Despite recent controversies surrounding the misleading promotion of prescription drugs, the European Commission (EC) appears to be pandering to the pharmaceutical industry and considering relaxing laws on how drug information is provided to the public. The move would amount to allowing companies to advertise directly to consumers in the EU, a practice that critics say is aimed at filling drug company coffers with scant regard for public safety. This move could come despite attempts to clamp down on direct-to-consumer (DTC) advertising in the US, following reports of serious harm to patients caused by the over-prescription of Vioxx and Seroxat. With the pharmaceutical industry’s reputation already in question, tighter – not fewer – restrictions on drug advertising are sorely needed if the industry is to restore its public image.
‘The EU, to its everlasting shame, is now actively promoting [DTC advertising],’ says Charles Medawar of Social Audit. ‘Once you start advertising prescription drugs to consumers and generating demand from that end, really you just debase the value of evidence completely,’ he adds.
Industry argues that DTC advertising of prescription drugs helps educate patients and encourages dialogue with their doctors, but critics say it misleads consumers into believing they need certain medicines, and is merely a marketing tool to increase sales.
In 1997 the Food and Drug Admin-istration (FDA) relaxed restrictions on DTC advertising in the US, allowing companies to conduct intensive campaigns advertising drugs directly to consumers. Between 1997 and 2005, drug company spending on DTCA increased nearly 20% annually to $4.2bn – twice as fast as spending on R&D – according to IMS Health. The result was a heavy increase in prescription drug sales, especially for chronic conditions, according to the US Government Accountability Office (GAO).
DTC advertising allows for a huge market expansion, with people being prescribed drugs that are unlikely to benefit them, explains Medawar. ‘The expansion of the antidepressant market, which was largely completely unjustifiable, is a symbol of what happened in this era as [companies] suddenly began to realise the only way [to survive] was through marketing and not through drug innovation,’ he says. Medawar estimates that nearly two thirds of those prescribed antidepressants have no expectation of benefit and yet some run very significant risks.
Only the US and New Zealand allow DTC advertising of prescription drugs, and EU directive 2001/83/EC currently prohibits the practice. But there are signs that the Commission, through its Pharmaceutical Forum committee, is heading towards amending the law. Currently, in most European countries, company-provided consumer information is limited to the tightly regulated patient information leaflets that come with drugs. Starting with diabetes, the idea is to lift that restriction, allowing freer information dissemination through a new system that is self-regulated by a public-private partnership, according to Jorgo Chatzimarkakis, an MEP involved in the Pharmaceutical Forum.
‘A relaxation of the rules on DTC information would be welcome and is overdue,’ says Richard Ley of the Association of the British Pharmaceutical Industry. ‘Lists of side effects on patient information leaflets can’t be put into any context,’ he says. Lifting the restriction would bring pharmaceuticals in line with every other commodity, allowing manufacturers to talk more freely about their products, he suggests.
Independent sources of information, such as the Drugs & Therapeutics Bulletin and the Cochrane Collaboration, are already available to the public. But both Ley and Chatzimarkakis argue that it is the manufacturer, not independent sources, that knows the most about a particular drug, has the most up-to-date research results, and is best placed to provide drug information to the public.
They also claim they are not looking to facilitate DTC advertising. However, amending the directive and giving the pharmaceutical industry the lead in providing drug information to the public would further blur the distinction between information and advertising.
The trouble is that development of disease awareness campaigns, compliance programmes, and direct and indirect pharmaceutical industry support of patient’s organisations have already blurred the boundaries between drug promotion and health information, according to Health Action International (HAI) Europe.
And DTC advertising has serious health implications, says Teresa Alves, European campaigns coordinator for HAI Europe. ‘It has been shown to increase expenditure by governments on drugs, and to lead to over prescribing, which in turn increases the rate of adverse drug reactions.’
‘Healthcare is not a commodity – it has enormous potential to do harm,’ agrees Des Spence of No Free Lunch, a lobby group that believes that pharmaceutical promotion should not guide clinical practice.
And oversight has proved to be a problem in the US. The FDA is responsible for making sure that DTC ads in the US present a fair balance of the risks and benefits. Despite FDA policing, however, drug marketing campaigns often involve deceitful ads (C&I 2005, 3, 6).
The GAO recently said it was concerned about the FDA’s effectiveness at limiting consumers’ exposure to false or misleading DTC advertising (Nov 2006 report). It found that the FDA haphazardly reviews only a small portion of the DTC materials it receives. And the effectiveness of its warning letters – issued an average of eight months after materials are first disseminated – is limited.
The EC’s plans for an industry-led self-regulating system of information dissemination is even less likely to protect the public. Despite current regulations and industry codes of practice, the UK’s House of Commons Health Committee says the pharmaceutical industry is already riddled with flawed clinical trials, suppression of important safety data, aggressive promotion of drugs, over-prescribing by GPs and inadequate post-marketing surveillance (C&I 2005, 8, 4).
One of the reasons the EU is looking to relax the rules, suggests Medawar, is that the EC is handsomely abetted by nation states, such as the UK, France and Germany, that have major pharmaceutical industries and that operate in effect as franchisees.
‘The pharmaceutical industry is a huge net contributor to the trading surplus of the UK and so there’s enormous political good will towards pharmaceutical companies,’ adds Spence. ‘It makes it very difficult to be negative about them.’
In short, the EC needs the pharmaceutical industry. But with the majority of big pharmaceutical companies facing patent expirations, increased generic competition, dwindling pipelines, and pricing pressures, future success is not assured. To make matters worse, Alves explains that in the EC pharmaceuticals do not come under the umbrella of the Health & Consumer Protection directorate, but the directorate of Enterprise & Industry, whose mission is to promote the competitiveness of Europe and European industry. So expanding markets – not consumer safety – is the priority.
The EC is expected to publish its information strategy proposals, for consultation, by April. Previous efforts to relax the rules were rejected by the European Parliament in 2004, but Chatzimarkakis says he is confident of a different outcome this time because 75% of people in the current parliament are new.
Clampdown on targeting doctors
It is not only consumers, but also doctors who are the targets of promotional drug campaigns. After all, it is ultimately doctors who must prescribe the drugs, if markets are to expand.
Drug companies advertise in medical literature, but predominantly target doctors through sales reps, according to Des Spence of No Free Lunch. The relationship has been largely based on hospitality, perhaps in the form of trips away, first class travel and payments made to leading consultants and GPs. ‘Reps tend to work in the same area for many years, building up a relationship with local doctors over time,’ he says. ‘So a sales force operates almost as a colleague or friend. It’s a very effective way of changing prescribing practices.’
The Prescription Project, a new campaign in the US, aims to change such conflicts of interest. It has called for an end to the billions of dollars in direct-to-physician marketing that is influencing prescribing practices of doctors, including prohibiting doctors from accepting industry gifts. The Prescription Project is an initiative of Community Catalyst, a non-profit healthcare advocacy organisation, in partnership with the Institute on Medicine as a Profession. Relying on information from industry marketing campaigns rather than unbiased scientific studies, it says, results in higher cost and poorer quality.
No Free Lunch is also calling for transparency. ‘Doctors and nurses should be brought in line with other public services,’ says Spence. ‘I want to know that the drug I’m being prescribed is based upon the best evidence, not on the hospitality my doctor has shared with a pharmaceutical rep.’
Signs of backlash
In the US, the Institute of Medicine has recommended that DTC advertising be restricted during the first two years a new drug is marketed until the health risks are better understood. And on 1 February, US senators Edward Kennedy and Mike Enzi re-introduced the Enhancing Drug Safety and Innovation Act for consideration by the Senate floor, seeking, among other things, to restrict DTC ads.
Moreover, cynicism about the pharmaceutical industry from medics and the public is growing. A recent PricewaterhouseCoopers (PwC) survey revealed that consumers and stakeholders (such as doctors, researchers and policy makers) believe the industry puts profits before patients. 98% of consumers and 81% of stakeholders said that drug companies are too aggressive in promoting unapproved uses of their products. Nearly 94% of stakeholders agreed that drug companies spend too much money on drug promotion overall, including DTC advertising as well as physician education and overall sales force initiatives. And 60% think companies manipulate or suppress trial results to maximise sales.
The survey also showed that 78% of consumers consider a company’s reputation when choosing products. With consumer power increasing, drug companies may be forced to improve their reputation to avoid losing business. ‘Research has shown that a 5% positive change in corporate reputation translates into a 3-5% positive change in market capitalisation,’ pointed out PwC’s Peter Claude.