Archive for Medical Ethics

The Nuances of Informed Consent

Modern medical ethics are built upon the concept of informed consent. This is not, however, as straightforward a concept as it may seem.

Physicians and health care providers have a duty to provide informed consent to their patients or their patients’ guardians, which means that they have to inform them appropriately about the risks and benefits of their recommendations and interventions. This includes informing them about the risks of not treating an illness.

This principle is, in turn, based largely upon the principle of autonomy – people have the right to control their own lives, and one cannot have control without information.

This is all simple enough, but where it becomes tricky is in deciding how much information to give patients, and how to present it. (more…)

Posted in: Critical Thinking, Medical Ethics, Science and Medicine

Leave a Comment (51) →

Revealed by the FDA: The results of the most recent inspection of the Burzynski Clinic

After posting the talks that Bob Blaskiewicz and I gave at TAM this year, I realized that it’s been a while since I’ve written about the topic of those talks, namely Stanislaw Burzynski, the Houston cancer doctor who inexplicably has been permitted to continue to administer an unproven cancer treatment to children with deadly brain cancers for nearly 37 years now. Beginning in 1977, when he left Baylor College of Medicine and opened up the Burzynski Clinic, Burzynski has administered a cancer therapy that he calls antineoplastons to patients. After nearly four decades and several dozen phase II clinical trials started, he has never published a completed phase II trial. The only evidence he’s published consists mainly of cell culture studies, case reports, and couple of preliminary reports of his phase II clinical trials. Of course, Burzynski’s lawyer, Richard Jaffe, even dismissively admitted that these clinical trials are designed solely to allow Burzynski to keep giving antineoplastons.

So Burzynski operated from the late 1990s until summer 2012, charging exorbitant “case management” fees to enroll patients in his clinical trials, working with a credulous filmmaker who wanted to make a movie about him—twice—and flouting regulations designed to protect human subjects involved in clinical trials. Meanwhile, he branched out to “personalized gene-targeted cancer therapy,” which he promoted through Suzanne Somers; to AminoCare, which is basically antineoplastons sold as an antiaging nostrum (or, as Burzynski puts it, a “genetic solution to aging“); and to selling an orphan drug as a “prodrug” for antineoplastons.

So what happened in the summer of 2012? Apparently, there was a treatment-related death of a child, which led the FDA to issue a partial clinical hold on the Burzynski Clinic that prevented him from enrolling any new children on his clinical trials, although he could keep treating existing patients and enroll new adult patients. That partial clinical hold was extended to adults in January 2013, at which time the FDA arrived at the Burzynski Clinic to investigate. It was an event that was included at the tail end of Eric Merola’s second propaganda film about Stanislaw Burzynski and represented as, in essence, jackbooted fascists trying to keep the cure for cancer from The People. None of this stops credulous reporters from writing misleading articles with titles like Young mother with brain cancer given just a year to live BEATS the disease and gets married after having controversial treatment in the US, which is a story about Laura Hymas, a woman whose good fortune is most likely not due to Burzynski. Not long before that, there was another credulous article featuring another Burzynski patient, Hannah Bradley, as one of four patients treated for cancer with alternative therapies who are allegedly doing well. Again, Hannah Bradley’s good fortune is highly unlikely to be due to Burzynski’s nostrums.

All of this is why those of us who follow Burzynski have been waiting with the proverbial bated breath to find out what the FDA concluded. Just before the government shutdown the first shoe dropped, when the FDA released a warning letter to the Burzynski Research Institute (BRI). Then last week, the second shoe dropped, when the FDA released the original forms describing its findings regarding the inspection. The findings are, to put it mildly, damning in the extreme. In fact, now, more than ever, I wonder how on earth Burzynski has been allowed to continue to run clinical trials—or even practice—for so long. The findings include massive deficiencies in the Burzynski institutional review board (IRB), the committee responsible for making sure that regulations designed to protect human subjects in research are adhered to.

Posted in: Cancer, Clinical Trials, Medical Ethics, Politics and Regulation

Leave a Comment (47) →

The sad saga of an Amish girl with a curable cancer whose parents are refusing chemotherapy in favor of “natural healing”

Over at my not-so-super secret other blog, one common type of story that I’ve blogged about has been that of the “chemotherapy refusenik.” It’s a topic I write about here not infrequently as well. People like Suzanne Somers and Chris Wark come to mind, mostly people who had effective surgical therapy for their cancers and then decided to forego adjuvant chemotherapy in favor of quackery. Not surprisingly, they attribute their having beaten cancer not to the surgery that saved them but to the woo du jour that they chose instead of chemotherapy, not understanding that such chemotherapy is not the cure; it only reduces the risk of recurrence after surgical extirpation of the tumor. What I haven’t discussed as much here as I have over there are cases of children with cancer whose parents refuse effective chemotherapy to treat their malignancy (other than Daniel Hauser). Because most childhood cancers are not treated with surgery, chemotherapy ± radiation therapy really is the primary therapeutic modality for most of them; so refusing it has a very high probability of resulting in the unnecessary death of a child. Generally pediatric cancers have an 80-90% five year survival, and recurrences after five years are rare, which, as I described recently, is an enormous improvement over 40 years ago.

Sadly, there have been many such cases, such as the aforementioned Daniel Hauser, Abraham Cherrix, Kate Wernecke, and Jacob Stieler. All of these are stories of children who were diagnosed with highly curable cancers who refused either chemotherapy or radiation therapy and were supported in that decision by their parents. Indeed, of these, Cherrix, Hauser, and Wernecke ran away with their parents to avoid chemotherapy. They all came back, but with different results. Hauser came back, started chemotherapy again, and is doing well. Cherrix ultimately came back, but the court made a deal with his parents that let him be treated by an “integrative medicine” doctors who treated him with low dose radiation and a bogus “immunotherapy.” As a result, several years later his tumor recurred, and he was last seen earlier this year asking for money for treatment. His battle in the courts in Virginia also inspired the passage of a supremely bad law that basically allows open season on teens for quackery. Wernecke disappeared when her parents refused radiation therapy after having undergone chemotherapy and took her for intravenous high dose vitamin C. In 2007, her cancer recurred, but the recurrence appeared to have been treated successfully. It’s not clear how much conventional therapy she had received, at least as of 2010, which was the last time I could find anything about her online.

The latest of these cases that has come to my attention is the case of a 10-year-old Amish girl from Medina County in Ohio named Sarah Hershberger, who developed T-cell lymphoblastic lymphoma, an aggressive form of lymphoma, underwent chemotherapy for a few weeks, and then decided she didn’t want it anymore. Her parents, convinced that the chemotherapy was killing her, instead of insisting that she undergo potentially curative therapy, which her doctors estimated to have an 85% chance of eliminating her cancer, refused to let undergo any further therapy. This led to a court case in which Akron Children’s Hospital (ACH) sued to obtain medical guardianship of the girl in order to make sure that she would undergo curative chemotherapy. The first ruling in the case in a Medina County court was for the parents. Then on appeal the 9th District Ohio Court of Appeals ordered Medina County Judge John Lohn to take another look at the case, ruling that he had failed to weigh adequately which course would best serve her interests — the decision of her parents to withhold treatment (at her request) or to appoint a limited guardian to make medical decisions, as proposed by Akron Children’s Hospital. Amazingly, Judge Lohn reiterated his previous ruling, finding that appointment of a guardian would interfere “with Sarah’s need and desire to be cared for by her loving parents” and stating that “the guardianship will not promote Sarah’s interests.” One month ago, Judge Lohn’s decision was reversed on appeal to the 9th District Ohio Court of Appeals, which caused everyone’s favorite quackery supporter to lose his mind in rage.

Since then the case has only gotten stranger, as hard as it is to believe. Indeed, it’s hard to know exactly what is going on, although discussing the case allows me to discuss a both the science and ethics of treating children with cancer using science-based modalities.

Posted in: Cancer, Medical Ethics, Religion

Leave a Comment (89) →

Integrative Medicine’s Collateral Damage

Integrative medicine combines the practice of medicine with alternative medicine. Proponents tend to take a paragraph or two to say this, but that is what remains when boiled down to its essence. By putting this more concise definition together with Tim Minchin’s often-quoted observation about alternative medicine, you get: integrative medicine is the practice of medicine combined with medicine that either has not been proved to work or proved not to work. If it is proved to work, it is medicine.

I couldn’t find an official start date for integrative medicine, but it seems to have been around for about 15-20 years. (Osher Center for Integrative Medicine at the University of California, San Francisco, an early adapter, opened in 1997.) Yet despite some lofty pronouncements about transforming patient care, there is still no good evidence that integrative medicine improves patient outcomes. It seems unlikely that such evidence is forthcoming. It is illogical to assume that adding therapies that do not work, or are proven not to work, would benefit a patient except by inducing the ethically problematic placebo response.

Whatever its goals initially, integrative medicine now appears to serve two purposes. First, it attracts funding from wealthy patrons (Samueli, Bravewell) and the government (the military, NCCAM). Second, it is a marketing device used by hospitals, academic medical centers and individual practitioners. As an added bonus, alternative medicine is usually fee-for-service because very little of it is covered by insurance. And whatever its charms as a money-making device, given the lack of proven health benefit it is fair to ask: is integrative medicine worth it? To answer that question, let us look at what might be called the supply side of integrative medicine practitioners’ delivery of alternative medicine. Here we run into some unpleasant facts proponents seem unwilling to acknowledge: integrative medicine’s collateral damage. (more…)

Posted in: Acupuncture, Chiropractic, Energy Medicine, Herbs & Supplements, Homeopathy, Medical Academia, Medical Ethics, Naturopathy, Traditional Chinese Medicine, Vaccines

Leave a Comment (43) →

Answering Our Critics, Part 2 of 2: What’s the Harm?

Last week I posted a list of 30 rebuttals to many of the recurrent criticisms that are made by people who don’t like what we say on SBM. I thought #30 deserved its own post; this is it. At the end, I’ve added a few items to the original list.

What’s the harm in people trying CAM? Science-based medicine has been criticized for being too rigid and intolerant. Why do we insist on randomized placebo-controlled trials to prove that a treatment is safe and effective? Isn’t it enough that patients tell us they feel better? Isn’t that what we all want, for our patients to feel better? Even if the treatment only works as a placebo, isn’t that a good thing? What’s the harm in that?

The albuterol/placebo study

I would argue that we don’t just want our patients to think they are better, we want them to actually be better. A study that illustrates that principle has been discussed on this blog before, here and here.

A group of patients using an effective albuterol asthma inhaler was compared to 2 placebo groups (a placebo inhaler group and a sham acupuncture group), and to a group that got no treatment at all. Patients reported the same relief of symptoms with each of the two placebo controls as with the albuterol inhaler; all three groups reported feeling significantly better than the no-treatment group. It could be argued that placebos are an effective treatment for the subjective symptoms of asthma. (more…)

Posted in: Medical Ethics, Science and Medicine

Leave a Comment (99) →

When urgency to cure beats research ethics, bad things happen

Editor’s note: Just for your edification, here’s a “bonus” post. True, you might have seen this recently elsewhere, but it’s so appropriate for SBM that I couldn’t resist sharing it with those of you who might not read the other source where this was published recently. :-)

I’ve written a lot about Stanislaw Burzynski and what I consider to be his unethical use and abuse of clinical trials. Before that, I used to regularly write about Mark Geier and his unethical use and abuse of IRBs and clinical trials. Both doctors use their own IRBs stacked with their own cronies to rubberstamp scientifically and ethically dubious studies. Mark Geier got away with it for years. Stanislaw Burzynski got away with it for decades and, apparently, is still getting away with it to some extent. (His IRB is chaired by an old Baylor crony of his from the 1970s, and he has been cited for numerous problems with his IRBs.) I’d like to contrast how their unethical research, in which Mark Geier and his son David subjected autistic children to chemical castration with Lupron to decrease testosterone levels and allegedly make mercury easier to chelate (to them mercury was bound by testosterone, something that doesn’t happen under physiological conditions but requires organic solvents) and Stanislaw Burzynski administered an unproven cancer chemotherapy (antineoplastons) to hundreds of patients over the years and charged them for it, compares to a recent case in the news.

The case has been mentioned by PZ Myers. It happened that it involves the same sort of tumors that Stanislaw Burzynski claims to be able to cure, namely brain tumors. It happened at the University of California Davis (UC Davis) and involved two very prominent neurosurgeons there, a former head of the department Dr. J. Paul Muizelaar and Dr. Rudolph J. Schrot, who were found to have violated university’s faculty code of conduct with their experimental work. When you read this part of the story, you’ll shiver. At least, I did:

Posted in: Cancer, Clinical Trials, Medical Ethics

Leave a Comment (30) →

The Overuse of Antibiotics for Viral Infections in Children

“For every complex problem there is an answer that is clear, simple, and wrong.”

-H. L. Mencken

This approach is not endorsed by the American Academy of Pediatrics.

As I sit in an apartment full of unpacked boxes and grumpy children, only a few days removed from driving 1,600 miles to a 3rd floor walk-up and a better life just outside of Boston, I find the task of writing a post somewhat daunting. But I must admit that this new town is not without the potential for inspiring future musings. In fact, I find myself surrounded by irregular medicine of all shapes, sizes and dilutions.

Next door is a chiropractor who cures Tourette’s syndrome and, according to the pamphlet available outside the clinic entrance, only uses the in-house x-ray machine on select patients who truly need it. A few buildings down from me is an acupuncturist that treats athletic injuries with ear acupuncture and Kinesio-tape while liberally sprinkling references to his practice of “sports medicine” and “orthopedics” throughout the clinic’s promotional material. But at least I was reassured that acupuncture is completely harmless because it is a natural medicine. Finally, a block further down the road, completing my welcome committee of woo is a clinic that uses homeopathy to treat just about every real and fictional condition under the sun. I checked out their website and it’s a good thing that the walls are well insulated or my neighbors would have surely been forced to ignore the sound of my forehead pounding a wooden desk like a flagellant monk hoping for divine intervention.

Posted in: Medical Ethics, Science and Medicine

Leave a Comment (26) →

Meet Your Microbes: uBiome Offers New Service

We are not alone. Walt Whitman didn’t know how right he was when he said, “I contain multitudes.” The microbes on and in our bodies outnumber our own cells 10:1.  Perhaps that creeps you out. Perhaps that makes you curious to know just who all these billions of creatures are that are using your body for a home and a transportation device.

For just $89 you can learn what’s in your gut, nose, mouth, skin, genitals…or sample anything!

The offer comes from uBiome, a “citizen science startup” that has scientific goals somewhere down the line, but for the moment is happy to just provide a personal service, to sequence your microbiome and tell you how you compare to others. The current utility of this offering is questionable. It’s just not ready for prime time. (more…)

Posted in: Diagnostic tests & procedures, Medical Ethics

Leave a Comment (33) →

Two Viewpoints

Most of what I read professionally is directed towards reality-based medicine. I spend my professional energies thinking about the application of reality to killing various and sundry microscopic pathogens.

The conceptual framework I use, and that used by others in medicine, does not concern itself with the application of the Supplements, Complementary and Alternative Medicines that occupy the attention of this blog. In acute care medicine SCAMs are of virtually no importance yet the approaches we need to take with patients and medicine are, with slight changes in emphasis, as applicable to SCAMs as real medicine. You need to remember, however, that the topic is not necessarily based in known reality.

Two viewpoints in JAMA caught my attention this month, both more thoughtful and reasoned than I am probably capable of. While focused on the application of reality-based medical practice, they apply to the topics of SBM as well. (more…)

Posted in: Clinical Trials, Medical Ethics, Science and Medicine

Leave a Comment (39) →

Angelina Jolie, radical strategies for cancer prevention, and genetics denialism

I had been debating whether to blog about Angelina Jolie’s announcement last week in a New York Times editorial entitled My Medical Choice that she had undergone bilateral prophylactic mastectomy because she had been discovered to have a mutation in the BRCA1 gene that is associated with a very high risk of breast cancer. On the one hand, it is my area of expertise and was a big news story. On the other hand, it’s been nearly a week since she announced her decision, and the news story is no longer as topical as it was. Also, I’ve already written about it a couple of times on my not-so-super-secret other blog, making the division of blogging…problematic. So, if some of this is a bit repetitive to those who are also fans of my more—shall we say?—insolent persona, I apologize, but try to be patient. I will be doing more than just rehashing a couple of posts from last week (although there will unavoidably be at least a little of that), because there have been even more examples of reactions to Jolie’s announcement that provide what I like to consider “teachable moments.” I will start by asserting quite bluntly that in my medical opinion, from the information I have available, Angelina Jolie made a rational, science-based decision. How she went about the actual mechanics might have had some less than scientific glitches along the way (more about that later), but the basic decision to remove both of her breasts to prevent breast cancer associated with a BRCA1 mutation that she carried was quite reasonable and very defensible from a scientific standpoint.

One advantage of waiting nearly a week to write about this story is that it provided me with the opportunity to sit back and observe the reactions that Jolie’s decision provoked. One thing that I really didn’t expect (although in retrospect maybe I should have) is the pure denialism on display that genes have any effect whatsoever on cancer. I say “in retrospect I should have” because I’ve written at least a couple of times before about how quacks use and abuse the term “epigenetics” in the same way that they abuse the word “quantum” and how they seem to believe that wishing makes it so (through epigenetics, of course!) to the point where they believe that genetics is irrelevant to cancer. Indeed, they go far beyond that, asserting that, in essence, environment is all. From what I’ve been reading thus far, the second strongest strain of reaction to Jolie’s announcement (after revulsion at the “mutilation” of women that it represented to certain quacks) is pure denial that mutations in BRCA1 and BRCA2 genes portend such a high risk of ultimately developing breast cancer. This denial is often accompanied by conspiracy mongering about BRCA1 and BRCA2 mutations being a “conspiracy” on the part of the “cancer industry” and Myriad Genetics & Laboratories, the company that holds the patents on BRCA1 and BRCA2, to increase genetic testing and preventative mastectomies. Myriad happens to have a complete monopoly on BRCA1 and BRCA2 testing because of this patent and has been criticized for its high prices and stifling of competition. There is currently a case before the U.S. Supreme Court regarding whether human genes are patentable under the law. I’m not a big fan of Myriad, and I’ll tell you why later. (Not that it matters; I’m stuck with them for now.) My personal distaste for Myriad Genetics aside, this sort of conspiracy mongering is part and parcel of the quack approach to denying the significance of BRCA1 mutations.

This denial is usually coupled with confident blather that Angelina Jolie didn’t need to undergo “disfiguring” surgery to prevent BRCA1-associated breast cancer but instead could have achieved the same—or even better!—risk reduction if only she had used this magic herb or that miracle supplement and making certain “lifestyle” changes. It’s utter nonsense, of course, but it’s everywhere.

Before I get to the reactions to Jolie’s announcement, let’s first take a look at what she did, why, and the science behind it.

Posted in: Basic Science, Cancer, Medical Ethics, Science and the Media

Leave a Comment (46) →
Page 4 of 19 «...23456...»