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Operator of drug trials charged with unlicensed medical practice

CLEARWATER — Vladimir Martin called himself "doctor" and ran 17 clinical trials of new drugs for major pharmaceutical companies before one patient noticed he didn't have a medical license.

The patient alerted the St. Petersburg Times, whose resulting story led to a state investigation. On Saturday, Martin, 43, was arrested on charges of practicing medicine without a license. He was later released from the Pinellas County Jail on $10,000 bail. The felony charge carries a maximum sentence of five years in prison and maximum fine of $5,000.

The Clearwater man, who changed his last name from Kossatchev after moving to Florida in 2003, went to medical school in the former Soviet Union and practiced in a hospital in his native Ukraine.

"I don't have to tell them I'm not a doctor," Martin told the Times last year when asked about his failure to become licensed in Florida. "I am not practicing medicine."

But Ruth Weber, a 74-year-old Clearwater resident, told the Times in April 2008 that the man who called himself Dr. Martin enrolled her in a study for lower-back pain and adjusted the dosage of her medicine. Only licensed physicians are supposed to conduct such activities. Patients in the study were randomly selected to receive a new Johnson & Johnson painkiller called tapentadol, a placebo or the potent narcotic oxycodone.

Though Dr. Robert Lee Jackson, a Clearwater osteopath, was listed by the FDA as the physician conducting the study, Weber said she never saw Jackson. In weekly visits to Alliance Medical Research Group on Belcher Road, Weber said it was Martin who drew blood, doled out medication and, at one point, doubled her dosage.

Martin also conducted electrocardiograms on Weber, although his techniques were so rusty the electrodes kept slipping off, she said. Weber eventually dropped out of the study when she saw no improvement for her back pain.

A second woman, Ann Reed, told investigators she also responded to an ad for a drug study trial at Alliance Medical Research. Martin took her blood, listened to her heart and gave her medications, Reed said. Martin sometimes had to stick her four times to draw blood, she said.

Like Weber, Reed said she never saw Jackson during her trial, which involved 13 visits between May 2007 and March 2008.

Jackson, who retired about a year ago, ran his medical practice from an office on Gulf-to-Bay Boulevard, about four miles from Martin's office. Jackson told investigators he did physical exams of every drug study patient, despite the two witnesses' statements to the contrary. Last year Jackson told the Times that he was paid about $5,000 for every patient enrolled in a trial, with three to seven people in most studies.

Jackson told investigators that, according to the trial's protocol, unlicensed people are allowed to dispense drugs in the absence of a physician. Jackson said he was unaware those protocols conflicted with state law.

Greg Panico, a spokesman for Johnson & Johnson, said the company audited Alliance Medical after the Times' story and submitted its findings to the FDA. He declined to discuss the nature of the report, but said the drug company is no longer working with Alliance Medical.

Panico also said data collected in the tapentadol study at that site was not submitted to the FDA.

The drugmaker said it reported its findings to the Sterling Institutional Review Board in Atlanta, which had been hired by Johnson & Johnson to oversee patient safety during the trial.

Months before she went public with her concerns, Weber had filed her own complaint about Martin's missing license with the oversight board. She had been assured everything was fine.

Despite losing the Johnson & Johnson trial, Martin told investigators in July that he was conducting four other drug studies.

Times researcher Caryn Baird contributed to this report. Kris Hundley can be reached at khundley@sptimes.com or (727)892-2996.

Operator of drug trials charged with unlicensed medical practice 06/22/09 [Last modified: Monday, June 22, 2009 9:30pm]
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