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Alzheimer's disease is the most common form of dementia, afflicting approximately 5.7 million Americans.[1] The number of patients with this progressive and irreversible brain disorder is expected to rise rapidly over the next few decades as the U.S. population continues to age.
Given the devastating effects of Alzheimer's disease and the lack of any effective treatments for slowing or reversing its progression, patients afflicted with the disease and their loved ones are desperate...
Alzheimer's disease is the most common form of dementia, afflicting approximately 5.7 million Americans.[1] The number of patients with this progressive and irreversible brain disorder is expected to rise rapidly over the next few decades as the U.S. population continues to age.
Given the devastating effects of Alzheimer's disease and the lack of any effective treatments for slowing or reversing its progression, patients afflicted with the disease and their loved ones are desperate for a miracle cure. Unsurprisingly, an increasing number of unscrupulous companies are seeking to exploit these vulnerable patients by marketing illegal drug products purported to treat, delay or cure their disease.
In February, the Food and Drug Administration (FDA) warned consumers to watch out for the false promises made by the purveyors of these illegal products[2] and simultaneously announced that the agency had issued warning letters to a dozen such companies.[3] These products, which come in a wide array of tablets, capsules and oils, are sold primarily on the internet and frequently are falsely labeled as dietary supplements.[4]
Examples of the false health claims made in the advertisements for these drug products include the following:
- "You can even reverse mental decline associated with dementia or even Alzheimer's in just a week"
- "Clinically shown to help disease of the brain such as Alzheimer's and even dementia"
- "Supplements are used to cure Alzheimer's disease"
- "Can...reduce the risk of Alzheimer's by half"
- "May have a role in preventing the progression of Alzheimer's"
- "Provides many benefits in addition to improving brain health... includng...removal of Amyloid plaque in the brain."[5],[6]
Besides being a waste of money and conveying false hope, these products in some cases may pose serious health risks because they have not been evaluated by the FDA for safety and effectiveness. In addition, the ingredients in these products may have dangerous interactions and potentially interfere with other prescription medications.[7] They also could cause patients to defer seeking appropriate diagnosis and management for their condition.[8]
In its recent warning letters to the companies engaged in illegal marketing of drug products for treating Alzheimer's disease, the FDA threatened to take additional actions, including seizure of the products and court injunctions, unless the companies took prompt action to stop violating FDA regulations.
Importantly, the dozen companies targeted with warning letters by the FDA undoubtedly represent the tip of the iceberg, as countless other companies peddle similar products.
Therefore, an educated and skeptical consumer is the most important line of defense against these illegal drug products. If you suffer from Alzheimer's disease or are a caregiver of someone with the disease, don't be conned by companies promising miracle cures.
References
[1] Alzheimer's Association. 2018 Alzheimer's disease facts and figures. Alzheimers Dement. 2018;14(3):367-429.
[2] Food and Drug Administration. Watch out for false promises about so-called Alzheimer's cures. February 11, 2019. https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm631046.htm. Accessed February 22, 2019.
[3] Food and Drug Administration. FDA news release: FDA takes action against 17 companies for illegally selling products claiming to treat Alzheimer's disease. February 11, 2019. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm631064.htm. Accessed February 22, 2019.
[4] Food and Drug Administration. Watch out for false promises about so-called Alzheimer’s cures. February 11, 2019. https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm631046.htm. Accessed February 22, 2019.
[5] Ibid.
[6] Food and Drug Administration. Warning letter to BR Naturals. February 5, 2019. https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm630588.htm. Accessed February 22, 2019.
[7] Food and Drug Administration. Watch out for false promises about so-called Alzheimer's cures. February 11, 2019. https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm631046.htm. Accessed February 22, 2019.
[8] Food and Drug Administration. FDA news release: FDA takes action against 17 companies for illegally selling products claiming to treat Alzheimer’s disease. February 11, 2019. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm631064.htm. Accessed February 22, 2019.
