Docs on Pharma Payroll Have Blemished Records, Limited Credentials

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Pro Publica

Docs on Pharma Payroll Have Blemished Records, Limited Credentials

by
Charles Ornstein , Tracy Weber and Dan Nguyen

ProPublica compiled thousands of records to track the financial ties between doctors and drug companies.

The Ohio medical board concluded [1]
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 U.S. Food and Drug Administration ordered [2]
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 [3]
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.

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 [4]
that represents the most accessible accounting yet of payments to
doctors. Compiled from disclosures by seven companies, the database
covers $257.8
million 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 U.S. 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 [5] 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 [6],
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?”

From drug reps to doc reps

For years, drug companies bombarded doctors with pens, rulers,
sticky notes, even stuffed animals emblazoned with the names of the
latest remedies for acid reflux, hypertension or erectile dysfunction.
They wooed physicians with fancy dinners, resort vacations and
personalized stethoscopes.

Concerns that this pharma-funded bounty amounted to bribery led the industry to ban most gifts voluntarily [7]. Some hospitals and physicians also banned the gift-givers: the legions of drug sales reps who once freely roamed their halls.

So the industry has relied more heavily on the people trusted most
by doctors — their peers. Today, tens of thousands of U.S. physicians
are paid to spread the word about pharma’s favored pills and to advise
the companies about research and marketing.

Recruited and trained by the drug companies, the physicians —
accompanied by drug reps — give talks to doctors over small dinners,
lecture during hospital teaching sessions and chat over the Internet.
They typically must adhere to company slides and talking points.

These presentations fill an educational gap, especially for
geographically isolated primary care doctors charged with treating
everything from lung conditions to migraines. For these doctors, poring
over a stack of journal articles on the latest treatments may be
unrealistic. A pharma-sponsored dinner may be their only exposure to new
drugs that are safer and more effective.

Oklahoma pulmonologist James Seebass, for example, earned $218,800
from Glaxo in 2009 and 2010 for lecturing about respiratory diseases “in
the boonies,” he said. On a recent trip, he said, he drove to “a little
bar 40 miles from Odessa,” Texas, where physicians and nurse
practitioners had come 50 to 60 miles to hear him.

Seebass, the former chair of internal medicine at Oklahoma State
University College of Osteopathic Medicine, said such talks are “a
calling,” and he is booking them for 2011.

The fees paid to speakers are fair compensation for their time away
from their practices, and for travel and preparation as well as
lecturing, the companies say.

Dr. Samuel Dagogo-Jack has a resume that would burnish any
company’s sales force: He is chief of the division of endocrinology,
diabetes and metabolism at the University of Tennessee Health Science
Center. Dagogo-Jack conducts research funded by the National Institutes
of Health, has edited medical journals and continues to see patients.

While most people are going home to dinner with their families, he
said, he is leaving to hop on a plane to bring news of fresh diabetes
treatments to non-specialist physicians “in the trenches” who see the
vast majority of cases.

Since 2009, Dagogo-Jack has been paid at least $257,000 by Glaxo, Lilly and Merck.

“If you actually prorate that by the hours put in, it is barely
more than minimum wage,” he said. (A person earning the federal minimum
wage of $7.25 would have to work 24 hours a day, seven days a week for
more than four years to earn Dagogo-Jack’s fees.)

For the pharmaceutical companies, one effective speaker may not only
teach dozens of physicians how to better recognize a condition, but
sell them on a drug to treat it. The success of one drug can mean
hundreds of millions in profits, or more. Last year, prescription drugs
sales in the United States topped $300 billion, according to IMS Health,
a healthcare information and consulting company.

Glaxo’s drug to treat enlarged prostates, Avodart — locked in a
battle with a more popular competitor — is the topic of more lectures
than any of the firm’s other drugs, a company spokeswoman said. Glaxo’s
promotional push has helped quadruple Avodart’s revenue to $559 million
in five years and double its market share, according to IMS.

Favored speakers like St. Louis pain doctor Anthony Guarino earn
$1,500 to $2,000 for a local dinner talk to a group of physicians.

Guarino, who made $243,457 from Cephalon, Lilly and Johnson &
Johnson since 2009, considers himself a valued communicator. A big part
of his job, he said, is educating the generalists, family practitioners
and internists about diseases like fibromyalgia, which causes chronic,
widespread pain — and to let them know that Lilly has a drug to treat
it.

“Somebody like myself may be able to give a better understanding of
how to recognize it,” Guarino said. Then, he offers them a solution:
“And by the way, there is a product that has an on-label indication for
treating it.’’

Guarino said he is worth the fees pharma pays him on top of his
salary as director of a pain clinic affiliated with Washington
University. Guarino likened his standing in the pharma industry to that
of St. Louis Cardinals first baseman Albert Pujols, named baseball
player of the decade last year by Sports Illustrated. Both earn what the
market will bear, he said: “I know I get paid really well.”

Is anyone checking out there?

Simple searches of government websites turned up disciplinary actions against many pharma speakers in ProPublica’s database.

The Medical Board of California filed a public accusation against psychiatrist Karin Hastik in 2008 and placed her [8] on five years’ probation in May for gross negligence in her care of a patient. A monitor must observe her practice.

Kentucky’s medical board placed Dr. Van Breeding on probation [9]
from 2005 to 2008. In a stipulation filed with the board, Breeding
admits unethical and unprofessional conduct. Reviewing 23 patient
records, a consultant found Breeding often that gave addictive pain
killers without clear justification. He also voluntarily relinquished
his Florida license.

New York’s medical board put Dr. Tulio Ortega on two years’ probation [10]
in 2008 after he pleaded no contest to falsifying records to show he
had treated four patients when he had not. Louisiana’s medical board,
acting on the New York discipline, also put him on probation [11] this year.

Yet during 2009 and 2010, Hastik made $168,658 from Lilly, Glaxo
and AstraZeneca. Ortega was paid $110,928 from Lilly and AstraZeneca.
Breeding took in $37,497 from four of the firms. Hastik declined to
comment, and Breeding and Ortega did not respond to messages.

Their disciplinary records raise questions about the companies’ vigilance.

“Did they not do background checks on these people? Why did they
pick them?” said Lisa Bero, a pharmacy professor at University of
California, San Francisco who has extensively studied conflicts of
interest in medicine and research.

Disciplinary actions, Bero said, reflect on a physician’s credibility and willingness to cross ethical boundaries.

"If they did things in their background that are questionable, what about the information they’re giving me now?” she said.

ProPublica found sanctions ranging from relatively minor misdeeds
such as failing to complete medical education courses to the negligent
treatment of multiple patients. Some happened long ago; some are
ongoing. The sanctioned doctors were paid anywhere from $100 to more
than $140,000.

Several doctors were disciplined for misconduct involving drugs made
by the companies that paid them to speak. In 2009, Michigan regulators
accused one rheumatologist of forging a colleague’s name to get
prescriptions for Viagra and Cialis. Last year, the doctor was paid
$17,721 as a speaker for Pfizer, Viagra’s maker.

A California doctor who was paid $950 this year to speak for
AstraZeneca was placed on five years’ probation by regulators in 2009
after having a breakdown, threatening suicide and spending time in a
psychiatric hospital after police used a Taser on him. He said he’d been
self-treating with samples of AstraZeneca’s anti-psychotic drug
Seroquel, medical board records show.

Other paid speakers had been disciplined by their employers or
warned by the federal government. At least 15 doctors lost staff
privileges at various hospitals, including one New Jersey doctor who had
been suspended twice for patient care lapses and inappropriate
behavior. Other doctors received FDA warning letters for research
misconduct such as failing to get informed consent from patients.

Pharma companies say they rely primarily on a federal database
listing those whose behavior in some way disqualifies them from
participating in Medicare. This database, however, is notoriously
incomplete.

The industry’s primary trade group says its voluntary code of
conduct is silent about what, if any, behavior should disqualify
physician speakers.

“We look at it from the affirmative — things that would qualify
physicians,” said Diane Bieri, general counsel and executive vice
president of the Pharmaceutical Research and Manufacturers of America.

Some physicians with disciplinary records say their past misdeeds do not reflect on their ability to educate their peers.

Family medicine physician Jeffrey Unger was put on probation [12]
by California’s medical board in 1999 after he misdiagnosed a woman’s
breast cancer for 2½ years. She received treatment too late to save her
life. In 2000, the Nevada medical board revoked Unger’s license for not
disclosing California’s action.

As a result, Unger said, he decided to slow down and start listening
to his patients. Since then, he said, he has written more than 130
peer-reviewed articles and book chapters on diabetes, mental illness and
pain management.

“I think I’ve more than accomplished what I’ve needed to make this
all right,” he said. During 2009 and the first quarter of 2010, Lilly
paid Unger $87,830. He said he also is a paid speaker for Novo Nordisk
and Roche, two companies that have not disclosed payments.

The drug firms, Unger said, “apparently looked beyond the record.”

Companies make their own experts

Last summer, as drug giant Glaxo battled efforts to yank its
blockbuster diabetes drug Avandia from the market, Nashville
cardiologist Hal Roseman worked the front lines.

At an FDA hearing, he borrowed David Letterman’s shtick [13] to deliver a “Top Five” list of reasons to keep the drug on the market despite evidence it caused heart problems. He faced off [14] against a renowned Yale cardiologist and Avandia critic on the PBS NewsHour, arguing that the drug’s risks had been overblown.

“I still feel very convinced in the drug,” Roseman said with relaxed
confidence. The FDA severely restricted access to the drug last month
citing its risks.

Roseman is not a researcher with published peer-reviewed studies to
his name. Nor is he on the staff of a top academic medical center or in a
leadership role among his colleagues.

Roseman’s public profile comes from his work as one of Glaxo’s
highest-paid speakers. In 2009 and 2010, he earned $223,250 from the
firm — in addition to payouts from other companies.

Pharma companies often say their physician salesmen are chosen for
their expertise. Glaxo, for example, said it selects “highly qualified
experts in their field, well-respected by their peers and, in the case
of speakers, good presenters.”

ProPublica found that some top speakers are experts mainly because
the companies have deemed them such. Several acknowledge that they are
regularly called upon because they are willing to speak when, where and
how the companies need them to.

“It’s sort of like American Idol,” said sociologist Susan Chimonas,
who studies doctor-pharma relationships at the Institute on Medicine as
a Profession in New York City.

“Nobody will have necessarily heard of you before — but after
you’ve been around the country speaking 100 times a year, people will
begin to know your name and think, ‘This guy is important.’ It creates
an opinion leader who wasn’t necessarily an expert before.”

To check the qualifications of top-paid doctors, reporters searched
for medical research, academic appointments and professional society
involvement. They also interviewed national leaders in the physicians’
specialties.

In numerous cases, little information turned up.

Las Vegas endocrinologist Firhaad Ismail, for example, is the top
earner in the database, making $303,558, yet only his schooling and
mostly 20-year-old research articles could be found. An online brochure [15]
for a presentation he gave earlier this month listed him as chief of
endocrinology at a local hospital, but an official there said he hasn’t
held that title since 2008.

And several leading pain experts said they’d never heard of Santa
Monica pain doctor Gerald Sacks, who was paid $249,822 since 2009.

Neither physician returned multiple calls and letters.

A recently unsealed whistleblower lawsuit against Novartis [16],
the nation’s sixth-largest drug maker by sales, alleges that many
speakers were chosen “on their prescription potential rather than their
true credentials.”

Speakers were used and paid as long as they kept their prescription
levels up, even though “several speakers had difficulty with English,”
according to the amended complaint filed this year in federal court in
Philadelphia.

Some physicians were paid for speaking to one another, the lawsuit
alleged. Several family practice doctors in Peoria, Ill., “had two
programs every week at the same restaurant with the same group of
physicians as the audience attendees.”

In September, Novartis agreed to pay [17]
the government $422.5 million to resolve civil and criminal allegations
in this case and others. The company has said it fixed its practices
and now complies with government rules.

Roseman, who has been a pharma speaker for about a decade,
acknowledged that his expertise comes by way of the training provided by
the companies that pay him. But he says that makes him the best
prepared to speak about their products, which he prescribes for his own
patients. Asked about Roseman’s credentials, a Glaxo spokeswoman said he
is an “appropriate” speaker.

Getting paid to speak “doesn’t mean that your views have necessarily been tainted,” he said.

Plus pharma needs talent, Roseman said. Top-tier universities such as Harvard [18]
have begun banning their staffs from accepting pharma money for
speaking, he said. “It irritates me that the debate over bias comes down
to a litmus test of money,” Roseman said. “The amount of knowledge that
I have is in some regards to be valued.”

ProPublica Director of Research Lisa Schwartz and researcher Nicholas Kusnetz contributed to this report.

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