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Modern-day medicine is supposed to be evidence-based, meaning that treatment recommendations are guided by up-to-date, reliable data from well-designed clinical research. But too often, medical charlatans deceive patients by promoting "miracle" treatments for which there is not evidence of safety or effectiveness.
We recently exposed the case of a clinic that had taken patient deception to new heights by falsifying scientific journal citations in its promotion of a now-illegal...
Modern-day medicine is supposed to be evidence-based, meaning that treatment recommendations are guided by up-to-date, reliable data from well-designed clinical research. But too often, medical charlatans deceive patients by promoting "miracle" treatments for which there is not evidence of safety or effectiveness.
We recently exposed the case of a clinic that had taken patient deception to new heights by falsifying scientific journal citations in its promotion of a now-illegal heart-toxic drug called cesium chloride for treatment of cancer.[1] Utopia Wellness — located just outside of Tampa, FL — promoted on its website intravenous cesium chloride as an alternative treatment for cancer and calls the chemical "safe"[2] despite Food and Drug Administration (FDA) scientists finding that it can cause fatal heart rhythm disturbances and sudden death. Intravenous cesium chloride is not an FDA-approved drug and has been available only through pharmacy compounding.
The Utopia Wellness website also stated, "As evidenced by the numerous studies cited below, this powerful… therapy has had astounding success in certain cancers."[3] But there is no evidence from any well-designed clinical trials to support this claim. Moreover, 30 citations of scientific papers listed on the website as purported evidence for this claim were clearly deliberately falsified. Specifically, these cited articles all relate to medical uses of ozone, but the word "ozone" in the actual title of each cited paper has been replaced with the words "cesium chloride." These papers have nothing to do with cesium chloride.
Importantly, in July, the FDA took regulatory action[4] that prohibits the use of cesium chloride in pharmacy compounding because agency scientists had determined more than two years ago that the chemical is "not safe for human use" and has not been shown to be effective "for the prevention or treatment of any form of cancer."[5] As a result, cesium chloride can no longer be legally used in pharmacy compounding.
On Oct. 9, we called on the Federal Trade Commission to investigate Utopia Wellness' advertising practices and urged the agency to demand that the clinic cease its deceptive promotion of cesium chloride.[6] We also asked the FDA to examine the clinic's use of cesium chloride for treatment of cancer since July and to take appropriate enforcement action if the agency finds that the clinic continued to compound cesium chloride after the prohibition against its use in pharmacy compounding went into effect.[7]
Utopia Wellness' deliberate falsification of scientific paper citations on its website represented a brazen attempt to dupe vulnerable cancer patients into believing that cesium chloride is safe and effective for treating cancer. Federal regulators must ensure that Utopia Wellness faces severe consequences for promoting such quackery and endangering the lives of patients.
References
[1] Public Citizen. Florida medical center fabricated study citations to make illegal, life-threatening cancer treatment appear safe and effective. October 9, 2018. https://www.citizen.org/media/press-releases/florida-medical-center-fabricated-study-citations-make-illegal-life-threatening. Accessed November 5, 2018.
[2] Utopia Wellness. Cesium chloride. https://utopiawellness.com/cesium-chloride-for-cancer-2/. Accessed November 5, 2018.
[3] Ibid.
[4] Food and Drug Administration. FDA alerts health care professionals of significant safety risks associated with cesium chloride. July 23, 2018. https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm614211.htm. Accessed November 5, 2018.
[5] Food and Drug Administration. FDA briefing document, Pharmacy Compounding Advisory Committee (PCAC) meeting. FDA. June 23, 2016. https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PharmacyCompoundingAdvisoryCommittee/UCM505041.pdf. Accessed November 5, 2018. PDF page 70.
[6] Public Citizen. Letter to the Federal Trade Commission. https://www.citizen.org/sites/default/files/2448.pdf. Accessed November 5, 2018.
[7] Public Citizen. Letter to the Food and Drug Administration. https://www.citizen.org/sites/default/files/2449.pdf. Accessed November 5, 2018.
