David Ferland for the Lansing State Journal

Dorothy Tupper went into surgery for cataracts two years ago. When it was over, she developed high blood pressure that would not come down on its own.

“It scared me to death,” said Tupper, who is 86, sitting with authority at the kitchen table of her home in Holt alongside two neighbors. All three women have high blood pressure.

The diagnosis alone can be intimidating. More than 370,000 Americans die each year from causes related to the disease, which doctors call hypertension.

But, for the past two years, there’s been an additional cause for concern: the medical community is sharply divided over when to treat high blood pressure.

National organizations representing high blood pressure researchers - the American College of Cardiology and American Heart Association, in particular - are pushing for a more aggressive approach to treatment, even if that means more medication.

Organizations representing primary care doctors — The American College of Physicians and American Academy of Family Physicians — do not think the benefits of increased treatment outweigh the risks.

For Tupper, like many patients, developing a treatment plan was a process of trial and error. After successful treatment with one medication, she broke out in hives. Her doctor switched it. Her blood pressure is still not under control but taking more medications means facing the rare risk of kidney failure and a host of side effects that come with each medication.

As the groups continue to move farther apart, people like Tupper, who already have a difficult time treating their high blood pressure, will start to hear conflicting recommendations.

“There’s a schism because the two major groups of primary care physicians decided at the beginning they would not be a part of it,” said Dr. Kenneth Jamerson, a physician at the University of Michigan Medical Center who was part of a group of researchers trying to create the most recent treatment guideline.

The primary care physicians see it differently. Their complaints revolve around one massive study of treatment for high blood pressure, a study known as SPRINT.

‘Game changer’

Researchers put together the Systolic Blood Pressure Intervention Trial - SPRINT, for short - to test whether aggressive treatment of high blood pressure would help patients avoid its more dangerous outcomes: strokes, heart attacks, kidney failure and death.

The study, started in 2010, was funded by the National Institutes of Health and organized by University of Alabama, Wake Forest and other universities known for their contributions to hypertension research. It included nearly 10,000 adults from Portland, Oregon all the way to San Juan, Puerto Rico. The results were published in 2015.

“A lot of people have the vision that SPRINT was a game changer,” said Dr. Supratik Rayamajhi, a physician at Michigan State University’s Department of Medicine, who is regarded as the university’s resident expert in the clinical practice of treating high blood pressure. “We never talked about controlling blood pressure strictly before that.”

Blood pressure is a measure of how powerfully your blood “booms” through your body as it feeds your organs and gets rid of waste. When we are exercising or scared, this pressure rises to supply our body with the tools it needs to survive. But when this pressure remains high for extended periods of time, it can have dangerous consequences.

Doctors and researchers have long debated what numerical value of blood pressure is safe and what pressure puts you at risk for these fatal events. These debates have real-life consequences.

For a long time, patients would be diagnosed with high blood pressure if their blood pressure was consistently above 140/90. That first number, called systolic pressure, measures how hard the heart has to work to get blood out to the rest of the body. The second number, diastolic pressure, measures the health of your blood vessels.

A blood pressure of 120/80 is widely considered ideal.

Researchers in the SPRINT divided people into two groups: one group received treatment only when their systolic blood pressure was above 140, which has been the standard. The other group was treated to push their blood pressure as close to 120/80 as possible.

The second course of treatment was so effective that the study was actually stopped early because the researchers considered it morally irresponsible to keep the life-altering benefits of increased treatment from the group that was receiving conventional treatment.

Fewer people died when their blood pressure was treated more aggressively.

Disconnect

In November of 2017, the American College of Cardiology and American Heart Association released a nearly 400-page document outlining changes they think should be implemented in the treatment of hypertension based on the research that has been done so far.

The major suggestion was that doctors should start diagnosing and treating patients earlier when blood pressure was only moderately elevated, above 130/80.

This is a consequential change. With the new threshold, the number of people in the United States with high blood pressure rises by 30 million to more than 100 million adults.

Members of the American College of Cardiology and American Heart Association are more often researchers than physicians, but the document was also supported by nurses, physician assistants and specialty physicians.

Its recommendations still haven’t been widely implemented, because primary care physicians, who often find themselves on the front line of the battle against high blood pressure, took a different tack.

Both major organizations that represent primary care physicians — the American College of Physicians and American Academy of Family Physicians released their own recommendations for changes to the hypertension guidelines, maintaining that, for most people, the threshold should stay at 140/90 and, in the elderly, that top number should increase to 150, lowering the overall number of high blood pressure patients.

And, starting just months after the release of the researchers' guidelines, the primary care doctors also put out critiques, saying in part that those guidelines had relied too heavily on the SPRINT study.

Dr. Mary Anne Forciea is a physician at the University of Pennsylvania School of Medicine, author of primary care physicians' guidelines and past chair of their Clinical Guidelines Committee.

She said the SPRINT trial excluded diabetics, measured the blood pressure in a way that isn’t commonly seen in the clinic, “and there was a sense, although it’s hard to document this, that patients recruited into SPRINT were perhaps slightly more fit and functional than the average patient population.”

If the people studied in the trial weren’t representative of the general population, how are doctors nationwide supposed to apply the results to their patients?

Gregory Fink, an expert in hypertension research and a professor at MSU, doesn’t find that argument convincing.

Studies like SPRINT go through a clinical guidelines committee, a group of people who are supposed to decide if the study design is good enough to be set into practice.

“If you look at the way the guidelines and SPRINT trial were done, there’s a tremendous amount of oversight,” he said.

And it wasn’t as if SPRINT was the sole source of the new recommendations, said Jamerson, who was an author of the researchers’ guidelines. Those guidelines referenced 367 separate studies or meetings.

There were several major trials that influenced his decision, Jamerson said, and “every trial showed some element of lower blood pressure control being better.”

There were threads running through the data that all came together suggesting that pushing patients to a lower blood pressure could reduce strokes and fatal events, he said.

Back when the diagnosis level of blood pressure was anything over 140 systolic, people with blood pressures between 120 (normal) and 140 still had an increased risk of death even if they were not labeled with “hypertension.”

What’s new, Jamerson said, is research has shown that treating this group can reduce their risk of death.

The two groups are looking at the same numbers, Forciea notes. “It basically has to do with how one interprets the evidence.”

“Where we disagree is how robustly you want to emphasize the results of a single trial,” she said.

She meant SPRINT.

Conflict

The 7th report and recommendation for how to diagnose and treat high blood pressure was released under the banner of the National Institutes of Health in 2003. Researchers and physicians both signed on, along with 37 other organizations. So did physician assistants and nurses.

By the mid-2000s, NIH decided to bring everyone back together for an updated guideline, which is when the first cracks in the coalition began to show.

Jamerson said the NIH tried to do so with an 8th report.

"Over the course of it, they decided we shouldn’t do this anymore," he said, and in the end the NIH decided not to endorse it.

The report was published anyway, just a few pages long. The NIH had mysteriously removed itself as the leader of the report, a role it had held for nearly 40 years.

And just before it was released in 2013, NIH released a statement called, “Refocusing the agenda on cardiovascular guidelines,” explaining that they had decided to limit their involvement in creating guidelines on cardiovascular medicine.

“There has also been debate about who should be in the driver’s seat,” the statement said, adding that the NIH would still partner and endorse guidelines but in a much more limited fashion.

In 2014, the researchers set out to put together a revitalized recommendation on the diagnosis and treatment of high blood pressure. The physicians were invited back in but refused to participate.

“Everybody said yes but (American College of Physicians) was like a little different,” Jamerson said. “I don’t know the true story…At the end of the day they didn’t sign on to be authors…by design, they chose not to be a part of the creation. They chose to be a part of the criticism.”

But does this schism between the scientific and medical community about how to treat this serious disease really come down to the results of a single trial?

When pressed about the absence of the primary care physicians from the researchers' guidelines, Forciea said, “We don’t routinely work with other organizations that are…” before she hesitated and restarted, saying, “how should I say this, the AHA guidelines came out while we were still working on ours so we were not aware of what they were going to recommend.”

Trickle-down effect

No one directly involved in the decision to separate, including representatives from the NIH, agreed to discuss explicitly the conversations that happened behind closed doors.

The 2013 NIH report and schisms that followed point to in-fighting that led to the scuttling of the 8th report and to the primary care physicians walking away from the table.

Even organizations with long-standing working relationships have conflicts, said Fink, who, in addition to his work at MSU, is also an editor for the American Heart Association’s journal, Hypertension, and was president of the American Heart Association’s Council on Hypertension.

“It’s like global politics or something where you have allies and antagonists and ground shifts over the years,” he said.

Some physicians have accused researchers involved in SPRINT of using the guidelines to further their own research. Others even said that the researchers lowered the threshold to sell more drugs.

“Many people felt, wrongly in my opinion, that the guidelines were made in such a way to increase the amount of drug therapy,” Fink said, “and that’s just factually not the case.”

Dr. Raymond Townsend is a professor at the University of Pennsylvania’s Perelman School of Medicine. Four months after the researchers’ guideline came out, he published a critique in the Annals of Internal Medicine, a leading journal for primary care physicians, that ended by saying, “as providers, the most valuable conclusion we can convey to our patients is that a guideline is never a substitute for clinical judgment.”

Some local physicians seem to have adopted the views of their organization’s leadership.

“I don’t think doctors are truly and strictly following the new guidelines,” said Rayamajhi, the MSU physician and high blood pressure expert. “They are aware of it… They are continuing to do what they did before.”

He struggles with the researchers’ guidelines because he worries they may push primary care physicians to give so many medications that the medications themselves will start to harm the patient. Concerns about SPRINT are part of his thinking.

But it’s also common for doctors to rely on opinions from their parent organizations, not least because these guidelines tend to be lengthy and complicated. The 7th report from NIH was 104 pages and the recent researchers’ guidelines were 481.

“The problem is I don’t think it’s been summarized well enough, and I don’t think it’s possible unless you go through line by line of 450 pages,” Rayamajhi said.

Other physicians are, at the very least, confused.

Dr. George Abela, chief of cardiology at MSU, said doctors were thrown off by the change in approach and by how quickly it came.

“It was a quick turnaround actually within a few years that this occurred that threw us off a bit to say the least. But in questioning people about this, the thinking is that most of the data supports the lower blood pressure rather than the slightly higher levels being proposed,” he said.

Whatever the motive, when there is a disconnect between the researchers and physicians, patients could be left without proper care.

“Surprised? No.” said Dennis Paradis, director of the Michigan Health Policy Forum. “Bluntly, I think an issue like this needs adult supervision.”

The organizations involved “may not come together,” he said, “but I believe the issue gets resolved over time.”

Organizations like health insurance companies may add some clarity to the argument. If insurers decide that hypertension must be diagnosed and classified in a certain way in order for doctors to get paid, “it would play in substantially,” Paradis said.

But don’t get too excited. An official statement from the Centers for Medicare and Medicaid said that while the “diagnosis and treatment of hypertension continue to be covered services in Medicare,” they will not define what the threshold is.

Mary Ann Nemshak is a retired nurse and a friend of Dorothy Tupper. She’s been diagnosed with high blood pressure, too, and has also experienced troubles with the management of her treatment.

After gaining 20 pounds on one medication, Nemshak had to confront her doctor admitting, “I couldn’t take it anymore.”

But she has something most patients don’t: a background in medical care. She doesn’t worry quite as much, she says, and she knows how to deal with doctors.

“You can push a little bit harder,” she said.

David Ferland is a doctoral student in the Department of Pharmacology and Toxicology at Michigan State University. Reporting on this story was supported, in part, by a grant from the Science and Society at State program at MSU.

High blood pressure

· In 2015, over 78,000 people died directly from high blood pressure and more than 370,000 from causes related to high blood pressure (like stroke, heart attack, kidney disease).

· Of people who had their first stroke, 77% have high blood pressure. Of people who had their first heart attack, 69% have high blood pressure. Of people who have congestive heart failure, 74% have high blood pressure.

· From 2005 to 2015, the number of deaths from high blood pressure rose 37.5%.

· The estimated cost of high blood pressure in 2010 was $46.4 billion. By 2035, the total direct costs of high blood pressure could increase to an estimated $220.9 billion.

· 76% of people with high blood pressure are on medication.

· Only 54.4% of people on medication for high blood pressure have their blood pressure down to normal levels.

Source: American Heart Association



