But news of increased risk of heart attack and stroke pushed the drug into the center of a still-lingering debate that questions what role the FDA should have played in Vioxx's tenure in the market.
For years, the FDA has been criticized about the way it handles product and food recalls; communicates during health crises, such as this summer's salmonella outbreak; and addresses a seemingly slow drug approval process.
Communications, or how the FDA chooses to communicate, remains a major cause for the problems that affect the agency. This is especially true as it is learning to navigate what has been a very traditional communication process through a changing media world of instant news cycles and consumer-driven healthcare.
“There's an increasing awareness... of the role effective communications can play,” says Nancy Ostrove, senior adviser for risk communication at the FDA, which is part of the Department of Health and Human Services, based in Rockville, MD.
In 2006, the Institute of Medicine of the National Academies issued The Future of Drug Safety: Promoting and Protecting the Health of the Public, a report advising Congress to pass legislation that would create an advisory committee regarding the agency's communication.
The Institute is a Washington-based nonprofit that offers science-based advice for issues relating to biomedical science, medicine, and health.
In June 2007, the FDA announced that it would form a new Risk Communication Advisory Committee (RCAM) that would look into how the agency can better communicate risk of the products it regulates to the general public.
The purpose of the committee, according to its charter, is that it will advise the commissioner on issues related to effective communications with the public in regards to all products that the FDA regulates. Those products encompass biologics, cosmetics, drugs, foods, medical devices, radiation-emitting electronic products, and veterinary precuts. Regulation can include labeling, approvals, manufacturing standards, and facilities.
As the landscape has shifted online – 79% of respondents in a 2007 Prospectiv survey have gone to the Web to better understand health symptoms and drug treatment – the FDA has been left in a position that is no longer as effective as it once was, says Ostrove, who is also the co-chair of the agency's internal committee that manages the RCAM.
“There's been a historical reliance on labeling as a way of communication,” she says. “It's not the end-all, be-all.”
Forming the committee
AnnaMaria DeSalva, worldwide director of healthcare at Hill & Knowlton, is the only PR professional who was selected to be a part of the committee when it was introduced in November 2007.
The other 14 members and chair have extensive backgrounds in risk communication, healthcare academia, consumer health and advocacy, and medical journalism, and are intended to represent healthcare professionals, patients, and consumers, says Ostrove. She adds that location, gender, race, ethnicity, and whether or not there are conflicts of interest also played a role in how
committee members were chosen.
“What they're bringing to the table is that perspective,” she says. The committee is scheduled to meet four times a year – there are only three meetings in 2008, though – for full-day meetings that follow an agenda laid out by an internal group created specifically for the RCAM.
Post-discussion, any recommendations are taken back to the relevant departments at the agency. The purpose of the RCAM, say its members, is not to create policy change, but offer solutions and discussion as related to a topic. It is not required to vote about any issues.
“It's a great opportunity for the FDA to take a very big step forward in this area,” DeSalva says. “We're not addressing current issues, just the risk communication message overall. We're planning for the future.”
At the first meeting in February 2008, the group discussed the proper press release template for product recalls. The second meeting, held in the second quarter, focused on direct-to-consumer advertising and its impact on underserved populations, says DeSalva.
Both topics – how the agency communicates in a recall situation and DTC advertising – have been the subject of various news stories in recent years. But, she notes, “the FDA is in the process of changing.”
For DeSalva, her representation as the sole PR practitioner on the RCAM allows for two roles: She can speak to how stakeholders – and the companies they invest in – view FDA risk communications, as well as how the public accepts and interprets the same news.
“We can reach that stakeholder and earn [his or her] trust,” she says. “We know how trust forms... From an industry standpoint, there's a new paradigm for communicating risk.”
Talking to consumers
But, the very methodology of communicating risk to the public has changed because of consumers' growing use of the Web for information and the increase of blogger and social healthcare communities.
“Most of our communication is mediated and moderated through the media,” says Ostrove. “Then the media goes to the public. With the growth of the Internet, people are searching for information.”
Like most government agencies, in the past the FDA primarily used the media as its venue for communicating with industry professionals and the public. Patients would seek out advice from healthcare providers and labeling would provide a second source of communication.
But communicating what “safe-and-effective” means to consumers, rather than a physician, is a struggle for the science-based agency, especially in the wake of consumers who now turn to the Internet to research drugs and other devices.
“Even with healthcare providers, we can do a better job communicating,” says Ostrove, who has worked at the FDA for 18 years. “We want to be more effective.”
The FDA “does a tremendous job of regulating the safety of the variety of products under their wing,” says John Paling, research director and founder of The Risk Communication Institute in Gainesville, FL, and a member of the RCAM. The committee will help “healthcare professionals and patients... better understand risks,” he adds.
Because of the complexity of the risks associated with the various products the FDA regulates, there are very few people trained to educate others about the products, he says. Now that the general education of the public has increased, there must be more education about the risks and benefits of these products, be it a heart drug or a new stent.
“Risk communication is far more different than you think,” says Paling. “People [will] inevitably use their emotions to size the risk.”
Especially in the healthcare space, where one's personal health or the health of family and friends is at stake, it is difficult to communicate that not all FDA products are totally safe and effective for all people.
Paling notes that personal resilience and the consequence of a product are both difficult to measure, making the task of communicating risk effectively very difficult.
“It's appropriate to have communications... to address communication-related issues across the board,” says Ostrove. “Not just patients and consumers. The scope is broader. It's products and devices.”
A broader outlook
Unlike other FDA committees, the RCAM does not focus on one particular device or department, allowing it to address larger, broader issues.
Other agency committees are as specific as the Pulmonary-Allergy Drugs Advisory Committee or the Cellular, Tissue, and Gene Therapies Advisory Committee. The RCAM is one of three Interdisciplinary Topics Advisory Committees, along with the Science Board to the FDA and the Pediatric Advisory Committee.
In addition, the committee is not tasked with addressing current events situations. All minutes and agendas are posted online.
“It's not likely we would get down to a... device,” Ostrove says. “[But] we have this pool of people with experience, and they can be pulled out as needed.”
At the third, and most recent, RCAM meeting, DeSalva made a presentation on urgent communication, focusing on an ordered protocol for how to handle a situation like a recalled medical device.
She took a component, special communications considerations, and broke down six reasons why the recall might be unique and require careful communications tactics. The media might be particularly interested in device recalls, a number of surgeons who favor the device may become frustrated, or the company may have faced numerous recalls in recent months were three specific reasons she cited.
DeSalva's presentation covered the day-to-day PR-focused efforts the agency could initiate to ensure stronger communication during a crisis. Examples for Day 1 include an 8am call for investors, a subsequent media briefing, the launch of a consumer hotline, and a post-market press release that would go out the night before.
“It's not about the research,” she explains. “It's more about the practical challenges about communicating risk.”
Will big pharma follow the FDA's lead?
Pharmaceutical companies face the same questions as the FDA when it comes to the communication of risk.
By creating the Risk Communication Advisory Committee, the FDA is addressing past criticism head-on, and pharma companies are watching, says Susan Newberry, SVP and director of Ketchum's healthcare practice in Washington. The firm has worked with Wyeth, GlaxoSmithKline, and Johnson & Johnson.
Both the FDA and Big Pharma are under pressure to provide and deal with more information. Companies now post a broader range of information, negative and positive, and more people seek out information for themselves.
The same is true for media coverage, Newberry notes. The absolute and relative risk of a drug cannot fit into a 20-second sound bite.
“There's been an explosion of media, a 24/7 news cycle,” she adds. “There are other challenges, in the [TV] format, who need to simplify the story and add drama.”
Vikram Dev, head of US patient safety at Wilmington, DE-based AstraZeneca, says vie e-mail that communicating benefit and risk is a challenge not just for the FDA and pharma industry, but also for doctors, patients, and pharmacists.
And as pharmaceutical companies watch the FDA's slow process in changing its communications, companies may follow the agency's lead. What the FDA does may very well be what Big Pharma does next.
“The industry is grappling with how to communicate risk with their products,” says Newberry. “These companies would love to partner with the FDA.”
Dev notes that a collaboration between the FDA and pharma companies would paint a much more consistent and accurate picture for healthcare professionals and patients.
“Like the FDA, pharmaceutical companies can benefit from better understanding the communication needs and priorities of the general public, and receiving input on the communication of product risks and benefits, including how to most effectively communicate specific product information.”