States seldom discipline doctors despite warnings
In the fight against cancer, you won’t find a mixture known as Allesgen on the long list of drugs approved as safe and effective by the U.S. Food and Drug Administration.
But a doctor in California has been peddling his own $1,800-a-month “cure” to desperate patients for years. Despite four years of warnings from the FDA, a patient lawsuit, scathing online reviews and a raid by federal agents, the California medical board has not taken action.
Benedict Liao is one of 73 doctors around the country with active medical licenses who got FDA warning letters over a five-year period alleging serious problems.
Only one was disciplined by his state medical board, an investigation by the Milwaukee Journal Sentinel, part of the USA TODAY NETWORK, and MedPage Today found.
The warning letters, which get scant public attention, are sent after FDA officials conduct inspections at offices, clinics and medical facilities to determine whether federal rules designed to protect patients are being violated.
State boards took no action on a wide range of problems: fertility clinics that didn’t test donors of eggs and sperm for communicable diseases; researchers who didn’t follow rules designed to protect patients who volunteer for trials of drugs and devices; and doctors — such as Liao — who pushed dubious treatments and supplements to unwitting customers.
In all, 28 states have doctors who have been warned yet have been allowed to practice unfettered.
The gap is the latest example of a lack of accountability in a system that allows doctors to continue practicing medicine without restrictions despite serious problems while patients are kept in the dark.
In this case, serious allegations cited in FDA warning letters were not picked up by state medical boards, the bodies in charge of regulating and disciplining doctors.
“It’s disturbing,” said Rita Redberg, a cardiologist at the University of California-San Francisco and editor of the JAMA Internal Medicine. “What it means is that patients are unaware that they are in dangerous mammography clinics or dangerous clinical trials.”
Letters often go untracked
State medical boards get information from a variety of sources — hospitals, courts and accrediting bodies — about the doctors they license. Congress created a special database to track malpractice cases and disciplinary actions against doctors, a resource available to each state board.
But the FDA warning letters, which are sent directly to the doctors, aren’t included in that database, and there’s no official process to share them with the boards. Some boards rarely check the database at all.
FDA spokeswoman Stephanie Caccomo said the agency communicates with state boards about questions raised in its letters on a “case-by-case basis.” She could not say how often that occurred or provide the names of any doctors the FDA discussed with state boards.
“We don’t have a system for tracking that,” Caccomo said.
From 2013 to 2017, the FDA sent 3,274 warning letters to doctors, drugmakers, pharmacists, device manufacturers, supplement suppliers and others, a review by the Journal Sentinel and MedPage Today found.
Of those, reporters found 78 letters sent to individual doctors. Letters sent to clinics weren’t included in the analy- sis if a doctor wasn’t identified.
Rarely do states take action
In only one case did a state medical board take action: a Texas doctor who violated clinical research rules, including failing to report adverse events in a cancer trial and failing to get informed consent from patients. He was put on probation for five years.
Nearly half of the letters to doctors cited violations of clinical trial research rules. Another 20 percent had to do with adulterated drugs, or selling drugs or supplements under false pretenses — more than twice the rate found in the letters overall.
Six doctors were cited by the FDA for marketing unproven remedies.
None was disciplined by their state medical boards.
In 2014, an FDA letter warned Liao about violating federal law in his marketing of Allesgen, an extract derived from pineapples, as a cancer drug. 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.”
A woman who answered the phone at Liao’s office in West Covina, California, in July called Allesgen an “anti-cancer medicine.” In the same phone call, Liao said a bottle would cost $1,800 but wouldn’t be covered by insurance.
“It is still cheaper than all the other drug companies’ medicine,” he said. “But they don’t have the good results we have.”
In a lawsuit deposition, Liao noted Allesgen “consists of 9 to 14 different protein components,” including “bromelain.” A clinical trial notice Liao filed with the National Institutes of Health says bromelain extract is derived from the stem and fruit of Ananas comosus, the Latin name for pineapple.
Other cancer treatments have undergone a rigorous FDA approval process and have been proven safe and effective. Allesgen has not.
In 2013, Jin Qu, 55, of Chino Hills, California, went to Liao when she noticed a small lump on the left side of her chest after breast cancer surgery in China in 2010. Liao recommended and performed another surgery.
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 the lawsuit. He also told her Allesgen was a safe alternative but that it was available only through his practice. He said many of his patients had positive experiences with Allesgen.
He told her she would have to pay $24,000 in cash for 12 bottles — more than the recently quoted cost over the phone.
Attorney Ying Xu said Qu reached a settlement with Liao in 2017. The terms of the agreement preclude her from discussing the details.
Qu said she wishes she had pursued conventional treatment. If she had, she believes, she may have recovered completely from the first recurrence.
“To hear from a doctor ‘your cancer is back’ is terrible,” she wrote in an email to reporters. “Having to hear it twice is much, much worse.”
In a short phone conversation, 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.
“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.”
He also argued he now can legally sell Allesgen to cancer patients under the recently passed federal Right To Try Act, a claim the FDA declined to address. Signed by President Donald Trump on May 30, the law gives terminally ill patients the right to try experimental treatments. It was written by U.S. Sen. Ron Johnson (R-Wis.)
Liao’s website claims his treatment passed an FDA clinical trial in 2015, which Liao said allows him to market the product. The FDA declined to comment on whether it approved such a trial or what any outcome was. In any case, Allesgen is not an FDA approved cancer treatment.
“They (the FDA) can have machine guns and raid my place,” Liao said. “I am not an outlaw. I am a licensed physician.”
Liao hung up without discussing the lawsuit against him. He did not respond to follow-up phone calls and an email.
Citing “ongoing compliance matters,” Caccomo, the FDA spokeswoman, said she could not comment on any investigation of Liao’s office.
The California medical board lists no disciplinary actions against Liao related to Allesgen. He agreed to a public reprimand in 2011 for his alleged “incompetence” and “gross negligence” in treating a 37-year-old woman who had gone to him for an abortion in 2005.
Carlos Villatoro, a spokesman for the California medical board, would not say whether the board had seen a copy of the FDA letters. He said that he could not comment on Liao and that the board’s complaints and investigations are confidential.
When reporters asked to speak to medical board executive director Kimberly Kirchmeyer, Villatoro responded: “The Board is unable to satisfy this request.”