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Doctor in Prescription Drug Case Claims Altruism

Posted on: Wednesday, 26 April 2006, 00:00 CDT

By Paula Reed Ward, Pittsburgh Post-Gazette

Apr. 25--The defense attorney for a Pleasant Hills allergist told a jury yesterday that the only reason his client is charged with violating federal drug laws is because the pharmaceutical industry lobbied for it to happen.

Dr. Joseph P. Rudolph is charged with one count of illegal wholesale distribution of prescription drugs without a license.

According to a federal indictment returned in January, Dr. Rudolph sold drugs to treat cancer, which he received at large discounts through the federal 340B program, to oncologists around the country.

But Dr. Rudolph's attorney, Fred Thieman, said his client was simply trying to provide under-insured and uninsured patients with the drugs they needed at a price they could afford.

"He believed not only that it was lawful but it was good," said Mr. Thieman during opening statements yesterday.

Mr. Thieman, who formerly served as U.S. attorney in this district, focused much of his opening on the state of health care in the United States and on the amount of power possessed by the pharmaceutical industry.

The 340B program allows certain hospitals and medical facilities that serve low-income communities to get medications at steep discounts from various drug companies.

It does not, however, allow a facility to resell the drugs or to dispense to people who are not patients there, said Assistant U.S. Attorney Shaun E. Sweeney.

And that's what Dr. Rudolph is accused of doing.

The allergist, who has made several unsuccessful runs for public office -- including Congress, Allegheny County Council and South Park's school board -- approached Aliquippa Community Hospital in late 2003 about implementing the 340B program and was contracted to run it.

Dr. Rudolph began by sending advertisements to oncologists across the country offering discounted drugs, Mr. Sweeney told the jury.

For those doctors that signed on, the hospital would participate in video-teleconferencing with individual patients, in which they discussed the medications they were taking and checked for potential drug interactions.

But Mr. Sweeney said that is not enough to list someone as a patient at the Aliquippa hospital.

"You will learn that [Aliquippa Community Hospital] didn't even have an oncology department," Mr. Sweeney said. Yet, the hospital bought millions of dollars worth of chemotherapy drugs, he continued.

"Most of the profit of these sales went to benefit Dr. Rudolph," Mr. Sweeney said, noting that he received "hundreds and hundreds of thousands of dollars" from the sales. "Some of it benefited the hospital."

But in his opening, Mr. Thieman denied that allegation, saying that his client is worth more than $10 million and had those assets long before he began working with the 340B program.

"The hospital made the lion's share of all the money," Mr. Thieman said.

Instead, it was Dr. Rudolph's desire to help patients obtain less expensive prescription drugs that drove him. He tried to meet that goal in 2002, when he started the Physician Medicine Assist Program, which helped patients buy medications from Canada. He dropped the program two years later, though, after federal scrutiny mounted.

Even so, Dr. Rudolph garnered both local and national media attention, Mr. Thieman said, as well as that of the pharmaceutical industry.

Then, when the hospital began making money off the discounted drugs available through the 340B program, attention came again, he said.

"It was new and unique, and it started ruffling feathers -- especially in the pharmaceutical industry," said Mr. Thieman.

But what his client did, he insisted to the jury, was legal. It was reviewed by two health-care attorneys to make sure.

"They told the government exactly what they were doing," he said. "If the government said 'Change it," they changed it."

The Office of Pharmacy Affairs, the federal agency charged with overseeing the program, knew how Dr. Rudolph was running the 340B program for months, and it never ordered him to stop, Mr. Thieman said.

But when the pharmaceutical industry called the FBI, an investigation began within days, he said.

"It's an [Aliquippa Community Hospital] program. ACH lawyers approved it. And Dr. Rudolph is on trial," Mr. Thieman said. "Go figure."

The trial, before U.S. District Judge Arthur J. Schwab, is expected to last two weeks.

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Source: Pittsburgh Post-Gazette

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