Imprecise marketing of precision medicine: Advertising may be running ahead of science

Public radio listeners across the country recently heard the following commercial: “Destroying cancers based on each tumor's genetic fingerprint. The promise of discovery. More information at VanderbiltHealth.com.”

“I heard the advertisements on drive-time radio,” said Dr. Mark Boguski, chief medical officer of Boston-based Precision Medicine Network, a for-profit outgrowth of Harvard Medical School's genomic medicine initiative.

Why was Vanderbilt in Tennessee beaming its message to National Public Radio listeners in Boston and other markets across the country? Jill Austin, Vanderbilt's chief marketing officer, said it was to educate the public about what personalized medicine has to offer and to raise the academic medical center's profile, which could help recruit faculty and staff. This is about “leading-edge kind of work,” she said. “Your message is on every station where NPR plays.”

Other health systems also have taken to the airwaves, print and the Internet to market their prowess in precision medicine. Boca Raton, Fla.-based Cancer Treatment Centers of America recently ran ads in O, the Oprah magazine and on CBS' “The Good Wife.”

The personalized medicine marketing wars are on. From national chains to regional powers, hospital systems are spending millions of dollars to claim leadership in this new field, which got a huge boost in January when President Barack Obama used the State of the Union Address to tout the promise of what he called precision medicine.

The National Human Genome Research Institute defines personalized medicine as using an “individual's genetic profile to guide decisions made in regard to the prevention, diagnosis and treatment of disease.” The idea is to analyze genomes to identify a disease or a person's genetic proclivity to contracting a disease.

The full human genome has about 25,000 genes. The first genomic analyses, conducted by the National Institutes of Health's Human Genome Project and unveiled in 2003, cost taxpayers about $3 billion. Today, a whole genome sequence can cost $1,000 to $2,000, although companies providing the service charge thousands more for interpretation.

As more companies and universities flock to the field, along comes the marketing. It's designed partly to quell skepticism among rank-and-file clinicians and partly to reach consumers who have heard about the concept but are largely unaware of either its promise or its currently limited applications.

Hospitals have seen marketing campaigns by national competitors and then have mounted their own communications campaigns to say, “Well, we do this here, too,” Boguski said.

While no national figures are available for genomics marketing, a number of top institutions have launched multimillion-dollar blitzes. Experts fear these campaigns may be creating the impression that precision medicine is far more advanced than it really is.

“A lot of the geneticists and a lot of the people marketing genetic tests would like to believe that everything can be boiled down simply to genetics,” said Dr. James Evans, editor-in-chief of Genetics in Medicine and a professor of genetics and medicine at the University of North Carolina at Chapel Hill. “But that's not usually the case. Like anything, it's a bit nuanced and people who have an ax to grind or dollar to make are a little bit oblivious to nuance.”

Evans says hospitals are promising too much. For example, one Vanderbilt ad features cardiologist Dr. John McPherson discussing how personalized medicine helps doctors at Vanderbilt Heart and Vascular Institute individualize therapy for patients on blood thinners, statins and other medications.

Using an individual's DNA to choose among competing drug therapies for the same disease—so-called pharmacogenomics—was one of the early promises of personalized medicine. Research had shown, for instance, that genetic factors influenced metabolism of warfarin, an anti-coagulant. Understanding those genetic differences could allow doctors to tailor the dose to the specific patient.

But subsequent research reported last year in the New England Journal of Medicine showed that dosing based on genetic makeup of patients didn't alter outcomes. “When your poster child has that kind of negative evidence associated with it, it's time to maybe temper your claim,” Evans said. “It's marketing run amok. The science is not there.”

Austin, the spokesman for Vanderbilt, stands by the accuracy of the ad campaign. "We believe in evidence-based marketing just like evidence-based science,” she said. “We test our messages to see what people understand out of them and we make adjustments.”

Based on his review of genomic marketing campaigns, Clarke Caywood, a marketing professor at Northwestern University, said many of the claims in the TV and radio ads verge on unethical and deceptive. “Exaggerated promises may be OK for candy,” he said. “But any puffery or deception in healthcare is cruel and dangerous to the patient, family and our confidence in the health system.”

Cancer Treatment Centers of America has taken the lead in marketing precision medicine. Kantar Media, which tracks strategic advertising, said CTCA spent $85.9 million on advertising in 2014, with $69 million going to TV advertising. Its total ad spending is up about 13% from 2013, when it spent $74.7 million. One TV spot from the cancer hospital operator says, “Shouldn't what makes each of us a unique individual help individualize our cancer treatment? Now, through advanced genomic testing, we may be able to pinpoint and diagnose what makes your cancer different.”

Among all disease categories, recent advances in cancer care have been most closely associated with genomic medicine. Understanding the genetic mutations of individual tumors holds the promise of giving physicians greater capacity to prescribe specific medicines to fight specific tumors types. But there are only a few tumors and tumor types that have been associated with specific genetic mutations. And not all of them have available therapies targeted to killing cells that have those mutations.

“So far, for most people's tumors, this approach is no magic bullet and the best approach remains traditional chemotherapy,” UNC's Evans said. “As usual, the marketing folks are way ahead of the evidence.”

Some of the most prominent U.S. cancer centers are also touting their precision medicine capabilities. Memorial Sloan Kettering Cancer Center in New York City said in a print ad headline aimed at the metro New York market: “There will never be one cure for cancer. There will be millions. Every person's cancer is unique.”

Genomics is just one theme in Memorial Sloan Kettering's “More Science, Less Fear” marketing campaign. Kantar Media says the cancer center spent $6.9 million on advertising in 2014, up about 36% from $4.7 million in 2013. The TV portion of its budget increased to $2.5 million in 2014, up about 42% from $1.7 million in 2013.

Genomics and cancer has been the main focus in marketing because it is better-established terrain. For some forms of breast cancer, for instance, doctors now have years of experience in genomic analysis to determine the most appropriate treatments for their patients. Physicians now can use DNA testing to look for the mutation of the BRCA gene in women with a family history of breast or ovarian cancer.

Vanderbilt has been promoting its genomics capacity for at least five years, a spokesman said. Its more recent ads grew out of a series of TV specials the academic medical center produced starting in 2000 about its research, Austin said. “Part of our responsibility is to tell our constituents what we're working on.”

In June 2010, Vanderbilt ran a TV special titled “Your Genome and the Future of Medicine” on the CBS affiliate in Nashville. The program resonated with the public and the staff and led to a national messaging campaign, “The Promise of Discovery,” on CNN and NPR.

Inova Health System, a not-for-profit, five-hospital system based in Falls Church, Va., has been running ads in the Washington market emphasizing its use of genomics for babies. Inova has its own genomics research group, Inova Translational Medicine Institute, headed by Dr. John Niederhuber, former director of the National Cancer Institute.

In a TV ad, Inova features a baby looking at a string of balls taking a double helix shape labeled with various medical conditions: “Some say your health is the luck of the draw. But Inova's groundbreaking genomic research is working to change that. We're studying the genetic makeup of infants to detect if, when, and how disease may occur so we can learn to tailor the best care for each patient.”

Inova, in partnership with Washington's CBS affiliate, also produced a 30-minute documentary, “Genomics: The Power to Predict,” that aired in January. It featured three stories about families treated by the Inova Institute using genomic tools.

Dr. Stacy Gray, a medical oncologist at Dana-Farber Cancer Institute, and colleagues published a recent study in the Journal of the National Cancer Institute of the website marketing of personalized cancer-care services by 55 companies, academic medical centers, physicians, research institutes and other organizations.

Gray said many websites offer genetic tests for guiding cancer treatment that have not been shown to be clinically useful. The study found that 88% of the websites offered one or more “nonstandard” tests with no evidence of clear clinical utility in routine oncology practice.

A typical example is chemotherapy sensitivity tests where samples of a patient's tumor are grown in a petri dish and then mixed with a variety of chemotherapy drugs to see which ones are effective. “While that sounds really good in theory, the American Society of Clinical Oncology has had two separate panels that came to the conclusion that there is no evidence that chemotherapy sensitivity testing actually works,” she said.

Gray said such marketing is largely unregulated by the Federal Trade Commission or the Food and Drug Administration. The FDA in 2013 shut down Mountain View, Calif.-based 23andMe's direct-to-consumer genetic test, which claimed to identify 254 genetically linked conditions. The FDA said the startup had not obtained marketing clearance for its collection kit and personal genome service.

But in February, the FDA approved the company's Bloom syndrome carrier test, which determines whether a healthy person has a variant of a gene that could lead to their offspring inheriting the serious disorder. The agency recently announced plans to regulate laboratory-developed tests.

“Regulation of the genetic testing industry is going to be inevitable,” Gray said. A more active FDA role “is appropriate, because some of these tests have very serious implications for patients' and family members' health and for the medical decisionmaking.”

That could open the door to regulators reviewing genomics advertising, just as they do for prescription-drug ads. Gray favors a system applied to ads for personalized cancer genetic services that would require a fair representation of the limitations and benefits of the tests as well as assurances that testing is safe and reproducible.

Howard Wolinsky is a freelance writer in the Chicago area.