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Reading Medical Literature with a Critical Eye

A long time ago I read a study about what makes a good doctor. Some things you might think were important, like grades in medical school, were irrelevant. What correlated the best was the number of medical journals a doctor read. I don’t know whether that means good doctors read more journals or reading more journals makes a better doctor.

One thing I do know is that most of us could learn better journal-reading skills. When I was a busy clinician, I did what I suspect many busy clinicians do: I let the journals pile up for a while, then tackled a stack when I got motivated. I would skim the table of contents to pick out articles that I wanted to read, then I would read the abstracts of those articles. If the abstract interested me, I would read the discussion section of the article. If I was still interested, I might go back and read the entire article. But until after I retired, I never really developed the skills to evaluate the quality of the study.

I knew enough not to jump on the bandwagon the first time something was reported, because I had seen promising treatments bite the dust with further testing. But I really wasn’t aware of all the things that can go wrong in a study, and I didn’t know what to look for to decide if the results were really credible. I’m not an academic; I thought the authors knew a lot more than I did, and I trusted them to a degree that was not warranted. (more…)

Posted in: Pharmaceuticals, Science and Medicine

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Monkey business in autism research

NOTE: I had originally planned on posting Part II of a series on cancer screening. However, something came up on Friday that, in my estimation, requires a timely response. I should also inform readers that, because next Monday is a holiday here in the U.S., I haven’t yet decided whether I will be doing a post next week or not. Stay tuned and check back.

I get e-mail.

Sometimes the e-mail is supportive. Other times, as you might imagine, given some of my posts, it is anything but. On Friday afternoon, I happened to notice an e-mail from an “admirer” of mine that said something like this:

You are a complete jack-ass.

- Generation Rescue

Appended to the e-mail was a link to this article on the Age of Autism blog.

Generation Rescue, as you may recall, is an organization that promotes the idea that vaccines cause autism, and this e-mail almost certainly came from the founder and head of GR, a man named J.B. Handley. In case you don’t know who he is, Handley is a man who is, even by the standards of antivaccinationists, incredibly boorish and possessed of a bull-in-a-china shop manner that alienates even some potentially sympathetic people, although parents who believe that vaccines cause autism seem to love him. He is also quite–shall we say?–flexible in his notions of how vaccines cause autism. Until about a year ago, the Generation website stated unequivocally:

Generation Rescue believes that childhood neurological disorders such as autism, Asperger’s, ADHD/ADD, speech delay, sensory integration disorder, and many other developmental delays are all misdiagnoses for mercury poisoning.

About a year ago, it changed to:

We believe these neurological disorders (“NDs”) are environmental illnesses caused by an overload of heavy metals, live viruses, and bacteria. Proper treatment of our children, known as “biomedical intervention”, is leading to recovery for thousands.

The cause of this epidemic of NDs is extremely controversial. We believe the primary causes include the tripling of vaccines given to children in the last 15 years (mercury, aluminum and live viruses); maternal toxic load and prenatal vaccines; heavy metals like mercury in our air, water, and food; and the overuse of antibiotics.

The kind interpretation is that GR was changing its hypothesis given that the data being published consistently and strongly refuted the myth that mercury in vaccines somehow cause autism. In reality, though, it’s fairly clear that GR was pivoting effortlessly to a hypothesis that not only was nearly completely unfalsifiable but also allowed GR to continue to blame vaccines for autism, which is what it’s really about. More recently, as I have pointed out before, antivaccinationist rhetoric has also pivoted even further and equally as effortlessly to blame unspecified “toxins” or “combinations of toxins” in vaccines. Be that as it may, having felt the love, I have to admit that Mr. Handley sure does know how to charm a guy. When he draws my attention to some abstracts so politely, abstracts that he clearly considers to be very important evidence, how can I refuse to take a look? After all, Mr. Handley himself apparently very much wanted to point me in the direction of these three abstracts, and it would be downright churlish of me to deny him and refuse to look at the studies with as open a mind as possible.
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Posted in: Basic Science, Medical Academia, Neuroscience/Mental Health, Politics and Regulation, Public Health, Vaccines

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“Chelation Therapy”: Another Unethical “CAM” Trial Sponsored by Taxpayers

Please forgive the promotion of our own work and the facile evasion of a full-length blog, but two of your faithful bloggers are co-authors of an article published this week:

Why the NIH Trial to Assess Chelation Therapy (TACT) Should Be Abandoned

Kimball C. Atwood IV, MD; Elizabeth Woeckner, AB, MA; Robert S. Baratz, MD, DDS, PhD; Wallace I. Sampson, MD

Medscape J Med.  2008;10(5):115.  ©2008 Medscape

Posted 05/13/2008

Available here.

You may be asked to “register”; don’t worry, it’s free. The article is very long, but the Introduction, Executive SummaryDiscussion, and Conclusion are reasonably succinct and make the important points. Readers who want to learn more details, who want to see more evidence for our assertions, or who are compelled by an odd fascination with crackpotism (my own weakness) will want to read more. Here is a small sample:

Abstract

The National Institutes of Health (NIH) Trial to Assess Chelation Therapy (TACT) was begun in 2003 and is expected to be completed in 2009. It is a trial of office-based, intravenous disodium ethylene-diamine-tetra-acetic acid (Na2EDTA) as a treatment for coronary artery disease (CAD). A few case series in the 1950s and early 1960s had found Na2EDTA to be ineffective for CAD or peripheral vascular disease (PVD). Nevertheless, a few hundred physicians, almost all of whom advocate other dubious treatments, continued to peddle chelation as an office treatment. They claim that chelation dramatically improves symptoms and prolongs life in 80% to 90% of patients. In response, academics performed 4 controlled trials during the 1990s. None favored chelation, but chelationists repudiated those findings.

We have investigated the method and the trial. We present our findings in 4 parts: history, origin and nature of the TACT, state of the evidence, and risks. We present evidence that chelationists and their organization, the American College for Advancement in Medicine, used political connections to pressure the NIH to fund the TACT. The TACT protocols justified the trial by misrepresenting case series and by ignoring evidence of risks. The trial employs nearly 100 unfit co-investigators. It conflates disodium EDTA and another, somewhat safer drug. It lacks precautions necessary to minimize risks. The consent form reflects those shortcomings and fails to disclose apparent proprietary interests. The trial’s outcome will be unreliable and almost certainly equivocal, thus defeating its stated purpose.

We conclude that the TACT is unethical, dangerous, pointless, and wasteful. It should be abandoned.

Readers of my postings on SBM will find more discussion (and abundant evidence) of familiar material: ethical breaches resulting from political incursions into science; the pitfalls, both scientific and ethical, of ignoring prior probability; a Dirty Secret of the Extraordinary Popular Delusion that is “CAM,” that much of what masquerades as sober research or the practice of “integrative medicine” was spawned by Laetrile; and widespread dishonesty in “academic CAM.”

Medscape Journal of Medicine invites readers to post comments or to send private letters to the editor for potential publication (and replies by yours truly, in this case). If you are so moved, you might consider posting comments in duplicate, both there and here on SBM, for the benefit of our select readership.

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

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The Trojan Horses of Education

Last time I described what I could find about the “Quiet Revolution” plan for medicine through the eyes and minds of the Bravewell Collaborative and Christy Mack, wife of the multi-millionaire or billionaire CEO John Mack. The idea seemed two-pronged; “humanize” physicians and medicine generally, and integrate folkway, sectarian and “alternative” methods into the system. What bothered me more, having become inured to patient philandering with quackery, was the brazen attempt to re-educate physicians and indoctrinate students into the political and social views of wealthy idealists. The entry below, one might conclude, has little to do with medical quackery and pseudoscience, but I beg your indulgence for this series as I attempt to connect dots between the stalls of the seemingly unrelated steeds of political indoctrination in universities and the proposed med school re-education camps of Bravewell. For several years a controversy has roiled at the University of Delaware over a program of educational activities for the dorms called Residence Life. The program structures student time with a number of usual activities – games, talks, discussion groups – but the content of the discussion groups and interpersonal counseling upset some students, who complained to an off-campus conservative organization, and got to the attention of faculty, which pressured the administration to stop the program last fall.

To outsiders such as we, the program looked like a feel-good, beneficent guidance tools. To the complaining students and critics the discussions seemed more like indoctrination groups, with political agendas taking on disguised roles as helpful guidance for student angst. Students complained about invasion of their privacy through group and leader pressures, and the faculty saw indoctrination and invasion of their educational duties (turf) by student counselors bearing ideological messages with little qualification.

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Posted in: Medical Academia, Politics and Regulation

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Canada Bill C-51 – Regulating Natural Health Products

In Canada a new bill has been proposed, Bill C-51, that would make changes to the Food and Drug Act – the body of laws by which the Canadian federal government regulates food and health products in Canada. This is the equivalent of the Food and Drug Administration (FDA) in the US. It seems that Canada, like the US, is struggling to deal with a burgeoning industry of “natural health products” that are minimally regulated.

The new bill will increase government oversight of natural health products (NHP) for the purpose of ensuring higher quality standards for products and accuracy in the claims that are made for them. Proponents of the bill claim that it will serve to improve consumer protection. But the NHP industry is not happy with the increased oversight the bill would bring. Their hysterical reaction to the proposed bill is very revealing about the propaganda and deception used by the NHP industry.

This history of NHP regulation in Canada also reveals the two primary strategies by which the promoters of unscientific medicine and health products seek to advance their business. On the one hand they seek licensure, certification, and other formal recognition by the government in order to bolster their legitimacy with the public and also to keep competition at bay. When seeking such things they argue that licensure etc. will give the government the opportunity to regulate the industry and ensure quality control. They therefore take the position of consumer protection.

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Posted in: Herbs & Supplements, Politics and Regulation

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The “Art” of Clinical Decision-Making

Much nonsense has been written about the “art” of medicine. All too often, it amounts to a rationalization for doctors doing what they want to do instead of following the evidence. Medicine is not an art like painting. Neither is it a science like physics. It’s an applied science. Since patients are not all identical, it can be very tricky to decide how to apply the science to the individual.

The New England Journal of Medicine periodically runs a feature called “Clinical Decisions.” They present a case history, then they present 2 or 3 expert opinions on how to manage the case. They stress that none of the options can be considered either correct or incorrect. They allow readers to “vote” as well as to submit comments about why they voted that way. It is understood that the voting is only for interest and to stimulate discussion: it does not result in a consensus.

In April 2008 the topic was the management of carotid artery stenosis. The patient is a 67 year old man who has no symptoms but who is found to have a narrowing of 70-80% in one carotid artery and 20% in the other, putting him at increased risk for stroke. He has other risk factors for cardiovascular disease: hyperlipidemia, hypertension, and overweight. The 3 options are medical management, stent placement, and carotid endarterectomy. (more…)

Posted in: Science and Medicine

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The early detection of cancer and improved survival: More complicated than most people think

“Early detection of cancer saves lives.”

How many times have you heard this statement or something resembling it? It’s a common assumption (indeed, a seemingly common sense assumption) that detecting cancer early is always a good thing. Why wouldn’t it always be a good thing, after all? For many cancers, such as breast cancer and colon cancer, there’s little doubt tha early detection at the very least makes the job of treating the cancer easier. Also, the cancer is detected at an earlier stage almost by definition. But does earlier detection save lives? This question, as you might expect, depends upon the tumor, its biology, and the quality and cost of the screening modality used to detect the cancer. Indeed, it turns out that the question of whether early detection saves lives is a much more complicated question to answer than you probably think, a question that even many doctors have trouble with. It’s also a question that can be argued too far in the other direction. In other words, in the same way that boosters of early detection of various cancers may sometimes oversell the benefits of early detection, there is a contingent that takes a somewhat nihilistic view of the value of screening and argues that it doesn’t save lives.

A corrollary of the latter point is that some boosters of so-called “alternative” medicine take the complexity of evaluating the effect of early screening on cancer mortality and the known trend towards diagnosing earlier and earlier stage tumors as saying that our treatments for cancer are mostly worthless and that the only reason we are apparently doing better against cancer is because of early diagnosis of lesions that would never progress. Here is a typical such comment from a frequent commenter whose hyperbolic style will likely be immediately recognizable to regular readers here:

Most cancer goes away, or never progresses, even with NO medical treatment. Most people who get cancer never know it. At least in the past, before early diagnosis they never knew it.

Now many people are diagnosed and treated, and they never get sick or die from cancer. But this would have also been the case if they were never diagnosed or treated.

Maybe early diagnosis and treatment do save the lives of a small percentage of all who are treated. Maybe not. We don’t know.

As is so often the case with such simplistic black and white statements, there is a grain of truth buried under the absolutist statement but it’s buried so deep that it’s well-nigh unrecognizable. Because we see this sort of statement frequently, I thought it would be worthwhile to discuss some of the issues that make the reduction of mortality from cancer so difficult to achieve through screening. I will do this in two parts, although the next part may not necessarily appear next week
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Posted in: Cancer, Public Health, Science and Medicine, Science and the Media

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“CAL”: a Medico-Legal Parable

Preamble

From the fall of 2000 to the winter of 2002, the Commonwealth of Massachusetts convened a Special Commission on Complementary and Alternative Medical Practitioners. There were 12 members: 6 legislators, 3 MDs, a naturopath, a lawyer who represented the New England School of Acupuncture, and the chairman, who was also the Director of the Massachusetts Division of Professional Licensure. At the start of deliberations two things became apparent: first, the Commission would concern itself almost exclusively with the petition of “naturopathic physicians” to become licensed health care practitioners in the Commonwealth*; second, there were only two recognizable, medically-sophisticated skeptics among the members. They were Arnold “Bud” Relman, the emeritus editor of the New England Journal of Medicine (appointed by the Massachusetts Board of Registration in Medicine), and I (appointed by the Mass. Medical Society). We expected a third, an MD soon to be appointed by the Commissioner of Public Health, Dr. Howard Koh.

Within a few weeks it became clear that the third MD would not be a skeptic. Dr. Koh, apparently thinking he had found an expert, appointed as his representative David Eisenberg, Director of the Harvard Medical School (HMS) Division for Research and Education in Complementary and Integrative Medical Therapies. Dr. Koh must not have known that in 1997 Dr. Eisenberg had called for

A national listing of licensed alternative medical providers (e.g., chiropractors, acupuncturists, massage therapists, naturopaths, and homeopaths) in each of the 50 states as well as a uniform credentialing process.

Commissioner Koh also must not have known that Dr. Eisenberg had received or was currently receiving funds from several sources committed to furthering the ambitions of ”CAM” practitioners in general or of “naturopathic physicians” in particular: the NCCAM, the Fetzer Institute, the New York Chiropractic College, Cambridge Muscular Therapy Institute, New England School of Acupuncture, American Specialty Health Plan, and the Southwest College of Naturopathic Medicine.

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Posted in: Politics and Regulation, Science and Medicine

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Near Death Experiences and the Medical Literature

MIRACLE MAX: See, there’s a big difference between mostly dead, and all dead. Now, mostly dead: he’s slightly alive. All dead, well, with all dead, there’s usually only one thing that you can do.

INIGO: What’s that?

MIRACLE MAX: Go through his clothes and look for loose change.

The Princess Bride

Can you trust anyone when they purport to tell you what the medical literature says? No. As an example we will use the issue of near death experiences, or NDE’s.

We will avoid the obvious paradox in this entry, sort of the ‘everything I say is a lie paradox’ that will cause computers in the Federation to shut down.

Why am I going to comment on this issue? Well, this months Skeptic has a back and forth between Michael Shermer and Deepak Chopra about life after death.

No. I am not going to comment on whether there is life after death. I am more interested in life during life, thank you very much. I’ll let the afterlife take care of itself.

But in their point counterpoint, they both refer to a Lancet article about NDE’s and it then begs the question:

Does anyone actually read or understand the literature they quote ?

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Posted in: Clinical Trials, Neuroscience/Mental Health, Science and the Media

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Science and Health News Reporting – The Case of the Regenerating Finger

Last week it was widely reported that an Ohio man, Lee Spievak, had regrown the end of his finger that had been chopped off in an accident. Reporters informed us, for example:

A man who sliced off the end of his finger in an accident has re-grown the digit thanks to pioneering regenerative medicine.

But this was not the real story. The true and amazing tale, rather, is of how the mainstream news media utterly failed to properly report this story. This is not an isolated incident, but a commonplace example of a broken system, and one that is getting worse. But first, let’s see how this reporting went wrong.

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Posted in: Science and the Media

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