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Researchers for the /NEJM/ collected data from three market-research firms that track advertising spending, especially by the pharma industry.

By Editor on Sep 4, 2007

Researchers for the NEJM collected data from three market-research firms that track advertising spending, especially by the pharma industry. They also looked at information gathered by the FDA and other government agencies and the annual report by the Pharmaceutical Research and Manufacturers of America (PhRMA). Their analysis showed some distinct trends in the industry.

Trends in spending


According to the NEJM, in 1996, total spending on pharma promotion was $11.4 billion. By 2005, that amount had grown to $29.9 billion. Total real spending on promotion, from 1996 to 2005, increased at an average rate of 10.6%. The percentage of sales spent on promotion grew from 14.2% in 1996 to 18.2% in 2005.

DTC marketing, while increasing by 330% between 1996 and 2005, only constituted 14% of total industry spending on pharma promotion in 2005. Both DTC and free-sample promotions have grown in terms of spending, while detailing and advertising in professional journals have seen decreases. However, promoting products directly to health care professionals still claims the lion's share of pharma's advertising budget.

The amount of spending dedicated to DTC ads varied by drug class. The three drug categories most heavily invested in DTC advertising in 2005 were proton-pump inhibitors (34% of total budget), statins (34%) and erythropoietin medications (31%). Only about 20 drugs make up 54.4% of total industry spending on advertising in 2005, but of those 20, 17 were being heavily advertised within a year after FDA approval.

Concerns about DTC advertising


In light of the withdrawal last year of Vioxx (rofecoxib) from the market, particular attention is being paid to the balance of potential benefits and harms of DTC advertising.

As the pharma industry well knows, the leading concern about DTC advertising is consumer safety. Since most DTC ad campaigns typically begin within a year of a new drug receiving FDA approval, many critics are concerned that campaigns for new drugs are being launched prematurely. According to the NEJM report, many new drugs have unknown safety profiles, and clinical trials are typically not designed to detect rare but significant adverse effects that only emerge over time.

Health care providers are also concerned about too-hasty advertising of new therapies; many say they need more time to educate themselves about the new drugs before advertising campaigns begin.

Overuse or inappropriate use of medications are also causes for concern. While advertising may help avoid under use of appropriate medications for chronic conditions, it may also drive up customer demand for inappropriate and expensive therapies.

The DTC ads themselves garnered criticism: from 1997 to 2006, 84% of the FDA's regulatory letters cited DTC ads for either minimizing risks, exaggerating effectiveness, or both. Critics were also uncomfortable with advertising that seemed to target minors either in content or in timing (broadcasting ads when children are typically the majority of the viewing audience).

Finally, according to a recently released FDAnews Drug Daily Bulletin, positive visual images in DTC television advertising may lessen the impact of audio warnings about side effects and other risks associated with medications. The FDA is planning to launch a study into DTC broadcast advertising to determine if TV ads distract viewers from paying adequate attention to risk information.

The study will observe 2,000 individuals and assess whether or not positive visual images alter viewers's perceptions of risk information. This move by the FDA may be in response to increased criticism that the agency is not doing enough to regulate the pharma industry.

FDA oversight


In 1997, the year a change in FDA policy allowed for advertising of prescription drugs, the FDA sent 142 letters to pharma manufacturers regarding violations of drug-advertising regulations. In 2006, that number was 21. While this decrease may be due to greater compliance by the pharmaceutical industry, it may also be due to inadequate oversight by the FDA.

One cause of the FDA's reduced oversight may have come in 2002. Then-Secretary of Health and Human Services Tommy Thompson began requiring that all FDA regulatory letters be reviewed by the FDA's Office of Chief Counsel before being issued. This led to reductions and delays, and the number of regulatory letters issued decreased by more than half between 2001 and 2002.

The number of FDA staff reviewing DTC ads is also problematic, according the NEJM study. FDA staff increased by only one from three members to four between 2002 and 2004, even though spending (and undoubtedly volume) had gone up significantly: from $2.9 billion to $4.2 billion in that time, a 45% increase. Accordingly, the proportion of DTC ads being reviewed by the FDA has gone down from 64% in 1999 to 32% in 2004.

Solutions


The NEJM article did point to some possible solutions for the difficulties plaguing DTC advertising. A recent study by the Institute of Medicine recommended restrictions on advertising of newer drugs, and PhRMA, the industry trade group, also recommends delays on campaigns of newer drugs. In fact, Bristol-Myers Squibb has already voluntarily ceased all DTC advertising for drugs within the first year after FDA approval.

Such a moratorium would give health-care providers a chance to educate themselves on newly released drugs before patients begin requesting them, and it would allow for greater time to reveal any potentially harmful side effects that may not have emerged during the approval process.

As David Kweskin, Senior VP and Practice Area Leader for TNS Healthcare, remarked, In a sense, a moratorium can serve as an extended drug trial's and once the moratorium expires, both physicians and consumers are likely to feel confident that the product is truly proven to be both safe and efficacious. Prolonging the time before an ad campaign begins, says Kweskin, will allow the industry to demonstrate that public safety is its first concern.

Health care professionals overwhelmingly support such a moratorium, according to a study conducted by TNS Healthcare: almost two-thirds of the physicians consulted were in favor, with half supporting a one- to two-year delay between FDA approval and DTC advertising. While consumers are less adamant than physicians in their desire for greater restrictions on DTC advertising, 39% of consumer respondents felt a waiting period would be appropriate.

Another solution suggested by the NEJM's findings and supported by both doctors and consumers is greater FDA oversight and more stringent penalties for violations. According to the TNS study, 43% of consumers and 38% of doctors were unhappy with the FDA's lax performance, particularly when it came to enforcing penalties against companies running inappropriate DTC ads.

With DTC advertising increasing, the debate over benefits versus harms becomes ever more vital. The implications of this debate don'st affect the United States alone: DTC pharma advertising is also permitted in New Zealand, and bans on such advertising in Canada and the European Union have recently been challenged.

It certainly seems clear that pharma is quickly facing a need to either revamp its approach to DTC advertising or strengthen its argument for maintaining the status quo.