RICHMOND – One had been to jail and nursed a gunshot wound. Another had run away from home as a teenager and lost her children to foster care. A third was struggling with the death of her daughter and had a history of alcohol abuse.
Before they died, they’d paid $100 for a visit with Dr. Edward Manougian in his East Bay offices and left with prescriptions for hundreds of opioid pain pills, highly addictive and, on the street, worth thousands of dollars. Records show that one Manougian patient sold his drugs before leaving the pharmacy parking lot.
In his career, Manougian has ordered so many OxyContin pillsOxyContin: an oxycodone pain reliever, similar to methadone; used for the long-term treatment of severe pain; highly addictive.
Click the link for more resources. for low-income patients that he ranked a few years ago as one of the state’s most prolific prescribers.
He prescribed patients a cocktail of sedative, antianxiety and narcotic pain pills, including VicodinVicodin: a combination of hydrocodone and acetaminophen; an opioid prescribed for relief of moderate to severe pain.
Click the link for more resources., Norco, methadoneMethadone: an opioid prescribed for pain relief, also used to help addicts withdraw safely from heroin.
Click the link for more resources., SomaSoma: a compound of aspirin and carisoprodol (muscle relaxant and pain reliever); Soma is a muscle relaxant meant to reduce pain, fever and inflammation.
Click the link for more resources. and ValiumValium: diazepam, used for treatment of anxiety disorders, alcohol withdrawal, muscle spasms and other conditions; similar to Xanax, this medication is highly addictive.
Click the link for more resources.. Until the California medical board stopped his prescribing last year, Manougian ordered patients to take doses of opiate pain pills that are three to 12 times higher than what doctors consider high.
Now, Manougian's practice has drawn the attention of federal investigators. The FBI, the Health and Human Services Office of the Inspector General and the Drug Enforcement Administration have subpoenaed Manougian's medical records, said FBI spokeswoman Julianne H. Sohn. She described their work as an ongoing investigation but declined to elaborate.
In an interview at his spare Richmond office, the 83-year-old doctor said he is fighting the medical board’s effort to take his license to practice medicine. Manougian denies playing a role in his patients’ deaths and likens himself to a fish swimming against the school: a doctor who offers hope to the 240 struggling men and women under his care, a bold prescriber who understands the doses required to effectively treat chronic pain.
“It’s like a big family,” Manougian said of his patients. “I'm part of their extended family.”
The doctor’s case offers a window into a thorny question that physicians increasingly face. Given the widespread problems of overdose and addiction related to opioid painkillers, when does prescribing actually exacerbate the suffering it’s meant to ease?
Health professionals are re-examining the risks and benefits of prescribing opioid pain pills – and whether their use should be limited.
Controversial limits have been mandated in Washington state, compelling doctors to refer noncancer patients to specialists when daily morphine-equivalent doses reach a certain level. In California, the medical and pharmacy boards have agreed to meet to take a closer look at policies on prescribing for pain.
There is little controversy over short-course opiate use for pain after surgery or even long-term use for patients who are dying. But many pain doctors agree that patients taking more than about 200 milligrams of morphine-equivalent medication per day are on a high dose and deserve a careful reassessment.
“The sands are shifting,” said Christine Miaskowski, a UC San Francisco nursing professor who has specialized in studying pain and its treatment.
She was part of a group of pain specialists who defined the 200-milligram red-flag zone for daily opioid prescriptions – less than two top-strength OxyContin pills in a day.
With some patients, Manougian surpassed that by 1,000 milligrams or more. He said he has ordered daily doses of 14 to 24 maximum-strength OxyContin pills for a single patient.
Manougian has built his legal defense around a state law that says no doctor can be disciplined for prescribing to a patient with intractable pain.
“Whatever it takes,” Manougian said, “that's what the Intractable Pain (Treatment) Act says.”
Manougian has operated a solo practice in Pinole and Hercules since 2003, seeing many patients whose pills are paid for by the state Medi-Cal program. Records show that since 2005, the state paid than $1.5 million for oxycodone prescriptions ordered by Manougian.
He has faced accusations from outraged pharmacists and a relative of a patient who died under his care that his methods are dangerous.
The Medical Board of California has linked his prescriptions to the death of Irma Jean Gray and two other patients who overdosed on pills the doctor had ordered. Gray was found dead at 62 in her San Pablo apartment in January 2010.
“To me, the guy is a drug dealer,” said Charles Agnew, Gray’s son. “I would have never thought she was getting that much drugs from a doctor.”
At the time of Gray’s death, Manougian’s daily prescription for opiates was nearly three times the dose that the American Pain Society deems high. And his order blended hypnotic drugs that can heighten the risk of death: four top-strength OxyContin pills, eight Norco pills, and nine more sedating and antianxiety pills.
During the medical board hearing over Manougian’s license, patients testified on his behalf, saying he is a thorough and caring doctor. Manougian said many of his patients know each other and found him through word of mouth. Others come from as far as Sonora – more than 100 miles from his practice – and recognize him as the only doctor willing to dispense the quantities they seek.
Attorney Marvin Firestone of San Mateo argued in a closing brief that Manougian “simply believes in the ultimate goodness of people and always had his patients’ best interests in mind.” He called the board’s allegations “hollow and without merit.”
Rethinking pain prescription policies
The movement to liberalize pain medication prescriptions was born in the 1980s out of compassion for terminally ill and dying patients. But in the intervening decades, admissions to programs for opiate addiction have soared. Overdose deaths from opiate pain pills also have shot up, to 15,597 in 2009, spurring the Centers for Disease Control and Prevention to declare a national epidemic.
Now, doctors and professional groups that have enjoyed the financial support of pharmaceutical firms are coming under scrutiny for perhaps painting too rosy a picture of the drugs’ potential.
U.S. Sens. Chuck Grassley, R-Iowa, and Max Baucus, D-Mont., are examining whether leading pain doctors glossed over risks when shaping the unlimited prescribing policies that back Manougian’s methods.
Dr. Andrew Kolodny, a New York physician who leads Physicians for Responsible Opioid Prescribing, said he hopes the senators’ probe makes state medical boards realize how much they have been influenced by the pharmaceutical industry.
“These are policies that are harming people,” he said, “and hopefully they should reverse them.”
California’s medical board, though, has relied on the state’s current laws to curb Manougian, winning an order in April 2011 to stop him from prescribing. Manougian will learn in a matter of days whether he will keep his medical license.
Medi-Cal authorities placed limits on Manougian’s OxyContin prescribing in 2009, after it was determined that he was the second-most prolific prescriber of the drug that year. (The top prescriber, a Bay Area doctor, surrendered his medical license this year.) Those restrictions were expanded the following year after finding more evidence that “excessive services, billings or abuse has occurred,” according to Department of Health Care Services spokesman Norman Williams.
Pharmacists file complaints
For years, health authorities who crossed paths with Manougian have sounded alarms over his prescribing.
David Ash had practiced as a pharmacist for 44 years when he balked at two prescriptions Manougian’s patients brought to the White Cross Professional Pharmacy in Pinole.
The patients were prescribed a cocktail of 1,100 pills to be taken in a month. They included opiate painkillers Norco and methadone; Valium, an antianxiety pill; and Soma, a muscle relaxer.
Ash faxed a complaint to the Medical Board of California in November 2007, decrying excessive quantities and combinations of drugs. He attached the prescriptions and asked the board “to see for yourself how he is overdosing his patients.”
“This is not pain management,” Ash said in an interview. “This is absurd.”
Less than a year later, Rose Gin, a Richmond Safeway pharmacist, also complained to the medical board about Manougian’s prescriptions. She decried excessive amounts of Vicodin and cough syrup with codeineCodeine: narcotic pain medication used to treat moderate pain; codeine comes in both liquid and tablet form.
Click the link for more resources., both opioid painkillers, and Valium.
“This type of practice should be investigate(d) before a fatality occurs,” Gin wrote. “Why are all the customers getting the same medications with the same directions that are excessive?”
A third pharmacist filed a report in 2008 with the Pittsburg Police Department after watching one of Manougian’s patients sell a bottle of grape-flavored, narcotic-infused cough syrup in a Brentwood Walgreens parking lot.
In October 2008, the medical board responded to Ash’s complaint by forwarding two patients’ records for expert review. While two experts agreed that Manougian was practicing outside of medical norms, no one could identify an upper limit under the law for prescribing pain medication.
The state’s pain policies and Intractable Pain Treatment Act “do not specify how much medication is too much,” according to a review written by board expert Dr. Bill McCarberg, a board-certified pain medicine physician who developed Southern California Permanente Medical Group’s chronic pain management program.
Yet, “I know of no pain expert in the country who would suggest this combination and certainly not in these doses except in extreme circumstances,” McCarberg concluded. He also noted that Manougian violated care standards by doing little to consider potential addiction, even though one patient tested positive for cocaine during a hospital stay.
The medical board filed a complaint against Manougian’s license based on McCarberg’s findings in 2009, accusing him of gross and repeated negligence. In April 2011, the board issued a second complaint against Manougian. This time, the board linked his prescribing practices to patient deaths and addictions.
Those deaths are outlined in court records from Manougian’s hearing before the medical board.
Depressed patient overdoses
The first to die under his care was Jeanette Dodds, 35, who saw Manougian in October 2008. Manougian determined that her complaint of bodywide pain was related to a kidney condition. Two experts, including one testifying on behalf of Manougian, said the condition should not have caused chronic pain.
Manougian prescribed her massive daily doses of medications: four methadone and 10 Norco opiate pain pills and 14 more antianxiety, muscle-relaxing and allergy pills.
Manougian also prescribed 10 full-strength fentanylFentanyl: an opioid used to treat pain in cancer patients, not for use with pain that is not cancer-related, such as headaches; because of its highly addictive nature, this medication is only available through special programs for which patients must register.
Click the link for more resources. patches, creating a “potentially toxic combination,” according to Kurt V. Miller, a Fresno pain doctor who served as a second medical board expert in the case.
In all, the cocktail added up to 600 milligrams of morphine-equivalent pain relief per day, far more than the dose of 120 milligrams that is linked to a spike in overdose death rates, according to a Journal of the American Medical Association.
Miller also said Dodds told Manougian that she was separated from her three children, who were put in foster care, and was depressed, making her a risky patient to trust with so many dangerous drugs.
About four months after her visit with Manougian, Dodds was found dead in her mother’s Oakley home. The cause was determined to be an overdose of fentanyl, one of the drugs Manougian prescribed. Miller testified that Dodds’ treatment was “likely detrimental to the patient, leading to her death.”
Manougian said in a deposition that he prescribed the medications to Dodds in hopes that relieving her pain would ease her sorrow. He said neither her death nor the two others were related to his care.
“The medical board is trying to make something out of nothing,” he said.
Experts for the board, though, said in declarations and testimony that Manougian did not take into consideration that his patients had histories of addiction and impulsive behavior. He did not refer patients to addiction or mental health specialists. Nor did he decrease doses when they reported feeling good. And he did not order urine tests to ensure drugs were being taken and not sold.
Manougian said his patients had medical histories consistent with chronic pain. For nearly all, he said, the problem was not addiction but that they weren’t getting doses needed to relieve their pain.
Red flags ignored
Manougian began treating Irma Jean Gray in September 2008, 16 months before she died.
At first, Gray complained to Manougian of pain all over – her back, neck, wrist and fingers. Manougian diagnosed her with a slipped disk in her back and another condition affecting her neck bones, records show. He did not order X-rays.
Miller said Manougian’s initial prescription of 22 daily pills included four daily maximum-strength OxyContin pills, “a potentially fatal dose.” He said Manougian ignored that doses should be gradually increased. And in combination with drugs that can shut down breathing, the opiates are even more risky.
Manougian’s notes show that after several months under his care, Gray said she felt better, went to a party and danced a little. He refilled three months’ worth of pills.
But Manougian noted that by the last time Gray saw him on Nov. 4, 2009, her speech was slow. She had a hard time relating details. And she said she felt like “checking into a mental hospital.”
Manougian ignored those red flags, according to Miller, and prescribed her three more months’ worth of her pain pill cocktail.
A little more than two months later, Gray was found dead on the floor of her kitchen, with soup boiling over on the stove.
Agnew, Gray’s son, said it should have been obvious that his mother had an addiction problem. She had a history of alcohol abuse. And records show that in the weeks before seeing Manougian, she sought one opiate pain medication from eight doctors, a “doctor shopping” practice that experts link to addiction.
Agnew, who already had lost his sister, said news of his mother’s death took the life out of him.
“He was supposed to help her; that’s the whole key,” Agnew said.
Miller noted that Manougian signed a death certificate without seeking an autopsy, which “prevented the public from knowing whether (she) died as a result of the potentially fatal doses” he prescribed.
Manougian acknowledged in an interview that many of his patients have cycled through other doctors before seeing him. He called it a sign of “pseudo-addiction,” though, saying other physicians are not bold enough to prescribe at levels that resolve chronic pain.
Man gets doctor’s highest doses
The third patient to die under Manougian’s care, Konya Mattie, 41, was given the highest doses of potent opioid drugs.
Mattie, who had been shot and jailed related to cocaine, came to Manougian in 2006. Manougian’s notes show that he suspected that Mattie, who had a dagger tattoo on his forearm, was in an environment of drug dealers. But still, the doctor prescribed Mattie large doses of narcotic pain pills, refilling prescriptions when they were said to be lost or accidentally thrown away.
In the weeks before Mattie died, Manougian prescribed him a daily regimen of 36 pills: 12 full-strength OxyContin; 10 methadone; four XanaxXanax: alprazolam, used to treat anxiety and panic disorders; similar to Valium, this medication is highly addictive.
Click the link for more resources., an addictive antianxiety drug; and 10 Norco, another opiate pain pill. He was ordered to drink nearly a gallon of opiate-laced cough syrup in a month.
The drugs provided Mattie more than 2,500 milligrams of morphine-equivalent pain relief a day – about 12 times more than what’s considered a high dose.
Mattie’s death on March 20, 2010, was determined to be from “polypharmacy,”Polypharmacy: the use of multiple medications on a patient.
Click the link for more resources. including toxic doses of Xanax and methadone, records show.
“Notably, no OxyContin was found in the patient’s system,” Miller noted in a declaration filed in court, “from which the presumption may be made that the patient was diverting or selling it.”
There was another sign that Mattie was not the one taking the OxyContin: About three weeks after Mattie died, a man who identified himself as Mattie’s uncle purchased a prescription that Manougian had written for Mattie and which was dated weeks ahead. Court records say the prescription was filled for $4,681 in cash for 360 top-strength OxyContin pills.
Family members of Mattie and Dodds could not be reached for comment.
Miller concluded that Mattie “died as a result of excessive prescribing by Dr. Manougian.” Manougian denied the claim, saying Mattie likely died for the opposite reason: that he did not get enough medication during a hospital stay for a stroke he suffered days before he died.
Miller concluded that Manougian “represents a clear and present danger to his patients and the public.”
Manougian said he is a target because the cost to the state to cover his prescriptions is high and the value of his patients to society is low. He said he is nothing like a drug dealer and has not profited from ordering high doses of pills.
He also said his patients are very religious and would not be tempted to sell drugs on the street. “Some of them are ministers,” he said of his patients.
As for Manougian’s own battle with pain in his knees and shoulder, he said he relies on isometric exercises for relief. “I never take drugs,” he said.