“Brain Health” Dietary Supplements Raise Concerns Over Pseudomedicines: JAMA Editorial

Some doctors are warning about the increasing popularity of so-called “pseudomedicine”, which is not backed by scientific evidence and may jeopardize the health of patients with Alzheimer’s and dementia. 

A recent editorial published in the Journal of the American Medical Association (JAMA) warns about dietary supplements advertised as treatments for Alzheimer’s disease, dementia and other neurodegenerative diseases, which may place patients at serious risk since the products are not established to be safe or effective.

The editorial was written by Doctors Joanna Hellmuth, Gil D. Rabinovici and Bruce L. Miller of the Memory and Aging Center at the University of California, San Francisco, and comes as FDA Administrator Scott Gottlieb recently announced new plans to strengthen regulation of dietary supplements.

With an aging population in the U.S., there have been increases in the prevalence of Alzheimer’s and other neurodegenerative diseases. As a result, many companies are now advertising supplements and medical interventions and protocols that are claimed to “treat” these diseases. However, claims about the benefits of these supplements for treatment of Alzheimer’s and improving brain health are simply “pseudomedicine” the doctors warn in this editorial.

These supplements and interventions are promoted as scientifically supported treatments, but in fact, lack credible data backing their efficacy or safety. The supplements and interventions often appeal to an individual’s health concerns, such as Alzheimer’s, and include individual testimony as evidence it works. Yet, the testimony is not proven and is often used simply to sell a product and achieve financial gain.

“These interventions lack a known mechanism for treating dementia and are costly, unregulated, and potentially harmful,” wrote study authors. “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 U.S. retailers.”

The most common example are supplements sold to improve cognition and brain health. This is a $3.2 billion industry focusing on “brain health” and preventing or reversing Alzheimer’s.

Consumers are often unaware the supplements are not tested by the U.S. Food and Drug Administration (FDA) for safety or effectiveness. The agency cannot step in until the supplements have been linked to health and safety problems.

These supplements are promoted by licensed medical professionals using sophisticated techniques like personalized detox, chelation, stem cell therapy or other methods not covered by insurance. They often offer false “scientific” support, the editorial notes.

The “evidence” is presented like a scientific study, but is not backed by rigorous scientific testing and analysis. Real scientific studies place a strong emphasis on attempting to disprove the findings. Studies meant to back products promoted to make money often do not do that.

The “studies” also lack key elements of a real scientific study, such as being randomized or including a control or placebo group. Similarly, they aren’t published in peer reviewed scientific or medical journals.

On February 11, the FDA sent 12 warning letters and five on-line advisory letters to dietary supplement manufacturers the agency says are illegally marketing unapproved drugs, because their supplements claim to treat Alzheimer’s disease and dementia.

Once a dietary supplement makes that kind of claim, it is no longer a supplement, but claiming to be a drug, which requires FDA approval.

Doctors Urged To Combat Pseudomedicine

The editorial’s authors recommend doctors counter this trend by focusing on understanding a patient’s motivation for using these methods and try to offer the best possible help available that is medically proven.

This can include providing honest scientific interpretation of any evidence given from supplement companies, along with the potential risks and costs. It is important to refer to these interventions as pseudomedicine, since they are not based in scientific or medical research, the study authors advised.

Any testimony given on behalf of the supplement should be compared to scientific data and evaluated for scientific integrity.

Authors of the study are calling on patients and medical providers to become a community where education flourishes to counteract pseudomedicine.

“More needs to be done on a national level to limit the claims of benefit for interventions that lack proven efficacy,” study authors emphasized.