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