A physician who was the subject of a 2018 Milwaukee Journal Sentinel/MedPage Today investigation has been indicted by federal prosecutors as part of an alleged $1.6-million scheme to sell an unapproved cancer drug to patients around the country.
The 27-count fraud indictment, filed Jan. 9 in federal court in California, says Benedict Liao, MD, had been selling his unapproved cancer treatment known as Allesgen over a six-year period to people in seven states, charging up to $2,000 a bottle.
Liao, who also used the name Masao Wada, made the drug in Fullerton, California, according to the indictment. According to a 2013 patent filing by Liao, Allesgen is a pineapple extract.
Last summer’s Journal Sentinel/MedPage Today investigation found Liao had been told by the FDA that he could not sell the drug or continue to conduct a clinical trial of it — yet he was continuing to do both. His website is still actively promoting the treatment (as of Feb. 8) and claims that it “passed US Food and Drug Administration Phase II human testing on January 25th, 2015.” However, according to the indictment, the FDA never approved any trials by Liao and, in fact, ordered him to stop clinical testing via “full clinical hold.”
The indictment said Liao knowingly devised a scheme to defraud people who bought Allesgen, failing to tell them it was not an approved cancer treatment and that it had serious, unpredictable side effects that could be long-lasting — or even lead to death.
Liao pleaded not guilty Jan. 28 at his arraignment in Santa Ana, California. In a phone call Thursday, he said what he is accused of “is not a crime or any illegal activity.”
He told a reporter he could not comment further.
Liao operates the Oeyama-Moto Cancer Research Foundation and Oeyama-Moto Medical Group in West Covina, California.
Last year’s investigation by the Journal Sentinel and MedPage Today focused on physicians who face discipline issues in one state — often losing their licenses — but are able to keep practicing in other states.
In August, an installment in the investigation included Liao as one of 73 physicians around the country with active medical licenses who got FDA warning letters over a five-year period alleging serious problems. The investigation found only one had been disciplined by a state medical board.
The problem: The FDA letters generally are not sent to state medical boards, and the boards typically do not check them.
In the wake of the investigation, the California medical board began monitoring the FDA letters sent to doctors engaged in potentially harmful practices.
The medical board in Wisconsin did the same and the FDA said it would start notifying state boards of potential patient safety issues raised in its letters, at least on a case-by-case basis.
In 2014, an FDA letter warned Liao about violating federal law in his marketing of Allesgen as a cancer treatment. The allegations were based on two inspections in the previous two years and a review of his website.
In its letter, the FDA noted two spots on Liao’s website where the drug was referred to as a cure, including one that said “over 80 people cured.” At the time, the price of Allesgen was $1,800 a bottle. Liao subsequently received two more FDA warning letters alleging violations of clinical trial rules.
In a brief phone conversation last July, Liao said, “It is still cheaper than all the other drug companies’ medicine” and added those medicines “don’t have the good results we have.”
The article noted the case of Jin Qu, 55, of Chino Hills, California, who in 2013 went to Liao when she noticed a small lump on her left chest following 2010 breast cancer surgery in China. Liao recommended and performed another surgery.
However, Liao failed to completely remove the growth, according to her lawsuit.
Normally, he said, she would need radiation or chemotherapy to eliminate the remaining cancerous tissues, according to Qu’s lawsuit. He then old her Allesgen was a safe alternative, but that it only was available through his practice.
Liao said many of his patients had positive experiences with Allesgen and told her she would have to pay $24,000 in cash for 12 bottles, the lawsuit said.
Attorney Ying Xu said Qu reached a confidential settlement with Liao in 2017.
Qu said she wishes she had pursued conventional treatment. If she had, she said, she may have recovered from the first recurrence completely.
“To hear from a doctor ‘your cancer is back’ is terrible,” she wrote in an email to reporters for the original story. “Having to hear it twice is much, much worse.”
In the July interview, Liao said the warning letter “doesn’t matter” and said he has not violated the law. He also rejected the FDA’s contention that Allesgen was being sold as a cancer cure. (Liao’s website continues to include the word “allesgencure.”)
“We sell it as a supplement,” Liao said. “We said we can deal with cancer. We did not mention a cure. It’s a medicine. It’s a product. I’m selling it as a remedy.”
Liao, a naturalized U.S. citizen who was born in Taiwan, was freed on $75,000 bond and was required to turn in his passport. According to the federal court docket a trial has been set for March 26.
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Source: MedicalNewsToday.com
