Originally published in MedPage Today
by Peggy Peck, MedPage Today Executive Editor
A red dress jauntily displayed on cans of Diet Coke has become the latest symbol in the ongoing debate about pharmaceutical company support of research or CME.
But whose dress is it? The American Heart Association says it’s “not our red dress,” even as leading pharma critic Steven Nissen, MD, claims that it is. The evidence, however, suggests that Nissen failed to make that case.
The controversy over the dress became a flash point in a debate about industry influence on the academic process presented at the American College of Cardiology meeting.
The debaters: Robert Harrington, MD, who is director of the Duke Cardiovascular Research Institute, and Nissen, head of cardiovascular medicine at the Cleveland Clinic Foundation and a past president of the American College of Cardiology.
In his presentation, Nissen said the red dress (displayed next to the slogan “The Heart Truth”) on the Diet Coke can was a clear sign that the American Heart Association had crossed an ethical line by endorsing a soft drink, even as observational studies have suggested that soft drinks — including diet drinks — are major drivers of obesity.
Harrington challenged Nissen about the soda can logo, saying that he did not believe the can had an AHA-approved logo on it. “I think that belongs to the NHLBI,” Harrington said.
AHA president Clyde Yancy, MD, agree that Nissen had it all wrong. The red dress on the Diet Coke can came from the closet at the National Heart, Lung, and Blood Institute. “And no money has changed hands between Coke and the American Heart Association,” Yancy said.
Nissen was dismissive of facts presented by the AHA, but an NHLBI spokesperson confirmed that the red dress is its trademarked logo, part of its Heart Truth educational program.
Moreover, the soda can branding was not about money, but all about “getting out a public health message,” said an NHLBI spokesperson.
In an e-mail, the NHLBI said “Diet Coke does not pay any money for use of the red dress logo on the can … NHLBI does not receive any money directly from Diet Coke.”
NHLBI said “Diet Coke has provided donations to the Foundation for the National Institutes of Health.”
The institute described the foundation, as “a nonprofit, 501(c)(3) corporation that raises private-sector funds for a broad portfolio of unique programs that complement and enhance NIH priorities and activities. The [foundation] issues grants to other organizations to support community-based educational programs. None of this funding goes to the NHLBI.”
The Heart Truth program is federally funded and receives no money from industry, the spokesperson said.
During his presentation, Nissen made a fairly strong circumstantial case against the AHA. For example, after Circulation the AHA’s leading journal published research from Framingham investigators linking soft drink consumption to obesity, the AHA issued a statement that pointed out the limitations of the Framingham study.
The AHA also released a statement that raised questions about a proposal to tax soft drinks as a means of underwriting some healthcare costs while also, possibly, discouraging consumption of the beverages. The soft drink tax proposal came from a Perspective article published in the New England Journal of Medicine.
Nissen connected the dots from those actions and drew a line that pointed straight to a Diet Coke can.
But Yancy told MedPage Today that the AHA often issues statements following publication of studies, especially observational studies. The goal of those statements, he said, is to inform the public of the quality of the findings. “It was disingenuous for Dr. Nissen to suggest otherwise,” Yancy said.
Nissen shrugged-off the AHA protestations. He said the AHA and NHLBI have an ongoing partnership to promote public education about heart disease in women and that partnership linked the AHA to the soda can.
A cadre of AHA staff and former presidents, objected to that interpretation. Rose Marie Robertson, MD, chief science officer and a former AHA president said, “that’s just not so.”
An AHA spokesperson told MedPage Today that the AHA-NHLBI agreement is limited to “co-branding of ‘Go Red for Women’ Day.”
The NHLBI, had a more granular response.
“National Wear Red Day is designated by The Heart Truth and its campaign partners, including the American Heart Association, as the first Friday in February when Americans nationwide are encouraged to wear red to show their support for women’s heart disease awareness. The AHA participates in National Wear Red Day, which they sometimes refer to as Go Red for Women Day. (National Wear Red Day is a trademark of the Department of Health and Human Services and the American Heart Association.)”
A close look at a Diet Coke can reveals a number of differences between the AHA dress and the NHLBI dress — the AHA version is a little more Texas — strappy, swingy — while the NHLBI frock is a bit more like a dress for a paper doll. “And their dress is not on a hanger, ours is,” explained an AHA spokesperson.
The NHLBI spokesperson said, “we had the dress first.” The Heart Truth program adopted the red dress logo in 2002.
The debate did go beyond high couture. Both Harrington and Nissen agreed that there have been abuses in both research and CME funding over the years, but, as expected, they mapped out distinct camps.
Harrington devoted most of his time to discussing ways in which industry funding — both research and CME funding — should be subject to oversight.
And he said that current rules governing industry funding of CME are “good rules, but the problem is often with us and the way we enforce those rules.”
Nissen disagreed and offered examples of single-sponsor CME that he said were “continuing marketing education, not continuing medical education.”
He singled out as an example a CardioSource CME program funded by Merck that appears on the ACC Web site Cardiosource.
The program, “Optimizing Patient Outcomes in Acute Heart Failure Syndromes: Strategies to Preserve Cardiorenal Function,” was, Nissen said, simply a marketing strategy to drive up interest in a drug, rolofylline, that Merck was developing for decompensating heart failure. Merck eventually dropped the development program because clinical trial results did not support a benefit.
“That drug is gone, but the CME program is still out there on CardioSource,” Nissen said.
During the discussion period, Dick Pasternak, vice president of cardiovascular clinical research at Merck Research Laboratories, said it was unfair for Nissen to criticize a CME program without showing any slides from the program. Pasternak maintained that the program offered solid education about heart failure treatment.
Nissen said he had reviewed the entire program, and he found it to be “marketing, not education.”
Jack Lewin, MD, executive vice-president of the ACC, said that he believed that societies like the ACC could successfully manage relations with industry and that such collaborations were essential.
Harrington argued that there is more to conflicts-of-interest than money. “Scientific hubris is also a conflict,” he said, and he defined scientific hubris this way, “when you believe that you are the only one who is capable of interpreting the data correctly.”