By Scott Glover and Lisa Girion
August 11, 2013, 7:00 a.m.
Over the last decade, the maker of the potent painkiller OxyContin has compiled a database of hundreds of doctors suspected of recklessly prescribing its pills to addicts and drug dealers, but has done little to alert law enforcement or medical authorities.
Despite its suspicions, Purdue Pharma continued to profit from prescriptions written by these physicians, many of whom were prolific prescribers of OxyContin. The company has sold more than $27 billion worth of the drug since its introduction in 1996.
Purdue has promoted the idea that the country's epidemic of prescription drug deaths was fueled largely by pharmacy robberies, doctor-shopping patients and teens raiding home medicine cabinets. The database suggests that Purdue has long known that physicians also play a significant role in the crisis.
Purdue's database, which contains the names of more than 1,800 doctors, could provide leads for investigators at a time when they are increasingly looking at how reckless prescribing of painkillers contributes to addiction and death.
Purdue has said little about the list since it began identifying doctors in 2002. A company scientist offered a glimpse into the database at a June drug dependency conference in San Diego, noting it was the first time the program had been discussed in public.
In a series of interviews with The Times, Purdue attorney Robin Abrams said the company created the database to steer its sales representatives away from risky doctors. Policing physicians, she said, was not Purdue's responsibility.
"We don't have the ability to take the prescription pad out of their hand," she said.
Abrams said the company had alerted law enforcement or medical regulators to 154 of the prescribers — about 8% of those in its database. The company's tally could not be independently verified.
Asked to provide cases reported to law enforcement, she identified three Southern California physicians implicated in major schemes to funnel OxyContin to addicts and dealers.
One of them, Masoud Bamdad of San Fernando, took in $1.5 million a year prescribing OxyContin and other painkillers to young addicts. He is serving a 25-year prison sentence on a drug dealing conviction. Bamdad was linked by prosecutors to six patient deaths.
Another doctor, Eleanor Santiago, is awaiting sentencing on federal charges that she helped flood Los Angeles' black market with more than 1 million illicit doses of OxyContin. Physician Kevin Gohar was linked to a suspected prescription mill in Reseda that authorities say sold OxyContin prescriptions to addicts across Southern California. Gohar died of a drug overdose in 2011 while a criminal investigation was pending.
Mitchell Katz, director of the Los Angeles County Department of Health Services, said Purdue has a duty to report all the doctors on the list, not just a select few.
"There is an ethical obligation," said Katz, a critic of what he says is the overuse of painkillers. "Any drug company that has information about physicians potentially engaged in illegal prescribing or prescribing that is endangering people's lives has a responsibility to report it."
Abrams said that some of the doctors in the database may no longer be active prescribers, but she could not provide a specific number.
OxyContin and other prescription painkillers have fueled a surge in drug overdoses, which in 2009 claimed 39,147 lives, surpassing for the first time traffic accidents as a leading cause of preventable deaths. Two years later, the U.S. Centers for Disease Control and Prevention declared prescription drug overdoses an epidemic.
Last year, a Times analysis showed that drugs prescribed by doctors played a role in nearly half the prescription overdose deaths in Southern California from 2006 through 2011. Seventy-one doctors prescribed drugs to three or more patients who fatally overdosed. Oxycodone, the active ingredient in OxyContin, was one of the most often cited drugs in the deaths.
Concerned by the mounting death toll, a congressional oversight committee in June called three top federal officials to testify about the government's response to the prescription drug crisis. Louisiana Republican Rep. Bill Cassidy asked why the government wasn't mining prescribing data to target rogue doctors.
"I'm expecting it's going to be a small percent writing a lot of the inappropriate prescriptions," said Cassidy, himself a physician. "What's the challenge in figuring out which doctors are the bad actors?"
President Obama's drug czar, R. Gil Kerlikowske, testified that the federal government didn't have access to such information.
Unbeknownst to Cassidy and Kerlikowske, Purdue Pharma had a database similar to what the congressman was looking for.
***
For decades, physicians avoided prescribing narcotic painkillers for anything but cancer and end-of-life pain because they feared the risk of addiction and overdose. But as Purdue and other drug companies pushed for their broad use, doctors began prescribing them for bad backs and other common ailments.
OxyContin — twice as potent as morphine — became one of the nation's most widely prescribed painkillers by marketing its patented time-release formula as safer than other drugs.
But it didn't take long for addicts to discover that "Oxy," as it is known on the streets, produced a heroin-like rush when crushed and snorted, releasing the pill's full potency at once.
By 2001, OxyContin sales hit $1 billion a year. The privately held Stamford, Conn., company was also under fierce attack. Local authorities up and down the East Coast, where problems with OxyContin first emerged, complained that the drug inflicted addiction and crime on their communities. Lawmakers pressed Purdue to do something.
At a hearing on OxyContin abuse that year, Pennsylvania Republican Rep. James C. Greenwood, then the chairman of a House oversight committee, told Purdue's top executives to use sales data to "weed out" bad doctors prescribing their drug.
The next year, Abrams said, Purdue's legal department began training sales representatives to report "red flags" at doctors' offices, including young patients, long lines, people nodding off in waiting rooms and frequent cash transactions.
Abrams said that if she and two other attorneys determine doctors to be too risky, Purdue bars sales representatives from marketing to them and stops paying commissions on the doctors' OxyContin prescriptions. Suspicious doctors are removed from the company's numbered sales territories and assigned to the database known as "Region Zero," she said.
By Purdue's account, the company has fielded 3,200 reports on suspicious doctors and other prescribers. About 75 doctors in the database did not prescribe OxyContin, according to Purdue.
Abrams said putting a doctor into the database is "essentially a judgment call."
"A lot of these are circumstances that if you were to walk into a doctor's office would give you pause and would make you turn around and walk out," said Abrams, a former federal prosecutor who specialized in criminal healthcare fraud cases.
Abrams declined to say precisely how the company decides which cases to refer to authorities. "I don't really want to open up an opportunity for folks come in here and start looking and second-guessing," she said.
Among the situations that would lead to referrals, she said, are cases in which sales representatives witness apparent drug deals in physicians' parking lots or observe doctors who appear to be under the influence of drugs or alcohol.
Law enforcement, she said, "wouldn't be interested" in more vague reports.
Steve Opferman, who heads a healthcare crime task force for the Los Angeles County Sheriff's Department, said Purdue could be sitting on valuable leads.
"That's definitely data that law enforcement and prosecutors could use," he said.
***
Purdue used its database this year to bolster an extraordinary argument to the U.S. Food and Drug Administration: The OxyContin it had sold for 14 years was so prone to abuse that generic drug companies should not be allowed to copy it. Purdue said in a letter to the FDA that the argument was based in part on an analysis of prescriptions written by 364 active prescribers of OxyContin in Region Zero.
According to Purdue, when the company introduced a tamper-resistant formulation in August 2010, the doctors' prescriptions for maximum-strength OxyContin — the one favored by addicts — plummeted by 80%. Prescriptions for Opana, a narcotic painkiller made by a rival that could still be crushed and snorted, shot up about 400%, the internal study found. When crush-resistant Opana came out two years later, the same doctors' prescriptions for that drug also plunged.
Purdue concluded that a small number of doctors might account for a "substantial portion" of the nation's black-market supply of prescription painkillers, according to a summary of the unpublished study. The findings held "important implications," Purdue said, for policies aimed at curbing prescription abuse.
The company provided the study to the FDA in a confidential filing; it did not include doctors' names.
On April 16, the day Purdue's patent was set to expire, the FDA agreed that the original OxyContin — the type easily crushed and often abused — was too dangerous to allow generic drugmakers to copy.
At the San Diego conference in June, Purdue epidemiologist Howard Chilcoat made a brief presentation about the study. He said there were doctors in the database who were prescribing painkillers "for what appears to be the wrong reasons."
When he opened the floor to questions, Jane Liebschutz, a medical professor from Boston, made her way to a microphone. "Shouldn't those 364 prescribers be investigated?" she asked.
Chilcoat responded that the company reported doctors to authorities when it deemed it appropriate.
In April 2011, eight months after the introduction of the tamper-resistant OxyContin, Purdue said it gave the names of 82 doctors to officials at the U.S. Drug Enforcement Administration, which is responsible for granting authority to physicians to prescribe narcotic painkillers. The company declined to identify the DEA officials.
Joseph Rannazzisi, the DEA official in charge of the office of prescription drug control, declined to be interviewed.
Abrams said the company waited to share its suspicions until after its analysis "showed some scientific validity" to its theories about the doctors.
"We are doing what we think is the right thing for the right reasons," she said.
Keith Humphreys, a Stanford University professor and former drug policy advisor to Obama, had a different view of Purdue's timing and motives. He noted that Purdue became more vigorous about alerting government authorities to potential problem doctors after it shifted to its tamper-resistant formula and when generic-drug makers were poised to produce the crushable version.
"Those doctors are a gold mine for Purdue Pharma. And the whole time they're taking the money, knowing that something is wrong, and not telling anyone until it gives them a market advantage to do so," he said. "That is really disgusting."
scott.glover@latimes.com
lisa.girion@latimes.com
http://www.latimes.com/news/local/la-me-rx-purdue-20130811,0,5485540,full.story
August 11, 2013, 7:00 a.m.
Over the last decade, the maker of the potent painkiller OxyContin has compiled a database of hundreds of doctors suspected of recklessly prescribing its pills to addicts and drug dealers, but has done little to alert law enforcement or medical authorities.
Despite its suspicions, Purdue Pharma continued to profit from prescriptions written by these physicians, many of whom were prolific prescribers of OxyContin. The company has sold more than $27 billion worth of the drug since its introduction in 1996.
Purdue has promoted the idea that the country's epidemic of prescription drug deaths was fueled largely by pharmacy robberies, doctor-shopping patients and teens raiding home medicine cabinets. The database suggests that Purdue has long known that physicians also play a significant role in the crisis.
Purdue's database, which contains the names of more than 1,800 doctors, could provide leads for investigators at a time when they are increasingly looking at how reckless prescribing of painkillers contributes to addiction and death.
Purdue has said little about the list since it began identifying doctors in 2002. A company scientist offered a glimpse into the database at a June drug dependency conference in San Diego, noting it was the first time the program had been discussed in public.
In a series of interviews with The Times, Purdue attorney Robin Abrams said the company created the database to steer its sales representatives away from risky doctors. Policing physicians, she said, was not Purdue's responsibility.
"We don't have the ability to take the prescription pad out of their hand," she said.
Abrams said the company had alerted law enforcement or medical regulators to 154 of the prescribers — about 8% of those in its database. The company's tally could not be independently verified.
Asked to provide cases reported to law enforcement, she identified three Southern California physicians implicated in major schemes to funnel OxyContin to addicts and dealers.
One of them, Masoud Bamdad of San Fernando, took in $1.5 million a year prescribing OxyContin and other painkillers to young addicts. He is serving a 25-year prison sentence on a drug dealing conviction. Bamdad was linked by prosecutors to six patient deaths.
Another doctor, Eleanor Santiago, is awaiting sentencing on federal charges that she helped flood Los Angeles' black market with more than 1 million illicit doses of OxyContin. Physician Kevin Gohar was linked to a suspected prescription mill in Reseda that authorities say sold OxyContin prescriptions to addicts across Southern California. Gohar died of a drug overdose in 2011 while a criminal investigation was pending.
Mitchell Katz, director of the Los Angeles County Department of Health Services, said Purdue has a duty to report all the doctors on the list, not just a select few.
"There is an ethical obligation," said Katz, a critic of what he says is the overuse of painkillers. "Any drug company that has information about physicians potentially engaged in illegal prescribing or prescribing that is endangering people's lives has a responsibility to report it."
Abrams said that some of the doctors in the database may no longer be active prescribers, but she could not provide a specific number.
OxyContin and other prescription painkillers have fueled a surge in drug overdoses, which in 2009 claimed 39,147 lives, surpassing for the first time traffic accidents as a leading cause of preventable deaths. Two years later, the U.S. Centers for Disease Control and Prevention declared prescription drug overdoses an epidemic.
Last year, a Times analysis showed that drugs prescribed by doctors played a role in nearly half the prescription overdose deaths in Southern California from 2006 through 2011. Seventy-one doctors prescribed drugs to three or more patients who fatally overdosed. Oxycodone, the active ingredient in OxyContin, was one of the most often cited drugs in the deaths.
Concerned by the mounting death toll, a congressional oversight committee in June called three top federal officials to testify about the government's response to the prescription drug crisis. Louisiana Republican Rep. Bill Cassidy asked why the government wasn't mining prescribing data to target rogue doctors.
"I'm expecting it's going to be a small percent writing a lot of the inappropriate prescriptions," said Cassidy, himself a physician. "What's the challenge in figuring out which doctors are the bad actors?"
President Obama's drug czar, R. Gil Kerlikowske, testified that the federal government didn't have access to such information.
Unbeknownst to Cassidy and Kerlikowske, Purdue Pharma had a database similar to what the congressman was looking for.
***
For decades, physicians avoided prescribing narcotic painkillers for anything but cancer and end-of-life pain because they feared the risk of addiction and overdose. But as Purdue and other drug companies pushed for their broad use, doctors began prescribing them for bad backs and other common ailments.
OxyContin — twice as potent as morphine — became one of the nation's most widely prescribed painkillers by marketing its patented time-release formula as safer than other drugs.
But it didn't take long for addicts to discover that "Oxy," as it is known on the streets, produced a heroin-like rush when crushed and snorted, releasing the pill's full potency at once.
By 2001, OxyContin sales hit $1 billion a year. The privately held Stamford, Conn., company was also under fierce attack. Local authorities up and down the East Coast, where problems with OxyContin first emerged, complained that the drug inflicted addiction and crime on their communities. Lawmakers pressed Purdue to do something.
At a hearing on OxyContin abuse that year, Pennsylvania Republican Rep. James C. Greenwood, then the chairman of a House oversight committee, told Purdue's top executives to use sales data to "weed out" bad doctors prescribing their drug.
The next year, Abrams said, Purdue's legal department began training sales representatives to report "red flags" at doctors' offices, including young patients, long lines, people nodding off in waiting rooms and frequent cash transactions.
Abrams said that if she and two other attorneys determine doctors to be too risky, Purdue bars sales representatives from marketing to them and stops paying commissions on the doctors' OxyContin prescriptions. Suspicious doctors are removed from the company's numbered sales territories and assigned to the database known as "Region Zero," she said.
By Purdue's account, the company has fielded 3,200 reports on suspicious doctors and other prescribers. About 75 doctors in the database did not prescribe OxyContin, according to Purdue.
Abrams said putting a doctor into the database is "essentially a judgment call."
"A lot of these are circumstances that if you were to walk into a doctor's office would give you pause and would make you turn around and walk out," said Abrams, a former federal prosecutor who specialized in criminal healthcare fraud cases.
Abrams declined to say precisely how the company decides which cases to refer to authorities. "I don't really want to open up an opportunity for folks come in here and start looking and second-guessing," she said.
Among the situations that would lead to referrals, she said, are cases in which sales representatives witness apparent drug deals in physicians' parking lots or observe doctors who appear to be under the influence of drugs or alcohol.
Law enforcement, she said, "wouldn't be interested" in more vague reports.
Steve Opferman, who heads a healthcare crime task force for the Los Angeles County Sheriff's Department, said Purdue could be sitting on valuable leads.
"That's definitely data that law enforcement and prosecutors could use," he said.
***
Purdue used its database this year to bolster an extraordinary argument to the U.S. Food and Drug Administration: The OxyContin it had sold for 14 years was so prone to abuse that generic drug companies should not be allowed to copy it. Purdue said in a letter to the FDA that the argument was based in part on an analysis of prescriptions written by 364 active prescribers of OxyContin in Region Zero.
According to Purdue, when the company introduced a tamper-resistant formulation in August 2010, the doctors' prescriptions for maximum-strength OxyContin — the one favored by addicts — plummeted by 80%. Prescriptions for Opana, a narcotic painkiller made by a rival that could still be crushed and snorted, shot up about 400%, the internal study found. When crush-resistant Opana came out two years later, the same doctors' prescriptions for that drug also plunged.
Purdue concluded that a small number of doctors might account for a "substantial portion" of the nation's black-market supply of prescription painkillers, according to a summary of the unpublished study. The findings held "important implications," Purdue said, for policies aimed at curbing prescription abuse.
The company provided the study to the FDA in a confidential filing; it did not include doctors' names.
On April 16, the day Purdue's patent was set to expire, the FDA agreed that the original OxyContin — the type easily crushed and often abused — was too dangerous to allow generic drugmakers to copy.
At the San Diego conference in June, Purdue epidemiologist Howard Chilcoat made a brief presentation about the study. He said there were doctors in the database who were prescribing painkillers "for what appears to be the wrong reasons."
When he opened the floor to questions, Jane Liebschutz, a medical professor from Boston, made her way to a microphone. "Shouldn't those 364 prescribers be investigated?" she asked.
Chilcoat responded that the company reported doctors to authorities when it deemed it appropriate.
In April 2011, eight months after the introduction of the tamper-resistant OxyContin, Purdue said it gave the names of 82 doctors to officials at the U.S. Drug Enforcement Administration, which is responsible for granting authority to physicians to prescribe narcotic painkillers. The company declined to identify the DEA officials.
Joseph Rannazzisi, the DEA official in charge of the office of prescription drug control, declined to be interviewed.
Abrams said the company waited to share its suspicions until after its analysis "showed some scientific validity" to its theories about the doctors.
"We are doing what we think is the right thing for the right reasons," she said.
Keith Humphreys, a Stanford University professor and former drug policy advisor to Obama, had a different view of Purdue's timing and motives. He noted that Purdue became more vigorous about alerting government authorities to potential problem doctors after it shifted to its tamper-resistant formula and when generic-drug makers were poised to produce the crushable version.
"Those doctors are a gold mine for Purdue Pharma. And the whole time they're taking the money, knowing that something is wrong, and not telling anyone until it gives them a market advantage to do so," he said. "That is really disgusting."
scott.glover@latimes.com
lisa.girion@latimes.com
http://www.latimes.com/news/local/la-me-rx-purdue-20130811,0,5485540,full.story
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