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Docs on Pharma Payroll Have Blemished Records, Limited Credentials

This story first appeared on the ProPublica website.

The Ohio medical board concluded that pain physician William D. Leak had performed "unnecessary" nerve tests on 20 patients and subjected some to "an excessive number of invasive procedures," including injections of agents that destroy nerve tissue.

Yet the finding, posted on the board's public website, didn't prevent Eli Lilly and Co. from using him as a promotional speaker and adviser. The company has paid him $85,450 since 2009.

In 2001, the US Food and Drug Administration ordered Pennsylvania doctor James I. McMillen to stop "false or misleading" promotions of the painkiller Celebrex, saying he minimized risks and touted it for unapproved uses.

Still, three other leading drug makers paid the rheumatologist $224,163 over 18 months to deliver talks to other physicians about their drugs.

And in Georgia, a state appeals court in 2004 upheld a hospital's decision to kick Dr. Donald Ray Taylor off its staff. The anesthesiologist had admitted giving young female patients rectal and vaginal exams without documenting why. He'd also been accused of exposing women's breasts during medical procedures. When confronted by a hospital official, Taylor said, "Maybe I am a pervert, I honestly don't know," according to the appellate court ruling.

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Last year, Taylor was Cephalon's third-highest-paid speaker out of more than 900. He received $142,050 in 2009 and another $52,400 through June.

Leak, McMillen and Taylor are part of the pharmaceutical industry's white-coat sales force, doctors paid to promote brand-name drugs to their peers—and if they're convincing enough, get more physicians to prescribe them.

Drug companies say they hire the most-respected doctors in their fields for the critical task of teaching about the benefits and risks of their drugs.

But an investigation by ProPublica uncovered hundreds of doctors on company payrolls who had been accused of professional misconduct, were disciplined by state boards or lacked credentials as researchers or specialists.

This story is the first of several planned by ProPublica examining the high-stakes pursuit of the nation's physicians and their prescription pads. The implications are great for patients, who in the past have been exposed to such heavily marketed drugs as the painkiller Bextra and the diabetes drug Avandia—billion-dollar blockbusters until dangerous side effects emerged.

"Without question the public should care," said Dr. Joseph Ross, an assistant professor of medicine at Yale School of Medicine who has written about the industry's influence on physicians. "You would never want your kid learning from a bad teacher. Why would you want your doctor learning from a bad doctor, someone who hasn't displayed good judgment in the past?"

To vet the industry's handpicked speakers, ProPublica created a comprehensive database that represents the most accessible accounting yet of payments to doctors. Compiled from disclosures by seven companies, the database covers $257.8million in payouts since 2009 for speaking, consulting and other duties. In addition to Lilly and Cephalon, the companies include AstraZeneca, GlaxoSmithKline, Johnson & Johnson, Merck & Co. and Pfizer.

Although these companies have posted payments on their websites—some as a result of legal settlements—they make it difficult to spot trends or even learn who has earned the most. ProPublica combined the data and identified the highest-paid doctors, then checked their credentials and disciplinary records.

That is something not all companies do.

A review of physician licensing records in the 15 most-populous states and three others found sanctions against more than 250 speakers, including some of the highest paid. Their misconduct included inappropriately prescribing drugs, providing poor care or having sex with patients. Some of the doctors had even lost their licenses.

More than 40 have received FDA warnings for research misconduct, lost hospital privileges or been convicted of crimes. And at least 20 more have had two or more malpractice judgments or settlements. This accounting is by no means complete; many state regulators don't post these actions on their web sites.

In interviews and written statements, five of the seven companies acknowledged that they don't routinely check state board websites for discipline against doctors. Instead, they rely on self-reporting and checks of federal databases. Only Johnson & Johnson and Cephalon said they review the state sites.

ProPublica found 88 Lilly speakers who have been sanctioned and four more who had received FDA warnings. Reporters asked Lilly about several of those, including Leak and McMillen. A spokesman said the company was unaware of the cases and is now investigating them.

"They are representatives of the company," said Dr. Jack Harris, vice president of Lilly's US medical division. "It would be very concerning that one of our speakers was someone who had these other things going on."

Leak, the pain doctor, and his attorney did not respond to multiple messages. The Ohio medical board voted to revoke Leak's license in 2008. It remains active as he appeals in court, arguing that the evidence against him was old, the witnesses unreliable and the sentence too harsh.

In an interview, McMillen denied nearly all of the allegations in the FDA letter and blamed his troubles on a rival firm whose drug he had criticized in his presentations.

"I'm more cautious now than I ever was," said McMillen, who said he also does research. "That's why I think a lot of the companies use me. I'm not taking any risks."

Taylor said that the allegations against him were "old news" from the 1990s and that regulators had not sanctioned him. "It had nothing to do with my skills as a physician," said Taylor, noting that he speaks every other week around the country and sometimes abroad. "Even my biggest detractors in that situation lauded my skills as a physician. That's what's most important."

Disclosures are just the start

Payments to doctors for promotional work are not illegal and can be beneficial. Strong relationships between pharmaceutical companies and physicians are critical to developing new and better treatments.

There is much debate, however, about whether paying doctors to market drugs can inappropriately influence what they prescribe. Studies have shown that even small gifts and payments affect physician attitudes. Such issues have become flashpoints in recent years both in courtrooms and in Congress.

All told, 384 of the approximately 17,700 individuals in ProPublica's database earned more than $100,000 for their promotional and consulting work on behalf of one or more of the seven companies in 2009 and 2010. Nearly all were physicians, but a handful of pharmacists, nurse practitioners and dietitians also made the list. Forty-three physicians made more than $200,000—including two who topped $300,000.

Physicians also received money from some of the 70-plus drug companies that have not disclosed their payments. Some of those interviewed could not recall all the companies that paid them, and certainly not how much they made. By 2013, the health care reform law requires all drug companies to report this information to the federal government, which will post it on the Web.

The busiest—and best compensated—doctors gave dozens of speeches a year, according to the data and interviews. The work can mean a significant salary boost—enough for the kids' college tuition, a nicer home, a better vacation.

Among the top-paid speakers, some had impressive resumes, clearly demonstrating their expertise as researchers or specialists. But others did not –contrary to the standards the companies say they follow.

Forty five who earned in excess of $100,000 did not have board certification in any specialty, suggesting they had not completed advanced training and passed a comprehensive exam. Some of those doctors and others also lacked published research, academic appointments or leadership roles in professional societies.

Experts say the fact that some companies are disclosing their payments is merely a start. The disclosures do not fully explain what the doctors do for the money—and what the companies get in return.

In a raft of federal whistleblower lawsuits, former employees and the government contend that the firms have used fees as rewards for high-prescribing physicians. The companies have each paid hundreds of millions or more to settle the suits.

The disclosures also leave unanswered what impact these payments have on patients or the health care system as a whole. Are dinner talks prompting doctors to prescribe risky drugs when there are safer alternatives? Or are effective generics overlooked in favor of pricey brand-name drugs?

"The pressure is enormous. The investment in these drugs is massive," said Dr. David A. Kessler, who formerly served as both FDA commissioner and dean of the University of California, San Francisco School of Medicine. "Are any of us surprised they're trying to maximize their markets in almost any way they can?"

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