Replies to post #48618 on Biotech Values

[xrymd]

Drug pusher offering sham procedures and narcotics for money. END OF STORY.

[DewDiligence]

90% of OxyContin Profit Was Consumed by Penalties

http://www.nytimes.com/2007/06/19/business/19drug.html

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June 19, 2007
By BARRY MEIER

The $634.5 million in penalties and fines that the maker of the painkiller OxyContin and some of its executives agreed to pay to resolve a false marketing charge represents 90 percent of the profits it initially made from the drug, according to court documents filed by federal prosecutors.

The company, Purdue Pharma, agreed to the penalty, one of the largest ever paid by a drug company in such a case, after an affiliate, Purdue Frederick, and three current and former executives pleaded guilty last month to criminal charges that it had misled doctors and patients when it claimed the drug was less likely to be abused than traditional narcotics.

In another aspect of the case, the lead prosecutor said in a recent interview that former Mayor Rudolph W. Giuliani of New York, who is now seeking the Republican presidential nomination, played the central role on behalf of the company in the negotiations that led to its felony plea. It was already known that Mr. Giuliani had participated in those talks on behalf of Purdue Pharma, which is a client of Bracewell & Giuliani, a law firm in Houston in which Mr. Giuliani is a principal. But in a recent interview, John L. Brownlee, the United States attorney for the Western District of Virginia, described Mr. Giuliani as playing the central role in talks with federal prosecutors. “When we had meetings, he was the lead counsel and the lead spokesman for the company,” Mr. Brownlee said.

OxyContin is a powerful narcotic that provides relief of serious pain for up to 12 hours. Soon after its introduction, it also became a popular drug of abuse among both drug addicts and novices, including teenagers.

After the pleas from the company and its executives, Judge James P. Jones of Federal District Court in Abingdon, Va., who is presiding over the matter, directed a series of questions to both federal prosecutors and lawyers for Purdue Pharma, which is based in Stamford, Conn.

Judge Jones is expected to decide at a hearing next month whether to accept the company’s guilty plea to a felony charge as well as misdemeanor pleas by the three company officials, who agreed to pay a total of $34.5 million in fines.

In their response to Judge Jones’s questions, prosecutors, along with disclosing the 90 percent figure, explained why they had agreed not to recommend incarceration for the executives.

They stated that they believed that the conviction of the officials would serve as a deterrent to other pharmaceutical industry executives. And they noted that the individuals’ deals were part of the overall agreement with the company.

“Each corporate official will bear the stigma of being a convicted criminal,” Mr. Brownlee stated in that filing. The three men are Michael Friedman, the company’s president; Howard R. Udell, its top lawyer; and Dr. Paul D. Goldenheim, its former medical director.

Some parents of teenagers and young adults who became addicted to OxyContin or died in overdoses in which it was a factor are expected to urge Judge Jones to reject the plea deal, saying they believe that the executives should go to prison.

After last month’s pleas, some drug industry critics also said the amounts to be paid by Purdue Pharma were too low, given the profit the company made from OxyContin. From late 1995 to mid-2001, when the company dropped its “reduced risk” claims, the drug produced $2.8 billion in revenue for Purdue Pharma. OxyContin’s biggest selling years, however, occurred after mid-2001, the period when prosecutors said the crimes ended.

Etc.
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[DewDiligence]

Needham Doctor's License Suspended for Drug Dealing

http://www.boston.com/news/local/articles/2007/09/14

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By Liz Kowalczyk
September 14, 2007

NEEDHAM - The first sign of trouble came at a neighborhood pharmacy.

Patients of Dr. Joseph Zolot began coming around in 1999, sometimes a half-dozen a day, to fill prescriptions for high doses of narcotics, the pharmacist later told investigators. He said he called Zolot to discuss the prescriptions, but that the doctor never returned his calls.

By 2002, the pharmacist not only stopped filling the prescriptions, he set up a phone line for area drugstores to call so they could keep track of which of Zolot's patients they had rejected. Soon after, a Boston detective, posing as a patient with back pain, paid Zolot $150 cash and received prescriptions for various narcotics on each of nine separate visits, according to investigators.

By 2005, a relative of at least one patient complained to regulators about Zolot's care. In 2006, two health insurers suspended him from their provider networks.

But it wasn't until May of this year - after six of his patients died of causes including prescription drug overdoses or abuse - that federal, state, and local law enforcement officials banged on Zolot's office door with a search warrant, seizing the medical records of dozens of patients. A month later, the state Board of Registration in Medicine suspended his medical license.

By then, Zolot and his nurse practitioner, Lisa Pliner, ranked 10th and 9th, respectively, on a list of the state's top prescribers of the most addictive narcotics, with only hospitals and other large institutions above them, according to an affidavit by board investigator Philip Beattie. Together, they wrote nearly 12,000 pain-pill prescriptions in 2006 - or about six prescriptions every working hour.

Zolot and Pliner both deny mistreating their patients.

Zolot's case, described in the affidavit, hearing transcripts, a board expert's reports, and medical examiners' reports obtained by the Globe, opens a window into the potential for highly profitable assembly-line prescribing, as the medical profession has become more aggressive in treating chronic pain, including putting suffering patients on narcotics.

Beyond that, his case also reveals the challenges to uncovering and stopping possible problem prescribers. These include agencies that don't coordinate with one another; addicted patients who don't cooperate with authorities; and regulators who don't want to discourage doctors from treating patients in serious and legitimate pain.

Now, at least six agencies are involved in the case, including the US Drug Enforcement Administration, the FBI, the medical board, and Needham, Boston, and State police. A grand jury also is investigating Zolot, a Russian surgeon who retrained in physical medicine and rehabilitation in the United States, according to one person close to the investigation.

Of the six patients who died from abuse of or overdoses of prescription drugs, according to the documents, four also had cocaine in their systems. Some were drug addicts when they began seeing Zolot, according to the affidavit and family members, while others went to him for treatment of pain and became addicted under his care.

At an appeal hearing of the temporary suspension of Zolot's license in July, Amy Sharff, a lawyer for the medical board, said Zolot acted like a "master drug dealer."

To some of his former patients, however, Zolot was a savior, a doctor who took their suffering seriously.

"I'm in near constant pain since I left Dr. Zolot," said Daniel Gharibian, 43, a construction worker and carpenter who has suffered from ruptured discs and back pain for years. He said Zolot prescribed him 150 milligrams of oxycodone daily and had him see a chiropractor and undergo other spine therapy, significantly reducing his pain. "He has a much better understanding of quality of life issues."

Zolot denies that he provided poor care to patients or contributed to any deaths, both in legal documents and through his lawyer, Jeffrey Catalano, who said Zolot was trying to help patients hobbled by chronic pain, difficult cases that other doctors couldn't or wouldn't take on. Pliner, who signed a voluntary agreement with the nursing board in July not to prescribe narcotics during the board's investigation of her prescribing patterns, also denies she mistreated patients.

"There is a war on drugs that has led hard-working physicians in this country to be called to answer before McCarthyistic type of accusations," Catalano told Judithann Burke, an administrative magistrate with the Division of Administrative Law Appeals, during the hearing in July, according to a transcript. Last month, Burke denied Zolot's motion to immediately reinstate his license, but Catalano said he will fight the permanent suspension of his license.

Board officials would not comment on Zolot's case but said narcotics prescribing cases in general can take years to investigate, because of the need to establish a pattern of improper prescribing among various patients over time, and the difficulty of coordinating among local, state and federal agencies. Executive director Nancy Achin Audesse said that patients normally are key witnesses against problem doctors, but that patients who are addicted often won't cooperate against a physician who supplies their narcotics.

In this case, said one source, state prosecutors did not have sufficient resources to devote to a long-term investigation, and the probe progressed only after federal law enforcement got involved.

Representative Peter Koutoujian, a Waltham Democrat who headed a legislative commission on OxyContin abuse, said the medical board, pharmacists, and physicians themselves could detect potential problems more quickly if they had better access to prescribing information that the state already collects. The Department of Public Health tracks prescriptions for the most addictive narcotics, but so far won't give other agencies or individuals access to this database partly because of privacy concerns.

That data, however, could help the medical board and pharmacists pinpoint physicians who prescribe large quantities. It could also help doctors identify patients who abuse medications, and direct them to treatment. According to a recent federal survey, nine states provide this type of data to physicians.

Koutoujian's commission last year recommended expanding access to the Massachusetts database, but the Public Health Council objected to changing the regulations. "We're falling behind the curve" by not doing so, Koutoujian said.

Most pain doctors follow strict guidelines when prescribing narcotics, including carefully monitoring patients through urine tests, doctor/patient contracts, and other methods to detect abuse. Catalano said Zolot regularly used such procedures.

But tension over the treatment of pain has grown in the United States between doctors, on one side, and law enforcement officials and regulators on the other. Partly because of research showing that many Americans who suffer from chronic pain are under-treated, and partly because of the aging population, doctors are prescribing more narcotics.

At the same time, the US Drug Enforcement Administration is investigating more doctors for diversion, a crime that results in prescription medication being abused or sold illegally. Seventy-one doctors nationwide were arrested last year and 412 physicians lost their authority to prescribe narcotics.

James Curley was a big, athletic man when he first visited Zolot's pain clinic. Curley had injured himself at work, his family later told state investigators, and in May 2002 sought Zolot's help with pain in his right shoulder, back, and right knee. Zolot prescribed OxyContin, a powerful narcotic. Soon, Curley's family began to notice changes. From an initial 240 pounds, he dropped weight. He stopped socializing, often falling asleep in a chair while smoking.

In the spring of 2005, his brother reported, Curley tearfully confessed that he was addicted to OxyContin and other pain medications Zolot was prescribing. But Curley continued going to Zolot, and after seeing the physician on Oct. 13 of that year, investigators said, he had prescriptions filled for OxyContin, methadone, and Endocet.

The next day, Curley, 44, was dead. The medical examiner ruled the cause of his death was acute and chronic substance abuse and prescription medication abuse.

Curley's medical records were among those seized when authorities raided Zolot's office in May. A physician who reviewed them for the medical board, Dr. Seyed Mostoufi, said Zolot should have prescribed short-term, milder opiates instead of OxyContin on the first visit. When the board suspended Zolot's medical license in June, it said he had prescribed narcotics to patients who didn't need them, inadequately monitored them, and took little action when they broke agreements not to abuse drugs.

Zolot, 56, went to medical school in Leningrad, Russia, and immigrated to the United States in 1988. In Massachusetts, he worked briefly at Faulkner Hospital before starting at Carney Hospital in Dorchester in 1996.

Zolot moved to an office building in Needham in 2003. He withdrew as a Medicaid provider that year, but patients from across Eastern Massachusetts kept coming, according to investigators, many paying $150 per visit. [Patients’ willingness to travel long distances would have been a tip-off for a legitimate doctor.]

His office was often packed, said Patricia Tardanico, 43, of Whitman, a former patient who praised Zolot and said he helped her immensely after she was in a motorcycle accident in 1998 and suffered multiple injuries.

In August 2003, Debra Dalton found Zolot. She had been abusing drugs since the 1980s, said Bill Dalton, a longshoreman who married her in 1984. During their marriage, he said, she got narcotic prescriptions from several doctors at once, rotating among pharmacies.

The couple separated in 1999, he said, but stayed in touch. "Once in a while she'd call me and say, 'I'm really broke. I'd like to get something to eat.' I'd meet her on Broadway [in South Boston] and give her $20 or $30," he said.

According to a report by the physician who reviewed Zolot's patient files for the board, Zolot diagnosed Dalton - who is referred to as "Patient Q" in the reviewer's report - with back and shoulder pain. He started Dalton on the painkiller Percocet without adequate evidence to support this treatment, the physician reviewer wrote, noting that Dalton's medical record had limited information about the history of her pain, medications she had tried, and results of imaging tests. Standard care for this type of pain, according to the reviewer, starts with physical therapy and anti-inflammatory medications.

At some point, Dalton failed two urine tests. Zolot decided to wean her off narcotics, "which was a good move," according to the reviewer.

But on Oct. 12, 2006, Dalton overdosed on opiates, cocaine, and other prescription drugs, according to a medical examiner's report. She died homeless in a Winthrop hotel, her ex-husband said: "Her life ended in a drug explosion."

During his appeal hearing and in documents submitted to the state, Zolot denied all allegations made regarding Dalton, Curley, and 28 other patients whose cases the medical board reviewed. Catalano said he will provide expert testimony to refute the board's allegations.

Now, many of Zolot's former patients are searching for new doctors. Dozens have called the pain clinic at Massachusetts General Hospital, where doctors are wrestling with whether to see them. Dr. Jane Ballantyne, chief of the hospital's pain unit, said some of "these patients [were] getting doses that other doctors won't prescribe."

Yet, she and other pain specialists said it can be very difficult even for the most astute doctors to detect drug abusers and get them into treatment.

Dr. James Rathmell, director of the clinic, said doctors there take only patients whose primary care doctor is involved in their care, knows their history, and can help monitor their use of narcotics.
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[DewDiligence]

Staten Island Doctor Charged in Oxycodone Scheme

http://www.nytimes.com/2010/11/17/nyregion/17doc.html

›November 16, 2010
By MICHAEL WILSON

For a drug operation, this one appears to have been a poorly kept secret.

There were the steady traffic to the two-story, white-paneled house in the New Dorp neighborhood of Staten Island and the prescription bottles that littered the well-kept block. Then there was the small matter of someone — a relative of a patient who had overdosed, the Federal Bureau of Investigation would say later — who attacked the house’s front door with an ax.

That rather unneighborly display prompted the homeowner and person suspected of providing the drugs, Dr. Felix Lanting, to hire “goons” to guard outside, the F.B.I. said.

What would seem to be bravado or carelessness or some combination may be a factor of the doctor’s age. He is 83.

“He’s resting, hon,” said a woman answering Dr. Lanting’s phone on Tuesday. She was mistaken; the F.B.I. had arrested him a few hours earlier. By midafternoon, he was awaiting a court hearing in Federal District Court in Brooklyn, where he was charged in a scheme to sell prescriptions for oxycodone, the main ingredient in OxyContin, from his home office, at 133 Hunter Avenue.

Dr. Lanting has drawn a range of reviews on Web sites that allow people to rate doctors. Some reviewers give him four out of five stars; others appear to have foreseen Tuesday’s raid. “Drug pusher,” an anonymous commenter wrote on Sept. 9 on Vitals.com, adding: “He gets you hooked on drugs then he will detox u when u need it ... what a guy.”

In an article in The Staten Island Advance on Aug. 7, Dr. Lanting seemed nonplussed about a state-run database that would allow doctors to find out if patients have received prescriptions from multiple doctors, suggesting they could be addicts or dealers. When patients seek prescriptions, Dr. Lanting told The Advance, “we take their word and we depend on the pharmacists’ computers.”

The F.B.I. disclosed details of the investigation in a 25-page complaint unsealed Tuesday. The investigation began around the time neighbors started complaining in May, the complaint says. An increasing number of people seeking prescriptions were seen visiting the house, and empty oxycodone bottles were littered outside. Since April, Dr. Lanting wrote about 3,029 prescriptions for the painkiller, or an average of about 15 every day of the week, the F.B.I. said. About 490 of his patients were younger than 30.

An F.B.I. agent developed an informer who visited the doctor numerous times. Another individual, identified as a conspirator, also came and went often, and resold the pills Dr. Lanting prescribed, the F.B.I. said.

During those visits, the F.B.I. said, Dr. Lanting’s examinations of his patients were perfunctory at best, consisting of a quick once-over with a stethoscope, and often not even that, and they lasted about a minute. The visitors gave Dr. Lanting fake M.R.I. reports, sometimes with a name different from their own, and he sent them on their way with a prescription, the F.B.I. said.

Over the summer, Dr. Lanting stopped seeing patients for a period after a young patient on Staten Island suffered an overdose and someone from the patient’s family “took an ax” to the doctor’s door, an informer told the F.B.I. The intruder also spray-painted the word “closed” on the house and left the ax behind.

By September, Dr. Lanting had hired three men described by an informer as “goons” and “bouncers” to guard his front door, the F.B.I. said. Someone had also broken in looking for drugs.

Soon, the bouncers had developed an elaborate arrangement for buying and selling drugs, the F.B.I. said: they recruited fake patients who, upon arrival, were given $200 to hand over to the doctor for a prescription. Then, the bouncers paid the patients $300 to fill the prescriptions at a pharmacy. The patients then returned to give the bouncers the pills, and were paid $500 or with 50 pills. The drugs were later resold, for $1,800 to $2,700 per prescription for 180 pills.

Dr. Lanting appeared haggard but alert on Tuesday, leaning forward in court. His family signed for his $100,000 bond, and he was released later Tuesday. He declined to comment outside the court, except to say, “I didn’t sell OxyContin.”

The judge ordered him to stop writing prescriptions for narcotics while on bail, and forbade travel. Dr. Lanting replied: “I can’t travel. I have no energy.”‹