CardioExchange Archive

Note: This post is accompanied by a separate post by James Stein.

What role should industry play in discussions about guidelines, especially when the debate about those guidelines includes allegations that industry may have influenced the final product of the guidelines? Should a public relations agency that represents a company with a product that would be affected by a guideline offer journalists a chance to interview an expert who has views that might benefit the company?

Let me first set the stage. An important debate assumed public form last November following the publication in Pediatrics of new National Heart, Lung, and Blood Institute guidelines recommending universal cholesterol testing for children. The debate heated up earlier this year with two JAMA articles containing biting criticism of the guidelines, one of which was co-authored  by a dissenting member of the guidelines committee. Now the controversy has flared yet again, with the recent appearance of two articles in Pediatrics, one attacking the guidelines and the other a defense of the guidelines by several members of the committee.

Before getting into the role of industry, I first want to emphasize that the  scientific and public health issues involved in this debate are of the highest possible importance. Cardiovascular disease remains the number one killer in the world, and although efforts to reduce cardiovascular disease have achieved remarkable success in recent decades, the rising tide of obesity and diabetes threatens to roll back much of this progress and is reshaping (literally and figuratively) childhood and adolescence. So prevention of cardiovascular disease, which starts in childhood, is a major concern that deserves serious discussion.

An excellent example of the type of discussion we need is provided in an accompanying article by James Stein. His eloquent piece provides a thoughtful perspective and overview of the debate. I don’t have much to offer beyond what Stein writes, but in this piece I’d like to present a recent and highly relevant anecdote that might help illuminate the part of his discussion about the role of industry influence in this debate.

A few days after the publication of the Pediatrics papers, I received an email message from a public relations agency. Here it is (names and other identifying details redacted):

Hi Larry,

Last week the journal Pediatrics published a paper that argued current guidelines for cholesterol screening among children are too aggressive, sparking a debate that garnered multiple news headlines. However, an important factor was widely overlooked – a genetic disease that causes high cholesterol at a young age regardless of common risk factors like diet and exercise.

[Dr. XXX] was a member of the expert panel that developed the current testing recommendations of the National Heart, Lung, and Blood Institute (NHLBI). The guidelines, which were endorsed by the American Academy of Pediatrics, call for screening for all children ages 9 to 11 and screening for certain high-risk children ages 2 to 8.

Dr. [XXX] points to familial hypercholesterolemia (FH), a genetic disorder associated with elevated cholesterol and premature coronary artery disease, as a primary concern when considering the need to test cholesterol levels in children. The disease affects about 1 in every 500 people in the general population, and can be 2 to 5 times more common in specific ethnic groups like French Canadians and Ashkenazi Jews. FH is caused by genetic mutations that lead to abnormalities on the surface of liver cells responsible for clearing LDL (bad cholesterol) particles from the blood. As a result, cholesterol accumulates in the bloodstream beginning at an early age.

Dr. [XXX] is available for an interview to share his perspective on the current NHLBI guidelines and why he strongly supports screening for cholesterol levels in children. He can also outline the steps that families should take to review family history to identify an elevated risk of FH inheritance. Might you be interested in speaking with Dr. [XXX]? I am happy to answer any questions you may have and look forward to your response.

Many thanks,
[PR Person]

[PR Company]

After a very brief internet search, I learned that the PR company was affiliated with a pharmaceutical company that has placed high hopes on a cholesterol-lowering drug that is in late-stage development for use in familial hypercholesterolemia. When I asked the PR person about this relationship, he readily acknowledged the connection, writing:

I’m working with [FH Drug Company ] on an unbranded effort to raise awareness of familial hypercholesterolemia. An interview with Dr. [XXX] about the disease won’t cover the company or its products.

I then spoke with Dr. XXX for nearly 90 minutes and, indeed, he did not talk about FH Drug Company or its products, and he provided a passionate defense of the guidelines, which in some sense may be said to represent the summation or fruition of his career as a physician and researcher who treats children with lipid disorders. Dr. XXX does not receive money from FH Drug Company, but he acknowledged that he does receive financial support for some of his activities from the National Lipid Association (NLA), and that he is well aware that FH Drug Company is a major funding source for the NLA. (I wrote a series last year about the NLA and its relationships with industry.) He also talked about the difficulty of performing research in the field without the support of industry.

After the interview I asked the PR person to elaborate on his firm’s relationship with FH Drug Company. He wrote:

We have been working with [FH Drug Company] for several months in efforts to raise awareness of FH, which as you’re aware is not widely known and often goes undiagnosed. Dr. [XXX] was actively involved in developing the NHBLI guidelines and also has an expert understanding of FH. As the debate about the guidelines has continued, reporting often has not referenced the needs of people affected by FH and the disease’s impact on early screening guidance. [FH Drug Company] is supporting efforts to help more people to learn about FH in general and also to make sure that the distinct needs of people living with FH are represented in these discussions.

Readers who are not journalists may be surprised to learn that this incident is not at all unusual in the world of medical journalism. PR companies regularly offer up academic “experts” to journalists, and this is rarely an altruistic endeavor. (See this post for my discussion about a particularly egregious example of this practice.)

One key criticism of the Pediatrics guideline is that the final product may have been influenced, consciously or not, by the relationship of its authors with industry. Here is how Newman and colleagues describe this problem in their Pediatrics article:

The greater a guideline’s reliance on expert opinion, the more important it is to avoid even the appearance of conflict of interest. Yet the majority of panel members, including those responsible for drafting the lipid and lipoprotein chapter, disclosed an extensive assortment of financial relationships with companies making lipid-lowering drugs and lipid-testing instruments. Accepting money from industry constitutes a conflict of interest that is not ameliorated by disclosure. That so many panel members with conflicts of interest were selected to draft the pediatric lipid guidelines undermines the credibility of both the guidelines and the process through which they were produced.

It seems to me nothing short of bizarre that the PR company responded to the allegation of inappropriate industry influence with a perfect example of inappropriate industry influence. Frankly, when I discovered the initial connection between the PR company and FH Drug Company I was astounded. However, the blithe response of the PR representative and Dr. XXX would suggest that in the perception of these issues there is an enormous gulf over which it will be extremely difficult to build any sort of bridge.

In his piece, James Stein provides an excellent brief summary of the potential problems involving physicians who have conflicts of  interest. What I want to add here is that through public relations activities, advocacy groups, and other related activities, companies extend their influence beyond their direct relationships to scientists and physicians and use these relationships to influence and shape the public discussion and perception of issues of importance to them. In my view, companies clearly have the right to express their views. However, when these views gain exposure and credence through outside “experts” through the support and subtle activities of public relations activities, we have moved out of the realm of simple free speech and into the arena of inappropriate commercial influence.