Thursday, November 18, 2010

Still on payroll despite fatal mistakes - Health News Florida

Of all the doctors in Florida that GlaxoSmithKline could have chosen as consultants, Steven Brooks and his partner E. “Jake” Jacobo would seem the least likely. They have a criminal record.

In 2001, the Orlando-area urologists pleaded guilty in U.S. District Court in Connecticut to one count of conspiracy to defraud Medicare and the military through a complicated black-market diversion of the pricey prostate cancer drug Lupron.

Despite the blotch on his record, Brooks is Florida’s third-biggest recipient of pharma speaking fees overall and commands by far the largest fees among those who have been disciplined, according to a data-mining  project by the investigative news site ProPublica. Working with the team there, Health News Florida analyzed the data for Florida and wrote a state-based analysis. 

Over the last 18 months, GlaskoSmithKline paid Brooks over $178,000, ProPublica found. The company also paid Jacobo $14,750.


In the criminal case, federal prosecutors allowed the doctors to plead to a misdemeanor in return for repaying the government $1.1 million. They were sentenced to five years’ probation and 500 hours of community service.

According to an account in the Orlando Sentinel at the time, the doctors' attorney portrayed them as duples of pharmaceutical sales reps. He said it seemed like a business deal: The doctors bought extra supplies of Lupron in states where it was less expensive and arranged for resale in states where costs were higher, records said. This violated wholesale drug distribution laws.

The Florida Board of Medicine fined each doctor $10,000 and required them to take classes in medical ethics and risk management. Brooks gave up his medical license in New York, rather than fight charges stemming from the case.

Neither Brooks nor Jacobo returned calls from Health News Florida. A call to the drug company seeking information on the urologists’ roles as consultants and on whether the company knew about the federal case also went unanswered.

Who's running trials on new drugs?

Pharmaceutical companies depend on physicians to run clean clinical trials so they can get the data they need for Food and Drug Administration approval. Yet two drug-company consultants in Florida received FDA warning letters the over the way they ran clinical trials.

Last year, the FDA cited Francisco Hernandez of Hialeah for enrolling the wrong patients in a clinical trial of a diabetes injectable drug made by Sanofi-Aventis. Of 15 patients Hernandez enrolled, the letter said, 12 didn’t qualify.

The FDA also said Hernandez didn’t report illnesses in two of the patients that were serious enough to require hospitalization.

A similar letter went to Jeffrey R. Levenson in St. Petersburg for his work on the investigational drug Zyvox for Pharmacia and Upjohn in 2000, records show.

Levenson enrolled some subjects who were too sick to meet the outlines for the trial or even to give informed consent, the letter said. He also failed to report serious adverse events, it said.

Hernandez received $6,000 in the past year and a half from Lilly for consulting, records show. Levenson received $2,000 from GlaxoSmithKline and about $1,800 from Pfizer.

Neither returned calls from Health News Florida.

Experts on prescribing? Not so much

Doctors who are  paid speakers for drug companies are supposed to be experts in prescribing. According to records, though, several in Florida were anything but -- including psychiatrist Joseph John Altieri of Vero Beach.

(He is not to be confused with Dr. John Joseph Altieri, a Sarasota-based cardiologist)

Psychiatrist Altieri came before the Board of Medicine in 2008, charged with inappropriate prescribing to three patients.

In case documents, Department of Health investigators said Altieri provided a “constantly changing cocktail” of addictive drugs -- including potentially lethal narcotics such as oxycodone and morphine – to patients who Altieri knew or should have known were addicts.

The Board of Medicine found Altieri violated a slew of codes on physician conduct. He was fined $30,000 and placed on two years’ probation, with another physician supervising.

The DOH web site says Altieri recently completed his probation, but while it was still in force last year, he received $1,040 in speaking fees from Pfizer.

He did not return calls from Health News Florida.

Still on payroll, despite fatal mistake

Some doctors remain as speakers for drug companies, even after making very public, fatal mistakes.

Case in point: Tampa urologists Tod Fusia and Mark Swierzewski remain in demand as drug-company speakers even though they made a slip-up in surgery, killing a popular high-school teacher in October 2002,

The aim of the operation at St. Joseph’s Hospital was removal of a cancerous kidney. With Swierzewski assisting, Fusia used the then-new robotic arm to snip what he thought were the proper blood vessels. But they turned out to be the aorta and vena cava.

Despite efforts to stitch the vessels back together, the patient died the next day.

Their insurer settled the malpractice case for $1 million. The Florida Board of Medicine and Fusia settled the administrative charges with a $10,000 fine and 100 hours of community service.

Still, during the past 18 months, Fusia has received $6,500 in speaking fees from GlaxoSmithKline, according to ProPublica. Swierzewski got $4,175 from Lilly.

Neither of them returned calls from Health News Florida.

Not fatal, but still...

Another who bounced back from public humiliation is Dr. Charles C. Greene, an ear-nose-throat specialist in Jacksonville. In March 2002, when he set out to repair a patient’s blocked nasal passages by inserting tubes and instruments, he went too far.

An instrument penetrated the brain and removed part of the frontal lobe, according to Department of Health records. When the patient developed symptoms, Greene failed to act swiftly enough, the records said.

Other doctors eventually diagnosed a leak of brain fluid, blood clots in the brain and brain damage.

The family sued Greene and the parties reached a $500,000 settlement in April 2004. Greene also paid a $326,700 settlement in 2004 in a separate case.

In 2009 and 2010, GlaskoSmithKline paid Greene $16,600 in speaking fees, ProPublica found.

He did not return calls from Health News Florida.

--David Gulliver is an independent  journalist and founder of Sarasota Health News. Carol Gentry, Editor of Health News Florida, can be reached by e-mail or at 727-410-3266. 


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