Banned pesticide allowed as medicine

U.S. bars lindane, except to treat lice

August 14, 2006|By ANDREW SCHNEIDER | ANDREW SCHNEIDER,SUN REPORTER

After more than a half century of use and thousands of reports of illness and deaths blamed on the pesticide, the federal government has banned all uses of lindane - except by those who rub it on their scalps and bodies to kill lice and mites.

This month, the Environmental Protection Agency banned all uses of lindane as a pesticide, but the Food and Drug Administration has decided to allow its continued use in medicines.

Many public health advocates and environmental activists are expressing outrage, and some are gathering petitions to send to the FDA.

"Lindane is a known cause of seizures and has no role in the routine management of lice or scabies," said Baltimore City Health Commissioner Dr. Joshua Sharfstein. "FDA should re-examine the question of whether it needs to be on the market at all."

The EPA issued the ban on lindane and other pesticides this month as it concluded a congressionally ordered 10-year review of 231 agricultural poisons and their components.

Lindane "is recognized internationally as one of the most toxic, persistent, bioaccumulative pesticides ever registered," said Jim Gulliford, assistant administrator for the EPA's Office of Prevention, Pesticides and Toxic Substances.

But Jim Jones, who heads EPA's pesticide office, said his agency has no control over the medical uses of any pesticide that the FDA may authorize.

The FDA says it has no plans to take action.

"As lindane has been deemed safe and effective for its intended use, FDA does not have any plans to take further action with this product at this time," said Kimberly Rawlings, an FDA spokeswoman.

Some form of lindane-based medication has been marketed since 1951 for the treatment of pediculosis, which is head and pubic lice and scabies, a contagious skin infection caused by the itch mite.

The FDA says it cannot talk publicly about the specific process under which drugs are approved. Government documents indicate that over the years there have been numerous adverse reactions - illnesses or deaths - from use of lindane. In 2003, the agency ordered the manufacturer to expand the warnings on the medicines' labels and told physicians that it should only be prescribed in doses large enough for one treatment.

The agency believes that the far more rigorous safety warnings and limits on the size of the dose will further protect consumers.

In its warning to physicians to prescribe only enough for a single application, the FDA wrote: "Patients are at risk for seriously neurologic adverse events and even death, particularly with early retreatment."

Morton Grove Pharmaceuticals, the only U.S. manufacturer of the controversial medical products, markets "Lindane Shampoo" and "Lindane Lotion." No one from the company would be interviewed, but Gordon Dobie, an outside lawyer for the company, said that the claims of harm are overblown. He said that there have been just 22 reports of adverse reactions "and just one lawsuit" since Morton Grove began marketing the products in 1995.

Groups that include the Natural Resources Defense Council, the Sierra Club and state and regional organizations across the country believe the FDA should ban lindane. The critics include Ann Heil, a supervising chemical engineer with the Los Angeles County Sanitation District, whose work led California to ban the sale and use of the medication. The medication was found in large amounts in county waste water treatment plants and the system was unable to neutralize it before the cleaned water was discharged into the environment.

Heil also had personal experience with the medication. As she discovered, any child can get lice. The Centers for Disease Control estimates that 10 to 12 million people get it a year. The problem cuts across all income groups.

"Don't believe that you need to be dumb and barefoot for your children to have a problem with lice," said Heil, who has a master's degree in chemical engineering from Cal Tech. "I remember far too vividly rubbing lindane over my child from toes to neck because he had scabies as did some of his classmates."

"I stopped and asked myself what in the world was I doing rubbing a neurotoxin like lindane over my child just because a doctor told me so," she said. "I'm a chemist and obviously should have known better and I worry about the other parents out there who just get their prescriptions filled."

In Albany, the Citizens' Environmental Coalition, an umbrella group of several organizations, is trying to get lindane medication banned in New York State.

"This substance has been proven repeatedly to be far too toxic to apply to our crops and our pets," said Laura McCarthy, a program associate with the group. "Who can possibly believe it's OK to apply it to our children's heads, which offer little protection to keep it from going directly to their brains?"

Deborah Altschuler says she has a hard time believing that the FDA won't take action.

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