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Archive for Clinical Trials

Anti-VEGF treatment of Macular Degeneration: Science-Based Success

Science-Based Medicine authors tend to focus attention on practices that misuse or ignore the tools of science. This is not a criticism. As a daily reader and occasional contributor, I recognize that shining a light on pseudoscience is a critical part SBM’s mission. It is what brings me back day after day. Sometimes, however, it is nice to highlight what real science and real evidence can do.

In my world of treating patients with retinal disease, a revolution has taken place over the past few years. The most aggressive form of macular degeneration has been transformed from a relentlessly progressive, disabling disease to one which can be tamed with medication. Now, patients diagnosed with exudative macular degeneration can expect stabilization and even improvement in vision.

It is a story worthy of a Hollywood movie. Start with a reluctant hero; add controversy, Wall Street, politics, and most important of all, a happy ending.
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Posted in: Clinical Trials, Science and Medicine

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Pump it up: osteopathic manipulation and influenza

First, my bias. I work in Portland and we have medical students, residents, and faculty who are DOs (Doctor of Osteopathy). Before he moved on to be a hospitalist my primary physician was a DO. From my experience there is no difference between an MD and a DO. In my world they are interchangeable. There are many more qualified applicants for medical education than positions in MD programs and some opt for a DO education. Osteopathy has a dark side.
As best I can determine from my colleagues, learning osteopathic manipulation (OM) is the price they pay to obtain an otherwise standard medical education. I have yet to see OM offered by any of my DO colleagues. It may be they know better than to offer such a modality around me given my ranty propensity for all things SCAM.

The literature would suggest that OM is left behind by most DOs upon graduation. DOs are not proud of their OM, and rarely invite them ‘round to dinner. It will be interesting to see if OM fades over time in DO school as the old time true believers die off and are supplanted by a generation of DOs trained with more traditional medical education.

OM, the small pseudoscientific aspect of DO medical school education, is a form of massage and manipulation invented in the 19th century with no basis in reality. OM postulates

the existence of a myofascial continuity – a tissue layer that interlinks all parts of the body. By manipulating the bones and muscles of a patient a practitioner is supposed to be able to diagnose and treat and variety of systemic human ailments.

Studies into the efficacy of OM find it to be ineffective for any process aside from low back pain (is there anything that does not help low back pain?), not surprising for a therapeutic intervention detached from reality. My purpose with this entry is not to review OM per se, which may be a good topic someday, but to focus on a specific application of OM. (more…)

Posted in: Chiropractic, Clinical Trials, History, Science and Medicine

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Obamacare, the Oregon Experiment, and Medicaid

Tomorrow, as mandated by the Patient Protection and the Affordable Care Act (PPACA, often called just the Affordable Care Act, or ACA, or “Obamacare”), the government-maintained health insurance exchanges will open for business (that is, assuming the likely government shutdown doesn’t stop them temporarily). We here at SBM have written about the ACA quite a few times, but I would like to write about it in perhaps an entirely different context than you’re used to now that the biggest change mandated by the law is here. Just to see the contrast, I’ll mention that Jann Bellamy has written about the ACA in the context of how provisions have been inserted by promoters of “complementary and alternative medicine” (CAM) could potentially provide an “in” for requiring reimbursement of CAM practitioners for their services by insurance plans sold through the exchanges or even how CAM practitioners might promote themselves as primary care providers (PCPs) under Obamacare, as did Matt Roman. I myself warned about legislative meddling that might permit funding of religion-based health care in the exchanges, and Kimball Atwood sounded early warnings about insertion of the provisions that Jann warned about. Instead, view this discussion as a follow-up to a post I did almost a year ago that used a statement by Mitt Romney during the height of the Presidential campaign as a jumping off point to look at the relationship between health insurance status and mortality. While we at SBM try to remain more or less apolitical, in some cases (licensing of naturopaths, for example) it is not possible to disentangle science from politics, and we have to dive in. Also, politics is the art of the possible; so, policy-wise, what is best as determined by science might well not be what is possible politically.

The reason I wanted to revisit this topic is because of a political battle that went on for quite some time over the last several months to expand Medicaid in Michigan according to the dictates of the ACA. The reason that this battle is occurring in many states is because when the Supreme Court ruled last year that the individual mandate requiring that citizens have health insurance was Constitutional, one provision that it ruled unconstitutional was the mandatory expansion of Medicaid in states participating in the Medicaid program to cover all people under 65 up to 133% of the federal poverty level. States thus had to decide whether or not they would accept the Medicaid expansion. In our state, Governor Rick Snyder supported the expansion. Even though he is Republican, he is also a businessman and realized that it was a good deal, with the federal government covering 100% of the cost for the first three years and then phase down to 90% of the cost in 2020. The bill to expand Medicaid managed to pass the House of Representatives, but then it stalled in the Senate. Unfortunately—and this is what got me involved—my state Senator Patrick Colbeck led the opposition to the Medicaid expansion in the Senate, much to my chagrin and disappointment. His argument, which is being repeated elsewhere in the blogosphere, is that Medicaid is worthless and doesn’t improve health outcomes. Instead, he endorsed an alternative that (or so he claimed) places Medicaid-eligible patients into in essence low cost, high deductible concierge practices, with health savings accounts. This was a plan promoted by practices like BlueSky Health. Ultimately Mr. Colbeck lost, and Medicaid was expanded in Michigan in a plan that was characterized by John Z. Ayanian in this week’s New England Journal of Medicine as “a pragmatic pathway to link Republican and Democratic priorities for health care.”

However, the whole kerfuffle got me to thinking. In my post a year ago, I basically asked what the evidence was that access to health insurance improves health outcomes, but I didn’t really stratify the question into kinds of health insurance. Rather, I just looked at being uninsured versus having health insurance. After my little Facebook encounter with one of my elected representatives, I wondered what, exactly, was the state of evidence. So I decided to do this post. In the U.S., currently we have in essence three kinds of health insurance, broadly speaking: private insurance, Medicare, and Medicaid. Medicare, for those of our readers from other countries, is a plan that covers the medical care of people 65 and over and those receiving Social Security disability benefits. It is funded through payroll taxes and directly paid for by the federal government. Medicaid, in contrast, is a plan designed for low income people who fall below certain income levels. Also in contrast, it is jointly funded by the states and the federal government with each participating state administering the plan and having wide leeway to decide eligibility requirements within the limits of federal regulations that determine the minimal standards necessary for states to receive matching funds. Indeed, the loss of this leeway to determine the income level at which a person is eligible for Medicaid is one of the reasons the provision for Medicaid expansion was part of the Supreme Court challenge to the ACA. These days, most Medicaid plans hire private health maintenance organizations (HMOs) to provide insurance. Finally, what needs to be understood is that, compared to private insurance, Medicare reimbursement rates tend to be lower and Medicaid reimbursement rates are lower still, which is part of the reason why a lot of doctors don’t accept Medicaid. Increases in reimbursement under the ACA might well help this situation. (more…)

Posted in: Clinical Trials, Epidemiology, Politics and Regulation, Science and the Media

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Everything Causes Cancer

It’s likely you know someone who has bought into the notion that nutrition is everything, the source of all health and the cause of all illness. Nutrition is very important, to be sure, but it is only one of many possible causes of disease, and if you live in a Western industrialized nation you probably have adequate nutrition. The notion, however, that food can heal is powerfully alluring, and it makes great headlines. The result is that people who read the headlines for the latest food to avoid, or the latest ingredient that will make them live longer or stave off disease, seem to have an association for everything. Eating around them is to be constantly told that food X is good for you and will prevent Y, or that some other food should be avoided because it causes Z.

Red peppers will help prevent cancer and help you lose weight. Garlic will help prevent heart disease and aids in iron metabolism. Cayenne pepper prevents strokes. Peaches prevent heart disease and cancer. In fact- think of any food at random and type “random food health benefits” into Google and chances are you will be rewarded with a list of the amazing health benefits of whatever food you wish.

My usual response when offered such advice is – you know, food is healthy for you. I recommend you eat food every day. Food is full of nutrition, essential vitamins and minerals, and will give you energy. If you don’t eat food, your health with dramatically suffer. But don’t eat too much food – that’s not healthful.

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Posted in: Cancer, Clinical Trials, Nutrition

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The Science of Clinical Trials

Science-based medicine is partly an exercise in detailed navel gazing – we are examining the use of science in the practice of medicine. As we use scientific evidence to determine which treatments work, we also have to examine the relationship between science and practice, and the strengths and weaknesses of the current methods for funding, conducting, reviewing, publishing, and implementing scientific research – a meta-scientific examination.

There have been several recent publications that do just that – look at the clinical literature to see how it is working and how it relates to practice.

Dr. Vinay Prasad led a team of researchers through the pages of the New England Journal of Medicine hunting for medical reversals – studies that show that current medical practice is ineffective. Their results were published recently in the Mayo Clinic Proceedings:

Dr. Prasad’s major conclusion concerns the 363 articles that test current medical practice — things doctors are doing today. His group determined that 146 (40.2%) found these practices to be ineffective, or medical reversals. Another 138 (38%) reaffirmed the value of current practice, and 79 (21.8%) were inconclusive — unable to render a firm verdict regarding the practice.

Prasad also found that 27% of published studies looked at existing treatments while 73% studied new treatments.

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Posted in: Clinical Trials

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When urgency to cure beats research ethics, bad things happen

Editor’s note: Just for your edification, here’s a “bonus” post. True, you might have seen this recently elsewhere, but it’s so appropriate for SBM that I couldn’t resist sharing it with those of you who might not read the other source where this was published recently. :-)

I’ve written a lot about Stanislaw Burzynski and what I consider to be his unethical use and abuse of clinical trials. Before that, I used to regularly write about Mark Geier and his unethical use and abuse of IRBs and clinical trials. Both doctors use their own IRBs stacked with their own cronies to rubberstamp scientifically and ethically dubious studies. Mark Geier got away with it for years. Stanislaw Burzynski got away with it for decades and, apparently, is still getting away with it to some extent. (His IRB is chaired by an old Baylor crony of his from the 1970s, and he has been cited for numerous problems with his IRBs.) I’d like to contrast how their unethical research, in which Mark Geier and his son David subjected autistic children to chemical castration with Lupron to decrease testosterone levels and allegedly make mercury easier to chelate (to them mercury was bound by testosterone, something that doesn’t happen under physiological conditions but requires organic solvents) and Stanislaw Burzynski administered an unproven cancer chemotherapy (antineoplastons) to hundreds of patients over the years and charged them for it, compares to a recent case in the news.

The case has been mentioned by PZ Myers. It happened that it involves the same sort of tumors that Stanislaw Burzynski claims to be able to cure, namely brain tumors. It happened at the University of California Davis (UC Davis) and involved two very prominent neurosurgeons there, a former head of the department Dr. J. Paul Muizelaar and Dr. Rudolph J. Schrot, who were found to have violated university’s faculty code of conduct with their experimental work. When you read this part of the story, you’ll shiver. At least, I did:
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Posted in: Cancer, Clinical Trials, Medical Ethics

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Survey Says…

Surveys are evidently a popular way to get a paper published. Put “complementary alternative medicine survey” into Pubmed and get 2,353 hits. I would have trouble coming up with a hundred groups about whom I would be interested in their use of SCAMs, but I tend to be a lumper rather than a splitter. But if you want to know about SCAM use in chronic pain patients in one Singapore hospital, the information is available.

I am a survey magnet and a remarkable number of people send me dead tree and electronic surveys which I generally ignore. So people like me, those who ignore surveys (but support public television), are underrepresented in surveys. But evidently there is no group whose attitudes about SCAM are not amenable to analysis including my medical brethren, Infectious Disease doctors.

So I was understandably curious when I was sent a link to “Infectious Diseases Physicians’ Attitudes and Practices Related to Complementary and Integrative Medicine: Results of a National Survey“. The abstract makes it sound like my colleagues are a bunch of ignorant rubes who just fell off the turnip truck: (more…)

Posted in: Acupuncture, Clinical Trials, Critical Thinking, Homeopathy, Science and Medicine

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A Different Perspective: Placebo, SCAM, and Advertising

Summertime, time, time

Child, the living’s easy.

Fish are jumping out

And the handicap, Lord

Handicaps high, Lord so high

~ Janis Joplin

It is summer. Time for the kids and the outside, not the computer. What follows is a summertime blog entry, for which I admit to feeling guilty for the comparatively little time I have spent on it, but as I have said before, no dying patient has ever told me “Doc, I wish I had spent more time at work.”

Mt. Hood has been a constant feature to the east my entire life. The mountain, on a clear day at least, is Portland’s most impressive geologic feature. If you are in the right part of the city, you may see Mt. St. Helens or the tips of Jefferson, Adams and even Rainier, but Mt. Hood dominates. It is solitary mass of rock, (diminishing) ice and snow only 50 miles from where I live. I have spent uncountable hours hiking in the Mt. Hood wilderness. When I think of Mt. Hood, in my mind’s eye it is from the perspective of west Portland looking east.

Last week was our yearly summer vacation in Sunriver, just south of Bend Oregon on the eastern side of the cascades in the Oregon High Desert. Driving north/south on highway 97 puts Mt. Hood in a different perspective. From the high desert you can see the huge swaths of the Cascades: calderas, mountains, lava fields and cinder cones. You see Mt. Hood differently. Not a single mountain to the east, but part of a chain of recent and distant historical volcanic activity along the Rim of Fire. Photographs do not do the view of the Cascades justice from this vantage point.

The eastern view puts Mt. Hood in a broader geologic and time perspective. It is still the same Mt. Hood, but in a different context. Like running into a nurse outside of the hospital, you have to recalibrate the context in which you understand and know the person.

I have written on placebo, the placebo effect, and its relationship to SCAM. To my understanding the preponderance of literature indicates there is no placebo effect upon any objective medical problem, only a change in the patients perspective of the problem. (more…)

Posted in: Basic Science, Clinical Trials, Science and Medicine

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Integrative Medicine Invades the U.S. Military: Part Three

Nobody seems to know exactly how to define “integrative medicine” (“IM”) or to demonstrate what it does that is superior to the “conventional” kind. There is a lot of talk about addressing the “whole person” and not just the disease, patient-centeredness and the like, all of which are already aspects of conventional medicine. But, however defined, the central idea seems to be that if you incorporate complementary and alternative (CAM) into conventional medicine the practice of medicine will improve tremendously.

Despite not having any clear idea of what IM is, or does, the military, prestigious medical institutions, hospitals, and individuals practitioners are eager to imprint the integrative medicine brand firmly on their public images. Hence the Consortium of Academic Medical Centers for Integrative Medicine, a newly minted medical specialty in integrative medicine, societies devoted to integrative medicine practitioners, CME courses, conferences, and so on.

But – whoops! – proponents, in their overblown hype for IM, apparently didn’t give enough thought to the fact that there isn’t much of an evidence base for this loosely-defined but supposedly superior system. And – whoops again! – you can’t really research something unless you know what it is you are researching. These little oversights have brought about efforts to decide which of the competing definitions of integrative medicine should prevail and, whatever it is, whether there is any evidence of benefit for the patient. (more…)

Posted in: Acupuncture, Clinical Trials, Homeopathy, Legal, Politics and Regulation

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The difference between science-based medicine and CAM

“Alternative medicine,” so-called “complementary and alternative medicine” (CAM), or, as it’s become fashionable to call it, “integrative medicine” is a set of medical practices that are far more based on belief than science. As Mark Crislip so pointedly reminded us last week, CAM is far more akin to religion than science-based medicine (SBM). However, as I’ve discussed more times than I can remember over the years, both here and at my not-so-super-secret-other blog, CAM practitioners and advocates, despite practicing what is in reality mostly pseudoscience-based medicine, crave the imprimatur that science can provide, the respect that science has. That is why, no matter how scientifically implausible the treatment, CAM practitioners try to tart it up with science. I say “tart it up” because they aren’t really providing a scientific basis for their favored quackery. In reality, what they are doing is choosing science-y words and using them as explanations without actually demonstrating that these words have anything to do with how their favored CAM works.

A more important fundamental difference between CAM and real medicine is that CAM practices are not rejected based on evidence. Basically, they never go away. Take homeopathy, for example. (Please!) It’s the ultimate chameleon. Even 160 years ago, it was obvious from a scientific point of view that homeopathy was nonsense and that diluting something doesn’t make it stronger. When it became undeniable that this was the case, through the power of actually knowing Avogadro’s number, homeopaths were undeterred. They concocted amazing explanations of how homeopathy “works” by claiming that water has “memory.” It supposedly “remembers” the substances with which it’s been in contact and transmits that “information” to the patient. No one’s ever been able to explain to me why transmitting the “information” from a supposed memory of water is better than the information from the real drug or substance itself, but that’s just my old, nasty, dogmatic, reductionist, scientific nature being old, nasty, dogmatic, reductionist, and scientific. Then, of course, there’s the term “quantum,” which has been so widely abused by Deepak Chopra, his acolytes, and the CAM community in general, while the new CAM buzzword these days to explain why quackery “works” is epigenetics. Basically, whenever a proponent of alternative medicine uses the word “epigenetics” or “quantum” to explain how an alternative medicine treatment “works,” what he really means is, “It’s magic.” This is a near-universal truth, and even the most superficial probing of such justifications will virtually always reveal magical thinking combined with an utter ignorance of the science of quantum mechanics or epigenetics.
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Posted in: Clinical Trials, Diagnostic tests & procedures, Homeopathy, Medical Academia

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