Archive for Medical Ethics

“Gonzalez Regimen” for Cancer of the Pancreas: Even Worse than We Thought (Part II: Loose Ends)

Last week I discussed the dismal results of the “Gonzalez Trial” for cancer of the pancreas,* as reported in an article recently posted on the website of the Journal of Clinical Oncology. I promised that this week I’d discuss “troubling information, both stated and unstated [in the report],” and also some ethical issues. More has come to light in the past few days, including Nicholas Gonzalez’s own voluminous, angry response to the JCO article. I’ll comment upon that below, but first a brief review.

The trial was begun in 1999 under the auspices of Columbia University, after Rep. Dan Burton had pressured NCI Director Richard Klausner to fund it. It was originally conceived as a randomized, controlled trial comparing the “Gonzalez Regimen” to standard chemotherapy for cancer of the pancreas. In the first year, however, only 2 subjects had been accrued, purportedly because those seeking Gonzalez’s treatment were not willing to risk random assignment to the chemotherapy arm. In 2000, the protocol was changed to a “prospective, cohort study” to allow potential subjects to choose which treatment they would follow. Gonzalez himself was to provide the ‘enzyme’ treatments.

After that there was little public information about the trial for several years, other than a few determination letters from the Office of Human Research Protections and a frightening account of the experience of one subject treated by Gonzalez. By 2006 or so, those of us who pay attention to creeping pseudomedicine in the academy were wondering what had become of it. About a year ago we found out: the trial had been quietly “terminated” in 2005 after it met “pre-determined stopping criteria.” As explained here, that meant that the Gonzalez group had not fared well.

Four years after the trial’s ‘termination,’ the report was finally published: The Gonzalez cohort had not only fared much worse than the cohort that received chemotherapy, but it had fared worse than a comparable group of historical controls. Here, again, is the survival graph from the JCO paper:

Snapshot 2009-09-11 16-16-15

The Gonzalez group had also fared much worse in ‘quality of life’ scores, which included a measure of pain.

Now let’s read between the lines. Forgive me for taking shortcuts; I’m a little pressed for time. (more…)

Posted in: Clinical Trials, Health Fraud, Herbs & Supplements, Medical Academia, Medical Ethics, Science and Medicine, Science and the Media

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“Gonzalez Regimen” for Cancer of the Pancreas: Even Worse than We Thought (Part I: Results)


One of the more bizarre and unpleasant “CAM” claims, but one taken very seriously at the NIH, at Columbia University, and on Capitol Hill, is the cancer “detoxification” regimen advocated by Dr. Nicholas Gonzalez:

Patients receive pancreatic enzymes orally every 4 hours and at meals daily on days 1-16, followed by 5 days of rest. Patients receive magnesium citrate and Papaya Plus with the pancreatic enzymes. Additionally, patients receive nutritional supplementation with vitamins, minerals, trace elements, and animal glandular products 4 times per day on days 1-16, followed by 5 days of rest. Courses repeat every 21 days until death despite relapse. Patients consume a moderate vegetarian metabolizer diet during the course of therapy, which excludes red meat, poultry, and white sugar. Coffee enemas are performed twice a day, along with skin brushing daily, skin cleansing once a week with castor oil during the first 6 months of therapy, and a salt and soda bath each week. Patients also undergo a complete liver flush and a clean sweep and purge on a rotating basis each month during the 5 days of rest.

Veteran SBM readers will recall that in the spring of 2008 I posted a series of essays* about this regimen and about the trial that compared it to standard treatment for subjects with cancer of the pancreas. The NIH had funded the trial, to be conducted under the auspices of Columbia, after arm-twisting by Rep. Dan Burton [R-IN], a powerful champion of quackery, and much to the delight of the “Harkinites.”

In the fall of 2008 I posted an addendum based on a little-known determination letter that the Office for Human Research Protections (OHRP) had sent to Columbia during the previous June. The letter revealed that the trial had been terminated in October, 2005, due to “pre-determined stopping criteria.” This demonstrated that Gonzalez’s regimen must have been found to be substantially worse than the current standard of care for cancer of the pancreas, as ineffective as that standard may be. I urge readers who require a review or an introduction to the topic to read that posting, which also considered why no formal report of the trial had yet been made available.

Now, finally, the formal report has been published online by the Journal of Clinical Oncology (JCO):


Posted in: Cancer, Clinical Trials, Health Fraud, Herbs & Supplements, Medical Academia, Medical Ethics, Politics and Regulation, Science and Medicine

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The price of cancer quackery

I don’t have much to add to this one, as it’s a tragic tale. Shadowfax, a blogging ER doc, relates to us what happens when cancer patients rely on quackery like the Gerson protocol instead of scientific medicine:

This was a young woman, barely out of her teens, who presented with a tumor in her distal femur, by the knee. This was not a new diagnosis — it had first been noted in January or so, and diagnosed as a Primary B-Cell Lymphoma. By now, the tumor was absolutely huge, and she came to the ER in agonizing pain. Her physical exam was just amazing. The poor thing’s knee (or more precisely, the area just above the knee) was entirely consumed by this massive, hard, immobile mass about the size of a soccer ball. She could not move the knee; it was frozen in a mid-flexed position. She hadn’t been able to walk for months. The lower leg was swollen and red due to blood clots, and the worst of the pain she was having seemed due to compression of the nerves passing behind the knee. It was like something you see out of the third world, or historic medical textbooks. I have never seen its like before.

So we got her pain managed, of course, and I sat down to talk to her and her family.


Posted in: Cancer, Health Fraud, Medical Ethics

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Sectarian Insertions

I will write occasional posts instead of being on a regular schedule.  The reasons: There are more contributors than positions. Newer people to the field have more ambition and belly fire.  I have a number of projects and papers to finish in increasingly limited time and decreasing efficiency.  So have at it. Meanwhile, some non-random thoughts.

I am as concerned with social and political expression of pseudoscience as with its errors.  Health care reformers can be just as pseudoscientific as sectarians who want to restructure the scientific edifice.  Political ideologues want to centralize the medical system without solid evidence that their substitute would work, let alone work better.  Sectarians already see a national government system as an opportunity for expansionism. Mark Hyman, the Functional Medicine promoter, met with the White House staff, displaying his vision of medicine under a federal plan. Word is out that other sects have also had input. Many hold  suspicions that the proposals front for more ambitious formulations. I am suspicious of their confidence – that they can fix a complex, fluxing system using epidemiology, mathematical models, treatment paradigms, and top-down control.  I might accept some proposals if it were not that all constructed systems are intrinsically inefficient, political, and corruptible. The closer the agents of control are to the controlled, the more control the controlled have over the controllers – if you can follow that.

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

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The perils and pitfalls of doing a “vaccinated versus unvaccinated” study

The anti-vaccine movement is nothing if not plastic. It “evolves” very rapidly in response to selective pressures applied to it in the form of science refuting its key beliefs. For instance, when multiple studies looking at the MMR vaccine and autism failed to confirm the myth that the MMR causes autism or “autistic enterocolitis,” most recently late last year, it was not a problem to the anti-vaccine movement. Neither was it a major problem to the movement when multiple studies similarly failed to find a link between mercury in the preservative thimerosal that used to be in most childhood vaccines and is no more (except the flu vaccine) and autism. No problem! Andrew Wakefield is alleged, based on strong evidence, to have falsified his data alleging a link between the MMR vaccine and “autistic enterocolitis”? Fuggedabouddit! The anti-vaccine movement simply pivoted neatly, de-emphasized points that the evidence was so clearly against that even they couldn’t spin it to a positive anymore, and found new bogeymen. These days, it’s the “toxins” (such as formaldehyde and the latest antivax bogeyman, squalene), and “too many too soon” (a gambit given seeming respectability by Dr. Bob Sears and Dr. Jay Gordon, apologists for and supplicants to the anti-vaccine movement both.

However, there is one trait of the anti-vaccine movement that, however its camouflaging plumage may evolve, never, ever changes. It is as immutable as believers say that God is. That trait is that, whatever other claims, the anti-vaccine movement makes, at its core it is always about the vaccines. Always. No matter how often science fails to find a link between vaccines and autism or vaccines and whatever other horreur du jour the anti-vaccine movement tries to pin on vaccines, no matter how many studies do not support the viewpoint that vaccines cause autism, no matter how much the anti-vaccine movement tries to deny and obfuscate by saying that it is not “anti-vaccine” but rather “pro-safe vaccine,” at its core the anti-vaccine movement is about fear and loathing of vaccines. Always. When inconvenient science doesn’t support their views, anti-vaccine activists either ignore the science, distort the science, or launch ad hominems against the people doing the science or citing the science. And, as I said before, the claims of the anti-vaccine movement evolve. Never again will the anti-vaccine movement make the horrific mistake of yoking itself to a hypothesis that is as easily testable as the hypothesis that mercury in vaccines causes autism. The claim that mercury in vaccines causes autism predicted that, if thimerosal were removed from vaccines or reduced to pre-“epidemic levels” of the early 1990s, then autism rates should plummet. Thimerosal was removed from nearly all childhood vaccines (the sole exception being some flu vaccines), reducing infant mercury exposure from vaccines to levels not seen since the 1980s; yet autism rates continue to rise. This is about as resounding a refutation of the hypothesis that mercury in vaccines is a major cause or contributor to autism that even the anti-vaccine movement has backed away from the pure claim, which has now evolved to unnamed “environmental toxins,” either in concert with mercury or with other nasty things, as being the Real One True Cause of Autism.

It’s evolution in action. These new claims are much “fitter” because they are much harder to falsify through scientific research, epidemiology, and clinical trials.

Posted in: Clinical Trials, Medical Ethics, Public Health, Science and Medicine, Vaccines

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The Microbial Metagenome

First some background.  I was first directed to the Marshall protocol by a reader who wondered about the information the found on the web.  So I went to the web and looked at the available information, much as any patient would, and discussed what I found there.

I have subsequently been lead to believe that none of the information on the website can be considered up to date or accurate.  As as result of,  I have told that my post is chockablock with errors, although, outside of writing doxycycline where I should have put minocycline, I am left in the dark as to exactly what my errors are.  I am told that it is my responsibility to locate the errors in the last post, yet I can find none when compared to the website.

However, to remedy the deficiency of having reviewed inaccurate and out of date material,  I have been sent 6 articles that I am informed represent the state of the art in understanding the science behind the Marshall protocol.  Ah, the peer reviewed medical literature.  An opportunity to carefully read and critique new  ideas.  It is one of the reasons people publish: to see if their ideas can withstand the scrutiny of others.

Several of these papers concern Vitamin D,  the Vitamin D receptor, and olmesartan which I will review, perhaps, another time.  I don’t find them a compelling read, but it not an area about which I have more than a standard medical knowledge. The other papers concern the role of infection in autoimmune diseases, which I will discuss here.  It is easier as an infectious disease doctor  to read this literature as I am, as least as far as the American Board on Internal Medicine is concerned, a specialist in the field.  Alternatively, I am a closed minded tool of the medical industrial complex who only seeks to push his own twisted, narrow agenda at the expense of suffering patients (1).  We can’t all be perfect.

Posted in: Basic Science, Medical Ethics, Science and Medicine

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Science-Based Medicine Meets Medical Ethics

There are four main principles in medical ethics:

  •  Autonomy
  •  Beneficence
  •  Non-maleficence
  •  Justice

Autonomy means the patient has the right to consent to treatment or to reject it. Autonomy has to be balanced against the good of society. What if a patient’s rejection of treatment or quarantine allows an epidemic to spread? Beneficence means we should do what is best for the patient. Non-maleficence means “First do no harm.” Justice applies to conundrums like how to provide kidney dialysis and organ transplants equitably in a society that can’t afford to treat everyone with expensive high-tech treatments or where the rich can afford better treatment than the poor.

Medical ethicist Ronald Munson has written a fascinating book entitled The Woman Who Decided to Die: Challenges and Choices at the Edges of Medicine. His clinical vignettes vividly illustrate the difficult decisions that must be made when science-based medicine runs up against the harsh practical reality of ethical dilemmas. (more…)

Posted in: Book & movie reviews, Medical Ethics

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Incorporating Placebos into Mainstream Medicine

Alternative medicine by definition is medicine that has not been shown to work any better than placebo. Patients think they are helped by alternative medicine. Placebos, by definition, do “please” patients. We would all like to please our patients, but we don’t want to lie to them. Is there a compromise? Is there a way we can ethically elicit the same placebo response that alternative theorists elicit by telling their patients fairy tales about qi, subluxations, or the memory of water?

Psychiatrist Morgan Levy has written a book entitled Placebo Medicine. It’s available free online. In it, he makes an intriguing case for incorporating the best alternative medicine placebo treatments into mainstream medicine.

In a light, entertaining style, he covers the placebo effect, suggestibility, and the foibles of the human thought processes that allow us to believe a treatment works when it doesn’t.

“Thinking like a human” is not a logical way to think but it is not a stupid way to think either. You could say that our thinking is intelligently illogical. Millions of years of evolution did not result in humans that think like a computer. It is precisely because we think in an intelligently illogical way that our predecessors were able to survive… [by acting on quick assumptions rather than waiting for comprehensive, definitive data]… We have evolved to survive, not to play chess.

He offers evidence from scientific studies indicating that belief in a treatment and the power of suggestion can have actual physiologic consequences such as production of endorphins or changes on brain imaging studies. He spices his narrative with colorful stories, including anecdotes from his own sex life and an impassioned plea (tongue in cheek?) for everyone to drink coffee for its proven benefits. (more…)

Posted in: Acupuncture, Book & movie reviews, Medical Ethics

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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.


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.


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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Chemical castration for autism: After three years, the mainstream media finally notices

We’ve written a lot about anti-vaccine zealotry on this blog, as Steve and I take a particular interest in this particular form of dangerous pseudoscience for a number of reasons. One reason, of course, is that the activities of antivaccine groups like Generation Rescue and its spokesmodel since 2007 (Jenny McCarthy, a frequent topic on this blog) have started to frighten parents about vaccines enough that vaccination rates are falling well below that required for herd immunity in some parts of the country. Indeed, McCarthy, at the behest of her handlers in Generation Rescue, serves up a regular “toxic” brew of misinformation and nonsense about vaccines, most recently in a video that was the subject of a post by Val Jones about her unbelievably pseudoscience-laden blather. Truly, it has to be seen to be believed. Meanwhile, Generation Rescue has sent McCarthy on a media propaganda tour for her latest antivaccine pro-quackery book and set up a misinformation-laden propaganda site called Fourteen Studies (blogged about by Steve Novella, Mark Crislip, and, of course, yours truly) in which they attack well-designed studies that have failed to confirm their pet idea that somehow, some way, vaccines must be the cause of autism. And, when their pseudoscience is criticized, the antivaccine movement has a tendency to launch vicious ad hominem attacks, as they recently did against Steve Novella and have done multiple times in the past against me.

However, there is one other consequence of the antivaccine movement, however, and it is at least as important as the public health implications of the potential dimunition of herd immunity caused by the fear mongering of groups like Generation Rescue. That consequence is the cottage industry of “biomedical” treatments to which desperate parents subject their children. Gluten-free diets, chelation therapy (which has caused deaths), hyperbaric oxygen chambers (a recent story described a child getting severely burned when one of these caught fire), autistic children have been subjected to it all. But of all the biomedical woo to which autistic children have been subjected, one form of woo stands out as being particularly heinous. Indeed, I agree with our fearless leader Steve in characterizing it as an “atrocity.”

I’m referring to Mark and David Geier’s favored “treatment” for autistic children, namely a drug called Lupron.

Posted in: Clinical Trials, Health Fraud, Medical Ethics, Neuroscience/Mental Health, Politics and Regulation, Public Health, Science and the Media, Vaccines

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