|
|
| |
Statement by Michael Paranzino, president, Psoriasis Cure Now,
to the Joint Meeting of the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee and the Nonprescription Drugs Advisory Committee, regarding the switch of dermatologic corticosteroids from prescription to over-the-counter use
March 16, 2005
Psoriasis Cure Now, a nonprofit patient advocacy group, appreciates this opportunity to address this Joint Meeting on behalf of the 6.5 million Americans with psoriasis.
Psoriasis is an incurable, recurring, non-contagious disease of the immune system that can first strike at any age, causing painful skin lesions, and often, arthritic symptoms. A 1999 study found that psoriasis causes reductions in physical and mental functioning comparable to that seen in diabetes, heart disease, hypertension, depression and other diseases. Psoriasis costs the U.S. economy billions annually.
While for many psoriasis patients, the disease will remain mild throughout life, for millions of others it is a daily impediment, and can be debilitating.
With that background, we would like to make a few observations that we hope the Committees and the FDA will consider as you continue this important work.
First, we applaud you for participating in this Hearing, and for considering moving some dermatologic corticosteroids from prescription to over-the-counter (OTC) use. We believe the evidence points towards approving for OTC use at least some of the corticosteroids that currently require a prescription. Where precisely to draw the line, however, we will not take a position on today.
These medications are a mainstay for psoriasis patients. While no two psoriasis cases are alike, one thing that connects almost all 6.5 million Americans with psoriasis is that nearly all of us have tried one, and usually many more, topical corticosteroids. (In my own case, a quick review of a common list of topical steroids showed 16 that I recall being prescribed for me over the last 20 years.) Based on the many psoriasis patients I have spoken with over the years, as well as the many others whose psoriasis message board posts I have read, it appears my experience is common.
Psoriasis patients, particularly those with moderate to severe disease, become quite sophisticated in understanding their own skin, and how to manage treatments for it. Since psoriasis has no cure, and many patients will have psoriasis for 50 years or longer, giving people greater control over their treatment options makes sense. These psoriasis patients typically want to minimize medical intervention, so the danger of over-use of topical corticosteroids, or any other medication, would appear to be limited.
Plus, the convenience and lower cost that would come from the ability to purchase stronger corticosteroids OTC would help many psoriasis patients. (Of course, there are some patients whose prescription drug insurance coverage is so favorable, they actually prefer prescription medications to OTC products.)
But while we urge you to make at least some of the prescription-only topical corticosteroids available OTC, there are some concerns we would like to raise as well.
First, despite their broad use, there appears to be poor understanding among many patients about possible side effects of prolonged or extensive steroid use, and about whether tapering use is important. So while many patients are sophisticated in their use of these products, there are others who use them extensively and some of them only later realize that there are risks associated with such use.
This range of patient views may reflect, in part, the broad range of approaches used by dermatologists in prescribing topical steroids. While some dermatologists show each patient a chart of relative steroid strengths whenever they prescribe a steroid, other dermatologists have been known to hand out prescriptions for the strongest topical steroids without so much as a mention that there are less strong alternatives available. Similarly, some, but not all, dermatologists urge patients to wean off steroids, rather than stop using them abruptly (some don’t raise the issue at all). And some, but not all, remind their patients not to use topical steroids on other body parts (for example, the face) without speaking first with the dermatologist.
If these anecdotal observations are accurate, it would suggest that refined labeling might be warranted for any steroids moved to OTC status. It would also suggest that both patient and dermatologist education efforts with respect to steroids should be enhanced, perhaps by patient education groups, the American Academy of Dermatology, steroid manufacturers and other stakeholders.
Other factors that the Committees should (and no doubt will) consider include the tendency of many patients to use steroids longer and over more body surface area than originally prescribed; the counter-tendency to under-comply with prescription demands, particularly with respect to applying steroids multiple times each day; and the fact that the steroid tubes remain sitting in a medicine cabinet after their initial use, a tempting solution to later skin eruptions and even for other family members.
There is also the issue of steroid use in children with psoriasis. Parents of children with psoriasis face challenging issues about how aggressively to treat their children’s disease, and they must typically do this with very limited information about the long-term implications (if any) of using various medications on children.
This has been made a bit more complex recently with the FDA’s actions with respect to Elidel and Protopic, which are used off-label by psoriasis patients, including on children whose parents were hoping to avoid steroid use. The number one search term bringing people to our website this month is the word “Elidel,” which suggests patients are concerned about the news they are hearing about these drugs.
It is a lot to ask of any lay patient, and particularly of a parent of a child, to weigh the relative costs and benefits of using a steroid on their child’s skin, versus Dovonex or one of its counterparts, versus Elidel or Protopic, versus UV light treatments, etc. Medical guidelines or recommendations from medical authorities about appropriate treatments for pediatric patients would be helpful to many parents. And OTC labeling with respect to children will be particularly important.
Finally, while topical steroids will continue to help millions of Americans with psoriasis for many years to come, most patients would agree they are imperfect treatments, with limitations of their own. This underscores the need for additional biomedical research funding for the National Institutes of Health (NIH), as well as a robust biotech/pharmaceutical industry interested in the needs of psoriasis patients.
Psoriasis has, for years, been woefully under-funded by NIH. While NIH funding has soared 99% over the last decade, after inflation; psoriasis-related research at NIH’s National Institute of Arthritis and Musculoskeletal and Skin Diseases is actually down 8% after inflation. Research on psoriasis and psoriatic arthritis receives about one dollar per patient annually, despite the untold suffering it causes and its cost to the U.S. economy of billions of dollars annually.
We hope the Committees will use their stature to encourage NIH to increase research funding for psoriasis to correct this imbalance.
Thank you again for holding this important hearing and for considering the needs of psoriasis patients as you make your recommendations to the FDA.
Psoriasis Cure Now encourages you to contact us if we can ever be of service.
!!!
|
|
|
|
