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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!

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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.”

 

 

Posted in: Humor, Science and Medicine

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Supplements are the Wild West of health. One Attorney General is out to change that.

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Bold moves from the New York State attorney general’s (AG) office are shaking up the supplement industry. In February, the AG accused four retailers (GNC, Target, Walmart, and Walgreens) of selling supplements that failed to contain their labelled ingredients. Using a testing method called “DNA barcoding“, the AG’s office concluded that few of the products it tested actually contained the labelled ingredient, and some contained undisclosed ingredients. It demanded that they stop the sale of those products. All four retailers complied.

When the recall occurred, I noted that the AG may not have had an airtight case: manufacturers and other critics challenged the AG’s methodology, claiming that DNA barcoding was unvalidated, inappropriate, and insufficient. They also stated that the DNA may not survive processing, so the absence of DNA didn’t imply a lack of the original product. Some claimed that the “contaminants” that AG found could have been acceptable fillers. The Attorney General refused to release further information about the testing methods it used, raising further questions about its validity. (more…)

Posted in: Herbs & Supplements, Politics and Regulation

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Wikipedia vs Quackery – Standards vs Chaos

Wikipediasmall

Wikipedia’s front page

Wikipedia, an online open-source encyclopedia, can boast 470 million visitors each month, making it one of the most popular websites on the internet. It is an incredibly useful resource – I think it’s fair to say it is the online reference of record. For that reason people care how topics important to them are represented in Wikipedia.

Wikipedia, in fact, has become no less than a battleground over certain controversial topics. In essence people generally want Wikipedia to reflect their opinions on controversial topics, and if it doesn’t then there must be something wrong with Wikipedia (rather than there being something wrong with their opinions). I don’t mean to imply that Wikipedia always gets it right – it is a crowdsourced reference and the content is only as good as the editors. But at least they make honest efforts to be neutral and to have standards.

Those standards are the real conflict here, and it is part of a broader conflict over standards. In medicine there is a standard of care, which in turn is based on an underlying system of professional and scientific standards. Medical education is standardized, students have to pass standardized exams, post-graduate clinical training is standardized, there are standardized exams for specialty certification, there are ethical standards enforced by institutions, hospitals, professional organizations, and the state boards of health, and peer-reviewed journals have standards.

This is all meant to ensure that individual patients receive the highest quality of care.

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Posted in: Politics and Regulation, Science and Medicine

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Healthy Habits Global: Spreading False Information about an MLM Coffee with Herbal Additives

Another kind of coffee pyramid scheme. Largest pyramid of coffee cups from the India Book of Records.

Another kind of coffee pyramid scheme. Largest pyramid of coffee cups from the India Book of Records.

When my husband was helping a friend with a project at the house of someone he didn’t know, the lady of the house gave him an earful about the health benefits of the coffee sold by Healthy Habits Global (HHG), a multilevel marketing (MLM) enterprise for which she is a distributor. She sent him home with samples and a brochure with a long list of health claims. She told him she could provide lots of testimonials, and there was a wealth of evidence for her products on PubMed.

Before believing any health claims, especially from an unknown source, it is only prudent to examine the evidence. I consulted the company website, PubMed, and other sources; and I learned that the company’s advertising was full of false information and the whole rationale of the products was questionable. I am not persuaded that HHG coffee has any health benefits. It appears to be just another in a long line of gimmicks used by MLM businesses to sell untested, usually ineffective “health” products to gullible consumers who have little knowledge of science. (more…)

Posted in: Herbs & Supplements

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Integrative medicine, naturopathy, and David Katz’s “more fluid concept of evidence”

The Integrative Medicine Wheel

The Integrative Medicine Wheel

Dr. David Katz is undoubtedly a heavy hitter in the brave new world of “integrative medicine,” a specialty that seeks to “integrate” pseudoscience with science, nonsense, with sense, and quackery with real medicine. In fairness, that’s not the way physicians like Dr. Katz see it. Rather, they see it as “integrating” the “best of both worlds” to the benefit of patients. However, as we’ve documented extensively here, on our personal blogs, and even in the biomedical literature (plug, plug), what “integrative” medicine means in practice is indeed what I characterized, the infiltration of woo into medicine. This infiltration seems to have started mainly in academia—hence the term “quackademic medicine” and “quackademia”—with the steady infiltration of nonsense into medical schools and academic medical centers, but has since metastasized to the world of community hospitals. This “integration” (or, as I like to refer to it, “infiltration”) has become so pronounced that a few years ago The Atlantic published an article entitled “The Triumph of New Age Medicine“, and just last December the Journal of the National Cancer Institute (JNCI) published a monograph full of articles touting “integrative oncology,” including guidelines recommended by the Society of Integrative Oncology (SIO) for the “integrative” treatment of breast cancer symptoms.

I mention Dr. Katz for two reasons. First, he’s taken another broadside at us at Science-Based Medicine in blog entry at The Huffington Postwhere else?—entitled “Holism, Holes and Poles” that I’ve been meaning to address for a while. But before I address Dr. Katz’s most recent complaint against science-based medicine (SBM), it’s necessary to step back and look at some history.
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Posted in: Clinical Trials, Homeopathy, Medical Academia, Naturopathy

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FDA and Homeopathy: Part Two.

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Edward De Vere.  Sort-of.

Friends, FDA, countrymen, lend me your ears;

I come to bury Homeopathy, not to praise it.

The evil that homeopaths do lives after them;

The good is oft interred with their bones;

So let it be with Homeopathy. The noble Ullman

Hath told you homeopathy was effective:

If it were so, it was a grievous fault,

And grievously hath Homeopathy answer’d it.

Here, under leave of Ullman and the rest–

For Ullman is an honourable man;

So are they all, all honourable men–

Come I to speak in Homeopathy’s funeral.

It was my nostrum, faithless and worthless to me:

But Ullman says it was effective;

And Ullman is an honourable man.

He hath brought many provings home to HPUS

Whose prescriptions did the general coffers fill:

Did this in Homeopathy seem effective?

When that the ill have died, Homeopathy hath wept:

Efficacy should be made of sterner stuff:

Yet Ullman says it was effective;

And Ullman is an honourable man.

You all did see that on the Cochrane

I thrice presented Homeopathy a meta-analysis,

Which he did thrice refuse: was this efficacy?

Yet Ullman says it was effective;

And, sure, he is an honourable man.

I speak not to disprove what Ullman spoke,

But here I am to speak what I do know.

Edward De Vere, 17th Earl of Oxford. Sort of.

We only have a vague idea as to what other bloggers are going to write about. Yesterday Jann wrote on the same topic (and Scott the week before), which I will read tomorrow after my post goes up. Why would I want my post to be informed by another’s well-reasoned and thoughtful essay? I have a reputation after all. So here is my response to the FDA. (more…)

Posted in: Homeopathy, Legal

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How should the FDA regulate homeopathic remedies?

Hyland's "4 Kids Complete Allergy" homeopathic preparation (not for use with food allergies)

Hyland’s “4 Kids Complete Allergy” homeopathic preparation (not for use with food allergies), one of many unregulated, unproven over-the-counter preparations sold in the United States

The FDA announced recently that it is holding a public hearing on April 21 and 22,

to obtain information and comments from stakeholders about the current use of human drug and biological products labeled as homeopathic, as well as the Agency’s regulatory framework for such products. These products include prescription drugs and biological products labeled as homeopathic and over-the-counter (OTC) drugs labeled as homeopathic. FDA is seeking participants for the public hearing and written comments from all interested parties, including, but not limited to, consumers, patients, caregivers, health care professionals, patient groups, and industry.

It’s about time. We know that homeopathic remedies are not, and cannot be, effective. I will not plough that ground again here. Unfortunately, the FDA does not have any authority to bar these fraudulent products from sale altogether. Only Congress can do that.

In this post, I review the current regulatory framework for homeopathic products. I then explore the possibilities, given the opportunities for regulatory change presented by the FDA at this time. In doing so, I answer some of the questions posed by the FDA in its formal notice of the hearing, printed in the Federal Register.

I argue that the FDA has no statutory authority for the manner in which it currently regulates (or, actually, doesn’t regulate) homeopathic drugs. I further argue this system, largely controlled by the homeopathic industry, must be abandoned, and that there is no reason why homeopathic drugs should not be regulated just like any other OTC or prescription drug.

(Note to those wanting to submit written comments or attend the hearing: there are deadlines and other requirements for participation. You can read those in the Federal Register.)
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Posted in: Clinical Trials, Homeopathy, Legal, Politics and Regulation

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