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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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The Truth?

Facepalm
Summertime and the living is easy. I am in Sunriver, Oregon for the week and I though, hilariously, that I would have plenty of time to write a post. Between the hiking, the biking, the golf, the food and the beer, there has been little time to sit in from of a keyboard. There may be no better place to spend a week if you like the outdoors, but they do not have internet on the hike around Paulia Lake. So while a caramel banana cake bakes for a dinner tonight, I have an hour or so churn out a post. Do not expect much.

One person’s ethics is another’s belly laugh, but in medicine ethics are formalized. The basic principles in the US are

  • Respect for autonomy – the patient has the right to refuse or choose their treatment (Voluntas aegroti suprema lex)
  • Beneficence – a practitioner should act in the best interest of the patient (salus aegroti suprema lex)
  • Non-maleficence – “first, do no harm” (primum non nocere)
  • Justice – concerns the distribution of scarce health resources, and the decision of who gets what treatment (fairness and equality).

These are guidelines, not mandated, but if you get an ethics consult in my institutions the above concepts are the framework within which the consult will be completed.

Patients can only be autonomous if they are given accurate, truthful information with which to make a decision about their treatments. You can’t lie to patients, but we all know how you phrase an idea can subtly alter the response. Do you say an 80% success rate or a 20% failure rate? I tend to say both. And not everyone can handle the unvarnished, blunt truth. Part of the art of medicine is trying to tell each patient the truth, the whole truth and nothing but the truth in a manner palatable for the individual patient. It is not easy and I am certain I do not always do a good job. (more…)

Posted in: Medical Ethics, Science and Medicine

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Consortium of Academic Health Centers for Integrative Medicine research conference disappoints even NCCAM

From the Wikimedia Commons, originally posted by Flickr user Alex E. Proimos (link)

From the Wikimedia Commons, originally posted by Flickr user Alex E. Proimos (link)

In May, the International Research Congress on Integrative Medicine and Health (IRCIMH) conference was held in Miami. In the words of its website, the conference was “convened by” the Consortium of Academic Health Centers for Integrative Medicine (CAHCIM), “in association with” the International Society for Complementary Medicine Research. As CAHCIM chirped in this tweet: “Three days, 22 countries, 100 academic medical institutions, [and] 900 researchers, physicians, educators, and trainees…” Interestingly, despite the fact that “use of all appropriate … healthcare professionals and disciplines to achieve optimal health and healing” is part of CAHCIM’s definition of integrative medicine, actual CAM providers were barely visible among the conference committee bigwigs.

Emmeline Edwards, Ph.D., Director, Division of Extramural Research at the National Center for Complementary and Alternative Medicine (NCCAM), herself on the conference’s Program Committee, was decidedly underwhelmed. (NCCAM helped fund the conference. Additional funding information here.) After offering rather tepid congratulations to the organizers and participants, Dr. Edwards launched into a pointed, but very politely delivered, criticism of the research presented (emphasis mine):

The poster sessions offered a great opportunity to meet many new investigators engaged in exciting research in the field of integrative health. Reflecting on some highlights of these sessions, I was brought to the realization that we could strive for better balance in the science featured in the IRCIMH poster presentations. The clinical research posters outnumbered the basic research presentations 3:1, and research on mind and body strategies dominated the research landscape. One concern is that many clinical research projects were not developed from adequate mechanistic studies and, hence, the outcomes from these projects may not be very informative, provide a well-defined path for the next study, or give direction for future research programs.

How right you are, Dr. Edwards! We’ve been saying some of the same things here at SBM for years. We’ve noticed these very same problems in the organization you work for. Recently, as a matter of fact. (more…)

Posted in: Acupuncture, Basic Science, Clinical Trials, Energy Medicine, Homeopathy, Medical Academia, Medical Ethics, Science and Medicine

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An Egregious Example of Ordering Unnecessary Tests

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Last week I wrote about doctors who order unnecessary tests, and the excuses they give. Then I ran across an example that positively flabbered my gaster. A friend’s 21-year-old son went to a board-certified family physician for a routine physical. This young man is healthy, has no complaints, has no past history of any significant health problems and no family history of any disease. The patient just asked for a routine physical and did not request any tests; the doctor ordered labwork without saying what tests he was ordering, and the patient assumed that it was a routine part of the physical exam. The patient’s insurance paid only $13.09 and informed him that he was responsible for the remaining $3,682.98 (no, that’s not a typo). I have a copy of the Explanation of Benefits: the list of charges ranged from $7.54 to $392 but did not specify which charges were for which test. It listed some of the tests as experimental and not covered at all by the insurance policy, and one test was rejected because there was no prior authorization. (more…)

Posted in: Diagnostic tests & procedures, Science and Medicine

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Medical marijuana as the new herbalism, part 1: Science versus the politics of weed in New York and beyond

A while ago, I wrote about how the Cleveland Clinic had recently opened a clinic that dispensed herbal medicine according to traditional Chinese medicine (TCM) practice. As regular readers of the SBM blog might expect, I was not particularly impressed or approving of this particular bit of infiltration of quackademic medicine into a major academic medical center, particularly given some of the amazingly pseudoscientific treatments espoused by the naturopath who was running the clinic. I also pointed out that, although herbalism is the most plausible (or perhaps I should say the least implausible) of modalities commonly associated with “complementary and alternative medicine” (CAM) or “integrative medicine”, it still exhibits a number of problems, the biggest of which is what I like to call either the delivery problem or the bioavailability problem. In brief, herbs, when they work, are adulterated drugs. The active ingredient is usually a minor constituent, embedded in thousands of other constituents that make up herbs, and it’s almost impossible to control lot-to-lot consistency with respect to content or active ingredients given how location, weather, soil conditions, rainfall, and many other factors can affect how the plants from which the medicines are extracted grow and therefore their chemical composition. To demonstrate the concept, I pointed out that it’s much safer and more predictable to administer digoxin to a patient who needs its activity on the heart than it would be for the patient to chew on some foxglove leaves, given that the therapeutic window (the difference between the doses needed to produce therapeutic effects and the lowest dose that will cause significant toxicity) is narrow.

Which brings me to medical marijuana, a.k.a. medical cannabis.
(more…)

Posted in: Cancer, Herbs & Supplements, Politics and Regulation

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The Buzzy: Revolutionary Acute Pain Management or Simple Distraction…

Buzzy

I’ve written about the management of acute pain in children in the past, and unfortunately my feelings haven’t changed in the interim. Acute pain, particularly pain related to procedures such as venipuncture for blood sampling and intravenous access, and intramuscular administration of medications such as antibiotics and vaccines, is commonly undertreated, downplayed and even ignored altogether by medical professionals and even caregivers. So when I was made aware of a device being used in pediatric clinics and emergency departments (and even available for home use) with apparent success in preventing or reducing procedural pain in children, I was intrigued and more than a bit hopeful. (more…)

Posted in: Science and Medicine

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Multiple Chemical Sensitivity: Separating facts from fiction

gas-mask

One of the challenges to providing science-based medicine is managing debilitating symptoms in patients who lack a clear diagnosis. If a comprehensive workup on an ill patient reveals nothing conclusive, patients and their health care providers are equally puzzled and frustrated. A diagnosis is seen as giving legitimacy to symptoms, and can be the first step towards defining a science-based treatment plan. Vague or “medically unexplained” symptoms are among the most difficult therapeutic challenges. To patients, the science and profession of medicine has failed to “deliver” and the patient can be left feeling their condition lacks legitimacy. These patients are at the greatest risk for alternative medicine approaches, such as unorthodox diagnoses and treatments. In this world, the lack of objective evidence is no barrier to defining conditions and their treatments. One of the most problematic tactics used is the attribution of these symptoms to conditions known as fake diseases. (more…)

Posted in: Science and Medicine

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The Center for Inquiry weighs in on the FDA’s mishandling of Stanislaw Burzynski’s clinical trials

We interrupt our usually scheduled post for an important announcement. OK, we do nothing of the sort. Scott Gavura’s post will go live a little later this morning. In the meantime, here’s a public service announcement about a frequent topic of mine, Stanislaw Burzynski, that I’d like you to read.

As you recall, last week, the FDA inexplicably decided to lift the partial clinical hold on Stanislaw Burzynski’s bogus clinical trials of antineoplastons, which he’s used since the 1990s as a pretext to charge huge sums of money for “case management fees” to patients for a treatment whose efficacy he has never demonstrated. Yesterday, the Center for Inquiry laid in, and has sent a letter to legislators:

“We are frankly stunned to hear that the clinical hold against Dr. Burzynski has been lifted,” writes CFI in its letter. For decades, Dr. Burzynski and the Houston-based Burzynski Research Institute have been trafficking in unproven and scientifically baseless cancer treatments based on compounds known as antineoplastons, derived from human urine, which Burzynski claims — without evidence — can target and destroy cancer cells. He has taken advantage of desperate patients who are at their most vulnerable, and willing to pay any price.

After the death of a six-year-old patient in 2012, the FDA placed a hold on Burzynski’s trials with children, followed by a hold on trials with adults in 2013, prohibiting him from taking on new patients on whom he could experiment and from whom he could extract more money.

Over several decades, his clinic has proven it is unable to properly protect patient rights, adhere to basic ethical or scientific protocols, or even maintain correct patient records. It has also shown it is willing to exploit desperate cancer patients and their families, milking them out of enormous sums of money. But it has yet to show even a shred of evidence that its cancer treatments have any positive effect whatsoever.

“We struggle to see why the FDA continues to enable this deceptive, antiscientific, and unethical medical adventurism and profiteering, even for patients who are terminally ill,” writes CFI. “Given the behavior of Dr. Burzynski and the Burzynski Research Institute over the course of nearly three decades of failed research and trials, and in the face of a complete lack of scientific evidence demonstrating the efficacy of their expensive and dangerous antineoplaston treatment, we find the FDA’s decision perplexing and profoundly disturbing.”

The full text of the letter can be found here.

If only groups like the American Cancer Society would write similar letters. Cancer patients have been taken advantage of for nearly four decades, and Burzynski has made a mockery of the clinical trial process for nearly 20 years. It’s gone on way too long.

Posted in: Cancer, Clinical Trials, Politics and Regulation

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Beware The P-Value

Part of the mission of SBM is to continually prod discussion and examination of the relationship between science and medicine, with special attention on those beliefs and movements within medicine that we feel run counter to science and good medical practice. Chief among them is so-called complementary and alternative medicine (CAM) – although proponents are constantly tweaking the branding, for convenience I will simply refer to it as CAM.

Within academia I have found that CAM is promoted largely below the radar, with the deliberate absence of public debate and discussion. I have been told this directly, and that the reason is to avoid controversy. This stance assumes that CAM is a good thing and that any controversy would be unjustified, perhaps the result of bigotry rather than reason. It’s sad to see how successful this campaign has been, even among my fellow academics and scientists who should know better.

The reality is that CAM is fatally flawed in both philosophy and practice, and the claims of CAM proponents wither under direct light. I take some small solace in the observation that CAM is starting to be the victim of its own success – growing awareness of CAM is shedding some inevitable light on what it actually is. Further, because CAM proponents are constantly trying to bend and even break the rules of science, this forces a close examination of what those rules should actually be, how they work, and their strengths and weaknesses.

(more…)

Posted in: Clinical Trials

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Why Doctors Order Too Many Tests

While cleaning out some old files, I was delighted to find an article I had clipped and saved 35 years ago: a “Sounding Boards” article from the January 25, 1979 issue of The New England Journal of Medicine. It was written by Joseph E. Hardison, MD, from the Emory University School of Medicine; it addresses the reasons doctors order unnecessary tests, and its title is “To Be Complete.” Today we have many more tests that can be ordered inappropriately and the article is even more pertinent and deserves to be re-cycled. He says,

When challenged and asked to defend their reasons for ordering or performing unnecessary tests and procedures, the reasons given usually fall under one of the following excuses…

(more…)

Posted in: Diagnostic tests & procedures

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