Controversial Pharma CEO To Chair AHA Charity Ball

–The Wizard of Oz-themed ball seeks to raise $2 million on the yellow brick road.

The American Heart Association’s annual Heart & Stroke Ball will be chaired by John Thero, the CEO of Amarin Corporation, the controversial pharmaceutical company.

Amarin manufactures the prescription fish oil product Vascepa for which it is aggressively seeking an expanded indication from regulators and in the guidelines, including major American guidelines issued by the AHA. The company has also gained notoriety in recent years for an aggressive and successful lawsuit against the FDA which has allowed it to promote off-label indications for Vascepa.

John Thero

Vascepa is currently approved for the small number of people who have extremely high triglyceride levels over 500 mg/dl. But Amarin is extremely eager to expand the indication and usage to the far larger and more profitable population of people with mildly elevated triglyceride levels between 150 and 500 mg/dl. The REDUCE-IT clinical trial is currently testing whether Vascepa reduces cardiovascular events in this population. The main results of the trial are expected to be announced next year.

“Amarin Corporation and its CEO, John Thero, bring passion and great leadership to the Heart & Stroke Ball. The American Heart Association is very pleased with their support and participation in this year’s event,” said the AHA’s Kathy Kauffmann, in a press release issued jointly by Amarin and the AHA. “Their long-term dedication to finding therapeutic solutions which improve cardiovascular health exemplify the spirit of the American Heart Association and American Stroke Association.”

“AHA event chairpersons are local volunteers that serve as the heart and stroke champions for the association in a particular city or town,” an AHA spokesperson told me when I asked about Thero’s role. “As a volunteer led organization, these chairs serve as the volunteer event leader helping local staff and other volunteers mobilize corporate and community leaders to engage with the organization in healthy living outreach such as employee wellness, and support the American Heart Association’s fundraising activities.”

In the 2015-2016 fiscal year the AHA received $60,000 from Amarin. An AHA spokesperson told me that “we don’t share information about individual donors.”

The 2017 NYC Heart & Stroke Ball will be held at Cipriani Wall Street on June 14. The AHA’s goal is to raise $2 million. The theme of the ball in 2017 is The Wonderful Wizard of Oz.

Follow the Yellow Brick Road

Marilyn Mann, a highly respected patient advocate, said she was uncomfortable with this sort of relationship. “Ideally, I would prefer that the AHA not accept funding from industry. To the extent they do, I wish they could do so in a way that is not designed to generate maximum favorable publicity for the corporations in question.”

I asked the AHA about whether Amarin’s relationship with the ball might represent an actual or apparent conflict of interest, or whether Amarin’s aggressive pursuit of off-label marketing of it drug was a position with which the AHA was comfortable. The AHA provided the following statement: “The AHA has strict policies for preventing any influence by industry. Regional and national corporate relationships are approved by a committee of national volunteers and executive staff. Sponsorship of an AHA program or event doesn’t imply an endorsement by the Association and has no connection to our guidelines and research grants.”

I also asked the AHA about the press release, which was issued jointly by Amarin and the AHA and is available in the “Investor Relations” section of the Amarin website. The AHA told me that “it’s not unusual for volunteers and sponsors to want to help us spread the word about our fundraising events. Generally, each entity sends out its own release. However, in this instance, our staff member made a mistake and it was issued as a joint release.”

Update:

Here is a comment from Matthew S. McCoy (University of Pennsylvania), the author of a recent NEJM article on conflicts of interest for patient-advocacy organizations:

Having the CEO of a biopharmaceutical company chair one of AHA’s premier events presents a conflict of interest. As the press release rightly notes, AHA’s mission is to save people from heart disease and stroke; Amarin’s mission is developing and marketing therapeutics. It’s important to emphasize that accepting money or in-kind support from a biopharmaceutical company represents a conflict of interest whether or not that support ultimately influences AHA’s decision-making. COIs are about the risk of undue influence; not undue influence itself. It’s also worth emphasizing in this context that even when an organization strives to act independently, COI can influence decision-making in unanticipated ways.

Voluntary health organization can benefit financially from partnering with biopharmaceutical companies, but they (and the constituents they serve) should think carefully about the risks to their independence that come along with these financial benefits.

Related Stories:

• Amarin Begins Legal Off-Label Promotion Of Vascepa
• The Amarin Decision: Free Speech Or Truthiness?
• Secret Letter To Doctors Shows That The Amarin Lawsuit Is About Marketing, Not Free Speech
• Amarin Says It Will Complete Cardiovascular Outcomes Trial For Its Fish Oil Pill
• FDA Throws More Cold Water On Amarin’s Hopes For Vascepa
• Why The FDA Probably Won’t Approve An Expanded Indication For Amarin’s Vascepa
• FDA Approves Vascepa, A New Fish Oil Pill From Amarin
• The Door Opens Wider For Drug Companies To Make Off-Label Claims
• FDA Advisory Panel: No Expanded Indication For Vascepa Without Outcomes Trial
• MARINE: New Fish Oil Pill Slashes High Triglycerides