From August 15, 2006
FDA
Allows Banned Pesticide To Be Used In Medicine
(Beyond
Pesticides, August 15, 2006) According to the Baltimore
Sun, despite action by the U.S. Environmental Protection Agency
(EPA) earlier this month to ban all remaining agricultural uses of lindane,
the Food and Drug Administration (FDA) has decided to continue to allow
its use in medicines which treat lice, mites and scabies. EPA banned
all remaining agricultural uses
for lindane as it concluded a congressionally ordered 10-year review
of 231 agricultural pesticides and their components. However, EPA has
no control over the medical uses of any pesticide that the FDA may authorize.
In this final chapter of EPA's regulation of Lindane, the agency focused on its uses as a pre-plant seed treatment for barley, corn, oats, rye, sorghum, and wheat. The pesticide is formulated into dust, emulsifiable concentrate, flowable concentrate, and liquid ready-to-use products. Lindane is applied to seeds using the following equipment: liquid seed treater, planter/seed box, air seed treater, canister tube applicator, and slurry-type seed treater. Approximately 233,000 lbs of active ingredient of lindane are used annually for seed treatment. The bulk of agricultural uses of lindane had been banned over the last two decades when EPA removed the major U.S. agricultural uses of organochlorine pesticides from the market.
The FDA says it cannot talk publicly about the specific process under which drugs are approved. However, according to the Sun, “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.” In its warning to physicians, according to the Sun, the FDA wrote: “Patients are at risk for seriously neurologic adverse events and even death, particularly with early retreatment.” Lindane is often prescribed to treat children with head lice, mites and scabies.
Lindane is one of the pesticides banned by the Stockholm Convention on Persistent Organic Pollutants, and is widely regarded as one of the most toxic pesticides ever created. Public health advocates and environmental activists are expressing outrage, and some are gathering petitions to send to the FDA.
Lindane “is recognized internationally as one of the most toxic, persistent, bioacccumulative pesticides ever registered,” said Jim Gulliford, assistant administrator for the EPA’s Office of Prevention, Pesticides, and Toxic Substances.
However, in spite of public concern, FDA 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.
“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 Citizens’ Environmental Coalition in Albany, New York. “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?”
Morton Grove Pharmaceuticals, the only U.S. manufacturer of the controversial medical products which contain lindane, including “Lindane Shampoo” and “Lindane Lotion” is suing the Ecology Center, a Michigan environmental group, over the distribution of statements discussing the hazards of lindane, calling the statements defamatory and libelous. The Ecology Center would not discuss the law suit for the Sun story, however, Kristin Schafer, program coordinator for the San Francisco-based Pesticide Action Network, told the paper she has examined the source of each statement that Morton Grove insists is false, and has concluded that “the lawsuit is a clear case of harassment.”