Who Are You Talking To?

Ever since US regulations prohibiting direct-to-consumer advertising were relaxed in August of 1997, pharmaceutical companies have been spending a lot of time, and billions of dollars, reaching out to average Americans. Increasingly, the Internet is their medium of choice. But in Europe, companies are at a distinct e-disadvantage. Drug firms are still forbidden to communicate with consumers about prescription medical products in almost any meaningful way. They are not allowed to mention brand names, nor to say specifically what a product does. Firms can, however, let consumers know that they are working in a general disease area. And they can encourage consumers to go see their doctors. For some companies--specifically, those with dominant market shares--such vague communications may be worthwhile. Pfizer, the manufacturer of Viagra, seems to think it will be. The American firm has reportedly budgeted $30 million for a Europe-wide ad campaign to educate consumers about the symptoms of erectile disfunction. Pfizer stands to benefit, because at the moment, Viagra is the only orally administered impotence drug on the market. It effectively has no competition. Other Big Pharma firms with major market shares in Europe have also begun communicating to consumers, encouraging them to see their doctor, knowing that doing so increases the odds that patients will emerge from consultations with prescriptions. For these firms, dominating markets such as contraceptive products, certain vaccines and insulin, the issue is how to get European consumers to the web sites that present their messages. But general-awareness campaigns aren't likely to help companies selling products in crowded markets such as hypertension, and might actually benefit competitors. Given the restrictions on DTC communication, it's little wonder that most drug marketers in Europe are directing their Net efforts to physicians, with whom they can communicate directly about prescription medicines. But frustration with the European restrictions is growing, and governments--who say the regulations prohibiting DTC advertising are meant to protect consumers-- recognize that European citizens are already accessing medical information and being exposed to product advertising via the Internet. Many industry observers expect Europe's anti-DTC regulations to be relaxed eventually. Companies leery of irritating bureacrats that might retaliate in some way are thinking what they can do within the bounds of current law.

Drug marketers in Europe are becoming more sophisticated in the way they talk to consumers and use the Internet—despite regulations that strictly limit such activities.

by Deborah Erickson

• In Europe, it's verbotenfor companies to direct advertising about prescription medical products to consumers. Governments say they want to protect vulnerable patients, and limit demand that would raise national health costs.

• Yet regulators know their citizens are already getting medical information, and being exposed to medical advertising from US-based firms, via the Internet. Given these realities, many observers say it's just a matter of time till the EU relaxes its anti-DTC position.

• For now, drugmakers are watching the States, and working on new ways of promoting products that won't violate European regulations. They proceed, knowing that the European pharmaceutical industry's self-imposed codes are sometimes stricter than government laws.

• Companies with dominant market shares find it worthwhile to sponsor general-awareness campaigns and web sites for consumers. But firms selling in crowded markets figure such efforts won't benefit them much, and might actually hurt.

• Debate over DTC advertising in Europe is growing more heated, but it's still not certain who will make the case for change to legislators.

Ever since US regulations prohibiting direct-to-consumer (DTC) advertising were relaxed in August of 1997, pharmaceutical companies have been spending a lot of time, and billions of dollars, reaching out to average Americans. Across the United States, advertisements for prescription drugs now appear on television, radio, in magazines and newspapers. Companies are also increasingly communicating to and with US consumers via the Internet, through web sites that highlight their products and offer information useful to patients. DTC pioneer Schering-Plough Corp. , for instance, still places ads on the sides of buses to promote its anti-allergy medication Claritin, but consumers can also sign up via the Web to receive e-mailed updates on local pollen counts.

Entities with all sorts of stakes in the medical field are talking to US consumers about medical matters these days—with the Internet as medium of choice. But in Europe, companies are at a distinct e-disadvantage. Drug firms are still forbidden to communicate with consumers in almost any way about medical products and treatment options. Governments, claiming a wish to protect their citizens—and, to limit demand for drugs that might raise national health care costs—maintain staunch policies against DTC advertising. The key piece of legislation, Council Directive 92/28/EEC, prohibits "any inducement designed to promote the prescription, supply, sale or consumption of medical products." The directive, implemented in the UK under the Medicines Act 1968, doesn't specifically mention the Internet, because it predates it—but it clearly applies to any form of electronic communication. Ironically, companies operating in Europe are hindered not only by government regulations but also by the European pharmaceutical industry's own self-imposed and self-regulated codes of practice. These codes can be even stricter than government laws.

Thanks to its relative pricing freedom, the US market is already the profit center of the pharmaceutical world, giving a strong business advantage to companies with a strong American presence. The ability to communicate directly with consumers in the States widens the competitive gap between companies ready to play there now and others that haven't yet found a way in. Firms that have already established themselves in the US have the potential, through advertising that drives consumers to consult their doctors, to boost sales above levels they could achieve by detailing to physicians alone. Companies that are effective in reaching consumers increase their share of the market and build brand recognition, not only of individual products but of the company as a whole. Consumer recognition is an asset that can pay dividends for years and years, for instance by helping firms establish franchises and extend their reach.

Drugmakers now advertising their products in America, particularly those using the Internet to do so, are not just building strength in the key global market—they're also gaining mind share with European consumers. That's because already some 15-20% of the contacts with US-based web sites are thought to originate from outside the US. The phenomenon will only intensify as more households around the world gain access to the Internet.

European consumers surfing the Net can easily learn about products sold in America, by choosing to disregard posted warnings that a site is "intended for US residents only." They can't get into the password-protected, physician-only sites that are just about the only web efforts pharmaceutical firms are making for Europe. Even though Europeans generally can't order products and services from American web sites, they can go visit their doctors and ask for the specific drugs they've learned about on the Internet. While Europe sits silent, competitive edge is going to pharmaceutical companies running US-based web sites.

Many observers of the pharmaceutical industry believe that the regulations now prohibiting DTC advertising in Europe will be relaxed eventually. The Internet is clearly the most powerful force for change, because government officials recognize that individuals are already using it to access medical information on-line, whether they approve or not. Longstanding laws permitting European citizens to buy small amounts of prescription medications overseas for "personal use" are also being stretched by the Internet. In Denmark, for instance, regulators have taken the position that residents can legally purchase medicines on-line, from sites physically located outside the EU—although direct mailing of drugs within Europe itself, even by brick-and-mortar pharmacies, remains illegal. The perception that US experience with DTC seems mostly positive so far, may also contribute to the loosening of European restrictions. Regulators see that the American Medical Association and the US Food and Drug Administration (FDA), both initially concerned about the Internet, have become proponents of distributing information to the public through this medium.

But it's still not clear when DTC advertising might be legalized in Europe, in part because it's not clear who will carry the flag for change. Pharmaceutical marketers fear that if they move forward too aggressively, they could face later reprisal. Irritated bureaucrats might, for instance, deny them approval on another drug, or grant them a punishingly low reimbursement price. Although several lawyers and executives speaking recently at a Vision in Businessconference about DTC advertising in Europe urged companies to "just try it and see what happens," few if any marketing people in attendance seemed willing to make this kind of potentially career-busting move.

For now, pharmaceutical manufacturers are studying and trying to apply the sorts of tactics that their competitors and their own US divisions are using in the States, to boost sales in Europe without violating existing laws. Some firms with dominant market positions are running or preparing to run general-information advertising campaigns and information sites for consumers, figuring increased awareness of treatment possibilities can only benefit them. Others—particularly those selling products in crowded markets—feel it simply isn't worth the expense to communicate vaguely with European consumers, when they can speak directly to prescribers instead. Certain companies feel they must have an Internet presence, if only to counterbalance messages that consumers are posting on personal web sites and in chat rooms, regulation-free. Despite Europe's prohibitions, companies are learning how to talk to consumers.

It appears that Europe will soon get a lesson in direct-to-consumer communication courtesy of Pfizer Inc. , the US-based manufacturer of Viagra. The company has hired the London office of advertising firm McCann Erickson to prepare a general disease-awareness campaign about erectile dysfunction, the disorderViagra treats. The campaign is expected to roll out in the UK, France, Germany, Italy and Spain initially, then elsewhere in Europe later this year.

The ads won't mention Viagradirectly, but will discuss symptoms of erectile dysfunction and urge sufferers to seek treatment through their doctors. Pfizer is said to have budgeted some $30 million to support its Europe-wide ad campaign. In a sense, the campaign will be a follow-on to the massive media play that Pfizer got for free, all over the globe, when the drug was first launched. Now that all the nervous laughter about "the erection pill" has died down, Pfizer is taking the opportunity to soberly discuss erectile dysfunction.

A symptom-awareness campaign stands to benefit Pfizer in Europe, even if it can't promote Viagraby name, because the drug is the leader in its market. If the company succeeds in encouraging patients to go to their doctors and talk about their symptoms, up go the odds that some of those people will emerge with prescriptions for Viagra. Although some of the company's spending to educate consumers could ultimately benefit the makers of another impotence treatment, Caverject, Pfizer won't waste much.

Viagrabecame the market leader for a reason—because consumers much prefer the idea of taking a little blue pill by mouth to inserting a pellet in the penis. If and when increasing numbers of European patients start talking to their doctors about erectile dysfunction, Pfizer can be confident that Viagra's perceived advantages will continue making it a winner.

Viagrawon't have the distinction of being the only oral medication for erectile dysfunction too much longer. Takeda Chemical Industries Ltd. and Abbott Laboratories Inc. just received a preliminary notification from the FDA of marketing approval on April 10 for Uprima, a new treatment for impotence that acts by a different mechanism—through the central nervous system, versus the vasculature. Perhaps that's one reason why Pfizer is moving now to educate Europeans about erectile disfunction—as an offensive move to assure its dominance, while it is still the only orally administered drug in town. If Takeda and Abbott tried to do a general campaign upon introducing Uprima, they'd probably just end up improving Pfizer's position as market leader instead of distinguishing their own branded product.

A general European marketing campaign may give a boost to Viagra, since it has virtually no competition, "but companies trying to sell products into more crowded markets generally have the feeling that it's not worth running vague campaigns—which are currently the only sort European regulations permit," Wolfgang Simon, MD, a member of Bayer AG 's E-commerce team, asserts. In the US until 1997, pharmaceutical firms were permitted to communicate only two of three things to consumers: the company name, the drug name, or the indication. In Europe now, the rules are even stricter. Companies simply cannot mention brand names to consumers or discuss in any specific way what a drug does.

"If the ads have to be so vague that consumers can't link the medical problem to a company's prescription product, that's not much help and it could actually hurt you in certain markets," Simon declares. In big-money markets like hypertension or high cholesterol, where up to 15 companies vie for share, an individual company that paid for "see your doctor" ads would arguably be helping competitors at its own expense.

Market Leaders Can Leverage the Internet

The hefty budget and Europe-wide scope of Pfizer's impending Viagracampaign makes it a rarity—but other companies with majority market shares have also begun taking limited steps to leverage their positions by communicating directly to European consumers. They don't need to advertise product names, because, like Pfizer in its niche, they don't have much competition. For them it's enough to promote their companies in association with disease areas. To date, European companies have made barely any use of TV, radio or other traditional consumer channels like magazines to discuss their products. They're using the Internet, where they've got time and space to provide in-depth information.

"Because we are a market leader in the areas of contraception, hormone replacement therapy and fertility/gynecological products, we believe it's worth providing generalized patient information about these subjects," declares Raymond Clarijs, Organon Teknika NV's marketing manager. "As more people learn that these sorts of products and treatments are available, and begin asking their doctors about them, our company benefits almost automatically, because we are a key supplier," he explains.

The crux of Organon's effort is an English-language web site, organon.com, where consumers can find general information about the company's main product areas. Clicking on product names either leads to a password request for physicians, or a sort of pink-paged newsletter geared to women, with sections about contraception, infertility, or osteoporosis.

Organon thinks its web site has been a cost-effective way of reaching patients, though Clarijs declines to say how much the firm has invested to establish or maintain it. "We judge the value just by counting the number of hits people make in an average session, how many paragraphs and pages they look at. You can't compare spending on this sort of thing to spending on sales reps that call on physicians. But it's helpful to see the traces people leave, showing where they've been, and what they've looked at," he declares.

The company has made few additions or changes to the electronic information it posted some years ago, Clarijs notes, and consequently, the site could benefit from updating. But it's hard for the company to find the time, and more importantly the expertise, to do so, he says: "Our business is not publishing; it's marketing products. So there are probably better sources of information available. That's why we're now thinking about allying with an on-line publisher, to help us improve the site content and refresh it on an ongoing basis." Nevertheless, Clarijs says, "we offer more to patients than many corporate sites, which only employees visit."

Even more than Organon, Novo Nordisk AS dominates its primary market—insulin-dependent diabetics. Indeed, it dominates the area to such an extent that it can, to some degree, succeed in creating web site traffic despite strictures that limit the kinds of cross-referencing methods that US-based sites use to draw consumers. People often find their way to sites sponsored by US-based drug companies by doing Net searches for the name of a product they've heard about through a magazine article or a friend or in a disease-oriented chat room. But that avenue of approach is essentially closed off to European firms unable to mention product names. Luckily for Novo Nordisk, so closely associated with insulin that is integral to the treatment of diabetes, the firm doesn't really need to mention a brand name.

"People are not looking for a company when they go on the Internet. They're looking for information about a product or a disease," says Ralf Ackermann, MD, head of informatics and training at Novo Nordisk AS. Consumers who log onto diabetes.dk find an attractive site which doesn't immediately mention a product, but gives opportunities for different age groups to ask questions about diabetes. At the moment, however, the site is useful only to people who speak Danish—not a big portion of the market. Indeed, 99% of Novo Nordisk's product is exported.

Novo Nordisk's web site will be changing, Ackermann says, explaining that the revisions will reflect the company's growing appreciation for segmentation profiling. "You've got to create the site and the service for the right audience," he declares. Newly diagnosed patients, for instance, probably don't hear much of what a doctor tells them in a brief office visit, "because they're still in shock," he points out. Ackermann believes the Internet provides opportunities for companies to support both doctors and patients with information. Before too long, newer technologies such as mobile phones and interactive TV will be used to deliver health care information, he believes.

In the meantime, Novo Nordisk is contemplating how else it might distinguish itself and its products with non-traditional methods that are not outlawed in Europe. The firm is, for instance, developing a CD-ROM game "to work on teenage behavior," he notes. "It'll be like a Jeopardygame, interspersing questions mostly about sports and entertainment with some questions about diabetes. We hope it'll help kids' friends understand what it's like to be a diabetic, because that's something they often complain about…that no one understands what it's like for them."

Thinking About Customers

SmithKline Beecham is also trying to take advantage of the dominant position it holds in certain pharmaceutical markets—and the Web is a big part of its strategy. The firm has been particularly active in utilizing the medium in Germany, long before its CEO Jan Leschly and Glaxo Wellcome PLC 's chairman Richard Sykes announced their intention to unite the organizations to create "an Internet company". SB maintains a central web site in Germany called sb-online.de, which mostly presents the company to medical professionals that see different kinds of patients each day. But Reinhard Merz, who's responsible for SB's Internet sites in Germany, feels strongly that drugmakers need to think about marketing via the Internet less in terms of promoting corporate identity and more in terms of serving consumers' needs. He declares, "No one knows SB, and merging with Glaxo isn't going to change that. So you can have a corporate web site, but not many regular people will go there. Why would they?"

Merz is convinced that thinking from the customers' perspective, and plotting a cohesive web strategy based on that understanding, can only benefit a corporation—whether direct-to-consumer advertising is legalized in Europe or not. With that in mind, the firm has been creating general-awareness web sites targeted to specific consumer groups. To help get people to the sites, SB has chosen domain names that reflect the interests and needs of the target audience. Net surfers can thus find their way to the sites without having to type in a specific product name—a point that's important given Europe's restrictions, but tactically valuable anywhere. (It may, however, be increasingly difficult to pull off in the States, where people have been complaining for some time now that "all the good names are already taken.")

In Germany, SB maintains a German-language web site called fit-for-travel.de, because it is a leading producer of vaccines that doctors could recommend if patients asked how they might protect themselves against diseases common in the tropics. The site has a bright and sunny feel, and features a cute, colorful cartoon of a big-beaked tropical bird. It doesn't mention any products, but does give viewers general reminders to ask their doctor about health precautions they might need to take before visiting the tropics. "The message we give consumers is, ‘There is risk. You could protect yourself,'" Merz says. He adds, "That works for us, because we've got more than a 50% share of the market for vaccines against typhus, and hepatitis A and B. Such a strategy is harder to support if you've got a market share of 10%. Then you're working for others."

All the medical and scientific data on the fit-for-travel.de site is prepared by The Institute for Tropical Medicine at the University of Munich, because Merz feels strongly that "The institution is a content certifier. Without it, Internet consumers won't trust the information." To help get traffic to the site, SB has linked the site to travel agents, insurance agencies and publishers that write about holidays. The drug company also does joint promotions with these groups, such as mailings, none of which mention any products specifically, out of respect for European laws.

The web site SB runs from the States to support its hepatitis A and B vaccines, and a combined product, is permitted to speak much more directly to US residents. The company takes advantage of that ability to reach out to gay men. Merz notes, "It's much easier to target a community like gay men than travelers, which include people going on holiday or travelling for business, children accompanying parents, elderly people, and others." SB's strategy for marketing to this audience via the Web revolves around a site called boymeetsboy.com. The site features a four-panel cartoon: Boy meets boy; boy gets Hepatitis A; Uh-Oh; Should've got Havrix! The accompanying text explains why gay males might want the protection offered by a hepatitis A vaccine, even if they practice safe sex.

SB is just now building a Parkinson's web site in Germany, parkinsons.de, to support Requip, a product that has been on the market there for two years. Like the tropical medicines web site, this site will also post information from a trusted institution—in this case, a hospital well known within Germany for treating Parkinson's patients. "We are not the market leader in this field, but we want to give our message, that there are old-fashioned products on the market as well as several new products that are modern and have fewer side effects," Merz says. He notes that the message is geared mostly to family members of people afflicted by the disease, rather than to patients themselves.

"In the next year or so, we will probably do web sites for each of our drugs in Germany, just to inform people in a way that we find correct," Merz declares. He notes that, "Vaccination is a field where these days there is always a discussion, with parents often saying it's not good, and others such as doctors and epidemiologists saying it is. We would just like to inform people on topics like this: Is it useful, or is it dangerous? If you look to the Internet, you find a tremendous amount of information on this subject. We think it's important to have our say, too."

Harnessing the Internet

"In half a year or so, I believe all pharmaceutical companies will have web sites about specific products—at least those firms with operations in the United States will have them. Because even for European companies, the US is our most important market, and consumers looking for information about our products and the role they play in treating disease should be able to get it from us," declares Wolfgang Simon.

American statistics on the way consumers are using product and disease-oriented web sites are too compelling for European marketers to ignore, even if laws currently prevent them from using the same techniques, Simon declares. Quoting numbers he says he found in an e-health review report prepared by an investment bank, Simon points out, "When Schering-Plough first launched its Claritinweb site, the site attracted 200,000 visitors per month. Now, they get about 400,000 visitors a month, and the average visit time is seven minutes."

Schering-Plough can track how people navigate the pages of the Claritinweb site, how long they stay in a particular region of the site, and the exact information they were looking at. By giving people the option to sign up for local pollen-count advisories that will be e-mailed to them, the company can get even more information. "And the economics of running the web site mean they're getting it for about $1.70 per individual," Simon asserts, adding, "These are customers, leaving information about their disease, so they can get reminders that make them compliant and brand loyal."

What traditional media campaign could compare to the consumer-exposure time currently being clocked by MSwatch.com, a web site about multiple sclerosis? Simon says this site, intended for US residents only, receives 60,000 visitors each month, each of whom spends an average of four hours a month there.

Not that all of these clicks result in buying decisions or physician visits. But traditional marketing tools don't work 100% of the time either—and their effectiveness is just as difficult to measure. "The impact of marketing through the Internet has got to be compared to off-line media," Simon asserts. He points out that pharmaceutical companies are accustomed to spending money for traditional marketing approaches, even though they have no clear means of gauging the benefit. "What's the impact of sponsoring a symposium, for instance, or putting up a booth at a conference?" he asks.

All Right for Some

Bayer has only just started to coordinate an e-commerce system, and build a strategy for that, Simon declares. If the firm were legally permitted to do more in Europe, it would. But until then, it's concentrating on developing opportunities in the US. The firm has product-oriented sites where consumers can go to learn about Baychol, its lipid-lowering agent, and Avalox, an anti-infective. It's also developing a sort of generalized health care portal called bayer-healthvillage.com, where visitors can be guided to different areas like cholesterol, and find out something about Bayer's products.

One of the company's initial projects is a web site called bayerdirect.com, intended to help Bayer increase its share of profits from two high-cost biological products: Prolastingamma-interferon, which treats a rare lung disease; and Factor VIII, a blood-clotting protein that hemophiliacs lack. Part of Bayer's motivation in founding the site was "to bypass wholesalers, who've captured a large portion of sales," Simon declares. US residents living with these serious chronic disorders can now access information about the treatments they rely on, and even order the products directly from Bayer, after they've provided detailed information about their doctors and their insurance companies. European citizens cannot participate.

"The Web can be excellent for doing targeted marketing to consumers, but its ability as a stand-alone tool should not be overestimated," Simon declares. Companies that really want to get the value out of the Internet have to spend around it, creating confirmation that a product is a good one and awareness that a web site even exists, he says. In the US, that rounding-out process is expensive but possible, and definitely Internet-enabled. Companies can, for instance, pay to post banners describing symptoms on various health care portals, so that Net surfers can click over, from "runny nose and watery eyes" to the Claritinweb site, where they can learn about the drug, what it does, and its side effects. That kind of targeted marketing can reinforce a broader campaign directed to consumers—but only in the States, not in Europe.

Given all the restrictions on advertising prescription medicines to consumers in Europe, it's little wonder that many firms are concentrating on reaching European physicians instead. After all, no matter which drugs patients come asking about, it's still the doctor who decides and writes the prescriptions. Not only is it easier for marketers to find doctors, because they gather in familiar ways and places, such as professional societies that meet at annual conferences—but marketers already know what they need. Marketers are clearly harnessing the Net to approach physicians, and specialist companies are springing up to help them do that. Abbott hired a small firm called IsisMedNet, based near Oxford, UK, to create a web site to help it reach urologists. The site, urohealth.org launched in March 1999, and comes across as an information/news center for those specialists, rather than a corporate or even product-specific site. Because it is based in the UK, the site relies on passwords to keep non-professionals away from the product information stored there.

"Doctors and patients may have different agendas, but why should companies be restricted to talking to only one or the other group?" asks Kevin Brent, director of an organization called Health in Focus (HIF). The company is a for-profit entity intent on getting commercial leverage from its links to patient groups in the United Kingdom. "We want to provide a trusted, high-quality UK site where doctors can send their patients," he says, adding, "Remember the power of trusted brands." He envisions HIF sponsoring web sites; earning fees for directing traffic to sites where patients buy something, and running consumer surveys and thus gathering saleable data.

Fighting for Change, and Against It

But the consumer-medical opportunities that many companies would like to see evolve in Europe will never come to be, if certain watchdogs have their way. Hans Heuvelmans, of the Health Care Inspectorate in the Netherlands, is one of those who makes plain that he's against DTC advertising in Europe and will fight to see that existing restrictions stand. "We're not against dissemination of information about disease or even products, but we are against pushing products directly to patients. Some companies have a policy to push the limits. They will find themselves in court and then we will see," he declares. Now that the European Community is compelled to pursue policy agreement between all its member states, the complaints of even a single disgruntled nation can slow legislative changes that others feel are right.

It's not just the odd activist who's come out against DTC advertising in Europe. "In the UK, consumer groups and patient groups have stated their opposition, too. It shocks me, but that's what's happening. They say they want companies to provide them with information, but not advertising," notes Paul Ranson, a UK-based consultant. British physicians have been opposed to DTC advertising also, as their peers were initially in the US. There's no doubt the issue remains a contentious one across Europe.

The European Commission has recognized that DTC advertising is an issue it needs to consider, says Marc Scheineson, former associate commissioner of the FDA for legal affairs and now a partner with the Washington, DC law firm Reed, Smith, Shaw & McClay. He notes that the EC issued an initial report in November 1998, and another in 1999, acknowledging the importance of the Internet, and the fact that this new medium was bringing lots of information to consumers. The authors thought the EC should identify minimum standards, and teach consumers the principle of "caveat emptor." But no definitive action has been taken as yet. "One can argue that times have changed, but until DTC advertising is made legal in Europe, it's not," Scheineson says.

"In 1998, the European Commission said it was reconsidering the ban on DTC advertising, and thought it would take five to ten years to decide. By 1999, it said it would take ‘a couple' years to sort out. But nothing in the EU happens that fast," declares Lorna Brazell, a senior solicitor for the London-based law firm Bird & Bird, and an expert on legislation and codes of practice concerning DTC advertising in the UK. "I believe it will be at least two or three years before we see any legislative changes," she says, adding, "They know they're backing down. The question is: what will they let companies do before they change the legislation?"

Pharmaceutical manufacturers operating in Europe ought to be a little bolder than they've been, Brazell asserts. "Companies here are very cautious. They stay two steps back from the law, so they can never be accused of doing anything wrong," she declares. Indeed, she points out that some of the industry's self-imposed codes of practice are stricter than government-imposed laws, and asks why. "The industry is hindering itself, and that must change," Brazell says.

She thinks pharmaceutical companies ought to start creating some DTC advertisements for Europe, and talking to regulators about them. "In the UK, if you get an ad pre-assessed, you get a chance to change it. And you can argue with the authorities. Ultimately, an independent review commission will rule, and then you must obey what they say. But there are opportunities to back-pedal, withdraw or change the ad along the way," she notes, adding, "This is a direct way to get the issues on the table."

Pharmaceutical companies ought to argue that "what's needed is not a ban on all communication to consumers, but quality control," Brazell declares. "But they can't do it as individual companies. There's going to have to be an industry group pushing for this, because we're talking about changing national policies to make something that is illegal, legal. There's a legitimate argument to be made for doing so, and the time is right to make it. The European Commission has recognized that there's a problem, and that the Internet is having a huge impact on communication. Europeans aregetting information about medical products from all sorts of sources, and it's not always good information. Companies need to be able to represent themselves, and that's a perfectly reasonable position from which industry can approach the authorities. Times have changed," Brazell asserts.

"Now the big question is, what's advertising and what's information," says Jürg Schrank, a member of the International Federation of Pharmaceutical Manufacturers Associations (IFPMA)'s Internet task force, and VP of Interpharma, the association representing research-based Swiss pharmaceutical companies. "At the moment, legislation takes different views. If a pharmaceutical company presents information about its products, on the Web or anywhere, now in Europe that's considered advertising. But if another provider, such as the publisher of the Physicians' Desk Reference puts the very same information about products into the public domain, then that's considered information. We think that needs to change," Schrank says. He notes that the IFPMA has scheduled a symposium on DTC advertising for October 2000, so that "all stakeholders—consumers, patients, prescribers, authorities and the industry—can gather to discuss the common needs of the community." The program is posted on the Web at IFPMA.org.

No matter who turns up at IFPMA's symposium, Pfizer's upcoming Viagracampaign is bound to refresh debate in Europe about the appropriateness of direct-to-consumer advertising, and the role that the Internet can play in consumers' medical decision-making. People concerned that commercially motivated groups may use the Internet advertising to take wrongful advantage of consumers' trust or desperation, have some fresh ammunition. They can, for instance, point to web sites such as CancerAnswer.com and ApricotsfromGod.com, which sell laetrile, a substance found in apricot kernels. The compound was touted in the 1970s as a cure for cancer but banned by the FDA. Yet cancer patients are buying it today over the Internet, in injectable form or simply as bags of apricot pits. Is this victimization, free enterprise, or consumers exercising freedom of choice?

Rogue web sites won't be the only targets drawing fire: major drugmakers that have recently had to withdraw products from the market are likely to be dragged into the debate too. "American Home Products Corp. weighed the risks of [diet drug] fen-phen, and promoted it to consumers anyway. Warner-Lambert Co. knew that the European and Japanese developers of glitazone drugs abandoned their efforts because of liver toxicity problems, yet continued to develop and launch Rezulin anyway," declares the Netherlands watchdog Heuvelmans. "These are examples of commercial pressure in action. If companies know they can advertise and so potentially sell more of their products, we will see many more cases like this," he asserts.

Freedom and Protection

In America, where freedom of information is a basic right, most people believe that the more information consumers can access, the better equipped they'll be to make intelligent decisions. To consumers that have become accustomed to doing Internet research before making major purchases of automobiles or stereo equipment, researching health care options seems a logical step. Having access to information is different from being bombarded by advertising messages. But the advertisements don't seem to be brainwashing people yet. If anything, medical advertising seems to be prompting people to go see their doctors to talk about symptoms and potential treatments, often armed with pages printed off of the Internet. Physicians initially resistant to that, angry when patients requested drugs by name, seem to be learning how to have a dialogue with patients, and even liking the more collaborative relationship. The American Medical Association, which represents US physicians, was initially concerned that DTC advertising would reduce patients' reliance on their physicians. It's now a proponent of the concept.

The guidance patients get from their doctors is one form of protection against exposure to medical advertising, but it's not the only one. A growing body of evidence suggests that pharmaceutical companies themselves are helping regulators keep things under control in the US. "It's a competitive market out there, and perhaps that's why most of the complaints we're hearing about DTC advertisements are being filed, anonymously, by companies' competitors," Marc Scheineson says. He notes that Zeneca, now part of AstraZeneca PLC , developed an ad for its asthma drug Accolate, which showed patients on a treadmill, and winning a race. But because the drug had never actually been tested in exercise-induced asthma, the company had to change the ad. Scheineson believes that this and other enforcement decisions, many directed at claim overstatements or misrepresentation, are helping establish the ground rules for what companies can and cannot do with advertising.

Watchful eyes are everywhere—not only in competing companies, but in health activist organizations like one called Social Audit. That group recently complained, successfully, to the UK's Prescription Medicines Code of Practice Authority (PMCPA) about an advertisement directed to physicians. The ad, for Pharmacia & Upjohn's urinary incontinence product Detrusitol(tolterodine), was cited for overstating efficacy data. PCMPA ruled that the claim, "Freed by Detrusitol," created a false impression that treatment would result in no symptoms. Company data accompanying the ad showed that fewer than two patients in ten experienced "no or minimal bladder problems after treatment," the activist group pointed out. It also questioned how trustworthy DTC ads are likely to be, if advertising to doctors is unbalanced.

Questions of adequate protection versus protectionism will surely be part of the European debate over DTC advertising—and there are other, tougher, questions to address. Does any government have the right to prohibit its citizens from accessing medical information over the Internet? How long could such a position hold, if citizens decide not to obey? Are European governments trying to protect their citizens by banning communication about medical matters, or trying to keep a lid on their health care spending? Has America's foray into DTC advertising of medical products gone on long enough for the ramifications to be clear? Should US policy on this matter be the guide for other nations?

There are no easy answers, but there's certainly plenty to think and talk about. Companies might begin by asking themselves which if any of the products they've already had approved in Europe are worth bringing to the attention of consumers, perhaps via a web site or a general-awareness campaign. Firms with dominant market shares seem to have solid opportunities to boost sales in Europe, even given current restrictions. Simply encouraging consumers to consult their doctors about specific symptoms ups the odds that new patients will emerge with prescriptions. Likewise, web sites that provide services or information to consumers may build awareness of products.

Pharmaceutical firms that haven't yet begun leveraging the Internet to communicate with consumers ought to ask themselves, "What are we waiting for?" There's much to do despite regulations. Organizations that have already begun utilizing the technology need to assess if they've taken the challenge seriously enough to pay off. If they haven't updated their web sites recently, why not? If they haven't begun thinking about integrating web efforts into other marketing and outreach efforts, what's stopping them? And if companies haven't begun formulating an argument that will convince European legislators that times have changed, there's no time to waste.