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Another U.S. Go-It-Alone Policy: Direct-to-Consumer Advertising

Worst Pills, Best Pills Newsletter article November, 2007

It’s true that sometimes the lone dissenting voice proves to be the correct one (think: Twelve Angry Men). But in an embarrassing number of instances, the U.S. finds itself swimming upstream against an otherwise unanimous tide of global opinion. For example, years ago, the U.S. was the lone vote against a code governing the promotion of infant formula, even after there was strong evidence that companies were using that promotion to drive women, particularly in developing countries, away from...

It’s true that sometimes the lone dissenting voice proves to be the correct one (think: Twelve Angry Men). But in an embarrassing number of instances, the U.S. finds itself swimming upstream against an otherwise unanimous tide of global opinion. For example, years ago, the U.S. was the lone vote against a code governing the promotion of infant formula, even after there was strong evidence that companies were using that promotion to drive women, particularly in developing countries, away from breastfeeding. We continue to bask in the distinction of being the only country that locks up for their entire lives those who have committed crimes as children. And there’s always the decidedly minority view the current administration holds on global warming.

This tendency also rears its head in a much less-heralded area: direct-to-consumer (DTC) promotion of prescription drugs. You know the ones: they interrupt your favorite television shows with floating butterflies conveying a restful night’s sleep or fields of flowers now suitable for frolicking in thanks to some antihistamine. But you may not have realized that the U.S. is essentially isolated when it comes to permitting DTC ads.  Other than the U.S., only New Zealand has ever permitted such ads – and health authorities there have been recently struggling valiantly to put an end to them.

With their proven ability to manipulate patients and spur prescriptions, it’s no wonder drug companies are so enamored of these promotions. But most of the time the ads encourage patients to use newer medications, exposing them to drugs with weaker safety records and driving up the cost of health care. And the ads have repeatedly been shown to omit important safety information (see Worst Pills, Best Pills News, May 2007). These attempts to transform patients into the agents of drug companies, pliantly pressuring their doctors for drugs they saw celebrated between 60 Minutes segments the night before, have been growing dramatically, even as prescription drug advertising enforcement at the Food and Drug Administration (FDA) has shown a mirroring decline, decreasing more than 85 percent in the past 10 years.

Sensing these looming dangers, most developed countries wrote legislation seeking to preempt the appearance of DTC ads, with the exception of New Zealand. The ads started to appear in New Zealand in the early 1990s, spurred on by deregulation in the U.S. in 1997. By 2000, women’s groups and health watchdogs were objecting, but it was not until the mid-2000s that doctors got on board. Now, essentially all health professional groups in New Zealand oppose the ads. Public Citizen has weighed in, writing a letter to the New Zealand government in April 2006 sharing the unfortunate experience of the U.S.

The current venue for a would-be ban on DTC advertising in New Zealand is complicated legislation seeking to establish a joint New Zealand-Australia regulatory body for all therapeutic goods. Australia does not permit DTC ads, hence the need to “harmonize” the regulatory structures between the two countries. To date, the legislation has not passed.

Meanwhile, the ever-avaricious eyes of the pharmaceutical industry have been trained on Europe, which summarily rejected DTC ads in 2002. “Not so easy,” says Big Pharma, which is pursuing a new effort to get DTC approval in Europe by characterizing these communications not as advertisements, but as the provision of objective information. A donkey painted with black and white stripes is still a donkey.

Writing in the October 6, 2007, British Medical Journal, two academics from the University of Otago in Christchurch, New Zealand, warn Europeans against following the path pursued by New Zealand:

Pandora’s irresistible jar contained within it the misfortunes of mankind. Europe is staring at the lid of pharma’s jar and, once opened, hope alone will not be enough to undo the damage. Having seen what lies inside, Europe should find nothing in there to tempt it to take this risk.

Here in the U.S., the problem is more intractable. A veritable army of drug companies and advertisers, to say nothing of their now DTC-dependent counterparts in the print and electronic media, now exists to resist any challenge to the primacy of these ads. But the ultimate culprit is the government. By failing to provide objective information on medications, the FDA, in particular, has ceded its authority and delivered a massive nest egg to industry – with the usual, predictable results. The best we can hope for is that no other countries follow us down this garden path.