Today’s Managing Health Care Costs Number is 2
There are two developed countries that allow direct to consumer (DTC) marketing of prescription pharmaceuticals – the United States and New Zealand. The FDA’s power to regulate drug company commercial speech is on the wane; a district court found earlier this month that the FDA couldn’t stop a company from communicating that its fish oil pills could be used for non-approved indications unless the company knew the claims were false. A federal appeals court ruled earlier that the FDA couldn’t mandate that tobacco companies admit their previous misstatements on cigarette packages, and plans to require use of plain packaging with large graphic warnings have been thwarted.
The US began to allow DTC pharmaceutical marketing in newspapers and magazines in 1985, and television in 1997. The rationale was that they could help educate Americans about various conditions which could be helped by drugs, and DTC advertising was consistent with a move to make health care less paternalistic. Why shouldn’t patients know about the drugs available to them?
But DTC marketing has made television a wasteland of ads for treatments for erectile dysfunction, insomnia, and hepatitis C. And many of the well-meaning regulations restricting how drug companies communicate actually obfuscate the real dangers and tradeoffs of medications. For instance, mandating the presentation of a raft of uncommon side effects makes it harder to focus on common side effects. Everything eventually looks like an iTunes user agreement – and who pays any attention to those.
What’s always really bothered me is advertising for expensive brand name drugs (Yes, I’m thinking of Nexium, the purple pill) that are absolutely equivalent to omeprazole at 16 times the price. Until Nexium lost its patent protection last year, it was among the top cost drugs for most employers whose data I reviewed – which certainly doesn’t speak to increasing value.
There are two articles in yesterday’s New England Journal focused on DTC drug advertising. “Rethinking DTC Advertising.. “ points to the failure over decades to develop meaningful “patient package inserts” (PPIs) to help patients understand the risks and benefits of a drug. The FDA initially intended to mandate PPIs – but gave up during the Reagan administration. The authors conclude
For all its capacity to encourage overdiagnosis and overmedication, DTCA's virtue is that it treats consumers as people who deserve to know something about the compounds they take into their bodies. After 30 years of DTCA, it's not clear that advertising is the best medium for communicating risk information,5 but marketers should at least be required to try to communicate risk information as effectively as they do their promotional messages.
“New DTCA Guidance — Enough to Empower Consumers?” points to the fundamental inequivalence between regulatorily mandated disclosure of risk and vigorous company marketing of potential benefit.
If disclosure is to work, as others have argued, it must be done right, in a format that's designed to be usable. As an example of success, Fung et al. cite the simple, salient, and familiar “A, B, C” system used to rate restaurants on the basis of public health inspections, with the results posted prominently by the door. The new FDA guidance is a move in this direction, at least if it gives companies more liberty to construct readable disclosures. However, even revised disclosures written by the companies themselves are unlikely to be simple and candid enough to steer patients away from drugs that are inappropriate for them. One can imagine a system that would grant drugs an “A” rating if they proved a substantial advance over the previous standard of care in treating a serious medical condition, with minimal risks or side effects. Regrettably, many of the most widely advertised drugs would not secure that golden ring.
I’m pretty sure we won’t see restaurant style A, B and C grades for drugs that include safety cost and effectiveness any time soon – and in fact a drug might be a “c” for some patients and an “a’ for others (think about high dose statins for those who had a heart attack, compared to those with a 3% risk of a heart attack in the next decade).
But we do desperately need better consumer information on pharmaceuticals – and given the strong incentives for pharmas to emphasize benefits, we need a standardized way to portray risk and overall value.
