Thimerosal on Trial
The theory that vaccines cause autism goes to court.
In June, the U.S. Federal Claims Court, across Lafayette Square from the White House, will begin hearings on 4,800 claims filed by parents of children on the autism spectrum who think that the government's vaccine program caused their children's disorders. The scientific consensus rejects the idea that thimerosal, a mercury-containing preservative used in vaccines, causes autism. Still, it's conceivable that some of the claimants could win, because the vaccine court requires a lower standard of scientific evidence than regular courts. And so the parents are trying to enhance the legitimacy of their arguments.
In April, the government-funded Institute of Medicine held a two-day workshop to discuss ways to research possible toxic causes of autism. Leading voices among the parents who believe in the thimerosal-autism link shared their views with Science publisher Alan Leshner, who ran the meeting, as well as senior government scientists. Two of the groups, Safe Minds and the National Autism Association, later issued a news release that appeared to distort the remarks of a CDC scientist to make it appear that he shared their views. The meeting probably wouldn't have taken place without the support of several members of Congress, including Sen. Joe Lieberman, D-Conn., and Rep. Dan Burton, R-Ind. Other activists have taken to harassing scientists whose results they don't like.
Then there is the activists' reliance on Dr. Mark Geier, a fixture as an expert witness in vaccine court, where he has testified about 100 times. Geier and his son, David, who holds an undergraduate biology degree, operate under various business names from a house in suburban Maryland. The special masters who run the vaccine court have tossed out their testimony on 10 occasions, and federal district courts have been similarly skeptical. One judge recently described Geier as "intellectually dishonest," and a special master called him "a professional witness in areas for which he has no training, expertise, and experience."
Geier and his son have published several journal articles claiming to show a link between autism and vaccines containing the mercury-based preservative thimerosal. But the papers have been contradicted by study after study, and the mainstream medical community has proclaimed their work on the subject to be bunk. (The Geiers did not respond to e-mail and telephone requests to be interviewed for this article.)
Despite all the bad publicity, Geier has recently moved into a new arena—by becoming a doctor for autistic children. Geier claims to have treated 120 children in the past 2½ years with a powerful set of drugs he calls the "Lupron protocol." Lupron, the trade name for lupreolide acetate, is a synthetic hormone most often used to treat prostate cancer or to carry out the chemical castration of sex offenders. It's prescribed for children only to treat precocious puberty, a rare condition in boys.
The theory that thimerosal—which was largely removed from vaccines by 2002—is the cause of rising rates of autism has spurred scores of alternative practitioners in recent years to "detoxify" kids with sulfur-containing compounds (called chelation agents) that bind to heavy metals. Although various advocacy groups swear by this treatment, it does not seem to have cured autism in most, if any, kids who've tried it. This is where Geier's Lupron protocol comes in. His theory, stated in patent applications and a 2005 issue of the journal Medical Hypotheses, is that chelation fails to remove mercury from some children's brains because the mercury binds to testosterone. Get rid of the testosterone with Lupron, the Geiers argue, and the mercury will come out with chelation.
Geier's foray into medicine has infuriated a number of parents of autistic children who sharply dispute the vaccine-autism link. In particular, it ticked off Kathleen Seidel, a doughty New Hampshire mother of a teenager with an autism-spectrum disorder. In a series of investigative blog posts, she laid bare the flimsy theoretical underpinnings of Geier's treatment protocol and its potential dangers. In January, the journal Autoimmunity Reviews retracted an article by the Geiers on the Lupron protocol after Seidel wrote a long, scathing letter to the editor in which she noted that both of the journal's co-editors are witnesses in vaccine litigation.
Lupron isn't the first radical remedy offered to the autism community. Visit the homes of some autistic children and you'll find kitchen cabinets stuffed with dozens of expensive supplements, vitamins, foods, antibiotics. There is money to be made in this field, as this legal dispute between two alternative practitioners reveals. But Lupron seems like particularly strong medicine to test on children. In their published work, Geier and his son cite as precedent a 1999 case report of a 24-year-old autistic man who was given Lupron because he was exposing himself in public and molesting children. The drug stopped the inappropriate sexual activity but not the psychosis. The Geiers' protocol, which they prescribe to some patients with whom they are in contact only by telephone, sometimes also includes Androcur, an even more potent prostate-cancer drug with side effects that include liver damage, depression, and blood-clotting disorders. Androcur is not FDA-approved and must be ordered from abroad.
To qualify children for their Lupron protocol, according to parents, the Geiers run 33 tests to check for abnormal hormone levels and to rule out genetic abnormalities. If not insured, the parent is out $10,000 for these tests, and they require copious blood drawings, which can be especially traumatic for autistic kids. When the Geiers accept a child for treatment, they order multiple injections of Lupron along with shots or oral doses of a chelating agent. It is not unusual for children under the Geiers' care to get 60 needle sticks in a month. The usual drill for a scientist who wants to conduct a medical experiment is to have it reviewed by an independent ethics monitor called an Institutional Review Board. The Geiers' homemade IRB included the Geiers themselves, Mark Geier's wife, a vaccine litigator, and the parent of a child on the protocol, who is also a vaccine litigant.
Seidel looked on listservs where parents related their experiences treating kids with Lupron and chelation. One man described pinning his 7-year-old autistic daughter to the bed to push a 2-inch needle into her buttocks. "We did this by holding her down while she lay on her belly. We were able to hold her still for the injection by sitting on/straddling her back while my wife held her legs still." As is the case with many unorthodox treatments of autism, a highly variable disorder, some of the children seemed to improve, according to their parents. Others didn't. Heartbreaking as it is to see parents signing their children up for this treatment, it reflects the foxhole bonds among those convinced that the government and drug companies poisoned their babies with vaccines.
The potential impact of the vaccine case Geier will testify in is huge. If the court finds that vaccines are guilty of triggering autism, it could order lifelong payments for the care of thousands of autistic children. This would bankrupt the vaccine-compensation program, created two decades ago to shield the drug industry from lawsuits while providing the parents of vaccine-damaged children with a no-fault means of payment. The compensation fund, which currently contains about $2.5 billion, is financed by a tax on pediatric vaccines. But concerns about potential liability already have helped drive the price of vaccines to levels that are making it hard for pediatricians to continue administering them. Meanwhile, the Geiers' Lupron treatments continue.