Science
Heartless Behavior
When the Texas Department of Health yanked a potentially life-giving vitamin from shelves, cardiac patients cried foul.
Shoppers at one of Austin’s Whole Foods Markets last February 11 thought at first they had walked into a drug bust. Four men in matching blue windbreakers and a man and a woman wearing suits were milling around the vitamin and herb shelves of the North Lamar Boulevard grocery store, removing various items and carting them off to a back stockroom. There they stayed busy for a couple of hours, tossing bottles back and forth to each other and checking items off a clipboard. After staring for a few seconds, though, most customers went on about their business, poking through the dried kiwi fruit and jars of live-culture yogurt. Few recognized the action as a routine inspection by the Texas Department of Health. Fewer still cared to know which substances had failed to meet the U.S. Food and Drug Administration’s strict regulations. And almost no one realized that among the goods confiscated was every bottle of an obscure vitamin known as Coenzyme Q10.
And yet, weeks later—even though the confiscated vitamin was soon released back to the store—shock waves of the raid were being felt across Texas and as far away as California. Letters started pouring in to congressmen’s offices. The phone began ringing at the headquarters of the Texas Department of Health in Austin. A small but vocal contingent was obviously mad and determined to do something about it. The furor was even more puzzling because it was completely unanticipated. Those who were taking flak for the health department’s actions found themselves wondering just what this coenzmye stuff was anyway and why people were so upset.
Coenzyme Q10, or CoQ10 (not to be confused with the controversial AIDS treatment Compound Q), is an oil-soluble vitamin. It occurs in every cell in the human body, most of it synthesized by the liver, the rest coming directly from food. CoQ10's central role is energy production, or bioenergetics. It helps the body’s cells convert food and oxygen into ATP (adenosine triphosphate), a chemical that all tissues require to function properly. Without CoQ10, the cell’s energy cycle is broken, and without energy, life stops.
In the human body, the constantly pumping heart is probably the second heaviest user of CoQ10, behind the liver. In a person with cardiomyopathy (weak heart muscle), levels of the vitamin are almost always drastically deficient. When supplements of CoQ10 are given to someone with heart disease, the recovery of heart function can be dramatic. Which is why in Japan, Sweden, Italy, Denmark, and Canada, the vitamin is a conventional and widely prescribed heart medication. More than one thousand research papers have been published on it worldwide, and six international symposia have been held documenting not only its efficacy but its almost astounding lack of side effects. In Japan alone, it is the treatment of choice for heart failure for millions of people.
In the United States, CoQ10 is not accorded such acclaim. Here CoQ10 is sold in health food stores, where people buy it to boost their energy or improve their circulation. It is not taken seriously by the medical community. Aside from programs in Indiana and Florida, the only other place in the country where CoQ10 is currently given on an extensive, regular basis for heart trouble is the Langsjoen clinic in Tyler. There it has been administered to some one thousand patients over the past twelve years, by father-and-son physicians who stand almost alone in this country in their belief that CoQ10 is extraordinary.
Per and Peter Langsjoen (“Lang-shin”) don’t look as if they are working on the outer fringes of medicine. In fact, if the two cardiologists were glimpsed in an examining room listening soberly to the chest of a wizened, elderly patient, they would look as if they had stepped out of a Norman Rockwell painting. Dr. Peter, as his staff and patients refer to him, is 38, with tousled brown hair and close-set blue eyes in a broad face. He carries his stethoscope draped around his neck St. Elsewhere—style, and peppers his speech with expletives like “gee” and “heck.” Dr. Per, 70, is tall and robust, with a direct gaze and a firm handshake. Their practice is in most respects very middle-of-the-road. They nag their patients to reduce fat and salt in their diets, and they prescribe all the usual anticoagulants and blood pressure medications. But they also give CoQ10, and they find that when they do, conventional treatments can frequently be reduced.
Says Peter: “CoQ10 is one of the biggest advances of this century. It is truly fundamental. To ask us to practice without it would be like asking an internist to practice without antibiotics.” Per adds, “It is so basic that all health problems we do not understand should be reevaluated.” The doctors see the day when CoQ10 will be administered for a host of disorders.
For nearly a dozen years, Per and Peter Langsjoen had been giving CoQ10 without any reaction from the FDA, which is why they were thunderstruck when word reached them that CoQ10 was off the shelves in Austin and other cities—though strangely not in all stores and not anywhere in Tyler. It looked to them like the beginning of an effort to ban the vitamin altogether. Peter says passionately, “We can’t practice medicine without it. If we didn’t know what it can do, maybe so—but not now. If I can’t use it here, I’ll move to a country where I can use it.” They put in frantic calls to the Texas Department of Health and sent each of their patients a letter telling them what had happened.
It was panic time in Tyler when the Langsjoens’ patients got the news. Many felt it was nothing less than a sentence of slow death. Brenda and Tom Miller in particular were outraged. Both of them take CoQ10—Brenda for a faulty heart valve and Tom for thickened heart walls that might have been caused by a coronary artery anomaly. Despite his brawny build, Tom, 51, had been in poor health since infancy. He worked as a roughneck and a traveling salesman, he rode rodeo and boxed, but he never knew when his energy level would suddenly drop. “It would be like someone cut off the faucet,” he says. After seeing a series of doctors without much in the way of results, he heard about Peter Langsjoen from a neighbor. “Peter sat me down and actually talked to me; he didn’t run me through like a herd of cattle,” Miller says. He credits heart surgery for a great deal of his improvement, but he also credits CoQ10: “I figure the Good Lord kept me alive until I found Peter Langsjoen. And CoQ10 kept me alive until I had surgery.”
Brenda—who in jeans, a red blouse, and purple socks, looks younger than her 41 years—was practically an invalid before she started taking the vitamin. “I just stayed in bed,” she says. “I couldn’t last two minutes on a stress test. But now I mow the grass, do the laundry, and act like a normal person.” When they received the Langsjoens’ letter, the Millers felt as if they had been sideswiped by a hit-and-run driver. Says Tom: “I call the FDA the ‘phantom board,’ and as far as I can tell, what they were going to do was kill a bunch of people and ruin a good doctor’s practice, and that makes me as mad as the devil.”
The Millers were not the only ones who were mad—and scared. CoQ10 takers spent hours on the phone to each other and the clinic. They alerted the news media, wrote hot letters to the FDA, congressmen, and senators, and phoned up the Texas Department of Health to bawl out Cynthia Culmo, the chief of the agency’s drug branch. Brenda Miller also helped organize the opposition, and on March 21, sixty agitated patients and family members assembled at the First Christian Church to plan a strategy for keeping CoQ10 on the market.
Meanwhile, Per and Peter kept trying to figure it all out. Why had all this happened now? Although he couldn’t be sure, Per thought he had a clue as to what had gone wrong, and it concerned his old friend and colleague, Karl Folkers, the brilliant and exacting director of the Institute for Biomedical Research at the University of Texas at Austin.
If there is a grand old man of CoQ10, it is Karl Folkers, 85. He has worked on it since it was isolated in 1957, doing pioneering studies and training many of the other scientists in the country and elsewhere who work on the vitamin. He has also been a tireless advocate of what he considers nothing less than a potential medical breakthrough. It was Folkers, in fact, who introduced Per Langsjoen to CoQ10 in 1980.
The two scientists met when Langsjoen was a cardiologist at Scott and White Clinic in Temple. Says Folkers, “Someone told Per about Q, and he wrote and asked me, ‘What is this thing?’ That opened the way to one of the most fruitful research collaborations I’ve had in my life. We’ve cooperated in studies for nearly twelve years. Per is one of a kind.” Though bound by a common interest in CoQ10, the two could not have been more different in temperament. Langsjoen was the perfect clinician—fatherly and empathetic. Folkers was the quint-essential researcher—single-minded and rigorous.
In 1970 the FDA had issued an Investigative New Drug number to Folkers for CoQ10, making him at the time the only person in the U.S. authorized to submit research on the vitamin to the agency. This he did, regularly and voluminously. Japanese pharmaceutical manufacturers—which made all of the CoQ10 in the world by either fermentation or organic synthesis—gave him all of the yellow crystalline powder he needed free. He developed cooperative research efforts with various universities. Still, it was hard to get the work published in major medical journals. They were just not interested.
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