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The Mystery of the Eli Lilly Rider

by STEVEN HIGGS

BROOKLYN, N.Y.

Anyone with a passing knowledge of Indiana’s political and business cultures would not be surprised to learn state leaders played feature roles in one of the first great scandals of the George W. Bush administration. Or that the episode involved perhaps the greatest environmental disaster of the postmodern age — the intravenous exposure of an entire generation of children to a powerful neurotoxin.

After all, “leaders” like Dan Quayle, Evan Bayh and Mitch Daniels have led their state to the No. 49 ranking in Forbes magazine’s 2007 comparison of state-by-state environmental quality. Of Indiana and other bottom-dwellers like No. 50 West Virginia, the business magazine said, “All suffer from a mix of toxic waste, lots of pollution and consumption and no clear plans to do anything about it. Expect them to remain that way.”

Indeed, former Eli Lilly and Company vice president, then-Bush budget director and now-Indiana Governor Mitch Daniels appears on Page 5 of David Kirby’s 2005 award-winning bestseller Evidence of Harm: Mercury in Vaccines and the Autism Epidemic: A Medical Controversy. So does then-Lilly CEO Sidney Taurel. In large measure, the Indiana players inspired the book, the former New York Times reporter said during a recent interview at his home in Brooklyn.

“I first got interested in vaccines and autism and that whole controversy back in 2002, in November, when the House of Representatives passed the Homeland Security Bill that created the Homeland Security Department,” he said. “Tucked away in that bill, in the middle of the night, was a secret rider that would have dismissed all lawsuits against vaccine makers for having put this substance called thimerosal, a mercury-based preservative, in vaccines given to children, with the idea that that may be causing autism.”

***

A chemist and Lilly fellow named Dr. Morris Kharasch developed thimerosal and applied for a patent in June 1929. Four months later, the Indianapolis-based Lilly registered it under the name Merthiolate. The pharmaceutical giant stopped manufacturing thimerosal in 1974 but maintained the patent and licensing rights.

While thimerosal had been used in vaccines for decades, its increased use in the late 1980s and early 1990s coincided with the rise of the autism epidemic in America. An exhaustive review of the scientific literature by the Institute of Medicine in 2001 titled “Immunization Safety Review: Thimerosal-containing Vaccines and Neurodevelopmental Disorders” found no causal link between thimerosal and the rising incidence of Autism Spectrum Disorders, Attention Deficit-Hyperactivity Disorder and speech or language delays in American children. But the authors made it clear they weren’t ruling it out, either.

“The committee concludes that although the hypothesis that exposure to thimerosal-containing vaccines could be associated with neurodevelopmental disorders is not established and rests on indirect and incomplete information, … the hypothesis is biologically plausible,” the report’s authors say in their Summary.

And by the time the House and Senate voted on a conference committee report on the Homeland Security Act of 2002, Lilly and other drug companies were the subject of growing litigation from parents who believed their children had indeed regressed into autism as a result of thimerosal-containing inoculations. The secret vaccine measure that caught Kirby and other journalists’ attention was called the “Lilly Rider.”

***

Kirby was writing for the Times in 2002 and had never heard of thimerosal. Neither did he know that mercury was in vaccines. But he knew enough about the heavy metal to question the wisdom of injecting it into the arms of infant children.

“I thought, ‘Well, the government must be keeping this well-monitored, and if they were using mercury in vaccines there must be a very, very good reason for it. And it must be in such tiny, miniscule amounts that couldn’t be harmful.’” He reiterates that he “didn’t know that much” about mercury or autism at the time.

Kirby’s journalistic instincts, however, sizzled. “What really struck me was the medical establishment coming out and saying, ‘Well, thimerosal is perfectly safe.’ And the drug companies saying, ‘It’s perfectly safe.’ And the politicians saying, ‘It’s perfectly safe.” If it were true, he reasoned, why were legal protections needed? Why wouldn’t they just publicly give liability protection to the drug companies?

Because the Lilly Rider was inserted into the bill in conference committee, no lawmaker except those directly involved knew it was there when they cast their votes on the final bill. “Why secretly try to stick it in in the middle of the night, when nobody knew it was there?” Kirby asked.

The story became a “real whodunit” in Washington, he said. House Majority Leader Dick Armey, R-Texas, said it was inserted at the behest of the Bush White House, which had long and close political relationships with Lilly. Former President George Bush Sr. had served on the Lilly Board of Directors in the 1970s. Bush Jr. had appointed Taurel to the elite Homeland Security Advisory Panel. And Daniels, of course, was among his top-level appointees.
“It turned out it was the majority leader, Dick Armey of Texas, who admitted to it,” Kirby said. “But I wanted to know why. I wanted to know what was it about thimerosal that they were so concerned about.”

***

Kirby initially thought the thimerosal story was ideal for the New York Times Magazine or other publications as an article. Unfortunately, the Magazine had just done an article on thimerosal called the “Not-so-crackpot autism theory.” He didn’t find much interest anywhere else, either, and eventually concluded what he really had was a book. An agent agreed, and five years ago in March, Evidence of Harm was published. A year later, it won the “Investigative Reporters and Editors 2005 Award for Outstanding Investigative Reporting in a Book.”

The connections between Washington and Indianapolis were “very, very vast,” Kirby said. And they offer one of the best examples of what he once called in an e-mail the “whacky world” of autism politics. “Completely coincidentally, a very conservative congress member from Eli Lilly’s district in Indiana is Dan Burton, a Republican who is arguably one of the most conservative members of the House of Representatives.”

Burton typically is pro-business and supportive of George W. Bush and Mitch Daniels, Kirby said. But his grandson regressed into autism after receiving seven vaccines in one day and being rushed to the Emergency Room with seizures, fever, etc. “Dan Burton completely blamed the vaccines, as many parents and grandparents do when they see that happen to the child,” Kirby said.

Burton was the chairman of the powerful House Government Reform Committee. Henry Waxman, a liberal Democrat from Los Angeles, was the Ranking Minority Member. And one of the issues they clashed the most over was the connection between autism and vaccinations.

“You had this liberal Democrat from Los Angeles constantly fighting this conservative Republican from Indianapolis, often at loggerheads over this whole thimerosal issue,” he said. “And whereas you would think the Republican conservative from Eli Lilly’s district would be fighting to defend his constituent and the company that hires so many people in his district and has done so much good, and this liberal Democrat railing against big Pharma, evil Pharma, their roles were completely switched around.”

***

In his capacity as Government Reform Committee chair, Burton held hearings and investigated the thimerosal-autism link for three years. In May 2003, the Subcommittee on Human Rights and Wellness, which he also chaired, issued a report called “Mercury in Medicine: Taking Unnecessary Risks” that effectively accused Lilly and other vaccine manufacturers of deceiving the nation for decades and contaminating a generation of children.

By the time that the federal government conducted a comprehensive review of mercury in vaccines in 1999 and recommended its use be discontinued, more than 50 licensed vaccines contained thimerosal, the report said. “In July 2000, it was estimated that 8,000 children a day were being exposed to mercury in excess of Federal guidelines through their mandatory vaccines.”
Despite thimerosal’s widespread use for most of the 20th century, the scientific literature was replete with warnings about its safety, the Burton report said. “In numerous publications, researchers suggested that caution be taken in human exposure. For example, a paper published in 1934 noted, ‘Little is known about the mercuric compounds when inoculated into humans. It is therefore preferable to use the minimum amount of this preservative.”
In a section titled, “Valid Concerns About Mercury In Vaccines Were Ignored by Federal Policymakers and Vaccine Manufacturers for Decades,” the report listed various warnings, issued from the early 1930s through the late 1970s, about the lack of knowledge on its safety or the adverse effects it had on humans and animals.

Among them was a 1935 letter from the Director of Biological Services at the Pittman-Moore Company to a Dr. Jamieson at Eli Lilly. “We have obtained marked local reaction in about 50 percent of the dogs injected with serum containing dilutions of Merthiolate,” it said. “… Merthiolate is unsatisfactory as a preservative for serum intended for use on dogs.”

***

The Burton report singled out Lilly for scrutiny. Daniels’s former employer was not the only manufacturer of thimerosal or other mercury-containing products, it said. However, Lilly’s history with it eclipsed any other company’s. “Therefore, it is appropriate to review Lilly’s track record in ensuring the safety and reliability of this product,” the report said.

The review said Lilly ignored the repeated warnings and used questionable science to defend its use of the mercury-containing concoction all those years. “A review of internal Eli Lilly documents dating back 70 years suggests that the only study of thimerosal involving human subjects was done prior to 1930,” the report said. “For the next seven decades, Lilly spokespeople would refer to that original study as evidence of thimerosal’s safety.”

History, however, showed this “uncontrolled study was woefully inadequate,” the report continued. An intravenous solution containing thimerosal was tried as an experimental treatment for 22 men who were seriously ill with Meningitis. While the treatment was found to be ineffective, the doctor who conducted the study concluded that the solution caused no harmful side effects.

“It is clear today that such a limited number of subjects, all suffering from the same serious illness, would hardly qualify as a sufficiently sized random sample, and a study such as this one would be of very little value by today’s standards,” the Burton report concluded.

In 1974, shortly before Lilly discontinued its manufacture of thimerosal, a U.S. Food and Drug Administration advisory committee determined that thimerosal in over-the-counter products was no longer “generally recognized as safe,” the Burton report said. And by the mid-1980s, Lilly itself was out of the business of selling thimerosal-containing products.

But its use continued, the report said. “In the 1990’s, thimerosal was manufactured by numerous companies, including Sigma-Aldrich, Inc.; EM Industries, Inc. (now EMD Chemicals Inc., the North American extension of Merck KGaA); Dow Chemical Company; Spectrum Laboratory Products, Inc. (formerly Spectrum Quality Products, Inc.); and GDL International, Inc.”

***

The Lilly Rider’s inclusion in the Homeland Security Act was denounced by politicians on both sides of the aisle. In Evidence of Harm, Kirby quotes an autism parent who was close to Burton. She said the congressman’s notoriously fiery temper got the better of him after he learned that he had voted for the Lilly Rider and confronted Majority Leader Armey. “I am told the two of them almost got in a fistfight,” the mother said.

While Armey quickly recanted his claim that the White House was behind the Lilly Rider, the controversy forced Daniels and the company to publicly deny culpability.

Daniels expressed ignorance of the rider and, almost incredulously, of thimerosal. “I personally had no involvement whatsoever with these provisions,” he told The Washington Post on Nov. 28, 2002. “I spoke to no one, either inside the administration or outside the administration. I did not have any communications with anyone from Eli Lilly regarding the issue. Indeed, I had not even heard of thimerosal until [now], which is not surprising because Eli Lilly stopped making thimerosal a decade before I began working there.”

When the public outcry over thimerosal erupted in 1999 after the U.S. Public Health Service and American Academy of Pediatrics recommended its use be phased out, Daniels was Lilly’s senior vice president for corporate strategy.

Lilly likewise adopted a who-me? attitude toward the affair. “We made absolutely no contact with Mitch or anyone in his office about this,” a company spokesman said. “It’s a mystery to us how it got in there.”
Faced with the bipartisan nature of autism politics and a growing media storm, House Speaker Dennis Hastert, (R-Ill.) and Senate Majority Leader Bill Frist (R-Tenn.) agreed before 2002 ended to remove the Lilly Rider from the Homeland Security Act in the next congressional session. Frist had championed the same provisions in the Lilly Rider in other legislation prior to the Homeland Security vote.

In a statement quoted in the Dow Jones Business News on Jan. 10, 2003, a Lilly spokesman said the company was disappointed with the Republican leadership’s capitulation on the issue and that the “process by which this legislation was enacted was not desirable.”

A Jan. 14, 2003, column in the Indianapolis Star by business reporter Thomas P. Wyman summed up the damage to Eli Lilly and Company, which, he wrote, emerged from the scandal “with little more than a public relations black eye. … The legislative sleight-of-hand put egg on Lilly’s corporate face.”

Lilly’s patent on thimerosal is about up, Kirby said, and it is still used in flu shots administered to children in doses that “contain 25 micrograms of mercury, which is more than what a 500-pound person could handle, according to the EPA.”

STEVEN HIGGS is editor of The Bloomington Alternative and writes the “Autism and the Indiana Environment Blog.” He can be reached at editor@BloomingtonAlternative.com

More articles by:

Steven Higgs is an environmental journalist and photographer living in Bloomington, Ind. He owns and operates Natural Bloomington: Ecotours and More. His new book A Guide to Natural Areas of Southern Indiana is scheduled for release by Indiana University Press on April 20, 2016.

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