Is the EU edging towards DTCA?

Examining the consequences of industry's latest lobby
by Lisa Hayes

As part of a set of proposals creating a new legal framework for medicines in the EU, the European Commission released a proposal this July which would allow pharmaceutical companies to promote prescription products for three types of illness (HIV/AIDS, diabetes and asthma) directly to consumers during a five-year trial period. Currently, all direct-to-consumer advertising (DTCA) of prescription medicines is banned within the European Union's member states. While an EU spokesperson stated that the proposal was meant to balance information already available through non-EU websites, some public health advocates believe this announcement may be the first step towards the introduction of direct-to-consumer advertising of prescription drugs to Europe's almost 400 million consumers. As little research is available on the public health benefits of DTCA, the question remains: who actually benefits from DTCA--consumers or industry?

During the past year, members of HAI Europe's international working group on DTCA [i] have worked to raise awareness about DTCA and its possible consequences in Canada, Australia, and the European Union-all areas where governments are considering whether to allow it in some form. They have based their recommendations on data from the US and New Zealand where DTCA is legal. Now that the EU proposal has been announced, HAI-Lights asked members of the working group to explain the current state of DTCA around the world and its implications for health and national budgets.

Consumers today are taking an increasingly active interest in their own health care. The public demands more and more information about health care options and available medicines. This development has led the research-based pharmaceutical industry to call for the legalisation of DTCA as a means of providing that information. Critics of this type of advertising, including HAI, argue that drug promotion is not the same as objective information on drugs and other relevant treatments. One is intended to sell a product, the other to inform.

Although DTCA remains illegal in the EU and all other developed countries except the United States and New Zealand, there is growing pressure from some sectors to change this situation. This is being done gradually through "disease awareness-raising" campaigns and information to alert consumers to conditions they might not have realised were treatable or to provide more background on chronic diseases. "This is, of course, in keeping with the classic drug company marketing which knows that in order to sell the cure, you have to first sell the disease" a recent article pointed out [ii]. A growing number of these campaigns has now been carried out in the UK, Spain, The Netherlands and other European countries. "You won't find a pharmaceutical company funding a disease awareness campaign that says avoid drug treatment at all costs, you're much better off changing your diet and starting an exercise programme," said Barbara Mintzes, a former HAI Europe staff member who is now analysing DTCA for her Ph.D. thesis. "It just won't happen."

The appeal of DTCA for industry

"Direct-to-consumer (DTC) advertising is a powerhouse whose potential is still untapped," proclaimed a recent article in Pharmaceutical Executive, an industry journal [iii]. "It promises enormous benefits for pharmaceutical stakeholders-patients, payers, and providers-as well as new markets and profits that, without DTC, pharma companies would never have."

Just how important is DTCA to European drug companies? Rising research and development costs, the uncertainty of gaining government reimbursement for new (often lifestyle) medicines and an increasingly competitive market make it irresistible, suggests a newly released report from the UK's Consumers' Association [iv]. "NHS [National Health Service] attempts to contain costs and limit demand have, then, come at a time when the industry needs to maintain sales," it states. "This combination has given companies a powerful incentive to create demand for their products by circumventing NHS gatekeepers and communicating directly with patients. In a parallel development-the rise of the 'patient-consumer'-has created a more responsive environment for this kind of communication." [v] Powerful pharmaceutical firms are also applying direct pressure to policy makers. For example, in the UK, the industry has announced that changing UK and EU rules on drug promotion should be a priority area of work for national and EU regulators [vi].

The amount of money being spent on DTCA in the US may give some indication of the risks companies are willing to take on websites and 'disease-awareness' campaigns. Prescription drug manufacturers spent US$1.9 billion on DTCA in 1999, an increase of 150% in the past five years since 1997 when the US relaxed its advertising rules [vii]. It now accounts for approximately 20% of drug companies' promotion budgets. Competition through DTCA is likely to become more intense in the future. DTCA spending by companies jumped 58% between 1999 and 2000 [viii].

The results of such spending may be good for companies' bottom lines, but what about other consequences? "We know that they [companies] spend a lot of money for direct-to-consumer advertising, and we know the advertising pushes patients in the direction of newer drugs with higher costs when, in many cases, lower-cost products will suffice," said Woodrow Myers, healthcare management director at Ford Motor Company in a recent Wall Street Journal interview [ix].

Last September, the US's National Institute for Health Care Management reported that the 25 drugs that most contributed to an increase in prescription medicine spending in the US were the medicines most heavily advertised and which had a quick jump in sales. It also stated that approximately ten percent of consumers who view a prescription drug advertisement will request that specific drug from their doctor. (To see the full report, visit: http://www.nihcm.org/DTCbrief.pdf [x]) In a related study, when more than 300 people were asked what they would do if they requested an advertised drug and their doctor refused to prescribe it, 24% of those surveyed said they would go to another doctor to get the medicine [xi]. Concerns about the growing cost of DTCA to health budgets and consumers' own wallets even led one US Senator to hold a hearing in July, 2001 to examine the impact of DTCA on the cost of prescription medicines and their use [xii].

While DTCA can increase costs, it also carries real risks for health, suggested Mintzes. Some DTCA campaigns carried out in the US could make one wonder if pushing products has taken priority over protecting health. She explained, "Take the drug for type 2 diabetes, Rezulin (troglitazone) which was advertised to the US public for over two years after the UK withdrew it for safety reasons. It was never found to save a single life, it just wasn't studied long enough or in a big enough group of patients to know its effects on serious complications of diabetes. But by the time it was withdrawn from the US market it was the suspected cause of nearly 400 deaths, including 63 from liver failure, the reason for the UK withdrawal," she explained. In a more recent case, Mintzes recounted that San Francisco's health department threatened to ban advertising of AIDS drugs on city billboards. "The reason? They found that the more ads young, gay men had seen, the less likely they were to be careful about practicing safe sex because they thought that AIDS is now curable." Past advertisements for triple therapy used to treat AIDS certainly made it look that way, she said. "The ads showed vibrant, young men climbing mountains. Hardly an activity real people on triple therapy would consider."

Why prohibit direct-to-consumer advertising of prescription drugs?

What are the economic consequences?
- Advertising drives up prescription drug costs.
- Companies almost always advertise their newest products to gain market share and recoup development costs. New drugs are not necessarily any safer or more effective, but they are usually costlier. Often little is known about rare or long-term risks.

Does it help people choose medicines well?
- The main goal of advertising is to increase product sales. It does not provide the impartial, objective information consumers need to make informed health choices.
- Prescription drugs are not like other consumer goods. Even when used properly, they can cause serious harmful effects, sometimes even death.
- A sick person is not like someone shopping for a new perfume. People are vulnerable when they are ill and often have to make extremely difficult treatment choices.
- There is no evidence that advertising helps patients to make better choices about prescription drug use or that public health will improve as a result.
- Doctors often rely heavily on manufacturers for information about drugs, rather than independent information sources, which are usually less easily accessible. Studies show that the doctors most influenced by pharmaceutical promotion tend to prescribe less appropriately. [xxxiii]

What's behind the EU proposal?

The advertising proposal, along with the rest of the reform package, seems to be driven by the G10, a high-level group created to examine medicines in Europe. Its membership of 12 includes four senior representatives of the pharmaceutical industry. According to its terms of reference, this group will between now and April 2002 debate and report on issues relevant to the balance between health objectives and industry competitiveness in Europe [xiii].

Officially, a spokesperson for the Commission said the proposal was meant to provide consumers with better information about medicines to treat these three health problems, but others disagree. "There is no doubt that the ultimate aim is direct marketing to patients within five to ten years" stated George Rae, chairman of the British Medical Association's policy-making division in a recent Lancet article on the announcement [xiv].

Erkki Liikanen, the European Commissioner on enterprise, told journalists that the three disease areas were selected because of patient demand and the fact that they are all chronic conditions that can be easily defined. Yet some patient groups directly affected by the proposal have wasted no time in announcing their opposition to it. The Insulin Dependent Diabetes Trust (IDDT), a group promoting the rights of consumers who have had adverse reactions to genetically produced "human" insulin, is totally opposed to any measure that means the pharmaceutical industry would be able to supply information about their products directly to the consumer, said Jenny Hirst, co-chair of the UK-based organisation. "While we accept the need for consumers to have more information about prescription drugs," she explained, "we believe this information should be unbiased and therefore it is inappropriate that it should be provided by industry whose understandable aim is profit." She has seen the problems that advertising aimed at the medical and nursing professions by the manufacturers of "human" insulin has had on their membership. "Their advertising does not contain information about the availability of animal insulins, but only about the more profitable but still unproven to be superior 'human' insulins. Some people are therefore suffering unnecessarily as a result of advertising to professionals being biased towards the insulin the company wants to promote." Looking ahead, she sees DTCA only compounding the problem. "We can only envisage that this situation will be worse if industry is allowed to provide information to the all too trusting consumer."

Liikanen also said the Commission had rejected US style advertising because of concerns of the impact on government health budgets. Because European governments pay for most medicines used in Europe, he stated, anything that might raise demand would mean a cost for countries [xv]. Surprisingly, health professionals' concerns apparently did not influence the Commission: it appears that the Commission did little to seek doctors' opinions on the change [xvi]. It also completely ignored a plea made to EU leaders at last year's Nice summit by the Pharmaceutical Group of the EU representing community pharmacists and the Standing Committee of European Doctors, which called on the EU to continue its ban on DTCA "for the sake of protecting the public health of EU citizens." [xvii]

Interestingly, the Commission was asked why it was proposing a change in the ways medicines are advertised when a report it had commissioned two years ago determined "the general view is that the advertising provisions are working acceptably and there is no clear support for consideration of any changes." A Commission spokesperson responded saying the new proposal did not talk about advertising [xviii].

Only a few days after the proposal was announced, the EU suddenly altered it in order to create a monitoring role for the European Medicines Evaluation Agency (EMEA). Reports suggest that the EMEA was only brought in to the process after the proposal had been circulated to member states and the EC Pharmaceutical Committee and following strong opposition from consumer groups [xix]. Under the new system, it appears that companies will be allowed to provide information about prescription drugs approved for treatment of HIV/AIDS, asthma and diabetes directly to consumers and patient groups in publications or on websites provided that the material is first reviewed and approved by the EMEA [xx]. The agency will have one month to judge the information generated by the company. If it makes no objections, the information will be released. There will also be a code of conduct to provide a framework for industry promotion which still has to be drafted. The EMEA is also expected to publish an annual report on the success of the code. Experts forecast that it could take up to two years before the advertising proposal and other parts of the overall pharmaceutical reform package are approved by the European member states and the Parliament and becomes law [xxi].

DTCA in New Zealand and Australia

DTCA has never been illegal in New Zealand. During the past five years, the number of drugs being advertised to the public has multiplied. Medicines are now promoted to consumers through a multitude of media, including television, radio, newspapers, and even on the backs of buses. Peter Mansfield, a long-time Australian HAI contact and drug promotion expert, became concerned about DTCA during the launch of Healthy Skepticism NZ, his newsletter on misleading promotion targeting doctors, now sent to all of New Zealand's general practitioners. "I became even more convinced that DTCA does more harm than good when I was commissioned to write reports on DTCA by the Australian Pharmacy Guild of Australia [xxii] and then by PHARMAC," [xxiii] he said. These reports have since been used for government inquiries into DTCA in both countries. The New Zealand inquiry produced a range of options ranging from maintaining the current law to endorsing a total ban [xxiv] [xxv] . The Australian inquiry recommended against allowing DTCA [xxvi].

In August 2000, the Australian National Prescribing Service invited Charles Medawar, Director of the UK group Social Audit, and Barbara Mintzes to visit Australia for a debate about DTCA at the National Medicines Symposium. As part of her trip, Mintzes accompanied Mansfield on a trip to New Zealand to talk with policy makers about DTCA. About two weeks after their visit to Wellington, Annette King, New Zealand's Minister of Health, stated at a public meeting that she would take action against DTCA.

Her decision came in August 2001 when she announced that DTCA would be allowed to continue, but with tighter regulations [xxvii]. In her statement she called for legislation regulating DTCA to be strengthened "to ensure advertisements provide balanced information to consumers." The lobby organisation representing the country's researched-based pharmaceutical industry immediately responded to her decision stating "On the whole we are confident that any tightening of the regulations will serve to keep all players in the market at the standard that our members have already set." [xxviii]

"Just how high is that standard?" wondered Margaret Ewen, HAI Europe's coordinator who is originally from New Zealand, after hearing about the industry's statement. "Today companies in New Zealand are allowed to promote prescription drugs by writing to individual patients, by running competitions, giving free offers and even paying for doctors' visits. The fact that the Minister is now considering restrictions which would ban brand names of drugs on vehicles, or sponsorship of events such as the 'Propecia Car Rally: a "hair-raising experience"' show the extremes to which the industry is already taking DTCA in New Zealand." Ewen believes that country's situation should be seen as a warning to others.

Lack of enforcement in Canada

Canadians have been flooded with DTCA via US television, radio and magazines since 1997 when this kind of promotion became easier for companies to use. Since the 1990's, the Canadian government has played a less active role in enforcing its ban and a number of drugs such as Zyban and Propecia have been advertised to the public in Canada's largest cities [xxxi]. Today, the government is considering allowing DTCA as part of an overhaul of national health protection legislation and has all but stopped enforcing the prohibition. It also claims that certain kinds of DTCA are legal including reminder ads and "help-seeking" ads. Critics say there has been little public discussion about the implications that such a change would have for public health or health care costs. They also point out that the Canadian Medical Association, the Canadian Pharmacists Association, the Consumer's Association of Canada and many other health groups oppose the move to legalise DTCA.

Peter Mansfield was invited to Canada by the Working Group on Women and Health Protection, a coalition of women's health groups that formed out of concerns about effects of government deregulation, to discuss the risks of DTCA with key policy makers and health organisations. The trip included stops in Vancouver, Victoria, Winnipeg, Toronto, Ottawa and Montreal and was funded by HAI Europe. During his stay, it became clear that a number of the provincial governments were against DTCA because of fears that it would drive up the costs of their various drug subsidy schemes. At the same time, there had been strong lobbying from multinational drug companies, advertising agencies and media interests that all hoped to profit from its introduction. Mansfield saw confusion over policy as a primary reason for companies to be bold enough to break the law. "Lacking clear policy from the top, the government officials in Health Canada have been left to drift," said Mansfield. "The strongest influence on them appears to be lobbying from the large drug companies aided by 'patient groups' created by or funded by the drug companies. The bureaucrats have reinterpreted the law, contrary to the intentions of Parliament, to effectively allow DTCA as long as individual advertisements promote only the name of the drug without claims or promote claims without the name." He continued, "Several large drug companies have used advertisements that go beyond even these weak limitations, but the government has not allocated adequate resources for enforcement. Consequently, the companies keep pushing to see what they can get away with before their competition beats them to it."

Canada's next move on DTCA is still undecided. Some experts say there is draft legislation ready on the issue, but it may never be acted on by the Minister. In such a political climate, a move towards DTCA in Europe won't go unnoticed. "Allowing DTCA in the EU will further accelerate the trend towards full DTCA in Canada," warned Joel Lexchin, an expert in pharmaceutical policy based in Toronto. "The Canadian government is already unwilling to enforce legislation against DTCA. Any indication that other industrialised countries are willing to legalise it could weaken what little resolve there is left in Health Canada to keep DTCA out of the country."

Consequences for the South

At the WHO-NGO Roundtable on Pharmaceuticals held last May in Geneva, Charles Medawar made a strong case for treating DTCA as an international public health emergency. At that time, it appeared that without urgent action there was a high risk of Europe following the US. He warned that such a move would place enormous pressure on Africa, Asia and South America to do the same. As the box to the right suggests, others from the developing world agree.

Looking ahead

"A careful look at the Commission's proposed wording leaves me more concerned about what is being suggested--whether or not official Commission statements include the insistence that they aren't introducing DTCA," said Barbara Mintzes after the EU proposals became public. For example, she points out, there are seemingly no restrictions to providing "information" to people who request it or the exclusion of television or other mass media advertising or a definition of that information as something other than product-specific advertising. She concluded "I'd go by the principle here that what's not said in the legislation matters a lot, given the experience we've had in Canada with reinterpretation of an excellent law."

If the EU does not enlarge its debate to more fully assess the implications of DTCA for all stakeholders, it risks introducing advertising that could seriously damage public health and national budgets, critics suggest. The European member states now have laws in place that ban DTCA and protect public health. HAI Europe believes if that law is to be changed, the burden of proof should be on the European Commission and the pharmaceutical industry to show health benefit and lack of harm. To date, not a single study has been published that supports industry's claim of health benefits due to DTCA. "This could all end up as an 'unfortunate experiment'," said HAI's Ewen. "And not just for Europe and developed countries. DTCA's effect on poor countries where prescriptions are not needed to buy medicines could be catastrophic." Ewen concluded, "One has to wonder if protecting public health is still a priority in the EU."

A survey conducted in May 2001 by Consumers' Association in the UK found that only six percent of the approximately 2,000 people questioned considered pharmaceutical companies a trustworthy source of information [xxxii]. Yet, the organisation has pointed out, the current EU debate on DTCA is dominated by industry's interests. While it seems the EU industry has not spent large resources to conduct research on DTCA, there are concerns that it is spending time and money lobbying EU policy makers to support its point of view. "The idea seems to be that it will be cheaper to get a pharmaceutical company to brief an advertising agency about AIDS or diabetes than to ask public health officials to do so," remarks Mintzes. "This is very short-sighted. A pharmaceutical company will always convey the idea that drug treatment is needed, preferably their own drug. As often as not, this is the wrong message to be giving the public."

The impact of DTCA on developing countries
by Andy Gray

John Bunzl, founder and director of the International Simultaneous Policy Organization, has written about how the power of transnational corporations and the increasing reach of international trade agreements have limited the policy options open to governments. In his words: "competitive markets now represent a sinister 'hidden hand' which narrows the policy parameters to what has now become a highly restricted, business-friendly stance which excludes all those restorative policies traditionally espoused by the political Left to balance social and environmental concerns against those of business".

It is interesting to examine how this trend might be reflected in the hotly contested area of DTCA. The trend appears to be towards a single standard, that of the United States. Shifts towards a single, US-style standard in two of the three largest drug markets in the world will have a profound impact on the policy options open to governments in the developing countries of the South. Already, such countries are bombarded with media coverage from the developed North. Increasingly, advertising campaigns from one country spill over into the next. Magazines and newspapers flow across borders. The Internet has also rendered national borders largely immaterial. This has another effect: the standards of the North are touted as the norms, as indicative of informed and civilised policy stances.

A creeping policy consensus that is portrayed as business-friendly, democratic, patient-empowering and (almost) globally acceptable will be hard to resist. Therefore, for Europe to abandon a long-held policy ban on DTCA will not only have an impact in the member countries of the Union, it will potentially weaken the ability of developing country governments to pursue appropriate drug policies. It could harm patients and consumers and hinder efforts to promote the rational use of drugs.[xxxiv]

Future events

HAI Europe plans to hold a seminar on DTCA later this year. The meeting will bring together various stakeholders involved in the issue. More information about the meeting will be available shortly from HAI Europe. In addition, Charles Medawar is spearheading efforts to create a website on DTCA that will allow viewers around the world to retrieve all kinds of data on this type of promotion.

Because DTCA will be discussed by the European Parliament during the next few months, HAI encourages its contacts to join the regional coalition lobbying on this issue. Those interested in joining HAI's campaign on DTCA and finding out more about HAI's work on the issue, should contact the HAI Europe office.

Documents available

To read the pharmaceutical reform proposals put forward by the European Commission, go to: http://www.pharmacos.eudra.org/F2/home.html. (as viewed in August 2001).

To see HAI's press release criticising the proposals, visit: http://www.haiweb.org/campaign/DTCA/EC release 170701.htm

References