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Threats to science-based medicine: When clinical trials for new drugs are designed by the marketing division

ResearchBlogging.orgTHREATS TO SCIENCE-BASED MEDICINE

The theme of this blog is science-based medicine. It’s even the name given the blog by our fearless leader, Steve Novella. By “science-based” medicine we generally mean medicine that is both grounded in scientific plausibility based on our best understanding of human physiology and disease as well as in strong evidence from well-designed clinical trials, both of which are extremely important We SBM bloggers tend to concentrate mainly on so-called “alternative,” “complementary and alternative,” or “integrative” medicine because it does indeed represent a major threat to the consensus among medical professionals that medicine should be science- and evidence-based. Moreover, the infiltration of pseudoscientific and antiscientific woo into medical schools, academic medical centers, and medicine at large, coupled with large amounts of money going to promote CAM, both from the government and wealthy private foundations, does represent an extremely worrisome trend that makes all of us, who range from mid-career to retired physicians, fear for the future generation of physicians and their ability to apply science and critical thinking to the evaluation of implausible health claims, such as reiki, homeopathy, applied kinesiology, and the large variety of woo that falls under the rubric of CAM. Worse, this trend began not long after a concerted push to make medicine more science- and evidence-based and less dogma- and authority-based.

Unfortunately, though, the antiscience of implausible health claims is not the only threat that science-based medicine faces. We bloggers here at Science-Based Medicine concentrate on it because its resurgence and infiltration into the very heart of academic medicine represent a sea change in the culture of scientific medicine, which once rightly and without reservation rejected much of what CAM represents as quackery. Also, I can’t speak for others, but pseudoscience interests me; it brings up questions of why people believe irrational and clearly false propositions. That being said, at the risk of ruffling a few feathers among my co-bloggers, I have observed that, if there is one thing that this blog has not to this point emphasized sufficiently, it’s that the commerce of medicine, the very manner in which we develop new therapies, can, if not carefully observed and regulated, represent a threat to science-based medicine even more potent than Andrew Weil, David Katz, and their all-out assault on the very foundations of scientific medicine and drive to return medicine to the days of anecdote-based rather than science-based medicine.

I’m talking about pharmaceutical companies. I’m also about to destroy any opportunity I might ever have to work for or receive any funding from Merck & Company. C’est la vie. A skeptical doc’s got to do what a skeptical doc’s got to do. Not that I won’t at least partially protect myself by adding the disclaimer that the following represents my opinion, and my opinion alone. It does not represent the opinion of my university, cancer institute, or partners.

Now that that’s taken care of, let’s start with a little primer on a pernicious phenomenon known as the “seeding trial.”
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Posted in: Clinical Trials, Medical Ethics, Pharmaceuticals, Politics and Regulation

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Science, Reason, Ethics, and Modern Medicine, Part 5: Penultimate Words

My Discussion with Dr. P

After last week’s post, Dr. Peter Moran answered with more salient points. I’ll spend this week discussing those, because I share Dr. Moran’s “interest in examining the kind of messages we are putting out.” Acknowledging the inequality inherent in his not being the blog author, I’ll offer the last word to Dr. Moran by ending this series* and letting whatever comments he may have in response to today’s post be the last, at least for now.

Here is Dr. Moran’s response to my response:

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

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Politics of N of 1 pseudoscience

More Politics

Medicine’s ethics and basis in science hang by a thread at times. At least in the US of A. I will present a few examples and illustrate them with correlates from other fields in which decisions with wide effects are sometimes made by the whim of one person. And that’s not just the declaring of war or whatever we call it these days.Start with an anecdote of mine from the mid-1970s or so. I somehow got involved in a dispute with the staff of then Gov. Jerry Brown over his proposal to de-license medical practice. He sent out early holistic medicine vibes and viewed health and medicine as fields open to anyone to practice by simply hanging out a shingle. I asked to meet with my state assemblyman and complained about the situation. I stated that physicians determined what medical practice is. He smiled benevolently and broke the news. “No, doc, we (in state government) do.“

I immediately recognized what he was saying. All licensure is granted by the state, and all regulations and laws referring to each occupation’s license are determined essentially by a majority vote and a governor’s signature. All those heroes in the history of medicine and science not withstanding. It was an awakening.

Jerry Brown’s vision did not materialize and he came to recognize holistic and alternative medicines as so much goofy stuff and quackery, as he later confided at a fund-raiser (yes, I went.)

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

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Science, Reason, Ethics, and Modern Medicine, Part 4: is “CAM” the only Alternative? And: the Physician as Expert Consultant

Dr. Moran Weighs In

In last week’s post, I dubbed Dr. Peter Moran the “conscience” of SBM, citing his commitment to doing what’s best for individual patients even if, in theory at least, that may involve some manner of benign but fanciful treatments. I countered with my own opinion that honesty and integrity are necessary parts of any discussion with a patient, and that they, in turn, must not conflict with science and reason.* I added passages from a couple of key medical ethics treatises to support my assertion. Dr. Moran’s response, thoughtful and provocative as always, was buried in the midst of other commenters’ tangential arguments about the theory of evolution. Rather than continue its exile there, I reprint it here to give it the exposure that it deserves:

A blatant appeal to authority, but one that I mostly agree with. The difference between us is that I insist that medicine is about an infinite number of individual contexts and I see many examples where ethical absolutes (actually these are ethical guidelines rather than directives) do not apply or don’t seem to apply very well.

We scientists are ever-so cautious when making scientific judgments about complex matters; let’s not pretend that arriving at absolutes in medical ethics is a piece of cake, especially when it is not quite clear how anything done with the undiluted welfare of the individual patient in mind can be entirely unethical. I mean, why are we obliged to consider the impact of our decisions upon the fate of the planets (or whatever) when THIS patient needs help? In fact, at least one medical ethicist has gone so far as to state that it is not unethical for a doctor to prescribe a placebo treatment, so long as the doctor believes it will benefit the patient. I don’t quite agree with that bald statement — there should be a rider specifying that this may apply to *some* contexts where there is no obviously superior evidence-based method.

Here are some examples of the intellectual minefield we have to negotiate.

1. All the doctors I know would be prepared to call in the witch-doctor if it would help assuage the fears, or help in the management, of a seriously ill primitive tribesman. It seems we are prepared to pander to the superstitions of SOME cultures while despising any similar inclinations in our own.

2. I have previously asked this question which has to do with public policy in relation to safe “alternatives”. Take my word for it that every pharmacy in Europe displays “Homeopathie” (or language equivalents) in large letters outside. Would skeptics prefer those using such remedies for their minor and self-limiting complaints to be using NSAIDs or antibiotics or antidepressants instead, treatments that will often in such contexts themselves perform no better than placebo, but at substantially greater risks? Behind the usual healthfraud position there is both an exaggeration of the capacity of modern medicine and insufficient recognition of the harm that it can do. We definitely do not yet have entirely safe and 100% effective solutions to all of mankind’s ills, and certain imperfections of everyday medical practice can heighten the risks of the use of unnecessarily powerful pharmaceuticals. So what is the safest and most pragmatically realistic position here?

3. Following on from that — what is the evidence-based answer to non-specific tiredness and unhappiness? If people feel better for taking a multivitamin or an innocuous herb, why should we care? We keep on offering the public temporary answers to these things, prescribing (historically) amphetamines, cocaine, opiates, barbiturates and phenothiazines in massive quantities, only to take them away when problems such as addiction ensue. Is it right to then turn around and say, well you didn’t really need these things anyway, even denying them any relief that they may derive from “pretend medicines”. The science that matters will be argued out in other arenas.

That’s to give you some idea of the kind of thing that I am on about. You seem to think I am talking about doctors promoting CAM or placebo treatment as a matter of policy. I am not prepared to go that far, although I think I understand why some doctors might do that.

I agree that “medicine is about an infinite number of individual contexts and [there are] many examples where ethical absolutes do not apply or don’t seem to apply very well.” Nor did I really think that Dr. Moran was “talking about doctors promoting ‘CAM’ or placebo treatments as a matter of policy.” We disagree elsewhere, but he makes some interesting points.

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Posted in: Health Fraud, Medical Ethics, Science and Medicine

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Science, Reason, Ethics, and Modern Medicine, Part 3: Implausible Claims and Formal Ethics Statements

The Ethics of Implausible Medical Claims (IMC)

In Part 2 of this series* we learned from David Katz, MD, a key member of the Yale School of Medicine’s “integrative medicine” program, that he had been “pushed toward integrative medicine by the needs of [his] patients.” We also learned that Dr. Katz’s rationale for this decision justifies a wide range of quackery—both in principle and in fact. I had previously alluded to arguments like those of Dr. Katz in a comment on SBM several months ago:

…we must be true to medical ethics, no matter what else we do. If that means losing a few patients, so be it. Patients are free agents, and we can only do so much to influence them. To the extent that we don’t do that as well as we might (which is obviously true in some cases), we might do better. But our ethical obligation is to science and truth; it is not, as many modern physicians would have it and as much as we may lament sometimes losing patients to woo, to seducing patients to stick with us no matter what, if the “what” includes engaging in a charade about “integration” or “complementary therapies”…

Realizing that some might argue that physicians’ obligations to patients ought to trump their obligations to “science and truth,” I later revised that statement:

Several weeks ago I argued here that a physician’s primary ethical obligation is to science and truth. In retrospect I probably should have put it a slightly different way: a physician’s primary ethical obligation is the same as everyone else’s. It is to honesty and integrity. For physicians, however, that means being true to real medical knowledge, among other things, and real medical knowledge comes from science.

In spite of that revision, two readers whose opinions I respect challenged my assertion. Dr. Peter Moran’s worthy efforts to educate patients about the realities of “alternative” cancer treatments are considerable. Here on SBM he has repeatedly challenged us to explain how, when confronted with testimonials of “alternative” cures, we ought to respond without using “a high-handed, ‘we know best’ stance” and thus “appear to want to distance [ourselves] from the intimate concerns of [our] patients.” I was thinking mainly of him when I wrote the revision above, because on this key topic—how to respond ethically, but with compassion, to patients who want to believe in implausible treatments—I’ve come to think of Dr. Moran as the “conscience” of Science-Based Medicine. Those with cancer, he has reminded us, “are folk very like you and me who are simply grasping at any straw that might save or prolong their lives.” His take on why IMCs are appealing to those with less ominous problems is well-developed and agrees with my own, mostly. We part ways, however, when he concludes (also here and here) that ethical physicians might have good reasons—unlike Dr. Katz’s—to entertain benign, if implausible treatments:

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Science, Reason, Ethics, and Modern Medicine, Part 2: the Tortured Logic of David Katz

In Part 1 of this series* I asserted that a physician’s primary ethical responsibility is to honesty and integrity, which in turn must be largely based on science and reason (I apologize if that sounded preachy; if there had been more time I might have couched it in more congenial terms). I mentioned the fallacious reasoning whereby proponents of implausible medical claims (IMC) point to real and imagined weaknesses of modern medicine to justify their own agenda. I offered, as a favorite example of such proponents, science-based medicine’s having not yet solved every health problem. This week I’ll show how this version of the tu quoque fallacy has led a prestigious medical school to advocate pseudoscience-based medicine.

Modern Medicine: a Brief, Fragile Commitment to Science

First, a few more words about the title of this series. Modern medicine is not science, even if it draws upon science for its knowledge: it is an applied science similar, in that sense, to engineering. Modern medicine is also not synonymous with the “medical profession,” if the term means the collection of all people with MD degrees. That is true for the obvious reason that medicine is more than people, but also because a small but loud minority of MDs rejects modern medicine and science.

Modern medicine has made an uneven commitment to science and reason. At its best, it has formally embraced them in the faculties and curricula of medical schools, in its codes of ethics, and in its contributions to knowledge, both basic and applied, over the past 150 years or so. As discussed last week, it is because of science and reason that modern medicine has made dramatic, revolutionary advances in a very short time. That is what distinguishes it from every other “healing tradition,” and why there is no legitimate competition. The only valid medicine in the modern world is science-based medicine—not “allopathic,” “Western,” “conventional,” “regular,” “integrative,” “complementary and alternative,” or any of the so-called “whole medical systems.” The pre-scientific (and, ironically, “post-modern”) designation of “schools” or “systems” of medicine, so stridently trumpeted by quacks, is an anachronism—even if it persists in archaic, governmental edicts.

Compared to the actual sciences, however, modern medicine’s commitment to science is fragile. Its recent confusion of error-prone clinical trials with science itself—the project called “evidence-based medicine”—has been a mixed blessing. Its growing tolerance of charlatans and crackpots, at times elevating them to celebrity status, would be unthinkable in physics or biology. Its dalliances with quackery, so depressingly recounted in recent posts here, here, here, and here, are why your SBM bloggers do what we do. Biologists, other scientists, and intellectuals in general have joined the battle against the pseudoscientific travesty known as “intelligent design.” Many physicians, however, even of the brainy, academic variety, act as though the equally pseudoscientific but more dangerous travesty known as “integrative medicine” is either a good thing or, at least, is a necessary addition to medical school curricula.

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Posted in: Health Fraud, Medical Academia, Medical Ethics, Science and Medicine

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A Guide for Confronting Patients

I sometimes lecture on science-based medicine to my colleagues and one of the most common questions I get is how to deal with a patient who expresses belief in unscientific treatments. The dilemma for the physician is that professionalism requires that we do not confront patients regarding their personal beliefs. We are there to inform and advise, not preach. And yet proper medical care is often hampered by unscientific beliefs on the part of patients.

David wrote previously about a case he reviewed in which a woman with a very treatable early stage of breast cancer opted for “alternative” treatment rather than the standard treatment, which carries a > 93% good outcome. As a result her cancer progressed horribly – but she clung to belief in CAM despite its obvious failure in her case. This story highlighted the fact that giving patients proper medical advice sometime requires confronting their false beliefs.

Unscientific and bizarre medical practices are in vogue and are increasingly infiltrating the medical system through a combination of misguided political correctness, stealth, and apathy. This is exacerbating the dilemma for science-based practitioners who are caught between the imperative to do the right thing in accordance with evidence-based guidelines and the default respect for the patient and the desire to maintain a therapeutic relationship.

In my experience, however, these two goals do not have to be mutually exclusive. An uncompromising but non-judgmental approach works very well.

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Science, Reason, Ethics, and Modern Medicine Part 1: Tu Quoque and History

Several weeks ago I argued here that a physician’s primary ethical obligation is to science and truth. In retrospect I probably should have put it a slightly different way: a physician’s primary ethical obligation is the same as everyone else’s. It is to honesty and integrity. For physicians, however, that means being true to real medical knowledge, among other things, and real medical knowledge comes from science. That is what this and the next several posts will be about.*

First, a little Tu Quoque

After reading some of the comments that followed my posting of two weeks ago, I reluctantly thought to add a few words about the medical profession’s view of physicians selling drugs. It felt tiresome to have to address the issue, because it is beside the point. The series was about “naturopathic medicine,” not about modern medicine. If readers who understand the point will excuse the interruption, I’ll quickly attempt to explain why by posing two extreme possibilities: If MDs are entirely innocent of the relevant breach of ethics, what would that have to do with naturopaths selling drugs? But if MDs are entirely guilty, two wrongs don’t make a right—demonstrating the same irrelevancy.

That is why the ”you should talk” sneer is known, in debate, as the tu quoque (“you too”) fallacy. It’s funny how parents seem to recognize it when faced with children who, in seeking permission to engage in dubious activities, invoke the parents’ own sordid histories or the equally irrelevant, alleged prerogatives of other people’s children. Yet the same parents appear to forget it in other contexts.

I was also weary and wary of those who would draw me into a strawman debate pitting the medical profession against any group of sectarian health advocates. I have only a small sense of “solidarity” with the group of people who have MD degrees, and even less so with organized medicine. My first allegiance, as I’ve explained elsewhere, is to science and reason. Those modes of inquiry, together with their obvious bearing on the integrity of all claims about nature, are the bases for my objections to naturopathy and to pseudoscience in general. The medical profession per se is related but not central to the issue. While thinking about these things, it dawned on me that a discussion of why that is might be useful. (more…)

Posted in: Medical Ethics, Science and Medicine

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Should We Study Chelation for Autism?

The National Institute of Mental Health (NIMH) supports doing a study on the effects of oral chelation therapy in autism. The proposal is highly controversial, is drawing criticism from many scientists, but has popular support among parents who believe this type of therapy might help their children with autism. The proposal raises many questions about the ethics of biomedical research.

Chelation and Autism

Chelation therapy is a legitimate FDA approved treatment for heavy metal poisoning. The drugs used for chelation, such as disodium EDTA, bind to heavy metals so that they can be removed from the body. Chelation drugs can be given either orally or intravenously. The treatment is somewhat risky because it can also remove needed electrolytes, like calcium, from the body or causes shifts in the electrolytes that can cause arhythmias and changes in brain function. There are reported cases of cardiac arrest and death due to chelation.

Chelation therapy has a long history of quackery – not for its intended use but for other uses for which there is no evidence. The classic example of this is the use of chelation therapy to treat atherosclerosis to prevent heart disease. This claim persists despite the utter lack of evidence for efficacy and the fact that all proposed mechanisms have been shown to be flawed or false.

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Posted in: Clinical Trials, Medical Ethics, Neuroscience/Mental Health, Vaccines

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Another State Promotes the Pseudoscientific Cult that is “Naturopathic Medicine.” Part 4

The “Science” and Ethics of “Natural Medicines” (and Nutrition) cont.

This is the continuation of a discussion concerning the explicit claim of “naturopathic physicians”* to being experts in the use of “natural medicines,” defined as “medicines of mineral, animal and botanical origin.” Last week’s post established that the cult has chosen to profit from the “retail selling of medications,” as evidenced by the relevant Position Paper of the American Association of Naturopathic Physicians (AANP) and by that organization’s having made a deal with a drug company to make profits for both itself and its members.

The Position Paper observes that such selling “could be construed as a conflict of interest on the part of the physician.” That is true, if embarrassingly understated: anyone representing himself as a physician, who both recommends and sells the same medications for a profit, has conflicting interests. The conflict undermines his claim to offering responsible advice regarding those medications, and as such is a breach of medical ethics.

The AANP’s deal with MotherNature.com was even worse: by promoting such peddling in a formal, institutional fashion, NDs and their national organization went beyond the already widespread problem of practitioners hawking drugs. It is unclear whether the deal still exists, by the way: MotherNature.com was a victim of the “dot com” bust of a few years ago. It has since been resurrected, but a quick perusal of its new website fails to reveal the old AANP relationship. Nevertheless, I have seen no evidence to suggest that the AANP has changed its view of that sort of deal.

Are NDs Truly “Learned Intermediaries” in the Use of “Natural Medicines?”

This entry discusses the other part of the claim of expertise: that, aside from their conflicting interests, NDs have real knowledge of “natural medicines.” It will become clear during the discussion that the purported naturopathic expertise in nutrition—another standard claim—is also under review. I will include or cite abundant evidence for my assertions, because I’ve found that a predictable response of representatives of the highest levels of “naturopathic medicine” is to flatly deny them. I apologize again for including excerpts from previously published material.

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