Heartless Behavior

When the Texas Department of Health yanked a potentially life-giving vitamin from shelves, cardiac patients cried foul.

June 1992By Comments

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.

When Karl Folkers talks about “Q,” his eyes light up behind black-rimmed glasses. “Q is here, today, in a bottle. It’s not ‘blue sky.’ It’s just about as important as water. If you don’t have enough, you’re sick. Without it, you’re dead.” He likes to talk about its uses (besides heart disease, it is very effective in treating periodontal disease because the cells in gum tissue divide very rapidly, which requires lots of energy). He enjoys enumerating the foods in which it is most abundant (beef heart, selected saltwater fish, grains, and soy oil, among others). He gets a kick out of CoQ10 trivia (all vertebrates have it, but rats and mice also have CoQ9). “I’ve been working on it nonstop since 1957, and it will become universally used,” he says with unshakable conviction. “I get letters all the time from people wanting to know what it does and how much to take. It will become a lifetime therapy for many people.”

One of the things that happens to scientists who work on lifesaving substances is that they tend to become evangelists. They believe they are morally bound to help disseminate the material to the world at large. And so, after decades of seeing CoQ10 ignored by the American medical community, Karl Folkers felt it was time for a change. Without FDA approval, thousands of doctors would never touch CoQ10, and hundreds of thousands of seriously ill people would die or, at best, lead truncated lives. He wanted to move CoQ10 out of the research lab and into mainstream medicine. So last year, after months of meticulous preparation, he made an appointment with the FDA to present a New Drug Application (NDA), a thick volume that he hoped would make unnecessary the lengthy round of testing protocols to secure the FDA’s blessing on CoQ10.

In August, Folkers and his old friend Per Langsjoen and their attorneys traveled to Washington, D.C. What happened there neither man will discuss in any detail on the record. What can be told is that instead of receiving their application positively, or even neutrally, the FDA rejected it, stating inflexibly that under the terms of the Food, Drug, and Cosmetic Act, CoQ10 was not Generally Recognized As Safe (GRAS) either as a drug or as a food additive. The administrators were adamant in their refusal to consider Folkers’ existing data. He could play by their rules or not at all—and their rules for approval of a new drug translated into ten more years’ and $50 million dollars’ worth of new testing.

It was as if all the material demonstrating CoQ10’s safety and efficacy that Folkers had sent to the FDA didn’t exist—never mind the more than one thousand foreign studies that had recorded not so much as a single adverse reaction to the vitamin. The problem was, in essence, bureaucratic procedure. In the eyes of the FDA, unless a food additive is shown to be safe and effective, it is technically considered unsafe. Carrying that idea one step farther, anything that hasn’t been demonstrated safe and effective is illegal, and once it’s illegal, it can be detained. Given that the public’s health can be jeopardized by quack remedies, caution is certainly warranted. But the agency had no provision for exceptional circumstances; it was unable to assess legitimate data that did not follow its guidelines.

According to the FDA, CoQ10 wasn’t approved as either a food supplement or a drug. It existed in a kind of bureaucratic limbo. The only hope the agency held out, in a subsequent written statement, was an offer for interested manufacturers to submit to the agency a proper NDA or a GRAS petition.

Folkers will not fault the FDA. He says, “I have no objection to the FDA. They were doing what they have to do by law.” But he agrees with Per Langsjoen, who—staring off into the middle distance—sums up the fruitless visit to Washington: “It was a most disappointing day.”

Six months passed, and in February the TDH made its sweep, zealously enforcing a strict reading of FDA regulations. Said Cynthia Culmo, the Texas agency’s drug chief, “We—Dennis Baker, the director of the food and drug division, and I—made the decision after we read in Food Chemical News that the government had won a summary judgment in a case in New York against CoQ10.”

When regular CoQ10 customers at Whole Foods discovered what had happened, they were almost as incensed as the heart patients in Tyler had been. Said a store clerk who had to tell them what had happened to the vitamin they were accustomed to buying: “They would yell at me and rant about government fascists for a while. Then they’d ask if the store had a petition for the FDA. One woman was in tears. I wouldn’t be surprised if there weren’t a nice little CoQ10 black market now.”

But in a way, the best thing that could have happened was that the raid occurred in Austin. The city has a thriving community of people who are committed to holistic health care and who have a network of contacts throughout the vitamin industry, and they quickly began to call anyone that they thought could do some good or had a little clout.

One of those contacted was Ed Fitzjarrell, the president of Metabolic Maintenance Products, a small maker of nutritional substances with $1.2 million annual sales, about $50,000 of it in CoQ10. MMP is headquartered in Oceanside, California, but as former Texan Fitzjarrell says, “Two nutritionists in Austin got me off my butt. I had never done any organizing before, but I looked in the mirror and said, ‘I guess I’m it.’ I felt that if CoQ10 came off the shelves in Texas, it wouldn’t be on the shelves anywhere by the end of the year.”

On March 10, Fitzjarrell came to Austin to meet with the Texas Department of Health. With him were James Heffley (one of the nutritionists who had called him) and two local attorneys. The meeting went better than they had dared hope. “The TDH people seemed kind of relieved, after all the hostile phone calls from people in Tyler and from Phil Gramm’s office. They pointed out that they had not held Whole Foods’ CoQ10 for more than a few days and said, ‘We’ll give you an extension on the ban if you file a GRAS petition,’” says Fitzjarrell. He went back to California feeling far better about the vitamin’s prospects. “It’s not just a business matter for me,” he added, “but a personal one too. My mom has had leukemia for eighteen years [it’s in remission], and she takes CoQ10.”

An opportunity to recruit the support Fitzjarrell needed came a month later, almost to the day, at the annual convention and trade show of the National Natural Foods Association in California. In a room at the Anaheim Hilton Hotel, Fitzjarrell gathered representatives of about a dozen major American vitamin manufacturers, including Twin Labs, Nature’s Life, Bronson, and others. Also present was a representative for Dainippon Ink (a Japanese supplier of CoQ10). After giving up trying to explain the FDA’s terminology to the thoroughly mystified Japanese, they all agreed to do a GRAS petition. It would be far quicker than a New Drug Application and would cost a mere $50,000 to $100,000 if all went smoothly.

So, two months after CoQ10 had been banned, the commotion subsided. A lot of hard work was ahead, but Fitzjarrell was optimistic about that. “I’m not excited about being a committee member,” he said, “but otherwise I feel very much relieved.”

What would not go away so easily, though, was the memory of the fear the episode had generated, especially in Tyler. People felt abused. One of Peter Langsjoen’s patients had spent hundreds of dollars to buy nearly a five-year supply of the vitamin. Others said they would gladly drive to Canada to purchase it there if it were banned in this country. And everyone was furious that their lives seemed to count for nothing in the machinations of a bureaucracy they could neither comprehend nor affect. On April 29, TDH drug chief Cynthia Culmo—who says she was “not real familiar” with CoQ10 before the brouhaha—went to Tyler to meet with the citizens’ group and take her lumps. Brenda Miller, for one, was not impressed. “I was not polite to her,” Miller says. “Ms. Culmo said that because of me, this story was all over the place. I told her I couldn’t take all the credit, but I thought that was marvelous. People’s lives depend on CoQ10.”

In retrospect, it is easy to look back on the episode and see it as a classic example of panic. Both the FDA and the TDH say that CoQ10 has never been designated as safe and has in fact been embargoed intermittently before, without much of a ruckus being raised. They claim they were not out to “get” CoQ10 any more than they had ever been. But mass panic doesn’t occur in a vacuum. It happens when people feel threatened and powerless.

If CoQ10 were a drug, it would be a wonder drug—at least in the eyes of its advocates. And perhaps that day will come, but the chances of it coming quickly are slim. Most doctors are too busy and too leery of lawsuits to try out non-FDA-approved therapies. And American pharmaceutical companies aren’t wild to promote a vitamin whose use can reduce the need for prescription drugs.

So for the time being, CoQ10 will continue to be relegated to the shelves of health food stores. At least, one hopes, it will stay there. The Texas Department of Health may have agreed to a truce, but who knows what could happen elsewhere before the GRAS petition is approved, if it is approved? In 1989 the FDA took distributors of CoQ10 to federal court in New York and won a summary judgment last December, upholding its right to regulate CoQ10 as unsafe under the law, thus putting sharper teeth in the regulatory authority.

Perhaps by design, perhaps by coincidence, the present seems to be a watershed in the history of CoQ10. If the worst happens, the GRAS petition could fail and, as Fitzjarrell predicted, CoQ10 could be off the shelves everywhere in a matter of months or years. If the GRAS petition succeeds, the FDA could take CoQ10 off its “Most Wanted” list and it could continue to be sold as it is now. The best that could happen is for someone to convince the FDA that it already has all the data it needs to approve CoQ10. When Karl Folkers is asked if that someone might be him, he just smiles and looks inscrutable.

In the meantime, one wonders what would have happened if folks in Tyler and Austin hadn’t gotten mad and decided they weren’t going to take it lying down.

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