. For the most part, however, the main complaint is that the administration is burying them in red tape.
Spokespersons for Dr. Gerberding did not return two phone calls. In the past, Gerberding has acknowledged poor morale among some CDC employees, but said the restructuring, while painful, was necessary to bring CDC into the 21st century.
A half-dozen senior scientists told The Washington Independent that they now spend roughly a third of their time on administrative tasks that previously took up no more than 10 percent.
“We’re doing the best we can,” said one longtime CDCer. “But we’re tired. Everyone’s hoping things will change. There’s a lot of angst and unhappiness and a lot of things that don’t work. But to tell you the truth, I can’t say whether the reorganization succeeded, because I still don’t know what its objective was. Julie Gerberding wanted a centralized chain of command, and she’s gotten that. She didn’t like a lot of the leadership, and she got rid of them. They were too independent. So, I guess it’s worked for her.”
But has it worked for the rest of America?
Investigators in the office of Sen. Charles Grassley (R-Iowa) found that poor morale and an exodus of high-profile scientists — 8 of the top 10 CDC scientists have left since Geberding took office — had damaged the agency’s’ ability to respond in a major public health crisis. The investigators also looked into charges that the agency couldn’t quantify how $3.8 billion in spending had improved bioterrorism and pandemic preparedness.
In a separate probe, Rep. Bart Stupak (D-Mich) criticized the agency last year for failing to take more aggressive action against hospital infections that kill more than 100,000 patients annually.
Dr. William Jarvis, who left the CDC in 2003 after a period in charge of fighting hospital infections, charged that a reorganization of his division, ordered by Gerberding, had created “five years of dysfunction. During that time, an enormous number of qualified people left.”
While it is difficult to find other direct evidence that turmoil in the agency is affecting public health, many scientists there speak darkly of the dumbing down of the CDC. Too much emphasis is being placed on delivering a unified, pro-CDC message, and not enough on independent inquiry, these scientists charged, echoing complaints heard throughout the government’s professional corps.
“The CDC was a rogue dog, a bunch of hippies traveling around the world doing neat things and speaking out. They fostered that kind of against-the-grain thinking. And it’s necessary in public health,” one former CDCer said. “You have to go against conventional thinking. You can’t make the CDC a business model, and that’s what Julie has tried to do. She’s run out everybody who represented the old way.”
These effects have been visible within the vaccine safety office, which until 2004 was led by a charismatic Taiwanese immigrant named Robert T. Chen. Chen aggressively expanded vaccine safety measures to include a linked nationwide database of 3 percent of the country’s population that could be used to investigate possible harm from vaccines. The database was key to the 1998 discovery that a new rotavirus vaccine, produced by Wyeth Co., apparently caused a severe bowel disorder in about 1 in 10,000 infants who received it. The vaccine was withdrawn.
Chen rubbed some of his superiors the wrong way, partly because of a blunt speaking style but more fundamentally because of his willingness to put the interests of public health ahead of those of the CDC. It was a combination of personal and philosophical conflicts that led to him being removed from his job. He now works in HIV prevention at CDC.
In 1999, scientists at the Food and Drug Administration noticed that a preservative called thimerosal, contained in two new vaccines and one old one, might cumulatively be exposing babies to harmful levels of organic mercury. Despite the misgivings of some immunization officials, Chen’s network of vaccine safety scientists leapt to investigate this theory.
Within a few months, the CDC-directed team put together a study that showed a faint signal of harm to children’s neurological function from the mercury in thimerosal.
After years of further study, consensus developed that thimerosal had probably been harmless at the dosages used. But in the meantime, activist parents had convinced members of Congress that the initial CDC study was being covered up because it showed that vaccines caused autism. Amid the controversy, many parents stopped vaccinating their children, and thousands of parents filed lawsuits.
Within the CDC, the thimerosal story created bitterness. Some had opposed the initial thimerosal study because they feared that, for reasons having to do with statistical probability, it was likely to produce a signal of harm even if none existed — a suspicion that may have been correct. They felt the vaccine safety scientists needed to be reined in.
Others praised Chen’s office for having had the guts to ask tough questions about a medical procedure that most Americans equate with apple pie and mother’s milk. The problem was that in looking for possible harm from vaccines, Chen’s agenda didn’t exactly mesh with the center he was part of, then called the National Immunization Program, whose overall goal was to assure the vaccination of as many American children as possible.
In the internecine struggle that ensued, Chen was removed from his job. But CDC Director Gerberding, in a nod to two GOP congressmen concerned about the alleged cover-up, moved vaccine safety activities out of the immunization program and into her own office. Some suggested that the agency might better be removed from CDC entirely.
In the past four years, at least eight other top scientists have left the safety division — most of them going to other parts of the CDC.
In 2006, the CDC hired a new vaccine safety director, Robert L. Davis, a respected epidemiologist who had worked in the CDC safety network from his position at the University of Washington. But Davis lasted only one year, after pitched battles with Tanja Popovic, whom Gerberding had named to replace a more seasoned scientist as the agency’s chief science officer.
Putting vaccine safety into Gerberding’s office seems to have largely crushed it, rather than increasing its independence, Davis said. “They fought tooth and nail to keep the Immunization Safety Office in the CDC,” he said, “but in retrospect, because of the desire to control the message, the ISO’s independence has been suffocated.” Davis complained that his superiors were overly meddlesome in setting the agenda of his office.
In the past four years, at least eight other top scientists have left the safety division — most of them going to other parts of the CDC. (Dr. John Iskander, the acting safety office chief who replaced Davis, noted that he has hired five new scientists with comparable credentials). Centralized control over the safety office, in the view of many interviewed by The Washington Independent, compromises public trust that the government is doing its utmost to prevent harm from vaccines.
“What’s really sad about it is, you had a few people with the power to eviscerate what I think most of the American public wants,” Davis said. “To me that was really, really shocking.”
To be sure, vaccine safety work continues. One study, presented at the Advisory Committee on Immunization Practices on Feb. 28, found an additional seizure in each 2,000 children who received ProQuad, an all-in-one measles, mumps, rubella and chickenpox vaccine, compared to those who get chickenpox in a separate shot. Though this type of seizure is generally benign, the report led the committee to stop recommending ProQuad as the preferred vaccine.
Iskander acknowledged, in an interview, that the increased vaccine load has posed challenges. He is focusing on a strategic plan that he hopes will enable the vaccine safety office to focus its resources more effectively. Whether that will happen remains to be seen.
“Studies are being done,” said a senior vaccinologist outside the CDC. “But you need people with judgment based on a strong science and methodology background. And, honestly there’s nobody there.
“If you had stronger and better CDC leadership, they could have prevented some of this infighting,” the scientist added. “There have been too many decisions based on politics and not the best science in the last six years.”
