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Stent sellers were allowed inside lab despite hospital ban

Salespeople for stent maker Abbott Laboratories were often allowed inside a cardiac treatment room at St. Joseph Medical Center while patient procedures were being performed, despite hospital rules against it, according to sworn testimony from Dr. Mark G. Midei taken as part of a lawsuit accusing him of implanting stents unnecessarily.

Midei also denied receiving cash compensation and benefits from the Illinois device maker, whose payments for consulting work and dinners at the physician's Monkton home were detailed in a U.S. Senate Finance Committee report released last week. And he claimed to have coached the Abbott sales team on how to pitch their stents to hospital administrators.

"I know some of the representatives because they're in the laboratory all the time, and I might tell them, you know, 'the hospital is very serious. You guys need to come in with the best, the best number you can give them,'" Midei said in the deposition, taken in June. He was fired last year for allegedly performing hundreds of unwarranted stent procedures.

The disclosures, contained in a lengthy transcript obtained by The Baltimore Sun, raise new questions about the influence marketers have on physician product choices. And they heighten concerns expressed last week by the Senate committee, which determined that close connections with Abbott may have "indirectly encouraged Dr. Midei to intensify his use of stents, with unfortunate results."

The committee concluded that Midei's questionable medical procedures, most of them billed to government and private insurers, represented "a clear example of potential fraud, waste and abuse."

Some lawmakers and physicians say improper implantations of stents, which prop open blocked arteries and typically cost patients $10,000 or more, could be part of a wasteful national trend made worse by manufacturers who send teams of people into the country's hospitals to sell products and train physicians on their use.

"The representatives are there to sell devices, so if they're present in a catheterization lab, they can have a subtle — and not so subtle — influence," said Steven E. Nissen, chief of cardiology at the Cleveland Clinic.

Industry representatives say regular interaction between physicians and salespeople is necessary to improve medical technology and health care through the exchange of information and ideas.

Abbott spokesman Jonathon Hamilton said company "sales representatives are expected to be subject matter experts on the features, benefits, preparation and deployment of each company's products" and are "regularly invited by doctors into the hospital to provide demonstrations and answer questions on the company's products to ensure they are being utilized in a safe and effective manner."

But a Stanford University study published in The American Journal of Cardiology last fall shows that the interaction of doctors and salespeople is not without consequences, even unintended ones. Reviewers looked at 431 stents implanted at Stanford over a six-month period and concluded that the presence of salespeople in the treatment rooms significantly increased the chances of that company's product being used — by more than 10-fold for one manufacturer.

And others have said the rapport can quickly grow too chummy. Dr. William A. Boden, an interventional cardiologist practicing in Buffalo, recalls salespeople showing up at his hospital wearing scrubs and ordering pizza.

Abbott threw parties at Midei's Monkton home and built a business strategy around his high procedure rate, paying him roughly $37,000 for consulting work before and after his termination from St. Joseph, according to records contained in the Senate report released last week.

In the deposition, Midei appeared to draw distinctions between those payments and other compensation. He said he never received cash "in response to the use of the devices" nor any benefits, which were defined by a lawyer as "vacations or anything through a manufacturer of a stent."

Midei's attorney, Stephen Snyder, has repeatedly denied that his client did anything wrong and said Midei was not influenced by Abbott, calling their association and financial exchanges typical of the industry.

On Tuesday, after representing Midei before an administrative law judge evaluating whether the cardiologist should be allowed to keep his medical license, Snyder said the "sinister" spin being put on Midei's relationship with Abbott is the result of allegations against his client that he intends to prove false. The administrative judge's decision is expected to take months.

Most hospitals throughout the country limit vendors' access to physicians, said Dr. Mark Turco, an interventional cardiologist at Washington Adventist Hospital in Takoma Park and a spokesman for the Society for Cardiac Angiography and Interventions.

He said the rules have gotten "more stringent" over the past few years in light of patient privacy issues and conflict-of-interest concerns. "We want our physicians to avoid any external influences … that may disrupt patient care," Turco said.

St. Joseph has had a vendor policy in place since 2006, limiting visits to scheduled appointments held during regular business hours for the sole purpose of "supporting the technology and addressing clinical usage concerns or questions — not as a sales call," the hospital said in a statement.

But according to Midei's deposition, Abbott employees "became friends with the technologists and the nurses and, you know, they sort of find ways into the cath lab and get around the rules."

He added that the company representatives "might see some of the cases that we did, but they didn't have a role in selecting devices or choosing cases appropriate for stenting."

Abbott valued close relationships with physicians, according to documents obtained by the U.S. Senate Finance Committee. A supervisor congratulated one regional sales rep, identified only as "Bonnie," for her work in the Baltimore area, writing in a December 2008 letter: "I have never seen personal relationships as strong as the ones you have developed with" Midei and two unidentified physicians.

In the deposition, Midei said that he remembered a Bonnie Seifert from Abbott and that "she had a lot of other helpers." Seifert could not be reached Tuesday.

Salespeople make a point of "befriending the personnel," Dr. Nissen said. "It's their ticket to income."

Even industry representatives say the medical device makers have cultivated "undeniably close" relationships with physicians.

"They're very close relationships, closer than most," said Christopher White, general counsel for the Advanced Medical Technology Association. But he added that there are "socially important reasons" for that closeness — including proper use of the device.

Hamilton, the Abbott spokesman, said sales representatives are expected to follow the rules of the hospital. And they did for a time, according to Midei.

"The rules would be enforced and they wouldn't be there for a couple months, and then the rules would become less — less enforced and they'd find their way back in," Midei said in the deposition.

St. Joseph revamped its policies last year, and hired a "Corporate Responsibility Officer" who now oversees what the hospital called a "robust system of tracking and monitoring for all of SJMC's vendor relationships."

The medical center said it "does not endorse any products," though Midei claimed in the deposition that the hospital seemed to encourage the use of Abbott stents because they were fairly priced. And he said he preferred them because he believed them to be medically superior.

"The data is incontrovertible," he said in the deposition.

That's how most medical professionals say decisions should be made, based on evidence and data. But some, like Nissen, believe there are still too many other influences at work.

"I think that what was [allegedly] going on in Baltimore, goes on in a lot of places," he said, adding that he is "worried about the overuse of medical technologies and medical devices in general."