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Drugs in Disguise 

Herbs and supplements tweak your biology, but fly under disclosure radar

The chants of Krisha Das thrum like a heartbeat. White sage and palo santo inhabit the air. A mother pushes her 7-month-old slowly back and forth in his stroller as she browses between the tinctures and the books. Her son always seems calm in here, she confides, tucked inside Moonrise Herbs on the Arcata Plaza. All around her, the shelves display Buddhas and Tarot cards, eye masks and teapots. Bulk herbs are nestled in fat, glass jars: fenugreek and guarana seed powder, lavender flowers and pennyroyal.

Down the road in Eureka, it's hard to find pennyroyal at Eureka Natural Foods, a health food emporium that has served Humboldt residents, in one incarnation or another, for more than 50 years. Many suppliers have stopped offering it, says wellness manager Suzanne Littlefield.

Pennyroyal has killed people. Among its victims are a sad handful of young women who tried to induce abortions and children who were accidentally overdosed by their parents. Very small amounts of the concentrated essential oil can be dangerous.

The National Institutes of Health and the U.S. National Library of Medicine, on their joint website, warn that "Pennyroyal is UNSAFE (emphasis theirs) for anyone to use," and particularly dangerous for children, pregnant women and people with liver or kidney disease. It can cause nervous system damage, lung failure and brain damage.

Even so, customers live to buy it another day at Moonrise in Arcata or Humboldt Herbals in Old Town Eureka. They use pennyroyal as flea repellant for their pets or to increase perspiration during colds or bring on menstrual cycles, shop owners say.

Irene Lewis, the herbalist who owns Moonrise, says the one pennyroyal death she has studied in detail involved drinking far more of its essential oil than anyone should choke down.

That's no surprise. It's a core principal of toxicology that the dose makes the poison. Even water will kill if you drink enough of it, as a California radio station learned in 2007, after unwittingly egging a contestant on to a water-poisoning death.

Yet dosage is one of the built-in mysteries for anyone who shops among the thousands of herbs, supplements and traditional remedies found easily on store shelves here in Humboldt, the land of alternatives.

If you want to know how much of an active ingredient is in that pill you're about to pop in your mouth, or whether it will do you any good, or even whether it's safe, then move on out of the supplement aisle. The U.S. health food industry has fought hard to stay free of safety restrictions that hobble its counterparts in Europe, Japan and much of such the rest of the developed world. As a result, America has two systems for overseeing the countless products we take to try to cure our ills or keep ourselves well. The systems are separate, and they are unequal.

 

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In 2000, Yale medical scientists published a study linking a common ingredient of over-the-counter cold medicines and diet aids to a small risk of stroke in young women. The Food and Drug Administration asked manufacturers to voluntarily pull products from store shelves and stop production, in a move toward reclassifying phenylpropanolamine as "not generally recognized as safe and effective." That action effectively produced a recall of a key ingredient in popular products such as Robitussin CF, Triaminic, Dimetapp, Dexatrim and Acutrim.

Around the same time, doctors were reporting rare cases of liver failure associated with another over-the-counter product, the herbal sedative kava-kava. Though the FDA issued a consumer advisory in 2002, kava-kava products are still available.

"I can buy it off the shelf today," said Amitava Dasgupta, a professor of pathology at the University of Texas Medical School in Houston. "Some people use kava for sleep. But if you use it for more than three or four months, it can cause liver problems."

Dasgupta thinks this is information that consumers need to know. But manufacturers are not required to warn users of the risk, or to label products with the amount of active ingredient in a dose.

The reason we can still buy kava-kava but not phenylpropanolamine, he said, is that the FDA classifies cold medicines containing phenylpropanolamine as drugs, but herbal products containing kava-kava as dietary supplements.

Drug manufacturers must show the effectiveness and safety of their products through rigorous testing before the FDA will approve sales. Makers of dietary supplements don't have to run this expensive regulatory gantlet, or divulge the exact formulations of their products. So consumers aren't entitled -- or often even able -- to learn as much about the contents of supplements, including herbs, vitamins, minerals and amino acids, alone and in proprietary mixtures.

The FDA insists that over-the-counter drugs have instructions for use, and a definitive statement of how much drug each dose contains. Drug companies can't change the formulations of their products without notifying the FDA.

Again, makers of herbal supplements have it easier. They can change their ingredient mix any time, and don't have to explain what's inside. If a manufacturer claims an ingredient, it is enough that the ingredient exists in the herbal compound in some amount.  An herbal supplement may come in convenient caplets labeled "450 mg", but this does not necessarily mean 450 milligrams of active ingredient, as it would on an aspirin bottle.

Roughly 30 percent of Americans take alternative medicines, said Dasgupta, who has studied their effects since 1998. His book, "Prescription or Poison: Benefits and Dangers of Herbal Remedies," was published by Hunter House in 2009.

"I wanted to write a book consumers could understand," said Dasgupta. He met resistance from some publishers, who told him they did not see a market for a cautionary as well as promotional herbal anthology. But the book has gathered positive reviews on Amazon and in the blogosphere from medical practitioners and herbal supplement advocates.

Dasgupta himself takes fenugreek, which, in addition to being a common ingredient in curry spice, he says is effective in lowering blood sugar in people showing borderline symptoms of developing Type II diabetes. He is careful to stress that the herb is not a substitute for standard treatment.

"If you are young and healthy, and not taking any western medication for chronic disease, it is safe for you to take many herbal products," he said.

Then he immediately launched into a list of caveats.

Even ginger, gingko, ginseng, and garlic -- plant products he believes are generally safe and beneficial -- have shown potential to cause bleeding when combined with blood-thinners such as aspirin. They're more problematic mixed with warfarin (Coumadin), a drug already difficult to administer, because blood-clotting is a complex and finely balanced equation. Messing with it is dangerous. Clot too much and you may have a stroke, too little and you could bleed to death from a bruise.

Other herbs that may be fine alone can be problematic in combination with other medicines. St. John's wort, an herb taken to counteract symptoms of mild depression, amps up the way the body processes a wide range of compounds, from birth control pills to the immunosuppressive drugs that protect transplanted organs from rejection. If the body breaks down these drugs too quickly, what's left in the bloodstream will be too low a dose to be completely effective. In 2000, the medical journal The Lancet reported two cases of organ rejection due to a metabolic interaction of St. John's wort and cyclosporine.

Because information about drug interactions and harmful side effects of herbal supplements are rarely available on the box, consumers must seek it out on their own.

That task is made more challenging by lack of standardization. Kava-kava, for example, appears on labels under more than 20 common names, including ‘ava, kawa, sakau, and its botanical name, Piper methysticum.

New legislation may push labeling requirements for dietary supplements toward the restrictions on over-the-counter drugs. In July, Sen. Dick Durbin (D-IL) sponsored Senate Bill 1310, which would require manufacturers to reveal the complete contents of supplements on their labels, with warnings for substances deemed dangerous by an FDA review of current research. The bill was referred to committee and has languished there without major action ever since.

Defending the supplement industry, Rep. Jason Chaffetz (R-UT) proposed House Bill 1364 in April. The "Free Speech About Science Act of 2011" would let supplement manufacturers promote health benefits for their products based even on experiments in petri dishes -- which medical researchers know often fail to produce the same results in people. That bill is also trapped in subcommittee.

A continent away from Congress, Eureka Natural Foods, which distributes hundreds of supplements under its own private label, is among those mustering support against regulation. On its customer service counter, bearing a bright red "SAVE OUR SUPPLEMENTS" headline, a flier urges "health enthusiasts" to insist on their right to buy whatever they please.

 

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Rick Littlefield, who has owned Eureka Natural Foods since 1985, appreciates the ironies of his position. He is a guy who registered Democrat for years before switching to independent. He lives in a county where active environmental groups pay homage to the precautionary principle, the idea that nobody should spew something into the environment unless it's proven safe.

And yet when it comes to supplements, he says, he thinks like a Republican.

"It's really a freedom of choice issue," says Littlefield. "Consumer rights activists and people in the wellness movement and preventive health are saying you know, we need to have the right to make these choices ourselves."

He figures that that right should extend to buying any supplement you'd like unless it has been proven unsafe -- the exact opposite of the precautionary principal.

After all, he says, "If they're not unsafe, the worst case scenario is that some unsuspecting consumer bought something that doesn't work for them."

Those who sell health to Humboldt approach their work with varying degrees of nuance.

Moonrise's Lewis likes to read studies on PubMed, a free, government-sponsored collection of the abstracts that summarize medical research. Littlefield is firmly convinced that double-blind studies or population studies provide far more reliable information that a few anecdotes from a doctor or other healer.

Yet his daughter Suzanne Littlefield, the store's wellness manager, bristles when asked about studies that suggest some popular herbs aren't effective. Did they come from the FDA? Or the American Medical Association?  Or anyone funded by them? She doesn't trust them.

"My personal opinion is that they feel like they're missing a piece of the pie, the AMA and the pharma industry," she said last month, as she and her father sat at a table in their store's café.

Western medicine has moved toward understanding traditional remedies, setting up complimentary medicine arms in medical schools and funding research through the National Institutes of Health. Yet it has bought itself so much ill will, though bungled diagnoses, over-prescribed drugs and its own conflicting recommendations that some are too disgusted to want anything to do with it.

For a few, the repugnance stirs something fundamental in their souls, and their minds slam shut. Drugs are bad. Plants are good.

Nicole Tipple, the wellness buyer for the North Coast Co-Op in Arcata, can rattle off lists drug overdoses and medical errors.

"Herbs have never killed anybody," she says. She says it again and again, after recounting each pharmaceutical sin. Well, not commercially sold herbs, she hedges when questioned. Not in the last 25 years.

But herbal products, including yohimbe and extract of bitter orange peel, have been associated with strokes and heart attacks, as has Chinese ephedra, which was banned in 2004 after documented deaths, said Thomas Kearney, director of the San Francisco Division of the California Poison Control System. Bitter orange has filled the gap left by ephedra in many weight-loss products, and, like ephedra, it contains chemicals that mimic adrenaline.

In deaths linked to herbal products, as in all deaths, personal circumstances make it hard to draw a simple line of cause and effect, Kearney said. With several stimulants, the difference between the effective dose and the toxic dose is narrow. "The issue with a lot of these is that they are pharmacologically active!" he said. They are dangerous because they are drugs.

 

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A plant is a complex mixture of chemicals.

Even in the wild, interactions among those chemicals can be lethal.

Some fungi convert coumarin, a chemical that makes sweet clover hay smell sweet and taste bitter, into discoumarol, an anticoagulant. The effect was discovered accidentally, when farm animals died horribly after eating moldy hay. Discomarol was later formulated as a rat poison, and modified into the blood-thinning drug warfarin.

The complete package that is a whole vegetable or herb varies from plant to plant, season to season, and region to region. It can easily lead to differences in potency of tenfold or more between herbal products, and even between lots of the same product. It can also lead to differences in safety.

Just as plants absorb water and nutrients, they can also take up metals and minerals from the soil, and concentrate the elements in their tissues.

Lead, mercury or arsenic exceeding the EPA's recommended daily limit have been found in 20 percent of herbal compounds studied by a team of Boston University investigators.

In their pilot study, published in the Journal of the American Medical Association in 2008, the team tested nearly 200 randomly selected products from 37 different manufacturers. All were advertised as Ayurvedic, an Indian tradition with roots reaching back several thousand years.

Lead, arsenic and mercury are intrinsically poisonous. Arsenic stops the energy production assembly line in cells. Lead accumulates in the body, and can seriously disrupt brain development in children. Mercury causes birth defects and damages multiple organ systems. Other elements, such as selenium, copper, magnesium and zinc, are important for health in micro amounts, but become toxic when consumed regularly.

These minerals and metal elements may contaminate agricultural land through industrial contamination or, more commonly, by direct application of fertilizers, pesticides and fungicides, even those that might be labeled organic. But metal and minerals are also natural constituents of the soil in many parts of the world.

In a 2004 paper by members of the same Boston University group, investigators found heavy metals in 20 percent of off-the-shelf products in "South Asian markets" in Boston.

"Some of the things that I would avoid, even though I am from India, are products manufactured in South Asia," said Dasgupta. "There have been more problems with products from that area."  Chinese products, too, from pet food to vitamins, have had a long and troubled history of being spiked with inappropriate ingredients. Many Indian and Chinese products are good, Dasgupta says, but it is harder to separate them from the bad ones.

 

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Felicia Tomasko is a registered nurse and president of the California Association of Ayurvedic Medicine, an American incarnation of the Indian teachings.

While full disclosure of the contents of herbal supplements sounds reasonable and perhaps desirable, she said, she worries about how the government will define "dangerous."

"Where is that line drawn?" Tomasko points out that aspirin and ibuprofen, drugs that may feel comfortably familiar to consumers, but both carry risks of serious side effects.

Derived from the active ingredient in willow bark, an old herbal remedy for pain and fever, aspirin may be safely taken daily at low dose -- as many people do to lower their risk of heart attack and stroke. But in children, aspirin has been linked to an extremely rare and debilitating swelling of the brain and liver called Reyes syndrome.

Ibuprofen, though it prevents fever and inflammation through a similar mechanism to aspirin, actually increases risk of heart attack and stroke when taken daily at the high end of the recommended dosage, a large Swiss study reported last summer.

Both aspirin and ibuprofen, when taken in high dose, long-term, can create painful and potentially dangerous stomach ulcers.

Here's the thing, though. We have a pretty good idea of the risks of ibuprofen and aspirin, and we continue to update our knowledge through ongoing research. Our knowledge of the benefits and risks of herbal compounds is, by contrast, extremely thin in modern data, though it may be deep in human history.

In using herbal supplements, we rely on tradition, not science. Our choices to use or avoid both herbals and drugs in turn reflect our gut reactions to the words "tradition" and "science" and all the connotations we attach to them.

One problem with putting confidence in thousands of years of tradition, says Catherine Hammett-Stabler, is that modern usage has drifted from tradition. We have, in some cases, found new purposes for old medicines, or started swallowing a compound that was once only applied to the skin. Hammett-Stabler, a professor of pathology and laboratory medicine at the University of North Carolina Medical School, wants supplements to stand up to modern research scrutiny for the efficacy and safety of drugs.

"Many times we aren't following the traditional use of these herbals, or we don't prepare them the same," said Hammett-Stabler. "We may not follow the tradition of how the herbals were collected, and the time of year that plants are collected can affect the potency. It may have been an occasional tea and we are taking convenient capsules of powder every day."

 

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To try to keep suppliers honest and consumers informed, Europe now requires herbal medicines to meet the same safety and efficacy standards as modern drugs. This means expensive clinical trials. In May 2011, the European Union began enforcing registration of herbal medicines in compliance with its 2004 Traditional Herbal Medicinal Products Directive, arousing vociferous protests (and lawsuits) from the supplements industry and herbal medicine users.

Labels must list all ingredients, offer safety warnings and counter-indications, and indicate the amount of active ingredient in a dose -- which is a sticking point, because many suppliers simply don't have the data to do so, or the means to acquire it.

An international panel, Codex Alimentarius Commission, produced similar guidelines in 2005 for vitamin and mineral supplements. The recommendations do not cover herbs. The commission, created by joint action of the Food and Agriculture Organization of the UN and the World Health Organization in 1962, does not make law, but does wield considerable power in resolving international trade disputes under the authority of the World Trade Organization. A July 2011 Codex agreement, for example, pushed the United States to accept voluntary labeling of genetically modified foods. Whether you see it as a consumer protection agency or a cudgel of the nanny state depends on your point of view.

"I would hate the Codex to take effect in America," said Lewis of Moonrise Herbs. "I don't think there should be restrictions on people's access to folk medicine."

Over at Humboldt Herbals in Old Town, owner and herbalist Julie Caldwell is ready for something to change. 

"In this industry, there's an awful lot of shady, scam-y products on the shelf, and people are being ripped off," she said. "There's a place for some regulation." She worries, though, about any enforcement that would come from the FDA, with its reputation for being overly cozy with big pharma.

 

 

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Using herbal products wisely means investing time to understand the history and known risks and benefits of each plant product.

The National Library of Medicine and a number of medical groups provide reliable online information about herbal products. Health practitioners are also good resources, and it is essential that you tell your practitioner about your herbal supplements, especially if you are taking Western medicines. Keep track of what you experiment with, how often you take it, and how you feel.

And resist the temptation to mix and match treatments, up the dosage, or apply a supplement in a new and adventurous way not recommended on the label.

"Use as instructed. If it says take it for three weeks, don't take it for three months," says Tomasko of the Ayurvedic association. People often feel safe with familiar cooking herbs and spices. But dosage matters, she says, and each plant is different in its effects and potency. She says, for example, she always feels comfortable taking turmeric, another component of curry, but warns that in large amounts, licorice causes vomiting and nutmeg creates hallucinations and convulsions, as well as stomachache.

"We want it all. We want access to everything and yet we want to be protected from things that are dangerous," said Tomasko. "We need to be educated as consumers and not expect labeling to educate us."

One good step in self-education is choosing producers that at least claim to be standardized and have transparent production lines.

An independent company, ConsumerLab.com, and the nonprofit watchdog, Center for Science in the Public Interest, produce information about consistency of dosage between product lots for selected products, and check that the contents match the label.

They also track research and FDA advisories on supplements for their subscribers. But the FDA does not take an active role unless consumers or scientists report problems with a product, or producers make blatant, unproven claims about their products' curative properties.

Dasgupta thinks the state of modern medical knowledge on supplements has reached a point where we can begin demanding a higher level of accountability from producers. But for now, he recommends the education. "Read about herbs on the FDA website. Go to Amazon and buy a book. Empower yourself."

 

Liza Lester has a doctorate in molecular and cellular biology, and has been known to dose herself with ginger or peppermint for stomachaches. She lives in Washington, D.C., where she does public information work for the Ecological Society of America.

Journal editor Carrie Peyton Dahlberg contributed to this report.

 

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