(See the bottom of the story for updates. Since the original publication of the story the cardiologists on the “peer review panel” have resigned and Novartis has withdrawn its support for the contest.)
Despite the fact that it had one of the biggest clinical trial successes in recent years, the Novartis heart failure drug Entresto has been struggling to gain acceptance in the marketplace. To help improve its position Novartis has turned to an old marketing trick, though this trick– a company-sponsored competition– has rarely been used by the pharmaceutical industry. The contest is designed to support the publication of peer review articles that will support the wider use of Entresto.
The competition is being judged by a “peer review panel” of cardiologists, most of whom are highly influential heart failure specialists. However, when I questioned several of the panel members about their involvement and any possible conflict of interest or perception of conflict of interest, two members immediately resigned from the panel.
The contest is taking place on Cureus, which calls itself a “medical journal for a new generation of doctors and patients.” Cureus appears to be a curious mixture of open access journal, publishing platform, and vehicle for industry-sponsored content.
The competition is pinned to the recent update of the ACC/AHA/HFSA heart failure guideline, which endorsed the use of Entresto (the combination of valsartan and sacubitril) as well as another new heart failure drug, Corlanor (ivabradine). The competition “seeks to develop” case reports and original articles about the new updated guideline. “Our goal is to share the results with global cardiology, primary care, and family practice clinicians to assist with keeping abreast of meaningful developments and bring genuine progress in the management of heart failure to their communities.”
Mark Arnold, the senior vice president for Life Science Partnerships at Cureus, told me that the competition is “an educational outreach mechanism” and that Novartis has no role in the operation of the competition beyond its initial sponsorship. He pointed out that the competition could reward papers that were critical of Entresto or that were about the other drug endorsed by the new guideline, ivabradine.
Fred Masoudi (University of Colorado), a co-author of the HF guideline, said that “by referencing new HFrEF therapies from the guideline it is hard not to construe it as relating directly to Novartis’ product Entresto without explicitly naming the product. It could also be reasonably construed as commissioning promotional papers; because of the wording of the invitation, it will at least be subconsciously apparent to submitters that material favorable to Entresto is the specific intent. Further by specifically soliciting case reports, they are looking less for evidence and more for stories, which tend to be scientifically very limited but promotionally valuable. This is not to disparage the committee—those that I know on the group are good people. However, if they are receiving compensation for this service or have other financial relationships with the manufacturer, the selection process is intrinsically conflicted.”
The Shrinking “World-Class Peer Review Panel”
Competition submission are evaluated, according to Cureus, by “a world-class peer review panel.” The panel was initially composed of 11 physicians, most of whom are well-known heart failure specialists. The original panel members included one co-author of the ACC/AHA/HFSA guideline (Javed Butler, Stony Brook) , an advisor/consultant to the FDA (Ileana Piña, Montefiore), and two leaders of Novartis-sponsored clinical trials with Entresto (Inder Anand, University of Minnesota, and James Januzzi, Massachusetts General Hospital). Two of the panel members, Javed Butler and James Januzzi, resigned their position on the peer review panel after I sent an email asking about their role on the panel and whether this could represent a conflict of interest. (See below for the original and revised web page listing of panel members.)
Javed Butler sent the following comment, defending the value of the competition but acknowledging the need for a strict firewall:
“While on one hand this competition is unusual, it can potentially serve some benefit. PARADIGM HF trial is the only trial with this agent and there are questions related to the generalizability of the results, especially considering that there was a run-in phase in that trial. In that sense, data on real life experience is essential. Hopefully in the long run we will get such data from ongoing registries, but individual experiences in terms of tolerance, side effects, and other aspects of switching patients off of their chronic heart failure medication would be interesting to know. But for the process to work, there needs to be a strict firewall between the review process and decision making by reviewers and the sponsor.”
Milton Packer (Baylor University), the co-principal investigator of the PARADIGM-HF pivotal trial, was highly critical of the competition:
“The competition being sponsored by Novartis to generate peer-reviewed papers to support the recent heart failure guidelines (which directly support its product) is inappropriate. It will not accomplish its goals; it raises important ethical issues; and it will offend many physicians. I cannot imagine why this is a good idea.”
The original peer review panel:
The new peer review panel:
Update, December 15, 2:00 PM:
Both Ileana Piña and Inder Anand have emailed me to let me know that they have also resigned from the peer-review panel. Their names have now been removed from the list of panel members. In addition, the name of another panel member, Marc Silver (Advocate Christ Medical Center) no longer appears on the website.
And then there were six. Here is the latest screen image:
Update, December 16, 10:45 AM:
And then there were four. Two more members have now dropped out:
Update, December 16, 6 PM:
And then there were none:
Update, December 19, 1 PM:
Novartis has now withdrawn its sponsorship of the contest. Here is a statement from the company:
Heart failure is a major public health issue and despite the recent update of clinical guidelines, the condition remains uncontrolled for a large percentage of patients. We believe that it’s important for the medical community to share their experiences with each other and demonstrate how they are practicing medicine in this evolving area. This program was designed to facilitate the exchange of scientific and clinical information about how the medical community is applying the new guideline update for the treatment of heart failure with reduced ejection fraction. However, Novartis has made the decision to end our support of the program because we are no longer confident that it will meet our goals of scientific exchange among healthcare providers. We remain committed to supporting independent medical education.