OTC’s voyage of self exploration

SBHD: With the big pharmaceutical companies planning to launch, among other things, over-the-counter home contraceptive and HIV test kits, it looks as though 1995 could be the year for self-diagnosis.

Unilever healthcare subsidiary Unipath is testing an over-the-counter home-test contraceptive kit, codenamed “Utopia”, for launch at the end of the year.

The computer-assisted monitor is claimed to be 100 per cent accurate and allows women to have sex without traditional forms of contraception such as condoms, the pill or the coil. The kit incorporates a stick for urine samples and a hand-held computer, which indicates fertile and infertile days of the monthly cycle.

Home-test kits are not new – pregnancy test kits have been available for eight years – but there are signs that it is about to move from being a low-volume, fringe sector, to a core activity for many pharmaceutical companies. Home-test kits offer direct access to consumers as well as opportunities for spin-offs and follow-on sales.

Boehringer Mannhiem is developing slick new cholesterol tests which also involve treatment. Breath-tests are also being developed to identify when ulcers and indigestion occur, allowing rapid treatment with appropriate drugs. Blood pressure and blood-glucose meters are two of the fastest growing products in the US market. Self-diagnosis tests for a host of different cancers and sexually transmitted diseases are also being developed by major pharmaceutical companies such as Wellcome.

Supermarket chain Safeway also uses in-store diagnostics in five of its 71 pharmacies; the “body MOT” for £4.99 includes tests for cholesterol, blood glucose and allergies, and uses “patient medical records” to monitor progress (MW November 11).

Self-diagnostic products offer an opportunity to develop closer relations with consumers as the traditional health service is broken up and doctors’ power is undermined across Europe. As EC health policy commissioner Padraig Flynn told the Euro-pean Proprietary Medicines Manufacturers Association in Vienna: “In my view there is more scope for doctors to develop their role as advisers rather than prescribers.”

De-regulation willing, into the next century pharmaceutical companies may try to catch up with the rest of the marketing profession by introducing mail order, database and relationship marketing. They may develop their own medical records of patients and use multimedia and home shopping facilities, as well as targeting large groups of company employees and nursing home patients.

Last week, general manager of Zeneca Pharma UK Mike Gatenby told the Pharmaceutical Marketing Society’s annual advertising awards at Grosvenor house that we could see Mail Order Pharmacy coming to the UK from the US.

Elsewhere in Europe, this has already begun. Before Christmas, the Dutch government announced the introduction of mail-order pharmacy. By then, US mail order drugs firm Caremark had already invested Fl10m (£3.7m) to set up a “mega pharmacy” in Utrecht.

With retailers and wholesalers wielding greater power in European markets, manufacturers are seeking new ways of re-gaining control of markets, by getting closer to the consumer.

However, pushing back regulatory boundaries will not be easy, particularly in the area of self-diagnostics.

According to Fabien Dufrasse, group manager in charge of new product development at Unipath, healthcare companies need to show that they are responsible. “Like the pill and the coil, which offer no protection from sexually-transmitted diseases, our system is not an appropriate method of contraception for people with certain lifestyles,” he says. For this reason when the product is marketed at the end of next year, he says, Unipath will target those in “stable” relationships, probably in the 25-to-40 age range.

However, the real test of how far drugs companies can push regulatory limits will come this year with the emergence of OTC HIV home-test kits in the US.

One of the big financial purchases of 1994 was Johnson & Johnson’s acquisition of Clinical Diagnostics from Kodak in September 1994 for $1bn. The company makes home pregnancy and blood glucose testing and blood screening for donor clinics. It is currently seeking Food & Drug Administration authorisation to market OTC HIV home-test kits in the US. According to sources, Johnson & Johnson is planning to bring the HIV home tests to Europe through alliances and is likely to start in France.

The home kit being tested in the US involves consumers buying the kit, making a test which lasts just eight minutes and involves three drops of blood, and mailing it to the diagnostic laboratory. After 24 hours, consumers dial an 800 number. They will then either get a negative result and be told to be careful in the future or will be put through to a life counselling centre. It will be available in the US by the beginning of this year. But a number of organisations in the US have protested against the use of home-testing kits which do not have adequate counselling back-up.

J&J is not the only company considering a move into HIV home-testing in Europe. Smith-

Kline Beecham’s managing director of consumer brands Peter Glyn-Jones says that he is in negotiations with another pharmaceutical company to develop HIV testing kits, though the SB version is likely to involve health professionals in the process. “If you are going to enter this market you have to make sure that you handle it as carefully as you can,” he says. With emerging anxieties about the efficacy of HIV home-testing, and plans already at an advanced stage, the first real test of this newly-emerging market may come sooner than many think.