“China’s environment ministry has issued a ban on the pesticides lindane and endosulfan, substances known to pose health risks to humans. The decision, made jointly with 10 other government departments and published this week, is intended to improve China’s compliance with the Stockholm Convention, an international treaty on pollutants. China formally joined the Stockholm Convention in 2004. Lindane and endosulfan, which are frequently used to treat crops and parasites on humans and animals, are classified under the Stockholm Convention as “persistent organic pollutants” (POPs) that stay in the environment for an exceptionally long time …” See full article. — Source: CX Live.
In 2009, more than 150 governments agreed to list lindane in the Stockholm Convention on Persistent Organic Pollutants (POPs) for global elimination. However, they provided a temporary exemption for its use as a human pharmaceutical to address head lice and scabies. In response to this and other listings, the Stockholm Convention Secretariat launched a pilot project to help countries identify POPs-free alternatives to listed substances. Among various requirements, candidates had to submit products for testing by the Environmental Agency of Austria (EEA) to ensure they did not contain any of the 21 substances listed in the treaty. The project identified the LiceMeister® comb as a POPs-free product and will feature it at the global meeting of more than 150 countries April 25 – 29, 2011.
The LiceMeister comb is considered a safe, non-chemical treatment choice over the use of lindane and other pharmaceutical applications using insecticides. The LiceMeister comb has the US Food and Drug Administration clearance as a medical device for the purpose of screening, detecting and removing lice and their eggs (nits).
In a recent editorial, NPA’s president, Deborah Altschuler reaffirmed: “Combing is a scientifically reliable method to remove all lice and nits – which is another way to say it can end an infestation – literally. Combing is the safest and most cost effective approach that accomplishes what chemicals cannot. It enables families to be self-reliant, proactive, and preventive. It allows regular screening and early detection which makes the combing approach practical and realistic. While chemical treatments, pediculicides, and broad spectrum antibiotics develop resistance and potentially adverse health effects, nothing compares to the kindness of a comb.”
Altschuler adds that the most gratifying part of participating in the POP-free initiative is the way it has put children’s health at the forefront.
More Coverage of this important development
Stockholm Convention Launches POPs-Free Initiative – International Institute for Sustainable Development
“April 2011: The Secretariat of the Stockholm Convention has launched an initiative on products and processes free of persistent organic pollutants (POPs).
According to the Secretariat, the initiative seeks to encourage consumer product manufacturers and retailers who have phased out POPs to provide information on POPs-free products, and on possible alternatives and substitutes, and processes for introducing such alternatives and substitutes.
In the pilot phase of the project, two entities agreed to have their products tested for POPs through a laboratory hosted by the Environment Agency of Austria.
These products included: the LiceMeister® comb, a potential alternative to pharmaceutical applications containing lindane, listed under annex A of the Convention with a specific exemption…”
IPEN Quick Views of Stockholm Convention COP5 – International POPs Elimination Network
“COP5 should request the Secretariat to cooperate with WHO to do the following:
- Identify and compile information on safer alternatives, especially technically feasible, affordable non-chemical alternatives such as the LiceMeister® Comb identified in the POPs Free Project
- Develop a guidance document on transition to safer, alternative treatments
- Promote use of safer alternatives to lindane as a treatment for head lice and scabies
- Promote awareness-raising on safer alternatives among all Parties
- Review the continued need for the specific exemption for evaluation by COP6″
Read the rest of this article (note: PDF document).
POPs-Free Initiative Pilot Project – Stockholm Convention
In a pilot project, two entities have agreed on a voluntary basis, to test products through a laboratory hosted by the Environment Agency of Austria.
The key criteria for being a POPs-free product was that such a product did not contain or consist of chemicals listed in Annex A, B or C of the Stockholm Convention. POPs-free was defined specifically for the pilot project and was not to be used as a definition outside of the project…
The LiceMeister® comb – The National Pediculosis Association®, a non-profit organization from the United States, submitted the LiceMeister® comb. The comb is an U.S. Food and Drug Administration cleared medical device to screen, detect and remove head lice and their eggs (nits). This combing tool is used instead of applying pesticides to the hair and scalp. Of particular relevance to the Convention, the LiceMeister® comb could be considered as an alternative to pharmaceutical applications containing lindane, listed under annex A of the Convention with a specific exemption.
More on the POPs-free Initiative and the Stockholm Convention (note: PDF document).
The Lindane Project is a petition to the United States Government to cancel lindane’s registration as a pharmaceutical as it has been cancelled by the EPA for all other uses.
THAT this compilation of government surveillance documents the presence and persistence of the pesticide lindane and its related isomers in the United States.
THAT the world via the Stockholm Convention has voted to take proactive measure to protect the citizens of the world from lindane and related isomers while the U.S. did not ratify the Convention but asked and received exception to allow lindane to be directly applied to humans as a pharmaceutical.
THAT lindane was banned by the US Secretary of the Interior in 1970 for use as a pesticide on lands managed by Department of Interior bureaus and agencies, or in any program run by them.
THAT child and school protection from pesticide laws exist because there are multiple other additional and cumulative pesticide exposure risks to children in addition to the direct exposure to lindane as a pharmaceutical.
THAT the US Government agencies and State Governments acknowledge the dangers of lindane, require surveillance measures to track the availability and risks of lindane and related isomers in the lives of Americans.
THAT the US Government Agencies go to great lengths using time and resources at taxpayer expense to monitor, measure, collect and document the scientific evidence in order to protect the public’s health, welfare and environment.
THAT lindane however remains regulated by the FDA and available as a pharmaceutical treatment for lice and scabies, as though this massive amount of government diligence and documentation does not exist.
THAT active permits allow lindane to be manufactured in the state of Mississippi.
THAT FDA’s guidance by industry rather than government surveillance and actions, puts the US population at unnecessary and avoidable risk.
THAT lindane is a persistent bioaccumulative toxic (PBT) chemical to which the US population continues to be exposed to and at risk from the past and current use via the ambient air, water, soil, food, manufacturing, Superfund sites, stockpiles, recycled plastic and the pharmacopeia.
Mothers have found that the cure can be worse than the complaint
By Paula Lyons – Ladies Home Journal – June 1994
For years it was the most commonly prescribed treatment for two of the most vexing and distasteful problems of childhood, head lice and scabies. The treatment’s most recognizable brand name has been Kwell, though it is no longer manufactured under that name. Generically, it is known as lindane. And though it comes in lotion and shampoo form, lindane is actually a very strong pesticide.
But parents rarely are aware of this, and they can learn too late that lindane can have the same effect on their children that it has on the insects they carry: In other words, it can attack and permanently damage the central nervous system.
On June 10, 1993, Jean Nabors*, of Boise, Idaho, had just gotten her husband and kids off for the day when she sat down with a cup of coffee to watch Good Morning America. She was soon caught up in a report that I, then GMA’s consumer editor, was presenting that morning.
It was the story of a young mother, Rosa Santiago, of Lawrence, Massachusetts, whose fourteen-month-old son had suffered brain damage, allegedly after she applied a prescribed lotion to treat a body rash her doctor said was caused by scabies, a microscopic insect that burrows under and irritates the skin.
The doctor had prescribed two ounces of the medicine, but the pharmacist gave Rosa four ounces by mistake, she says. The pharmacist did not, Rosa says, give her any written instructions. Her doctor had told her to apply the lotion at night and wash it off in the morning. Neither the doctor nor the pharmacist made it sufficiently clear to her that she was to use the lotion just once, Rosa says. She thought she was supposed to use the lotion until the rash was gone or the lotion was used up, so she applied it every night for a week. On the eighth day, her son, José, had multiple convulsions. Jean Nabors sat in her Idaho home wide-eyed as she watched on the television as the now seven-year-old José stumbled and fell while playing, battling the brain injury and permanent retardation that allegedly resulted from applying a simple “cure” for a common condition.
And as soon as she heard the medicine’s name – lindane – Jean began to cry. “Oh, my God,” she said. “That’s it. That’s what happened to us. That’s what did this to my son.”
Jean’s adopted son, Scott,* now eight, was treated with lindane for scabies at age two. Like Rosa, Jean received few instructions and was assured by her doctor that lindane was safe. “I’ve used it for years,” the doctor said. So Jean applied it at night, as she was instructed, following her son’s bath. Since it was August and hot, she put Scott to bed in just a diaper and a T-shirt. She noticed Scott licking his arm, scratching and putting his hands in his mouth, but she didn’t worry since the doctor had said the lotion was safe.
Even the family dog, a six-year-old black Lab, seemed attracted to the lindane. Jean caught him licking Scott’s legs. After the first application, Scott’s rash persisted. Following the doctor’s advice, Jean waited ten days and treated him once again with lindane. The dog had a seizure. Jean and her husband, Paul, rushed the animal to the vet and wondered what had happened; now they believe the incident was caused by the dog licking Scott again.
In another ten days, Scott received a third application of lindane. The next day, he had what Jean now knows was a mild seizure. He was glassy-eyed, lethargic, nonresponsive. Three days later, his eyes rolled back, his lips turned blue, his body stiffened, he convulsed and lost consciousness. On the way to the emergency room, he stopped breathing. He was revived, but his seizures continued. They persist to this day.
“The reason I cried when I saw your story is that boy’s problems are so much like Scott’s,” Jean told me. Scott now has cerebral palsy, brain damage, and a damaged left foot, leg, arm and hand. He can’t jump or skip. he can’t write his name. His language development is slow. He has also been diagnosed with Attention Deficit Disorder. He is on medication in an attempt to control his seizures, though nothing really does.
Both of these mothers believed that lindane was a medicated lotion that would soothe their children’s itch and irritation. The mothers say that no one told them, nor did the labeling make sufficiently clear, that lindane is a pesticide, a poison that kills insects by attacking their central nervous system. Doctors and pharmacists have, however, known this for years..
“I think lindane should be thrown in the trash somewhere. They’ve hurt my son forever, and it wasn’t even necessary,” Jean says.
Jean is not the only mother I heard from after that June report. My office, the office of the National Pediculosis Association (a nonprofit group formed to educate parents about the prevention and proper treatment of head lice), and the office of the Boston attorney who represented Rosa Santiago were flooded with calls, many from parents who believe that their children, too, had been harmed.
And Jean is right. It isn’t necessary to use lindane to treat scabies or lice. These days, there are effective alternatives that must be used carefully. But they aren’t as toxic as lindane.
So, why is this substance still on the market? Why has its labeling not been clearer? Why do parents almost never know what it can do? Why aren’t doctors more careful?
Barre-National, Inc., the largest manufacturer of generic lindane, says it has updated instructions on both shampoo and lotion to make errors in use less likely. “The importance of the doctor-patient relationship,” the company said in a prepared statement, “gives further assurance that the product will be used safely and effectively.”
NOT SAFE AND EFFECTIVE
To a mother like Jean Nabors, that response is painfully inadequate. Jean’s heartbreak began in 1988, after she adopted Scott from South America. Three doctors examined him, found him weakened by malnourishment and suffering from a cold and an ear infection, but all pronounced him otherwise healthy, happy, curious and intelligent.
But a diagnosis of scabies came about three weeks after Scott entered the United States. “I noticed him itching and scratching; he looked so uncomfortable,” Jean said. “Some of the rash had turned into open sores.”
Medical reference books found in every doctor’s office are quite clear in warning against the use of lindane on open wounds. They are also clear about the consequences of misuse of the product. Lindane “penetrates the human skin and has the potential for central nervous system toxicity,” says one. It goes on to say that seizures are a possible outcome and that the “potential toxic effects of topically applied lindane are greater in the young.”
“How could my doctor have told me it was safe?” asks Jean.
Part of the reason has to be because the federal Food and Drug Administration (FDA), despite years of controversy over lindane’s potential toxic effects, especially on children, continues to call the substance “safe and effective when used as directed.”
Yet reports of seizures following its use as a treatment for scabies and head lice have been surfacing in significant numbers for decades. The FDA, which regulates lindane as a medicine, held hearings and ruled that the industry should provide written instructions to patients when lindane products are dispensed.
But the first FDA-approved patient instructions failed to mention that lindane was dangerous, poisonous or toxic. In 1983, when reports of seizures and other neurological damage persisted, Public Citizen, a consumer group founded by Ralph Nader, petitioned the FDA to ban all medicines containing lindane. Today, eleven years later, the group is outraged that lindane is still being used.
“We have recently looked at reports filed with the FDA, and there are almost fifty reports of convulsions, half of which are in children under the age of ten, from using products containing lindane,” says Sidney Wolfe, M.D., director of Public Citizen’s Health Resource Group. “Generally, fewer than one in ten adverse drug reactions gets reported to the FDA. The fact that there are forty-seven cases of convulsions reported means that there are probably hundreds of cases.”
But to the FDA, these numbers apparently do not suggest a need for anything more than superficial changes. Murray M. Lumpkin, M.D., deputy director for review management at the FDA’s Center for Drug Evaluation and Research, says that the agency’s current position “is that lindane is safe and effective when used as directed. Last May , we did ask our Dermatological Advisory Committee if this product should be pulled from the market. They voted unanimously not to pull it.” The FDA believes that efforts should focus on educating users, not on banning lindane.”
The agency’s newest patient instructions, approved just last year, do, for the first time since reports of convulsions surfaced in the 1950s, finally state unequivocally that lindane can “be poisonous if misused.” (However, a spot check of lindane products by Ladies’ Home Journal showed that not every product was so labeled.)
Such labeling comes too late, though, for one family. A New Mexico attorney represented the family of a healthy nine-year-old who was treated for head lice in 1986 upon the recommendation of their physician. The child did not have head lice; her baby brother did, but treatment for the whole family was recommended. The child used the shampoo in the shower, followed by a cream rinse, and suffered a seizure just hours after the one application. She suffers from brain damage and permanent seizure disorder to this day. Experts say a hot shower and the use of conditioner or cream rinse can increase the absorption of lindane.
Lindane does not always cause permanent harm. At least Nancy Stivers, of Lubbock, Texas, hopes that will be the case with her daughter, Jennifer. Now thirteen, Jennifer was prescribed lindane for scabies in November 1992. “The doctor wasn’t convinced it was scabies but said, ‘Let’s treat it as if it is,’” Nancy explained. The doctor told Nancy to use it two nights in a row, she said; Nancy remembers the pharmacist telling her he had questioned the doctor because the usual recommendation was one treatment, a week’s wait and retreatment if necessary. Nancy did what the doctor said.
Six months later, the school nurse said Jennifer had scabies again – diagnosis that was later questioned. Another doctor refilled the lindane prescription by phone, and, at the urging of a family friend who was a nurse, Jennifer used it three nights in a row. After the third application, Jennifer suffered seizures – multiple ones for several days. She and her mother believed they were caused by lindane. But they appear to have stopped now, and Jennifer seems fine.
It is important to note that the use of lindane has fallen in recent years. Many physicians years ago gave up using it on children under five, or wouldn’t dream of prescribing it without giving detailed, written instructions.
There are now less-toxic alternatives to treat both scabies and head lice. In fact, increasing competition from other products is the only reason that Reed and Carnrick, originator of the brand-name lindane product Kwell, has stopped manufacturing it.
Says Lumpkin, “There are alternatives for the treatment of both scabies and head lice. We believe that parents should try the safer products first.” But families on Medicaid do not always have the option of trying the safer treatment first, unless they pay for it themselves, because prescription drugs may be the only medicaid-reimbursable treatment; policies vary from state to state. Robert Wardwell, director of the division of coverage policy of the Health Care Financing Administration’s Medicaid Bureau, suggests that families on medicaid who want to avoid lindane should have their doctors prescribe an over-the-counter alternative and see if that will be covered. But that is a piecemeal remedy, effective only when families are persistent and skilled enough to argue their case with officials who are willing to listen.
And, says Deborah Altschuler, president of the National Pediculosis Association (NPA), it is not enough. Instead, she says, “The NPA wants the government to take some steps to make it impossible for another family to suffer the negative consequences of this chemical. Whether that means the strictest possible control of it or the banning of it, I don’t know. My job is to report to the government and to the public that we are averaging fifty calls a day here, from people who don’t know how to use lindane or other treatments. It’s got to stop.”
*name has been changed
Printed with the permission of Paula Lyons
© Ladies Home Journal