A.K. Gupta MD, FRCPC
Division of Dermatology, Department of Medicine, Sunnybrook and Women’s College Health Sciences Center (Sunnybrook site), and the University of Toronto, Toronto, Canada
ABSTRACT
In a matter of months, consumer’s word of mouth, presentations at scientific meetings and Internet hype result in spectacular sales for an unlabelled use of Skin-Cap.. This OTC product is eventually banned after the presence of a potent corticosteroid is suggested by the private sector and later confirmed by drug agencies. Nothing quite like this has taken place in the modern era of dermatology. With all-powerful drug regulatory agencies, evidence based medicine and sophisticated, accurate drug assays, how could this saga take place?
Dr. Stuart Maddin, Editor
Key Words:
corticosteroid, Cheminova
A Chronology of Events
Manufacture
Early 1980s:
- Skin-Cap® developed by Cheminova Internacional S.A., Spain.
- Active ingredient is listed as zinc pyrithione and the labelled indication is seborrheic dermatitis (dandruff).
Marketing
- Marketed as an OTC in many countries. Patients treating their own psoriasis spread the word about good results and usage increases.
Mid 1990’s:
- In the USA, available from distributors through mail-order with dandruff as the labelled indication.
Early 1997:
- Rumors of unlabelled corticosteroid present in Skin-Cap.
March, 1997:
- Preliminary results from a clinical trial in progress at the University of Minnesota, presented at the AAD by Dr CE Crutchfield III, are reported widely generating much interest.
- Patient psoriasis self-help groups and discussion on the Internet fuel further interest in the product.
Mid 1997:
- Skin-Cap is widely endorsed by some dermatologists after they witness improvement in patients’ psoriasis.
- World-wide demand for Skin-Cap. reaches 1,000,000 units per month.
Regulatory concerns
- Regulatory agencies in Spain, Austria, Belgium and the Netherlands express concern about the possibility that Skin-Cap® contains corticosteroids.
- Acting on concerns expressed by the National Psoriasis Foundation and others, the FDA in the USA and the HPB in Canada decide to investigate the formulation.
1st August, 1997:
- At the AAD Summer meeting, Professor Mark Lebwohl, Mt. Sinai School of Medicine, announces that clobetasol proprionate was present in several units of Skin-Cap® tested.
- FDA detects “prescription” levels of clobetasol proprionate.
- Analysis at the Mayo Clinic and assays conducted independently in several other laboratories in North America detect the presence of corticosteroids in Skin-Cap®
4th August, 1997:
- Cheminova repeatedly deny that the US product contains steroid. Most recent denial dated 4th August in a letter to the National Psoriasis Foundation.
Warnings and regulatory action
8th August, 1997:
- FDA issues a warning about Skin-Cap® containing steroids and orders detention of shipments at all border entries.
- National Psoriasis Foundation issues a warning.
- AP, Reuters and other news agencies circulate the warnings and mentions appear in daily newspapers.
12th August, 1997:
- AAD president circulates an alert to all members.
13th August, 1997:
- Health Canada issues a warning and states that the Canadian distributor has voluntarily stopped sale of Skin-Cap® in Canada.
26th August, 1997:
- Withdrawn in Belgium
September, 1997:
- It is rumored that the 7-8 American distributors of Skin-Cap® are meeting to consider whether or not to start a class-action against Cheminova.
- Manufacturers of DermaZinc®, through a Florida distributor, are attempting to meet the needs of psoriatics unable to obtain Skin-Cap®
Counter-claims
- Cheminova, still claiming that appropriate assay procedures will show that corticosteroids are not present, submits samples to an assay using a MALDI-TOF mass spectrophotometer located in Vancouver, Canada. This test was positive for the presence of corticosteroid.
September 5th, 1997:
- An independent laboratory (Michigan State University, Dept. of Biochemistry), using specified extraction techniques and Fast Atom Bombardment Mass Spectroscopy, is unable to detect clobetasol.
September 9th, 1997:
- Cheminova International states that Skin-Cap® is once again allowed to be marketed in the Netherlands, that new batches have been dispatched to Germany, Holland, France and Italy, and the product is legal in all these markets.
With regard to the reintroduction of Skin-Cap) into the Netherlands, it should be understood that tests conducted at four different laboratories in the Netherlands DID show the presence of prescription amounts of steroids and the original formulation is not allowed to be marketed and sold there. A REFORMULATED product can be marketed if it does not contain steroids, and if the accompanying patient information leaflets make no medical claims about psoriasis. The reformulated product will be subjected to random testing for the presence of steroids.
Future
After reviewing the events that have unfolded, it is quite likely that in the future Skin-Cap. reformulated without corticosteroids, or similar products containing zinc pyrithione, will continue to be promoted for dandruff and/or psoriasis.
Dr. Stuart Maddin
The Internet Angle
Dermatology feels the influence of the Internet
Physicians treating AIDS patients are no strangers to the power of the Internet, but this is the first time that dermatologists have experienced such pressures.
- A quick surf demonstrates intense interest and lively debate about Skin-Cap®
- A web-site (http://members.tripod.com/ ~saveskincap/) is spreading the message – Save Skin-Cap)! Psoriatic patients find the product effective and don’t want any interruption in the availability of Skin-Cap®, regardless of whether steroids are present.
- Advice is given on obtaining “cross border” supplies from Mexico.
- As one would expect, rumours of a conspiracy between regulatory agencies, drug companies and the dermatologic establishment abound. The National Psoriasis Foundation is said to be influenced by heavy sponsorship from drug companies. Dermatologists are said to be trying to protect their income.
