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Of the Trial to Assess Chelation Therapy, Bayes, the NIH, and Human Studies Ethics

An experiment is ethical or not at its inception; it does not become ethical post hoc—ends do not justify means.
~ Henry K. Beecher

tact

A couple of weeks ago, Dr. Josephine Briggs, the Director of the National Center for Complementary and Alternative Medicine (NCCAM), posted a short essay on the NCCAM Research Blog touting the results of the Trial to Assess Chelation Therapy (TACT) (italics added):

The authors found that those receiving the active treatment clearly fared better than those receiving placebo. The accompanying editorial in the AHJ reminds readers about the value of equipoise and the need to “test our beliefs against evidence.”

Most physicians did not expect benefit from chelation treatment for cardiovascular disease. I readily admit, initially, I also did not expect we would find evidence that these treatments reduce heart attack, strokes, or death. So, the evidence of benefit coming from analyses of the TACT trial has been a surprise to many of us. The subgroup analyses are suggesting sizable benefit for diabetic patients—and also, importantly, no benefit for the non-diabetic patient. Clearly subgroup analyses, even if prespecified, do not give us the final answer. But it is also clear that more research is needed to test these important findings.

And TACT findings are indeed a reminder of the importance of retaining equipoise [sic], seeking further research aimed at replicating the findings, and neither accepting nor rejecting findings based on personal biases. The scientific process is designed to weed out our preconceived notions and replace them with evidence.

Dr. Briggs concluded:

So, TACT is a reminder—an open mind is at the center of the scientific method.

Dr. Briggs’s title was “Bayes’ Rule and Being Ready To Change Our Minds”, a reference to a recent editorial that had accompanied one of the TACT papers. That editorial, by Dr. Sanjay Kaul, a physician and statistician from UCLA, begins with this quotation:

Preconceived notions are the locks on the door to wisdom.
~ Merry Browne

Here is the relevant passage from Dr. Kaul’s editorial (italics added):

Sixth, it has been argued that the trial was unethical because there was no compelling clinical or preclinical evidence that chelation therapy has significant efficacy against atherosclerotic cardiovascular disease, and given that chelation therapy can cause harm, the risk was not minimal. A Bayesian analysis would not look kindly on the results because of the low prior probability of treatment effect (the so-called implausibility argument).6 This is an uncharitable (and unwarranted) interpretation of the data because previous systematic reviews concluded, “insufficient evidence to decide on the effectiveness or ineffectiveness of chelation therapy in improving clinical outcomes among people with atherosclerotic cardiovascular disease.” It is axiomatic that absence of evidence of efficacy is not the same as evidence of the absence of efficacy.

From a Bayesian perspective, the strength of evidence is often summarized using a Bayes factor, which is a measure of how well 2 competing hypotheses (the null and the alternate) predict the data. The Bayes factor and the corresponding strength of evidence for the primary end point result in TACT overall, and diabetic cohorts are shown in Table 1. The p-value of 0.035 for TACT overall cohort translates into a Bayes factor of 0.108, which means the evidence supports the null hypothesis ≈1/9th as strongly as it does the alternative. This reduces the null probability from 50% pretrial (justified by suspension of one’s belief in treatment effect) to 10% post-trial. Although this does not represent strong evidence against the null, it does reduce the level of skepticism surrounding chelation therapy. In the diabetic cohort, the nominal p-value of 0.0002 translates into a Bayes factor of 0.002 (1/500), which reduces the extremely skeptical prior null probability of 95% to 4% post- trial, indicating very strong evidence against the null.

In concluding, Dr. Kaul states:

Finally, TACT highlights the double standard when it comes to accepting inconvenient results not aligned with our preconceived notions on so-called dubious quack cures such as chelation…

Closed minds?

Dr. Kaul’s reference “6” above is to a lengthy article that we published in 2008 titled “Why the NIH Trial to Assess Chelation Therapy Should Be Abandoned”. So, it seems, both Drs. Briggs and Kaul were chastising us for our biased, preconceived beliefs about so-called dubious quack cures. Our minds were, apparently, not open. Let’s examine this contention. (more…)

Posted in: Clinical Trials, Health Fraud, Medical Academia, Medical Ethics, Politics and Regulation

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Beware the Integrative Pharmacy

pharmacy window

Imagine a retail pharmacy where some of the medicines on the shelves have been replaced with similar-looking packages that contain no active ingredients at all. There is no easy way to distinguish between the real and the fake.

Another section of the store offers a number of remedies with fantastic claims, such as “boosting” the immune system, “detoxifying” the body, or “cleansing” you of microscopic Candida. They look sciencey, unless you realize that they treat imaginary medical conditions.

A corner of the store offers unpurified drugs supplied as tinctures and teas. The active ingredients aren’t known, and the batch-to-batch consistency of the product is unclear. The store will suggest products for you based on your symptoms.

Walk past the enormous wall of vitamins and other supplements and you’ll find a nutritionist who will tell you what products you should be taking. You’ll also find a weight loss section. From a science-based perspective, this shouldn’t even exist, given no product has been shown to offer any meaningful benefit. But there are dozens of products for sale.

At the back of the store you’ll finally find the pharmacist. A sign on the counter offers blood- and saliva-based tests for food “intolerance” and adrenal “fatigue”, claiming to test for medical conditions that actually don’t exist or lack an evidence base. The pharmacy also offers a large compounding practice, advertising what it calls “personalized” approaches to hormone replacement with “bioidentical” hormones.

Welcome to the “integrative” pharmacy.

You may not see all these features in your local drug store, but they’re coming: claims of a new “integrative” way to provide health care that is changing the face of retail pharmacy. Unfortunately, it’s harkening back to the era of patent medicines and snake oil. It’s not good for the pharmacists and the profession of pharmacy, and it’s even worse for patients. (more…)

Posted in: Homeopathy, Medical Ethics, Politics and Regulation, Science and Medicine

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Telemedicine: Click and the doctor will see you now

Think you need to see a doctor? How about seeing him (or her) on your computer (or tablet or smart phone) screen instead of in the doctor’s office?

The technology of telemedicine, or telehealth, is here. So far, there is no single definition of what it does, and does not, encompass. For example, in some definitions, one of which we discuss today, it includes only video communication. Other definitions are broader, including fax, telephone, and e-mail. Here, we focus mainly on the direct patient-physician telemedicine encounter, unmediated by the presence of a physician who has actually seen the patient face-to-face. This is unlike, for example, the more common specialist consultation, in which the patient and physician have met face-to-face and the specialist is brought in via technology. A typical example of this is the radiologist who reads x-rays from a remote location. (Sometimes so remote that the radiologist isn’t even in the same country.) There is some evidence, but not much yet, that certain kinds of physician-mediated telemedicine can benefit the patient.

One can think of many ways a patient’s accessing a doctor via computer might improve access to healthcare. This could be a godsend for patients in rural areas who must drive an hour or more to find a doctor’s office. For example, here’s a program from the University of Mississippi Medical Center:

The Diabetes Telehealth Network will [put telemedicine] technology in the hands of the patients themselves in the form of Internet-capable tablets equipped with the Care Innovations™ Guide platform.

The Care Innovations™ Guide platform enables health-care providers to offer a clinically driven, fully integrated remote care management solution for populations with chronic conditions. The project will recruit up to 200 patients in Sunflower County, MS, who will use Care Innovations technology to share health data, such as weight, blood pressure, and glucose levels, daily with clinicians.

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Posted in: Acupuncture, Chiropractic, Computers & Internet, Herbs & Supplements, Homeopathy, Legal, Medical Ethics, Naturopathy, Pharmaceuticals, Politics and Regulation

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GSK Investigated for Bribing Doctors

The BBC reports that 11 doctors and a GlaxoSmithKline regional manager in Poland have been charged with alleged corruption. The apparent scheme was simple — GSK sales reps are given targets for new prescriptions for whatever drugs they are promoting. In order to meet those targets, it is alleged that one sales rep agreed to pay doctors £100 to give educational lectures to patients. The lectures never took place, and it was understood that in exchange for the payment the doctors would prescribe more of the rep’s drug.

The case is still under investigation but one doctor has already admitted guilt, stating that the £100 was simply too tempting.

Assuming the charges are upheld, such cases are very damaging to public confidence in the system. This is similar to cases of researchers faking their published research — I cringe every time I read about such cases.

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Posted in: Medical Ethics, Pharmaceuticals, Politics and Regulation

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When healing turns into killing: religious and philosophical exemptions from parental accountability

Parents have a fundamental right to guide the upbringing of their children protected under the Due Process Clause of the U.S. Constitution. This includes the choice of medical care for the child. They also have a First Amendment right to the free exercise of their religious beliefs, including the right to care for their children in accordance with the tenets of their religion. In a better world, these rights would be exercised in a manner that is consistent with a reasoned selection of medical care among choices supported by the best available scientific evidence. If, for example, deeply religious parents choose to forego a treatment that had only a minimal chance of extending their child’s life and terrible side effects in favor of palliative care because they believe that their child would be better off in heaven we could all agree that their choice is constitutionally protected.

Unfortunately, that is not the case. Religious believers and those whose “philosophy” favors pseudoscience in child medical care (surveys bloviating about the popularity of CAM to the contrary) are in fact a tiny minority of the American population who influence public policy in a manner that far exceeds their actual numbers. This influence allows these special interest groups to cause needless suffering and death among children and their families. As well, their actions siphon off medical and legal resources that could more properly be directed toward the common good when states and medical institutions are put in the position of having to go to court to protect children from their parents. And, by giving parents false choices between a belief in magic and standard medical care, unnecessary complications are introduced into what are already difficult and heart-wrenching decisions by parents who truly want to act in the best interests of their children. (more…)

Posted in: Cancer, Epidemiology, Legal, Medical Ethics, Politics and Regulation, Religion, Vaccines

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Measles gets a helping hand

In a recent post I shared a bit of my personal, near-death experience with measles during the US epidemic of 1989-1991. As I describe in that post, I contracted a very serious measles infection at the end of medical school, and was highly infectious when I interviewed for a residency position at Seattle Children’s Hospital. Like others my age who received an ineffective, killed measles vaccine between 1963 and 1967, I had not been adequately protected. The MMR vaccine was not yet available, and no boosters were recommended at the time. Unfortunately, though my measles titers (a test of immunity to measles) were checked when I entered medical school, the school’s student health department failed to notice or respond to the results – I was not immune and did not receive a booster dose at that time, as I should have. That mistake was huge, and could have cost me my life. It also caused me to potentially sicken many vulnerable children during my tour of the hospital, as well as others I may have inadvertently exposed during the window of communicability as I walked the streets of Seattle. The Department of Health had to be called to trace all of my steps and attempt to track down and protect any potential contacts.
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Posted in: Epidemiology, Medical Ethics, Politics and Regulation, Public Health, Science and Medicine, Vaccines

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Tribalism and Medical Ethics

Science is intended to discover the “is”, not the “ought;” facts, not values. Science can’t tell us whether an action is moral; it can only provide evidence to help inform moral decisions. For instance, some people who believe abortion is immoral reject birth control methods that prevent implantation of a fertilized ovum on the grounds that it constitutes abortion; science can determine that a particular birth control method prevents fertilization rather than preventing implantation of a fertilized ovum. A new book, Moral Tribes: Emotion, Reason, and the Gap Between Us and Them, by Joshua Greene, provides some intriguing insights that are pertinent to medical ethics.

He thinks tribalism is the central tragedy of modern life. Evolution equipped us for cooperation within our own tribe but not for cooperation with other tribes. Cooperation with related individuals helps spread our own genes, but we are in competition with other tribes and cooperating with them might help spread their genes to the detriment of our own. It boils down to Us vs. Me and Us vs. Them. He uses the word “tribes” not in the original sense (Hutus vs. Tutsis), but to include Democrats vs. Republicans, Catholics vs. Protestants, CAM vs. science-based medicine, Arabs vs. Israelis, climate change activists vs. climate change deniers, and any other ideological or nationalistic group. (more…)

Posted in: Book & movie reviews, Critical Thinking, Evolution, Medical Ethics

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An update on the case of Sarah Hershberger: Parental rights trump the right of a child with cancer to live

Five weeks ago, when last I touched on the case of Sarah Hershberger, the now 11-year-old Amish girl from Medina County, Ohio near Akron with lymphoblastic lymphoma whose parents had taken her off of chemotherapy after only two rounds, reports had been coming out of the cancer quackery underground that Sarah’s parents, Andy and Anna Hershberger, had fled to avoid a court order that appointed a medical guardian for her to make sure that she received appropriate science-based therapy. At the time I was unable to confirm these stories in the mainstream press. However, over the last month there have been significant developments in this case and even over the last week; so I thought that now would be a good time to update SBM readers on developments in the case.

The Thanksgiving confirmation

One thing that I didn’t mention a month ago is that David Michael and others have been actively raising money to support the Hershbergers’ legal battles. Then, over the long Thanksgiving Day weekend news reports began to trickle out confirming what the “alternative” health sites had been reporting, namely that the Hershbergers had fled. These reports started with story from a local Medina newspaper, then spread to a northeast Ohio television stations, and then to national news sources (like Good Morning America and CNN) and international news outlets. The Medina Gazette first reported:
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Posted in: Cancer, Medical Academia, Medical Ethics, Politics and Regulation

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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

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

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