Friday, January 02, 2009

The Touch That Doesn't Heal

Feeling a tad listless? Perhaps your DNA is insufficiently activated. You may want to consult the healers at Oughten House Foundation, specializing in "tools and techniques for self-empowerment . . . through DNA Activations." Oughten House recommends regular therapy as part of its DNA Activation Healing Project, at $125 per hour-long session.

The foundation isn't as far from the mainstream as you might think. A survey of 32,000 Americans by the National Center for Health Statistics, released earlier this month, suggests that 38% of adults use some form of "complementary and alternative medicine," or CAM -- now aggressively promoted for everything from Attention Deficit Disorder to the Zoster virus. The survey polled consumers on 10 provider-based therapies -- for example, acupuncture -- and 26 home remedies, such as herbal supplements.

Hundreds of colleges operating in all 50 states offer coursework in sundry CAM disciplines. Many more advertise online. Typical is the Global College of Natural Medicine, which is somewhat more welcoming than traditional medical schools: Its literature cheerfully advises that even "if you do not hold a high school diploma or equivalent you can still enroll online today." A 60% grade on an admission exam puts you on the path to becoming a nutritional consultant, master herbalist or holistic chef for animals.

This should be a laughing matter, but it isn't -- not with the Obama administration about to confront the snarling colossus of health-care reform. Today's ubiquitous celebration of "empowerment," combined with disenchantment over the cost, bureaucracy and possible side effects of conventional care, has spurred an exodus from medical orthodoxy. As a result, what was once a ragtag assortment of New Age nostrums has metastasized into a multibillion-dollar industry championed by dozens of lobbyists and their congressional sympathizers. Among the most popular therapies are acupuncture, at $50 to $100 per session; reflexology, which involves massaging various parts of the hands and feet, starting at $35 an hour; and aromatherapy, which relies on the supposed healing properties of about 40 "essential oils," with treatments at $30 to $90 an hour.

The largest well-documented study of CAM's financial footprint, a decade ago in the Journal of the American Medical Association, estimated that Americans spent $36 billion to $47 billion on CAM in 1997, depending on how one defined the category. Since then, at least 40 states have begun licensing CAM practitioners. Major hospital systems, notably Baltimore's Johns Hopkins and New York's Sloan-Kettering Cancer Center, incorporate CAM-based programs like aromatherapy and therapeutic touch, often bracketed as "integrative medicine."

Indeed, one of the great ironies of modern health care is that many of the august medical centers that once went to great lengths to vilify nontraditional methods as quackery now have brought those regimens in-house. "We're all channeling East Indian healers along with doing gall-bladder removal," says Arthur Caplan, director of the University of Pennsylvania's Center for Bioethics. Mr. Caplan harbors no illusions about what's behind the trend: "It's not as noble as, 'I want to be respectful to Chinese healing arts.' It's more, 'People are spending a fortune on this stuff! We could do this plus our regular stuff and bill 'em for all of it!'"

Fees for CAM services are increasingly passed on to insurance through a creative -- some might say fraudulent -- interpretation of the Current Procedural Terminology codes that govern reimbursement for authorized services. (Various tutorials, some online, guide practitioners through the reimbursement maze.) Such creativity may soon be unnecessary if the alternative medicine proponents have their way. For example, ABC Coding Solutions, a medical-software company, has been promulgating a set of 4,000 treatment codes that cover "nearly every healing modality practiced by alternative healthcare providers," to quote one report. If such codes are fully absorbed by the health-care industry, CAM will have been mainstreamed -- while bypassing all the customary peer review, controlled studies and other hallmarks of sound medicine.

Not by coincidence is CAM most avidly touted by a loose alliance of self-help gurus (Andrew Weil, Deepak Chopra, et al.) and veteran hucksters like erstwhile infomercial king Kevin Trudeau. Mr. Trudeau has been sued for deceptive business practices several times by the Federal Trade Commission. In 2004, the agency deemed his sins so egregious that it barred him from "appearing in, producing, or disseminating future infomercials that advertise any type of product, service, or program to the public." Undaunted, Mr. Trudeau reinvented himself as a health-care expert and, the following year, published the runaway best seller "Natural Cures 'They' Don't Want You to Know About." The book continued to sell briskly even after the New York State Consumer Protection Board warned that it "does not contain the 'natural cures' for cancer and other diseases that Trudeau is promising."

Meanwhile, CAM has secured its own beachhead within the National Institutes of Health in the form of the National Center for Complementary and Alternative Medicine (NCCAM). "Special commercial interests and irrational, wishful thinking created NCCAM," writes Wallace Sampson, a medical doctor and director of the National Council Against Health Fraud, on the Web site And Sen. Tom Harkin (D., Iowa), who credited bee pollen with quelling his allergies, was single-handedly responsible for the $2 million earmark that provided seed money for NCCAM, chartered in 1992 as the Office of Alternative Medicine. Despite the $1 billion spent in the interim, the center has failed to affirm a single therapy that can withstand the rigors of science.

Even the center's own fact sheets unfold as unintentionally comical. After noting that echinacea is "traditionally used to treat or prevent colds, the flu and other infections," the center concedes that "most studies to date indicate that echinacea does not appear to prevent colds or other infections." St. John's Wort as a natural antidepressant? "Two large studies, one sponsored by NCCAM, showed that the herb was no more effective than placebo in treating major depression." Evening primrose for hot flashes? "Does not appear to affect menopausal symptoms." And so forth. "It is the only entity in the NIH devoted to an ideological approach to health," writes Dr. Sampson, who has called for the center to be defunded.

Is there anecdotal evidence that unconventional therapies sometimes yield positive outcomes? Yes. There's also anecdotal evidence that athletes who refuse to shave during winning streaks sometimes bring home championships. It was George D. Lundberg, a former editor of the Journal of the American Medical Association, who said: "There's no alternative medicine. There is only scientifically proven, evidence-based medicine supported by solid data." We'd do well to keep that in mind as we plot the future of American health care. It's not like we've got billions to waste.


The FDA Is Killing Crohn's Patients

Science didn't require that I get a placebo

Right now there are millions of individuals whose lives are directly dependent on the rate at which new drugs come to market. I'm one of them. I'm fighting for my life. To date, half of my intestine has been removed to manage Crohn's disease. Last year, at age 23, I enrolled in a clinical trial for a treatment that could save my life: an adult stem-cell therapy that helps damaged intestinal tissue regenerate from the relentless inflammation and scarring caused by Crohn's.

The sponsor, Osiris Therapeutics, reported that Crohn's patients in the therapy's Phase II trial all experienced clinical improvement after receiving the cells. A Phase III trial for the treatment is now nearing completion, but Food and Drug Administration (FDA) approval could be years away, despite its FDA "fast track" designation. In accordance with antiquated FDA policies, the Phase III trial is randomized with three groups of patients, and double-blinded, which means neither the doctors nor patients are told what treatment is being administered. One group received full-strength stem cells, another received half-strength, and a third got a placebo (the proverbial "sugar pill"). It appears I got the placebo.

Foregoing all other treatments, I received the four scheduled infusions, and yet my disease progressed with a vengeance. In a matter of weeks, I became dangerously malnourished. I've since been readmitted to the hospital countless times, as my doctors continue to plead with Osiris for information. But Osiris has refused, citing adherence to FDA protocol. I am now a lab rat. I have no right to know what happened to me in the study, nor do I have a right to try the promising treatment as my health deteriorates. It doesn't have to be this way.

Under the Fifth Amendment's guarantee that "No person shall be deprived of life, liberty or property without due process of law," a critically ill patient should have access to a potentially lifesaving drug that has been deemed safe for human consumption, if the patient agrees to bear the risks involved. But earlier this year, the Supreme Court refused to hear a case on the issue, denying countless patients their right to pursue life.

Thankfully, some members of Congress have stepped in to ensure our rights as patients. In May, Sen. Sam Brownback (R., Kan.) and Rep. Diane Watson (D., Calif.) introduced the Access, Compassion, Care and Ethics for Seriously Ill Patients Act. If passed, this bipartisan legislation will begin to restore the rights of millions of patients by widening access to promising investigational drugs.

Human clinical research is an intricate scientific and moral process, but it does not justify taking immoral advantage of patients. Tragically, FDA and Osiris think it does. Typical approval protocols almost always guarantee patients taking the placebo access to the actual drug -- at the very least -- after the study has ended. But in what appears to me a deliberate act of cruelty, Osiris hung its patients out to dry without any recourse, refusing to confirm which patient got what. The FDA has endorsed Osiris's decision by enabling it to proceed with the study.

Withholding a potential cure is just as bad -- if not worse -- than the potential death sentence of a serious illness. If patients like myself have the audacity to put their lives on the line for the betterment of science and those in their predicament, their decision should not only be embraced, it should be rewarded.

Furthermore, trials without ethical recourse can lead to inadequate and incomplete data, compromising the integrity of the study. If trial patients are treated like lab rats, they won't feel obliged to cooperate unconditionally and report accurate data -- something the FDA and the drug industry rely on heavily, but have failed to consider.

Everyone agrees it is a fundamental right for patients to dictate their course of treatment with FDA-approved drugs. So why do the rules evaporate at the most critical moment, when the only life-preserving options are highly promising investigational drugs?


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