ICIM Blog

Submitted by John Parks Trowbridge MD, quoted from Carole Jackson, Bottom Line's Daily Health News

It's a national success story: Integrated medicine has truly arrived. A recent major news magazine cover says: "Top hospitals are now embracing such unconventional techniques as acupuncture, homeopathy and energy healing." Sadly, one journalist wants you to be very afraid of this very important movement that has the potential to significantly reduce medical costs and improve the health and wellness of our nation.

In the cover story for its January 21, 2008, issue, U.S. News & World Report health and medical writer Avery Comarow reports on the nationwide trend toward including complementary and alternative medicine (CAM) in hospital care and mainstream medicine. It has an upbeat title -- "Embracing Alternative Care: Top Hospitals Put Unorthodox Therapies Into Practice" -- but really the article is a thinly veiled CAM-slam. Heavy-handed and bordering on journalistic sensationalism, Comarow's piece is replete with erroneous research conclusions about CAM and sweeping omissions on its documented benefits and efficacy.

While the article seems to debate the scientific evidence behind CAM therapies, Comarow reports, "All 18 hospitals on U.S. News's most recent 'America's Best Hospitals' super-selective Honor Roll provide CAM of some type. Fifteen of the 18 also belong to the three-year-old Consortium of Academic Health Centers for Integrative Medicine, and 36 US teaching hospitals are pushing to blend CAM with traditional care." Can all of these elite centers, the emblems of Western medicine, be wrong? To find out, I went to an expert who is highly knowledgeable about CAM treatment modalities, naturopathic physician Mark A. Stengler, ND. His take: The trend speaks for itself -- if mainstream medicine is embracing CAM, it's for good reason.

WHAT COMAROW SAYS ABOUT CAM

Throughout the article, Comarow swims against the strong currents of CAM acceptance among America's premier hospitals and academic medical centers. He employs the old journalistic tactic of using words and phrases intended to shock or disturb his readers. Right from the get-go, the article's title contains the word "unorthodox" to mean "unconventional" therapies. Most telling about the U.S. News article's intentions is the usage of loaded language about CAM and the "thicket of therapies deemed to fall within CAM's broad reach"... citing "at one extreme" yoga and massage as having "some benefit, if only to lower stress and anxiety" and at the other end, therapies that "even many who applaud CAM's newfound academic popularity call 'woo-woo medicine' because of the sheer implausibility of their rationale," such as homeopathy. In what he calls "the broad middle," Comarow puts acupuncture, herbal medicine and "other CAM approaches that seem to benefit some people with certain conditions." In a dismissive review of CAM's history, he likens CAM's presence in academic centers before the mid-1990s to "a pack of scruffy mutts, noisy and unworthy of notice."

Dr. Stengler was shocked at Comarow's blatantly biased treatment of CAM throughout the article, with his selective focus on negativity and avoidance of well-documented CAM therapies. For instance, Comarow is especially critical of homeopathy, and ignores other well-accepted CAM therapies such as chiropractic care.

ERRONEOUS RESEARCH CONCLUSIONS

Public demand for CAM: Comarow disputes the "public's clamor" for CAM services by questioning statistics that support the trend. For instance, he deems as "highly misleading" surveys that show widespread CAM use, such as a 2004 Centers for Disease Control and Prevention (CDC) report that showed 62% of adult Americans had used some form of CAM in the previous year. According to Comarow, "the big numbers" reflect activities such as prayer, meditation and diet-based therapies. A "more selective reading," he proposes, would include yoga (5%), acupuncture (1.1%) and energy therapy (0.5%). Dr. Stengler counters that this view depends on how CAM is defined. When CAM therapies such as natural products (defined as non-vitamin and non-mineral, such as herbs and other products from plants) (18.9%)... deep breathing (11.6%)... chiropractic care (7.5%)... and massage (5%), in the CDC report are factored in, the numbers reflect a strong trend in various other areas of CAM as well. Furthermore, a study published in the Journal of the American Medical Association showed an increase from 36% to 46% in total visits to alternative medicine practitioners, from 427 million in 1990 to 629 million in 1997 -- a number that reportedly exceeded total visits to all US primary care physicians in the same year. A study in Alternative Therapies in Health and Medicine compared surveys on CAM use between 1997 and 2002 and found that over one in three respondents had used CAM in the previous year, representing about 72 million US adults. These numbers have increased since 1997 and 2002 and are now even higher, notes Dr. Stengler.

"Modest" results: Comarow concedes that a few CAM treatments have yielded "at least modest results," such as massage therapy for relieving post-operative pain and acupuncture for relieving discomfort and nausea from chemotherapy, surgery and dental procedures. In Dr. Stengler's view, the premise that a moderate benefit isn't good enough is faulty... especially in view of conventional medical treatments that in some instances yield modest results but have become accepted mainstream therapy, such as drug therapies to treat irritable bowel syndrome, chronic pain, psoriasis, addiction and fatigue. Another example: Cholesterol-fighting drugs such as statins, which continue to be prescribed for post-menopausal women though they don't appear to reduce mortality in this group. Or, more dangerous yet, the mainstream therapies that suppress one symptom only to deliver side effects that require additional treatments.

Nationality of study author bias: In another attempt at undermining CAM, Comarow comments "disconcertingly, some of acupuncture's claimed successes seem related to nationality of study authors," citing a 1998 analysis of 252 published trials in which 51 of the 52 studies conducted by researchers from Asian countries, where acupuncture is uncontroversial, had a 98% success rate. In comparison, "only 53% of the trials run by US investigators showed success." Dr. Stengler attributes some of this difference in success rates to the fact that Asian scientists have more thorough training in acupuncture compared with their US counterparts. Also, in 1997 the National Institutes of Health Consensus Statement stated acupuncture showed efficacy in treating post-operative dental pain and post-operative and chemotherapy-induced nausea and vomiting, and that it may also be useful for headache and low back pain.

DENYING THE EVIDENCE

Comarow states, "The effectiveness of most herbal remedies and supplements is largely an open question, and there are issues of toxicity, side effects and interaction with other medications." Amazed at this comment, Dr. Stengler retorts that Comarow overlooked tens of thousands of well-designed studies that demonstrate the effectiveness of vitamin, mineral and herbal therapies.

Moreover, the toxicity comment is just plain bogus, says Dr. Stengler. He finds that most CAM therapies are safely used by seasoned practitioners. In terms of side effects and risks, even conventional treatments come with those. Pharmaceutical drugs have their own problems, despite rigorous government approval, so let's allow their record to speak for itself. JAMA published an eye-opening report in 1998 that 106,000 hospital patients die each year from adverse reactions caused by prescription drugs. Over-the-counter or non-prescription nonsteroidal anti-inflammatory drugs (such as ibuprofen, aspirin and naproxen) are responsible for about 16,000 deaths each year. In 2005, the FDA received more than 300,000 serious adverse event reports about drugs. In the same year, it received only 500 such reports about dietary supplements.

OTHER BLUNDERS

Placebo effect: Comarow reports that a compelling argument posed by CAM critics is that "the risks of some therapies are real and the benefits illusory -- a placebo effect." Yet Comarow also reported on how the placebo effect can be effective in providing relief from symptoms such as pain. Comarow is trying to infer that much of CAM's success is due to placebo, which is a ridiculous conclusion, says Dr. Stengler. It is always a possibility that a therapy is having a placebo effect, but this is not unique to CAM. The same holds true for conventional therapies such as surgery, psychotherapy and pharmaceuticals. Comarow fell into the trap of thinking that because you can't explain a result, it must not exist. The fact is, we do know a lot about mechanisms behind therapies such as chiropractic, vitamin therapy, massage and others, says Dr. Stengler. He believes Comarow did not do his homework in this area, evident by his lack of interviewing experts in CAM for the article, who would have provided documented mechanisms for many of these therapies along with studies demonstrating efficacy.

CAM "mimics" the natural course of illness: Comarow suggests that CAM gets undeserved credit due to the natural course of chronic problems, which tend to ebb and flow over time. For instance, chronic pain from an arthritic knee or frequent headaches have cycles of remission, and sufferers may attribute the disappearance of pain to CAM therapy rather than the natural progression of the condition. Again, Dr. Stengler counters, the same can be said of conventional medicine, for example, where pain medication is prescribed for arthritic conditions or antibiotics are given for viral illnesses on which they may have no effect. Yet doctors continue to burden patients with the cost and risk of using these drugs.

Wrong definition for naturopath: To those in the field, Comarow's definition of "naturopath" reveals an utter lack of research -- not to mention being a display of naivetî`n his part, says Dr. Stengler. Comarow defines these highly trained practitioners as "generally a non-MD who advocates nonmedical aids such as proper nutrition, colonic irrigation... and special water baths to stay healthy without drugs or surgery." Hogwash, retorts Dr. Stengler. Here's the truth about naturopathic doctors or naturopathic physicians (the proper terminology): Like MDs they complete a four-year Bachelors degree in science and then four years of medical school that also includes internship, plus two years of clinical residency. However the naturopathic physician's coursework includes not only the same scientific study of modern diagnostic tests, pharmacology, injection and intravenous therapy and so on as for medical doctors, but also additional training in natural medicine areas that include nutrition, homeopathy, botanical medicine, acupuncture and a variety of mind-body approaches. Also, he should have at least noted that with the greatest number of clinical training hours in these areas, NDs are the most well-trained doctors in the world in CAM, studying both conventional and natural medicine.

U.S. NEWS GOT IT WRONG ON INTEGRATIVE MEDICINE (PART II)

STENGLER SETS THE RECORD STRAIGHT: CAM EFFICACY

Dr. Stengler explains that there is ample evidence of the efficacy and safe use of CAM therapies such as acupuncture, chiropractic care, vitamins and minerals, herbs and homeopathy.

For instance, numerous well-documented studies demonstrate the efficacy of chiropractic care to treat chronic pain, and acupuncture for musculoskeletal pain management such as neck pain and knee osteoarthritis.

Regarding vitamins, minerals and herbal supplements, Dr. Stengler lists some of the well-designed clinical studies and research that demonstrate the effectiveness of:

Omega-3 fatty acids from fish or fish oils or from supplements to improve cardiovascular disease outcomes and reduce cardiovascular disease risk (American Heart Association) and reduce the risk of Alzheimer's disease (Archives of Neurology, July 2006).
Vitamin C and E to reduce mortality rates from heart disease and other causes. A National Institute of Aging study of over 11,000 people between the ages of 67 and 105 found that those who used supplements of vitamins C and E in various dosages had a 53% reduction in mortality from heart disease and a 42% reduction in all-cause mortality, compared with non-users.
Vitamin E to reduce heart disease. A Harvard study of more than 80,000 female nurses ages 34 to 59 found a 41% reduction in the risk of heart disease in those who had taken daily vitamin E supplements of 100 IU or more for at least two years. A study of almost 40,000 male health professionals ages 40 to 75 years found that those who took daily vitamin E supplements of at least 100 IU for at least two years experienced a 37% reduced risk of heart disease.
Vitamin E to delay progression of Alzheimer's disease. One study of moderate-severity Alzheimer's patients conducted at Columbia University in New York City showed that a very high dose of vitamin E (2,000 IU) delayed the progression of Alzheimer's disease.
Vitamin D helps keep bones strong and may help prevent osteoporosis (National Institutes of Health Office of Dietary Supplements).
Glucosamine/chondroitin for arthritis. Research funded partially by the National Institute of Arthritis and Musculoskeletal and Skin Diseases found this supplement combination significantly reduced osteoarthritis pain in those who initially had moderate to severe pain.
Ginkgo biloba to manage or improve cognitive function in elderly and Alzheimer's patients (MedlinePlus), and for normal tension glaucoma (Ophthalmology, February 2003).
HOMEOPATHY

Homeopathy is the use of extremely dilute preparations of natural agents that stimulate the body's own healing response. Comarow describes homeopathy as "highly controversial" and quoted one expert who deemed it "absurd." Dr. Stengler cites numerous studies supporting its efficacy:

In a meta-analysis of placebo-controlled clinical trials, patients taking homeopathic medicines were 2.45 times more likely to experience a positive therapeutic effect compared with placebo. This research was published in The Lancet, September 20, 1997.
In another meta-analysis of clinical research that included 107 studies of homeopathic medicines, 77% showed positive effect (British Medical Journal, February 9, 1991).
Other studies suggest the effectiveness of homeopathic remedies in helping treat chronic obstructive pulmonary disease (Chest, March 2005)... and aiding recovery from bruises after plastic surgery (Archives of Facial Plastic Surgery, January-February 2006).
Tens of thousands of medical doctors around the world use homeopathy including here in the US, adds Dr. Stengler. Moreover, most doctors regularly employ medical treatments that draw on the very same "law of similars" principal behind homeopathy to provoke a reaction in the patient that serves to protect against it. For instance epinephrine, used to treat allergic reactions, contains a one in 10,000 dilution of adrenalin.

LET THE CRITIC BEWARE: THE CAM TREND SPEAKS FOR ITSELF

Like a snowball coming down a hill, the presence and influence of CAM on the medical landscape is getting larger and larger, says Dr. Stengler. The mainstream medical bureaucracy -- including pharmaceutical companies and insurance companies -- would like to dismiss CAM as bunk in order to protect their fiefdom. But when you consider the consumer demand for CAM, a flood of scientific studies that prove its efficacy and the increasing proof that our current medical system is not working thanks to skyrocketing costs and treatments that are not only ineffective, but dangerous (Vioxx anyone?)... you simply can't cling to the notion that the science isn't there anymore. It would be lying to do so. The bottom line, concludes Dr. Stengler, is that it's clear that the public understands that CAM has become mainstream medicine. Now all we have to do is let market demand reign, rather than allowing it be held victim to an outdated structure struggling to remain relevant.

Source(s):

Mark A. Stengler, ND, a naturopathic physician and leading authority on the practice of alternative and integrated medicine. He is director of the La Jolla Whole Health Clinic, La Jolla, California, and associate clinical professor at the National College of Naturopathic Medicine, Portland, Oregon. He is author of the newsletter Bottom Line Natural Healing, www.DrStengler.com.

Submitted by L. Terry Chappell MD:

Researchers in London reported that the U.S. had dropped from 15th place to 19th in deaths that could have been prevented by access to effective medical care. 47 million U.S. citizens do not have health insurance. And still, the U.S. health care system spends $7026 for every person in the country, by far the highest in the world. Our system is dominated by unnecessary surgery and expensive, dangerous drugs. We know that there is a better way. To find an integrative medicine doctor, visit www.icimed.com.

Submitted by L. Terry Chappell MD:

Universal Health Insurance—a Message for Presidential Candidates One way or another everyone should have catastrophic health insurance. But we should be very careful, because the “health” care that is currently insured is the wrong kind of health care! If we allowed patients to choose preventive medicine and alternative and complementary care with the first dollars of coverage, we would great reduce costs, diminish complications, and improve health.

Submitted and approved by Dick Tapert of Designs for Health:

Barry Jay, Ph.D.

I specialize in optimizing the brains of people (adults and children) with attention and impulse control problems. Psychological research supports the effectiveness of brain optimization through the three different modalities listed below. These can be done on or off medications, and focus on supporting brain function in order to reduce specific symptoms (e.g. distractibility, attention problems, impulse control issues, temper outbursts). These approaches do not cure disorders but have been successful in improving the functioning of some individuals who have the diagnoses of ADHD/ADD, Oppositional Defiant Disorder, Anxiety, Autism, Asperger’s Disorder, etc.

Neurofeedback- I utilize a state of the art EEG program that provides feedback to the brain in order to help brainwave patterns shift and become more flexible. LENS (Low Energy Neurofeedback System) has been helpful in getting some people unstuck from dysfunctional symptom patterns. The Healing Power of Neurofeedback: The Revolutionary LENS Technique for Restoring Optimal Brain Function by Stephen Larsen, Ph.D. 2006 is a seminal reference on this topic.

Cognitive Training- research suggests that if children perform game like computerized tasks that require frontal lobe involvement (much like a weight lifter lifts weights to get stronger) for two hours per week for 12 consecutive weeks, that structural changes occur in the frontal lobe. The cognitive training program that I use is Captain's Log. The US Department of Education has awarded a Duke University researcher a $1.5 million grant for a three year large sample study to explore the efficacy of Captains Log to improve attention problems for inner-city public school children. The results of the study will be available this year. Visit www.braintrain.com for more information.

Vitamin Supplements and lifestyle changes- Daniel Amen, M.D. has utilized brain imaging to identify six different types of ADD and seven different types of Anxiety and Depression. Each of these different types has their own treatment protocol. I have been trained by Dr. Amen and utilize his questionnaires to identify typology and recommend protocols that support that person’s brain. A wealth of fascinating information is available on his website at www.amenclinics.com

My office is in West Bloomfield on West Maple near Farmington Road. Attached is a summary of my experience. I would be happy to talk with you about any of your students who you think could benefit from brain optimization. You can email me, or call 248.626.8889.

Barry Jay, Ph.D.

drbarryjay@comcast.net

Distributed by Bill Benda MD:

"I’ve attached some background info (from Joe Pizzorno’s journal Integrative Medicine – A Clinician’s Journal) for those interested in catching up on Wyeth and the FDA’s shenanigans over the past few years . . ."
Compound Fractures

William Benda, MD

Bioidentical hormones are purported to have the exact molecular structure as endogenous hormones made in the human body, and in theory produce the same physiological responses. Upwards of two million women in the US use such hormones on a daily basis for relief of symptoms associated with menopause and perimenopause. Both advocates of and companies involved in the manufacture and sale of compounded hormones claim such compounds are safer and more efficacious than synthetic prescription hormones sold by drug companies.

Synthetic hormones do not have the same chemical structure as endogenous hormones, and may elicit different responses in the human body. Such potential variation in effect have been implicated, although without definitive proof, in the increased incidence of diseases reported in the 2002 Women’s Health Initiative (WHI), which linked the synthetic hormones Premarin® and Prempro® to elevated risk of stroke, breast cancer, heart attacks and circulatory disease.1 (For more information, please see the “Managing Menopause” article on p. TK.)

The growing industrial and legislative battle over synthetic vs compounded hormones culminated in an October 2005 citizen’s petition to the Food and Drug Administration (FDA) filed by Madison, NJ-based Wyeth Pharmaceuticals, one of the world's largest pharmaceutical and health-care products companies. Wyeth requested the FDA to designate compounded bioidentical hormones as a “new drug” subject to all FDA restrictions and requirements regarding the manufacture and sale of new drugs.

A public, political, and medical maelstrom soon followed.

History of Drug Compounding

Drug compounding is a process by which a pharmacist or doctor combines, mixes, or alters ingredients to create a medication tailored to the needs of an individual patient. Until the advent of drug manufacturing in the 1950s, compounding was the exclusive method of preparing medications for clinical use. During the 1930s and 1940s approximately 60% of all medications were compounded, compared to about 1% in 2006. The lack of interest in compounding by the emerging pharmaceutical industry was quite understandable, as it was found to be much more cost-effective to focus manufacturing energy on bulk production of the fewest number of individual combinations and standard dosages rather than attempt to meet the needs of large numbers of individual customers.
Today compounding is typically used to prepare formulations that are not commercially available, such as medication for a patient who is allergic to an ingredient in a mass-produced product, liquid versions that are easier to swallow, flavored medicines for children, crème- or gel-based versions for topical application, medications discontinued by a manufacturer, or medicines of a different dosage or concentration than what is typically available. In-hospital compounding allows for formulation of intravenous antibiotic solutions, total parenteral nutrition units, and special pediatric dosages. Pharmacists may provide compounded drugs to patients only upon receipt of a valid prescription from a doctor or other medical practitioner licensed to prescribe medication. Many states specifically regulate compounding practices as part of their regulation of pharmacies, and some require that all licensed pharmacies offer compounding services.

A variety of concerns have been raised over the past two decades by both pharmaceutical companies and physician organizations regarding the formulation and distribution of compounded medications. Opponents of compounding voice concerns regarding maintenance of the quality, purity, potency, sterility, and stability of the original bulk ingredients used in compounding. Allegations have been made as to bulk pharmaceuticals being re-manufactured and tailored to an individual patient (such as preparing costly 5 mg tablets of an antihypertensive medication from one generic 20 mg pill). With specific regard to compounded hormones, pharmaceutical companies allege compounding pharmacies are essentially acting as drug manufacturers by mass-producing bioidentical hormones, which would violate federal law. Physician oversight on the industry is next to non-existent, as compounding is rarely if ever mentioned during conventional medical training and most physicians reflexively expect products to be free from contamination and of uniform quality. In 2003 the U.S. General Accounting Office concluded: “While drug compounding is important and useful for patient care, problems that have occurred raise legitimate concerns about the quality and safety of compounded drugs and the oversight of pharmacies that compound them. However, the extent of problems related to compounding is unknown.”2
(For more information on quality and safety, please see “Quality Assurance Issues in Compounding Pharmacy” on p. TK.)

Wyeth Pharmaceuticals, manufacturer of the synthetic hormone replacement therapy drugs Premarin® and Prempro®, suffered financially as a result of the 2001 WHI report. Sales of these drugs dropped significantly, with a 68% decline in sales of Premarin Family products between 2002 and 2004, plummeting from $1.3 billion to $880 million.

On October 6, 2005, Wyeth asked FDA to investigate bioidentical hormone replacement therapy, stating that many compounding pharmacies were making unsubstantiated marketing claims that were confusing women about the risks and benefits of the hormones. In addition to casting doubt on safety and efficacy, they alleged that compounding pharmacies, not physicians, were dictating what patients should take, and demanded that the FDA penalize compounding pharmacies via enforcement actions such as seizure of products, injunctions, and warning letters.

"As a pharmaceutical company we're highly regulated, and we're sitting here watching people get prescriptions for things that aren't adequately tested or that they aren't being adequately warned about," states Ginger Constantine, Wyeth vice president for women's health care. "If the FDA takes a look and says, 'We don't see any problem here,' then so be it, but we need to raise the issue."3

The pharmaceutical industry has powerful advocates in their corner. A number of respectable medical organizations, fearing that lack of federal oversight of the industry puts consumers at risk, filed amicus briefs to Wyeth’s citizen’s petition (an amicus brief is filed by an organization that is not party to a particular lawsuit but is allowed to advise the court regarding a point of law directly concerning the lawsuit).

"The American Medical Women's Association is concerned about the safety and purity of these unregulated compounds and about misleading claims related to the marketing of some of these ... products," wrote Linda Hallman, AMWA executive director, in a recent letter to the FDA supporting the Wyeth petition. "For these compounded products, there is no regulation of production, purity of product and safety of dose, nor safety and efficacy studies."4

Perhaps the most politically credible ally of the pharmaceutical industry has been the American College of Obstetrics and Gynecology (ACOG). According to ACOG, most compounded products, including bioidentical hormones, have not undergone rigorous clinical testing for either safety or efficacy. Citing the lack of well-designed and well-conducted clinical trials of these compounded hormones, ACOG recommends that they should be considered to have the same safety issues as those synthetic hormone products approved by the FDA, and may furthermore exhibit additional risks unique to the compounding process.

“There is no scientific evidence to support claims of increased efficacy or safety for individualized estrogen or progesterone regimens prepared by compounding pharmacies,” according to a Committee Opinion released by ACOG. “Furthermore, hormone therapy does not belong to a class of drugs with an indication for individualized dosing.”5

In response to this political assault, a group of compounding pharmacies supported filed a lawsuit seeking protection from FDA incursion, stating that regulation of compounding pharmacies already falls under state law.6 They argued that compounding has been approved and regulated by state boards of pharmacy since the Food, Drug and Cosmetic Act was passed in 1938, and that all ingredients are purchased from manufacturers or repackagers who must be FDA registered and meet FDA specifications for safety and purity. The plaintiffs pointed out that, as with all pharmacists, compounding pharmacists are regulated and licensed by state pharmacy boards, in the same way states regulate and license doctors and other health care providers. They noted that compounding pharmacists do not write prescriptions, but only fill prescriptions written by healthcare providers. Finally, the pharmacists stated that the compounding of medications was in the best interest of the public, the protection of which is the mandate of the FDA.

According to one amicus brief, “When manufactured products are not appropriate for a patient, the pharmacist’s efforts to help patients make the best use of their medication are thwarted unless compounding is an option. Without pharmacy compounding, there would be no medication to dispense, nor any medication therapy to optimize. Compounding enables pharmacists to contribute their medication knowledge and expertise to produce individualized medications that meet these needs and improve health outcomes.”7
Legislative history seems to secure the compounding pharmacy’s position. In 2002 the Supreme Court of the United States wrote:

“The Government has an important interest … in permitting the continuation of the practice of compounding so that patients with particular needs may obtain medications suited to those needs. And it would not make sense to require compounded drugs created to meet the unique needs of individual patients to undergo the testing required for the new drug approval process. Pharmacists do not make enough money from small-scale compounding to make safety and efficacy testing of their compounded drugs economically feasible, so requiring such testing would force pharmacists to stop providing compounded drugs8.
However, the late 1990s witnessed an interesting and relevant twist to the “new drug” vs. “not new drug” controversy. The Food and Drug Administration Modernization Act (FDAMA) of 1997, signed by President Bill Clinton, exempted compounded drugs from "new drug" requirements provided they satisfy a number of restrictions. The most relevant constraint to the current controversy was that pharmacies, licensed pharmacists, or licensed physicians compounding a drug may "not advertise or promote the compounding of any particular drug, class of drug, or type of drug." In response, a coalition of licensed pharmacies specializing in compounding drugs sought to prohibit enforcement of the subsections of FDAMA dealing with such advertising and solicitation, arguing that these provisions violate the First Amendment's guarantee of free speech. The United States District Court for the District of Nevada agreed with pharmacists, holding that the provisions do not meet the test for acceptable government regulation of commercial speech. The court invalidated the relevant provisions, essentially severing this one restriction from FDAMA. (The District Court did not overrule a federal legal decision – it overruled a federal legislative law.)

The federal government appealed to the Court of Appeals for the Ninth Circuit (I don’t know where the Ninth is), which did agree that the provisions regarding advertisement and promotion were unconstitutional, but also found them not to be severable from the rest of FDAMA. The case went before the US Supreme Court, which affirmed the Ninth Circuit’s ruling and, as a result, the entire section—including separation of compounded drugs from “new drug” status—was invalidated. With the rejection of this section of FDAMA, there was again no definitive legislation clarifying the legal status of compounded medications with regards to FDA jurisdiction. Thus, the battle over “new drug” vs. “not new drug” began anew.

It was through this loophole that Wyeth filed its citizen’s petition to the FDA in October of 2005, renewing its request in early April 2006. The agency has yet to respond to Wyeth's request, other than saying it needs more time to review the issue.

Meanwhile, the compounding industry undertook a grassroots effort both in pharmacies and on the Internet urging women and doctors to write the FDA to protest Wyeth’s petition. The ensuing flood of more than 40,000 emails and letters over a six month period of time underscored how emotional the issue had become, specifically for the thousands of menopausal women who utilize compounded bioidentical hormones. 9

Whatever the FDA finally decides with respect to the designation of compounded bioidentical hormones, there is little doubt that it will have dramatic implications for both the compounding industry and women's health.