From Mr J. Kneale
SIR,—I write conrerning the report of the inquiry by the All-Parliamentary Group on Skin into fraudulent practice in the treatment of disease. The December 18/25, 1999, issue of The Journal (p971) featured this report's criticism of the way the Medicines Control Agency has exercised its regulatory powers in this area; in particular its handling of investigations into reports of skin creams contaminated by undisclosed topical steroids. The MCA shares the inquiry's deep concern about the risks to patients presented by "cosmetic" skin creams contaminated by corticosteroids, or which make claims (true or false) to treat diseases of the skin effectively. But the MCA was not invited to give evidence to the inquiry, or to comment on its emerging findings, and unfortunately as a result the report misrepresents the agency's actions.
Your readers may like to know what the MCA has been doing. First, I want to make it clear that the MCA, as the responsible regulatory agency, does have the necessary powers to regulate these medicinal products, and to enforce the law, by prosecution in the criminal courts when appropriate. Second, the MCA's enforcement group always investigates allegations of fraudulent practice with adulterated, counterfeit or contaminated medicines. In particular, the group investigated 20 cases involving skin creams in 1998 and 38 in 1999, ranging from skin lightening creams to skin creams (including traditional Chinese medicines) to treat disease, typically eczema and psoriasis. Currently 30 cases are in action: three are in the course of prosecution, nine are being considered for prosecution, and one is being considered for a formal caution. Some £12,000 worth of illegal creams have been seized and destroyed.
The report highlights the cases of Skincap and Zx (identified by the MCA as Psorigon). These cases were investigated by the agency during the early stages of the inquiry and the abuse was stopped. The MCA decision not to prosecute was, in each case, based on legal advice on the public interest implications, and the strength of the evidence available. A detailed account of action in these cases is in the Appendix below.
The MCA welcomes the report's illumination of the serious problem which skin creams of this kind present. We are asking the inquiry to let us have any evidence or information which will help the agency to continue to investigate and enforce against the suppliers of fraudulent products. That invitation is extended to your readers. All information can be treated as "in confidence" and will be investigated.
John Kneale
Manager, Policy & Borderline Unit, Inspection & Enforcement Division, Medicines Control Agency, London SW8 5NQ
Appendix
Skincap The agency received a complaint in 1997 that this product, manufactured in Spain, was an unlicensed medicine presented for treating skin disease and marketed illegally. We confirmed its classification as a medicine and instructed the distributor to stop advertising or supplying the product. He complied. Subsequently, the agency received reports from dermatologists suggesting probable steroid contamination. We had samples tested. Once the agency had evidence that the product did contain steroids, the distributor was ordered to recall the product from all retail outlets immediately, and a Drug Alert was issued. The distributor complied, declaring in writing that unsold product had been returned to the Spanish manufacturers. The Spanish authorities were kept informed at all times of the investigation and the outcome.
Further Skincap problems arose during late 1997 and 1998 when a Dublin-based company marketed it again in the UK. The Irish Medicines Board informed us about a storage site in the UK. The agency's enforcement group seized those supplies, and the Irish Medicines Board obtained an injunction against the distributor to prevent further distribution from the republic.
Psorigon As in the case of Skincap, the agency initially instructed the distributors of this imported product to halt supply because it was an unlicensed medicinal product presented illegally for treating or preventing disease, namely, psoriasis. The distributor complied. When later testing of samples confirmed the presence of topical steroids, the agency instructed the distributor to withdraw the product from sale immediately. The distributor complied. A replacement, renamed product was launched without claims to treat disease. When samples were tested they were found not to contain steroids. Subsequently, enforcement officers paid an unannounced visit to the distributor to ensure that compliance was continuing. Samples were taken and tested, but again proved negative for steroids.