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

ResearchBlogging.org

Review

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):

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

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The Golden State of Pseudo-Science

The state of California (CA) which is home to the most advanced education and research in biomedical sciences, computational biology, genomics and proteomics, etc, is also home to 19 institutions that have state-approved training programs in Traditional Chinese Medicine (TCM), a pseudo-medicine that is based on ideas and practices sourced by ancient cosmology, mythology, astrology, and a range of other pre-scientific beliefs that have been partially “sanitized” during the Maoist era.

Emerging out of the recent hype about complementary and alternative medicine (CAM), the educational curricula of these institutions include the study of acupuncture’s point-and-meridian system, the health and safety beliefs of ancient and medieval China, humoral pathology, herbalism, Asian massage, and a limited amount of modern biomedical sciences at a level below what is required from vocational nurses. These curricula are supposed to provide the necessary knowledge and skills for the graduates to pass a comprehensive state licensing exam and provide “primary” healthcare in CA. However, pursuant to CA Code of Regulations, Title 16, Section 1399.451(b) it is improper for these “primary” healthcare providers, “to disseminate any advertising which represents in any manner that they can cure any type of disease, condition or symptom!” Nonetheless, both the internet and the local press abound with ads by CA licensed practitioners who claim that acupuncture can cure or mitigate many diseases, ranging from allergies and infertility to stroke and paralysis.

Under the banner of CAM, a handful of these practitioners also advertise that they can communicate with spirits and heal with crystals, colors or sounds; they practice healing touch (reiki) and distance healing (via PayPal!); provide spiritual counseling and ministerial services, and make implausible medical claims such as healing a chronic condition with just one needle!

All 19 programs are approved by the CA Department Affairs’ (DCA) Board of Acupuncture, since CA law requires that the content of an acupuncture training program be assessed and approved by the State.

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Posted in: Acupuncture, Politics and Regulation, Public Health

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

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“There must be a reason,” or how we support our own false beliefs

ResearchBlogging.orgFor a change of pace, I want to step back from medicine for this post, although, as you will see (I hope), the study I’m going to discuss has a great deal of relevance to the topics covered regularly on this blog. One of the most frustrating aspects of being a skeptic and championing science-based medicine is just how unyielding belief in pseudscience is. Whatever realm of science in which there is pseudoscience I wander into, I find beliefs that simply will not yield to science or reason. Whether it be creationism, quackery such as homeopathy, the anti-vaccine movement, the “9/11 Truth” movement, moon hoaxers, or any of a number of pseudoscientific movements and conspiracy theories, any skeptic who ventures into discussions of such a topic with believers will become very frustrated very fast. It takes a lot of tenacity to keep going back to the well to argue the same points over and over again and refute the same nonsense you’ve refuted over and over again. Many do not have sufficient stick-to-it-iveness, leading them to throw up their hands and withdraw from the fight.

Although some of us here have blamed this phenomenon on “cultishness” and, make no mistake, I do think that there is an element of that in many of these movement, particularly the anti-vaccine movements, cultishness alone can’t explain why people hold on so hard to beliefs that are clearly not supported by science or evidence, such as the belief that vaccines are responsible for an “autism epidemic.” Then last week, what should pop up in the newsfeeds that I regularly monitor but a rather interesting article in Science Daily entitled How We Support Our False Beliefs. It was a press release about a study1 that appeared a few months ago in Sociological Inquiry, and the the study was described thusly:
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Posted in: Clinical Trials, Politics and Regulation, Science and Medicine, Vaccines

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The Rise of Placebo Medicine

It is my contention that terms such as “complementary and alternative medicine” and “integrative medicine” exist for two primary purposes. The first is marketing – they are an attempt at rebranding methods that do not meet the usual standards of unqualified “medicine”. The second is a very deliberate and often calculating attempt at creating a double standard.

We already have a standard of care within medicine, and although its application is imperfect its principles are clear – the best available scientific evidence should be used to determine that medical interventions meet a minimum standard of safety and effectiveness. Regulations have largely (although also imperfectly) reflected that principle, as have academia, publishing standards, professional organizations, licensing boards, and product regulation.

With the creation of the new brand of medicine (CAM and integrative) came the opportunity to change the rules of science and medicine to create an alternative standard, one tailor made for those modalities that do not meet existing scientific and even ethical standards for medicine. This manifests in many ways – the NCCAM was created so that these modalities would have an alternate standard for garnering federal dollars for research. Many states now have “health care freedom laws” which create a separate standard of care (actually an elimination of the standard of care) for self-proclaimed “alternative” practices.

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Posted in: Politics and Regulation, Science and Medicine

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Health care reform and primary sources

One thing I always encourage my residents and students to do is to go to primary sources.  If someone tells you that thiazide diruetics should be the first line treatment for hypertension, get on MedLine and see if that assertion is congruent with the evidence.  It’s important to see how we arrive at broad treatment recommendations, how strong and consistent the evidence is, and the best way to do this is go back to the beginning.

This is not an explicitly political blog, and for that reason, I don’t feel it’s appropriate for me to advocate for one or another proposed health care reform plan.  But I do want to encourage everyone to follow health care reform closely, and to go to the primary sources. Certain aspects of the proposed bill will be hard for any of us to understand, especially cost.  There are all sorts of wild claims about how much reform will save us or cost us, and I’m betting that none of these claims is completely congruent with the truth.  But some of  what we’re hearing on the news is so far from the truth that to call them lies would be generous. (more…)

Posted in: Politics and Regulation, Science and Medicine

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Quack Clinics

Reuters recently reported on the raid of a stem-cell clinic in Hungary. This is welcome news, if the allegations are correct, but really is only scratching the surface of this problem – clinics offering dubious stem cell therapies to desperate patients. And in fact this is only one manifestation of a far greater problem – the quack clinic. They represent a serious problem for patients, doctors, and health care regulation.

Stem Cell Clinics

There is a very disturbing trend in the last few years – the proliferation of clinics offering stem cell therapy for a variety of serious, often incurable, diseases such as spinal cord injury, ALS, Parkinson’s disease, and other neurological disorders. These clinics claim to improve and even cure these diseases by injecting stem cells into the spinal cord or other parts of the body. Treatments typically cost 20-25,000 dollars, plus travel expenses, for a single treatment.

The problem is that these clinics do not have any published evidence that their treatments are valid. There is good reason to think that they are not – stem cell technology is simply not at the point yet where we can use them to cure such diseases. There are many technical hurdles to be overcome first – knowing how to control the stem cells, to get them to survive and become the types of cells necessary to have the desired therapeutic effect, and also figuring out how to keep them from growing into tumors. Basic issues of safety have not yet been sorted out.

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Posted in: Politics and Regulation, Science and Medicine

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Senator Tom Harkin and Representative Darrell Issa declare war on science-based medicine

In discussions of that bastion of what Harriet Hall likes to call “tooth fairy science,” where sometimes rigorous science, sometimes not, is applied to the study of hypotheses that are utterly implausible and incredible from a basic science standpoint (such as homeopathy or reiki), the National Center of Complementary and Alternative Medicine (NCCAM), I’ve often taken Senator Tom Harkin (D-IA) to task, as have Drs. Novella, Lipson, and Atwood. That’s because Senator Harkin is undeniably the father of that misbegotten beast that has sucked down over $2.5 billion of taxpayer money with nothing to show for it. NCCAM is the brainchild of Senator Harkin, who foisted it upon the National Institutes of Health not because there was a scientific need for it or because scientists and physicians cried out for it but rather because Senator Harkin, who believed that alternative medicine had healed a friend of his, wanted it, and he used his powerful position to make it happen, first as the Office of Unconventional Therapies, then as the Office of Alternative Medicine, and finally as the behemoth of woo that we know today as NCCAM. The result has included a $30 million trial of chelation therapy in which convicted felons were listed among the investigators and a totally unethical trial of the Gonzalez therapy for pancreatic cancer. It’s not for naught that Wally Sampson called for the defunding of NCCAM, as have I and others. Not surprisingly, alternative medicine practitioners are appalled at this idea.

Most recently, Harkin has been most disturbed by the observation that NCCAM’s trials have all been negative, going so far as to complain that NCCAM hasn’t produced any positive results showing that various alternative therapies actually work. This is, of course, not a surprise, given that vast majority of the grab bag of unrelated (and sometimes theoretically mutually exclusive) therapies are based on pseudoscience. One of the only exceptions is the study of herbal remedies, which is a perfectly respectable branch of pharmacology known as pharmacognosy. Unfortunately, as David Kroll showed, in NCCAM the legitimate science of pharmacognosy has been hijacked for purposes of woo. Meanwhile, earlier this year, Senator Harkin hosted a hearing in which Drs. Dean Ornish, Andrew Weil, Mehment Oz, and Mark Hyman (he of “functional medicine“) were invited to testify in front of the Senate. Add to that other powerful legislators, such as Representative Dan Burton (R-IN), trying to craft legislation in line with his anti-vaccine views and pressure the NIH to study various discredited hypotheses about vaccines and autism. Clearly, when it comes to quackery, there are powerful legislative forces promoting pseudoscience and studies driven by ideology rather than science.
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Posted in: Acupuncture, Chiropractic, Homeopathy, Politics and Regulation, Science and Medicine

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Is Tylenol Safe?

Tylenol (acetaminophen, also known as paracetamol outside the US) has been in the news recently. Most of the stories I’ve seen have been accurate, but I’ve run across a couple of people who misunderstood what they read. I thought I’d try to put the record straight.

An FDA advisory panel has recommended reducing the maximum allowed single dose from 1000 mg to 650 mg in over-the-counter acetaminophen products. The 1000 mg dose would be available by prescription only. They also recommended eliminating painkillers like Percocet and Vicodin that contain a combination of a narcotic and acetaminophen. They did not recommend removing acetaminophen from over-the-counter cold remedies, cough medicines and similar products that combine acetaminophen with other drugs. Advisory panel recommendations are not binding, but the FDA usually follows them.

Some people got the impression that the FDA had just discovered that acetaminophen can be dangerous. No, we always knew that. The danger is when you take too much: it can damage the liver. The “new” information is just that acetaminophen overdose is now the leading cause of liver damage, causing an estimated 1600 cases of liver failure each year. (more…)

Posted in: Pharmaceuticals, Politics and Regulation

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DSHEA: a travesty of a mockery of a sham

In 1994, Congress enacted the Dietary Supplement Health and Education Act (DSHEA). This act allows for the marketing and sales of “dietary supplements” with little or no regulation. This act is the work of folks like Tom Harkin (who took large contributions from Herbalife) and Orrin Hatch, whose state of Utah is home to many supplement companies.

DSHEA has a couple of very important consequences (aside from filling the pockets of supplement makers). (more…)

Posted in: Health Fraud, Herbs & Supplements, Politics and Regulation, Science and Medicine

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