Itching For Change: Lice & Pharmaceutical Products
By Ed Silverman
A small, but controversial non-profit group has just won a symbolic - and potentially significant - victory thanks to the Stockholm Convention on Persistent Organic Pollutants, which has determined its comb can be listed as an alternative to pharmaceutical treatments containing an insecticide banned by dozens of countries for agricultural use. The comb is cleared by the FDA for screening, detecting and removing head lice and their eggs.
April 6, 2011
The move comes after nearly two decades in which the non-profit, called the National Pediculosis Association, has tussled with drugmakers and government agencies over the insecticide. Known commercially as Lindane, the chemical has been widely used as an agricultural tool around the world, but is also a key component in a topical lotion and shampoo that are approved by the FDA for combating lice and scabies, although only as a second-line treatment.
Two years ago, the Stockholm Convention banned Lindane production and agricultural use (look here). Why? Lindane is a neurotoxin that can affect the liver and kidney, and infants and children may be more susceptible to the potential adverse effects of lindane than adults, a finding that was noted by the US Department of Health & Human Services Agency for Toxic Substances and Disease Registry. Over the years, Lindane has shown up in all sorts of food in many places, such as dried dates in Algeria, raisins in Canada, ginseng in China and garbanzo beans in India, among other foods and places.
For this reason, NPA has fought to have Lindane banned as a pharmaceutical treatment in the US, and points to concerns over both direct and indirect effects of Lindane as an ingredient in FDA-approved products. The package inserts, for instance, list the possibility of seizures and deaths. A 2008 study in Environmental Health Perspectives found that a 2002 California ban - which was imposed over concerns about water quality - was associated with a reduction in reported unintentional exposures and did not adversely affect head lice and scabies treatment. “This ban serves as a model for governing bodies considering limits on the use of Lindane or other pharmaceuticals,” the authors concluded. The current World Health Organization model list of essential medicines, by the way, does not contain Lindane as a substance for treating lice or scabies, since it was deleted in 1992 due to availability of safer alternatives (see this).
However, the Stockholm ban includes a specific exemption allowing the chemical to continue to be used as a second-line pharmaceutical treatment for lice and scabies until 2014. Moreover, the US signed - but did not ratify - the Stockholm Convention on POPs treaty, which means the US is not obligated to put a halt to pharmaceutical usage. Separately, the US Environment Protection Agency five years ago cancelled registrations of all remaining pesticide products containing Lindane, but this has no effect on pharmaceutical use.
Nonetheless, the non-profit is treating the Stockholm Convention pilot program for its comb as a sort of vindication. “The convention’s goal is to protect human health and the environment, and also embraces the broader picture that manufacturing (POP) pesticides, no matter what the purpose, is a risk. And that includes pesticides that are marketed for people who have lice,” says Deborah Altschuler, who heads NPA. “This will enable people to have a choice. This is a global statement they are making.”
The pilot program amounts to a rare success for the non-profit, which three years ago was sued by Morton Grove Pharmaceuticals, the marketer of Lindane shampoo and lotion. The drugmaker, which is owned by India’s Wockhardt, charged NPA and another group with defamatory remarks about safety and risks associated with its products, and that NPA “masquerades” as a health organization in order to sell its comb as a competitive item, which is called LiceMeister. The drugmaker, which sought $9.3 million in damages, also maintained that dangers from agricultural use “differ vastly” from short-term exposure as a topical salve. The suit was eventually settled and NPA was not required to admit liability or make any payments to Morton Grove.
Ironically, the accusations in the lawsuit were made not long after the FDA sent Morton Grove a December 2007 warning letter for its Lindane promotions. Specifically, the agency cited the drugmaker for websites and a newsletter that were misleading because they omitted or minimized “the most serious and important risk information” concerning the shampoo.
“We are very concerned about the potential for significant negative health consequences in children who use Lindane Shampoo because you are promoting Lindane Shampoo as being safer and more effective” for children than was demonstrated, despite a black box warning and a March 2003 public health advisory describing the risk of severe neurotoxicity in patients, including children, who weigh less than 110 pounds, the FDA wrote.
Nonetheless, the FDA has not taken steps to ban or restrict Lindane use as a second-line pharmaceutical treatment. Last June, the National Resources Defense Council and nine other groups petitioned the agency to ban Lindane. To date, though, the FDA has not taken any action. In a January 28 letter to the NRDC, Jane Axelrad, associate director for policy at the FDA’s Center for Drug Evaluation and Research, wrote that the “FDA has been unable to reach a decision on your petition because it raises complex issues requiring extensive review and analysis by agency officials”. We asked the FDA for comment, but there was no reply.
UPDATE: An official for Morton Grove notes the drugmaker responded to the petition by maintaining the NDRC did not offer any new evidence about safety or effectiveness, especially when used as directed, and the specifics offered by the petition have purportedly been reviewed in the past by the FDA. The drugmaker also maintains labeling changes, which included a boxed warning in 2003, “enhanced” the benefit-risk profile of Lindane treatments. Morton Grove also argues that agricultural and pharmaceutical exposure remains decidedly different.
The drugmaker adds that its Lindane.com website provides additional evidence supporting its contentions, along with testimonials from such people as former US Surgeon General Jocelyn Elders, who was one of several people to write the Michigan legislture three years ago to dissuade the state from banning the ingredient for pharmaceutical use.