Coal Tar Lawsuit #2
This is a reprint of the second of eight documents originally published by the National Psoriasis Foundation (NPF) regarding the 2000-2002 lawsuit in California over coal-tar products and Prop 65.
March 26, 2001
Mr. Bill Lockyer
Attorney General
State of California
Department of Justice
1515 Clay Street, 20th Floor
Oakland, CA 94612-1413
Dear Mr. Lockyer,
We are contacting you concerning a Proposition 65 lawsuit that could limit the availability of prescription and non-prescription products containing coal tar. The National Psoriasis Foundation (NPF) is concerned that, if this lawsuit is successful, Californians with psoriasis will not continue to have access to a safe, and effective medical treatment that helps them live with a potentially disabling disease.
The NPF is an independent, nonprofit voluntary health agency that works on behalf of people with psoriasis and psoriatic arthritis. We serve as patient advocates for our 34,000 members and for the more than 7 million American men, women and children that suffer from this potentially devastating disease.
Psoriasis is a genetically-acquired, immune-mediated disease of the skin and joints that affects 2.6 percent of the U.S. population. Nearly 1 million California men, women and children are affected by this disease. Coal tar products are a valuable and cost-effective treatment option for many of these Californians, and we are very concerned that this lawsuit may affect their access to this treatment.
As there is no cure for psoriasis, most people with psoriasis face a lifetime of treatment. While there are treatments that help some people with psoriasis some of the time, there is no universally effective therapeutic approach. Unfortunately, response to therapy varies from individual to individual, and psoriasis usually relapses or rebounds when therapies are discontinued. Thus, it is critical for people to have access to the entire spectrum of psoriasis treatments if they are to have hope of effectively managing their disease.
Over-the-counter coal tar products, such as shampoos, gels and lotions, are frequently first-line treatments for psoriasis for people who have a localized form of the disease, i.e., knees, elbows, scalp; have no insurance, or cannot use prescription anti-psoriasis therapies because of side effects.
Topical coal tar preparations have been a mainstay of psoriasis therapy for decades in this country. And, as you know, over-the-counter (OTC) coal tar products with concentrations of 0.5% to 5.0% coal tar are approved by the U.S. Food and Drug Administration (FDA) to treat psoriasis. While OTC coal tars are among the weaker forms of psoriasis therapy, they can still significantly improve the appearance of the skin by reducing the symptoms of inflammation, itching and scaling that characterize the disease.
They also do not expose the user to the long-term side effects, or even short-term side effects, that are found with the stronger, prescription anti-psoriasis therapies. We know from our conversations with patients around the United States that OTC coal tar provides an inexpensive form of symptomatic relief and is an important part of the skin care regimen for thousands of people.
We certainly support the consumer awareness and education that seems to be the intent of Proposition 65. If we believed that OTC coal tar was carcinogenic, we would be in total agreement with a warning label. However, according to the studies we have seen and patients we have spoken with over the 30 years the NPF has been in existence, we have not seen any evidence of serious side effects from OTC coal tar use. We have also read many retrospective reviews in the medical literature of coal tar-treated patients that would confirm this.
We are concerned that a warning label on the OTC coal tar products may unnecessarily discourage some manufacturers of OTC coal tar, especially the smaller ones, from continuing to offer this rather specialized product line. We are also concerned about the increased costs that may get passed on to the consumer and which will add to the cost burden of many people who already are having a difficult time paying for medications.
As you are aware, the FDA ruled recently on a citizen’s petition that requested a formal agency review of all coal tar products, the restriction of the sale and distribution of coal tar to prescription only, and the requirement of additional warning language on package labeling. The FDA concluded that the petition failed to provide sufficient basis for the agency to limit the distribution of coal tar products or to require additional warning statements in the product label. Indeed, the FDA specifically disagreed with the validity of the same studies used to support the Proposition 65 litigation.
In our view, coal tar products are important, medically helpful and cost-effective treatments for people with psoriasis. We believe that it is important that people with psoriasis have access to them. We hope you will contact us if we can provide any information or further explain our position. We respect the intent of your state law, but we do not believe that OTC coal tar is a carcinogen that comes under the requirements of Proposition 65.
Sincerely,
Robert M. Day, Ph. D.
Chairman, Board of Trustees
Gail M. Zimmerman
President and CEO
This document was reprinted with the permission of the National Psoriasis Foundation. The original can still be found in the Internet Archive.