News Column

Doctor's Ties with Sales Rep Raises Ethics Questions

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Mark Sabbota, a Hollywood, Fla., cardiologist, regularly implants $5,000 pacemakers in patients at Memorial hospitals in South Broward -- generating, last year alone, more than a half-million dollars in sales for a manufacturer called St. Jude Medical.

Sabbota, public records show, also happens to be partners with a St. Jude sales rep in two corporations that run frozen yogurt shops.

What's yogurt got to do with health care?

Perhaps nothing. Perhaps a lot. The question is connected to an on-going lobbying battle in Washington over a pending disclosure policy intended to more clearly reveal financial ties between physicians and the health care industry -- often-murky relationships that have produced a long history of whistle-blower lawsuits, federal investigations and fines.

Sabbota, in a brief interview, adamantly denied any conflict of interest. "There has been no wrongdoing at all," he said.

Memorial spokeswoman Kerting Baldwin also said the hospital saw no problem with the yogurt arrangement. As a "community" doctor, not a staff employee, Baldwin said Sabbota can select from a list of pacemakers approved by the hospital but has no say over what companies made the list.

"As for why he prefers to use St. Jude, I won't speak for him," she said. "You'd have to ask him that."

But several medical ethics experts said such relationships fall in a gray area. They raise what Kenneth Goodman, bioethics director at the University of Miami, called "red flags" about whether the doctor's motivation in choosing a device "is something other than the best interests of the patient."

"Maybe it's just a good business arrangement that has nothing to do with the devices he chooses," said Charles D. Rosen, a California physician who is co-founder of the Association for Medical Ethics.

"But the issue is public disclosure and transparency. You as a patient should have the right to know about a doctor's financial relationships with companies."

Concerns about the relationship between doctors and health care companies have been simmering for years. Americans are so suspicious of doctors' connections that, in a 2008 Pew Charitable Trusts survey, 86 percent of patients said doctors should not be allowed to get free dinners from drugmakers and 70 percent said doctors shouldn't even be allowed to get free notepads and pens.

The 2010 Affordable Care Act includes a provision intended to address some aspects of these often-cozy relationships. Starting Jan. 1, health care companies were supposed to publicly post how much they were paying doctors. But that provision has been held up in the White House by intense lobbying.

"I don't know why the hold-up, except the intense opposition of the industry," Rosen said. His group, including members of the Harvard Medical School and Cleveland Clinic, wrote a letter to the Obama administration last month protesting the delay.

The group complains that the health care industry is trying to soften the rules so that foreign subsidiaries and doctors engaged in clinical trials wouldn't have to reveal payments. But even if the disclosure rules are implemented, a side deal like Sabbota's yogurt company would not have to be revealed under the new law, Rosen said.

The cardiac device field has been dogged by federal investigations and legal actions for years. Major manufacturers, such as Boston Scientific, Johnson & Johnson, Medtronic and St. Jude Medical, have been among those that have paid fines to settle federal charges that they illegally promoted sales. For the past year, a major federal investigation has been going on in Nevada, examining whether Biotronik was improperly paying doctors to use its pacemakers and defibrillators.

In South Florida, a former Miami technician for Ela Medical, maker of cardiac devices, filed a whistle-blower complaint about the company using several schemes to pay kickbacks to doctors -- allegations that Ela settled for $9.2 million in 2010. At Jackson Memorial, a 2006 ethics probe focused on University of Miami cardiologist Alberto Interian Jr., who acknowledged his girlfriend was the St. Jude sales rep. He said it was mere coincidence that during their relationship St. Jude sales at Jackson soared by 400 percent.

The county ethics commission decided Interian had not violated government conflict of interest codes because he was not a Jackson employee. In 2009, the commission urged Jackson to adopt a policy that would extend its ethics policies to nongovernment employees, but Jackson spokesman Edwin O'Dell said Jackson still doesn't require outside doctors to sign codes of conduct.

Medical device sales reps and doctors often work closely together, with the rep going into the operating room to make sure that the device is working properly before it is implanted. Sabbota and St. Jude's sales rep, Charles Lodowski, generally work side by side in operating rooms, said Memorial spokeswoman Baldwin.

The pair, state corporate records show, also developed a working relationship outside the hospital. They are partners in two corporations, HTW Froyo and HTW2 Froyo. A 2011 Palm Beach Post story on "the yogurt craze" said Sabbota and Lodowski had bought franchise rights to three Menchie's frozen yogurt shops. One was open at PGA Commons and another was planned to open in Wellington.

The Post article noted that Sabbota was a cardiologist. He told the reporter: "You don't put a lot of smiles on people's faces in medicine any longer. For a long time I've been looking at getting into something that would add to my ability to support myself and my kids, but also something I would enjoy."

Sabbota, 44, who lives in Plantation, is one of two doctors in Cardiovascular Specialists of South Florida, which has an office in Davie. He obtained his Florida medical license in 2001. State and Broward County court records show no public complaints or malpractice suits.

In a phone conversation with The Miami Herald, Sabbota denied any wrongdoing and said he would have a lawyer call the reporter. But neither an attorney nor the doctor responded to five follow-up calls over two weeks. He also did not respond to two emailed lists of questions, including whether he informs patients about his relationship with the sales rep.

Lodowski also did not respond directly to five calls over two weeks.

When The Miami Herald tried to reach him through the Memorial Health care System, spokeswoman Baldwin responded: "I did reach out to Charles and he said to refer you to St. Jude's public relations department."

St. Jude spokeswoman Amy Jo Meyer, responding to an initial Herald inquiry about the Sabbota-Lodowski relationship, said: "We have only recently become aware of this information and are in the process of reviewing it."

She referred a reporter to the code of ethics of the Advantaged Medical Technology Association, which represents device makers. The code limits sales reps in giving doctors trips, sports tickets, fancy meals and lucrative consulting contracts -- all methods that have been used in the past for device makers to reward friendly doctors.

The AdvaMed code says, "Company interactions with Health Care Professionals should be professional in nature and should facilitate the exchange of medical or scientific information that will benefit patient care." It says nothing about business partnerships, and a spokeswoman for the trade group refused to say whether partnerships were or should be forbidden under the code.

St. Jude did not respond to six follow-up calls and emails.

For most hospitals, the business relationships of non-staff doctors tend to fall outside the scope of their ethics rules. Like Memorial, Baptist Health South Florida, the largest Miami-Dade hospital group, doesn't require outside doctors to sign codes of conduct.

Though Sabbota almost exclusively used St. Jude devices, Baldwin said doctors who work at Memorial are also free to use pacemakers made by Biotronik, Medtronic and Boston Scientific devices.

Does that mean Memorial doesn't care what side deals its non-staff doctors does with vendors? "I don't want to say Memorial doesn't care -- it's not about that," Baldwin said.

Biomedical experts say that for hospitals there is a conflict between pushing physicians to provide more transparency for patients and real-world economic considerations.

Hospitals are always seeking qualified outside or "community" doctors to use their facilities and generate revenue, said Sal Barbera, a former Broward hospital administrator who won a 2004 whistleblower judgment exposing illicit relationships between doctors and hospitals.

Barbera, who now teaches at Florida International University, believes Sabbota's and Lodowski's business relationship "is clearly a conflict of interest" but acknowledged that it's hard to know specifics because outsiders don't have access to financial dealings within the corporation.

Michael Carome, a physician with the Washington watchdog group Public Citizen, said the underlying problem is the cost of health care.

"Companies spend hundreds of millions of dollars on sales and marketing, and they wouldn't be doing that unless they had an effect on their bottom line," Carome said. Those marketing costs are ultimately paid by the government, through Medicare and Medicaid, or by employers and consumers, through private insurers.

Not commenting directly on the Memorial case, he said the health care industry should be concerned any time there is an unusually close relationship between doctor and device rep. "It certainly raises concerns that the decision to use that device may be influenced by their relationship, and that influence could be very subtle."

Goodman, the UM bioethicist, said that because of all its legal troubles, the medical device industry has strengthened its code of ethics, and a growing number of institutions, like the University of Miami, have online sites that are intended to reveal all relationships between its doctors and outside companies. Relationships like the UM cardiologist and his girlfriend/sales rep would no longer be tolerated.

"There's been a sea change," Goodman said. "The trips and dinners for the most part are nearly over. ... But maybe some people are finding new ways." A situation like Sabbota's, he said, raises "questions about whether somebody's judgment" is shaped by non-medical considerations.

Still, Barbera, the former hospital executive, said it's not coincidental that the device makers have the toughest code.

"They've got caught doing all this devious behavior," he said. "So on paper at least they're looking good."



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