1 Boring Old Man

I periodically peruse the Coalition for Healthcare Communication web site. It’s essentially a proPHARMA organization that predictably attacks any attempt to reform any current practices. I visit it to see what they’re talking about. There’s a current commentary supporting a report by the Congressional Budget Office on Direct to Consumer advertising [those "ask your doctor if drug x is right for you…" ads]. In my new spirit of declaring personal biases, I hate those ads. Everyone around me hates those ads too, at least when I’m around, because I start talking to the television set. But I’m going to try to rise an inch or so above my automatic visceral reaction because I found the Congressional Budget Office report kind of interesting.

The report studies a proposal by the Institute of Medicine to declare a moratorium on DTC advertising for the first two years  after a new drug is approved. That actually seems like a sound idea – to give us a couple of years to see if undiscovered problems missed in the FDA approval process emerge. The CBO comes down opposing the idea [thus the CHC support]. What I found interesting were the stated reasons in the report. But first a Table from the report. Those ads cost a mint! – an impressive revenue stream for the media and quite an outlay for the manufacturer. The ads must be effective for the companies to pay that kind of ticket.

^{In 2008, spending on DTC advertising totaled $4.7 billion, nearly one-fourth of pharmaceutical manufacturers’ expenditures for all promotional activities. The rest of the $20.5 billion that pharmaceutical manufacturers spent on promotional activities in 2008 was directed at physicians and other health care professionals. In a practice called “detailing,” drug makers send representatives to visit physicians, nurse practitioners, and physicians’ assistants to discuss their products and to provide samples and reprints of academic literature on their company’s products. Pharmaceutical manufacturers also target physicians by advertising their drugs in medical journals and by sponsoring professional meetings and events, both in person and online.}

^{Over the 1999–2008 period, manufacturers varied their emphasis on consumers in their promotional spending for drugs during their first two years on the market (see Figure 2). That variation may have resulted in part from the relative newness of DTC advertising in the early part of that period because the FDA did not finalize its regulatory guidance on broadcast advertising for prescription drugs until August 1999.6 The changing characteristics of the new drugs approved by the FDA over the decade probably also contributed to the variation in the emphasis on DTC advertising over time. Between 2004 and 2006, when DTC advertising peaked as a share of promotional spending for new drugs, a large portion of the drugs in CBO’s data set that were less than two years old were counted among the top-selling drugs in the country. DTC advertising’s share of promotional spending for new drugs has declined since then because drugs approved more recently have not had such broad potential markets.}

^{In 2007 and 2008, there were fewer newly approved drugs in CBO’s data set than in the preceding few years, and an even smaller number that were top sellers. Manufacturers submitted and the FDA approved fewer applications for new brand-name drugs than they had a decade earlier, and fewer still with large potential markets like a number of the drugs that obtained FDA approval in the 1990s.8 As a result, among the drug classes in CBO’s data set, new brand-name drugs made up a small and shrinking share of all retail sales of brand-name drugs, falling from nearly 10 percent in 1999 to less than 2 percent in 2008.}

^{The share of brand-name prescriptions attributed to drugs within their first two years after FDA approval exhibited a similar pattern, suggesting that lower sales, rather than declining drug prices, caused the drop in the share of retail sales for new drugs. New drugs accounted for 7 percent of brand-name prescriptions in 2004, but that share fell to less than 2 percent in 2008. The total number of brand-name prescriptions in CBO’s data set was dropping at the same time, from roughly 1 billion in 2004 to roughly 700 million in 2008, while the total number of prescriptions for generic drugs increased at a double-digit pace; during that period, patents expired for a number of older brand-name drugs, and prescriptions shifted to new generic versions of those drugs. The combination of a declining number of brand-name prescriptions and a declining share of those prescriptions representing new drugs meant that the number of prescriptions for new brand-name drugs plummeted. The number of prescriptions for newly approved brand-name drugs without DTC advertising fell from 19 million in 2004 to 5 million in 2008, and the number of prescriptions for newly approved brand-name drugs with DTC advertising dropped from 61 million in 2004 to 7 million in 2008 [see Figure 3].}

^{Concerns about large numbers of patients taking drugs whose safety and possible side effects might not be fully understood underpin proposals to impose a two-year moratorium on DTC advertising for newly approved prescription drugs. Indeed, researchers have found a link between the promotional activities that pharmaceutical manufacturers use to expand the market for their drugs and increased reporting to the FDA of adverse events from a greater number of people taking those drugs. A moratorium on consumer advertising would provide more time for possible safety problems with some drugs to be uncovered and to become widely known.}

^{However, a moratorium on DTC advertising that delayed the widespread use of new drugs could also worsen — rather than enhance — public health in some ways. Positive effects on health from DTC advertising could be lost or delayed: Some studies have found that DTC advertising spurs individuals to seek treatment when they otherwise might not and improves patients’ compliance with prescribed drug regimens. Therefore, for drugs whose health benefits outweigh their safety and other concerns, a moratorium might reduce their use by a portion of the population who would benefit from the drugs. Moreover, in some cases, a moratorium on consumer advertising could postpone the realization of a drug’s true risks—if, for example, the number of people taking the drug was reduced enough by a moratorium that the full risks were not discovered as quickly.}

I don’t like DTC advertising because the target audience has no way to really evaluate what they’re hearing. Some attractive older actress demonstrates her dancing skills after a fantasy recovery from fibromyalgia and the toxic possibilities are rapidly mumbled in the background. Another actress plays a depressed person and then laughs and plays with her pretend grandchildren because she’s added a long-acting antipsychotic while the downside drones on in a voice-over. That’s just not how I see medicine being practiced. But I don’t think we should use unproven speculations about public health to actively punish the pharmaceutical industry for sins past. There are enough non-speculative sins to put to an end. Our role should be to keep them honest, and to vigorously fight what they’ve done behind the scenes – not what they do in plain view.