PRELUDE: SOME BAD NEWS FOR ADVOCATES OF SCIENCE-BASED MEDICINE
It was a bad week for science-based medicine. It was a good week (sort of) for science-based medcine.
First the bad.
There has been a development that anyone who supports science in medicine and opposes quackery will likely find disturbing. Do you remember Senator Tom Harkin (D-IA)? We’ve written about him extensively over the last several months on this blog. First of all, he is the man most responsible for the creation of that government-sanctioned, government-funded bastion of pseudoscience, the National Center for Complementary and Alternative Medicine. He’s also one of the men most responsible for the Dietary Supplement Health and Education Act (DSHEA) of 1994, which has done more to protect the supplement industry from making dubious health claims than any other piece of federal legislation. More recently, Harkin has made a name for himself in the health care reform debate currently ongoing by inviting advocates of “integrative” medicine (IM), which in essence integrates quackery and the pseudoscientific with scientific medicine, to Capitol Hill as a means of trying to persuade his fellow legislators to include a CAM/IM version of “wellness” care as part of any bill that might pass this fall. In essence, he is trying to hijack any health care reform bill to include government sanction of unscientific medicine. Meanwhile, he has been chastising NCCAM because it hasn’t “validated” enough “alternative medicine” for his taste. (Actually, it’s validated none, because virtually none of it is likely to be valid.)
This is the man who, according to reports, will almost certainly be taking over the chair of the Senate Committee on Health, Education, Labor, and Pensions (HELP) after the death of its former chair, Senator Edward Kennedy. This committee is among the most important for government health policy and will be in the thick of the final negotiations and battles over any health care reform that may arise from Congress this fall.
The existence of powerful supporters of pseudoscience in the highest eschelons of government has real consequences. As I’ve described before, NCCAM, being based entirely on studying highly–even ridiculously implausible–notions about disease and how to treat it, has resulted in the infiltration of quackery into academia, where ideas once rightly dismissed as quackery are respectfully given deference and studied as though they were anything other than Tooth Fairy science, a process that Dr. R. W. Donnell has amusingly termed “quackademic medicine.” One result was the expenditure of $30 million on an unethical, poorly designed, and corrupt trial of chelation therapy for cardiovascular disease. Another result was an even more unethical trial of an even more scientifically implausible remedy for a deadly cancer. Although the fact that the trial was even done is a horror, at least last week we finally found out the results, which had been suppressed for nearly four years, namely that this protocol is not just useless, but worse than useless. It’s a Pyrrhic victory for science-based medicine and cold comfort to patients with pancreatic cancer who may have continued to use this protocol during those four years, but at least we finally know.
Let’s take a look at the study. But first, a little background.
The PowerPoint presentation that I gave at the Skeptic’s Toolbox workshop at the University of Oregon on August 7, 2009 is up on their website with the complete text of what I said. The theme of the workshop was scientific method. The title of my talk is “Tooth Fairy Science and Other Pitfalls: Applying Rigorous Science to Messy Medicine.” Click here for the link. It covers a lot of things that are pertinent to the subjects we discuss on this blog, and I thought some of our readers might enjoy it. I put in a lot of information and some good cartoons. Note: this was a talk to the general public, not an academic presentation, and it does not include citations or references.
Peter Lipson wrote a post last week entitled Before You Trust That Blog…, which was a criticism of Dr. J. Douglas Bremner’s blog Before You Take That Pill. Dr. Bremner was not pleased, and posted a rebuttal entitled Response to Peter Lipson MD of “Science” Based Blogs, My Blog Does Not Suck, Yours Does. Given the kerfuffle and my role as managing editor of SBM, I felt the need to put my two cents in, which is why I’m posting this open letter to Dr. Bremner. This letter started as a much briefer response that I was going to e-mail to Dr. Bremner, but as I wrote it grew and grew to the point where I decided that, given the public nature of the disagreement between Dr. Lipson and Dr. Bremner, I might as well make my commentary public too. Consider it a bonus post from me. I still plan a post for my usual slot on Monday. In the meantime, here’s my open letter:
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):
In which we try to be smarter than the average bear.
Flu season is upon us (it kind of never left us this year), and there is a new strain of flu, the H1N1, aka Swine flu that adds a wrinkle or two to the usual potential for influenza related morbidity and mortality. And with the new flu is the new woo. I know that others have addressed flu in this forum and some of this may be redundant. Still, we each have our different styles and interests, so I hope the various posts are additive rather than redundant. I am going to wander through some odds and ends about flu in general and H1N1 specifically and compare some of the woo with the reality. At least my reality.
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.
The marketing of so-called CAM or integrative medicine continues. These terms are just that – marketing. They are otherwise vacuous, even deceptive, and meant only to conceal the naked fact that most medical interventions that hide under the CAM/integrative umbrella lack plausibility or credible evidence that they actually work.
Medicine that works is simply “medicine” – everything else needs marketing.
Last week in the British Medicine Journal (BMJ) Hugh MacPherson, David Peters, and Catherine Zollman wrote a very telling editorial entitled Closing the evidence gap in integrative medicine, which Edzard Ernst has rightly characterized “a masterpiece in obfuscation.”
The essence of the editorial can be boiled down to this – proponents of integrative medicine are disappointed that scientific research has not validated their failed modalities. Therefore they want to weaken the rules of evidence so that they can get the results they desire.
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.
Fear is a curious thing. It often bears no relation to the actual risk of what we fear. When swine flu first broke out in Mexico, people were understandably afraid. Travel was restricted, schools were closed, and so many people stayed home that the streets of Mexico City were empty. As the disease spread around the world, Egypt developed a paranoid fear of pigs and committed national pigicide. They ordered the slaughter of all 300,000 of their country’s innocent little porkers, ignoring the fact that the flu is spread person-to-person, not pig-to-person. Now that the disease has officially been labeled a pandemic, fears have switched from the real threat of the disease to an imagined danger from the vaccine.
Some people just plain hate the idea of vaccines – to the point that they are willing to spread old falsehoods, make up new lies, distort the results of studies, misrepresent statistics, and endanger our public health. There are websites like “Operation Fax to Stop the Vax” and even anti-swine-flu-vaccine rap videos. Press releases, e-mail campaigns, talk shows, and blogs are being used to stir up irrational fears. These people are irresponsible fearmongers. They are wrong, and they are dangerous.
Doug Bremner has a blog. That blog stinks.
Bremner is an apparently well-regarded psychiatrist, and takes a refreshing look at the influence of industry not just on pharmaceuticals but on the conduct of science itself. His outspoken views have led to attempts to squelch his academic freedoms. But his sometimes-heroic record does not excuse dangerous idiocy.
I can understand how wading into the cesspool that is conflict of interest can leave one cynical. But cynicism and suspicion turned up to “11″ is no longer bravery—it’s crankery. It’s not his snarkiness that burns—it’s his inability to separate his biases from the facts.
It’s not like the pharmaceutical industry doesn’t deserve to be taken to the wood shed. Examples of unethical and downright immoral practices abound, such as ghost-writing, fake journals, and a host of other sins. But the industry has also helped develop a most remarkable pharmacopeia which saves and improves countless lives. There is good, and there is bad. And telling the two apart, well, that makes all the difference.
He tends to go for headlines that hit hard, but miss the point entirely. Examples:
- Angioplasty Found to be Useless Waste of Money: he cites a journal article which he says concluded that “not useful for patients with stable coronary artery disease (CAD). ” His title would be accurate if angioplasty were used only in stable CAD—it is not.
- Should I Take Aspirin or Put a Gun To My Head?: here, he sort of gets the difference between primary and secondary prevention, but not really. He also likes to admit that the data contradict his conclusion but he’s nice enough to say, “screw the data”:
Although technically the risk of stomach bleeding is outweighed by the heart benefits of aspirin (which can only be shown when large numbers of patients are studied), in terms of what that means to you the differences are clinically meaningless.
- This Just In: Breast Cancer Screening Essentially Useless: yes, Doug, breast cancer screening doesn’t benefit everyone equally. For example, the prevalence of breast cancers in men is low enough that recommending it for you would be stupid—like your article.