Power to the people

October 1, 2008
Jacky Law
Pharmaceutical Technology Europe

Volume 20, Issue 10

The most public argument against direct-to-consumer advertising in Europe is essentially paternalistic: to protect people from companies who are considered unable to present an objective account of their drugs.

The most public argument against direct-to-consumer advertising in Europe is essentially paternalistic: to protect people from companies who are considered unable to present an objective account of their drugs. The other, perhaps more convincing case, is that cash-strapped public healthcare administrators know they would face rising costs. Why, they ask, would companies bother to produce advertisements if they didn't increase demand for drugs?

Jacky Law

In the US, where prescription drug advertisements have been around since the 1980s, the former argument is now being actively put to the test. Last month, FDA's Center for Drug Evaluation and Research (CDER) started enlisting the public's help in determining whether a drug advertisement violates laws that say the information provided should be truthful, balanced and accurately described. Working in conjunction with the nonprofit and fiercely independent charity, EthicAid, the idea is to inform the public about how drug advertising can be misleading and to help people shop the culprits.

It should also work to make companies more accountable for what they do and say, thus avoiding debacles such as the one earlier this year when Pfizer pulled its Lipitor advertisements after the New York Times challenged the authority of the doctor they featured by pointing out he had never actually practised medicine.

The US, by permitting a stronger pharma presence in society through advertising, helps to create a stronger public voice, something healthcare administrators, governments and companies the world over say they want. The US experience also shows, however, that an informed public can make life considerably tougher for pharma — and not just in terms of their advertising.

No gain without gain

Consider another FDA initiative, which was also initiated last month, that enables public awareness of drug safety issues earlier than ever before. Under the FDA Amendments Act, the agency is now legally obliged to post, every 3 months, a list of drugs that are being investigated because of complaints from drug companies, doctors and patients. The first quarterly list, covering adverse effects reported from 1 January to 31 March 2008, contained 20 drugs, only four of which had safety concerns that had previously been made public. Some of the others being investigated involve names or packaging issues rather than new side-effects; for example, a cream called Carac to treat precancerous skin conditions is being investigated because it has been confused with Kuric, for fungal infections. Whichever way you look at it, the list will pose a greater degree of uncertainty for both patients and investors, neither of which is good for the pharma companies involved.

In consumerist times, however, such moves are almost inevitable. "I think the public has told us in recent years that 'we want to know what you're working on'," Gerald Dal Pan of CDER told the Washington Post. "We are telling the public at pretty much the earliest stage what we are working on."

The positive side to the public being encouraged into the pharma arena is that it should go some way to ensure that the industry's reputation, as well as everything that flows from that, is kept in better check. If nothing else, companies should feel less tempted to cut corners as the economic environment worsens. The European industry, in contrast, will continue to be subject to allegations of paternalism for some time to come.