CAMLAW: Complementary and Alternative Medicine Law Blog

Are Drugs More Dangerous than Supplements?

Ask parents of those teenagers who committed suicide while taking antidepressants, and the parents might respond, "yes, drugs are more dangerous than dietary supplements."

Particularly in treatment of depression. Some of these parents filed lawsuits alleging that antidepressant drugs approved by the federal Food and Drug Administration (FDA) played a causal role in killing their children. If their loved one had, for example, taken St. John's Wort, instead, the worst the teen might have experienced would have been photosensitivity in strong sunlight.

Dangers of Herbal Products and Other Dietary Sufpplements Versus Drugs

A recent article in Lancet suggested that a patient on the drug Indinavir could find the bio-availability of that AIDS drug compromised by simultaneously taking St. John's Wort. That is about the worst St. John's Wort has been found to do, although adverse reactions have been found with other herbal supplements.

The debate about regulation of dietary supplements continues to rage. In some circles, that Lancet article has been referred to as the "smoking gun" of complementary health care: as if the news about adverse herb-drug interactions somehow should change Americans' right to access medicines of their choice. It is also a strange metaphor, turning a flower into a gun.

Are "Natural" Herbal Products Necessarily "Safe" or Necessarily "Dangerous?"

It is true that herbal products are not necessarily safe, simply because they are marketed as being "natural." And it is also true that the public needs to be better informed about potential dangers (as well as of negative clinical trials) of both drugs and herbal products.

And finally, it is true that herb-drug interactions are a legitimate and growing source of concern to clinicians. That, in turn, has policy implications, as hospitals now will have to modify existing institutional policies concerning medication use to account for patient use of dietary supplements; clinicians have to include questions about dietary supplements in the medical history and intake; government to provide mechanisms to monitor adverse interactions more intensively; researchers to boost efforts to study interactions between conventional and complementary therapies (such as the drug-herb interactions); promoters of wellness clinics, medical spas, and holistic health and integrative care centers, to factor in potential herb-drug interactions; and legislatures and other regulatory authorities, such as those delineating scope of practice for complementary and alternative medical providers (acupuncturists, chiropractors, naturopaths, massage therapists, and others) to continue consideration fashioning rules that prevent public harm from such adverse interactions.

All those concerns are valid: regulatory policy and institutional risk management must adapt to research findings suggesting that therapies once considered inherently safe indeed have greater safety risks than presupposed.

Patients' Right to Choose: Information to Empower Health Care Consumers

The greater smoking gun--or perhaps radioactive isotope, leaking poison, whatever metaphor we choose--is this: drugs are deadly, too. We've known this, to be sure; but the conventional medical wisdom has been that drugs are safer than dietary supplements. And in terms of regulatory policy, one source of conventional wisdom has been to condemn dietary supplements as inherently dangerous, and herald FDA-approved drugs as presumably safe. And in this way conservative segments of biomedicine again have functioned as priesthood to lawgivers, determining the right of the people to access (or not) medicines of their choice.

Until this new evidence about antidepressants, the equation was relatively simple: FDA-approved meant blessed, vetted by known criteria and therefore 'objectively' fine; whereas those 'other things' citizens were taking into their bodies were deemed condemnable, available only as a result of "consumer demand" and "lobbying"-- euphemisms, perhaps, for superstition and pressure.

An Even-Handed Approach to Drug and Dietary Supplement Regulation

Now there is a lot of greed, chicanery, and perhaps downright fraud in the dietary supplements industry, no doubt, as in other industries, and precious little research in many (but not all) cases.

Thus, not all dietary supplements are good, but not all are bad, either. This is no time for fundamentalism on either side of the debate. What we need are sensible approaches that work across territories, whether one identifies a therapy as "conventional" or "alternative," "CAM," "holistic." We need an end to Us and Other, This and That, polarity versus polarity; a reconciliation that takes into account the Medicine Buddha notion that everything can be medicinal or, on the other hand, toxic.

I'm not a particular believer in 'St. John's Wort pretzels' or other commercial efforts to prey upon human gullibility, but philosophically, I am predisposed to favor choice: the right to make discerning decisions based on adequate disclosure and information. I would rather see legislation and regulation increase disclosure requirements on product labels, than ban products based on a paternalistic view that people are too stupid to make their own decisions. (See Chapter 9 of Beyond Complementary Medicine for more detail.)

More than likely, the parents who put their deceased children on antidepressants, on drugs that may have had a causal role in the teens' deaths, were following sound medical advice. They simply did what they were advised to do by their doctors, and by industry. This is the way it is and has always been. The headlines should present no surprise in suddenly announcing in bold letters that the 'FDA is broken' or that there is no way to prevent the American public from receiving dangerous, FDA-approved drugs.

I am for an even-handed approach, across therapies, an approach that takes account of consumers preferences and respects their ability to make choices based on adequate, available information.

Many physicians would like to see dietary supplements regulated as drugs. Ethically, this position is sheer paternalism--taking decisions out of health care consumers' hands because patients are presumed (by some) too irresponsible to make their own decisions. This is a return to the white-coat, 'doctor knows best' position that Yale physician-scholar Jay Katz critiqued in his landmark book on informed consent, The Silent World of Doctor and Patient.

The contrary position, which is to leave supplements as currently regulated under DSHEA (the Dietary Supplement Health Education Act of 1994), actually allows consumers to make their own decisions about whether and what to take, yet allows government to ban products proven unsafe.

The Founding Fathers observed: "that government is best which governs least," and in this spirit, I have advocated the least autonomy-restrictive approach (Cohen MH. A fixed star in health care reform: the emerging paradigm of holistic healing. Ariz State L J 1995;27:79-173.)

The latest data on antidepressants suggests that even drug regulation is no fail-safe. By giving consumers all the information necessary to make choices among a range of therapies, government governs best by empowering patient decision-making.

Disclosure of Information as a Mechanism for Freedom of Choice in Health Care

I had ample opportunity this week to contemplate this potential shift in regulatory policy while sitting as a passenger in the front row of the Fung Wah bus from New York to Boston. We had just stopped at Roy Rogers; the smell of baked beans, French (or freedom) fries, pickles, horseradish sauce, half-eaten hamburgers, ketchup, and onions permeated the caboose. Nothing around was remotely recognizable from the vegetable kingdom, except perhaps a limp flap of white lettuce that dangled from the plastic garbage bag the Fung Wah folks had tucked by my seat.

The sound of cell-phone jingle punctuated and punctured my policy reverie. It came from a moderately-on-the-way to obesity teen, wearing too-tight pants made from a dead animal's skin and chomping on the remains of dead animal flesh coated in corn syrup dyed with Red #30. She was multi-tasking by hugging her Super Sized cheese curls between her knees and plunging a handful of curls into any unfilled space in the cavernous aperture of her mouth with her telephone hand, miraculously veering the antenna from her cheek at just the last second. From time to time, my seatmate muttered the word "asshole" into the phone, causing our driver's head and the wheel to veer from the path.

Seeing this phenomenon caused me to reflect on cause and effect. Who or what was to blame? For many erudite professors and medical doctors had been quoted on this question in a New York Times magazine spread on the latest case of teen suicide linked to antidepressants.

Who was at fault: the FDA, for approving the drug without a "black box" warning label? Or were the parents, for feeding their teen the antidepressant? How about the boy's doctor, for prescribing the product? How about the manufacturers? Or was it the pharmaceutical industry, for funding trials and nixing publication of negative results? And what really caused the boy's death?

Blame is easy. It would be too facile to point the finger at the FDA; the parents; the doctor; the teen; the manufacturer. And the Buddha within me had to make peace with my seat-mate. I had three more hours and forty-five minutes to do so.

Of Human Bondage: Depression, Obesity, Cell-Phones, and Cheese-Curls

Perhaps responsibility could not be fixed in any one quarter, but did, in a larger sense, belong to the larger community, which also held a collective obligation to remedy. We're all connected, as Ma Bell used to say; and from the perspective of energy medicine, literally connected by cords of relationship, cords that may be invisible and non-testable in today's laboratories but can nonetheless be felt and perceived by the subtle senses. In a larger sense (I like that phrase; Lincoln used it to great effect in the Gettysburg Address, which has stayed in my subconscious ever since I had to memorize and recite it in the sixth grade), in a larger sense we share responsibility for our wounded world in which the greatest gift a human can experience, the birth of a child, results in inane tragedy.

Perhaps the boy's death is part of a larger puzzle. What caused the depression in the first place, and the need to turn to antidepressant drugs? Nobody knows.

Depression, like obesity, is widespread in our society, and, statistics show, a leading cause of death in one form or another. (I continued contemplating this as my seat-companion crumpled her completed bag of cheese curls, elbowed her way across the seat bar, and continued to engage in unbridled oral gratification, stuffing her other facial orifices with the cell-phone, nasal spray, and other FDA-approved devices while toying with an onion and pickle at the bottom of the multicolored box from Roy Rogers.) Depression is a multifaceted disease, one which many of us has suffered in some respect, large or small (visit a copy of Rodin's sculpture Expulsion from Eden and you'll see that Adam, too, had some taste of primordial guilt and shame).

Perhaps original sin lives within us--not as a matter of doctrine--but simply as recognition that together we share a sphere of existence that can be terribly lonely, if we consider the degrees of separation that keep us isolated and insulated on buses, subways, trains, and on the street. What could I say to my seat-mate? Was anyone home, or did I have the temerity to try? She was, after all, "very busy" at the moment...and she was one of thirty-plus passengers, on one of numerous buses, speeding down numerous highways....I suddenly felt like reading Kafka.

The walls, I thought, break down a bit in weddings, funerals, baptisms, and bar mitzvahs....or maybe my Fung Wah ride was more tumultuous than expected, leading to an over-generalized train of thought.

Blackborgs

Beyond hormonal changes and possibly genetics, what else led to the teens' severe discontent with life?

I sometimes wonder whether the intrusion of technology into every orifice of our lives is changing the oracular mystery of human contact; I meditate on how the thumb, the digit that separates Man (and Woman) from the Apes, has now evolved into a semi-processor (for those of us glued, Pavlovian-style, to Blackborgs or transfixed by our videophones or email regimen) as the human Cyborg increasingly emerges, like it or not, within our breast. Also to be cognized is the fact that children, unlike earlier generations, live under the nuclear shadow, and studies have shown that the long-standing, hair-trigger nuclear status of our world has sufficiently penetrated children's minds as to create chronic, deep-seated anxiety, terror, and pessimism. It could also be growing up in a world where terrorism could, at any moment, infest any situation, turn any social encounter into death. Worse (if that is possible), the threat could be from a fellow student down the hall who has studied the art of making bombs on the Web, if not from some fundamentalist overseas.

There are obviously many factors and social forces impinging on today's children and teens, including human inability to control the shadow aspects of technology, and the existential separation and anxiety that this out-of-control status engenders. It would indeed be depressing to catalogue all the wounds our world currently suffers, but it may be helpful to observe in daily life how human dependence on the machine increases all the time, a gradual slide toward enmeshment in the Matrix.

We've eaten the from the apple of knowledge, but don't know how to handle what we've learned. Blaming the FDA or drugs or supplements shifts focus for a few moments from the larger sources of pain, but that is not healing. If holism we seek, then, let us be authentic in the search for answers.

Of Borgs, Beasts, Clops, Mind and Healing

When the Cyclops asked Ulysees for his name, Ulysees cleverly replied, "No Man." When Ulysees later put his burning poker in the Cyborg's eye, and the Cyclops spun around in agony, the beast could not find his tormentor. His friends asked, "who hurt you in this way," to which the Cyclops adamantly shouted: "No man! No man has hurt me!"

The Yoga Vashista, an ancient India text, speaks of a beast with many arms, who holds a spiked club in each arm. The beast thrashes about, each time clubbing itself with a different arm, and screams in agony, never understanding that the injury stems from self-immolation. That beast is the mind, the scripture asserts, and its many arms are the thoughts, feeling-states, and other movements of the mind.

Is Resistance Futile? Toward Possible Solutions

The effect is easy to identify: teen suicides; the causes are more difficult to pinpoint, and solutions more difficult to invent. We cannot lay the blame at the doorstep of the FDA, the parents, the kids, their peer group, television, Big Pharma, the supplement industry, medicine, or any one person, profession, or agency. Nor is this message targeted to makers of cell-phones and cheese-curls, or even Roy Rogers. Although, to be sure, oral gluttony, recently popularized in the documentary, Super-Size Me, does speak more broadly to our appetite for gadgets, refills, stimulation, distraction, and the many arms of consciousness working on feeding, some arms holding medication and others holding a spiked club (in pill or verbal or other form).

Perhaps we can, for the moment, simply acknowledge our wounded world for what it is, take a moment, share a desire to heal, in whatever form that desire for healing may manifest.

That alone, a moment of stillness, away from cheese curls, Blackberries, and other goodies, may allow a kind of human contact that seemed as alien on my Fung Wah ride as Martians to a Boston-New York commuter.

And we can perhaps drop a little more of the rhetoric and our preconceptions, in fashioning regulatory policy around drugs and dietary supplements.

Finally, we can begin to re-conceptualize our vision of medicine, and of legal rules around heaeling: what medicine includes, and what it must and must not include; what choices are and should be available to consumers; the government's role in banning or facilitating our access to products and to information about those products; how other social forces and choices shape the extent to which our daily ride on this planet turns out to be healthy, healing, and deeply nourishing and if not, what can make it so; and our collective share, in every moment, in forging the collective happiness and fate of our emerging generations.

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Michael H. Cohen, Esq.; 468 North Camden Dr. | Beverly Hills, California 90210 | 310-844-3173