FDAnews Drug Daily Bulletin


April 3, 2006

House lawmakers have drafted legislation that would require a new government study on the potential link between autism and the mercury-based vaccine preservative thimerosal. Such a study could have serious implications for manufacturers of thimerosal-preserved flu vaccines.

"Make no mistake, this is a major public health issue. This is an epidemic," said Rep. Carolyn Maloney (D-N.Y.) in announcing the bill, H.R. 881, at the National Press Club. "Just like any other epidemic, our government has a responsibility to fully investigate the root causes of autism and defend against it," she said.

Maloney noted that during the 1950s, one in every 4,000 children was afflicted with autism. Today, the condition affects roughly one out of every 166 U.S. children.

A 2004 study by the Institute of Medicine (IOM) of the National Academies found no link between thimerosal and autism. But Maloney, who is sponsoring H.R. 881 with Rep. Dave Weldon (R-Fla.), called for a "more thorough scientific study" that would compare the incidence of autism in vaccinated and nonvaccinated children. To date, no autism study of note has compared these two groups, Maloney said.

The Centers for Disease Control and Prevention (CDC) phased thimerosal out of children's vaccinations beginning in 1999, but almost all flu vaccines still contain some thimerosal. Millions of flu shots are distributed every year, including to pregnant women and infants as young as 6 months old. The U.S. said in October 2005 it expected to receive nearly 100 million doses of flu vaccine for the 2005-2006 flu season. Flu season can begin as early as October and run through May, the FDA said. The World Health Organization still vaccinates children in other countries with products containing thimerosal.

In a recent letter to the National Institute of Environmental Health Sciences (NIEHS), Maloney and other lawmakers from the House and Senate asked the institute to conduct a study into a potential mercury-autism link using data in the CDC's Vaccine Safety Datalink (VSD). The VSD database contains information on 7 million children vaccinated in the U.S. from 1990 to the present.

One of the lawmakers seeking an NIEHS study is Sen. Joe Lieberman (D-Conn.). "While a previous study has been conducted by the [CDC], they did not explore the issue with the scale or scope that the senator is requesting," Lieberman spokeswoman Catherine Ribeiro told DID. "The senator hopes that continued research into the effects of thimerosal will help the public to regain trust in what is currently a contentious relationship with vaccine companies."

To read the bill, go to http://maloney.house.gov/documents/health/mercury/20060330DraftAutismBill.pdf (http://maloney.house.gov/documents/health/mercury/20060330DraftAutismBill.pdf). (http://www.fdanews.com/did)