Email: Biobased USA

Biobased USA LLC
Donald Wilshe
4237 Cornelius Road
East Bend, NC 27018
800 995-9203 
(10am - 10pm EST)

HEAD LICE - A UNIVERSAL PROBLEM

Head lice have long been a health problem world-wide, predominantly affecting children. In the United States alone, 12 million school-age kids are afflicted each year, at a cost to their parents of over $250,000,000 for treatment. Just as troublesome have been the various treatments used to treat head lice, as recent tests have shown a growing insect resistance to conventional methods of treatment. The solution has been the apparent acceptance to the use of toxic chemicals, which are only tolerated as being the lesser of two evils. Consumer Reports has taken the position that, due to the danger of using these chemicals on school aged children, the only procedure they would recommend is trying to remove all head lice solely by combing, which has proved to be an unrealistic solution.

Permethrin

Permethrin and pyrethrin are the same chemical compound, the only difference being that permethrin is derived from plants (chrysanthemums) and pyrethrin is manufactured synthetically. America's best selling lice shampoos, NIX and RID, list permethrin as their active ingredient. So do a number of other products : Proto Plus, A-200 and Equate, among others. Their labels also state that permethrin is considered "Safe" by the FDA.

However, the New York Attorney General's office takes exception to this designation, reporting a fatal asthma attack in a child after use of a pyrethrin based animal shampoo. In a letter entitled, "Troublesome inconsistencies in the federal regulation of pyrethrin-based shampoos", the Attorney General points out that under current federal regulatory practices, the EPA regulates various pyrethrin-containing products used to control insect infestations on animals, as well products applied to inanimate objects (i.e. carpets and furniture) for insect control. EPA regulations specifically prohibit any claim of safety on the product label.

On the other hand, the FDA's final regulatory review of over-the-counter pediculicide products includes a specific finding that they are "Safe", even though the products must bear precautionary labeling. The irony of all this is that while manufacturers of permethrin/pyrethrin-based products intended for use on animals or rugs and furniture are forbidden to label them as "Safe" or "Non-toxic", the manufacturers of over-the-counter shampoos intended for use on children are permitted to label them as "Safe". They base this claim citing the FDA document. In other words, shampoos intended for use on children, which may have even higher concentrations of pyrethrins than the product involved in the reported fatality, can be listed as "Safe" by the FDA, despite the danger of acute allergic reactions, while the EPA will not allow such a designation on similar products used for carpeting.

However, the factor that may limit or eliminate the use of NIX, RID or other permethrin based shampoos for the control of head lice, may not be warnings of toxicity, but rather the growing resistance of the lice to its effectivenenss. According to a study in the journal Archives of Dermatology, head lice are becoming resistant to NIX, in particular in south Florida, where the tests were conducted. And researchers at the Harvard School of Public Health, in 2002 reported that head lice collected from children in Massachusetts and Idaho are no longer killed by permethrin.

"Head lice sampled from children who were chronically infected and treated multiple times with pyrethroid shampoos tend to be resistant to permethrin."

Deborah Altshculer, Executive Director of the National Pediculosis Associatioon (NPA) went a step further

"Tests have shown that lice from American children are solidly resistant to permethrin."

In fact, as far back as 1996, she had already stated that "Reports of treatment failure with often used products such as NIX Creme Rinse and RID, are increasing at an alarming rate."

Litigation is presently (2005) ongoing in Texas against the pharmaceutical companies that advertise their permethrin and pyrethrum based products as being effective killers of head lice. This lawsuit filed against NIX, RID, Pronto Lice Treatment, Clear Lice Egg Remover and Clear Lice Killing Shampoo states as its cause of action

"Plaintiffs are consumers of defendants' products who, in reliance upon defendants' false and deceptive claims, marketing and advertising purchased and used defendants' products for plaintiffs' personal consumption or for their family members to cure lice infestation. Defendants' products failed to cure plaintiffs' lice infestations."

"Plaintiffs received no effective benefit from the use of such products."
Results from using these widely sold non-prescription products must have been totally pitiful to motivate a group of consumer citizens to institute a class action against Warner-Lambert, Pfizer, Bayer and Del.

This problem appears to be world-wide. The Department of Dermatology of the University of Bristol, in Bristol, UK, in a study conducted on 2800 school children in Wales found 1 in 10 had head lice. And of these, two-thirds had lice that were resistant to pyrethroid based treatments. The data in their conclusion indicated lice resistance in many parts of England to over-the-counter products containing synthetic insecticides (permethrin, phenothrin and malathion). They further suggest that resistance is starting to develop to carbaryl in head lice in Leeds and that extensive use of this product would lead to significant resistance.

As further documentation emerges proving NIX, RID and other permethrin based treatments to be neither the effective nor benign products that parents have been led to believe, a public health dilemma will face the public.

Lindane

One of the older treatments for head lice is Lindane, definitely a toxic agent. In the March 1996 issue of California Morbidity, it states, "Lindane, used since the 1950s, is both the least effective and, by far, the most toxic."

The National Pediculosis Association, in that same year, went a step further. In a study related to the use of Lindane, its National Registry listed over 325 reports of seizure, behavioral changes, neuromuscular complaints, attention deficit disorders, chronic skin eruptions, cancer and death.

Nevertheless, nine years later, the FDA still believes the benefits of Lindane outweigh the risks when used as described. The warning label on Lindane products suggests it be used as a second-line therapy for the treatment of scabies and lice, as it is not effective enough in and by itself. See if you agree.

Lindane is consistently ranked among the top chemicals of concern by the Agency for Toxic Substances and Disease Registry. Lindane is 99% pure gamma isomer of hexachorocyclohexane, and was first introduced as a pediculicide in 1952. A greatly simplified description of its manufacturing process is that Lindane is made by passing chlorine into benzene (a known carcinogen) until absorbed. According to the Merck Index, poisoning from Lindane usage may incur by ingestion, inhalation or skin absorption. Without going into the acute reactive symptoms, it suffices to say that, according to Merck, "Lindane and other hexachlorocylohexane isomers may reasonably be anticipated to be carcinogens."

The New York State Assembly introduced a bill on February 15, 2005, to ban the selling of Lindane. Here are some of the reasons quoted in the legislation:

"… extended exposure to Lindane causes the absorption of its chemicals into the skin, the digestive system, and the respiratory tract, resulting in seizures and, in rare cases, death."

"The World Health Organization (WHO), the Environmental Protection Agency (EPA), and the Department of Health and Human Services… report a six fold increase in the number of farmers who have developed non-Hodgkins lymphoma after exposure to Lindane. Recent case studies report high rates of childhood brain cancer due to treatment with Lindane shampoo. Furthermore, studies have proven that Lindane causes a potentially fatal or lifetime condition called aplastic anemia, the deficiency of essential nutrients in the blood and a precursor to leukemia. Adverse effects have resulted from recommended dosage of this product."

"Lindane is exceptionally toxic to the environment."

"Even a small amount of Lindane when ingested is lethal."

"In California, one dose of Lindane was shown to pollute six million gallons of water."

"There is no viable reason to keep Lindane on the consumer market, it light of its dangers. It is a deadly poison that safer alternatives can easily replace."

How's that as a treatment for your child?

Lindane has been banned in 52 countries world-wide and in 2000, the State of California forbid its use for the treatment of head lice and scabies. Similar legislation is currently under consideration in Illinois as well as New York. Paradoxically, in July 2000, the EU banned the use of Lindane for all agriculture and gardening applications, while still allowing it to be used in the home.

The new Lindane box warns that it is to be used with caution in patients who weigh less than approximately 110 pounds. It is not recommended for use in infants.

Although the FDA has finally restricted the use of Lindane on children and the National Pediculosis Association reports that Lindane products have caused over 500 cases of serious adverse effects, over one million prescriptions are written each year to treat new cases of head lice and scabies, which occur mostly in school-age children. The largest drug store chain in America, CVS, charges $132.99 for a two ounce bottle, sufficient for one shampooing. And the State of California states that one two ounce treatment is toxic enough to pollute six million gallons of water. Poisoning does not come cheap!

Ovide

Ovide remains today as the most effective killer of head lice. Researchers at the University of Massachusetts-Amherst, and other institutions, collected head lice from people in south Florida, Texas and Ecuador (where the lice have not yet developed resistance). The lice from Florida took 3x as long to die when exposed to permethrin, indicating the tolerances and resistance they were developing.

Ovide, which relies upon malathion as its active ingredient, is available only through prescription. University tests noted that it killed lice 10 times faster than NIX, so it is the treatment of choice, in particular where lice have become resistant to permethrin. Despite the fact that Malathion is a neurotoxic insecticide that is readily absorbed through the skin and through mucous membranes, the Ovide instruction sheet calls for it to be applied to the dry scalp of your child and left on for a period of 8-12 hours before shampooing! Its use was discontinued in the early 1990's, but it has recently been re-launched and re-introduced to pediatricians and school nurses, even though its safety for young children has never been established.

The malathion contained in a single Ovide treatment can be up to 30 times the recognized safe one-time dosage for a young child, yet according to the product's label, no tests have been done to measure how much malathion is absorbed through the scalp, nor is it known whether Ovide is safe for children under 6. The FDA estimates skin absorption is low enough to make it safe for older children, but again this is not based on actual test results. So one can only speculate upon what criteria the FDA bases its opinion.

Parents should note that malathion is an organophosphate (OP) poison, a suspect mutagen and teratogen, and a delayed neurotoxin. It causes allergic reactions, behavioral effects, ulcers, gastrointestinal inflammation, damage to eyesight, abnormal brain waves and immunosuppression. OPs can easily enter the body through the nose, skin or mouth. The issue of putting this stuff on your child's head and then leaving it there for an extended period of time has never been tested or resolved. Yet, it is becoming the treatment of choice for head lice, as NIX and RID (which is comparatively safe) becomes less and less effective.

Incidentally, what the makers of Ovide don't tell you is that organophosphates were developed by Nazi chemists during the course World War II as a chemical weapon nerve agent. Again, nerve agents don't come cheap. A prescription for a two ounce bottle, sufficient for one shampoo for your young child, will cost you $124.99 at CVS. Toxic chemicals don't only attack your health, they are very efficient at depleting your pocketbook as well!

ENTER Biobased AG

Biobased USA is a modern-age revolutionary development in colloidal chemistry, the successful culmination of many years of research. A totally bio-based, non-hazardous ("0" OSHA Rating) and bio-degradable colloid soap/cleaner, it is made entirely of FDA approved foodstocks - corn, soybeans, potatoes, grains, yet it possesses the remarkable ability to kill soft bodied insects. Biobased USA has been deployed worldwide by growers of fruit trees, crops and plants for the total control of insects, and has proved to be extremely effective in the treatment of fungal and bacterial diseases as well.

"Test results clearly demonstrate antibacterial/antifungal activity on the organisms tested."

Since 1999, various parents and school nurses have sent the company unsolicited testimonials attesting to the effectiveness of Biobased USA as a shampoo for the killing of head lice on children. One school nurse in Florida even went to the trouble of examining the death of a louse under a microscope as it was sprayed. However, as the company was primarily involved in commercial and industrial cleaning, as well as its use in agriculture, it did not wish to become involved in human health issues at that time.

Embodying new concepts of nanotechnology, scientists were at first baffled as to the reason for Biobased AG's potency, not only as to effectiveness on insects, but with a host of other applications as well. Accordingly, tests were undertaken to determine the answers to these questions.

A sample of Biobased USA was sent to a major independent testing laboratory for a comprehensive analysis. Their report read,

"Biobased USA immediately impacts the exoskeleton structure of the pest upon contact by disrupting the molecular structure of the chitin and other protein substances that protect the insect. This mechanism of action triggers the rapid and irreversible deterioration of the insect's spiracles and tracheal system, resulting in suffocation (as in the case of the adult mosquito). "The major benefit of this revolutionary method of insect control is the absence of undesirable side effects on human health and the ecosystem. Additionally, unlike standard insecticides in use today, no built-in resistance can be developed by the targeted insects, since this new insecticide does not act on the nervous system, but rather on the respiratory apparatus."
Biobased USA thereupon contracted with the University of Massachusetts, which has designed an artificial scalp, in conjunction with researchers at the University of California-Davis, for the study of head lice. This scalp, funded by the National Institutes of Health, presented an ideal testing medium to determine the effectiveness of Biobased USA on the adult louse and its eggs.

The preliminary report, received at the end of March 2005, stated that Biobased USA was effective in the killing of head lice, "almost as well as Ovide." By that, they were referring to the speed of the kill, not its ability to kill.

The most recent letter was received by Biobased USA in October 2005 from the father of two young girls, who were sent home from school the first week in September with notes from the school nurse stating their hair was 'infested with headlice.' He had been using Biobased USA for over a year on garden pests told them to wash their hair with it and leave it on for 15 minutes. The kids decided if once was good, twice would be better, and they washed their hair again as soon as the first time period expired. Thirty days later, they still had no head lice, which meant that Biobased USA had killed the nits as well as the lice. Their father has requested that the school inform all their students about this new biobased head lice treatment.

Biobased USA provides schools, nurses and parents with a totally safe effective alternative to exposing their children to the very toxic dangers of Ovide and Lindane. Biobased USA is equally effective against head lice, body lice and crab lice. There is no possibility of over-exposure to dangerous chemicals and Biobased USA is also available at a fraction of the cost.
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