The Florida Department of Health is seeking to sanction a doctor who committed suicide in February, distraught over getting swept up in an off-label promotion sting.
Psychiatrist Peter Gleason will be unable to respond to Florida Board of Medicine Case No. 2009-18280, in which the state's Department of Health seeks to discipline the doctor for touting off-label uses of a drug during industry-funded talks in several states years ago. His family says the resulting legal and professional woes, which they argue would have been mooted by the recent Supreme Court decision on prescription data, drove him to hang himself.
Gleason was arrested in 2006, and indicted by a federal grand jury in the US District Court for the Eastern District of New York. He pled guilty to one misdemeanor count of engaging in interstate commerce of a misbranded drug. He received a year of probation and a nominal fine.
“My brother never should have been arrested for speaking truthfully to his fellow physicians about the off-label uses of an FDA approved drug—anywhere or any time,” Sally Gleason Goodson told MM&M by e-mail, referencing Sorrell v. IMS Health, in which the majority concluded that a Vermont statute imposed a burden on protected expression.
“He enjoyed being a speaker for Jazz Pharma; talking about a drug that he truly believed in and used in his psychiatric practice,” Gleason Goodson continued. “The over-reaching powers of a federal prosecutor and the [Department of Justice] led to his suicide after 5 years of their torment.”
Whether the Supreme Court decision in Sorrell v. IMS, which some say calls into question FDA restrictions on truthful company speech including truthful off-label statements by drug firms, might have put Gleason in a better position, is an open question.
Gleason, who explained in letters to state officials that since his 2006 arrest he had “learned a lot about providing CME material in conformance with FDA regulations,” argued that he was never accused of providing fraudulent information. “I always provided clinical information I believed was true from my own research and clinical experience.”
But paid speaking, especially in the psychiatry field, has proven to be a gray area for academic and private physicians serving as faculty in both promotional med ed and certified CME courses without fully understanding the difference.
Legal experts say one potential red flag for government attorneys looking to build an off-label case is when a company's marketing plans tout off-label indications as growth opportunities. Another could be using the same med ed vendor or speaker, which could compromise independence.
The Justice Department, according to a press release, accused Gleason of getting paid tens of thousands of dollars to give lectures around the country promoting Xyrem to physicians for non-approved indications. In 2004 alone, officials charged, he delivered more than 100 presentations and got paid more than $70,000 by Orphan Medical, which was bought in 2005 by Jazz Pharmaceuticals, to advocate its narcolepsy drug for off-label uses like depression and fibromyalgia, an indication for which Jazz had been trying to get approval. Some of the talks were promotional, and some were CME, Gleason noted.
"Gleason was allegedly in high demand by Orphan sales representatives because of his proven ability to generate 'off-label' sales of Xyrem in their respective sales territories," prosecutors alleged.
The indictment also charged Gleason of conspiring with Orphan employees to defraud public and private health insurance plans by concealing, and advising prescribing physicians to conceal, evidence that Xyrem prescriptions were being filled for off-label indications that generally were not reimbursable. The fact that Xyrem's active ingredient, sodium oxybate, is a derivative of GHB, a drug notorious for its illegal use, and carries a black box warning about the risk for abuse, made his actions seem especially egregious.
Gleason's employer didn't escape the long arm of the law, either. Jazz and subsidiary Orphan Medical were subpoenaed in 2006, and in 2007 Orphan pled guilty to one felony count of introducing a misbranded drug into interstate commerce. Both Jazz and Orphan settled with the government for $20 million in civil and criminal payments and entered a corporate integrity agreement. A former Orphan Medical regional sales manager, who also worked for a short time for Jazz, also pled guilty based on similar allegations.
The FDA never did approve Jazz's fibromyalgia application, and the company is unsure whether it will undertake the additional studies needed. The drug had net sales last year of $143 million.
Gleason had a harder time moving on. As his sister explained, the physician was trying desperately to get a suspension of his license in Pennsylvania reduced to probationary status so he could resume practicing psychiatry. The state's medical board had levied the suspension in October for failing to disclose on his licensing application his arrest and federal conviction.
In letters to Pennsylvania authorities as high up as the office of the chief counsel, Gleason wrote that he had misinterpreted a question on the application asking if he had ever been charged with “assault, rape or drug charges.”
Regarding his earlier arrest, Gleason admitted, “I disseminated truthful peer-reviewed information about the off-label uses of FDA approved drugs to fellow physicians at CMEs and company-sponsored promotional when asked. I placed too much trust in the quality assurance and compliance program of Jazz/Orphan Medical. I should have assumed that role myself.”
But officials in Pennsylvania's prosecution division were unsympathetic to his pleas, as a follow-up letter sent by his sister to Pennsylvania's chief counsel makes clear. In the letter, dated February 16—nine days after her brother's suicide—Gleason Goodson told them what happened.
“[Peter] told me immediately after his call to you that you told him that you could not be of any assistance; that it was too late for you to do anything for him,” she wrote. “My family wants you to be aware that my brother committed suicide by hanging on Monday, February 7, 2011.”
An obituary published in the Buffalo News, a newspaper close to Gleason's boyhood town of Snyder, NY, notes that he died in Morgantown, West Virginia, at the home of a family member.
Pennsylvania wasn't the only state to find fault with Gleason. In July 2008 the State Board of Physicians in Maryland, where he owned a private practice, reprimanded him for improper patient record-keeping, finding that Gleason “has lost touch with the importance of maintaining adequate medical documentation.”
And because of the suspension in Pennsylvania, Gleason's license was suspended for a year in California, where he had been working for inpatient and outpatient mental health units starting in 2008. Gleason asked the state to lessen the sanction and had also contacted Florida's medical board, possibly while applying for a license in order to practice there, to bring them up to date.
Florida officials “indicated to me that the actions by Pennsylvania and California should not affect my medical license in Florida,” Gleason wrote to California in a request for a pre-hearing settlement.
Nevertheless, a complaint by Florida's Department of Health against Gleason was endorsed by the state surgeon general on July 8, some five months after his death. Florida law provides that being convicted or found guilty of a crime in any jurisdiction “which directly relates to the practice of medicine or to the ability to practice medicine” subjects a licensed physician to discipline by the state's medical board, according to the complaint.
Will Florida rescind its complaint, which provides for a range of punitive options, from permanent revocation or suspension of Gleason's medical license to a refund of fees billed or collected? Yolonda Green, assistant general counsel, Florida Department of Health, directed questions to a DOH press secretary, who told MM&M that she would look into the matter.
Gleason's sister feels that legal hurdles like these only compounded her brother's anguish. “This wonderful doctor, fantastic brother, terrific father, gentle friend, and beloved son lost his valued medical reputation,” Gleason Goodson told MM&M. “The embarrassment was too heavy a burden for him.”
UPDATE: According to Jennifer Hirst, deputy press secretary for the
Florida Department of Health, "The complaint was filed as a result of a
conviction for Dr. Gleason on January 29, 2010. While DOH is aware of
deaths in the State of Florida, Dr. Gleason did not die in Florida, and
therefore the Department of Health did not receive a confirmation of
death through a death certificate and therefore the Department was not
aware of his death until after the administrative complaint was filed.
"As you know, originally the probable cause panel found probable cause to go forward with an administrative complaint. The administrative complaint was never served on the decedent. The case is going back before a probable cause panel for file closure due to Dr. Gleason's death in September."