Videolyzing Pharmaceutical Ads

There are just two countries in the world where Direct-To-Consumer (DTC) advertising is allowed for pharmaceuticals: the US and New Zealand. The ostensible motivation? To educate consumers, to raise awareness of medical conditions, to get people talking to their doctors, or to reduce the stigma associated with certain conditions (e.g. Viagra)

Since the laws changed back in 1997 in the US opening the floodgates for big pharma to peddle their wares directly to patients, there has been a debate about the efficacy and value of DTC advertising. Even today the FDA lists several ongoing studies evaluating the understandability and effects of DTC advertising. But the debate is political too. Congress has recently started floating proposals to limit the marketing powers of pharmaceutical companies for the first 2 years after a drug has been approved by the FDA. This would give regulators additional time to evaluate a new drug’s broader risks once it were available on the market.

Drugs aren’t the only DTC advertising issue generating controversy either. DTC medical device advertising is already generating a debate about the ethics of advertising products to people that can’t possibly understand the medical risks and decisions necessary for a medical device implant.

This is not to mention that DTC could be pushing up the overall costs of health care by directing people toward brand name “designer” drugs that may not be any more effective than alternative treatments. Obama’s $1 billion stimulus funding for Comparative Effectiveness Research (CER) should help with this somewhat by doing real comparisons of which treatments are “worth it” both in $$$ and patient value.

But big pharma is big business. Huge sums of money are invested in pharameutical advertising ($5.2 Billion in 2007), with spending growing at an annual rate of about 20% from 1997 to 2005. And with huge returns on investment, who can blame big pharma for wanted to drive traffic for new drugs by going straight to the people who would need treatment. The birth-control pill, Yaz, increased its sales from $262 million in 2007 to  $616 million in 2008, utilizing a few high profile (and misleading) broadcast ads.

Misleading or inaccurate information could lead consumers to make poor health decisions, or take risks that they may not fully understand.
So how does the government keep consumers safe and pharmaceutical advertisers honest? Right now the process is managed by the FDA Division of Drug Marketing, Advertising, and Communications (DDMAC). Advertisers are required to submit promotional materials to the DDMAC when they are first used or published, but not before. This means the FDA’s role is purely to “check up on” what advertisers publish, ex post facto. Ads can be circulating for months before they are critiqued and evaluated. And if an ad is found to be misleading, the FDA sends a warning letter to the offender asking them to retract the ad. That’s it most of the time.

What does the FDA check? According to their website, “advertisements cannot be false or misleading or omit material facts. They also must present a fair balance between effectiveness and risk information. FDA has consistently required that appropriate communication of effectiveness information includes any significant limitations to product use.” They require that all drug advertisements contain information as a brief summary relating to side effects, contraindications, and effectiveness. For instance, the law states that, “an advertisement may be false, lacking in fair balance, or otherwise misleading if it: “Fails to present information relating to side effects and contraindications with a prominence and readability reasonably comparable with the presentation of information relating to effectiveness of the drug, taking into account all implementing factors such as typography, layout, contrast, headlines, paragraphing, white space, and any other techniques apt to achieve emphasis.” The FDA has a very specific set of guidlines for how ads can be used in the video domain as well; including different categories of ads such as “product-claim ads”, “reminder ads” and “information seeking” ads.

The current FDA procedures for the evaluation of DTC video (broadcast) ads are wholly unwieldy. They include the submission of TEN (!!!!) copies of an annotated storyboard with each sequentially numbered frame and associated annotated references and precribing information (PI) supporting claims. Isn’t there a better way to do this?

This got me thinking about how an application like Videolyzer, that I originally built as a tool for bloggers and journalists to critique and debate online video, could be used by someone like the FDA (or the pharma companies) to streamline and digitize the evaluation and sourcing of video advertisements. This is in addition to exisiting journalism outfits, like Consumer Reports Ad Watch, which could use the tool to add back context to an overly curt video advertisement. Yaz, a birth control pill marketed by Bayer gained notoriety in late 2008 for two ads that were deemed misleading by the FDA and for which they had to run corrective ads in 2009. I’ve added the original version of one of the Yaz ads to Videolyzer for anyone interested in seeing how the tool can be used to critique a pharaceutical ad.