Latest Articles

Magnesium Has Role in Reducing Dementia Risk

By Krystal Krisciunas, Contributing Writer

Recent research suggests that magnesium plays a role in neuroplasticity, and that supplementation with this important mineral could help to prevent Alzheimer’s and other forms of age-related dementia. 

New Bills Urge Wider Federal Coverage of Supplements, Medical Foods

By Kristen Schepker, Assistant Editor

Two new pieces of federal legislation propose to expand access to vital health supports for millions of low-income Americans. If passed, the bills will make crucial medical foods and dietary supplements available to individuals and families who otherwise struggle to afford them.

What the Helminth! Are “Purposeful Parasites” The Next Probiotics?

By Megan Copeland, MS, CNS, Contributing Writer

If the idea of utilizing parasitic worms as therapy makes you squirm, you’re certainly not alone. Sure it sounds strange, but the use of “purposeful parasites” is not as far-fetched as it seems. Researchers like Duke University's William Parker, PhD, believes certain types of helminths can be helpful in treating immunological, gastrointestinal, autoimmune, and even cognitive disorders.

Fed Targets Maker of Addiction Gene Test, Claiming Fraud

By Kristen Schepker, Assistant Editor

Earlier this month, federal agents took action against Proove Biosciences, the maker and marketer of an opioid addiction genetic test, alleging that company is perpetrating healthcare fraud.

On June 7, agents from the US Attorney's office in Southern California arrived at the headquarters of the Irvine-based company, whose Opioid Risk Profile is marketed as a gene-based testFed Raid Proove to determine predispositions to opioid addiction. For the past six years, Proove has promoted the test as a tool to aid physicians in making the best decisions related to patients' pain management. Critics say it's nothing more than a money-making strategy backed by questionable science, charges the company categorically denies.

In what media sources described as a raid, officers from both the FBI and the Department of Health and Human Services (HHS) delivered to Proove a subpoena and executed a search warrant, removing documents from the company's office. Proove issued a press release shortly thereafter, insisting that "there was no 'raid', nor have there been any 'arrests' or 'indictments'" associated with the incident. The company, it said, "will continue to cooperate with any future requests for information from the government."

STAT's Accusations

The federal action, which received some local media coverage but limited national exposure, was covered by STAT News --an independent healthcare and biotech news outlet owned by Boston Globe Media.

STAT's has covered Proove several times, challenging the company's science, its clinical claims, and its marketing practices. In an article posted in late February 2017, STAT writer Charles Piller pointed out that the company was already under scrutiny by the FBI for "possible criminal wrongdoing." Current and former employees cited in Piller's article stated they were questioned by federal agents about "possible kickbacks involving payments to doctors." 

STAT also conducted its own independent analysis of Proove, through which it obtained and published documents illustrating what Piller described as, "largely a ploy to boost Proove Biosciences's revenues."

Among these documents was a copy of a Proove sales brochure indicating that physicians were promised $30 for each person they enrolled in a study of genetic tests intended to guide personalized pain treatment.  STAT claimed that a typical doctor could make $144,000 a year in "research fees" without ever conducting any actual research, raising questions about Proove's  incentive strategies.

An estimated 400 doctors around the US have been using the Proove opioid test, which is based on cheek swab DNA sampling. STAT contends that, "the way the company pays physicians involved in two ongoing Proove trials — both key to the firm's monthly revenues of roughly $2 million — might violate anti-kickback laws."

Piller and other critics also say that the company exercises coercive marketing tactics. Proove has purportedly stationed its employees inside doctors' offices, where they completed tasks including filling out evaluation forms on behalf of the physicians.

There are also questions about the science behind Proove's test--and, for that matter, any gene-based test for addiction risk.

Some addiction and genomics experts interviewed by STAT say Proove's test is inconsistent at best, highly dubious at worst. They point out that it has not been adequately studied in clinical trials--a common problem with newly emerging tests in general. In a December 2016 piece, Piller posited that Proove opportunistically exploits mounting fears about opioid addiction within the medical community.

Unverified Allegations

Then, and now, the company denies any wrongdoing.

Proove's CEO, Brian Meshkin, stands by the accuracy and legitimacy of his company's products. He argues that Piller's "defamatory" coverage of the opioid risk profile inappropriately portrays the company in a negative light and, furthermore, played a direct role in prompting the federal investigations now underway. The STAT publications, Meshkin told HPC, are rife with "many inaccurate claims that have been terribly damaged not only our reputation, but affected our collaborators and customers."

“We are disappointed in the process that allowed these unverified claims to be published and then pique the interest of federal agents,” Meshkin added.

In an official response to Piller's articles, Proove stated that the company "reimburses participating investigators only for the time they spend providing research services. No research or payment is tied to the number of tests ordered, patients referred, or the size or prestige of an institution or medical practice. Investigators are required to submit completed and signed time records, as well as the original source research documents to support an audit of their time records."

Proove reports that the major source of the company's income is third-party reimbursements for laboratory procedures and services.

In a series of official statements, the company responds to STAT's main allegations, arguing that the news site's December 2016 and February 2017 articles, "contained many errors and misstatements about Proove®’s technology, science, business practices, and leadership. Even more disturbing was Mr. Piller’s overall approach and obvious bias. In an age where anyone can post “fake news” online, both pieces contained errors of omission, lacked context and/or perspective in key areas... featured some sources that have no knowledge of our company or our emerging industry, and relied on information – much of it incorrect and/or misleading – provided by disgruntled and discredited former employees."

Meshkin says the company is standing by its methodology, claiming that, "There are five clinical studies demonstrating the high accuracy with which the Proove Opioid Risk® profile performs. These studies were conducted in 126 clinics throughout the United States, which specialize in orthopedics, pain management, psychiatry, primary care and addiction treatment. The accuracy of the test, as measured by the gold-standard of statistical methods, ranged from 76.7% to as high as 96.7%. Three of these studies supporting the algorithm in Proove Opioid Risk® have been accepted for publication in peer-reviewed publications...with 6 additional studies currently under review."

Legal & Regulatory Questions

Proove's leaders are consulting with both in-house and external legal counsel, and "pursuing all possible legal actions to recover damages and protect itself from further harm from these defamatory allegations."

In our Summer edition, Holistic Primary Care reported on Proove's test, and the broader questions of whether genomics can be used clinically to predict addiction risk. At the time of writing, we were unaware of STAT's allegations about coercive marketing and kickbacks.

However, our previous article did underscore the fact that so-called "laboratory-developed tests" like Proove's, fall into a regulatory netherworld with little to no federal oversight. The government defines LDTs as part of a larger class of in vitro diagnostic devices "intended for clinical use and designed, manufactured and used within a single laboratory," but does not require the FDA to oversee the development or marketing of LDTs.

This regulatory loophole allows manufacturers to produce and promote novel tests or devices without extensive clinical testing or premarket approval from the FDA or any other federal body.

Reps. Larry Buchson (R-IL) and Diana DeGette (D-CO), propose to remedy this situation. They recently released a draft of their bipartisan bill entitled the Diagnostic Accuracy and Innovation Act (DINA) that would reclassify LDTs, put them under FDA jurisdiction, and require their premarket approval. 

Given the current climate in Congress, the behind-closed-doors healthcare negotiations, and the generally anti-regulatory views prevailing in the Trump administration, this bill is unlikely to generate much political excitement. But the Buchson-DeGette draft does indicate that the issue of LDTs, and the lack of clear regulations, is on the radar of some legislators.

However it shakes out, the controversy now surrounding Proove serves as a stark reminder of the need for clinicians to be cautious with any rapidly developing medical technology. Dozens, if not hundreds, of genome tests have emerged in the last few years. Many testing companies are marketing at functional, holistic and naturopathic medical conferences, hoping to catch the wave of clinician enthusiasm for personalized medicine.

No doubt, it is challenging to balance the desire to be on the leading edge of innovation care while guarding onesself and one's patients from questionable products and services. It behooves practitioners — and those they treat — to approach technological advancements with a healthy dose of vigilance. The desire to help patients with new tools must be balanced with an equally keen eye for good science. Without substantial changes in federal regulations, the clinical community cannot count on the government to do this for us.

END

Gaby's Nutritional Medicine, 2nd Edition, Brims with Clinical Pearls

By Kristen Schepker, Assistant Editor

In today's era of disposable digital media and ephemeral "alternative facts", there's something reassuring about a good old fashioned medical textbook---especially one as thorough and carefully referenced as the new second edition of Dr. Alan Gaby's landmark work, Nutritional Medicine.

Tackling the "Seven Deadly Toxins"

By Kristen Schepker, Assistant Editor

A number of pervasive toxins -- seven, to be exact -- are wreaking daily havoc on health and wellbeing, according to detox expert Deanna Minich, PhD.

"We are living in a sick, toxic world," Minich said at the recent Clinical and Scientific Insights (CASI) conference sponsored by Designs for Health in San Francisco. She discussed her unique holistic approach to detoxification.

Minich, a faculty member of the Institute for Functional Medicine, is a nutrition researcher, clinician, and author of the book Whole Detox.  She holds that effective detoxification programs need to address much more than just diet alone. To successfully clear the body of toxins, it is essential to consider the whole spectrum of toxic elements to which an individual patient is exposed. This includes factors that negatively affect the the mind and spirit.

Deanna MinichThroughout human history and across the globe, we find examples of specific practices aimed at cleansing and purifying the body, but also for clearing the mind and heart. These include salt baths and saunas, fasting regimens, and even more extreme interventions like bloodletting. The point here is that medical traditions in all times and places have understood that people have a need for periodic cleansing activities.

Our present-day infatuation with detox diets and juice cleanses shows that we still share this urge today. And while many who cleanse certainly notice positive physical changes, they often report other less tangible benefits like achieving a clear state of mind or a sense of feeling centered and grounded.

Minich outlined what she defines as the "Seven Deadly Toxins," a constellation of destructive forces that profoundly heighten toxic load. Describing their myriad impacts on human health and wellbeing, she offered practical detox strategies to target each one and support healing throughout all the body's systems.

Food

Like many other detox experts, Minich focuses first on food. Our highly processed modern food supply is rife with agricultural chemicals, industrial byproducts, heavy metals, and other toxins that present serious health risks. To identify and avoid the main sources of food-based toxins, patients must first learn how food is produced, packaged, and distributed.

Each year, the average human consumes around 2,000 pounds of food. Unfortunately, there area fair number of toxins in among the nutrients. 

The Natural Resources Defense Council reports that over 80,000 different synthetic man-made chemicals are currently in use in the United States. Those thousands of substances lurk not just in the diet but in countless everyday items, from cosmetics and household cleaners to furniture and even toys. Over 2,000 new substances are added to the chemical index each year, Minich noted.

These numbers capture just the substances that scientists presently know about. They do not include chemicals that researchers have not yet catalogued, or toxic metabolites of known compounds that only appear once those compounds are ingested.

The average human adult human body contains over 7,000 different chemicals, approximately 200 of which are already present in the blood at birth. 

Some food-borne chemicals have direct negative effects on the neurological and endocrine systems, and epidemiological studies show associations between environmental toxins and increasing rates of food intolerance, escalating cancer rates, and rising autoimmunity diagnoses (see Death & Toxins: Tackling the Main Drivers of Chronic Disease).

Some foods are more likely than others to contain toxic chemical residues, and understanding how food is made helps to inform safer, healthier dietary choices. On a more philosophical level, Minish added, failing to recognize where food comes from leads to spiritual fragmentation, separating us from the earth that provides our nourishment.

Understanding the intricate link between human health and the health of the planet is an equally important step in the cleansing process. It is difficult for us to achieve collective wellness without a healthy Earth -- and today, the planet's health status is far from optimal.

"If the planet were a person or a patient, we'd say she is out of balance, toxic, inflamed, and most of all, she's really distressed," Minich said. "Our air, food and water -- our most basic elements of survival -- are now in jeopardy."

To reduce toxic exposure,  Minich recommends eating a colorful diet rich in phytonutrients and whole, unprocessed, organic foods. She also stresses the importance of developing a healthy, constructive emotional relationship with food.

Emotional Baggage

Enjoyment of food comes easier to some personality types than others. A host of negative emotions and conditions can block one's ability to enjoy the simple process of preparing and eating food. For some people, guilt or shame around dietary choices can be major obstacles. In other cases, people may be struggling with serious eating disorders. 

Emotional baggage connected with food is a major health stressor, Minich said, which is why it also appears on her list of deadly toxins.

Whether associated with food or any other element in our lives, unprocessed negative emotions cloud our ability to live as fully and vibrantly as possible. Helping people "detox" requires clinicians to develop a lexicon for talking with patients about emotions, and aiding them in identifing and expressing what they are feeling.

Although it's common to extol the physical benefits detoxing, Minich asserted that, "Detox is a unique interface of medicine and spirituality."

When intentionally addressing both emotional and physical wellbeing, detox is a powerfully cathartic process -- and is not one to be entered lightly. Emotional cleansing can take a long time and require support, Minich counseled. "The longest distance a human travels in the lifetime is 18 inches," she said, defining the short but complex seperation between our heads and our hearts.

Undertaking that lengthy journey with purpose, awareness, and guidance from trained professionals prompts profound detoxifying benefits beyond what can be obtained with dietary changes alone.

Negative Thinking

Similarly to emotional baggage, negative thinking is a toxic health risk. Of the 60-80,000 different thoughts we think in a given day, most of which are reccurring, the majority are also negative, Minich said. All too often, she declared, "we feed ourselves with negative programming."

The scientific literature on negative thought patterns illustrates the health dangers of chronic pessimism: premature aging, inflammation, and stress. Because bad attitudes can deter wellness, it is as important that patients learn to identify and distance themselves from their pessimistic thoughts as it is for them to learn to read food labels.

Minich believes that every thought we think has the capacity to either boost us up or deplete us. It is essential that we ask ourselves which thoughts are draining our vital energy rather than replenishing it.

Sedentism

Minich's fourth deadly toxin is failure to move the body. "We're becoming more toxic because we're sedentary," she argued. Breathing, sweating, and oxygenating the blood through movement are all fundamental pieces of the detox puzzle.

Vigorous rhythmic movement also promotes neuronal plasticity, supports healthy aging, and stimulates a fluid, dynamic emotional flow.

In a study of prostate cancer patients receiving androgen-deprivation therapy (ADT), researchers found that supervised aerobic and resistance exercise not only significantly reduced treatment-related toxicity, but also improved social functioning and mental health (Cormie, P. et al. Brit J Urol Int. 2015; 115(2): 256–266).

For chronic disease patients and healthy individuals alike, moving the body is paramount to the detoxification process. To develop sustainable exercise habits, Minich asks patients what they love to do, crafting movement plans based around activities they find pleasurable. Whatever form exercise takes, if it's not enjoyable, it is not likely to last long.

Not Speaking Truth

When detoxing, honesty is the best policy -- though perhaps the least intuitive of Minich's recommendations for toxin removal.

In the Ayurvedic healing tradition, the mouth represents a source of authenticity, awareness, and personal choice. Like the food we put into our mouths, the words that come out of them hold tremendous power. Speech has its own form of gluttony: some people speak, lie, brag, or swear too much, which not only negatively affects others but also disrupts metabolism, chewing mechanics, and other sensory experiences like smelling and hearing.

Individuals who overspeak often do so because they have difficulty hearing and believing themselves. They benefit from learning to hear and harness their own voice, Minich suggested.

On the other hand, some individuals tend to remain silent when it would better serve them to speak up---a form of self-expression anorexia.

To prevent the buildup of toxic thoughts and emotions, it is helpful to guide quieter patients to learn to express themselves and share their vital truths. For those who struggle to speak out, Minich recommends the use of positive affirmations to develop a strong, loving voice.

Poor Sleep

Poor sleep is the sixth of Minich's deadly toxins. Many toxic substances are eliminated during sleep. At the same time, buildup of toxins can often disrupt sleep or degrade the quality of slee-, creating a negative feed-forward cycle.

Dreams are another important  facet of sleep. According to Minich, dreaming represents a potent form of detoxification, providing us with messages that offer insights into elements in our lives that require attention. But most people only sleep for four or five hours a night, challenging their ability to clearly remember their dreams. Deep, adequate sleep that fuels dreaming and restores the body is crucial for detoxification.

For patients with difficulty sleeping, Minich recommends visualizations and guided imagery to encourage a "best self" view and to achieve a higher quality of rest. She believes that an ability to visualize what we want to manifest in our lives can offer a locus of control, teaching us to "step into the driver's seat of our life, harness our intellect and imagination, well it up, and bring it out."

Lack of Purpose

Lacking purpose is the final toxin on Minich's list. Inability to experience awe and joy in life, or a numbness to the absolute miracle of life will contribute to a sense of disconnection from ourselves and others. In Minich's view, these are all toxic states of mind that over time have serious negative effects on health.

In many traditional healing practices, mediation is a powerful pathway towards finding meaning in one's life. Minich encourages patients to develop meditation or prayer practices that facilitate connection to a greater sense of purpose, fulfillment, and healthful vitality.

Combining science and spirituality, Minich takes a broad scope view toward detoxification. The process involves far more than just juice-fasts or intensive supplement regimens. Deep detoxification requires attention to all the aspects that make us human.

END

Probiotics Have Adjunctive Role in Diabetes Care

By Lucy Karanja, PharmD, Contributing Writer

Nearly a decade ago, microbiome researchers began publishing reports suggesting that bacteria in the intestines play a role in glucose metabolism.  Recent studies support that thesis, and provide a basis for use of probiotics as adjunctive treatments for people with type 2 diabetes.