Indictment of Doctor Tests Drug Marketing Rules

Indictment of Doctor Tests Drug Marketing Rules

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In 2000, after highly publicized cases in which young women died or were raped after GHB was slipped into their drinks, Congress designated the drug a Schedule I controlled substance, in the same class as heroin.

But by then, doctors had shown that GHB could treat cataplexy, a variant of narcolepsy that causes people to suffer temporary paralysis. After lobbying from doctors and Orphan Medical, Congress said that if the F.D.A. chose to approve prescription GHB, it would be designated as a Schedule III controlled substance, legal for medical use, like the painkiller Vicodin or steroids.

In 2002, after Orphan presented clinical trial data showing GHB’s effectiveness against cataplexy, the F.D.A. approved the drug, under the brand name Xyrem, as a cataplexy treatment. In 2005, the agency approved Xyrem for the treatment of all forms of narcolepsy.

To help persuade the F.D.A. to approve Xyrem, Orphan Medical agreed to make the drug available only from a single pharmacy in Missouri, which ships it to patients nationally. No other prescription drug, even other Schedule III medicines, is so tightly controlled. For now, Xyrem, which costs more than $600 a month, is a niche product, with sales of about $25 million last year.

Dr. Gleason said he had been interested in Xyrem even before the drug was officially approved because he believed that other medicines for insomnia and depression were addictive or had serious side effects. “I immediately just started prescribing this stuff in 2002,” he said.

He prescribed the drug to about 100 of the patients he saw in his private practice in Maryland, almost always for off-label conditions like insomnia and severe depression. Xyrem seemed to work better than existing treatments, he said.

By early 2003, a sales representative for Orphan Medical, noting Dr. Gleason’s high rate of prescriptions, asked him if he would give talks to other doctors about Xyrem.

“I started doing those, and I started getting requested a lot,” Dr. Gleason said. He received $450 to visit a doctor in the office, $750 for speaking at a luncheon and $1,500 for a dinner speech. He made as much as $3,000 a day, he said.

Although he continued to see some patients, the Xyrem talks gradually became his primary source of income.

In April 2005, after a tip from a whistleblower inside Orphan Medical, the government began investigating Dr. Gleason and the company, according to an affidavit that Darren Petri, a criminal investigator for the F.D.A., filed in February in support of an arrest warrant for Dr. Gleason.

The affidavit says that a cooperating witness repeatedly taped Dr. Gleason as he discussed Xyrem, including the Denver talk where he compared Xyrem to table salt and a meeting in November where he said Xyrem was safe for children.

The indictment also charges that Dr. Gleason committed fraud against insurance companies by advising doctors to leave blank an area on the Xyrem prescription form that asked for a disease diagnosis. Dr. Gleason acknowledges that he told doctors not to offer a diagnosis but says he never told them to lie if they were asked for one.

Dr. Gleason says he did not know he was under investigation when he went to Great Neck, N.Y., on March 5 to talk to doctors about Xyrem during a lunch meeting at the office of Dr. Richard Blanck, a neurologist. The meeting had been arranged by a Jazz Pharmaceuticals salesman, Al Caronia, Dr. Gleason said.

An Unexpected Arrest

Dr. Blanck confirmed the meeting and said Dr. Gleason’s comments seemed typical for a sales presentation sponsored by a drug company. Mr. Caronia did not return calls seeking comment.

Afterward, Dr. Gleason says that Mr. Caronia drove him to the Long Island Rail Road station in the village center, to begin his journey home. When he stepped out of the car, Dr. Gleason says, Mr. Petri and other investigators surrounded him, bundled him into a sport utility vehicle and drove him to the Great Neck police station.

Mr. Caronia was not arrested.

The federal agents said he would have to cooperate in their investigation into Jazz Pharmaceuticals, Dr. Gleason contends. “They said, ‘Who in this company roped you into this conspiracy?’ ’’

Insisting that he had broken no laws, Dr. Gleason said he tried to persuade Mr. Petri and the others that his views on Xyrem were scientifically based. He was released later that day.

Dr. Gleason’s account is at least partly supported by a letter on March 13 from Geoffrey Kaiser, an assistant United States attorney, to Lois Bloom, the federal magistrate judge overseeing the case. In the letter, Mr. Kaiser asks that the case be kept quiet because Mr. Gleason may “be willing to cooperate with this office in its broader investigation.”

On Bail and Short on Work

The same day, Dr. Gleason was arraigned in Federal District Court in Brooklyn, where he was released on a $150,000 bond.

It was not until three weeks later, on April 5, that the federal attorney’s office announced Dr. Gleason’s arrest, with the news release comparing him to a snake-oil salesman. As he awaits further hearings and trial, Dr. Gleason, who is divorced, is supporting himself by working as an in-house doctor on short-term contracts. For a brief period, he worked at a Maryland state hospital, before being let go. He said the hospital told him he had been fired because of the indictment; a spokesman for the hospital declined to comment.

Now he is filling in at various hospitals in Western states, which he did not want to identify for fear of losing the work.

As for his former benefactor, Jazz, Dr. Gleason says the company told him it was now cooperating with the investigation and that he would have to face the indictment on his own.

“They’re just cutting me loose,” he said.

For all that, Dr. Gleason said he still believed in Xyrem. “The only thing symmetrical with the efficacy and safety of GHB is the hysteria about it.”

Those sorts of claims discomfort even other doctors and researchers who agree that the drug may be useful.

“He is a very smart man, and I believe he is extremely well intentioned,” Dr. Scharf said. “But this is not candy. It’s not a cure-all.”

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Last updated: 7/06

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Indictment of Doctor Tests Drug Marketing Rules