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The Texas Medical Board vs. Stanislaw Burzynski, 2014 edition

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As I begin this post, I’m on a miserably crowded, hot, stinky flight winging my way home from TAM. This puts me in the perfect mood to write about my bête noire to conquer all bêtes noires, namely Stanislaw Burzynski, the Polish expat doctor who claims to have much better results treating deadly brain cancers than conventional oncology, even though he is not an oncologist and has never even completed the prerequisite training for an oncology fellowship, namely an internal medicine residency. Actually, I don’t mean that in the way that you probably think I mean it. This time around, unlike the last time around, writing about Burzynski will put me in a better mood to endure being slapped into a sardine can in coach, barely able to move, barely able to type, but needing to get a blog post out on Monday.

If you remember, the last time I wrote about Burzynski, the Food and Drug Administration (FDA) had caved, and by “caved” I mean that it had lifted the partial clinical hold on Burzynski’s clinical trials. As is usual with the long and winding saga that is Burzynski, I feel compelled to give a brief review for any newbie who might encounter this post. Old hands at this story can skip ahead or just skim.

Two years ago, a child named Josia Cotto died of hypernatremia (elevated sodium level in the blood) due to receiving treatment for a brain tumor from the Burzynski Clinic using Burzynski’s “miracle drug” antineoplastons. Hypernatremia is a known complication of ANP treatment, and, as a result of this child’s death, the FDA put a partial clinical hold on Burzynski’s clinical trials for pediatric patients, which meant that he could continue to treat children already enrolled in his clinical trials but could not enroll any new patients. Six months later, this partial hold was extended to all of Burzynski’s clinical trials, and in early 2013 the FDA inspected the Burzynski Clinic and Burzynski Research Institute (BRI). (more…)

Posted in: Cancer, Clinical Trials, Politics and Regulation

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Now that Burzynski has gotten off in 2012, Burzynski The Movie will spawn a sequel in 2013

About a year ago, I became interested in a physician named Stanislaw Burzynski who has been treating cancer with compounds that he calls “antineoplastons” for over three decades without, in my opinion, ever having ever produced any compelling evidence that antineoplastons have significant anticancer activity. Although I had been vaguely aware of Burzynski and his activities, it was the first time that I had looked into them in a big way.

Having found very few skeptical, science-based takes on Burzynski and having noted that the Quackwatch entries on Burzynski (1, 2, 3) were hopelessly out of date, I wrote a trilogy of posts about him, starting with a review of an execrably bad movie made by a simultaneously credulous yet cynical independent writer, producer, and director named Eric Merola whose primary business, appropriately enough, is mainly marketing. The movie was Burzynski The Movie: Cancer Is A Serious Business, a “documentary” (and I’m being polite here) that I characterized at the time as a bad movie and bad P.R. In brief, I saw this movie as a hagiography, a propaganda film so ham-fisted that, if she were still alive, it would easily simultaneously make Leni Riefenstahl blush at its blatantness and feel nauseated how truly awful it was from a strictly film making standpoint. It was also chock full of highly dubious science, in particular Burzynski’s latest venture, which is to sell “personalized gene-targeted cancer therapy” similarly lacking in oncological insight, so much so that I observed at the time that it was as though Dr. Burzynski read a book called Personalized Cancer Therapy for Dummies and decided he is an expert in genomics-based tailoring of targeted therapies to individual cancer patients. Finally, I completed the trilogy by pointing out that lately Burzynski has been rebranding an orphan drug that showed mild to moderate promise as an anticancer therapy.
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Posted in: Book & movie reviews, Cancer, Clinical Trials

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The Texas Medical Board acts in the case of the Winkler County whistle blowing nurses

I can’t speak for anyone else who blogs here at Science-Based Medicine, but there’s one thing I like to emphasize to people who complain that we exist only to “bash ‘alternative’ medicine.” We don’t. We exist to champion medicine based on science against all manner of dubious practices. Part of that mandate involves understanding and accepting that science-based medicine is not perfect. It is not some sort of panacea. Rather, it has many shortcomings and all too often does not live up to its promise. Our argument is merely that, similar to Winston Churchill’s invocation of the famous saying that “democracy is the worst form of government except all the others that have been tried,” science-based medicine is the worst form of medicine except for all the others that have been tried before. (Look for someone to quote mine that sentence soon.) It’s not even close, either. SBM has produced far and away better results than any form of medicine that has come before it, which is why it’s always puzzled me that so much of “alternative” medicine seems to be a throwback to ancient, pre-scientific, sometimes religion-based medical systems that existed in the days before germ theory and a rudimentary understanding of human physiology. After all, it wasn’t until William Harvey in 1626 that doctors even knew for sure that there was a direct connection between the arterial and venous system, for example, and the sphygmomanometer wasn’t invented until 1881. Monitoring blood pressure didn’t become routine until the early 20th century, and monitoring the diastolic blood pressure wasn’t routine until the 1920s.

If there’s one area that SBM needs to do better in, it’s regulating our own. To me, the license to practice medicine is a privilege, not a right. That I should even have to emphasize such a statement is bothersome to me, but all too often medical licenses, once obtained, seem to be treated as a right that can’t easily be taken away. That’s not to say that actually getting to the point of being licensed and board-certified isn’t difficult. It is. There’s the need to maintain excellent grades in college, after which there’s medical school and residency, both of which can be quite brutal. But once a physician is fully trained, board certified, and licensed, it seems that medical boards bend over backwards not to take away his license, seemingly even if he’s providing treatments so far outside the standard of care that they might as well be magic.

The case that provoked this complaint from me is one I’ve written about before, namely that of the Winkler County, TX family practitioner, Dr. Rolando Arafiles, Jr.. At the time, Dr. Arafiles was selling dubious supplements, hawking colloidal silver, promoting Morgellon’s disease quackery, and had anti-vaccine propaganda on his website. It turns out that — finally! — Dr. Arafiles is facing the Texas Medical Board for his substandard practice, as documented in a story on Medscape entitled Physician in Whistle-Blower Case Charged by Texas Medical Board:

The Texas Medical Board (TMB) has charged a family physician at the center of a nationally publicized whistle-blower case involving 2 nurses with poor medical judgment, nontherapeutic prescribing, failure to maintain adequate records, overbilling, witness intimidation, and other violations.

The charges follow a report that the 2 nurses — Anne Mitchell, RN, and Vickilyn Galle, RN — made anonymously to the TMB last year about patient care rendered by Rolando Arafiles, Jr, MD, at Winkler County Memorial Hospital in Kermit, Texas, where the 2 nurses and Dr. Arafiles worked.

After the TMB contacted him about the report, Dr. Arafiles asked the sheriff of Winkler County to investigate its source. The sheriff, the physician’s acknowledged friend and patient, traced the report back to Mitchell and Gale, who were then charged in a state court with misuse of official information, which is a third-degree felony.

The American Nurses Association at the time called the criminal prosecution “outrageous,” arguing that nurses were obligated to stand up for patient safety.

A local news report on the case can be found here:

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Posted in: Health Fraud, Herbs & Supplements, Politics and Regulation

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The Winkler County nurse case and the problem of physician accountability

A MISCARRIAGE OF JUSTICE THAT HAD A (SORT OF) HAPPY ENDING

Back in September and then again last week, I wrote briefly (for me) about an incident that I considered to be a true miscarriage of justice, namely the prosecution of two nurses for having reported the dubious and substandard medical practices of a physician on the staff of Winkler County Hospital in Kermit, Texas. The physician’s name is Dr. Rolando Arafiles, and he happened to be a friend of the Winkler County Sheriff, Robert Roberts, who also happened to have been a patient of Dr. Arafiles and very grateful to him for having saved his life. The nurses, Anne Mitchell and Vickilyn Galle, were longtime employees of Winkler County Hospital, a fifteen bed hospital in rural West Texas. Although some of you may have seen extensive blogging about this before, I thought it very important to discuss some of the issues involved on this blog. Moreover, there is an aspect to this case that the mainstream media reporting on it has missed almost completely, as you will see. Finally, this case showed me something very ugly about my profession, not just because a doctor tried to destroy the lives of two good nurses through his connections to the good ol’ boy network in Winkler County

Let’s recap what happened, a story that reached its climax last Thursday. In 2008, Dr. Arafiles joined the staff of Winkler County Hospital (WCH). It did not take too long for it to become apparent that there were serious problems with this particular doctor. Mitchell and Galle, who worked in quality assurance were dismayed to learn that Dr. Arafiles would abuse his position to try to sell various herbal remedies to patients in the WCH emergency room and the county health clinic and to take supplies from the hospital to perform procedures at a patient’s home rather than in the hospital. No, it wasn’t the fact that Dr. Arafiles recommended supplements and various other “alt-med” remedies, it’s that he recommended supplements and various other “alt-med” remedies that he sold from his own business–a definite no-no both ethically and, in many states, legally. Mitchell reported her concerns to the administration of WCH, which did pretty much absolutely nothing. Consequently, on April 7, 2009, Mitchell and Galle anonymously reported their concerns to the Texas Medical Board (TMB). In June, WCH fired the two nurses without explanation.
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Posted in: Health Fraud, Homeopathy, Politics and Regulation, Science and the Media, Vaccines

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The legal establishment of Winkler County, Texas conspires to punish whistle blowing nurses

On Science-Based Medicine, several of us have at various times criticized state medical boards for their tolerance of unscientific medical practices and even outright quackery. After all, Dr. Rashid Buttar still practices in North Carolina and the medical board there seems powerless to do anything about it. However, state medical boards have other functions, one of which is to respond to complaints of unethical and dubious behavior about doctors. Key to this function is protection; i.e., if someone reports a doctor, that person needs to be sure that the state will protect her from retaliation from that doctor of the hospital. About five months ago, I reported a true miscarriage of justice, the sort of thing that should never, ever happen. In brief, it was the story of two nurses who, disturbed at how a local doctor was peddling his dubious “herbal” concoctions in the emergency room of the local hospital when he came in to see patients, reported him to the authorities. Moreover, they had gone up the chain of command, first complaining to hospital authorities. After nothing happened for months, they decided to report the physician, Dr. Rolando Arafiles, to the Texas Medical Board because they honestly believed that this physician was abusing his trust with patients and behaving unethically by improperly hawking herbal supplements that he was selling in the rural health clinic and the emergency room of Winkler County Memorial Hospital.

Even though under whistleblower laws the identities of these nurses should have been kept secret, after he learned that a complaint had been filed against him Dr. Arafiles went to his buddy the Winkler County Sheriff Robert L. Roberts, who left no stone unturned in trying to find out who had ratted out Dr. Arafiles:

To find out who made the anonymous complaint, the sheriff left no stone unturned. He interviewed all of the patients whose medical record case numbers were listed in the report and asked the hospital to identify who would have had access to the patient records in question.

At some point, the sheriff obtained a copy of the anonymous complaint and used the description of a “female over 50″ to narrow the potential complainants to the two nurses. He then got a search warrant to seize their work computers and found a copy of the letter to the medical board on one of them.

The result was this:

In a stunning display of good ol’ boy idiocy and abuse of prosecutorial discretion, two West Texas nurses have been fired from their jobs and indicted with a third-degree felony carrying potential penalties of two-to-ten years’ imprisonment and a maximum fine of $10,000. Why? Because they exercised a basic tenet of the nurse’s Code of Ethics — the duty to advocate for the health and safety of their patients.

On Saturday, the New York Times reported on the story, as there have been significant developments since August. Specifically, although the charges against one of the nurses has been dismissed, Anne Mitchell, RN, is going to stand trial beginning today:
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Posted in: Medical Ethics, Politics and Regulation

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