Mercury Rising: As Doctors’ Groups Face Off Over BP Guidelines, Will Patients Fall Through the Cracks?
The ACC/AHA and AAFP have dug in their heels over the new hypertension guidelines, putting clinicians in a bind.
At 97 years of age, Helen had had a blood pressure cuff slipped over her arm countless times, but during a recent routine checkup it was her treating physician who felt the squeeze. Her blood pressure reading, at 147/90 mm Hg, might have gone unremarked in the past but, according to new hypertension guidelines, now puts her in the category of stage 2 hypertension.
“I sat there and looked at her and said, ‘According to the rules, Helen, I’m supposed to be more aggressive with your blood pressure medication,’” Raymond Townsend, MD (University of Pennsylvania, Philadelphia), told TCTMD. “She’s already outlived the national life expectancy for women, she uses a walker, and I’m a little afraid of making her blood pressure low enough to create dizziness or a fall. In the end I said, ‘I feel you’re doing okay as things stand,’ and I left her alone.”
That seemingly benign doctor-patient encounter constitutes a violation of the new guidelines, which—depending on how they ultimately influence reimbursement—could incur penalties for Townsend and many others who choose not to treat to the new, more aggressive targets.
Issued late last year by the American College of Cardiology (ACC) and the American Heart Association (AHA) in conjunction with nine other medical societies, the recommendations pushed the number of US patients with hypertension from 32% to 46% literally overnight. Within weeks of the guideline release, the American Academy of Family Physicians (AAFP) and the American College of Physicians (ACP) announced that they would not be endorsing them. In the ensuing months, the disagreement has sparked a national conversation among physicians and patients about blood pressure targets and the consequences of meeting or not meeting the new cutoffs.
Conflicts and Discord
As previously reported by TCTMD, the AAFP’s concerns center around the studies used to compile the recommendations, in particular the completeness, quality, and weight given to certain studies such as SPRINT over others and the inclusion of the ACC/AHA atherosclerotic CVD risk calculator—a tool for which outcomes data are lacking. In an article on its website, the AAFP said it would instead continue to endorse the JNC 8 guidelines, which recommend a BP goal of less than 150/90 mm Hg for persons aged 60 and older—such as Helen—and a goal of less than 140/90 mm Hg for persons aged 30 through 59.
Contacted by TCTMD, AAFP president Michael L. Munger, MD (Saint Luke’s Physicians Group, Overland Park, KS), declined to expand on these concerns, referring TCTMD to a statement on the Academy’s website outlining each reason the guideline was not endorsed. In addition to concern over SPRINT being given too much weight, the group also notes that “the Chair of the SPRINT trial steering committee was commissioned as chair of the guideline panel, even though that trial provides the basis for the recommended change in blood pressure targets. Several other members of the panel also have intellectual conflicts of interest. While relationship to industry was addressed, intellectual conflicts of interest were not considered.”
These are serious statements. Repeated attempts by TCTMD, however, to get details or clarification from the Academy on these intellectual conflicts were unsuccessful, with staffers responding again and again that their online statement was their final word.
Given the enormity of the guideline, its 43 authors (writing committee and task force members), and 996 references, it is nearly impossible to try to tease out what these conflicts may be, although some have tried. In an opinion piece in the Baltimore Sun, a family physician, Max J. Romano, MD (MedStar Franklin Square Medical Center, Baltimore, MD), called out members of the guideline committee for what he believed to be conflict omissions, which he found by checking a public federal website that reports pharmaceutical and device-manufacturer payments to physicians. But seven of the guideline writers, in a letter given to MedPage Today, said they were “astonished” by the accusations and characterized them as “misattributions (MD with the same name) or other errors.”
The ACC and the AHA have responded to Romano’s allegations in a comment posted below the article, saying they share his concerns, are aware of the issues raised, and are investigating.
“We're conducting a thorough review of formal disclosures, as well as an examination of any potentially undisclosed relationships,” write Rose Marie Robertson, MD, on behalf of the AHA, and William J. Oetgen, MD, on behalf of the ACC. “Based on initial review, we believe some of the assertions regarding specific authors may be errors, misrepresentations of fact, or simply unrelated to the hypertension guideline in question.”
What we’re watching here is a war, and [both] parties are trying to win. Milton Packer
Primary care physician David O'Gurek, MD (Temple University Hospital, Philadelphia, PA), told TCTMD he backs the AAFP’s stance on the guidelines. What’s more, he says the group has made their concerns about conflicts of interest abundantly clear to the ACC and the AHA on numerous occasions when they’ve been asked to participate in drafting guidelines, but that those requests have been repeatedly ignored. The AAFP has also pressed both groups on the need for systematic review of all available evidence. Yet preference was given to SPRINT, said O’Gurek, while trials showing the dangers of tighter blood pressure control, such as data from the Veterans Administration, were not included in the review. Of note, none of the authors of that paper were on the guideline committee.
ACC/AHA guideline writing committee chair Paul Whelton, MD (Tulane University School of Public Health and Tropical Medicine, New Orleans, LA), was the SPRINT trial chair referred to in the AAFP statement. Speaking to TCTMD, Whelton defended the scientific merit of the process that was used to draft the recommendations, noting that special steps were taken to minimize intellectual conflicts. Specifically on the issue of SPRINT and conflicts of interest, he told TCTMD that he and other members who had leadership roles in that trial recused themselves from discussions in which SPRINT data were evaluated. That being said, he thinks the fuss about SPRINT being given more weight than other trials is mostly moot.
“With respect to the goal blood pressure, it doesn’t matter whether you include SPRINT or not,” he said, adding that countries such as Canada and Australia have already lowered their target BP goals.
‘Web of Confusion’
It’s not just general cardiologists and primary care physicians who are feeling the fallout. “[The guidelines] have already had a real impact on society,” said vascular specialist Michael Jaff, DO (Newton-Wellesley Hospital, Boston, MA). “My patients are asking me ‘Is my blood pressure good enough?’ This is a very real issue for everyone.”
Indeed, Townsend and others say that’s where attention should be focused: on the patients now caught in the middle of an extreme difference of opinion between cardiologists and primary care physicians.
“There’s going to be this back and forth, with the primary care doctor telling them one thing and the cardiologist telling them something else,” O'Gurek observed. “When that happens . . . , the person who suffers the most is the patient, because they’re already caught in the middle of a really complicated system that is sort of just a web of confusion.”
Nor is this confusion necessarily new in medicine when it comes to specialists and generalists. The AAFP has a checkered history when it comes to endorsing guidelines produced by other groups. Milton Packer, MD (Baylor Heart & Vascular Institute, Dallas, TX), pointed out to TCTMD that the AAFP has lent its support to a number of guidelines from the ACP, including those on osteoporosis and acute, recurrent gout, but has declined to endorse several previous cardiovascular guidelines, such as those on arrhythmia and heart failure. “This is not just an isolated incident,” he said. “They have pushed back [numerous times] and that raises a number of interesting questions [including] why are they pushing back, and what are the consequences for the American people?”
It’s not surprising, said Packer, that patients might feel confused and unsure of who to trust when they see prominent organizations that are supposed to be looking out for public health having vastly different views.
We’re not trying to be antagonistic. We’re not trying to say that we know better than you, we’re just trying to do right by our patients. David O'Gurek
“What we’re watching here is a war, and [both] parties are trying to win,” Packer, who wrote a recent blog post on what he called a “fake hypertension war,” told TCTMD. “The goal should not be to win, the goal should be to help people.”
Otherwise, as Townsend put it, there is bound to be “mistrust.”
“On the other hand, this is why the doctor-patient relationship and good communication can bail you out,” he continued. “The problem is that the typical office visit in the United States is 12 to 15 minutes. In order to give a full explanation of why you are or are not changing medication based upon the most recent guidelines [you may need] a little bit more than the 1.6 minutes you have in the visit to do that.”
O'Gurek agreed. “At the end of the day we need to make individualized decisions with the patients who are sitting in front of us,” he said in an interview, noting that he fully supports the AAFP’s decision not to endorse the guidelines. “I think all of us just want to do what’s right for our patients.” he added.
“We’re not trying to be antagonistic. We’re not trying to say that we know better than you, we’re just trying to do right by our patients,” O’Gurek said, asserting that there needs to be national dialogue. Some of that, he said, is happening at the local level, with AAFP chapters inviting cardiologists to speak to their members on this issue.
However, since not every primary care physician in the country belongs to the AAFP, some doctors may not even realize the Academy has not endorsed the new guidelines and is recommending they stick with the old ones, O’Gurek noted. “This is challenging for primary care physicians across the country,” he said, “because they are bombarded with information from all sorts of different sources, and they need to have a critical eye and review all of these things that are being said and written about and then decide what is the right thing for their practice and for their patients.”
Searching for Common Ground
Whelton said something that may be lost in the controversy over the numbers is that the guideline places great emphasis on proper BP measurement.
In an interview with TCTMD, Erin Michos, MD (Johns Hopkins University School of Medicine, Baltimore, MD), agreed, adding that the importance of proper technique for home and office monitoring is something that everyone should support. Even the AAFP, she said, likely sees some good in certain components of the new guidelines.
“It’s important not to throw the baby out with the bathwater and dismiss the guidelines completely, because I think both parties also agree on the importance of individualized assessment based on risk,” she commented. “The guidelines are a goal, not a mandate for all.”
Michos added that she’s in favor of the “lower is better” approach to BP, but only if it can be done safely.
“You do have to look at the individual, and there may need to be some modifications in individuals for whom the lower thresholds might not be appropriate due to underlying comorbidities, which the guidelines state,” she said. “The choice of drugs and the target should be part of the patient risk discussion [and] management of hypertension should be a team-based approach.” It may even empower some patients to take better care of their health, she added.
Concerns About Reimbursement and Penalties
Not being able to reach targets, or choosing not to based on discussions with patients, however, is a big part of what frustrates some physicians, who feel they must choose between doing what is best and doing what may be ultimately required to meet reimbursement and performance measures if the new guidelines influence payments.
Plus, with an additional 14% of patients now bumped into the stage 1 hypertension category, for which lifestyle change is advocated as the initial approach, the responsibility for counseling will likely fall to primary care physicians much more so than other providers. And as Townsend notes, their patient time is already spread thin.
Michos said while concerns about being penalized are important and need to be addressed going forward, she sees the current climate as an opportunity to not only to educate patients, but to help them educate themselves on blood pressure and its relationship to overall health.
When people get panicked about not being able to reach targets, that’s where accurate blood pressure reading is especially important. Erin Michos
She has created patient instruction forms for home BP monitoring for her patients, advising them to relax, sit with their feet on the floor, not to measure BP within 30 minutes of exercising or drinking caffeine, and to empty their bladder.
“All those things are important, but when the patient is in the office they are rushing to get into the room and sitting with their legs dangling on the exam table, and it’s not an ideal way to get an accurate reading,” Michos said. She also instructs patients to bring in their home BP cuffs at least once a year to compare them with the office reading.
“When people get panicked about not being able to reach targets, that’s where accurate blood pressure reading is especially important,” she added.
Where to Go From Here?
Michos compared the current situation to the controversy that erupted around new lipid guidelines from the American Association of Clinical Endocrinologists (AACE) and the American College of Endocrinology (ACE) that were released last year, and that differed significantly from those released by the ACC and AHA in 2013. There, too, the main topic was targets and thresholds, with debate over who got it right.
“People panicked over the lipid guidelines worrying that everyone was going to end up on statins,” she commented. “Again, that was a case where it was important to factor in the patient risk discussion.”
The only thing that seems certain now is that no one knows what will happen next in the saga of the new hypertension guidelines. Everyone interviewed was asked if there is a way for the two sides to come together and make things less complicated for patients caught in the middle. Some experts laughed, others sighed. Whelton acknowledged that the goals set forward in the guidelines may never be fully achieved, but said he felt strongly that they have a chance to “do some good” and hopefully improve the health of the US population as a whole.
“The problem isn’t necessarily the guidelines,” Michos said, “the problem is the unhealthy lifestyle of many Americans. I think the different organizations can come together on this, but there needs to be some understanding that there are data [supporting] benefit [of the lower targets] and there may need to be individual variation among patients.”
While the guidelines do say that “clinical judgment, patient preference, and a team-based approach to assess the risk-benefit trade-offs of treatment are reasonable” when making decisions in older patients about drug therapy and intensity of blood pressure control, physicians like Townsend still wonder if they will ultimately end up getting “dinged” every time they make their own decision for patients like 97-year-old Helen.
His tone was glum: “Everyone is holding their breath right now waiting to see where the hammer starts to fall.”
- Townsend, O’Gurek, Packer, Whelton, Jaff, and Michos report no relevant conflicts of interest.