Eli Lilly and Thimerosal

Thimerosal is an organic compound that is 49.6 percent ethylmercury. Eli Lilly and Co., the Indianapolis-based drug giant, developed and registered thimerosal under its trade name Merthiolate in 1929 and began marketing it as an antibacterial, antifungal product. It became the most widely used preservative in vaccines. Thimerosal cannot be used with live-cell vaccines, such as MMR (measles, mumps, rubella) or polio, because it would kill the vaccine. The only research looking into the safety of thimerosal was done in 1930 by Eli Lilly-sponsored doctors, who injected it into 22 patients with meningitis. The human experiments failed to prove that thimerosal was nontoxic. Nonetheless, researchers H.M. Powell and W.A. Jamieson published a study in September 1931 in the American Journal of Hygiene that stated thimerosal had a “low order of toxicity” for humans, without mentioning that the human subjects were ill and subsequently died. Internal Lilly documents from the time, however, revealed that the company’s researchers were worried about Merthiolate’s “burning qualities” when used on the skin. By 1935, Eli Lilly’s Jameison had further evidence of thimerosal’s toxicity when he received a letter from a researcher who had injected it into dogs and saw severe local reactions, leading him to state: “Merthiolate is unsatisfactory as a preservative for serum intended for use on dogs.”

In the 70 years since thimerosal/Merthiolate was developed, the FDA never required Eli Lilly to conduct clinical studies of its safety, despite ample evidence of its toxicity and its highly allergic properties. In fact, the FDA today still refers to the 1931 Powell and Jameison study on its Web site as indication of the “safety and effectiveness” of thimerosal as a preservative. Thimerosal/Merthiolate was widely used in over-the-counter products, including ointments, eye drops, nasal sprays and contact lens solution. In 1998, the FDA finally banned Thimerosal for use in OTC products—18 years after it began a safety review of mercury-containing products. It took another year before the CDC and the FDA would ask manufacturers to remove thimerosal from childhood vaccines. Eli Lilly stopped making Merthiolate-containing products in the mid-’80s but still profits from licensing agreements with pharmaceutical companies around the world.

Eli Lilly faces hundreds of civil lawsuits from parents who blame thimerosal for their autistic children. But the pharmaceutical giant has powerful friends in the White House and in Congress. The elder George Bush sat on Lilly’s board of directors in the 1970s, and White House Budget Director Mitch Daniels was a Lilly executive. Lilly CEO Sidney Taurel was named by President George W. Bush to the Homeland Security Advisory Council. In November 2002, Congress passed a provision, tucked into a spending measure for homeland security, to indemnify Eli Lilly from lawsuits and require families to seek compensation through the federally funded Vaccine Injury Compensation Program. It was repealed in February 2003 after public outcry. Senate Majority Leader Bill Frist (R-Tenn.) still hopes to pass a similar bill. Congressional consideration for Eli Lilly makes sense: In the 2002 election cycle, the company gave more than $1.5 million to federal candidates, with three quarters to Republicans, making it the fourth-biggest giver in the pharmaceutical industry, according to the Center for Responsive Politics. In the current election cycle, the company already has given close to $230,000 (67 percent to Republicans) to federal candidates.

Eli Lilly may be determined to avoid liability for thimerosal, but that doesn’t mean it has abandoned children with neurological problems. This year, the FDA approved Straterra, a new Eli Lilly drug for the treatment of Attention Deficit Hyperactivity Disorder. The irony that Eli Lilly profits from damaged children is not lost on parent Robert Krakow: “When Eli Lilly is promoting Straterra on TV, saying up to 10 percent of children can be helped, you realize what we are up against.”