A Cholesterol Gamble Dr. David Becker is betting on lifestyle changes as an alternative to drug remedies.

Posted: November 12, 2006

David Becker surveyed the 29 people sitting in the bright auditorium at Presbyterian Church of Chestnut Hill.

He was worried. His experiment had just five weeks left.

Five weeks to prove that people could change. That people did not have to rely on statins - with their potentially serious side effects - to manage high cholesterol.

Becker's bet was that people could do just as well with the right diet, exercise, less stress and natural supplements. Yes, he knew he was asking a lot.

He was a community cardiologist from the suburbs taking on the drug industry's $32-billion-a-year remedy for high cholesterol. He wanted to prove that statins such as Pfizer's Lipitor and Merck's Zocor were not the only option for the 65 million adult Americans with elevated cholesterol.

In his own mild-mannered style, Becker was standing in defiance of a drug-dependent culture that emphasized the easy way over the healthy way.

The genial, wisecracking cardiologist from Chestnut Hill Hospital, who insisted everyone call him David, tried to catch the eye of each person, but couldn't tell if, after nearly two months, he was getting through.

Was Deborah exercising five times a week? Had Howard given up the steak dinners he so loved? Did Greg quit smoking?

Too many of them were coming late, skipping meetings. After nearly two months, the group still hadn't gelled.

He wasn't angry. It was just time to don his tough-doctor persona, do the deep-voice thing, and throw in a little guilt trip for good measure. Word would spread even to those playing hooky tonight.

He transformed himself into Dr. Becker - the one only his most recalcitrant patients saw.

"I am disappointed in how many people are not here tonight," he told the group. "We only have 12 short weeks to get you to change habits developed over years. We're running out of time."

Maybe their lack of engagement had to do with the fact that his program was free this time. Maybe they weren't scared enough; they hadn't had heart attacks - yet.

Many doctors rely on cholesterol-lowering statins, paying only lip service to diet and exercise. But high cholesterol doesn't hurt, and many people - even some who have suffered heart attacks - stop taking the pills.

In his practice, Becker treated scores of patients who wouldn't take statins because of the side effects: muscle aches and trouble concentrating.

He had taken a page out of famed cardiologist Dean Ornish's heart-healthy diet and rewritten it to be easier to follow and better at fighting cholesterol.

He was a believer. For more than a decade, Becker had preached diet-plus-exercise, stress-busters, and other lifestyle changes to prevent heart disease.

As a doctor, he wanted to help people avoid the disease. He was also curious and wanted to test his program. Besides, it was a challenge, something different.

An optimist, he didn't consider statins bad - at least not if the patients didn't get side effects - but lowering cholesterol was only part of his battle plan.

Becker had been offering this program for 11 years, but this time he was conducting a real clinical trial. This time he was armed with a $125,000 state grant. And this time he was trying out two natural supplements that he thought could help lower cholesterol: fish oil and red rice yeast.

So there he stood, in front to the auditorium's wooden stage, his arms crossed, pondering how to get this crowd over the hump.

His goals were huge, but the experiment was simple.

There were two groups.

Each had 17 men and 20 women randomly chosen from the hundreds he had screened. The total cholesterol averaged 241 for one, 239 for the other. The low-density lipoprotein, or LDL cholesterol, averaged 157 and 154, well above the recommended maximum of 100.

One group would take Zocor, Merck's blockbuster statin, and get the standard lecture about diet and exercise.

The second would go through Becker's program of lifestyle changes and take the fish oil and red rice yeast, a natural substance with statinlike properties used medicinally in China for at least 1,200 years.

The people in this group, called Change of Heart, would meet every Wednesday for 12 weeks. To help with diet, they would hear from a nutritionist and eat meals made by a vegetarian chef. To combat stress, there were the tai chi master, the yoga instructor, the psychologist and the acupuncturist. And to rev up exercise, there was a personal trainer.

In the end, blood tests would reveal how Becker's approach stacked up.

If the results were promising, he hoped some big-time researcher at a university medical center would copy his little experiment on a grander scale.

Maybe that would happen if he got the results published in a medical journal. Maybe this study by a community doctor could dent conventional medical wisdom.

Maybe. But there were just five weeks left.

Committed to change

On a chilly, cloudy Wednesday evening, they arrived at the church. They came alone or in pairs, tentatively looking for familiar faces as they peeled off coats and gloves worn against the early April snow squalls.

Men and women, black and white, trim and heavy, all had one thing in common - high cholesterol.

Ron Howard wasn't sure he wanted to be there. Like most people in the group, he was busy.

He wondered whether he could really spare the 3 1/2 hours a week that Becker's program required. Besides, he already had tried exercise and changed his diet to fend off his doctor's demand that he take Lipitor, the top-selling statin.

But Howard's cholesterol remained high, and rather than go on a drug for the rest of his life, the 64-year-old from Mount Airy decided to check out the program.

At the front of the large room, Becker - a short, wiry, 49-year-old with closely cropped, salt-and-pepper hair - appeared at ease as he leaned against the edge of the stage chatting with those who ventured up to him.

But he was a little nervous. He had a lot riding on these 37 people, most of them strangers, and he knew he would be asking much of them in the next three months.

Instead of having them take a pill, Becker would ask them to make major changes to the most fundamental aspects of their lives - what they ate, how much they exercised, and how they dealt with stress.

What he offered in exchange - better long-term health - felt a little intangible. So he would cajole them with entertaining and informative evenings.

He would rely on his coterie of helpers to show them the way, but Becker was the star of the show.

He taught the group about heart disease. He answered questions about everything from the benefits of garlic supplements - they give you bad breath, but don't help your heart - to the effect of diabetes on cardiac arteries.

Side effects came up often. An estimated 5 to 15 percent of statin users suffered from muscle pain, depression and irritability, difficulty thinking, and even sexual dysfunction.

The most serious side effects - liver and muscle tissue damage - are rare.

A few minutes after 5:30, Becker launched his experiment.

"Don't call me Dr. Becker. We are going to be on a first-name basis here," he told them. "I'm David, and together we are going to break down barriers and prevent heart problems."

He hoped to arm them with information on how to avoid becoming one of the 1.2 million Americans who suffer heart attacks each year. But it was up to them to change.

Turning to the giant flip pad on the easel next to him, Becker drew two parallel lines from the top right corner of the paper to the bottom left corner.

This is a coronary artery, he explained. As we age, starting around 12 years old, each of us begins to build up plaque on the walls of our arteries.

Some factors - like high LDL cholesterol in our blood, too many fatty foods, diabetes, and high blood pressure - affect the amount of plaque and the "stability" of those deposits.

That plaque can grow to the point that it dramatically reduces or blocks blood flow. More often unstable and inflamed plaque deposits, sometimes ones that narrow the blood vessels only 20 or 30 percent, will rupture, causing a clot that blocks the artery and leads to a heart attack.

Each element of Change of Heart, the doctor explained, was designed to limit the risk of getting the disease.

"So how do we know what is working - the diet, exercise, fish oil, or red rice yeast?" Howard asked from his third-row seat.

It doesn't matter, Becker said. "The idea is to show there is an alternative."

Becker thought all the strategies were important.

And he wasn't interested in showing that the supplements alone, or in combination, could replace statins. His goal wasn't to supplant one manufactured pill a day with eight made from natural substances.

"I am hoping that you will walk out of here after 12 weeks having made major lifestyle changes that will stay with you for the rest of your lives," Becker said.

He told them that the red rice yeast had a cholesterol-lowering effect that might get a boost from the fish-oil supplements. And he warned that some people reported muscle aches and other side effects from red rice yeast similar to statins.

In the 1980s, Merck distilled the first statin, Mevacor, from a fungus with similar properties to red rice yeast. Red rice yeast has compounds called monacolins thought to act like low-dose statins by inhibiting the liver's production of cholesterol.

Howard listened closely. He was president of OIC International, the global offshoot of the Rev. Leon H. Sullivan's self-help network in the African American community.

He sat back while the good doctor explained just how much time he and his new compatriots would have to commit.

At least 30 minutes of vigorous exercise five days a week. Plus all the extra time it took to cook the meals for the modified Mediterranean diet.

Howard, looking distinguished with his wavy silver hair and mustache, found he liked Becker and his approach. His total cholesterol was 250, and his LDL was 177.

He was in.

Coach and role model

Strains of the choir's hymns spilled across the hall into the church's basement, where Becker's group met on the third Wednesday of April.

The carpeted room was cozier than the auditorium, but not cramped.

Becker, dressed in a tan shirt and his customary olive khakis, stood next to the flip pad and explained how stress contributed to heart problems.

Stress raises blood pressure and causes inflammation to artery walls, he told the group. And it causes blood to clot more easily, often the final straw leading to a heart attack.

That's why it is critically important, he said, for each one of them to find something that helps release stress.

Exercise can be that release, and it was "the single most important thing you can do" to reduce the risk of a heart attack.

Do it whenever you can, he told them. Do it in the morning or during your lunch hour. Do it after work or at night, he said, sounding a lot like Dr. Seuss.

Of course, that was easier for Becker than most.

With a successful medical practice and nine partners, he worked four-day weeks and limited the number of patients he saw. Most nights he was home for dinner with his wife, Sherri, and their four children.

Still, he asked no more of the group than he was willing to do himself. He was training to run in his first road race - the 10-mile Broad Street Run.

He also ate the diet he advocated. Becker was so strict that when he was out of town, his kids only half-joked that it was "steak night."

A member of Becker's team interrupted to announce dinner.

As a line formed up the stairs to the kitchen buffet, Jeff Alper approached to give Becker some good news.

Thirteen days into the program, Alper had taken a routine blood test. His "bad" LDL cholesterol had fallen almost by half to 75.

"Great," Becker told Alper. He was genuinely excited for the 56-year-old retired environmental engineer.

But Alper's results weren't really good news.

It was too soon for diet and exercise to have had such a dramatic effect. Becker knew it was the red rice yeast, possibly with a boost from the fish oil, that had lowered Alper's numbers.

Becker worried that if the numbers came back too low, his study would be criticized for replacing one drug, a statin, with another, the red rice yeast.

"The whole point of this program is instead of taking a pill," Becker said, "you understand what is going on in your body."

Exercise reduces inflammation and raises HDL, or "good," cholesterol. The diet cuts LDL cholesterol and weight. Stress reduction reduces irritation and keeps circulation healthy. All three lower blood pressure.

Finally, Becker told them, the fish oil has an anti-inflammatory effect and helps reduce unhealthy triglyceride levels. The red rice yeast keeps down LDL cholesterol.

Becker recommended only top quality fish oil that had had impurities removed. The 600-milligram capsules of red rice yeast were available from a variety of supplement makers, he said.

He stopped and looked around the room.

Was anyone listening? Were they getting this?

There were nine weeks left.

An early hint, a late hitch

One of Becker's problems with statins is they must be taken every day, which is hard. The entire class of drugs, known as HMG-CoA reductase inhibitors, slow the liver's production of cholesterol. But they work only for 24 hours.

About three years ago, a patient came to Becker's office showing terrific cholesterol numbers. As he began to compliment his patient for taking his Lipitor, Becker noticed a sly smile.

The patient told him that he had stopped the Lipitor and was taking fish oil and red rice yeast.

That experience repeated itself several times, so Becker looked into it.

He found very little in Western scientific literature about red rice yeast, also known as monascus and hung qu. But a handful of studies from Asia, mostly Taiwan and China, reported on the cholesterol-lowering benefits of red rice yeast.

Becker reluctantly told those patients who refused to take a statin about the supplements. He was worried about the lack of scientific data.

In addition, Becker was concerned about the reliability of the supplements because he knew the industry was poorly regulated. Unlike medicines, supplements do not have to meet the Food and Drug Administration's purity and quality standards and the manufacturers can change the ingredients.

Halfway through Becker's experiment, that's exactly what happened.

The company that made the red rice yeast changed its product, replacing the active ingredient with something else. Becker found out about the change when the cholesterol levels of office patients started soaring.

Becker had bought enough of the supplements for the entire experiment, but he needed to tell the participants to be careful, and to read labels.

"They can do that because there is no regulation of the supplement industry," he told them.

It's important to know the pros and cons not only of the statins, he said, but also of the supplements you take and the food you eat.

Information was key to making changes.

There were four weeks left.

And the results are in

On a hot and humid Wednesday in June, they gathered once again in the church auditorium.

In groups of six and seven, Change of Heart participants chatted happily among themselves. They were companions melded together by nearly three months of common effort.

For the first time since the program began, they were getting weighed at the back of the room, this time joined by 37 strangers.

Members of the Zocor group entered alone or in pairs, looking for familiar faces. It was their first time at a Wednesday night meeting.

Near the door the always buoyant Becker seemed to have trouble standing still.

Clutched in his left hand was a sheaf of papers. The raw results.

The room swallowed even the 74, who began to settle into seats as Becker walked to the front of the room.

He had the results, he told them. He'd be happy to call out scores if anyone was interested.

Ruth from the Zocor group stood up:

Total cholesterol dropped from 221 to 123, LDL from 128 to 50.

The meeting took on a feel combining a high school pep rally and a faith healing.

Liz from Change of Heart stood up:

Total cholesterol fell from 298 to 155, and LDL was down from 209 to 88.

A hallelujah moment.

Anne, from Zocor:

Total, 221 to 150, and LDL, 142 to 76.

Brenda, Change of Heart:

Total, 220 to 190; LDL, 141 to 88.

Another hallelujah moment.

And so it went for more than a half-hour.

Ron Howard's total cholesterol was cut by more than half, to 119. His LDL fell 71 percent, to 52 from 177.

Those were great numbers, completely in the healthy range. On top of all that, he lost the 20 extra pounds he had been trying to get rid of for the last decade.

Becker told the group that overall, the total cholesterol for the Zocor group fell 27 percent to 173. LDL cholesterol was down 40 percent to 92.

The Change of Heart group's total cholesterol was down 33 percent to 159. LDL fell 44 percent to 87.

A statistical tie, and a big hallelujah moment.

In addition, Becker said, the Change of Heart group lost an average of 10 pounds, while the Zocor group lost less than one.

Another Change of Heart program would be scheduled for the fall. Twenty-seven Zocor members signed up on the spot.

Waiting for acceptance

Becker drove the three miles along Bethlehem Pike from Chestnut Hill Hospital to his Flourtown office.

He was back to his normal routine, practicing traditional cardiology, doing rounds at the hospital.

Six weeks earlier, he had submitted his study for the American Heart Association's scientific sessions. He should have heard by now if it had been accepted.

Acceptance was the clincher. The study was scientific proof the program worked as well as a statin to lower cholesterol.

It was a little before 4 p.m., so traffic wasn't bad. And for August in Philadelphia, the weather was fine.

He pulled his silver Acura SUV into the parking lot and walked into his office through the back door.

He sat down at his desk, surrounded by diplomas, certificates of achievement, and the crayon drawings by 8-year-old Chloe, and turned on his computer.

He had mail.

It was from the American Heart Association.

The committee gets many "meritorious proposals. . . . We are able to select only a small fraction of those. . . . We regret to inform you . . . your trial was not among those that were selected" for the late-breaking trials sessions.

Becker's heart sank.

He had spent well over a year planning the study, getting approval from the hospital's review board, recruiting participants. And it was, he thought, a stunning success.

Still, the AHA regretted to inform him.

Becker gathered himself and read on. There was a "however."

"Because your trial was judged to be of high quality . . . it has been accepted for presentation elsewhere in the program."

He leaned back in his high-back chair and looked around his office in relief.

He had pierced the medical establishment's consciousness with a small experiment on the value of lifestyle changes.

Turning back to the computer, Becker scrolled back to the top of the e-mail and reread the 246-word note.

His trial would not only be presented in the scientific sessions, it also would be included in a supplement to the journal Circulation - the leading medical journal aimed at cardiologists. And then, maybe, there would be a larger study - maybe even an alternative treatment.

Becker reached for the phone. Sherri was out of town so he called several of his partners who had helped him. He called members of the Change of Heart team to give them the news.

Yes, we did it!

Becker's bet had paid off.

The payoff

Four months later, by November, Ron Howard was still sticking with the program. He was thrilled with his cholesterol numbers and his new weight.

"This program jolted me into an awareness of what kind of foods you really want to stay away from," Howard said. "Once I got over the diet and nutrition, I was home-free. When I matched that with the exercise, the results were astounding."

Howard and some others from the program formed an ad hoc support group that meets monthly. Together, they buy the fish oil and red rice yeast supplements in bulk.

Today, David Becker is in Chicago presenting his study at the American Heart Association's scientific meetings.

It's steak night back at home.

Contact staff writer Josh Goldstein at 215-854-4733 or jgoldstein@phillynews.com.

philly.com

Starting tomorrow, Dr. Becker will conduct a Q&A forum on heart disease, cholesterol and lifestyle changes at http://go.philly.com/davidbecker.

For more information and resources on heart disease and cholesterol, go to http://go.philly.com/cholesterol.

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