Rather than just railing against this stuff, why don't you set up clinical research trials to prove one way or the other? Or is that too fucking hard? Complaining is much easier and you can sit on your high horse looking down on the riff raff.
The Rise of Pseudomedicine for Dementia and Brain Health
JAMA. Published online January 25, 2019. doi:10.1001/jama.2018.21560
The US population is
aging, and with it is an increasing prevalence of Alzheimer disease,
which lacks effective approaches for prevention or a cure.1
Many individuals are concerned about developing cognitive changes and
dementia. With increasing amounts of readily accessible information,
people independently seek and find material about brain health
interventions, although not all sources contain quality medical
information.
This landscape of limited treatments for dementia,
concern about Alzheimer disease, and wide access to information have
brought a troubling increase in “pseudomedicine.” Pseudomedicine refers
to supplements and medical interventions that exist within the law and
are often promoted as scientifically supported treatments, but lack
credible efficacy data. Practitioners of pseudomedicine often appeal to
health concerns, promote individual testimony as established fact,
advocate for unproven therapies, and achieve financial gains.
With neurodegenerative disease, the most common example
of pseudomedicine is the promotion of dietary supplements to improve
cognition and brain health. This $3.2-billion industry promoting brain
health benefits from high-penetration consumer advertising through print
media, radio, television, and the internet.2
No known dietary supplement prevents cognitive decline or dementia, yet
supplements advertised as such are widely available and appear to gain
legitimacy when sold by major US retailers. Consumers are often unaware
that dietary supplements do not undergo US Food and Drug Administration
(FDA) testing for safety or review for efficacy. Indeed, supplements may
cause harm, as has been shown with vitamin E, which may increase risk
of hemorrhagic stroke, and, in high doses, increase risk of death.3,4
The Alzheimer’s Association highlights these concerns, noting that many
of these supplements are promoted by testimony rather than science.5
These brain health supplements can also be costly, and discussion of
them in clinical settings can subvert valuable time needed for
clinicians and patients to review other interventions.
Patients and caregivers encounter sophisticated
techniques that supply false “scientific” backing for brain health
interventions. For example, referring to scientific integrity, Feynman
coined the term “cargo cult science” to describe endeavors that follow
“…the apparent precepts and forms of scientific investigation, but
they’re missing something essential….”6
Cargo cult science is apparent in material promoting some brain health
supplements; “evidence” is presented in a scientific-appearing format
that lacks actual substance and rigor. Feynman suggested 1 feature of
scientific integrity is “bending over backwards to show how [the study]
may be wrong…,” which is a feature that is often lacking when
interventions are promoted for financial gain.6
A similarly concerning category of pseudomedicine
involves interventions promoted by licensed medical professionals that
target unsubstantiated etiologies of neurodegenerative disease (eg,
metal toxicity; mold exposure; infectious causes, such as Lyme disease).
Some of these practitioners may stand to gain financially by promoting
interventions that are not covered by insurance, such as intravenous
nutrition, personalized detoxification, chelation therapy, antibiotics,
or stem cell therapy. These interventions lack a known mechanism for
treating dementia and are costly, unregulated, and potentially harmful.
Recently, detailed protocols to reverse cognitive
changes have been promoted, but these protocols merely repackage known
dementia interventions (eg, cognitive training, exercise, a
heart-healthy diet) and add supplements and other lifestyle changes.
Such protocols are promoted by medical professionals with legitimate
credentials, offer a unique holistic and personal approach, and are said
to be based on rigorous data published in reputable journals. However,
when examining the primary data, the troubling and familiar patterns of
testimony and cargo cult science emerge. The primary scientific articles
superficially appear valid, yet lack essential features, such as
sufficient participant characterization, uniform interventions, or
treatment randomization with control or placebo groups, and may fail to
include sufficient study limitations. Some of these poor-quality studies
may be published in predatory open access journals.7
An argument can be made that even though pseudomedicine
may be ethically questionable, these interventions are relatively benign
and offer hope for patients facing an incurable disease. However, these
interventions are not ethically, medically, or financially benign for
patients or their families. While appealing to a sense of hope can be a
motivating factor for clinical trials or complementary or alternative
practices, the difference is in how these circumstances are framed.
Complementary or alternative practices are often adjunct treatments and
might not result in direct financial gain by the practitioner
recommending the therapy. Further, in clinical trials, there are
structured conversations between researchers and participants (such as
during the informed consent process) that include research coordinators
explaining that any studied interventions are experimental, may result
in no gain, and can cause harm. In contrast, pseudomedicine may involve
unethical gain for practitioners and manufactured illusion of benefit
for patients.
What Can Be Done?
Health care professionals have the responsibility to
learn about common pseudomedicine interventions. If a patient or family
member inquiries about such an intervention, clinicians can take several
steps:
- Understand that motivations to pursue such interventions often come from a desire to obtain the best medical care, and convey that understanding to the patients.
- Provide honest scientific interpretation of any supporting evidence, along with the associated risks and costs. This approach creates a productive dialogue, rather than dismissing any inquiries outright.
- Appropriately label pseudomedicine interventions as such.
- Differentiate testimony from data, and assess whether studies display scientific integrity by “bending over backward” to address any limitations.
- Suggest an exploration of the financial interests behind the intervention (eg, the sale of supplements, out-of-pocket payments to a clinician or organization, book sales). Note that the gain may not only be financial, but also temporary fame that can accompany spearheading a new protocol.6
- Provide education on the US Dietary Supplement Health and Education Act that limits FDA testing and regulation of supplements.
- Point out that any effective interventions for common diseases would already be widely used.
- Express a willingness to continue to partner with patients in their medical care even if opinions and interpretations about pseudomedicine differ.
Conclusions
It is disheartening that patients with dementia and
their family members are targeted by practitioners and companies
motivated by self-interest. Physicians have an ethical mandate to
protect patients who may be vulnerable to promotion by these entities.
More needs to be done on a national level to limit the claims of benefit
for interventions that lack proven efficacy. Clinicians must
distinguish testimony and cargo cult science from quality medical
research and explain when interventions may appear to represent
pseudomedicine. While unethical forces promote the existence of
pseudomedicine, an educated community of physicians and patients is the
starting point to counteract these practices.
Corresponding Author: Joanna Hellmuth, MD, MHS, 675 Nelson Rising Ln, Ste 190, San Francisco, CA 94158 (Joanna.Hellmuth@ucsf.edu).
Published Online: January 25, 2019. doi:10.1001/jama.2018.21560
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