WATCHDOG

Bad medicine: California takes action on FDA warning letters to doctors

John Fauber
Milwaukee Journal Sentinel

The California medical board has begun monitoring warning letters sent by the U.S. Food and Drug Administration to doctors engaged in potentially harmful practices following a Milwaukee Journal Sentinel/MedPage Today investigation about the failure of states to act on allegations raised in the letters.

The investigation found that 73 doctors around the country with active medical licenses had been the subject of FDA warning letters alleging serious problems over a five-year period, but only one had been disciplined.

RELATED: Doctors who surrender a medical license in one state can practice in another — and you might never know

RELATED: How to find out if your doctor was accused of harming patients in another state

The warnings involved 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; doctors who pushed dubious treatments and supplements to unwitting customers; and a mammography clinic faulted for inadequate quality control testing. 

The story highlighted the cases of several doctors with California licenses who had received warning letters.

In response to the inquiries from the news organizations, the California board began getting the warning letters, said spokesman Carlos Villatoro.

“The Board reviews the letters and if they contain information regarding physicians licensed by the Board, the Board looks into the matter,” he said in a recent email. The practice began in June, but only now is being confirmed.

With nearly 150,000 physicians, California has more doctors than any other state. The next closest is New York with 94,000.

It is unclear how many other state medical boards have taken similar steps. 

In August, a spokesman for the Wisconsin Department of Safety and Professional Services, which oversees the medical board, said the board had begun getting the letters following a story on a Wisconsin doctor.

Marc Lazzaro, of the Medical College of Wisconsin.

The story involved Marc Lazzaro, a doctor with Froedtert Hospital in Wauwatosa, who was testing a device that is implanted in the brain to treat aneurysms and another one used to remove clots. The FDA was checking whether the research complied with federal rules designed to protect patients.

It did not.

In response to the Journal Sentinel/MedPage Today investigation, the FDA also is taking action. A spokeswoman said the agency may start notifying state boards of potential patient safety issues raised in its letters, at least on a case-by-case basis.

“We do intend to conduct outreach to state healthcare practitioner and pharmacy licensing boards to remind them about our public warning letter database and encourage them to sign up for our email updates,” spokeswoman Stephanie Caccomo said in a statement.

Michael Carome, a physician with the watchdog group Public Citizen, applauded efforts to ensure that doctors named in the letters are brought to the attention of their state medical boards.

“It is a positive step to protect patients who might be put in harm’s way,” he said.

He said that is especially important, because there is no requirement that the letters be sent to the National Practitioner Data Bank, a central clearinghouse created by Congress in 1986 to confidentially share information of alleged doctor misconduct. 

The data bank is a repository for various reports, including malpractice payments, discipline by state medical boards and loss of hospital privileges. States are able to use the database to track doctors, but the news organizations found use of it varies widely.

Series exposed problems

The Journal Sentinel/MedPage Today series examined many aspects of the broken world of doctor discipline. The warning letter story focused on how doctors engaged in questionable behavior can fall through regulatory cracks.

For instance, the FDA does not have the authority to discipline doctors or regulate the practice of medicine. It is limited to regulating products under the federal Food, Drug, and Cosmetic Act.

Meanwhile, the job of investigating and disciplining doctors is left to state medical boards. Yet the two sides do not regularly communicate.

In March, a separate Journal Sentinel/MedPage Today story highlighted the case of a California doctor who had not been disciplined despite being the subject of FDA warning letters dating back several years.

In June, the California medical board began proceedings against Michael Arata, a doctor who had been performing risky and 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.

In August, the Journal Sentinel/MedPage Today, highlighted the case of several doctors who had received warning letters but had not been disciplined by their state medical boards.
 
One involved Benedict Liao, a doctor in California who for years had been selling his own $1,800-a-month “cure” to cancer patients. He continued to sell the product despite four years of warnings from the FDA, a patient lawsuit, scathing online reviews and a raid by federal agents. 

Benedict Liao

 Another case involved Thomas Gionis, a doctor with a criminal record whose stem cell clinics in California, Florida and New York were subject of an FDA warning letter which noted potential contamination of the products, not having a license to use them in people and numerous manufacturing process failures.
 
John Fauber is a reporter for the Milwaukee Journal Sentinel. 

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.
 
Read the investigation

To read the Journal Sentinel’s “Bad Medicine” investigation, into doctors who face problems in one state but are allowed to practice in others, go to jsonline.com/badmedicine.