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From the publisher.

New England Compounding Pharmacist Guilty of RICO

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As most of you know, the New England Compounding Center (NECC) in Framingham, Massachusetts, distributed tainted injectable corticosteroids in 2012 that resulted in a huge number of fungal meningitis cases. The CDC reported that 751 individuals developed the rare meningitis and 64 of them died. The meningitis followed the injection of the steroid into the spinal cord to treat back pain and related disorders. How the corticosteroid became contaminated with fungus is not explained. However, the federal prosecution stated that NECC, a compounding pharmacy, manufactured the vials in an environment contaminated with fungus, bacteria, detritus, and "seeping oil." The defense attorney for NECC pharmacist, Barry Cadden, denied that the injectable manufacturing conditions were contaminated. Yet, if the compounding rooms were clean, how did fungal meningitis develop in so many patients across 20 states?

According to the news report in the March 23, 2017 USA Today, Cadden was cleared by a jury of second degree murder charges. (1) However, he was found guilty of RICO (Racketeer Influenced and Corrupt Organizations) violations that include mail and interstate commerce fraud. Cadden's business operation was supposed to be a compounding pharmacy. However, he made tens of millions of dollars manufacturing medical injectables and distributing them to a wide number of clinics. The guilty finding for RICO may result in 20 years in prison for Cadden when sentencing is made in June. Another 12 individuals involved with NECC have been charged and will face court trials.

As a result of this medical disaster, Congress acted to empower the FDA with new regulatory oversight of compounding pharmacies in 2014. The new regulations that are beginning to come on line have greatly limited the scope of compounding. Essentially, pharmacies involved in the production of injectable medicines are required to demonstrate pharmaceutical manufacturing standards. Such standards have effectively made older equipment and facilities obsolete. Injectable compounding pharmacies are required to elect whether they will meet the standards as a manufacturing facility or follow a reduced standard as a local compounding pharmacy. Needless to say, many compounding pharmacies elected to quit compounding injectables due to their inability to upgrade their equipment and facilities. For those compounders who continue to produce injectables, the FDA is breathing down their necks to ensure that the draconian standards are met. One compounding facility in Texas, Downing Labs, recently announced that they have met the guidelines as an injectable manufacturing facility.

As far as Cadden is concerned, he did not apologize for his role in the manufacture of the contaminated corticosteroids resulting in many patient deaths and chronic illness. As a result of his disregard for safe manufacturing practices, compounders have needed to shut down their compounding facilities resulting in less access for patients and physicians. What Cadden did was a horror for the ill and dead patients as well as consumers who benefit from compounded medications. The jail time he will receive is well deserved.

A Mud Bath in Calistoga

While travelling to Calistoga, California, for the wedding of our friends' daughter and fiance, we decided to pass the morning before nuptials at one of the local spas and have a mud bath. The last time we enjoyed such a treatment was at the Dead Sea. Memories change over the years, but I recalled the Israeli spa had a cabana atmosphere with a boardwalk leading from the heavily salted waters. The mud was applied to us from top to bottom and we were caked with it basking in the sun. After a time, we showered outdoors and then relaxed not departing before being sold mineral salts to do our own baths in the US. The mud bath and bathing in the Dead Sea were wonderful memories but, like other travel adventures, were slowly forgotten until we found ourselves in Calistoga. Now part of the wine tasting circuit in Napa Valley, Calistoga has always been a retreat for dwellers of San Francisco to escape the drudgeries of city life and enjoy the sulfur-containing mineral springs. Along with the mineral baths, spas like the Indian Springs Resort offer massage and mud baths. We couldn't pass up this opportunity to enjoy another treatment like we enjoyed in the Middle East.

Of course, I didn't really know what I was in for and took instructions from the spa staff with a certain degree of trepidation. After a preliminary shower, I was directed to a rather large rectangular "bath" of brownish-black, tarry, odoriferous viscous mud and told to step in and then lie supine. It wasn't quite like molasses, but it was thicker and stickier that I would have imagined. The mud was heated from the bottom as I discovered later when I plunged my hand downward. It was primarily squishy in consistency, but there were hard lumps and cubical stones scattered in the mud. The density of the mud prevented one from submerging, and the attendant needed to sweep mud over the body in layers to cover one entirely. In some ways, it was what I imagined quicksand might be if one stood in a barrel of the mud, although after descending a few feet one would not be able to sink any further, while quicksand reportedly sucks one down continuously until fully submerged (an urban myth?).

After a few minutes of becoming adjusted to the embracing mud and closing my eyes, I became aware of muscle tension lightening, stress reducing, and worrying dissipating. Where some joints had been painful, the inflammation was changing, becoming less. The relaxation was both as soothing as a massage but invigorating at the same time. I didn't quite fall asleep, but I was aware that the mud was healing myself physically, mentally, if not spiritually. It was supposed to last twelve minutes but I asked to stay in longer. Arising from the bath was a challenge, becoming so languorous after twenty minutes. Scraping much of the mud off oneself before stepping out of the tub, I was pointed to a shower that was alternatively warm and cool, perhaps not purposely. The mud did come off easily although with some effort. I then had a very warm bath and drank cool lemon/apple water. A steam bath was next, and I stayed only as long as I could tolerate. Finally, one lay on a comfortable cot with light music and pale light regaining stamina.

Altogether, I would rate the mud bath a first-rate experience definitely deserving repeating on a routine basis. I didn't see any downside. My wife, Deborah, thought her bath had been wonderful as well. We both found the spa experience was quite different in Calistoga than at the Dead Sea - but both were very therapeutic. Spa treatments have been considered especially therapeutic in other cultures, especially in Europe, the Middle East, and in the Orient. In the US, we appreciate the mineral bath and warm springs. But the mud bath is not so readily available. That is too bad as it has much to offer. Even less available is treatment with a specialized peat, peloids, as discussed by Sussanna Czeranko, ND in the Feb./March Townsend Letter.

Functional Gastroenterology

To many physicians and patients, gastroenterology only becomes important after age 60 when one is ordered to have a colonoscopy. The increasing incidence of colon cancer justifies such screening although the prognosis for aggressive tumors remains poor. Younger adults and children requiring gastroenterology care for ulcerative colitis and Crohn's disease are managed with immunosuppressive drugs with minimal dietary intervention. The recent advent of drugs capable of arresting Hepatitis C virus has overturned the only partially effective interferon treatment previously used for hepatitis, a boon for gastroenterologists, patients, and pharmaceutical companies. However, for many patients, digestive symptoms are largely managed with antacids, omeprazole, and psychiatric medications. Unfortunately, medicine largely ignores functional Gl tract disorders simply labeling the lot as irritable bowel syndrome and gastric hyperacidity. The result is that while patients experience hypochlorhydria, pancreatic enzyme deficiency, or hiatal hernia syndrome their symptomatology does not get a workup in the primary care practice or with the specialist. Of course, a major reason there is no evaluation is that gastroenterology focuses on pathology--disorders with definable pathologic findings. Symptomatic disorders lacking pathology are given short shrift during the medical exam.

Steven Sandberg-Lewis ND, DHANP has devoted much of his professional naturopathic career to studying functional gastroenterology. His work examines the medical literature and includes functional medicine assessments that go largely unused in the conventional medical practice. Sandberg-Lewis embraces the tenets and traditions of naturopathic medicine employing diet modification, herbal medicine, homeopathy, and visceral manipulation to treat diverse functional disorders such as hiatal hernia syndrome and ileo-cecal valve syndrome. The combined focus of standard-of-care gastroenterology, functional medicine, and naturopathic traditional medicine is offered in Sandberg-Lewis's recently published second edition of Functional Gastroenterology:

Assessing and Addressing the Causes of Functional Gastrointestinal Disorders. From comprehensive exam questionnaires, physical exam, and laboratory, Sandberg-Lewis provides the basis for primary and specialty physicians to diagnose and treat functional Gl tract disorders.

What is the extent of symptomatology? In Chapter 1, he discusses heartburn, dysphagia, reflux, dyspepsia, nausea and vomiting, abdominal bloating, constipation, diarrhea, abdominal pain, incontinence, and defecation disorders. Sandberg-Lewis reminds us that gastrointestinal bleeding, weight loss, and severe diarrhea indicate that functional symptoms may represent more serious conditions. While irritable bowel syndrome (IBS) is generally recognized as a functional Gl disorder, it is not unusual for most patients to have significant low-grade pathology, such as increased pro-inflammatory cytokine activity. For many individuals with IBS, abnormal intestinal pathogens are produced by dysbiosis. In fact, there is an overlap between the symptoms of small intestine bacteria overgrowth (SIBO) and IBS. Unfortunately, SIBO is another functional disorder that is largely ignored and thereby undiagnosed and untreated. Hence, IBS sufferers are given prescriptions for symptomatic support, such as Bentyl, but do not undergo laboratory examination and receive neither definitive dietary support nor appropriate prescription for SIBO. Sandberg-Lewis emphasizes that IBS may benefit from the use of botanical and homeopathic remedies, betaine hydrochloride, enzyme replacement, organ extracts, probiotics, visceral and spinal manipulation, breathing exercises, mindfulness, and counseling.

It is important to have a good conceptualization of the hormone system of the GI tract. Understanding how physiologic disorders, such as hypochlorhydria, can disrupt gastrointestinal hormones, provides an understanding of how functional disorders develop. The iatrogenic use of proton pump inhibitors further disrupts these interdependent GI hormones, potentially threatening the development of early neoplasia in the intestine as well as the stomach. Furthermore, when the intestinal microbiome is disrupted by hormonal abnormalities, hypochlorhydria, and pancreatic enzyme insufficiency, it is not surprising that SIBO worsens together with intestinal permeability. Sandberg-Lewis emphasizes that the judicious employment of appropriate diet, nutrition, botanical medicine, manipulation, and, if needed, medication not only can improve SIBO, hypochlorhydria and enzyme deficiency, but rebalance the GI hormonal system. Unlike conventional medicine that considers gastrointestinal pathology to be wholly unknown as to causation, this book identifies the functional disruption of the gastrointestinal tract's physiology as the key to development of inflammation and, potentially, cancer.

The diagnosis of SIBO through hydrogen/methane breath testing is perhaps the hallmark of functional gastroenterology diagnostics. A solution of lactulose that is non-absorbable is swallowed to test fermentation of intestinal bacteria. As the lactulose transits through the stomach and intestine within two hours, bacterial digestion is noted by the production of hydrogen and methane gas. Specimens are obtained every 20 minutes for three hours. While testing is generally performed at the office, patients may collect specimens at home for later testing. Elevated measurements of hydrogen and methane gas are diagnostic for overgrowth of intestinal bacteria. Medicine treats SIBO with antibiotics and elemental diet; naturopathy employs diet and herbal antimicrobials. Sandberg-Lewis credits Allison Siebecker, ND, MSOM, for developing the SIBO Specific Food Guide, a combination of the low FODMAP diet, Specific Carbohydrate diet, and Cedars-Sinai diet.

Functional Gastroenterology is updated and includes up-to-date citations including many from 2016. Sandberg-Lewis also includes the manipulation work of past naturopathic physicians; his use of visceral manipulation for hiatal hernia syndrome and ileo-cecal valve syndrome would be a welcome addition to the conventional gastroenterologist office. I was also pleased that he explained his use of focalized muscle testing as a means to assess functional disorders; too often muscle testing has been dismissed by individuals who do not understand its methodology. This is a welcome text for the newcomer to understand functional gastroenterology as well as a reference text for physicians needing to substantiate their diagnostics and treatments.

For a sample of Sandberg-Lewis's writing read his article in this issue of the Townsend Letter.

Low-Dose Immunotherapy

There are few therapies that come along that deserve immediate practitioner study but low-dose immunotherapy may fit the bill. This treatment combines the principles of allergy desensitization together with patient individualized therapy. In this issue, Ty Vincent, MD reviews his work with enzyme-potentiated desensitization (EPD), low-dose allergy therapy (LDA), and low-dose immunotherapy (LDI). Shrader and McEwen treated about 11,000 patients from 1993-2001 with EPD; more than 75% of patients had excellent response for their allergies. Vincent's early work with LDA, starting in 2008, demonstrated immediate and dramatic response not only to allergic-based disorders but also to many autoimmune conditions. Vincent has modified LDA into an oral sublingual therapy rather than injection treatment he calls LDI. The treatment permits practitioners to treat patients at home rather than the office and offers the best of EPD and LDA as well as "autologous" treatment derived from the patient's own body fluids or stool.

Vincent is convinced that much of what we label as autoimmune disease need not be treated with immunosuppressant medication. Chronic Lyme disease need not be treated with antibiotics or antimicrobials. Instead, these conditions are easily and dramatically treatable using LDI-derived (or LDA-derived) low dose antigens in a base of low dose beta-glucuronidase. Vincent's explanation is that the LDI antigen(s) switch off the misbehaving T-regulator cells that are attacking body tissues, leading to chronic illness. Vincent's experience has shown that LDI is effective in the treatment of 60 different conditions including inflammatory bowel disease, systemic lupus, and multiple sclerosis. His work has been remarkably effective in treating Lyme disease patients, albeit, the treatment does require patience as these patients respond very differently and require individualized treatment strategies. Perhaps the most surprising use of LDI is treating the autism patient.

Vincent wants to teach practitioners this treatment approach so that the treatment becomes widely available. He has set up LDI training and clinical services and invites all practitioners to become proficient.

Jonathan Collin, MD

Publisher

(1.) MacDonald G, Bacon J. Pharmacist cleared of murder in steroid case. USA Today. March 23, 2017.
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Title Annotation:compounding pharmacist found guilty of Racketeer Influenced and Corrupt Organizations
Author:Collin, Jonathan
Publication:Townsend Letter
Geographic Code:1USA
Date:Jun 1, 2017
Words:2441
Previous Article:The next big CAM battle is here and it's ugly.
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