Pulling the plug

Whether or not advertising prescription drugs on television would pay off was always going to be a bit of a gamble. For advocates it was hailed as the winning hand in any direct-to-consumer (DTC) advertising campaign, while for critics, as the point at which commerce and medicines meet, it presented a moral dilemma that few have reconciled since.

At its best, DTC was never as good as those who extolled its virtues had expected, and at its worst, it was never as bad as naysayers had predicted.

While some critics have tried to blame DTC for a multitude of sins, including holding it more than partially responsible for the number of deaths linked to Vioxx, pharma has been re-evaluating the blunderbuss approach to television advertising. The industry has gradually been turning its back on consumer television ads for months, as figures reveal that return on investment (RoI) on the high-cost activity is relatively poor.

As the future of the concept, as it was originally intended, hangs in the balance, those in the UK and across the rest of Europe who steadfastly believed that the whole idea of DTC was akin to blasphemy must be using all their willpower in battling the urge to say to advocates the world over, I told you so.

Critics will be rubbing their hands with glee as consumer groups up the ante in their war against DTC, regulators rethink their stance on approval processes on television and print advertising for prescription drugs, and pharma companies slash spending on DTC following the withdrawal of Vioxx.

The Pharmaceutical Research and Manufacturers of America (PhRMA) may have been galvinised into action by the relentless criticism of pharma's 'aggressive and unsuitable' product promotion resulting in the Guiding Principles - a thorough, if not prescriptive, document outlining the dos and don'ts of television and print DTC advertising - but its actions have failed to silence the critics.

Consumer groups have attacked the voluntary code, labelling it as 'meaningless' and, with the potential threat of Congressional involvement and legislation looming, other more cynical onlookers have accused PhRMA and pharma of self-protectionism.

Serious cash injection
For years, pharma companies have spent millions on DTC advertising on television, bagging high-profile slots in prime-time programmes, such as the US Super Bowl. But times are changing.

Following the withdrawal of Vioxx, which resulted in almost every process from drug conception to promotion being analysed, doctors, patients, regulators and industry alike turned their attention to the way newly launched drugs are advertised to consumers.

Critics made links between the number of deaths from Vioxx and a raft of television ads they believe exaggerated the benefits of the treatment while downplaying the risks. In their view, the drug was widely advertised to healthcare professionals and patients too soon after launch; at a time when the wider implications of side effects were not yet really known.

Vioxx was pulled, Merck went to court and the industry prepared for the demise of a therapy class as regulators battled against claims that they knew all along of the dangers of Vioxx.

Million-dollar cutbacks were made in the advertising of COX-2s and even companies without interests in this therapeutic area cut DTC television budgets. Ad spending has already fallen at seven of the top 10 drug firms, including GlaxoSmithKline and Novartis.

Figures from TNS Media Intelligence reveal that consumer ad spending by pharma companies was flat at around $1.9bn dollars for the first five months of 2005 compared to the same period in 2004 - a significant change after a decade of unrelenting growth. If the trend continues, 2005 may be known as the year when pharma tightened its advertising belt.

Why are firms pulling back? The Vioxx debacle certainly has something to do with it, but it is by no means the only, or indeed the overriding factor, in pharma companies' decisions to stem the flow of DTC spending - poor returns from scattergun consumer advertising that costs the earth have a place in the line up too. There is also a dearth of blockbuster drugs that lend themselves to broad consumer marketing.

On top of all this is a rise in the number of pharma firms charged by politicians in Washington with over-hyping the benefits and glossing over the risks in ads for prescription drugs.

The Food and Drug Administration (FDA) took issue with Pfizer late last year over its television campaign for Viagra, saying it was misleading as it suggested that the drug was more effective than trials had proven. It also failed to address side effect issues, the regulator criticised.

Yet, this was not the calamity that some may have expected. Figures from US market research firm NDCHealth revealed that new prescriptions fell by just 3.8 per cent after the ad campaign came off air. As a result, Pfizer set about re-evaluating its television advertising strategy for Viagra.

At a time when the trend towards analysing RoI has never been stronger, it is unsurprising that pharma companies are waking up to the fact that DTC television advertising simply doesn't work as well as was hoped - not for the money anyway.

Even DTC spending for erectile dysfunction (ED) drugs, Cialis and Levitra, was cut in the first five months of 2005, after big-buck campaigns last year failed to provide the expected increase in product sales. Despite a combined consumer ad spend of $400m in 2004, sales in the US were just $100m, according to figures from market research firm, IMS Health.

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Heading off the regulators
With Washington watching its every move, big pharma is backing away from DTC as a child does from an angry dog. A Bill has already been introduced in Congress that could give the FDA more clout when it comes to DTC, and Senate Majority Leader Bill Frist, a Tennessee Republican, has called for more stringent rules for prescription drug advertising.

The FDA has also started to review the requirements of DTC ads; a move which could lead to much tighter controls.

With the threat of intervention by Congress or the FDA looming, firms were not going to sit back and wait for sentence to be passed: they approved a new code of conduct.

PhRMA's Guiding Principles (click here) demand that pharma be more balanced in its product advertising and advise consumers that other treatments may be available to treat their condition.

They call for ads, in particular those for ED drugs, to be aired at an appropriate time and to a suitable audience and state that there should be more educational content in the ads.

David Brennan, executive vice president for North America at AstraZeneca (AZ), who will take over as chief executive in January 2006, says the company is already looking at more educational ads but acknowledges that the new approach of focusing heavily on side effects makes it more challenging to get a message across.

The heat is on
PhRMA and its members had hoped that the Guiding Principles, their amulet with which to ward off potential legislation and further criticism, would signal a shift in opinion and enable both parties to set to work repairing a tarnished corporate image.

However, the soft language, ambiguous phrases and intangibles, such as 'where appropriate' and 'spend an appropriate amount of time educating', that populate the guidelines have left consumer groups and scruntineers far from satisfied.

Sidney Wolfe, director of consumer group Public Citizen Health Research, said the PhRMA Guiding Principles were a meaningless attempt to fool people into believing the guidelines are stronger than they really are. He has also urged regulators to enforce guidelines pertaining to the accuracy and balance of DTC campaigns more stringently and said they should have the authority to fine pharma companies that violate the new guidelines.

History dictates that any moves by the pharma industry to do anything, no matter how well intentioned, are treated with suspicion. Gary Ruskin, president of advertising watchdog, Commercial Alert, says that the pharma industry is its own worst enemy because it has no self-control. In his mind, PhRMA and its members introduced the code of conduct for two main reasons: craven self-preservation and to stave off lawsuits.

In this instance, you could argue that the critics have a point. For years, PhRMA has tried to roll out a voluntary code of conduct for DTC advertising but its pleas have fallen largely on deaf ears for one reason or another. Yet, in just three months PhRMA - under scruntiny from the FDA and Congress - was able to move from president Billy Tauzin's original announcement on producing such a code to publication of the Guiding Principles.

In the minds of more ardent critics, the speed at which the code was pushed through seems more than just mere coincidence. They are also angered by the fact that several of the measures they have been calling for have not been implemented in the 15-point voluntary code of conduct, including the one- or two-year moratorium on ads following FDA product approval.

So far, only Bristol-Myers Squibb (BMS) has said publicly that it will hold off advertising new products for at least a year following FDA approval. Although Pfizer has affirmed it will not advertise products for at least six months post-approval, BMS had committed to this course of action nearly two months before the Guiding Principles were published.

AZ, one of the most prominent television advertisers, particularly for Nexium and Crestor, has reaffirmed its commitment to the medium but says it is re-assessing its level of spending. David Brennan says the company has changed its strategy to include more online activity and admitted to having concerns about the depth of message it is possible to get across on television to a wide-ranging audience in just 30 seconds.

Some 23 companies have pledged their support for the code of conduct and a number of them have promised to stop making 'reminder ads', for both television and print, that simply mention a brand name but give no further information.

While in Europe, a code of conduct on DTC advertising as a whole is likely to have little impact, news that pharma has agreed to stop making reminder ads could cause problems for some medical journals if companies decide to implement this promise globally.

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In defence
PhRMA has rigorously defended the language it used in the code. Despite being criticised by Republican Bill Frist, who said he was disappointed that the code did not put a time limit on the advertising moratorium, PhRMA remains steadfast. It feels that putting a time limit on an advertising ban for new products could lead to patients going without much-needed drugs.

The response to the guidelines has not been entirely negative however. Head of the FDA, Lester Crawford, also welcomed the code, but much like Frist said the guidelines would have to be policed. We don't need [ads] to be flippant or frivolous or obscene, and I think the new guidelines that PhRMA has put forward have the possibility of causing improvement, he told Reuters. I think it is a step in the right direction.

In a bid to back up the code of conduct and monitor its effectiveness, PhRMA has also established an Office of Accountability to receive comments and complaints about DTC. All comments will be made public and include responses from the pharma company responsible for an ad in question.

As part of its remit, one year on from the Guiding Principles coming into effect (January 2006), the Office of Accountability will select an independent panel to review reports submitted to it in the preceding 12 months and make recommendations based upon them.

While both Frist, who called for an independent review panel, and Crawford have welcomed the establishment of the Office of Accountability, they are still intent on keeping a watchful eye on the industry. Frist has said that he will continue to evaluate whether legislative measures are needed to improve patients' safety, while Crawford said the FDA will watch them carefully and reserve judgement.

Next stop
So, where to next? All the signs point to pharma in the US taking a more European approach to communicating with patients and doctors. With an emphasis on conveying risks as well as benefits, and mentioning (when appropriate, of course) that other treatments are available, it seems that European-style disease awareness campaigns could be putting in an appearance state-side.

A number of companies are already restructuring their DTC campaigns in an attempt to make them more educational. Pfizer is making changes in three major areas aimed at improving consumer understanding of the benefits and risks of a treatment, encouraging more dialogue between patients and doctors, and motivating people to overcome potential barriers to better health.

The firm is also introducing a new consumer-friendly risk/benefit summary for its products. Pfizer plans to use the summary, which has been filed with the FDA, on all products if it is approved.

Of course, the move towards campaigns focused more on disease awareness and patient education, rather than selling specific products, does not sound the death knell for DTC. Many pharma companies are looking at other ways in which to promote their products in the media - while sticking to the new guidelines.

Cable channels offer access to a specific audience, such as Lifetime and Oxygen which have high female viewing rates. The ability for pharma to better target its messages is given by experts as one reason that advertising on cable television spending went up by 35 per cent to $335m in the first five months of 2005.

It is for the same reason that spending on internet advertising has grown. While it represents just 3 per cent of the overall $4bn promotional spend for DTC, it is growing with pharma companies spending $56m in the first five months of the year, up $7m on figures for the same period in 2004.

While a handful of companies, including Novartis, have seen their e-marketing budgets grow significantly, pharma is still testing the water when it comes to internet advertising, which is unlikely to take off in the way that its televisual counterpart did.