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Clearwater doctor's drug study raises questions

CLEARWATER

When the man at Alliance Medical Research Group introduced himself as Dr. Vladimir Martin, Ruth Weber had no reason to doubt he was a licensed physician. And when he proceeded to enroll her in a study for an experimental drug for lower-back pain, then follow her progress during weekly visits and adjusted the dosage of her medicine, Weber, 73, thought nothing of it.

It was only about two months into the study, after never seeing another patient in Martin's sparely decorated office on Belcher Road, that Weber started wondering what was going on. It seemed particularly strange because the doctor's appointment book always appeared to be full.

After Martin's young female assistant quit two weeks into the study — and Weber found herself alone with Martin every week — the Clearwater retiree had become downright uncomfortable.

"I'd lift up my shirt so he could give me an EKG (electrocardiogram) and I got antsy," she said. "I thought, 'I don't know if I can keep this up.' "

Telling Martin she no longer had time for the study, Weber quit in mid December over the doctor's protests. It was only then that she learned the truth.

Martin, a native of Ukraine who says he got his medical degree in Russia, has no medical license in Florida.

According to Food and Drug Administration records, the clinical study, of a new Johnson & Johnson painkiller called tapentadol, is being conducted by Dr. Robert Lee Jackson, a Clearwater osteopath. Though Martin, 41, is listed with the FDA as study coordinator, his authority is strictly limited by federal clinical trial rules. All patients are supposed to be seen by the licensed physician, particularly when they first enroll and whenever drug dosages are changed.

But Weber, whose youthful attitude and quick wit belie her years, insists she never met Jackson, whose family practice on Gulf-to-Bay Boulevard is 4 miles away from Martin's Alliance Medical Research.

"I saw Jackson's name on the pill packages and wondered when I'd meet him, but I never did," said Weber, who did not know if she was receiving the study drug, a placebo or the potent narcotic OxyContin. "When I asked Dr. Martin about Jackson, he said, 'He reviews all your charts.' "

In an interview last month, Martin, square-jawed and sturdy in a short-sleeved plaid shirt, defended his handling of Weber's trial, the 17th he has conducted.

"I don't have to tell them I'm not a doctor,'' said Martin, who changed his name from Kossatchev when he moved to Florida in 2003. "I am not practicing medicine."

Jackson and Martin insisted that the tapentadol trial was conducted in accordance with FDA guidelines and that Jackson saw every study subject at least once a month. Referring to Martin's office, Jackson said, "I'm here every day from 11 to 2."

Weber said she booked her visits on different days of the week, usually at 10 a.m., but once closer to noon. Even after seeing a photo of Jackson, Weber was adamant.

"I never saw him," she said. "The only doctor I ever saw was Dr. Martin."

Asked by a reporter about Weber's complaints, a spokesman for Johnson & Johnson Pharmaceutical Research said, "These allegations concern us, and we are looking into them to determine the facts and take appropriate action."

• • •

Weber, who has occasional back pain because of osteoporosis, was surfing the federal government's Web site of new drug studies (www.clinicaltrials.gov) last fall when she came across the listing for the Johnson & Johnson trial, which was being conducted at more than 100 locations across the country.

Though she'd never been involved in a clinical trial, a friend back in Ann Arbor, Mich., had a good experience with one. More important, Weber's daughter, Marti, has been overseeing clinical trials for 16 years and it seemed like a way to get a better understanding of her work.

"When it turned out there was a site right down the street (at Alliance Medical), I thought, 'Why not?' " she said.

During her first visit, Weber met Martin, who explained the protocol for the 13-week trial and had her sign the informed consent form. Since the study involved weekly visits, as well as EKGs and blood tests, subjects were paid $25 a visit.

Martin, whose income depends on finding suitable study subjects, seemed eager to make sure Weber would qualify for the trial.

"He told me that in order to join, my pain had to be at least a 5 on a scale of 1 to 10,'' said Weber, who took only an occasional Tylenol for her back. "I thought my pain was only about a 3, but he said it had to be 5 or above, so I told him it was 7."

Though neither Martin nor Weber was supposed to know what drug she was taking, Weber said on several occasions he suggested she was on tapentadol, in violation of trial regulations.

"I told Dr. Martin I didn't know if I wanted to be on OxyContin and he said he was pretty sure I was on the study drug," Weber said. "I remember him saying, 'We know you're not on the placebo.' "

Recording her pain level twice daily in a handheld computer, Weber initially thought she felt some relief. When the discomfort returned to previous levels, Martin doubled her dosage, telling her to take four pills in the morning and four at night. Feeling no improvement or any side effects, Weber dropped back to the original dosage after a week.

"That was too much popping pills for me," she said.

Though she said Martin seemed meticulous in his note-taking during their weekly visits, his clinical technique left a little to be desired.

"He had to redo my EKGs a couple of times because the leads slipped," Weber said of Martin, who also did weekly blood draws.

Unsettled by the fact that she never saw anyone else in Martin's office, Weber told him she was going to be too busy to participate during the holidays and intended to drop out.

"He wasn't very happy about it," she said. "He told me if I stayed in for a year, I could keep the iPod thing I put my data in. But if I want something like that, I can go out and buy it."

• • •

In an interview last month, Martin strongly denied mishandling the study of extended-release tapentadol. (Studies have already been completed on an immediate-release formulation of the painkiller, and it is pending FDA approval.)

Martin said he never asks subjects leading questions about their pain levels, either during the initial screening process or during the trial.

"We cannot do this," he said firmly.

He also said he does not imply that he knows which drug a subject is taking in a double-blind study.

"I don't know what drug they're on," he said. Martin also said he never adjusts a patient's drug dosage. "That is only done by Dr. Jackson," he said.

But Weber is not the only person who had problems with Martin's trials. Kelly Sims became romantically involved with Martin shortly after he moved to Florida, and she introduced him to Clearwater physician Valli Subramanian. With Sims as his assistant and working out of the doctor's office on Fort Harrison Avenue, Martin landed four drug studies in which Subramanian was listed with the FDA as lead investigator. Sims, now 37, said Martin persuaded her to join a study in 2006 of the depressant Niravam for anxiety disorder.

"He enrolled me even though he knew I had a problem with substance abuse and you were supposed to be clean for two years," said Sims, who was living part time with Martin during the study. "I'd take the pills while I was drinking and black out."

Martin said last week that the doctor, not he, was responsible for approving his former girlfriend for the trial. Subramanian did not return a call seeking comment.

Sims, who had hoped to marry Martin and now feels misled, recently asked Subramanian for her medical records from the Niravam trial. The doctor replied by letter, saying that since the trial was conducted by telephone survey, "there is no medical study-related information."

Tamera Norton Smith, who has 17 years' experience in the clinical trial industry, nine of those as an FDA investigator, said the doctor's claim that there were no lab tests or other documents from the study was "a bunch of malarkey."

"If they're missing the informed consent document, that's huge," she said of the missing paperwork from Sims' trial. "It's just so unethical, it violates all kinds of international drug trial regulations." Smith now works as president of Norton Audits in Lexington, S.C.

In an effort to recruit subjects for Martin, Simsims said she encouraged her dad, John Garnish, to join the study of a new cholesterol-lowering drug in mid 2006. Though Dr. Jackson was lead investigator, Garnish, now 65, said he never saw the doctor. It was his daughter who drew his blood for the initial screening. And he said it was Martin who told him to stop taking his cholesterol medication in preparation for the study. A month into the "washout" period, however, Garnish's doctors discovered he had severe blockage in his arteries and he underwent a triple bypass.

Last week, Martin denied ever telling Garnish to go off his pills, saying the man never qualified for the trial because his initial HDL levels were too high. Martin said that he probably called Garnish with the news and that written documentation of his exclusion was not required.

Garnish, who recently requested all his records from the trial and received only the lab report, has a different recollection of the incident. "If Dr. Martin didn't tell me to stop taking my pills, why would I do that?"

• • •

Martin, who monitored clinical trials for Pfizer for five years before starting his own business, defended the quality of his work.

"You really have to know what you're doing and you have to be meticulous," said Martin, who opened his Belcher Road office a year ago. "Because of our experience, we are now being approached by pharmaceutical companies to do these trials."

Martin said most of his trials involve three to seven subjects. Depending on the work involved, the principal investigator is paid about $5,000 per person, Jackson said.

"I don't make much money doing studies, and it takes a lot of time," said Jackson, 61. "I do it for the enjoyment."

Jackson's new avocation hasn't been hampered by a few blemishes on his official record. In 1988, Jackson was put on probation by the Florida Board of Osteopathic Medicine. The official state document showing why he was disciplined is illegible; Jackson said the action was taken "because they couldn't read my medical records."

In 2002, Jackson was sued for malpractice when a patient, Joseph Kalecki, overdosed after eating a fentanyl patch. After reviewing the patient's medical records, an expert for Kalecki's widow testified that it should have been clear to Jackson that Kalecki was abusing prescription drugs. The case was settled in 2005, with Jackson's insurer paying $240,000. Jackson said the Board of Medicine found no wrongdoing in his handling of Kalecki's care. "But I have had a few inquiries from drug companies about it," he acknowledged.

• • •

At her daughter's urging, Ruth Weber filed a complaint about never seeing the doctor who was supposed to be conducting her drug trial. On Jan. 5, she called Cassie Mitchell, director of regulatory compliance and quality assurance at the Sterling Institutional Review Board in Atlanta. Drug companies hire IRBs like Sterling to oversee patient safety during clinical trials. In mid March, Weber got an e-mail from Mitchell saying the drugmaker, Johnson & Johnson, had conducted a two-day audit at "Dr. Jackson's site" and everything looked fine.

"All the documentation was reviewed and found to support that the research personnel only performed tasks for which they were qualified," Mitchell wrote. "Please let me know if there is anything else I can do for you at this time."

That response left Weber feeling brushed off, and her daughter, the veteran clinical trial monitor, livid.

"What recourse does the patient have when the IRB won't help?" said Marti Weber, whose job is to ensure that clinical trials are conducted according to the rules. "Research participants are scientific heroes, and I don't want to discourage people from participating in trials. But who's really there for the patient?"

A spokesman for Johnson & Johnson said Thursday that he was not aware of the earlier audit, but that the company would be "commencing an investigation."

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

Before new medicines can be sold to the public, drug companies have to gather data on their efficacy and safety through carefully designed clinical trials using volunteers like Ruth Weber. Most of these studies are conducted by private-practice physicians, who are hired and paid thousands of dollars per subject by the drugmaker. The federal Food and Drug Administration inspects fewer than 1 percent of the 80,000 clinical trials conducted worldwide each year, and then usually only after the trial has been completed. Data gathered by these doctors is presented to the FDA, which relies on its accuracy when deciding whether to approve a new drug for the market.

Clinical trials are the final — and most expensive — link in the multiyear, multimillion-dollar chain that moves a new compound from the drugmaker's lab to a drugstore's shelves. If doctors cut corners, or overdelegate their responsibilities to unlicensed personnel, trial subjects as well as the general public could be hurt.

Art Caplan, a professor of bioethics at the University of Pennsylvania, is a frequent critic of lax oversight of clinical trials. "The FDA is supposed to keep an eye on investigators (doctors) but they completely dropped the ball on being able to keep up with the volume of research," he said. "Some trials have an investigator who is there in name only and that's a huge danger.''

Tamera Norton Smith, a former FDA investigator and now president of Norton Audits in Lexington, S.C., said Weber's claim that she had never seen a licensed physician during her trial was frightening — but all too familiar.

"It's pretty scary these kinds of things happen, because patient safety is at stake," said Smith, who is an expert on fraud detection in trials. "These products are investigational, so there's more risk with them. The doctor has to be actively engaged to make sure she's a proper candidate and that she's safe during the trial. But I deal with these kinds of issues every day."

Kris Hundley, Times staff writer

Clearwater doctor's drug study raises questions 04/19/08 [Last modified: Thursday, April 24, 2008 10:38am]
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