Taking liberties

While media attention was being held by which medicine will revive the ailing National Health Service, another medical issue has been brewing as the pharmaceutical companies quietly plan how to market their pills to the public.

The morning-after pill, also called the emergency contraceptive, will be advertised in women’s glossy magazines in February, to make women aware of the options available to them if “normal” methods of contraception have failed (MW last week). The advertising, a first for the UK market, has already been criticised by the Church of England and anti-abortion organisation Life.

The pill, marketed under the name of Levonelle, is owned by Schering Health Care, a company which has “interests” in the fertility control drugs market. Critics are concerned that Levonelle’s advertising drive could mean that the pill will easily end up in schoolgirl satchels as a “lifestyle drug”.

Gaining credence through the back door

A City analyst, while not wishing to comment on the moral issue of contraception, says: “This seems exactly what Pfizer did with Viagra – marketed it in such a way that it has rapidly and readily been absorbed into popular culture.”

Schering first launched an emergency contraception pill in the early Eighties called Schering PC4, a combined oestrogen-progestogen hormonal pill. The pill was withdrawn in October last year, following the launch of Levonelle, a progestogen-only pill that doesn’t have the side-effects of the combined pill. The morning-after pill was declassified from being a prescription-only medicine to a pharmacy drug last year, and Levonelle has been on sale since January 30, 2001 as an over-the-counter (OTC) drug from pharmacies priced at &£19.99 for one treatment.

According to Schering’s research, only 40 per cent of women are aware of the availability of emergency contraception through pharmacies. The drugs company claims its advertising campaign will help inform women that “the sooner they take Levonelle after unprotected sex, the more likely it is to work.” The ads, created by Dewar Alexander, will also appear in poster formats in pharmacies and in women’s toilets in bars, clubs and cafés. Media planning and buying is through Jones Britton Breckon Company.

But somewhere along the line, the pharmaceutical companies appear to have fused the distinction between advertising and information in an industry-inspired attempt to boost sales, says a City analyst.

James Dudley, a healthcare strategist, explains: “The purpose of advertising for any manufacturer is to increase its market share, and the same holds true for pharmaceutical manufacturers. They would like to create a set of consumer choices just like other markets, and make good money”, he adds.

Who’s in control?

Another City analyst questions the controls on the sale of drugs once they become OTC drugs. “Who is to say that under-16-year-olds will not go into pharmacies to buy Levonelle? Also, I have a 13-year-old daughter, and if she were in any kind of trouble I would send her mother to buy the pill if the pharmacist refused it to my daughter,” he says.

The Medicines Control Agency (MCA), the regulatory body of the pharmaceutical companies, initiated a review in December to look at declassifying more prescription drugs and within a shorter time span. The time taken to declassify a drug from prescription-only to OTC has already been reduced from 18 to 12 months, but the MCA is proposing to introduce a wider range of OTC medicines by the end of 2002.

“This could precipitate an advertising war,” says Peter Cartwright, a healthcare analyst at Williams de Broe.

Cartwright agrees with the Government’s argument that declassifying drugs will take an unnecessary burden off the NHS by reducing demands on GPs’ time, but is more reticent over marketing OTC drugs. ” I believe the US-style of advertising for pharmaceutical drugs is already creeping into the UK. A recent Pfizer sponsorship of a radio programme on a London station was nothing less than a thinly disguised ad for Viagra,” he says. He adds that the Internet is already being used by most manufacturers to disseminate information about their products and brands.

The National Pharmaceutical Association (NPA) is also concerned about whether manufacturers of pharmaceutical drugs will draw a clear distinction between advertising and providing information. NPA director of pharmacy practice Colette McCreedy believes there needs to be more sensitivity when handling such messages: “We do not have a problem with declassifying prescription-only to OTC pharmacy drugs. The issue here is dealing with consumer expectations once a drug is advertised. For instance, when companies began to advertise hydro-cortisone creams, such as the insect-bite creams, people expected to be able to go into the chemist and buy the cream and simply use it. But the creams were not licensed to be used on the face and the ad did not spell that out clearly.”

The problem with the Levonelle ad, says McCreedy, is that there is no mention of the legal age of sexual consent and that under-16-year-olds should not be able to buy it.

Side-effect or goal?

Others go further, and blast the Levonelle-style of advertising as just a clever tactic to attract more consumers and drive sales.

A spokeswoman at the Family Planning Association (FPA) says: “Clearly one of the aims of advertising is commercial gain.” But FPA chief executive Anne Weyman says she cannot understand the fuss created by Levonelle’s advertising.

“It’s extraordinary that advertising emergency contraception should create such a storm. Women have the right to control their own fertility, and if a small minority are uncomfortable with that idea they need to get real. You don’t get this kind of fuss over condom advertising,” she says.

The Society for the Protection of the Unborn Child (SPUC), which has brought a suit against Schering challenging Levonelle’s status as an emergency contraceptive as opposed to an “aid-to-abortion drug”, finds the drug’s ad unacceptable. The court case is still pending in the High Court.

An SPUC spokesman says the advertising does not issue any warning that Levonelle can induce miscarriage or that its use does not prevent sexually transmitted diseases. The pill is taken in two doses, 12 hours apart, and claims to be 95 per cent effective if taken within 24 hours of unprotected sex.

Schering takes the line that it is increasing women’s access to emergency contraception and that this achievement, now one year old, is worth celebrating.

Consumer watchdog the Consumers’ Association (CA) has been leading the resistance to the European Commission’s proposals to relax the ban on advertising prescription medicines directly to the consumer. The CA has always maintained that consumers do need more information on pharmaceuticals, but not from companies that sell them (MW July 19, 2001).

Strangely, the CA does not want to comment on Levonelle’s advertising. It says that the ads, which say “Oops, split condom” and “Oops, missed pill”, are entirely “within the prerogative of the company.” The CA also welcomes Levonelle’s declassification to an OTC pharmacy drug. But it is lobbying to keep the ban on consumer advertising for prescription-only drugs.

The EC is proposing to allow consumer advertising for three specific medical conditions initially – AIDS, diabetes and respiratory problems such as asthma. Brands that could profit include GlaxoSmithKline’s Retrovir, an anti-AIDS drug; asthma brands such as AstraZeneca’s Oxix; and Novartis’ diabetes drug Starlyx.

According to healthcare strategist Dudley, most companies do not intend to use a switch to OTC as an excuse to advertise because the prescription-only market is much more lucrative, but switching does create the opportunity to advertise to consumers. He cites Gaviscon and Clarityn as examples.

One industry insider goes so far as to claim that drugs companies are pushing the MCA to get OTC clearance so that they can advertise their brands to consumers without real impediment.

Stephen Waterman, an analyst at Teathers & Greenwood, challenges this, saying OTC sales are not as profitable a business as prescription drugs. “For instance,” he says, “Zantac used to make lots of money for GSK as a prescription drug, but since it went OTC and off-patent, the company has not been the same.”

Slippery slope

According to Waterman, in the US, drugs companies spend as much as $150bn (&£106bn) a year on advertising to consumers alone and he does not buy into the idea that the UK will be able to avoid the US-style of advertising. “This will be good news for big organisations such as Pfizer and GSK.”

Schering, meanwhile, is lucky not to have any rival to its Levonelle brand, according to the Proprietary Association of Great Britain (PAGB). The PAGB, an industry body responsible for OTC drugs, says that although companies have a clear advantage being able to advertise their drugs once they have the OTC pharmacy licence, they lose out on the prescriptions market. “These companies then need to sell a lot more drugs through OTC to make a profit than they would have to have done through GPs,” says a PAGB spokesman.

But the PAGB does not believe the pressure to make a profit will lead to false claims in advertising. The Association of the British Pharmaceutical Industry (ABPI), a trade organisation representing UK drugs companies, agrees and a spokesman says: “We are a very ethical industry. There are no fears of it resorting to enticing customers simply to buy its products.”

The ABPI has long been the supporter of consumer advertising in the UK but adds that it does not favour the US system, as that would lead to consumers favouring those brands that receive advertising support. “We support providing information to promote awareness of availability,” adds the ABPI spokesman.

But few believe it will end there. Most analysts see drug giants pitching their goods directly to consumers in the near future, using basic marketing skills that will contribute to a drug’s profitability.