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Less benefit, more risk. Our assumptions about health treatments are probably wrong.

Patient discussing treatment options with a pharmacist.

Patient discussing treatment options with a pharmacist.

I’m a health professional, but sometimes a patient as well. And like most patients, I generally don’t want health decisions being made without my input. Yes, I want the best medical information, and the advice of medical professionals, but ultimately I want to make my own decisions about my care. That’s the norm in health care today, but relatively new in the history of medicine.

Medical paternalism, where patient preferences are secondary (or even ignored), is disappearing. Even informed consent, where patients are given information on risks and benefits, doesn’t adequately describe the drive towards a two-way exchange, with an empowered, engaged patient. Today the goal is shared decision making, which describes a mutual decision that is informed by a health professional’s medical knowledge and advice, but also incorporates a patient’s own preferences and wishes. Truly shared decision-making includes an explicit consideration of a treatment’s expected benefits and potential harms, yet reflects patient values.

Screening is a textbook example of why shared decision-making should be our goal. Given the benefits of a disease screening program may be modest, and not without harms, understanding and incorporating individual preference is essential. Some may value the small but incremental benefits of screening, and choose to be screened despite the risks of false positives, investigations, and possible overtreatment. Given the exact same circumstances, another individual may opt to forgo screening, making a different, yet equally acceptable decision. While there are some health interventions for which the benefits are unequivocal, and others for which the harms are just as clear, most health treatments (and interventions like screening) have both benefits and potential harms that must be carefully assessed within the context of patient preferences. Research published earlier this year has identified a significant barrier to truly effective shared decision-making and risk assessment: Across a wide range of interventions, we routinely overestimate the benefits of health treatments, and underestimate their risks. (more…)

Posted in: Diagnostic tests & procedures, Pharmaceuticals, Science and Medicine, Science and the Media

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Still No Association Between MMR and Autism

Pictured: not a risk of autism

Pictured: not a risk of autism

A new study published this week in JAMA, “Autism Occurrence by MMR Vaccine Status Among US Children With Older Siblings With and Without Autism”, puts one more nail in the claim that the MMR is associated with autism.

You may wonder why, after years and multiple studies showing no association between the measles-mumps-rubella vaccine (MMR) and autism spectrum disorder (ASD) there would even be a need for such a study. The authors explain:

Despite research showing no link between the measles-mumps-rubella (MMR) vaccine and autism spectrum disorders (ASD), beliefs that the vaccine causes autism persist, leading to lower vaccination levels. Parents who already have a child with ASD may be especially wary of vaccinations.

The study is a retrospective cohort study involving 95,727 children with older siblings. They looked at whether or not the older sibling had a diagnosis of ASD, whether or not they were vaccinated with MMR, and whether or not they themselves developed ASD. They found:

MMR vaccination rates (≥1 dose) were 84% (n = 78 564) at age 2 years and 92% (n = 86 063) at age 5 years for children with unaffected older siblings, vs 73% (n = 1409) at age 2 years and 86% (n = 1660) at age 5 years for children with affected siblings. MMR vaccine receipt was not associated with an increased risk of ASD at any age. For children with older siblings with ASD, at age 2, the adjusted relative risk (RR) of ASD for 1 dose of MMR vaccine vs no vaccine was 0.76 (95% CI, 0.49-1.18;P = .22), and at age 5, the RR of ASD for 2 doses compared with no vaccine was 0.56 (95% CI, 0.31-1.01; P = .052). For children whose older siblings did not have ASD, at age 2, the adjusted RR of ASD for 1 dose was 0.91 (95% CI, 0.67-1.20; P = .50) and at age 5, the RR of ASD for 2 doses was 1.12 (95% CI, 0.78-1.59; P = .55).

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Posted in: Vaccines

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Dr. David Villarreal’s “Holistic Dentistry:” Full of Holes?

Screenshot of the "BioDental Healing" website showing the "Meridian Tooth Chart".

Screenshot of the “BioDental Healing” website showing the “Meridian Tooth Chart”.

I get a lot of e-mails from publicists offering suggestions for articles and interviews with their clients. I quickly delete most of them, but one recently caught my eye. It said that patients travel from as far as Europe and Africa to have California “holistic dentist” Dr. David Villarreal remove the old silver fillings that are damaging their health. He has removed 20,000 of them in his 30-year career; removing fillings accounts for 75% of his practice. It said your dental fillings could be killing you – and not just the mercury in your “silver” fillings. Dr. Villarreal says that filling materials that are not compatible with your particular body chemistry can suppress immune responses, leading to a host of illnesses from frequent colds to autoimmune diseases to far worse conditions. He performs a blood compatibility evaluation to pick the right material for your body. He picks the right composite to maintain optimum health and help heal the immune system. (more…)

Posted in: Acupuncture, Dentistry

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Stem cells versus Gordie Howe’s stroke, part 3

Gordie Howe in his Red Wings days.

Gordie Howe in his Red Wings days.

Here I am in Philadelphia attending the 2015 American Association for Cancer Research (AACR) meeting to imbibe the latest basic and translational science about oncology. So what am I doing in my non-conference time? I’m holed up in my hotel room near Rittenhouse Square writing a DoD Grant and this post. Fortunately, I am nearly done with the grant, with nothing I can do until I receive one last letter of support from a person who, as much as he’s my bud, is incredibly annoying and always makes me sit on pins and needles waiting for his letter of support. (Those of you who’ve applied for a lot of grants know what I mean.) Then tomorrow I will have to assemble the PDF package to get to my grants office two days before the deadline, which is pushing it to make sure they get it uploaded to Grants.gov in time. Fun times.

With the Stanley Cup playoffs just getting underway (complete with the ugly faux “Stanley Cup” made out of garbage cans our next door neighbor’s son puts on his lawn every year, bathed in red light for the Red Wings), it’s also the perfect time to revisit a story I’ve written about a couple of times before right here on this very blog. I’m referring (this time) to the story of hockey legend Gordie Howe and news stories of his “miraculous” recovery from a serious stroke suffered back in October due to treatment at a stem cell clinic in Tijuana back in December. Of course, when I looked into it, there were a lot of holes in the story and clearly a lot of hype on the part of several parties: Howe’s son Murray Howe, whose love for his father apparently blinded him to some rather obvious issues with the care that his father was receiving and whether it was responsible for his recovery; Stemedica, the American stem cell company based in San Diego that sells its stem cells to a dubious Mexican stem cell company, Novastem, for use outside its U.S. clinical trials; and, of course, the credulous sports media, led by that most credulous of the credulous (with respect to Gordie Howe), Keith Olbermann, who was none too pleased with a certain not-so-pseudonymous “friend” of SBM and completely embarrassed himself in the process of attacking anyone who questioned whether stem cells caused Howe’s recovery. The whole story did have one salutary effect, though. It introduced me to a real stem cell scientist, Paul Knoepfler, who did a guest post for us.

It’s been a couple of months since I last paid attention to what was going on with Gordie Howe’s recovery. Fortunately, our very own Scott Gavura tweaked me by sending me a story by Avis Favaro and Elizabeth St. Philip that appeared over the weekend in the Toronto Star, entitled “A closer look at the startling recovery of Gordie Howe.” Accompanying the story is a broadcast on CTV’s W5 entitled “Gordie’s Comeback”. (See part 1, part 2, part 3.) Also accompanying all of this is a press release discussing how a Canadian stem cell researcher visited Novastem and left unimpressed.
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Posted in: Clinical Trials, Neuroscience/Mental Health, Science and the Media

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Mediocre Expectations

Pictured: Relevant.  Oh yeah, it's going to get weird. Image courtesy of the Wellcome Trust Image Library via the Wikimedia Commons.

Pictured: Relevant. Oh yeah, it’s going to get weird.

I had a dickens of a time writing this entry. The last week has been spent in New York for NECSS. It is safe to say that New York has plenty of distractions for us Dug the Dog types. Reality may be a honey badger, but New York is a squirrel. I say that when I travel I usually do not come across food better than I can find in Portland. Nope. Not true of New York. It joins Paris and New Orleans in the holy trinity of good eats, although I will stick with Pacific Northwest beer. And the rule is that for every day you are gone, three days’ worth of work piles up. I really need to stop taking time off.

I spoke at NECSS on a favorite topic of mine, how acupuncture works. It doesn’t. But I discussed a few studies that I found interesting. Like all studies, no single paper is definitive. The third law of the medical literature states that for every study, there is an equal and opposite study. A bit of an exaggeration perhaps but I do find the direction that the following studies point interesting both as to acupuncture’s mechanism of inaction and how the mind functions, making them worth collecting in an essay. (more…)

Posted in: Science and Medicine

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Anesthesia-Assisted Rapid Opioid Detox

Legitimately prescribed drugs can be stolen from a medicine cabinet a few at a time, usually without notice. From the Iowa Governor's Office of Drug Control Policy.

Legitimately prescribed drugs can be stolen from a medicine cabinet a few at a time, usually without notice. From the Iowa Governor’s Office of Drug Control Policy.

Opioids are widely available as prescription drugs for pain: hydrocodone (e.g., Vicodin), oxycodone (e.g., OxyContin, Percocet), morphine (e.g., Kadian, Avinza), and codeine. Heroin, which has no medically approved use, is also an opioid. Unfortunately, opioids are also widely abused.

How enticing it is to imagine a magic bullet for opioid drug addiction. Addiction causes huge social problems. Yet it is hard to treat and suffers from a stigma that does not attach to other chronic diseases, like diabetes. Drugs like naltrexone, methadone and buprenorphine, as well as behavioral therapies, are common opioid addiction treatments, although the relapse rate for addiction treatment is high.

One of the barriers to treatment is the addict’s fear of the side effects of withdrawal, which can be extremely uncomfortable, including nausea, cramping and vomiting. It is no wonder, then, that the opioid addict and his family would be drawn to a detoxification procedure advertised as both rapid, to speed up the initiation of relapse-prevention therapy, and relatively painless: anesthesia-assisted rapid opioid detox (AAROD), sometimes called ultra-rapid detox, or even just plain rapid detox, although the latter also refers to detox under lighter sedation.

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Posted in: Clinical Trials, Legal, Pharmaceuticals, Politics and Regulation

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WHO Statement on Reporting Clinical Trials

Flag of the World Health Organization (WHO)

Flag of the World Health Organization (WHO)

The World Health Organization (WHO) has recently released a new position statement on mandatory reporting of all interventional clinical trials. This is a positive step in the trend towards higher quality and greater transparency in clinical trials.

The underlying ethical concept here is that the public has a right to data that results from experimentation on humans. The researchers do not ethically own that data. They have been granted the privilege of performing research on humans as part of a social contract that includes the timely public reporting of the data.

The WHO statement calls for all registered clinical trial results to be made public in an open-access public forum in a searchable format within 12 months, and publication in the peer-reviewed literature within 24 months. They urge more rapid dissemination, but state that the 12/24 month time frame is the upper limit of when results should be reported.

The WHO statement is part of a larger trend toward greater transparency but also quality in scientific research. It is part of a recognition that we cannot understand how to best practice medicine and allocate resources based upon individual studies. We need to look at the entire scientific literature as a whole. Even when individual studies may be of high quality, there are many potential factors that can distort the scientific literature and therefore misinform doctors, scientists, and regulatory agencies. (more…)

Posted in: Science and Medicine

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Cancer Centers and Advertising Practices

Video advertisement for the Cancer Treatment Centers of America, hosted on their website. Note at the bottom the statement “No case is typical. You should not expect to experience these results” (click to embiggen).

You have probably seen the TV commercials or other ads for Cancer Treatment Centers of America. They make it sound like “the place to go” if you have cancer. They claim to be “different,” to combine the best cancer technologies with natural therapies in a humane, patient-centered approach that helps you fight the disease and maintain your quality of life. They offer a kinder, gentler, more effective oncology. Those ads are misleading.

Dr. Gorski has written about the practices of Cancer Treatment Centers of America here and here. He has shown how they “integrate” real medicine with nonsense like homeopathy and how they misrepresent components of science-based medicine like exercise and diet, re-branding them as “alternative.”

A recent study by Vater et al. published in the Annals of Internal Medicine asked “What are cancer centers advertising to the public?” They found that the ads appealed to emotion, failed to provide important information, falsely portrayed testimonials as typical, and should be viewed as critically as any other advertising. (more…)

Posted in: Cancer, Medical Ethics, Science and the Media

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The Wild West: Tales of a Naturopathic Ethical Review Board

Two recent SBM posts have used the “Wild West” metaphor for poor health care regulation. Arizona may be the wildest: a worst-case scenario of a state licensing pseudoscience as medicine, under the cover of so-called naturopathy “research.” (Photo courtesy of the Orange County Archives, some rights reserved).

Right before I left the naturopathic profession, an Arizona naturopath told me that “all NDs are doing something borderline illegal.” Alarmed, I began looking around me.

Arizona naturopathic cancer clinics promote illegal substances, advertise results that are too good to be true, and use compounds that have yet to be proven effective in humans. Many clinics focus on intravenous therapies using ozone, hydrogen peroxide, sodium bicarbonate, vitamin C, and blood UV irradiation; some drugs and herbal preparations for injection are claimed to be imported from Europe.

In Arizona, current regulation enables naturopaths to craft hollow research projects under the cover of a private naturopathic institutional review board (an IRB, also often called an ethical review board). This allows them to legitimize experimentation on patients in private clinics and expand the naturopathic scope of practice in the name of so-called research. The IRB appears to influence the state’s naturopathic board, which seems reluctant to do its job properly.

Naturopathic regulation in Arizona may be the worst-case scenario of any state licensing pseudoscience as medicine. The ramifications are grave. Patients, especially those with cancer or other serious conditions, are easily duped and can be severely harmed by medical practitioners who seem kind, charismatic, and confident, but are actually inept and experimenting without the oversight of an ethical review board.

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Posted in: Health Fraud, Legal, Medical Ethics, Naturopathy, Science and Medicine

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March Madness: Basketball, Brackets and Psi! Oh my!

complicatedgraph

A complicated graph, shown here mere moments before proving the existence of precognition

In 2011, psychologist Daryl Bem published a highly controversial series of nine experiments designed to tease out the potential existence of precognition, the ability to experience future events. In order to isolate the potential influence of future events on the present, Bem’s experimental design reversed the standard order of psychological investigations. In one experiment, for example, subjects were allowed to practice with random words after having already taken a memory test comprised of some of them.

Bem’s results were controversial for many reasons, mostly because they were positive. But the question of whether or not they should have even been published in the first place, regardless of the results, was raised by many in the scientific and skeptical community. As history has shown us repeatedly, the risk of falsely legitimizing nonsense by publishing positive but typically poorly-designed studies is very real. And negative studies tend to be ignored by believers and policy makers.

Bem’s experimental design was made available from the beginning of his research in 2002, and he encouraged others to perform their own studies. Unfortunately for Bem, attempts at replicating his findings were largely reported, if not always published, as negative. Apparently this was not enough to discourage the intrepid believer. In fact, he currently has a meta-analysis of 90 experiments using the same protocols as his original research under editorial review.

The conclusions of his new analysis [PDF] are, not surprisingly, supportive of the existence of precognition, and in his manuscript he attempts to address all of the skepticism regarding his findings. He even quotes Feynman and implies that physicists are taking the possibility of quantum-based explanations of psi seriously. It’s an interesting read to say the least.

What does NCAA basketball have to do with the topic of psi research?

A new name in the field of parapsychology research has been making headlines since going public with his efforts on the 1st of the month, and not surprisingly the media coverage is increasing now that his findings have been announced. Dr. Mort Fishman, a psychologist and paranormal researcher out of Tuono di Legno University in Florence, has ingeniously incorporated one of the world’s most popular sporting events, the NCAA Men’s Basketball Tournament, into a study of precognitive abilities. The results, if they are to be believed, may change the minds of even the hardiest psi skeptics.

In anticipation of March Madness each year, millions of basketball fans around the world fill out tournament brackets in an attempt to correctly predict which teams will win, and ultimately who will emerge victorious from the championship game. Many make a contest out of it, with office pools now a nearly ubiquitous aspect of life this time of year. ESPN even holds a Tournament Challenge, the winner of which is given a chance for $20,000 and a trip to Hawaii. It might even be Mitt Romney this year, leading some to regret their vote in the 2012 Presidential election.

The reasons people give for their choices are myriad, ranging from a thorough evaluation of the various teams’ stats to something as primitive and powerful as a gut feeling or how cute the mascot is. Fishman, an avid basketball fan who played three seasons for the European Basketball Federation’s Florence Nightingales, set out at the beginning of the NCAA college basketball season to determine if there might be a precognitive component to these choices. Inspired by Bem’s study designs, he also incorporated a reversal of standard protocols into his research.

The typical approach to filling out a bracket is to do so before the first game of the tournament. In fact, most official contests require it in order to avoid any unfair advantage. Fishman, who had a league record foul-to-rebound ratio of 2.5 during his stint on the Nightingales, instead asked study participants to fill out their bracket after the completion of the championship game, which was won by beloved perennial tournament underdogs, the Duke Blue Devils. According to Fishman, the most challenging aspect of the study was preventing participants from being exposed to any potential contamination with information about the teams during the season.

We went to great expense to protect subjects from potential bias or even outright cheating by basing their bracket picks on outside information. They were sequestered in a reasonably priced hotel, without access to the internet, television, or radio from November 1st of last year through Monday night. They were not allowed to speak to anyone outside of each other and us. No family. No friends. I think there were a few old Reader’s Digests and maybe a Redbook in the room. Progress requires sacrifice.

Once the brackets were completed and turned over to the research team, the real science began. Each subject entered a sensory deprivation tank and was randomly exposed to the results of 25 of the tournament’s 67 total games. The brackets were analyzed using math to see if subject picks were retroactively impacted by knowing the result of games after the fact. Choosing to courageously forego the stifling process of peer review, Fishman announced the positive findings at a press conference held in the parking lot of a Buffalo Wild Wings eight minutes from Lucas Oil Stadium on East Washington Street in Indianapolis.

Conclusion

As believers in Science-Based Medicine, we must have open minds when it comes to fringe or even highly implausible claims because you never know when seemingly-incontrovertible assumptions about the natural world will be proven wrong. Science is imperfect and historically has been very wrong on many occasions. Experts used to believe that the Earth was flat and we still don’t know how Tylenol even works.

Intellectual humility is a key component of scientific skepticism. Sometimes ideas which were ridiculed turn out to be true. Having a closed mind might help prevent any untrue new idea from being accepted, but some of them are pretty interesting and already very popular with the public. Who are we to judge truth from fiction?

Though the existence of psi has now been proven by the Fishman study, it doesn’t mean that more studies aren’t needed. In fact, the hard part lies ahead. We need to figure out how best to harness its potential in order to improve patient outcomes, and only science can lead the way in that regard. But we must not be afraid of the unknown or of different approaches to discovery. As Endocrinologist Dr. Deepak Chopra said, “All great changes are preceded by chaos.”

 

 

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