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Archive for March, 2008

On the ethics of clinical trials of homeopathy in Third World countries

ResearchBlogging.orgI’m on the record multiple times as saying that I reject the entire concept and nomenclature of “alternative medicine” as being distinct from “conventional” medicine as a false dichotomy, when in reality there should be just “medicine.” Indeed, if there is one major theme to which this blog is dedicated it’s that medicine should be as much as possible science-based, a concept that takes into account not just clinical trials, which are prone to all sorts of false-positive results in the case of modalities that have no plausibility from a scientific perspective. In essence, I advocate treating “alternative” medicine the same as “conventional” medicine subjecting it to the same scientific process to determine whether it has efficacy or not, after which medicine that is effective is retained and used and medicine that fails the test is discarded. Where it comes from, the “alternative” or the “conventional” medical realm, matters little to me. All that matters is that it is based on sound science and that it has been demonstrated to have efficacy significantly greater than that of a placebo.

Given that, you’d think I’d be all in favor of subjecting alternative medicine, be it woo or more credible, to rigorous scientific testing. In many cases, you’d be right. My sole caveat is that, when testing alt-med, priority should be given to modalities that have at least a modicum of scientific plausibility, even if a bit tenuous. Herbal remedies would thus be at the front of my line to be tested, while obvious woo whose core principle on which it is based is so utterly ridiculous and scientifically implausible (like homeopathy, for instance) would be relegated to the back of line, if it’s ever tested at all. More implausible modalities that might work (albeit by a method that has nothing to do with the “life energy” manipulation that is claimed for it) like acupuncture would be somewhere in the middle. It’s a matter of resource prioritization, in which it makes little sense to test blatant woo before more plausible therapies are examined. Indeed, it’s arguable whether blatant woo like homeopathy should even have resources wasted testing it at all, given its extreme scientific improbability. Finally, regardless of what modality is being tested in scientific and/or clinical trials, it has to be done according to the highest ethical standards, on adults fully cognizant of or able to be taught about the questions being asked, the issues involved, and the potential risks who are thus able to give truly informed consent.
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Posted in: Homeopathy, Medical Ethics, Public Health, Science and Medicine

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How Can Smart People Be So Stupid?

This is a quick posting that begins to respond to the question posted today by Joe:

What I don’t understand is why the majority of doctors at Columbia did not say “This is obvious abuse of patients, and it will not be tolerated here.” Given his richly-deserved malpractice record, why was [Gonzalez] even associated with Columbia?

David Gorski answered it in part: “Grant money.” There are also other factors: widespread naivete about the nature of quackery, ignorance of the methods themselves, widespread lack of scientific sophistication among physicians (!), unwillingness to appear contrary to whatever the current trendy thing may be and more. I’ll mention some of the particulars regarding Columbia and Gonzalez over the next couple of weeks.

But today this advertisement arrived:

FOR IMMEDIATE RELEASE

A discussion about Integrative Health with Christy Mack, President of The Bravewell Collaborative, Ralph Snyderman, Chancellor Emeritus for Health Affairs at Duke University, as well as President and CEO of Duke University Health System and Dr. Harvey Fineberg, President of the Institute of Medicine will air on the Charlie Rose show tonight. Please check your local listings for times and future air dates.

For more information or to view the segment on-line, please click on the following link: http://www.charlierose.com/shows/2008/03/28/2/a-discussion-about-integrative-health

Those of you who’ve been following SBM will recognize the imprints of all 3 of Charlie Rose’s guests in recent posts: Harvey Fineberg, who presided over the IOM’s entry in the most recent W^5/2; Christy Mack of the Bravewell Collaborative, which bankrolls the Consortium of Academic Health Centers for Integrative Medicine; and Ralph Snyderman of Duke. Snyderman and the “Consortium” were the authors of two of the misleading passages quoted in Misleading Language: the Common Currency of “CAM” Characterizations Part II.

I suspect that this show will reveal a lot—to those who are aware of the language distortions—about the insidious creep of pseudomedicine into places where it has no business going. If you can’t watch it tonight, go to the website and see it another time.

Posted in: Health Fraud, Medical Academia, Science and the Media

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The Ethics of “CAM” Trials: Gonzo (Part I)

Blogger’s note: This blog, which is rough going in places, will be presented in either 2 or 3 parts (I won’t know which until next week). I’ll post a part each week until it is complete, but due to overwhelming popular demand I promise to maintain the every-other-week posting of the far more amusing Weekly Waluation of the Weasel Words of Woo/2.

Introduction

On Feb. 25, 2008, the federal Office for Human Research Protections (OHRP) cited Columbia University Medical Center (CUMC) for violating Title 45, Part 46 of the Code of Federal Regulations: Protection of Human Subjects (45CFR§46). The violations involved Columbia’s administration of the NIH-sponsored trial of the bizarre “Gonzalez Regimen” for treating cancer of the pancreas.† The OHRP’s determination letter to Steven Shea, MD, the Director of the Division of General Medicine and Senior Vice-Dean at CUMC, cited ethical problems of a serious kind:

We determine that the informed consent for the 40 of 62 subjects referenced by CUMC was not documented prior to the start of research activities, nor was the requirement for documentation waived by the CUMC IRB for subjects in this study.

It was the second time that the OHRP had cited Columbia for its dubious management of the “Gonzalez” trial. The first occurred in Dec. 2002, after investigators had determined that the trial’s consent form “did not list the risk of death from coffee enemas.” The OHRP listed several other violations at that time, but “redacted” them from the letter that it made available to the public. (more…)

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

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My Woo: A Confession

It’s a case of mind over matter. I have no mind but it doesn’t seem to matter.
— George Burns

I should be working on my taxes. Instead, I’ll dwell on the other, more pleasant, inevitability.

Its been a bad couple of months for death. Everyone dies, and people often die of infection, but the flu season has been busy and with the MRSA lurking in the community, I have seen too many young die who should have otherwise survived their influenza.

I spend most of my professional day working in an acute care hospital, and most people in the hospital die of something. They die when their heart or lungs or liver or brain or some combination sustain more damage than can be compensated for. People live within fairly narrow operational parameters and when those parameters are exceeded for any length of time, they die. It is never a surprise when people die due to organ failure past the point of return or support. That is the cause of death in most of the patients I see.

Sometimes, and not very often, people die of nothing in particular. They just die. You get an autopsy, and there does not appear to be any single event that caused the death, nor does the sum of the underlying diseases seem to have lead to death. Usually it is the advanced elderly who just die. There reaches a point where the organism shuts down. I once had a patient die as I walked into the room on rounds. He looked at me and then died. He had many medical problems, but none that should have killed him, and his blood work on the day of death was normal and his autopsy had no clue as to why he died. Creepy. I like to have a definitive cause of death, but I do not always get one.

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Posted in: General

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Airborne Settles Case On False Advertising

The story of Airborne – a popular supplement marketed as an “herbal health formula that boosts your immune system to help your body combat germs” – is representative of what is wrong with the supplement industry and how it is regulated in the US. Recently the company that sells Airborne – Airborne Health, Inc – agreed to pay $23.3 million to refund consumers who purchased the product (if they have proof of purchase). This was to settle a class-action law suit brought by the Center for Science in the Public Interest (CSPI) and others claiming false advertising. In the settlement the company did not admit any wrongdoing. While this can be viewed as a minor victory for science-based medicine, it actually highlights the many deficiencies in the system.

For background, Airborne was launched in 1999 as a supplement designed to ward off the common cold. It has been extremely successful, due largely to its slick packaging, a clever slogan that it was developed by a school teacher, and promotion by Oprah Winfrey. The Airborne brand of products has expanded, including pixie powder for children, Airborne seasonal, Airborne Jr., Airborne on-the-go, and others. Advertising urged users to take Airborne at the first sign of a cold or as a preventive treatment if about to enter a germ-filled area, like an airplane. They also cited a “scientific” study that demonstrated Airborne is effective.

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Posted in: Herbs & Supplements, Science and Medicine

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The Business of Being Born

One of our readers asked for a critique of the movie “The Business of Being Born.” I guess my sex and specialty make me the best qualified to comment. I delivered over 200 babies as a family physician. I had two babies of my own (at age 37 and 39), one with intervention (forceps) and one 9-pounder who almost “fell” out before the obstetrician was ready.

“The Business of Being Born” is a movie about midwives, home births, and hospital births in America. It’s a sort of kinder, gentler “Sicko” with onscreen births, gooey, bloody newborns and fat naked women. The message of the movie is that for an uncomplicated pregnancy, natural home births with midwives are better and safer than medicalized hospital births with obstetricians. It’s strong on sound bites, emotional appeals, and superficial arguments, but weak on substance, depth, and scientific evidence for its claims.
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Posted in: Science and Medicine, Science and the Media

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When impressive science fails to impress patients

One of the greatest challenges in medicine can sometimes be to convince patients that the results of scientific and medical research apply to them, or, at the very least, to explain how such results apply. One of the reasons that medicine based not on science or evidence fluorishes is because it can be so hard to explain to patients why a particular intervention is viewed as effective. My co-blogger Steve Novella wrote about some of the fallibilities of human perception that lead to perceiving correlations and treatment effectiveness where there are none. R. Robert Bausell wrote about the same thing in his recent book Snake Oil Science. While it is undoubtedly true that people tend to pay more attention to anecdotes than to studies and statistics, there is also another reason why doctors often have problems convincing patients of the value of health interventions, and that’s the difference in perception and how we value different kinds of evidence.

A couple of years ago, I came across an article that explains this gulf between how those of us trying to practice science- and evidence-based medicine perceive the world and how most human beings not trained in medicine or science perceive it. The article, which was published in 2006 in the New York Times and written by Dr. Abigail Zuker, proposed one reason why this might be, beginning with a discussion with her mother in which she tries to convince her of the benefit of exercise, even in the elderly, a concept that her mother would have none of and dismissed contemptuously:

“Studies,” she says, dripping scorn. “Don’t give me studies. Look at Tee. Look at all the exercise she did. She never stopped exercising. Look what happened to her.”

End of discussion. Tee, her old friend and contemporary, took physical fitness seriously, and wound up bedbound in a nursing home, felled by osteoporosis and strokes, while my mother, who has not broken a sweat in the last 60 years, still totters around on ever-thinning pins. So much for exercise. So much for studies. So much for modern clinical medicine, based on the randomized allocation of treatment and placebo. All that beautiful science, stymied by the single, incontrovertible, inescapable image of Tee, the one who exercised but grew hunched and crippled anyway.

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Posted in: Clinical Trials, Public Health, Science and Medicine

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The Weekly Waluation of the Weasel Words of Woo #2

You Can’t Foo’ Stu with Woo!

A Spitzerian (“pointed”) analysis

Last week’s inaugural game elicited several amusing and penetrating analyses, including that of the hands-down Gold Medal Winner, Stu. His was the first entry, introduced in a concise and alliterative imperative, and was both hilarious and timely. It implied most of the points discussed by others. This distinctive combination has moved me to grant Stu a legacy here at the W^5. In the future there may be, undoubtedly no more than once in a very long while, entries that live up to the Soaring Standard of Stu®. If so, they will be Duly Acknowledged. (more…)

Posted in: Chiropractic, Humor, Medical Academia, Medical Ethics

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Where Are We Going?

Where is it all headed? Medicine on another threshold. Allow me to present several previously unconnected news articles that illuminate the serious problem we face in today’s increasingly scientifically rootless world.

Who are scientific medicine’s friends; on whom can we rely for support of reason and common sense, unbiased approaches to funding, unbiased efficacy evaluation, fair law enforcement, and a return to the logical world of decades ago? The private insurance industry is taking it in the gut, while Pharma receives the repeated jabs. Corrupt administrations run off with hundreds of millions, inadequately punished for the degree of misbehavior. Academicians, no longer squeaky clean, unwilling to keep house on big-money grant recipients while tolerating massive private consulting fees. Schools infiltrated by mindless relativism satisfy the lowest academic levels despite the revolutionary changes in biology and massive knowledge base new MDs have to apply.

Just in 2 weeks a number of seemingly unrelated developments in the news got one to thinkin’, …there aren’t any to trust anymore. The government agencies are just as bad. Start with the FDA. Steve Barrett’s Consumer Health Digest Quackwatch.com has been trying to reassess the status of one or more quackery proponents and practitioners. One of his routes is the examination of FDA records of enforcement and warning letters to violators. From CHD of 3/11/08:

FDA “hides” old warning letters. The FDA Web site has made several changes that greatly decrease the visibility of warning letters about products and safety violations. Letters issued before January 2007 have been moved into a new directory so that all incoming links to them from other sites have been broken. This directory is also coded so that search engines cannot index its contents. Searching for warning letters on the FDA site is difficult because (a) the newer and older letters have to be searched separately, (b) the search page for pre-2007 pages in not easy to find. (c) letters are moved to the archive folder at irregular intervals, and (d) many of the older letters are in PDF format, which means that they will be found only if the searcher uses specific keywords. The agency as become extremely slow in responding to Freedom of Information Act requests. In August 2005, Dr. Barrett asked for a document related to a warning letter. If one exists, finding it would take only a few minutes. Barrett’s Congressman has asked twice for the document, and FDA staff members have phoned Barrett four times during the past year to find out whether he still wants it. But it still has not come. Bloomberg News has reported that in May 2007, the agency had 20,365 unfilled requests, including 1,924 that were more than three years old and that the the number of workers filling requests has been cut even though the backlog had been steadily rising. [Blum J. (more…)

Posted in: Politics and Regulation, Science and Medicine, Vaccines

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Be Wary of Stem Cell Pseudoscience

At the end of the 18th and beginning of the 19th century electricity and magnetism were cutting edge science, full of excitement and unknown potential. Capitalizing on this excitement, Franz Anton Mesmer captured the imagination of the European intelligentsia with his bogus claims of animal magnetism. At the turning of the next century radioactivity was the new and fascinating scientific discovery, and this lead to a market for radioactive tonics good for a multitude of complaints, or just for extra energy. A few decades later radio waves were the latest healing craze.

Cutting edge science is cool and exciting, it evokes the promise of the future and the public has learned to expect that the latest gee whiz science appears like magic. Its newness also virtually guarantees that the public at large will mostly not understand the science or its true implications. This is a situation ripe for exploitation.

Today one medical technology that does possess great promise but is not yet ready for prime time is stem cell therapy. Legitimate scientists involved in stem cell research are almost giddy about the possibilities. Early applications are possibly just around the corner, and only time will tell what the full potential of this technology is. But right now there are no legitimate stem cell therapies outside of research protocols. It is therefore not surprising that the con artists of today are exploiting the tremendous hype of stem cells.

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Posted in: Health Fraud

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