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Sublingual Immunotherapy Proves Effective for Dust Mite Allergy

By Erik Goldman

dust miteSublingual 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.


New Testing Array Fine-Tunes Dx of "Leaky Gut"

By Erik Goldman

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






Don't Call Breastfeeding "Natural" says Peds Journal

By Erik Goldman

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.

BreastfeedRather, 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 Chief Faces Racketeering Lawsuit

By Erik Goldman

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 withMargaret Hamburg articleInline 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.



States Challenge Requirements for Physician Certification

By Erik Goldman

Earlier this Spring, two states--Oklahoma and Kentucky--passed legislation freeing physicians from requirements to maintain specialty slide anti moc 1board certifications in order to keep their licenses and hospital privileges.

The fight over "MOC" has been heating up across the country in recent years.

In many states, specialists are mandated to renew their certifications periodically in order to maintain their licenses to practice. In other states there are no explicit requirements, however hospitals and managed care plans require recertification in order to participate in preferred provider networks or acquire hospital privileges.

A number of physicians groups have argued that maintenance of certification has become extremely burdensome, expensive, and time-consuming. Some practitioners within the holistic and functional medicine fields add that most specialty certification exams include nothing about prevention, nutrition, lifestyle change and other aspects of holistic practice. They resent having to spend large sums of time and money to re-learn concepts and modalites that are not relevant to how they practice.

Specialty board certification has a long history in this country. Originally, recertification was voluntary, and the process was promoted as a way to help physicians stay abreast of their rapidly evolving fields, and to promote a culture of quality improvement across the healthcare landscape.

But like many things that started out with good intentions, the certification process quickly became burdensome. Some states, as well as hospitals and health plans began setting requirements and mandates, and the costs of staying board-certified started to rise.

On April 12, Oklahoma governor Mary Fallin signed SB1148, a state bill that eliminates MOC requirements in that state. The new law states that nothing in Oklahoma’s medical licensure laws, “shall be construed as to require a physician to secure a maintenance of certification as a condition of licensure, reimbursement, employment or admitting privileges at a hospital in this state.”

"Right to Care"

The Oklahoma move came just a week after Kentucky's legislature passed a similar law pre-empting requirements for board-certification as a prerequisite for licensure in that state. Similar bills are under review in several other states including Missouri and Michigan.

Mary FallinThe politics around the MOC issue are complex and contentious. Freedom from onerous MOC requirements has become a rallying cry among right-leaning libertarian physicians who believe that obligatory certification has made specialty boards fat, lazy, and narrow-minded.

"Our complaint isn’t against ABMS and their subspecialty boards. They can do what they want and require what they want of their diplomates.  We cannot change that. Our complaint is with being forced to participate in an ever-changing process they claim is voluntary," writes Dr. Meg Edison, on Rebel.MD, a libertarian physicians' blog.

"We should be free to care for our patients, free to pursue novel clinical research, and free to choose our own continuing education.  If ABMS and the subspecialty boards are providing a quality educational product at a good value, doctors should be free to participate. If doctors do not see educational value in ABMS MOC products, they should be free to pursue education elsewhere without fear of losing their jobs or ability to practice."

Edison, a pediatrician, hailed the Oklahoma move as a major victory. "One small step for Oklahoma, one  giant leap for physicians." 

She and others in the anti-MOC movement, frame the issue in terms of "right to care," a principle similar to the one invoked by anti-union critics promoting "right to work" legislation.

But MOC requirements also have critics from the leftward end of the political spectrum, who view the specialty boards as tools of the pharmaceutical industry that serve to perpetuate reductionistic, drug-based thinking throughout the healthcare system.

Oklahoma's Gov. Fallin, a Republican who also served a term in the US House of Representatives from 2007-2011, has a long track record for taking strong, culturally-conservative stances on many issues including same-sex marriage and the death penalty. Her name has been floated in Republican circles as a potential running mate for Donald Trump.

But the anti-MOC bill in Oklahoma passed unanimously, with support from Democrats and Republicans alike.

The controversy over specialty certification comes at an interesting time for the holistic amedical community. A number of groups, most notably the American Board of Integrative Medicine (ABOIM) has been fighting for recognition as a legitimate medical specialty.

But recognition is one thing, requirement is another. Critics of MOC are not necessarily dismissing the value of specialty certifications. Rather they believe it should be up to physicians themselves to choose whether to seek and maintain certification or not.



Vaxxed gets Axxed: Tough-Guy De Niro Caves on Controversial Vaccine Film

By Erik Goldman

When it comes to making a stand for a controversial documentary on vaccines, it seems that actor/director Robert De Niro is not nearly as tough as some of his onscreen characters.

Last week, the film luminary, who made his cinematic bones with heavy-hitting roles in Mean Streets, Goodfellas, and Raging Bull, was all-in for including Vaxxed logothe new film, Vaxxed: From Cover-Up to Catastrophe, at the highly visible Tribeca Film Festival beginning next month.

De Niro, one of the Festival's founders, and an influential figure in the movie world, stopped short of personally endorsing the film, which alleges to tell the complete story of the CDC's "elimination" of data implicating the MMR (mumps, measles, rubella) vaccine as a trigger for autism. But up until last Friday, he was strongly supportive of the screening.

While emphasizing that he is not "anti-vaccination" in principle, De Niro said he believes, "it is critical that all of the issues surrounding the causes of autism be openly discussed and examined." The actor, who has a child with autism, admitted that the issue is "very personal to me and my family, and I want there to be a discussion, which is why we will be screening Vaxxed."

Sudden Reversal

Then, in a startling reversal, De Niro announced on Monday that the festival is nixing the movie, citing "concerns with certain things in this film." After reviewing Vaxxed with "festival organizers and scientists" De Niro now says he has come to the conclusion that, "We do not believe it contributes to or furthers the discussion I had hoped for."

robert de niro 435Neither the Festival nor De Niro have issued any further statements on the rationale for changing course.

The movie--which we have not yet seen here at Holistic Primary Care--is directed by and prominently features Andrew Wakefield, a British physician who made headlines nearly 2 decades ago with a paper published in the Lancet, suggesting a link between the MMR vaccine and developmental disabilities in exposed children. Lancet retracted the paper in 2010 after a decade of controversy, and after several other large studies dismissed the vaccine-autism link.

Wakefield, based at the Royal Free Medical School in London at the time, turned out to be on the payroll of an attorney forwarding a lawsuit against vaccine makers. Accused of scientific misconduct, Wakefield was stripped of his license to practice medicine and essentially banished from the medical community.

He has since become an outspoken critic of the vaccine industry and of mainstream medicine. To some, he is a hero challenging a corrupt and deceptive healthcare establishment. To others he is a traitor and the epitome of a pseudoscientist.

The film also includes recordings of phone calls between Brian Hooker, a  biochemical engineer and outspoken vaccine critic, and Dr. William Thompson, a CDC scientist who contends that CDC researchers manipulated and omitted crucial data from a report disproving the MMR-autism link.

Announcements that Vaxxed was to be feautured at the Tribeca festival met with outcry from a number of physicians, public health advocates, and pro-vaccine pundits who voiced concern that by spotlighting a film (and a filmmaker) they consider fraudulent, the festival was promoting an "anti-vax" agenda, and that the star power associated with the festival would encourage more people to choose not to vaccinate their kids.

Some mainstream media outlets took the angle that TFF was being hijacked by "crackpots" and irrational, anti-science lunatics.

Sensible or Censorship?

Vaccine critics, of course applauded the film's initial inclusion, and view the TFF's subsequent reversal as yet more evidence of a cover-up, and of the far-reaching censorial fingers of Big Pharma.

Some of the harshest criticism of Vaxxed came from documentarian Penny Lane, whose own recent film Nuts! focused on Dr. John Romulus Brinkley, a depression era country doctor who became famous for transplanting goat testicles into impotent men. Lane accuses the Vaxxed filmmakers of "knowingly spread(ing) dangerous lies." She adds that "This film is not some sort of disinterested investigation into the 'vaccines cause autism' hoax; this film is 'directed by the person who perpetuated the hoax."

Let's leave aside for a moment the questions of whether it is fair game for a controversial figure to make a documentary about his own controversy, whetherVaxxed has any documentary merit, or whether there really is any reason to suspect that vaccines play a causative role in autism. 

There's another important question to consider: Is a film festival the appropriate province for scientific debate? And more deeply, what was it specifically that prompted De Niro and company to do a sudden about-face?

If the decisive factor was truly lack of merit based on legit scientific information presented by credible scientists to the festival's board, why won't De Niro or the Festival's leaders come forward and say so?

So far, statements from the Festival's leadership have been decidedly vague about the specific factors that led them to drop Vaxxed .  That leaves vaccine critics and autism bloggers to speculate. Among the allegations: someone from Big Pharma threatened a lawsuit or something worse; Festival board members with deep ties to pharma and biotech companies "suggested" that the film be axed.

No doubt, this story will continue to develop in the weeks leading up to the Festival. We hope the Festival organizers will be more forthcoming with information about why they cut the film, and also that the film will ultimately be released so that we may all judge it--and its arguments--on their own merits or lack thereof.








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