FDA warning letters to doctors flag serious problems, but state medical boards do nothing
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 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 if federal rules designed to protect patients are being violated.
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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.
The inspections included a hospital in Wisconsin, a fertility clinic in Washington, a plastic surgery center in Pennsylvania, a medical lab in North Carolina and the Arizona office of a doctor promoting an unproven eye treatment.
Among the cases where no action was taken:
Zoya Maksumova, a radiologist and medical director of a mammography clinic in New York who was warned about unqualified technicians and quality control testing. The clinic and Maksumova also were named in three malpractice lawsuits involving mammograms, including ones that allegedly were misread.
Thomas Gionis, a doctor with a criminal record whose stem cell clinics in California, Florida and New York were called out for potential contamination of the products, not having a license to use them in people and numerous manufacturing process failures.
Neither has faced state action despite FDA warnings dating back several years. 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 issues 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.
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Between 2013 and 2017, the FDA sent 3,274 warning letters to doctors, drug makers, 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 analysis if a doctor wasn’t identified.
In only one case, a state medical board took 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.
The case is an example of a state using an FDA letter to discipline a doctor. However, Texas did not take action against five other doctors who received FDA warning letters, records show.
Two-thirds of the cases remain open. That means the problems remain unaddressed, at least to the FDA’s satisfaction.
For the doctors, 82 percent of the cases remain open.
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 were disciplined by their state medical boards.
A dubious “anti-cancer medicine”
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.”
As of Aug. 14, the website still had the word “allesgencure” next to the doctor's phone number, with images of X-rays that purport to show cancer that “disappeared” after patients used the product, according to a translated version of the site.
A woman who answered the phone at Liao’s West Covina, Calif., office in July called Allesgen an “anti-cancer medicine.” On 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 that bromelain extract is derived from the stem and fruit of Anasas Comosus, which is the Latin name for pineapple.
Other cancer treatments have undergone a rigorous FDA approval process and have been proven to be safe and effective. Allesgen has not.
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In 2013, Jin Qu, 55, of Chino Hills, Calif., 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 the lawsuit. He also told her Allesgen was a safe alternative, but that it only was available 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 deal preclude her from discussing the details.
Qu said she wishes she had pursued conventional treatment. If she had, she believes, 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. “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 Trump on May 30, the law gives terminally ill patients the right to try experimental treatments. It was authored 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.
Liao, who the FDA letter notes is also known as Wada Masao, was the subject of two more FDA warning letters in 2016 alleging various violations of clinical trial rules
One letter instructed Liao to stop giving a drug to participants in a trial, as the FDA felt the trial should be postponed. A clinical researcher administered the drug anyway, according to another letter.
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 if the board had seen a copy of the FDA letters. He said he could not comment on Liao, saying 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.”
Experts say the FDA letters by themselves show the matters are serious.
“The FDA doesn't trigger a letter like this lightly,” said Milton Packer, a cardiologist at Baylor University Medical Center in Dallas, who has a long history of overseeing large medical trials.
Legally, he said, the FDA doesn’t have the power to stop Liao. But, Packer said, the state medical board should use the FDA’s actions as a reason to step in.
"It's a communications issue,” he said. “Someone who has jurisdiction should be looking at what the FDA is saying and taking action.”
In June, the California medical board began disciplinary proceedings against Michael Arata, a doctor who had been performing unproven vein-opening procedures on multiple sclerosis patients.
Arata had been the subject of three FDA letters dating to 2012. On June 28, the California board filed a 14-page action that could lead to the revocation or suspension of his license.
The action came three months after a Journal Sentinel/MedPage Today story exposed how Arata and other doctors were continuing to perform the procedure.
Mammography clinic doctor warned
In a 2014, the FDA warned Zoya Maksumova, about glaring problems — including unqualified personnel and missing quality control records — at Union Square Medical Imaging and Mammography in New York City, where she served as medical director.
Because of serious image quality deficiencies, the facility’s accreditation by the American College of Radiology was revoked and it lost its federal mammography certificate, which is overseen by the FDA. The clinic also was required to notify patients and their doctors about the problems.
After the problems were corrected, the facility regained its accreditation in 2015.
No disciplinary actions have been taken against Maksumova by New York or California, where she also holds a license.
The concerns raised in the FDA letters were not the only signs of serious problems.
A 2014 malpractice lawsuit alleged negligence on the part of Maksumova, the Union Square clinic and another Union Square doctor in the reading of the mammogram of a woman who later died of breast cancer. The lawsuit was settled for $1.2 million in 2016, a payment made by the other doctor, not Maksumova, according to court records.
Maksumova, a former radiologist at the facility, and Union Square also were named in a 2015 malpractice lawsuit in which there was an alleged failure to properly read the mammogram of a woman later diagnosed with breast cancer.
Attorneys for both sides last year filed a “stipulation of discontinuance,” which ended the case, though the reason was not stated.
Another 2015 malpractice lawsuit by a third woman alleged that Maksumova and Union Square violated federal laws involving mammography quality standards. The attorney for that woman said the case was settled in 2017.
New York medical board spokesman Jeffrey Hammond declined to comment on why no action has been taken against Maksumova.
“Unless charges are served upon the physician or a public action is taken by the state medical board, the New York State Department of Health cannot confirm or deny the existence of an Office of Professional Medical Conduct investigation of a physician,” he said in an email.
Reached by phone, Maksumova said she is now retired and has stopped doing mammograms. Though she occasionally does some other medical work, including for Union Square, she stopped working there in 2014, she said.
She said there has long been a high number of lawsuits related to mammograms.
“Our job is very defensive,” she said. “It is not fair what they are doing to us.”
She did not comment on the FDA letter and ended the conversation.
Terrance Lee, a cardiologist who later took over the Union Square business, noted that the violations occurred under a different owner, were immediately corrected, and the mammography equipment was sold.
The center stopped doing mammograms three years ago, he said.
The business now is called Union Square Medical and focuses on cardiovascular-related medicine.
He said he did not know anything about lawsuits that had been filed against Union Square.
Stem cell doctor warned
In 2015, Newport Beach, Calif., physician Thomas Gionis got an FDA warning letter raising concerns about his stem cell clinics in California, Florida and New York.
The letter cited potential microbial contamination of the products, not having a license to use them in people and numerous manufacturing process failures. He was told to promptly correct “these deviations.”
Such treatments largely are unproven. In a news release last year, FDA Commissioner Scott Gottlieb noted they are potentially dangerous and have been linked to “unscrupulous actors.”
Gionis’ stem cell clinics used a person’s fat tissue to produce adult stem cells that then were re-administered to the person via an IV or injections, with the claim of treating a variety of conditions and diseases, including Parkinson’s, multiple sclerosis, cerebral palsy, and ALS.
In its letter to Gionis, the FDA said his stem cell products did not have an approved biologics license, nor was there an investigational new drug application, which is needed to use the product in people.
Beyond that, FDA investigators documented evidence of significant deviations from good manufacturing practice and good tissue practice, the letter said. Among those were a failure to follow procedures to prevent microbiological contamination of the products and a failure to perform lab testing for objectionable microorganisms.
A dozen other manufacturing and tissue concerns were mentioned.
Reached on his cellphone, Gionis said, “We’re not involved in that anymore.” He hung up and declined to respond to other texted questions.
At the time of the FDA letter, he told the FDA he had terminated his relationships with the clinics and that the New York clinic had closed.
Even before the stem cell matter, Gionis faced problems.
In 1992, he was sentenced to five years in prison for arranging the beating of his ex-wife, the daughter of actor John Wayne, and her boyfriend, according to news accounts.
In 1998, the California medical board placed him on three years probation based on the conviction.
The medical board in California, which has nearly 150,000 doctors, did not discipline Gionis for any of the matters cited in the FDA warning letter. Medical boards in New York and Florida did not take action either.
Citing the confidentiality of its investigations, Villatoro, the spokesman for the California medical board, would not comment on why the board did not take action based on the FDA letter.
“The Board is always searching for ways to gather complaint information and will review the website to determine if the FDA warning letters pertain to California physicians and to determine if action can be taken,” he said in an email.
A mired investigation
Records obtained from the FDA about its investigation into Liao show just how long it can take to investigate questionable doctors.
The earliest documents indicate the FDA began its case in 2012, after Liao received a shipment from abroad for Allesgen. The agency found a newspaper ad, written in Mandarin and published in the U.S., that said Liao reported the product had “cured 30 cancer patients.”
In a visit to Liao’s office, investigators found a binder that was given to prospective patients. The binder had materials that indicated promising results of Allesgen as a cure for cancer.
But the clinical trial for the supposed “anti-cancer therapeutic agent” was fraught with problems.
The medical board that was to oversee the trial process — usually an independent group of objective evaluators — included Liao, his two sons and brother.
The FDA found that the trial broke a number of other guidelines. For instance, patients were included who shouldn’t have qualified and several were shifted from one study group to another, a violation of clinical procedures.
As inspectors left his clinic in 2012, Liao assured them his product worked, telling them:
“Pharmaceutical companies in 10 years will be losing a lot of money once my product hits the market.”
Read the investigation
To read the Milwaukee Journal Sentinel's Bad Medicine investigation, go to journalsentinel.com/badmedicine.
John Fauber is a reporter for the Milwaukee Journal Sentinel. Matt Wynn is a reporter for the USA TODAY network. He began his reporting for this story while at MedPage Today.
This story was reported as a joint project of the Journal Sentinel and MedPage Today, which provides a clinical perspective for physicians on breaking medical news at medpagetoday.com.