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Human Subjects as Political Pawns

When it comes to “alternative medicine” trials, it seems that the NIH is willing to experiment on people in ways that would be unthinkable for real biomedical research. The federal Office for Human Research Protections (OHRP) has posted a preliminary determination letter, dated May 27, 2009, addressing some of the charges we had made against the politics-driven NIH Trial to Assess Chelation Therapy (TACT).

It is a remarkably damning statement, particularly regarding an NIH study. That is, it found—or the recipients admitted—that each of several charges was valid. Among these are misleading statements and unstated risks in the consent form, and the embarrassing backgrounds of TACT investigators. According to the determination letter,

…investigations revealed multiple instances of substandard practices, insurance fraud, and felony activity on the part of investigators.”

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Posted in: Politics and Regulation, Science and Medicine

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I get mail–chiroquacktic edition

A long while back, at the original wordpress incarnation of my usual blog, I wrote a piece on the reasons that chiropractic is unscientific nonsense. Because it was popular, I resurrected it. Well, a chiropractor has come to bravely defend his field and left me a comment.

A study in the May 2007 issue of the Journal of Manipulative and Physiological Therapeutics reports health plans that use Chiropractors as Primary Care Providers (PCPs) reduce their health care utilization costs significantly.

The study covers the seven-year period from 1999 to 2005. Researchers compared costs and utilization data from an Independent Physicians Association (IPA) that uses Chiropractors as PCPs and a traditional HMO that doesn’t.

The Chiropractic PCPs had 59 percent fewer hospitalizations, 62 percent fewer outpatient surgical cases and 85 percent lower drug costs compared with the HMO plans.

The patients in the Chiropractic PCP group also reported higher satisfaction with their care than the HMO group. Over the seven-year period, Chiropractic patients consistently demonstrated a high degree of satisfaction with their care that ranged from 89 percent to 100 percent.

Study co-author James Winterstein, D.C. says that patients using Chiropractic PCP health care groups “experienced fewer hospitalizations, underwent fewer surgeries and used considerably fewer pharmaceuticals than HMO patients who received traditional medical care.”

Hmmm…interesting assertions. Let’s examine these assertions and the “article” they come from. (more…)

Posted in: Science and Medicine

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“Acupuncture Anesthesia”: a Proclamation from Chairman Mao (Part IV)

The Cultural Revolution

After investigating ‘acupuncture anesthesia’ in the People’s Republic of China in 1973, John Bonica wrote:

From the guarded comments made by several anesthesiologists, I concluded that this disuse [of ‘acupuncture anesthesia,’ after its introduction in 1958 until the Great Proletarian Cultural Revolution began in 1966] was the result of disappointing failures in a significant proportion of patients. During the Cultural Revolution this “negative” trend of not using acupuncture was considered the work of revisionists, and subsequently greater emphasis was given to the widespread use of acupuncture in all hospitals.

Similarly, according to Petr Skrabanek,

Those who dared ask such awkward questions [about ‘acupuncture anesthesia’] were branded as “counter-revolutionary revisionists.”

Skrabanek’s reference for that assertion was this 37-page pamphlet:

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Posted in: Acupuncture, Science and Medicine, Science and the Media

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The death and rebirth of vitalism

One of the common themes in biology and medicine is the feeling that somehow there must be more. Creationist cults simply know that life must be more than matter, and mind-body dualists (which includes most alternative medicine advocates) are certain that humans are more than an “ugly bag of mostly water” (sorry for the geek reference). If you can stick with me here, I’ll explain to you a bit of the history surrounding this fallacy.

Most of us intuitively feel that we are both a body and a person. In every day life, it makes a certain operational sense to think of our “mind” as being something distinct. From a biological standpoint, however, this doesn’t work as well.

Biology was one of the last of the “natural philosophies” to become a science. It was clear to those who studied chemistry and physics that certain principles seemed to explain the natural world, but those who studied living things were mostly involved in description. Still, biology has become a science in its own right. According to Ernst Mayr, one of the greatest biologists of the last century, a number of events preceded biology being recognized as a legitimate science. One vital event was the recognition that all biological processes were constrained by the laws of physics and chemistry. Another important step was the rejection of two erroneous principles: vitalism, and teleology. (more…)

Posted in: Science and Medicine

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Tactless About TACT: Critiques Without Substance Should Be Abandoned

In May 2008, the article “Why the NIH Trial to Assess Chelation Therapy (TACT) Should Be Abandoned” was published online in the Medscape Journal of Medicine. The authors included two of our own SBM bloggers, Kimball Atwood and Wallace Sampson, along with Elizabeth Woeckner and Robert Baratz. It showed that the existing evidence on treating heart disease with IV chelation did not justify further study, and that the TACT trial was questionable on several ethical points. Their ethical concerns were taken seriously enough that enrollment in the trial was put on hold pending an investigation. It has now been re-opened after a few band-aids were applied to the ethical concerns. The scientific concerns were never addressed.

I have seen many critiques of the Atwood study, and not a single one has offered any cogent criticism of its factual content or reasoning. Most of them could have been written by someone who had not bothered to read beyond the title. Their arguments can be boiled down to a few puerile points that can be further simplified to:

(1) I believe the testimonial evidence that chelation works.
(2) Atwood and his co-authors are bad guys.

Now Beth Clay has chimed in with an article entitled “Study of Chelation Therapy Should Not Be Abandoned.” I found it truly painful to read, but even the worst has some value as a bad example. Clay’s article could be used for a game of “Count the Errors.” I will point out some of them below. (more…)

Posted in: Clinical Trials, Politics and Regulation, Science and Medicine

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Cranks, quacks, and peer review

Last week, I wrote one of my characteristically logorrheic meandering posts about what turns a scientist into a crank or a doctor into a quack. In a sort of continuation of this line of thinking, this week I’ll turn my attention to one of the other most common characteristics of a crank, be he scientific crank (i.e., a creationist), a quack, or historical crank (i.e., Holocaust deniers), specifically how he views the peer review system.

Not suprisingly, one of the favorite targets of pseudoscientists is, in fact, the peer review system. Indeed, it’s a very safe thing to say that, almost without exception, cranks really, really, really don’t like the peer review system for scientific journals and grant review. After all, it’s the system through which scientists submit their manuscripts describing their scientific findings or their grant proposals to their peers, and their peers make a judgment whether manuscripts are scientifically meritorious enough to be published and grant applications scientifically compelling enough to be funded. Creationists hate peer review. HIV/AIDS denialists hate it. Anti-vaccine cranks like those at Age of Autism hate it. Indeed, as a friend of mine, Mark Hoofnagle pointed out a couple of years ago, pseudoscientists and cranks of all stripes hate it. There’s a reason for that, of course, namely that vigorous peer review is a major part of science that keeps pseudoscientists from attaining the respectability that science possesses and that they crave so.
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Posted in: Medical Academia, Politics and Regulation, Science and Medicine

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Naturopathic Prescribing: The Dark Side Beckons

I am a terrible Oregon chauvinist.  I think there is no better place to live on the planet. Period.  Great natural beauty, not a lot of people, best beer ever and no pro football team. Oregon is both casual and tolerant.  It is safe to say that dressing up in the Pacific NW means tucking your t shirt into your jeans.  And the citizens of the NW, especially in the Portland metro area, are tolerant of  a diverse number of alternative life styles. What more could you want?

No good deed goes unpunished. The downside of toleration is the proliferation of alternative medicine.  Portland has  a school of chiropractic, a college of oriental medicine and  the country’s oldest school of naturopathy, established in 1956.  It is a year older than me. There are about 850 ND’s in Oregon.  To judge from the number of alternative practitioner offices around my hospital,  most of the graduates stay in Portland.

There are five health care systems in Portland.   Three of the five have hired naturopaths as part of their complementary medicine programs.   My system, as of yet, does not have a scam practitioner on staff, a fact of which I am most proud.  Yet,  I suppose it will come some day. However, if you wonder if a hospital practices evidence and science based medicine, see if they have a naturopath, a chiropractor or an acupuncturist on staff.  If they do, they may be interested in issues other than providing quality health care.

Oregon has had a Board of Naturopathic physicians since 1929 to oversee naturopathic practice.  There has been a long tradition of legislative oversight of naturopathy in Oregon, but they have been able, until recently, to only prescribe medications that are naturally derived.  None of that synthetic nonsense for naturopaths. Natural products only.  Until this month.

In Oregon, naturopaths are no longer limited to natural, herbal and homeopathic concoctions, they can also prescribe substances that actually work.  Recently House Bill 327  was passed by the Oregon legislature to expand the prescriptive privileges of naturopaths.  Drugs can now be added to the naturopathic  formulary just by asking.  The bill was passed by the Senate 22-7 and the House unanimously.  Bummer. If you live in Oregon and want to pester your representative on their profound stupidity, a list is at  http://gov.oregonlive.com/bill/SB327/. Send them a link to this post.

As a shill for big pharma and a tool of the medical-industrial complex, I suggest this may not be such a  good idea.  Naturopaths do not have the training, experience  or understanding of medicine to safely prescribe medications. Their understanding of disease and the various therapies taught at naturopathic schools are antithetical to what is required to safely and knowledgeably  prescribe modern medications.
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Posted in: Legal, Naturopathy, Pharmaceuticals, Politics and Regulation, Science and Medicine

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How do scientists become cranks and doctors quacks?

As a physician and scientists who’s dedicated his life to the application of science to the development of better medical treatments, I’ve often wondered how formerly admired scientists and physicians fall into pseudoscience or even generate into out-and-out cranks. Examples are numerous and depressing to contemplate. For example, there’s Linus Pauling, a highly respected chemist and Nobel Laureate, who in his later years became convinced that high dose vitamin C could cure cancer. Indeed, Pauling’s belief that high dose vitamin C could cure the common cold and cancer fueled the development of a whole new form of quackery known as “orthomolecular medicine,” whose entire philosophy seems to be based on the concept that if some vitamins are good more must be better. In essence, “orthomolecular medicine” is a parody of nutritional science; indeed, its advocates take credit for how some strains of “complementary and alternative medicine” (CAM) so frequently advocate the ingestion of huge amounts of dietary “supplements.” I could even go farther and say that orthomolecular medicine is clearly a major part of the “intellectual” (and I do use that term loosely) underpinning of the various biomedical treatments for autism that Jenny McCarthy and Generation Rescue advcoate.

There are other examples as well, all just as depressing to contemplate. For example, consider Peter Duesberg, a brilliant virologist who in the 1980s was widely believed to be on track for a Nobel Prize; that is, until he became fixated on the idea that HIV does not cause AIDS. True, lately he’s been trying to resurrect his scientific reputation with his interesting and possibly even promising chromosomal aneuploidy hypothesis of cancer, but, alas, true to form he’s been doing it by acting like a crank. Specifically, he sees his hypothesis as The One True Cause of Cancer and disparages conventional thinking as having been so very, very wrong all these years (with his being, of course, so very, very brilliant that he saw what no one else could see). Then there are people like Dr. Lorraine Day, who was a respected academic orthopedic surgeon in the 1980s. In the late 1980s, she started to flirt with AIDS pseudoscience through a scare campaign about catching AIDS from aerosolized blood. Of course, given the mystery and fear over HIV in the early years of the epidemic, such a fear, although overblown, was not so far out of the mainstream as to be worthy of the appellation crank. However, after being diagnosed with breast cancer, unfortunately Dr. Day rapidly degenerated into a purveyor of rank pseudoscience, as well as a New World Order conspiracy theorist, religious loon, and Holocaust denier. And let’s not forget Mark Geier, who, although not a distinguished scientist, did, before his conversion to antivaccinationism, apparently do a real fellowship at the NIH and appeared to be on track to a respectable, maybe even impressive, career as an academic physician. Now he’s doing “research” in his basement, injecting autistic children with a powerful anti-sex hormone drug and abusing epidemiology. There are innumerable other examples.
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Posted in: Clinical Trials, Health Fraud, Science and Medicine

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Is translational research impaired by an emphasis on basic science?

Sharon Begley, the Science Editor for Newsweek, wrote about translational research in the latest issue, and the tone of the essay reminded me of Begley’s previous piece on comparative-effectiveness research. Being an MD/PhD student (just defended!) I am very interested in the process of communicating “from bench to bedside.” New to science as I may be, I found Begley’s arguments to be overly simplistic and short-sighted. (more…)

Posted in: Science and Medicine, Science and the Media

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“Acupuncture Anesthesia”: a Proclamation from Chairman Mao (Part III)

A Digression: The Politics of Chinese Medicine in the People’s Republic of China (The Early Years)

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A Partial Book Review: Chinese Medicine in Early Communist China, 1945-63: a Medicine of Revolution, by Kim Taylor

Mao’s was a complex personality. He was by nature a control freak, highly secretive, quickly suspicious, ruthless in revenge. These were all personal characteristics that were to determine the flow of politics in early Communist China. (Taylor, p. 4)

We have already seen that attempts to create ‘acupuncture anesthesia’ began in the People’s Republic of China (PRC) in 1958. As suggested by the title of this series, this resulted from neither rigorous research nor the serendipity that occasionally heralds important discoveries. Rather, the apparent prominence of acupuncture in health care in the PRC was a matter of governmental fiat. Even before the Communist victory in 1949, it was clear to Chairman Mao Zedong that there were not enough ‘Western’ trained physicians to handle the massive health problems of the country, which included an infant mortality rate of 1 in 5, an overall death rate of 30 per 1000 per year, and widespread disability. Most of this was due to malnutrition and infectious diseases, including many that sound exotic and ominous to the modern ear:

…schistosomiasis, filariasis, ancyclostomiasis, Kala-azar, encephalitis, plague, malaria, smallpox and venereal disease…measles, dysentery, typhoid, diphtheria, trachoma, tuberculosis, leprosy, goitre, Kaschin-Beck’s disease…(Taylor, p. 103)

Pre-scientific Chinese medicine, acupuncture in particular, was identified by Mao and other Communist leaders as worthy of cultivating:

Our nation’s health work teams are large. They have to concern themselves with over five hundred million people [including the] young, old, and ill. This is a huge enterprise, and one that is extremely important. Thus our responsibility weighs heavily…At present, doctors of Western medicine are few [10,000-20,000], and [thus] the broad masses of the people, and in particular the peasants, rely on Chinese medicine to treat illness. Therefore, we must strive for the complete unification of Chinese medicine. –Mao Zedong, 1950, quoted in Taylor (p. 33)

Taylor writes that there may have been 500,000 doctors of ‘Chinese Medicine’ at the time. It is tempting to conclude that Mao’s call for the ‘unification of Chinese medicine’ was a cynical way to make it appear that the Chinese Communist Party (CCP) could provide adequate health care in a much shorter time than would be required to train sufficient numbers of modern physicians and to build and equip modern facilities. This is undoubtedly true, but Taylor argues that there were additional considerations:

…Mao evidently saw the profession of Chinese medicine not so much as a therapeutic practice, but more as a large, and therefore significant, body of people. Mao’s support of Chinese medicine during this time can be linked to a concern for adequate health care manpower, and by extrapolation, to a concern for social stability. If the Chinese medical practitioners were ignored and not forcibly, as it were, integrated into the new Communist society, and if their medicine was not encouraged, it would mean hundreds of thousands of people would be without a livelihood. Including their dependents, this would mean that there would be hundreds of thousands of people without any means of support. It is likely that Mao interpreted the more serious problem to be one of economics, and the importance of keeping people usefully employed within society, rather than the dangers of supporting a potentially ineffective medicine. (Taylor, p. 35)

Mao also wrote:

Although we should have an all-round and correct understanding of Chinese medicine, Chinese medicine also has to transform itself. We must accept this slice of our old heritage critically. To look down upon Chinese medicine is not correct. To claim that everything about Chinese medicine is good, or too good, this is also not correct. Chinese and Western medicines must unite. (Mao Zedung, 1954, quoted in Taylor, p. 35)

Thus there was, according to Taylor, to be a ‘scientification’ of Chinese medicine. This did not mean ‘scientific’ in the familiar sense:

In Mao’s definition of this ‘new democratic culture’, he was to use three words which were to describe its development. These were ‘new’ (xin), ‘science’ (kexue), and ‘unity’ (tuanjie). The term ‘new’ implied free from superstition and the heavy links to a feudal past. Instead the components of the new culture would have to be forward moving and enterprising. Mao advocated that such a change would be possible through the use of ‘science’. By ‘science’ Mao was not so much referring to the science linked with the Western investigation of nature, but more to the Marxist ideal of science as the criteria for true knowledge. For Mao stated that ‘this type of new democratic culture is scientific. It is opposed to all feudal and superstitious ideas; it stands for seeking truth from facts, it stands for objective truth and for unity between theory and practice’. ‘Unity’ was the third criterion in the building up of a new China. Everybody had to join together and fight for the same cause, and this included all classes of Chinese society, from the upper bourgeoisie to the peasantry, so long as their beliefs were not against those of the Party. It also implied a unity of knowledge, and this had particular implications for the revolutionary intellectual. (Taylor, pp. 15-16)

In other words, as Mao later asserted,

In the future there will be only one medicine; that is to say a [single] medicine guided by the laws of dialectical materialism, and not two [separate] medicines. (Quoted in Taylor, p. 35)

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