A photo of Mackenzie Ames is posted on the FH Foundation web site above her column entitled “A New FH Family.”
This week a New York Times story introduced readers to a young woman with a genetic condition called familial hypercholesterolemia (FH), which is characterized by high cholesterol levels and early heart disease.
The story — titled “These Cholesterol-Reducers May Save Lives. So Why Aren’t Heart Patients Getting Them? — began:
Heart disease runs in Mackenzie Ames’s family. Her grandfather had a fatal heart attack at age 30 while dancing with her grandmother at the Elks Lodge in Bath, N.Y.
It said Ames was among patients deemed “eligible” to be treated with pricey drugs known as PCSK9 inhibitors. “But she can’t get them,” it said. “Two insurers have turned her down.”
“I have followed every rule, and I still can’t get access,” Ames is quoted saying. “My doctor can’t get a straight answer.”
Her plight served to illustrate the story’s theme, that thousands of patients have had their prescriptions for PCSK9 inhibitors turned down for coverage by insurance companies:
“Like many similar patients, she has gotten caught in the crossfire of a marketplace battle between insurers, providers of prescription drugs and the makers of these drugs.”
But is Ames really “similar” to other patients whose claims have been rejected? In a key way, she’s not.
Ames is part of the “Advocates for Awareness” program run by the FH Foundation, an organization sponsored by companies that make PCSK9 inhibitors. In 2016 tax forms, the foundation indicated it spent nearly $230,000 on the volunteer program, which pays for participants to attend training workshops.
The story does not mention her advocacy work, but it should have.
While Ames may be sincere, she was hand-picked by the foundation to deliver her narrative of insurance companies rejecting legitimate claims for life-saving medications. It’s a narrative that closely aligns with the agenda of the PCSK9 inhibitor manufacturers, which are fighting to loosen payment restrictions.
(A similar narrative appeared in an op/ed under the byline of a patient advocate with the Global Healthy Living Foundation, which is funded by Amgen, a maker of PCSK9 inhibitors.)
FH advocates agree to coordinate their activities with the foundation, including referring media inquiries to foundation staff.
That raises questions about whether Ames is really a typical patient.
Further, readers deserve to know that there was a bit of grooming behind her industry-friendly message.
In 2015 she wrote an impassioned column about her advocacy training with the FH Foundation.
“We hit the ground running with two days of interviews, science discussions, lessons on social media and brainstorms on how to raise FH awareness,” Ames says in the piece.
It’s a safe bet that such training is performed by facilitators who are prone to put a rosy spin on products sold by the foundation’s primary sponsors. Those major sponsors include Amgen and Sanofi/Regeneron, which make the two PCSK9 inhibitors currently on the market; The Medicines Company, which has been developing a similar drug; and Quest Diagnostics, which does cholesterol testing.
One clue of this influence is Ames’ use of the word “access” when referring to coverage barriers. It’s a term favored by drug companies and their supporters to imply that insurers erect unreasonable hurdles, while skirting the issue of high drug prices.
Journalists need to be cautious about interviewing patients who have advocacy connections or are fed to them by PR departments because they might not be truly representative. And if such sources are quoted, it’s up to journalists to provide information readers can use to weigh their validity.
A story in Everyday Health did disclose Ames’ connection with the FH Foundation, but did not mention the foundation’s industry funding.
Not reporting such connections “risks further obfuscation of an already titanic level of non-transparency about drug marketing, drug pricing, and risk/benefit calculations for any given patient,” science journalist Joann Rogers said via email.
She said disclosure “is an important way to put information and context into readers’ hands.”
That dictate is reflected in the Society of Professional Journalists’ ethics code, which states that the public “is entitled to as much information as possible to judge the reliability and motivations of sources.”
University of Florida journalism professor Kim Walsh-Childers, PhD, said the story should have told readers what benefits Ames gets for her work on behalf of the foundation.
“For instance, if FH Foundation advocates get free services of any type or if they’re offered free trips, etc., then it would be in their best interests to make sure FH Foundation and the companies that sponsor it do well financially,” Walsh-Childers said via email.
“That’s not to say that Ames might not be completely sincere in her support for these drugs or that she’s less than honest in what she says about them. But readers still need to know who they’re hearing from,” she said, just as the public would want to know about who contributes to a political candidate.
Ames’ link to an industry-funded foundation wasn’t the only missing information in this story.
Readers weren’t told that three people quoted complaining about insurance barriers — cardiologists Leslie Cho, MD, cardiologist Keith Ferdinand, MD, and economist Jalpha Doshi — have received funding from companies that make PCSK9 inhibitors, for things like research and consulting.
Doshi also has reported receiving funding from insurers.
Readers also weren’t told that a study documenting insurance coverage denials was sponsored by the FH Foundation, and that several authors of that study were paid by the same companies that make those drugs.
Readers might have discovered those conflicts by clicking on embedded links and checking a CMS physician database, but chances are most did not.
Readers were also left in the dark about how well these drugs actually work.
The headline called PCSK9 inhibitors “powerful,” and the story said they “save the lives” of people like Ames.
But there were no numbers to give readers a true sense of how many patients might benefit from them, and to what extent.
Larry Husten, a veteran journalist who covers cardiovascular medicine, characterized trial results for Sanofi/Regeneron’s Praluent and Amgen’s Repatha as showing “significant but modest 15% reduction” in cardiovascular events such as heart attacks and strokes.
Those trials were conducted in high-risk patients with established heart disease, which is a much larger population than people with FH.
The actual numbers are enlightening.
For example, the Repatha trial showed those bad events happened to 11.3% of patients who didn’t take the drug, and 9.8% of patients who did take it. In other words, 1.5% of patients avoided a problem event, but 9.8% still experienced a problem event despite taking the drug.
Neither drug has been definitively shown to save lives, and longer-term studies are needed to better establish their safety and effectiveness.
Cardiologist Christopher Labos, MD, said smaller studies have shown the drugs profoundly lower cholesterol in people with FH, and based on the early results in people with established heart disease, it is “not unreasonable” to conclude that the drugs would similarly reduce cardiovascular events in FH patients.
The story did offer some balance by including the views of insurers that exorbitantly priced drugs can lead to premium increases, and that there’s been a dearth of data about their effectiveness.
But those points should have been raised higher, said Earle Holland, a former science and medical communications officer at Ohio State University.
His impression: “The story seems, in effect, much like a lobbying effort on behalf of drug manufacturers to increase demand for their very expensive drugs.”
So what’s the takeaway? While the interests of insurers and pharmacy benefit managers are fairly transparent, those of researchers, doctors, and patients can be messy and opaque. That’s why journalists need to point them out.