A California physician could go to prison for allegedly selling an unapproved cancer remedy, after being indicted by a grand jury.
Benedict Liao, MD, now faces 27 charges that include wire fraud, mislabeling his product, and introducing unapproved drugs into interstate commerce.
However, Liao told Medscape Medical News, “I am a cancer researcher, not a criminal.”
The federal indictment was filed January 9 in federal court in Southern California.
Arraignment proceedings followed, and Liao was forced to surrender his passport. He was freed on a $75,000 bond.
His court date has been tentatively scheduled for March 26.
According to the indictment, Liao has been selling Allesgen, which he says is a nontoxic alternative to standard cancer treatment, for up to $2000 a bottle to cancer patients in various states and overseas.
Between 2012 and 2014 he sold about 400 bottles, earning over $800,000 in sales. From July 2014 to January 2018, Liao is said to have sold additional bottles of Allesgen, both in the United States and abroad, earning about another $800,000.
The allegations were based on two inspections that were conducted by the US Food and Drug Administration (FDA) and a review of his website.
Allesgen is made from bromelain, which is extracted from pineapples, and was sold out of Liao’s Oeyama-Moto Cancer Research Foundation in West Covina, California, without a doctor’s prescription.
Long Saga With the FDA
In 2011, Liao filed an investigational new drug (IND) application with the FDA under the alias of Masao Wada, MD, and stated that he planned on conducting a clinical trial of Allesgen. The FDA received the application on December 15, 2011. A month later, the FDA informed him that his application was placed on a full clinical hold.
He submitted another application in October 2012, using the same alias, and the FDA also responded that this too was being placed on a full clinical hold. In both of these correspondences, Liao was informed by the FDA that he could not legally initiate or resume the proposed clinical trials of Allesgen.
In 2014, an FDA letter warned Liao that he was violating federal law in his marketing of Allesgen, in that it was being promoted as a drug. “According to official FDA records,” the letter states, “your INDs have never gone into effect, and were either cancelled or placed on clinical hold.”
An investigational new drug may only be used in a clinical investigation if the IND has gone into effect, and that was not the case with Allesgen.
The FDA also pointed out that he had participated in interstate commerce, which is illegal unless the application of the drug has been approved.
The agency cautioned that Liao should “take prompt action to correct the violations cited in this letter” and that within 15 working days, he should notify the FDA in writing about “the specific steps you have taken to correct violations.”
Two years later, Liao received a second letter from the FDA, citing infractions in regard to clinical trials that he was conducting. Citing several lapses in protocol, the agency stated that “we conclude that you did not adhere to the applicable statutory requirements and FDA regulations governing the conduct of clinical investigations and the protection of human subjects.”
At that time, the FDA again said that he needed to contact the office in writing about the actions he had taken to prevent similar violations in the future. “Failure to explain the violations noted above adequately and promptly may result in regulatory action without further notice,” the letter stated.
Medscape Medical News contacted the FDA for further information, but the agency spokesperson declined to comment, explaining that the FDA does not comment on ongoing litigation.
Cancer Researcher, Not a Criminal
Liao tells a different story, and in an interview with Medscape Medical News insisted that he is “not a criminal.”
He also said that he has at least 100 pages of supporting documents regarding his dealings with FDA.
With respect to the warning letters from the FDA, Liao said that he has been investigating the new drug “#116911” and that it has been registered with FDA since 2014. The phase 2 human trial was registered on May 9, 2014, and was completed in January 2015.
“The complete report had been submitted to FDA for their review and the FDA published our report in their website ‘ClinicalTrials.gov PRS’ which the FDA approved, and they accepted our phase 2 clinical trial results,” Liao said.
Liao added that the phase 2 trial showed a complete response rate of 52% (64 of 126 patients) and a partial response rate of 27% (34 of 126 patients). Stable disease was achieved in 11% (14 of 126 patients), and progressive disease in 10% (12 of 126 patients).
“Our animal toxicity tests were completed on November 14, 2018, and have shown no animal toxicity,” Liao said. “This toxicity test was being performed by Sinclair Research Laboratory in Missouri and the research protocols were approved by FDA on March 6, 2018.”
He also pointed out that Allesgen’s label says that the product is for use as a food supplement only. “We did not call it a drug,” Liao added.
According to his curriculum vitae (CV) and other documents that Liao sent to Medscape Medical News, Liao is a native of Taiwan and graduated from Taipei Medical University. He also lists residencies and fellowships in the United States at the University of Utah, the University of Minnesota, and Temple University, Philadelphia. He has held academic appointments at Drew University in Los Angeles, Temple University, and Taipei Medical University, Taiwan.
According to his CV, for the past 20 years, he has been senior director of the Molecular Biology and Molecular Biochemistry Department at the Oeyama-Moto Cancer Research Foundation in West Covina, California.
The clinic’s website, cancertreatmentus.org, which contains information about Allesgen, is no longer publicly accessible.