Collusion between Hollywood script writers and pharmaceutical companies isn’t new. Nor is the call to regulate it.

Plenty has been written about a recent “disease awareness” plotline in ABC’s General Hospital that indirectly promoted ruxolitinib, the only prescription drug approved to treat a rare blood cancer called polycythemia vera (PV).

The drug’s manufacturer, Incyte, said in a news release that it “teamed up” with the show and actress Finola Hughes, whose character was diagnosed with PV, “to raise awareness and inspire patients and caregivers impacted by these under-recognized blood cancers.” Here’s a video of the scene: 

The novelty of this veiled marketing stoked coverage by Vox, CBS News, STAT and WIRED among others. As some pointed out, non-branded “disease awareness” campaigns aren’t regulated like traditional direct-to-consumer ads, which are subject to explicit requirements including balanced portrayals of a drug’s efficacy and risks.

Coverage highlighted an opinion piece in the Journal of the American Medical Association, in which oncologists Vinay Prasad and Sham Mailankody said disease awareness efforts “can lead to unintended consequences, including wasteful diagnostic testing, overdiagnosis, and inappropriate therapy.” They said “attempts may be necessary to regulate disease awareness promotions” including “collaboration and input from the FDA regarding the content of advertisements or disease awareness campaigns.”

We’ve been down this road before

But involving the FDA in Hollywood script-writing isn’t likely. The fact is, we’ve been down this road before. A similar alarm about the need for regulatory attention was sounded nearly a decade ago with the growing use of product placements in TV shows and movies.

Product placements proliferated as the spread of digital video recorders made it easy to skip commercials. Fortune reported in 2007:

So far this year, medicines like Vicodin, Cialis, Ambien, and Cipro have been cleverly woven into primetime plot lines more often than ever before. Between January and early September, pharmaceutical products and logos were seen or mentioned 705 times on broadcast and cable television, up from 630 such occurrences within the same period last year according to Nielsen Product Placement.

Nielsen didn’t respond to requests for an update on product placement numbers. Two years ago, it reported overall product placements had declined.

Two researchers at the University of California-Los Angeles drew attention to a regulatory gap in prescription drug product placements. Writing in the Journal of Public Policy & Marketing in 2008, Sony Ta and Dominick L. Frosch argued consumers are likely to lack sufficient knowledge to judge the usefulness of prescription drugs portrayed onscreen and may perceive characters — particularly doctors and nurses — as possessing “assumed medical knowledge of risks and benefits.”

“It could be argued that if prescription drug placements are intended for marketing, they should be considered like other types of drug advertising and be regulated by the FDA accordingly,” they wrote. “Our observation suggest that drug inclusion in scripts is, at best, poorly supervised and leaves the possibility for aggressive marketers to abuse this potential.”

Bartering is a regulatory gray area

Creating a regulatory framework for marketing insertions wouldn’t be simple. For one thing, Ta and Frosch pointed out, it would require extensive monitoring.

Another challenge is that money doesn’t always change hands, so the line between creative license and marketing is blurred. Data cited by the UCLA researchers said a direct payment occurred in just 29 percent of all product placements in 2004; most placements resulted from bartering in which companies provided the product, consulting and technical services, or the donation of items and services used in production.

The placement of posters featuring the Nuvaring contraceptive device logo in the background of the sitcom Scrubs was a notable exception. As noted by “Pharma Guy” John Mack, Organon, which manufactures the Nuvaring, acknowledged paying for the placement as a way to reinforce its brand image with physicians who watch the show, according to a piece in Brandweek.

The FDA can act if a company pays for a message that conveys false or deceptive information, said Herbert Jack Rotfeld, a marketing professor at Auburn University, via email. “The agency can stop the messages or force the company to send correct information to the relevant decision makers,” Rotfeld said.

That is what happened two years ago when the FDA sent a warning letter to morning sickness drugmaker Duchesnay about a social media post by Kim Kardashian. Regulators said the post was misleading because it presented claims about the drug’s efficacy without mentioning risks.

But without money changing hands, it’s simply free publicity, Rotfeld said. “Under the U.S. Constitution, the (FDA) can’t do anything if it is not a paid placement.”

An FDA spokesman said staff “cannot recall a specific example citing content within a television program that was in violation of the applicable regulations for prescription drug promotion.”

Even without payment, product placements are a bad deal for viewers

But just because the FDA can’t or won’t police marketing insertions in entertainment doesn’t mean these tactics are a good thing for viewers. Whether or not they pay, companies won’t cooperate if the portrayal isn’t favorable to their products. The manufacturer has a hand in the creative process, which pretty much guarantees that viewers will get an unbalanced view.

For example, device maker Intuitive Surgical receiving positive publicity when its da Vinci robot appeared in a 2011 episode of ABC’s medical drama Private Practice. In the episode, a doctor tells a patient with advanced cancer: “I did some research and found a new protocol…on this machine, the da Vinci…  I’d be able to cut in ways that I’d never be able to do freehand.” The doctor later tells the patient’s lover: “We got it. All of it.”

The program’s technical adviser, Susie Schelling, told Peninsula Press, a publication of the Stanford Journalism Program, that the show didn’t typically receive money for product placements but using “real medical stuff” added a dose of reality. Schelling said the show “has to clear it with the company who produces the product and show them the script.  Companies wouldn’t want their products used on patients who die, for example.”

“Usually it’s a good collaboration,” she told the Press. “We understand the limits of the products, and they understand the drama.  And somewhere in the middle there’s a mutual meeting point.”

Doctors may gripe, but fans gush

In the case of Incyte, neither the company nor ABC would disclose whether there was a direct payment for the disease awareness plotline. But both General Hospital and the company may have perceived it as good PR. Comments posted on ABC’s web site after it aired were overwhelmingly positive, with patients lauding both the show and the drugmaker for educating the public about their disease and making them feel less isolated. One said it might encourage more research into a cure.

But not everyone was impressed. In a piece entitled General Hospital is Being Majorly Criticized by Real-Life Doctors on women’s media site SheKnows, Kristyn Burtt wrote:

The real issue is that it could give misinformation if a patient took everything in the GH storyline to heart. In fact, many patients live long and successful lives without interference from an experimental drug that used a soap storyline to promote its use. GH needs to stay in their lane when it comes to medical advice.”

The bottom line: viewer beware.