Health Letter, November 2018
By Michael Carome, M.D. and Meena Aladdin, M.S., Ph.D.
If you’re not outraged,
you’re not paying attention!
Read what Public Citizen has to say about the biggest blunders and outrageous offenses in the world of public health, published monthly in Health Letter.
Modern day medical practice is supposed to be evidence-based, meaning that treatment recommendations are guided by up-to-date, reliable data derived from well-designed clinical research. But too often, medical charlatans seeking to line their own pockets deceive patients by promoting “miracle” treatments for which there is a lack of evidence of safety and effectiveness.
Last month, Public Citizen exposed the case of a Florida-based medical center that has taken patient deception to new heights by falsifying scientific citations in the advertisement and promotion of an illegal heart-toxic drug, called cesium chloride, for treatment of cancer.
Utopia Wellness — located just outside of Tampa and led by Dr. Carlos Garcia, its Director of Medicine and apparently only physician — promotes on its website the use of intravenous cesium chloride as an alternative treatment for cancer and calls the chemical “safe” despite Food and Drug Administration (FDA) scientists finding that it can cause fatal heart rhythm disturbances and sudden death. Cesium chloride is not an FDA-approved drug and has been available only through pharmacy compounding.
The medical center’s online promotional materials also claim the following:
As evidenced by the numerous studies cited below, this powerful…therapy has had astounding success in certain cancers.
But there is no evidence from any well-designed clinical trials to support this claim. Moreover, we discovered that 30 citations of scientific papers listed on Utopia Wellness’ website as purported evidence for this claim were clearly deliberately falsified. Specifically, these cited articles all related to research on or 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 had nothing to do with cesium chloride.
In July, the FDA partially granted Public Citizen’s 2017 petition requesting that the agency prohibit 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.” As a result of the agency’s July action, cesium chloride cannot be legally used in pharmacy compounding.
On Oct. 9, we sent a letter to the Federal Trade Commission (FTC) calling for an immediate investigation of Utopia Wellness’ advertising practices and urging the agency to demand that the medical center cease and desist its deceptive promotion of cesium chloride. That same day, we also asked the FDA to examine the medical center’s promotion and use of cesium chloride for treatment of cancer since July and to take appropriate enforcement action if the agency finds that the medical center continued to compound cesium chloride after the prohibition against its use in pharmacy compounding went into effect.
In addition, on Oct. 24, we sent a letter to the Florida Board of Medicine asking for an investigation of Dr. Garcia’s role in Utopia Wellness’ dissemination of false and misleading advertisements promoting the use of the drug cesium chloride. We also asked the board to determine whether Dr. Garcia and his staff have continued to treat cancer patients with compounded intravenous cesium chloride since late July 2018, in violation of FDA regulations. We urged the board to revoke his medical license if our allegations are confirmed.
Utopia Wellness’ deliberate falsification of scientific paper citations on its website represents a brazen attempt to dupe vulnerable cancer patients into believing that cesium chloride is safe and effective for treating cancer. In addition to causing financial harm to these patients, the medical center has exposed them to a drug that poses life-threatening risks but offers no proven benefits.
Federal and state regulators must ensure that Utopia Wellness faces severe consequences for promoting such quackery and endangering the lives of patients.