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.






Gluten Exposure in Infancy May Double Celiac Risk

By Kristen Schepker, Assistant Editor

Exposure to gluten during infancy may double the risk of celiac disease (CD) in babies genetically predisposed to gluten intolerance, according to a study published earlier this year in the journal Clinical Gastroenterology and Hepatology.

Can Young Blood Reverse Aging?

By Jeannie Hall, Contributing Writer

The notion that “young blood” contains substances that might rejuvenate older adults has been around for centuries. Current research indicates that there may be something to this idea after all.

Acupuncture: From NICU to Battlefield and Beyond

By Rachael Adams, Contributing Writer

Three recent articles highlight the successful use of acupuncture in very unique areas of practice: neonatal intensive care, management of cardiovascular risk, and reduction of PTSD in military veterans. 

Help celebrate our 20th year at TPC Forum at the TWA Hotel April 23 at 6pm
Help celebrate our 20th year at TPC Forum at the TWA Hotel April 23 at 6pm