Stents vs. bypass surgery vs. TRUST

by Carolyn Thomas        @HeartSisters

In 2018, Dr. Dhruv Khullar warned his colleagues at an American Board of Internal Medicine conference that patients need answers on three dimensions of trust:

  1. Competence:Do you know what you’re doing?”
  2. Transparency:Will you tell me what you’re doing?”
  3. Motive:Are you doing this to help me or yourself?”        .     .

He told his Rebuilding Trust forum audience that failure to openly answer those questions can affect public trust – both trust in individual physicians and throughout the medical profession. 

This week, our trust was tested when a BBC NightNews investigation made worldwide headlines like this: Heart Doctors ‘Held Back Stent Death Data’ “.

Others far above my own pay grade have already dissected this BBC report about a cardiology study called the EXCEL trial(1) whose findings were published in the New England Journal of Medicine. For me, it’s not what the headlines were saying that worried me, but the more important issue simmering beneath: how cardiac research is done is affecting patient trust.

Basically, you have dueling heart specialists who are engaged in a very public pissing contest over how best to treat heart patients diagnosed with blockages in the left main coronary artery.

In one corner of this contest are the interventional cardiologists (the ones who implant our coronary stents). The EXCEL study was funded by Abbott, a medical device and pharmaceutical company that manufactures the Xience stents used in this study (the world’s best selling stent). And, despite the BBC investigation that found left main patients  in the EXCEL trial who had received stents had 80% more heart attacks than those who had open heart surgery, the published study didn’t say that.

Instead, it suggested that stents were just as safe as open heart surgery in treating patients with left main coronary artery blockages.

Dr. Lars Wallentin, a senior professor of cardiology and founder of the Uppsala Clinical Research Centre in Sweden, was also the head of the study’s safety committee. The BBC report included a copy of his warning email to the EXCEL research team in 2017 (an email that was ignored):

“It might be very concerning if in the future, suspicions were raised that already available information on mortality was withheld from the cardiology and thoracic surgery community.”

In the other corner: the cardiac surgeons (the ones who do coronary artery bypass graft surgery, which has until recently been the recommended approach to treat heart patients diagnosed with left main coronary artery disease). They view the controversial EXCEL trial results as inaccurate. Dr. David Taggart, a cardiothoracic surgeon at the University of Oxford, was one of the original authors of the EXCEL study, but because of his personal concerns about the research, withdrew his name from the New England Journal of Medicine paper.

His European surgical colleagues have also issued an official statement following this week’s BBC report, demanding an independent review of EXCEL findings, and confirming their objections to the new stent-friendly left main treatment guidelines that were partly based on EXCEL.

The BBC NightNews report also quoted Dr. John Ioannadis, a Professor of Medicine at Stanford University and a respected expert on medical research design, who bluntly explained the problems with doctors taking money from the industry whose products they’re studying:

“All the main doctors working on this EXCEL trial, and the lead doctor writing the guidelines for left main disease, have declared financial contributions to either themselves or their institutions from companies that manufacture stents.

“You have the same people who run the show at all levels. They design the trials. They set the agenda, they choose what to present. They are involved in disseminating the information and running the large conferences that are attended by tens of thousands of people, specialists in the field.

“And then they also populate the guideline panels that reach the recommendations.”

Those observations nicely sum up what so many physicians don’t seem to get. Once you take money from the drug or device industry, no matter how noble you insist your own motives are, whatever you publicly claim about that industry’s products or treatments becomes suspect.

In other professional fields, for example, judges are not allowed to take money from defense attorneys. Sports referees are not allowed to take money from team owners. To allow these kinds of financial conflicts of interest would be to cast doubt on the trustworthiness of each expert decision.

So why do physicians believe themselves to be somehow above such basic societal expectations?

One cardiologist blithely confirmed on Twitter: “We all do it!” – a patently wrong-headed attempt at justifying behaviour, as anybody who’s ever been a parent can attest.

And in a remarkably candid statement, Dr. Fiona Godlee, editor-in-chief of the British Medical Journal (BMJ) since 2005, claimed that the New England Journal of Medicine had “not done a good job” by publishing the EXCEL results, and should have put the trial under closer scrutiny.

She further added that, while BMJ was “very, very choosy” about what papers it published, it had not “solved the problem” of biased data being published – a problem she said has been going on “for years” and one that is “getting worse, not better”. She explained:

Patients are right to be skeptical about clinical trials – ones that are funded by industry, and that have principal trial investigators funded by industry. We need to have more independent research.”

Both cardiac surgeons and interventional cardiologists earn their paycheques by doing what they are trained to do best. And as Upton Sinclair once explained back in 1934:

You can’t get a man to understand something when his salary depends on not understanding it.”

Not surprisingly, responses to the BBC NightNews investigation fall distinctly along that professional divide: interventional cardiologists are generally on one side in support of the EXCEL findings, while surgeons generally support calls for an independent investigation of EXCEL.

So what does this mean to the average heart patient with left main coronary artery disease?

Many of the physicians surveyed on this important question in Cardiology News this week echoed a belief (or a hope?) that shared decision-making among physicians and their patients will simply continue on as before.

As one interventional cardiologist explained, his message to patients will still be that patients with left main blockages are more likely to require repeat interventions if they have a stent implanted compared to bypass surgery, “but to get the benefits of surgery, you have to have the operation, and not all patients are keen on this. In the end, it is the patient who decides what treatment they will submit to, not the doctor.”

Or is it?

What happens when people begin to lose trust in those they have always considered to be “the experts”? 

First of all, it’s not my role as a heart patient to come up with ways to slow an erosion of trust, but I’m concerned when I observe how what doctors do (or don’t do) can hasten that erosion.

We want and need to trust our physicians.

Dr. Bob Wachter is chairman of the Department of Medicine at the University of California San Francisco; in 2018, like Dr. Khullar, he too spoke to his colleagues at the American Board of Internal Medicine’s Rebuilding Trust forum. They examined the importance of trust, and strategies for building trust across a range of health care relationships, including public trust in the medical system as a whole. He summarized a set of conditions that can affect the public’s trust in medicine, including:

  • a growing volume of competing and contradictory sources
  • treatment recommendations that change over time
  • overhyped research findings
  • financial conflicts of interest
  • perceptions among the public that medicine is just a business
  • the quality and safety movements that highlighted medicine’s defects
  • clumsy efforts to restrain health care costs
  • an increasingly diverse society
  • tribalism in politics

He also suggested that our feelings about trust generally are “complicated and contradictory”, noting that a lack of trust is sometimes an appropriate and healthy stance.

That last line is interesting, especially in light of online responses from a number of physicians who prefer to criticize the BBC for daring to expose this controversy rather than the actual controversy itself. Better to just pretend that what is happening is not really happening. . .

Dr. Khullar, who is in the Weill Cornell Department of Healthcare Policy & Research, told his ABIM colleagues at the same event three reasons that patient trust really matters:

  • Trust makes people more likely to engage in healthful behaviors:  “Patients who trust their doctors are more likely to take their medications as prescribed, exercise, eat a healthy diet, and follow important instructions. Trust is critical for patient satisfaction and the development of long-term physician-patient relationships.”
  • Trust helps us respond to public health crises: “A Liberian study, for example, showed that people who did not trust health officials were less likely to engage in precautionary measures to protect themselves and others from the Ebola virus.
  • Trust can enable innovation: “Patients who trust their doctors are more willing to engage with new technologies and treatments, and trust is also among the best predictors of whether patients would participate in clinical research.”

1. Stone GW, Sabik JF, Serruys PW, et al. “Everolimus-eluting stents or bypass surgery for left main coronary artery disease.” N Engl J Med. 2016; Epub ahead of print.

Heart image: American Heart Association

NOTE FROM CAROLYN:   I wrote more about cardiac interventions in my book, A Woman’s Guide to Living with Heart Disease. You can ask for it at your local library or favourite bookshop, or order it online (paperback, hardcover or e-book) at Amazon, or order it directly from my publisher, Johns Hopkins University Press (use their code HTWN to save 20% off the list price).

 

UPDATE: March 6, 2020 from the British Medical Journal (BMJ):

The New England Journal of Medicine has launched a review into the EXCEL trial comparing stents with bypass surgery for blocked arteries, after a series of allegations made by the BBC’s Newsnight program.

Newsnight alleged that important data about myocardial infarction had not been published, and that the five year follow-up paper did not sufficiently emphasise that PCI (stent) patients had a higher mortality rate than those who had surgery..

The trial was sponsored by the US stent manufacturer Abbott and was led by Gregg Stone of the Cardiovascular Research Foundation and the Icahn School of Medicine at Mount Sinai in New York.

Q:  When physicians disagree publicly, does it help or hurt public trust?

.

See also:

– the BBC NightNews investigative report from February 18, 2020 by investigative reporters (who had been working on this report on the EXCEL study controversy for the past year).

– the brief official statement in response to this BBC NightNews report from the European Association of Thoracic Surgeons, issued on the following day, demanding an investigation, and announcing that their association was confirming their previous decision to withdraw support from the 2018 guideline recommendations on how to treat left main coronary artery disease.

Coronary stents: interventions that come with a cost

Post-stent chest pain

Did you really need that coronary stent?

8 thoughts on “Stents vs. bypass surgery vs. TRUST

  1. I can’t speak for the public, because it is diverse and my experience with physicians is individual and complex.

    However I worry about those who are not able to choose their physician due to where they live or the urgency of their situation.

    While it is alarming that money can rule practice, I have usually been able to discuss the pros, cons and risks of medical/surgical procedures for me. If there is time, I do specific research so that I can ask more questions.

    Liked by 1 person

    1. You bring up such a good point, Jenn – i.e. how we (as responsible patients) can inform ourselves as much as possible on pros and cons of all med/surg procedures we face. For example, if I were a patient recently diagnosed with a blocked Left Main Coronary Artery, I’d be doing some serious homework right about now before the stent-or-surgery decision gets made…

      You comment “money can rule practice” reminds me of another type of financial conflict-of-interest in medicine:

      My longtime (30+ years) family doctor started getting involved in offering injectable facial fillers and other “medical aesthetics” procedures in her office (while still trying to see all of her regular GP patients). I asked her one day about these really awful “Ask the Doctor!” before and after ad videos playing on continuous-loop big screens in the waiting room AND in every exam room (you can imagine: the dreary black-and-white ‘before’ photos of a sad-looking wrinkly woman alongside the full-colour ‘after’ shots of the now cheerfully-glowing woman, deliriously happy because she’d just had her facial injection…) I found these really offensive (reminding us at every visit that the way we looked was just not good enough!)

      My doctor just laughed at my question, and answered, “Oh, this is my new all-cash retirement plan!” She eventually hired two full-time ‘medical aesthetiticians’ to help handle all the new business, moved her GP patients to a new waiting area (a row of straight-backed wooden chairs lined up along the hallway off the reception area) while the Botox clients enjoyed nice leather couches, fancy espresso service, and lovely orchids in THEIR big waiting room!)

      Making appointments soon became impossible, and waits were interminably long even when we could get in to see her. She made it clear without even a word to us that she was simply no longer interested in the practice of medicine. I put up with this distressing change for years (out of loyalty, I guess) before I too joined the rest of her patients in finding a new doc.

      So there’s more than one way that “money can rule practice”.

      Like

      1. Yours, unfortunately, is not the first story I’ve heard first hand of a woman having to find a new family doctor because the doctor she’s been seeing has changed her focus – my friend’s doctor turned her practice into a “medical spa”.

        Do these family doctors who abandon their previous patients think about the ‘First, do no harm’ they have promised?

        Liked by 1 person

        1. Good question, Jenn – although I’m guessing that a person who makes this decision is likely too burned out to really care much by the time they start up the spa. (One ‘dermal filling’ training organization advertises to doctors that it focuses “particularly on wrinkle treatments”, which honestly seems like a career choice that all those years of specialized medical education ultimately make you pretty over-educated for… 😦

          Like

  2. Thanks for this perspective, Jill. The nature of trust is complicated (and your car repair analogy is a good one).

    In this particular BBC scenario, it’s entire groups of dueling “experts” with contrary public opinions on the best treatments for their patients. How’s even an informed patient supposed to make sense of that, especially when opinions are based on financial self-interest?

    It’s also getting much harder now to maintain the traditional medical hierarchy (as Dr. Wachter itemizes in his list of reasons) that used to include by definition blind trust in all medical experts. (Remember the good old days of Marcus Welby MD?)

    These days, I’d be far more likely to ask Dr. Welby how much he was earning every year from his industry payments as one of their “Key Opinion Leaders” before deciding on his trustworthiness…

    Like

    1. One of the reasons I like my Kaiser Plan where physicians are salaried. I have interviewed several about why they left private practice and came to a salaried position in an HMO. Most of them site the ability to NOT walk with pharmaceutical reps, NOT deal with academic pressures to publish or perish, and especially Not dealing with office management… They get to take care of patients and that’s what they really want to do.

      I would imagine with Canada’s National Health Care that these are positive points with physicians also.

      Liked by 1 person

      1. Hi again Jill – I’m guessing there are some advantages and disadvantages in either system. But in general, Canadian physicians earn on average significantly less than US docs do (income is determined by provinces, not by the federal government, so earnings and other circumstances do vary from province to province, of course.

        But here’s an odd example of how things work around here: in the province of Québec a year or so ago, 700+ physicians, both GPs and specialists, signed a petition from Médecins Québécois Pour le Régime Public (a group that represents Québec doctors who strongly support public access to healthcare) saying they did NOT want a planned pay raise, and they would rather have the extra money go to patient care and services. Speaking of taking care of patients, right? ♥

        Like

  3. I believe that calm evidence and experience based discourse is helpful to those patients, like you and I who are ready, willing and able to digest complex medical information.

    To others, who are not of that comportment, they need to at least chose a physician they have vetted to be their needed expert and be able to trust that they have done the research and analysis, and have the experience to weigh in on the patient’s health care decisions.

    We can’t know everything ourselves … and I can tell you when it comes to fixing my son’s car… I wish I had a service provider I could trust.

    It’s a balance between the dangers of BLIND trust (been there) and knowing that experience and wisdom can be just as or more important than scientific data.

    Liked by 1 person

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