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Lindane Facts: The Truth About Lindane

Retractions and CLARIFICATIONS

Ecology Center Issues Retractions Regarding Lindane Medications

In an effort to defend itself against misinformation, Morton Grove Pharmaceuticals, Inc. filed a complaint in federal court alleging that the Ecology Center in Ann Arbor, Michigan, had “intentionally and maliciously launched a false, misleading and defamatory attack campaign on Morton Grove and Lindane” by disseminating numerous false and misleading statements about lindane to healthcare providers and consumers. Oftentimes, agricultural and pharmaceutical research was swapped and selectively quoted and/or misstated, with little or no relevance to the clinical use of lindane medications, which have been repeatedly vetted by the FDA and other experts and determined to be safe and effective when used as directed for the diseases they are indicated and approved. (See Points of View: Medical & Scientific Opinions) Morton Grove tried to resolve the issue directly by providing the Ecology Center with documented proof as to the inaccuracy and misleading nature of their statements, and a request for corrective action. While the Ecology Center admitted that certain statements were inaccurate, no action was taken. Instead, The Ecology Center attempted to avoid any liability or public responsibility by filing a series of substantive and procedural motions to dismiss Morton Grove’s complaint—all of which failed. In fact, on June 18, 2007, Judge Elaine Bucklo held that Morton Grove had properly pled a case suitable for trial based on its merit and the facts presented. On February 29, 2008 the Ecology Center agreed to settle the matter by publishing retractions to several statements Morton Grove found to be highly egregious and damaging. The Ecology Center’s retractions are presented below along with Additional Facts for context and clarity.

False Statement #1

One dose of lindane can contaminate 6 million gallons of water.

Ecology Center Retraction:

This statement is from the publication Environmental quality Management, (Winter, 2002; pp. 89-95), citing a Los Angeles County Sanitation District calculation. In 2002, the EPA concluded that "the Agency does not have risk concerns for concentrations of lindane in surface water used as a source of drinking water from consumer use for both lice and scabies."

Additional Facts
  • The amount of lindane formulated for medicinal purposes is nominal - just 0.3% v. 99.7% that has been used agriculturally in the U.S. as noted in 2006 (See Healthcare v. Agricultural Uses)
  • The EPA has estimated the amount of lindane reaching water supplies from use of lindane medications to be 6,666-times lower than the water level standard considered safe for drinking (See Drinking Water Contamination)
  • The EPA further noted that a "conservative approach"" was taken in its assessment, which was based in part on reported discharge water levels of lindane from the Los Angeles County Sanitation District specifically (See Points of View: EPA)

False Statement #2

In the FDA’s Adverse Event Reporting System, 20% of those reporting health effects due to lindane used the product according to the directions.

Ecology Center Retraction:

The 2002 FDA review of 50 years of adverse event reports relating to lindane medications identified 488 reports. Of those 488 reports, 74 were classified as serious. Of the 74 serious cases, "Forty-three (58%) described misuse of lindane," while "14 cases reported using lindane according to the label." Based on this report, the FDA concluded that, "[i]n all age groups, adverse events occurred mainly in patients who appeared to have misapplied or orally ingested lindane."

Additional Facts
  • The FDA post-marketing safety analysis of lindane misquoted by the Ecology Center reflects use of lindane medications in tens of millions of patients, if not more, yet only 14 serious adverse events were reported for patients presumed to have used lindane properly (See Adverse Events)
  • Based on these findings, The FDA concluded that lindane medications are safe when used as directed, noting further that serious adverse events are “rare” with proper use (See Points of View: FDA)
  • In 2003, lindane medications were limited to small 2 oz. unit-dose bottles to mitigate the risk for misuse and enhance product safety (See Product Advancements)

False Statement #3

Fourteen other deaths have been attributed to lindane, but have not been confirmed. All of these 14 deaths involved topical application; in 5 cases use was in accordance with directions.

Ecology Center Retraction:

The statement should have read that fourteen other deaths have been associated with (not attributed to) lindane. In this FDA report, only two deaths were attributed to lindane, one in an adult and one in an infant, each involving misuse of the product.

Additional Facts
  • In each of these 14 cases, the FDA noted that the direct causes of death were “attributed to reasons other than lindane" (See FDA Postmarketing Safety Report)
  • From 1951 through 2002, the FDA reported on just two deaths attributed to lindane medications—one successful suicide in an adult who drank lindane and excessive lindane applications involving a 6-month old infant—both gross misuse scenarios ” (See Points of View: FDA)
  • Every year, roughly 400 deaths are attributed to penicillin and about 500 to acetaminophen (e.g. active ingredient in Tylenol®)1, 2

False Statement #4

Lindane is acutely toxic to the nervous system and can cause numbness, motor restlessness, anxiety, tremors, cramps and unconsciousness.

Ecology Center Retraction:

Although acute side effects, such as those noted above, have been reported for lindane, the majority of such events have resulted from oral ingestion (which is not how lindane medications are directed to be applied).

Additional Facts
  • The FDA has determined serious adverse events, including those of the nervous system to be “rare” when lindane medications are used as directed (See Points of View: FDA)]
  • In one of the largest post-marketing safety studies of head lice treatments involving more than 34,000 patients, less than 0.5% of those treated with lindane shampoo reported an adverse event of any kind—none were serious 3 (See Points of View: Medical & Scientific Opinions)
  • The most common side effects associated with topical use of lindane medications are non-serious reactions of the skin, such as burning and itching (See Adverse Events)

False Statement #5

Due to its toxicity, the FDA recommends not using lindane to treat individuals weighing less than 110 pounds- this corresponds to most children on whom lindane is used

Ecology Center Retraction:

The FDA-approved prescription labeling for both Lindane Lotion and Lindane Shampoo states in a boxed warning that these medications “should be used with caution in infants, children, the elderly, and individuals with other skin conditions and those who weigh <110 lbs (50kg) as they may be at risk of serious neurotoxicity.” Lindane Lotion and Lindane Shampoo are FDA approved as second-line medications for the treatment of scabies, pubic lice (crabs) and head lice.

Additional Facts
  • The incidence of scabies and lice has increased steadily in recent decades yet the number of effective treatments remain limited (See Understanding Scabies and Lice)
  • Lindane medications are second-line therapies, meaning they are indicated for patients who fail or cannot tolerate first-line treatments, sometimes as a last resort (See Need for Second-Line Therapies)

  • The FDA has reviewed the evidence on lindane on more than 12 separate occasions and repeatedly concluded that lindane medications serve a medical need and should remain on the market for patients who need them (See Regulatory History)

False Statement #6

Lindane is classified as a possible cancer-causing agent by the EPA

Ecology Center Retraction:

While it is possible to access a page on the EPA website which posts this sentence (based on an older EPA assessment), current information on the EPA website notes that the EPA updated the cancer classification of lindane in 2003 to “suggestive evidence of carcinogenicity, but not sufficient to assess cancer risk to humans.” The above statement remains attributable to the position of the International Agency for Research on Cancer based on a 1987 monograph.

Additional Facts
  • The older 1987 IARC position cited by the Ecology Center is based on chronic oral dosing studies of lindane in rodents and not on the topical use of pharmaceutical lindane in humans (See Point of View: Medical & Scientific Opinions)
  • In 2001, the EPA’s Cancer Assessment Review Committee concluded after review of old and newer data (not previously considered by the IARC) that “quantification of human cancer risk is not required” (See EPA Cancer Assessment Review Committee on Lindane)
  • In 2004, the Joint Committee on Pesticide Residues, coordinated through the World Health Organization, also concluded that “[L]indane is not likely to pose a carcinogenic risk to humans” (See Cancer-Causing Potential)

False Statement #7

The use of pediculicidal shampoos (including lindane) was associated with increased risk of childhood leukemia, with odds ratios of 1.5 (95% CI 0.9 to 2.5) for use of pesticide in one head lice episode and 1.9 (95% CI 1.1 to 3.3 for use of pesticide in two or more episodes.

Ecology Center Retraction:

Six of the 568 children participating in this study were treated with lindane shampoo. The authors concluded that leukemia was "significantly associated with maternal home insecticide use during pregnancy and during childhood, with garden insecticide use, and fungicide use during childhood." With respect to insecticidal shampoo treatment (e.g., permethrin, malathion, lindane, etc.), the authors determined that the issue "requires further study." The reported 95% confidence interval for lindane was CI 0.5 to 8.7.

Additional Facts
  • The Ecology Center’s concession that the reported 95% confidence level was CI 0.5 to 8.7—as a matter of introductory statistics—means that the association between the use of lindane medications and leukemia was not statistically significant (See Basics of Statistical Interpretations)
  • Indeed, when the authors of this study evaluated lindane shampoo separately, they found no statistically significant difference in the risk of leukemia for children who had never been treated with lindane shampoo v. those who had
  • Lindane medications have never been shown to cause cancer in humans, despite more than 50 years of clinical use (See Cancer-Causing Potential)

References:

  1. American Association for the Study of Liver Diseases (AASLD). Acetaminophen use and liver injury. 2008. Available at: http://publish.aasld.org/patients/Pages/acetaminophen.aspx.

  2. Neugut AL, Ghatak AT, Miller RL. Anaphylaxis in the United States: An investigation into its epidemiology. Archives of Internal Medicine. 2001;61(1):15-21.

  3. Andrews EB, Joseph MC, Magenheim MJ, et al. Postmarketing surveillance study permethrin créme rinse. Am J Public Health. 1992;82(6):857-861.

Tylenol® is a registered trademark of McNeil Consumer Healthcare