Late last summer, the Drug Enforcement Administration (DEA) adopted a new policy designed to foster an increase in medicinal cannabis research. The Administration’s decision opens doors to a larger number of marijuana suppliers qualified to produce cannabis for scientific study, a shift that will arguably lead to broader and more comprehensive study of a drug which, despite widespread medical use throughout the country, remains highly controversial.
The numbers are small, but the headlines linking dietary supplements to liver damage are big--- big enough to generate yet another round of medical and regulatory hand-wringing about the problem of “uncontrolled” supplements.
Sublingual immunotherapy (SLIT) can reduce exacerbations of asthma associated with dust mite allergens, according to a recent study published in the Journal of the American Medical Association.
House dust mites are a common trigger of allergy-associated asthma, and up to 30% of all patients who are allergic to dust mites are non-responsive to inhaled corticosteroids, beta agonists, and other drug therapies.
SLIT, which involves daily sublingual exposure to highly dilute concentrations of an allergen, has proven effective in reducing the frequency and severity of allergic reactions to a number of common allergens. Until recently, however, it had not been tested in the context of dust mite asthma.
J. Christian Virchow and colleagues at the University of Rostock, Germany, explored the impact of SLIT in a cohort of 834 adults with confirmed dust mite-triggered asthma and related rhinitis, whose symptoms were not well controlled with inhaled corticosteroids.
The patients, seen at 109 centers across Europe, were randomized to once-daily treatment with a sublingual placebo (277 patients), or a low-dose (275 patients) or high-dose (282 patients) SLIT preparation of dust mite allergens. All were treated for a total of 6 months, and all were permitted to continue conventional drug therapies.
A total of 693 participants completed the full 6-month trial. Compared with the placebo group, both groups of SLIT patients showed small but significant reductiosn in moderate to severe asthma attacks over the 6 month period.
Dr. Virchow estimated that the absolute reduction at 6 months was "9 or 10 percentage points," and there was no significant difference between the high and low-dose SLIT preparations (Virchow JC, et al. JAMA: 315 (6): 1715-25).
Though clearly not a definitive treatment for dust mite-related asthma, SLIT does represent a new adjunctive option for patients who are not getting substantial relief from conventional drug therapies. Virchow believes it is one well worth further exploration. He notes that, “among adults with house dust mite allergy–related asthma not well controlled by ICS, the addition of house dust mite SLIT to maintenance medications improved time to first moderate or severe asthma exacerbation during ICS reduction."
The authors acknowledge that the current study has limitations, among them the fact that the 6-month study period was significantly shorter than the typical durations of immunotherapy, which sometimes extend to 3 years.
Still, the fact that dust mite SLIT did produce measurable changes in clinical outcomes after only 6 months, suggests that this approach does have promise.
Intestinal permeability, or "leaky gut," which used to be dismissed as a bogus diagnosis, has become the focus of much attention in recent years, as researchers identify the mechanisms by which chronic exposure to toxins and food allergens damages the integrity of the endothelial lining.
In clinical practice, however, the diagnosis and treatment of this increasingly common condition could hardly be called precise. Practitioners have traditionally relied on symptom patterns, a handful of food allergy tests, and large doses of educated guesswork to make the diagnosis.
Enter Array 2, the new test panel just launched by Cyrex Laboratories.
The new test spotlights seven antigens and bacterial lipopolysaccharides associated with increased intestinal permeability and the breakdown of endothelial barrier function, enabling clinicians to arrive at a more precise diagnosis. Specifically, the new test panel can distinguish specific pathways by which the intestinal wall is breached and large, pro-inflammatory molecules are entering the bloodstream.
Speaking broadly, antigens cross from the lumen of the intestine to the bloodstream via either paracellular pathways (ie between endothelial cells at sites where tight junctions have broken down) or via transcellular pathways (resulting from breakdown of endothelial cell membrane integrity). The Array 2 panel gives specific, detailed information to help clinicians fine-tune their diagnoses.
“I consider the Cyrex Array 2 to be the most effective laboratory study available for evaluating gut permeability," said neurologist David Perlmutter, MD, author of the popular Grain Brain, in a press release issued by Cyrex.
Increased intestinal permeability has been linked to a host of common autoimmune conditions including chronic fatigue, arthritis, inflammatory skin conditions, neurodegenerative disease, and cardiovascular disease. It also correlates with increased permeability of the blood-brain barrier.
Perlmutter says that knowing the precise pathways of degeneration of intestinal barrier function will take some of the guesswork out of treating patients with clear signs of leaky gut, and help practitioners tailor their therapeutic strategies.
For more information about Array 2, visit www.joincyrex.com.
A recent article in the American Academy of Pediatrics' journal is urging physicians to nix the word "natural" when talking to new mothers about breastfeeding.
Authors Jessica Martucci and Anne Barnhill, of the Department of Medical Ethics & Health Policy, University of Pennsylvania, are not disputing the fact that breastfeeding is natural. Nor are they challenging the idea that breastfeeding is healthy.
Rather, they are concerned that the word "natural" has certain problematic connotations, and that by using it, doctors are unwittingly leading their patients down a primrose path of thoughts that lead to things like concern about GMOs in food, questions about the safety of vaccines, or worries about environmental toxins......things that Martucci and Barnhill don't think doctors or their patients should be thinking about.
"We are concerned about breastfeeding promotion that praises breastfeeding as the “natural” way to feed infants. This messaging plays into a powerful perspective that “natural” approaches to health are better," write the authors. "Promoting breastfeeding as “natural” may be ethically problematic, and, even more troublingly, it may bolster this belief that “natural” approaches are presumptively healthier. This may ultimately challenge public health’s aims in other contexts, particularly childhood vaccination." (Martucci J, Barnhill A. Pediatrics. 2016; 137(4)).
In other words, to Martucci and Barnhill, "natural" is a gateway word.
They base their view on internet searches showing a large overlap between parental interest in complementary/alternative medicine and natural foods, and anti-vax sentiments. They argue that people who want a more "natural" lifestyle--which includes breastfeeding--are also more inclined to challenge institutional authority, to question the intentions of corporations, and to seek cultural alternatives like home births, home-schooling, organic GMO-free foods, and non- fluoroidated water.
"If doing what is ‘natural’ is best in the case of breastfeeding, how can we expect mothers to ignore that powerful worldview when making choices about other health practices, like vaccination?" they ask.
Martucci and Barnhill are right, to a point. The term "natural" has come under a lot of scrutiny lately. Some people do automatically assume that anything "natural" is by definition "healthy." And in the context of consumer product marketing, the term is vague enough to mean almost anything but emotionally charged enough to conjure a specific set of ideals and values.
It is widely used--though poorly defined--in food marketing, and many products promoted as "natural" foods are, in fact, highly processed and unlike anything found in the natural world. Absent any consensus on what the term should mean, and absent any strong federal regulation of said definitions, the loose and fast use of the term will continue.
When it comes to breastfeeding, however, the facts are quite clear. It is as natural as anything gets, and it is generally quite healthy. It is certainly not the only healthy way to feed an infant, and practitioners should avoid stigmatizing mothers who, for whatever reason, do not breastfeed.
But Martucci and Barnhill's call to squelch physicians' use of the term, "natural," when discussing breastfeeding is misguided and, frankly, Orwellian. Practitioners should not have to censure truthful communication (ie, breastfeeding is truly natural) out of fear of "implications."
People seek natural alternatives for a reason; it is a signal that they want to optimize their own health and that of their children. Honest dialog around how best to do that should be encouraged, not suppressed.
Former FDA commissioner Margaret Hamburg, and her husband, investment banker Peter Brown, have been named in a federal-level anti-racketeering lawsuit alleging that the two conspired with executives from Johnson & Johnson and Ortho-McNeil-Jansen Pharmaceuticals to supress data about side-effects associated with Levaquin.
The suit, filed on April 11, in the US District Court for the District of Columbia, charges that during her tenure as head of the FDA, Dr. Hamburg colluded with her husband--who runs a hedge fund called Renaissance Technologies, LLC, to "reap large financial returns by failing to disclose to Plaintiffs and the public at large the full extent of the devastating, life-threatening, and deadly effects of a highly dangerous pharmaceutical drug named Levaquin."
Levaquin, aka levofloxacin, is a broad-spectrum antibiotic approved by the FDA in 1996 and marketed by the J & J-owned Ortho McNeil company. Though most mainstream clinicians consider it to be a fairly safe drug, Levaquin has in recent years come under scrutiny for its potential adverse effects. The drug has been the subject of roughly 3,400 individual state and federal lawsuits, as well as a class-action suit filed by people who claimed exposure to the drug caused severe tendon damage. J & J has opted to settle in all but 363 of these cases.
The new suit was brought by Larry Klayman, a former federal prosecutor, on behalf of five individuals who claim they were severely injured by taking Levaquin.
Citing the federal Racketeer Influenced and Corrupt Organizations (RICO) law, Klayman claims that while serving as FDA Commissioner, "acted as the instrumentality that all Defendants used to perpetrate their conspiracy and racketeering enterprise by having her act illegally and outside the scope of her authority as FDA Commissioner to suppress material information to Plaintiffs and the public that Levaquin was inherently dangerous and in fact, deadly."
Klayman, who served as a Justice Department prosecuter during the Reagan Administration, is considered a thought leader in right-wing Tea Party circles, and he has been an outspoken critic of President Obama, and both Clintons.
Dr. Hamburg resigned from her FDA post in March 2015, after a tenure of nearly 6 years. Shortly after leaving FDA, she was appointed as the Foreign Secretary for the Insitute of Medicine, under the National Academy of Science.
In his Levaquin filing, Klayman contends that Hamburg had access to a 2013 FDA report entitled, “Disabling Peripheral Neuropathy Associated with Systemic Fluoroquinolone Exposure,” that directly links Levaquin to mitochondrial toxicity and, possibly, neurodegenerative diseases like ALS, Parkinson's and Alzheimers, but that she deliberately failed to take action to disclose and disseminate this information because she had a personal financial stake in the success of Ortho-McNeil and J & J.
The suit states that Hamburg, and her husband "reaped and continues to reap huge financial gain as a result of Renaissance Technology's holdings of Johnson & Johnson stock."
It also claims that Hamburg basically turned a blind-eye to data from the Federal Adverse Events Reporting System (FAERS) documenting a link between Levaquin exposure and a host of multi-system disabilities--a constellation of side-effects that an FDA advisory committee terms "Fluoroquinolone-Associated Disability." The drug's manufacturer does not include this on it's warning labels.
During Hamburg's tenure at FDA, J & J was involved in a number of questionable actions, including a program of illegally bribing Omnicare--a large pharmaceutical distributor in the nursing home industry--to increase the sales of Levaquin.
In addition to these charges, the suit also alleges that Hamburg and her husband were engaged in quid pro quo political donations to President Obama's campaigns; that Hamburg's appointment as FDA head in 2009 was a result of her donations to the Clinton Foundation in exchange for endorsements by Secretary of State Hillary Clinton; and that during the congressional deliberations prior to her confirmation, Hamburg failed to disclose the large pharmaceutical holdings by her husband's investment firm--a red flag for what Klayman sees as a "clear-cut conflict of interest."
The plaintiffs in this suit are seeking $120 million in compensatory damages, as well as up to $750 million in punitive damages from the drug makers. Since racketeering and conspiracy are criminal acts, the defendants could also face prison sentences if found guilty.
So far, none of the defendants has issued a formal statement specifically addressing the suit or the allegations therein.