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Archive for 2009

The Marshall Protocol

Revised 7/23/9 to correct an error.

While there are many taxonomies of alternative medicines, one thing almost all alternative therapies have in common is they are originally the de novo discovery of one lone individual. Working outside of the mainstream, they are the gadflies who see farther because those around them are midgets.

  • Hanneman conceives of homeopathy, the treatment of all disease.
  • Palmer conceives the cause of all disease and its treatment in chiropractic
  • Mikao Usui, while having a mid-life crisis, conceives Reiki.

Virgin births all. These pioneers boldly go where no man has gone before.

Others have been less acclaimed after seeking out new life. An example is Virginia Livingston, MD, the discoverer of the cause of all cancer (1). She discovered a bacterium, the cause of cancer, she called Progenitor cryptocides, which, unfortunately only she could grow. Her therapies include an autogenous ‘vaccine” made from your own urine, which will probably preclude widespread use even in alternative therapies circles. I wonder if Jenny would object to vaccines if there were naturally derived from the patients urine?

Discovering a new form of pathogenic microbiology that no one else can see or grow is not uncommon, since people seem to be unable to recognise artifact on slides, be it Oscillococcinum being seen by Joseph Roy 200 years ago or Virginia Livingston in the 1960s. Sometimes I regret the discovery of H. pylori as a cause of gastritis as it gives the alternative microbiologists a medical Galileo to point at. H. pylori is used as an example, erroneously, of a bacteria causing disease that was laughed at by the medical establishment (Parenthetically, as my flawed memory has it, while I was an Infectious Disease Fellow the data for H. pylori came trickling in. I remember discussing the papers with one of my attendings who was an expert in GI infections. We all thought it was an interesting hypothesis and waited further data with interest. I cannot remember anyone dismissing the idea out of hand with derisive laughter. But then, I remain convinced that infections are the cause of all disease, at least the diseases that matter).

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Posted in: General, Herbs & Supplements

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Woosceptibility: A Brief Interview With James Randi

James Randi, perhaps better known as “The Amazing Randi” has spent most of his life performing magic shows. In 1996 he created the James Randi Educational Foundation (JREF) designed to expose the fraudulent claims made by psychics, faith healers, and snake oil salesmen. The ultimate goal of the JREF is to create a new generation of critical thinkers – people who will not be hoodwinked by the aforementioned hucksters.I had the good fortune of interviewing Mr. Randi briefly at the recent conference known as “The Amazing Meeting.” I was eager to pick his brain about human behavior and magical thinking. This is what I learned…

Randi identified certain groups of people who seem to be more susceptible to magical thinking and/or belief in the paranormal. According to him, the top two are:

1. News reporters. Although at first I wasn’t sure if Randi meant that reporters like a good story versus they believe a good story – he told me that in his experience, they were some of the most gullible people on earth. In fact, they were more interested in implausible stories than true ones – and Randi said that the more fantastical his explanation for phenomena, the more likely they were to believe it and write about it.

2. Academics. This surprised me since I assumed that this group would actually be less susceptible. Randi suggested that they are more likely to be taken in because they are single-minded about phenomena. They are over confident in their ability to understand how things work, and when something cannot be explained in their framework, they’re willing to attribute it to the paranormal.

Who are the least susceptible? Children. Why? Because they are simple thinkers, and harder to distract. The art of magic is in distraction of the sophisticated mind. Children tend to be very concrete, so they don’t expect things to happen with hand-waving and flourishes. They keep their eye on the coin (or other item being transferred from hand to hand), and are more likely to know where it is at all times.

To wrap up our short interview, I asked Randi if he could explain why people believe in magic, fantasy, and the paranormal? He responded plainly:

Ultimately it’s not about intelligence or lack thereof. It’s about people not wanting to accept that life is random, suffering is inevitable, and there is no good reason for bad things happening.

What do you make of Randi’s observations?

Posted in: Faith Healing & Spirituality, Health Fraud, Neuroscience/Mental Health

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Report from the SBM Conference

On July 9th we held our first Science Based Medicine conference in Las Vegas. The event was definitely a success – we filled our room to capacity (150 attendees) and almost everyone stayed until the end. It also appeared that most attendees were actually awake, a rarity for a full-day medical conference. The Q&A session at the end was lively and interesting.

Kimball Atwood and I covered the history of science-based medicine and explored the differences between EBM and SBM. David Gorski discussed cancer quackery, including specific cases to illustrate the potential harm of pursuing worthless therapies for serious diseases. Harriet Hall gave us an overview of the the pseudoscience endemic in chiropractic. Mark Crislip discussed the chronic Lyme disease controversy. And Val Jones discussed health information online.

Based upon the feedback from those attending the conference, as well as the general enthusiasm, it seems that there is a hunger for this type of information. The audience was split about even between health care professionals and interested lay public. Many people asked if we plan on giving the conference again, and the answer is definitely yes. We have no plans set as of yet, and will certainly announce any future conferences here.

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Posted in: General

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Birth Day

So many of the posts on this blog are critical and deal with examples of poor science or other problems. I’d like to offer a breath of fresh air in the form of a book by Mark Sloan, MD: Birth Day: A Pediatrician Explores the Science, the History, and the Wonder of Childbirth.

It is a very positive book. Sloan has attended over 3000 deliveries but he has not lost his sense of wonder. He tells us what life is like in the womb – how much the fetus can see and hear – and smell! He explains the labor process. He explains how a fetus has to rapidly adapt to life outside the womb with a number of physiologic changes. He reflects the joy of bringing a new life into a family, and the experience of becoming a father. He delves into the history of childbirth, with fascinating anecdotes about “salting” newborns, Queen Victoria’s influence on obstetric analgesia, and the attempt to keep forceps a proprietary secret of one family.

He shows the many contributions science has made to childbirth, some of the mistakes it made along the way, and how it corrected those mistakes. (more…)

Posted in: Book & movie reviews

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The clinician-scientist: Wearing two hats

About a week ago, Tim Kreider wrote an excellent post about the differences between medical school training and scientific training. As the only other denizen of Science-Based Medicine who has experienced both worlds, that of a PhD and that of an MD, and as the one who two decades further along the path than Tim (give or take a couple of years), his musings reminded me of similar musings I’ve had over the years, as well as emphasizing yet again something I’ve said time and time again: Most physicians are not scientists. They are not trained like scientists; they are trained to apply scientific knowledge to the care of their patients. That’s what science-based medicine is, after all, applying science to the care of patients. Not dogma. Not tradition. Not knowledge of antiquity. Science.

Leave dogma, tradition, and “ancient knowledge” to practitioners of “alternative medicine.” That’s where they all belong. Whether you want to call it “alternative medicine,” “complementary and alternative medicine” (CAM), or “integrative” medicine (IM), it rarely changes and almost never abandons therapies that science finds to be no better than placebo, whereas scientific medicine is, as it should be, ever changing, ever improving. I’ll grant you that the process is often messy. There are often false starts and blind alleys, and physicians are all too often reluctant to change their practices in response to the latest scientific findings. We sometimes even joke that for some practices, it takes the supplanting of one generation of physicians with a new generation to get rid of some practices. But change does come when the science and evidence are there. Indeed, for example, in response to evidence that a bacterium, H. pylori, causes duodenal ulcers, medical practice changed in a mere decade, which is about as fast as anyone could do the science and clinical trials to show the validity of the new concept. Although CAM practitioners like to hold up the example of Barry Marshall and Robin Warren, the researchers who discovered that H. pylori causes most duodenal ulcers, as an example of how researchers with radical ideas are ostracized, but that story is largely a myth, as our very own Kim Atwood showed.

The application of science to medicine is a difficult thing. It takes basic scientists and clinicians, but the two of them exist in different worlds. Or so it often seems. That’s why some individuals seek to straddle both worlds. Tim is one such person. So am I. Unfortunately, most people don’t understand what we do very well. We wear two hats. In my case, I’m a surgeon, and I’m a scientist. In Tim’s case, he’s a scientist and a physician, but he doesn’t yet know what kind of physician he will end up being. At the risk of sounding somewhat arrogant, I believe that we, and others like us, represent an important element in bridging the gap between basic science and clinical science, in, essentially, building a more science-based medicine.
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Posted in: Basic Science, Clinical Trials, Medical Academia

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Functional Medicine (FM) What Is It?

Functional Medicine – What is it?

After extensive searching and examination, my answer is still – only the originators of “FM” know. Or, at least one must assume they know, because so far as I can see, I certainly see nothing that distinguishes “FM” from other descriptions of sectarian and “Complementary/Alternative Medicine” practices. A difference may lie in the advocates’ assumptions to have found some “imbalance” of body chemistry or physiology before applying one or more unproved methods or substances. From what I could determine, the “imbalance” or dysfunction is usually either imaginary or at least presumptive. And the general principles are so poorly defined as to allow practioners vast leeway to apply a host of unproven methods.

I figured there would be several ways to find out. One would be to read FM’s material – mainly what “they” placed on the Internet. Another would be to enter the system and find out as a patient or as a prospective practitioner what it is that “FM” claims to be. The third would be to listen to a practitioner or advocate on tape, disk, radio, etc.
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Posted in: Basic Science, Herbs & Supplements, Nutrition, Science and Medicine

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NIH Awards $30 Million Research Dollars To Convicted Felons: Cliff’s Notes Version

In case you’re coming late to this discussion (or have ADD), I’ve summarized Dr. Kimball Atwood’s terrific analysis of the ongoing clinical trial (TACT trial) in which convicted felons were awarded $30 million by the NIH.

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In one of the most unethical clinical trial debacles of our time, the NIH approved a research study (called the TACT Trial – Trial to Assess Chelation Therapy – a supposed treatment for arteriosclerosis) in which the treatment had no evidence for potential benefit, and clear evidence of potential harm – and even the risk of death. Amazingly, the researchers neglected to mention this risk in their informed consent document. The NIH awarded $30 million of our tax dollars to ~100 researchers to enroll 2000 patients in this risky study (ongoing from 2003-present). Even more astounding is the fact that several of the researchers have been disciplined for substandard practices by state medical boards; several have been involved in insurance fraud; at least 3 are convicted felons.

But wait, there’s more.

The treatment under investigation, IV injection of Na2EDTA, is specifically contraindicated for “generalized arteriosclerosis” by the FDA. There have been over 30 reported cases of accidental death caused by the administration of this drug – and prior to the TACT, 4 RCTs and several substudies of chelation for either CAD or PVD, involving 285 subjects, had been reported. None found chelation superior to placebo.

So, Why Was This Study Approved?

The NIH and the TACT principal investigator (PI) argued that there was a substantial demand for chelation, creating a “public health imperative” to perform a large trial as soon as possible. In reality, the number of people using the therapy was only a small fraction of what the PI reported.

It’s hard to know exactly what happened “behind the scenes” to pressure NIH to go forward with the study – however a few things are clear: 1) the National Heart, Lung, and Blood Institute (NHLBI) initially declined to approve the study based on lack of scientific merit 2) congressman Dan Burton and at least one of his staffers (Beth Clay) and a lobbyist (Bill Chatfield) worked tirelessly to get the study approved through a different institute – NCCAM 3) some of the evidence used to support the trial was falsified (The RFA cited several articles by Edward McDonagh, the chelationist who had previously admitted in a court of law to having falsified his data.) 4) The NIH Special Emphasis Panel that approved the TACT protocol included L. Terry Chappell, whom the protocol had named as a participant in the TACT.

All evidence seems to suggest that political meddling managed to trump science in this case – putting the lives of 2000 study subjects at risk, without any likely benefit to them or medicine.

A formal analysis of the sordid history and ethical violations of the TACT trial was published by the Medscape Journal of Medicine on May 13, 2008. Atwood et al. provide a rigorous, 9-part commentary with 326 references in review of the case. Congressman Burton’s staffer, Beth Clay, published what is essentially a character assassination of Dr. Atwood in response.

The NIH Writes TACT Investigators a Strongly Worded Letter

On May 27, 2009 the Office for Human Research Protections Committee sent a letter to the investigators of TACT, stating that they found, “multiple instances of substandard practices, insurance fraud, and felony activity on the part of the investigators.” The letter describes a list of irregularities and recommends various changes to the research protocol.

It is almost unheard of for a letter from the NIH to state that research study investigators are guilty of fraud and felony activity – but what I don’t understand is why they haven’t shut down the study. Perhaps this is their first step towards that goal? Let’s hope so.

Conclusion

The TACT trial has subjected 2000 unwary subjects and $30 million of public money to an unethical trial of a dubious treatment that, had it been accurately represented and judged by the usual criteria, would certainly have been disqualified. Political meddling in health and medical affairs is dangerous business, and must be opposed as strongly as possible. Congressmen like Tom Harkin and Dan Burton should not be allowed to push their political agendas and requests for publicly funded pseudoscience on the NIH. I can only hope that the new NIH director will have the courage to fend off demands for unethical trials from political appointees.

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

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