“The moral test of a government is how it treats those who are at the dawn of life, the children; those who are in the twilight of life, the aged; and those who are in the shadow of life, the sick and the needy, and the handicapped.” – Hubert Humphrey
passionate pachyderms
Pharmacist Steve steve@steveariens.com 502.938.2414
UPDATE: Number for FDA is 1-888-463-6332 option 3, then 2, then 4 to get pharmacist about Opana ER. If it goes and it will take the generic too.
The US Food and Drug Administration (FDA) has asked Endo Pharmaceuticals to remove its abuse-deterrent extended-release formulation of oxymorphone (Opana ER) from the market.
“After careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks,” the FDA said in a statement.
This marks the first time the FDA has taken steps to remove a currently marketed opioid pain medication from sale because of the public health consequences of abuse.
“We are facing an opioid epidemic — a public health crisis, and we must take all necessary steps to reduce the scope of opioid misuse and abuse,” FDA Commissioner Scott Gottlieb, MD, said in a statement.
“We will continue to take regulatory steps when we see situations where an opioid product’s risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse,” Dr Gottlieb said.
The FDA’s decision is based on a review of available postmarketing data, which demonstrated a significant shift in the route of abuse of Opana ER from nasal to injection after the product’s reformulation. Injection abuse of reformulated Opana ER has been associated with an outbreak of HIV infection and hepatitis C, as well as cases of thrombotic microangiopathy.
“The abuse and manipulation of reformulated Opana ER by injection has resulted in a serious disease outbreak. When we determined that the product had dangerous unintended consequences, we made a decision to request its withdrawal from the market,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research. “This action will protect the public from further potential for misuse and abuse of this product.”
As previously reported by Medscape Medical News, on March 17, an FDA advisory panel of independent experts voted 18 to 8 that the benefits of reformulated Opana ER for relief of severe pain no longer outweigh its risks.
Opana ER was first approved in 2006 for the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period. In 2012, Endo replaced the original formulation of Opana ER with a new formulation intended to make the drug resistant to physical and chemical manipulation for abuse by snorting or injecting.
“While the product met the regulatory standards for approval, the FDA determined that the data did not show that the reformulation could be expected to meaningfully reduce abuse and declined the company’s request to include labeling describing potentially abuse-deterrent properties for Opana ER. Now, with more information about the risks of the reformulated product, the agency is taking steps to remove the reformulated Opana ER from the market,” the agency explains in the statement.
The FDA has requested that the company voluntarily remove reformulated Opana ER from the market. Should the company choose not to remove the product, the FDA said it will take steps to formally require its removal by withdrawing approval.
The agency will “continue to examine the risk-benefit profile of all approved opioid analgesic products and take further actions as appropriate as a part of our response to this public health crisis.”
VININGS, Ga. – Officials are warning about the dog flu after five confirmed cases in Georgia.
The new strain was apparently spread by out-of-state dogs at a dog show in Houston County last month.
Veterinarians said the dog flu is so contagious that a dog can sneeze 20 feet away from another dog and pass it or people can spread it by petting another dog.
“It can easily be transferred from one city to another, simply because of a plane flight or a car ride,” Dr. Cary Mackey said.
Mackey’s clinic is stocking up on vials of the dog flu vaccine, which may soon be administered all around the metro.
“It may not offer full protection, but if the dog gets infected, it should help prevent severe symptoms of the flu in your pets,” she said.
A growing number of pet owners are getting their dogs vaccinated and state officials are spreading the word that the flu is out there.
“(It can spread in) shelters, kennels, things like that where you have a lot of dogs collected in one place,” Assistant State Veterinarian Dr. Janemarie Hennebelle said.
Officials advise dog owners to be on the lookout for dogs that are sneezing or coughing. They said the flu can make dogs sick, but it is not usually fatal.
“Very rarely is this fatal, but unfortunately there have been a few patients that have passed away due to the flu and side effects of being infected,” Mackey said.
FBI agents have raided the headquarters of Proove Biosciences, a controversial genetic testing company that claims its DNA tests can improve the effectiveness of pain management and determine whether a patient is at risk of opioid addiction.
Over two dozen FBI agents appeared at Proove offices in Irvine, California Wednesday as part of a healthcare fraud investigation. They were later seen carrying dozens of boxes out of two buildings
“It is an ongoing investigation out of our San Diego office. It involves healthcare fraud. And unfortunately we are unable to say anything more about it at this time. The affidavit supporting the search warrant is under seal,” Cathy Kramer, an FBI special agent, told KABC-TV.
STAT News reported in February that the FBI and the Inspector General for the Department of Health and Human Services (HHS) were investigating possible criminal activity at Proove.
Former and current employees who were interviewed by the FBI told STAT the agents were focused on possible kickbacks to doctors who encouraged patients to take Proove’s DNA tests. Physicians reportedly could make $144,000 a year in kickbacks that were called “research fees.”
The HHS Inspector General issued a Special Fraud Alert in 2014 warning physicians that any payments, referrals, rent or reimbursements from lab testing companies could be seen as violations of anti-kickback laws.
Proove promotes itself as the “leader in personalized pain medicine” and claims its genetic tests can identify medications that would be most effective at treating pain. The company recently claimed that 94% of patients experienced significant pain relief within 60 days of treatment changes recommended by Proove. Critics say most Proove studies are not peer-reviewed and one genetic expert has called them “hogwash.”
According to STAT, doctors affiliated with Proove in California, Florida and Kentucky were also raided by FBI agents this week.
Proove Linked to Montana Pain Clinic
Proove is the second laboratory testing company raided by the FBI that has been linked to Benefis Pain Management Center, a pain clinic in Great Falls, Montana.
As PNN has reported, FBI agents last November raided the offices of Confirmatrix Laboratories near Atlanta. Two days later, the company filed for Chapter 11 bankruptcy protection. Confirmatrix was founded by Khalid Satary, a convicted felon and Palestinian national that the federal government has been trying to deport for years.
In 2013, Medicare identified Confirmatrix as the most expensive urine drug testing lab in country, charging an average of $2,406 for each Medicare patient.
Benefis has continued to send urine drug samples to Confirmatrix for testing even after the company filed for bankruptcy. Some Benefis patients have recently been contacted by collection agencies seeking payment for urine tests costing over $1,000 that their insurance companies refuse to pay for. Similar tests by other labs cost only a few hundred dollars.
According to its bankruptcy filing, Confirmatrix has 152 employees in 15 different states, including one employee in Montana who apparently works on site at the Benefis pain clinic. PNN has also learned that Proove Biosciences has had employees working at the clinic. A Proove “patient engagement representative” was employed there as early as May 2016.
“We had a meeting one day and here are these people from Proove Biosciences. They told us they were doing a research project,” says Rodney Lutes, a physician assistant (PA) who was later fired by Benefis. “They wanted to come to Benefis, into the pain department, and test our patients. We were told this would be at no cost to the patient. My understanding was that they weren’t going to charge anybody, but I found out afterwards they were charging insurance companies.
“They said providers who participated in this would get some form of payment for participating in the program and for filling out all the paperwork. What they did is they had a technician there in the department and every day I would get a list from that technician of patients that they would like to try to include in the program.”
Lutes says he recommended the DNA test to many of his patients, but never received any money from Proove. He says some of his patients later complained that their insurance was billed for the DNA test.
“One of the things that bothered me was that I signed a lot of the papers, but they also had my supervising doc on all of those papers,” Lutes told PNN. “I also felt like she was the one that brought them (Proove) in there.”
“Dr. Lewis works for Benefis one week a month and has been instrumental in the development of our multidisciplinary approach and current protocols,” said Keri Garman, Director of Corporate Communications at Benefis.
In a statement emailed to PNN last month, Lewis said regular urine drug testing was necessary to ensure that “appropriate levels” of medication are present. Current clinic policy is that “high risk” patients should have a urine test at least once every two months.
“Presence of too high of a level of opioids or other substances in the urine can make it inappropriate and unsafe to continue prescribing opioids. Presence of none of the prescribed opioids in the urine indicates the care plan is not being followed and further prescribing is medically unnecessary,” Lewis said.
Benefis: No Kickbacks from Testing Labs
PNN has made repeated requests to Benefis to clarify its relationship with Confirmatrix and Proove, and whether Lewis or any other Benefis employees were receiving compensation from the laboratories for referring business to them.
“Benefis and its employees, including Dr. Katrina Lewis, do not receive kickbacks from Confirmatrix or Proove. As for any questions you have regarding the lab business practices of these facilities, these would be best answered by the companies directly,” Benefis spokesman Ben Buckridge said in a statement emailed to PNN last week.
“We take these accusations and defamatory statements against our organization and staff seriously. We appreciate your diligence on this issue.”
In an earlier statement, a Benefis official said the DNA tests are voluntary and only done on patients if they are appropriate.
“Patients have the option to decline this testing, however, it proves to be very helpful in determining treatment plans for our patients in many cases. This testing has not been readily available until recently,” said Kathy Hills, Chief Operating Officer of Benefis Medical Group.
“Genetic testing allows us to see if the patient is appropriately synthesizing specific medications and can drastically alter treatment plans, showing us that sometimes the medications are not effectively metabolizing and therefore not as effective, which is why some patients have needed high doses. Our partners in this have an extensive patient assistance program that waives many costs, and patients are not penalized or removed from opioids if they refuse to have a genetic test performed.”
“All patients on dosing levels at or higher than the maximum policy dose MUST be submitted for genetic testing,” the policy states. The word “must” is capitalized in the document.
One Benefis patient who took the DNA test said Lutes recommended it.
“He said everyone was doing it and that the insurance would be billed, but if they did not pay for it then Benefis would. I think he said something about it being a $6,000 test,” she told PNN. “To me it was a waste of time and money. The meds it said I should be taking either didn’t work, stopped working, or made me sick. And the meds I should not be taking I do just fine on.”
It is not clear whether the pain clinic’s association with Proove or Confirmatrix had anything to do with Lutes’ firing in March. The 68-year old Lutes treated several hundred pain patients and was popular with many of them.
Lutes was discharged for violating Benefis policy about documentation, opioid dosage and urine drug testing, but feels he was “written up for violations that do not exist.” His supervising physician – Katrina Lewis – also requested removal from that role, meaning Lutes could no longer practice at Benefis as a physician assistant.
Since his dismissal, many of Lutes former patients who were on relatively high doses of opioids say their medication has been reduced or stopped entirely. One patient, whose opioid dose was cut significantly, committed suicide. Still others complain they were labeled and treated as addicts by clinic doctors and staff, and now have trouble finding new physicians in the Great Falls area. The ones who remain at Benefis say they are being told to take new tests and exams.
Benefis says it cannot comment on the accusations because of patient and employee privacy rights.
“Unless Rodney Lutes, PA, or the patients with whom you are speaking will sign written releases allowing us to comment fully on the facts of their employment or their care, respectively, we are simply unable to engage in any further back and forth discussions. We have provided all the information we are able given the legal limitations governing our industry,” Buckridge said.
Worst Epidemic in U.S. History? Opioid Crisis Now Leading Cause of Death for Americans Under 50
Start watching this video at 44:00… All of these “over dose deaths” Just chose a number… any old number.. it seems like everyone has their own number that they like… there are so many variables in the numbers that AT LEAST some of them … someone must have pulled them out of their lower posterior orifice… and comparison to deaths in some wars… Not the first mention of the two most LETHAL DRUGS — ALCOHOL & NICOTINE… NO MENTION of the potential of their being addictive. Maybe they are just afraid of the Tobacco & Alcohol industry as they comfortable SUCKING UP to the DEA.
Days after he relapsed on heroin last summer, Patrick Graney received an offer that was too good to turn down.
How would he like to get treatment in a beach town with a hipster vibe in South Florida — with all expenses paid, including airfare from his Massachusetts home? Graney didn’t have to think long. He was on a flight south the next day. Two months later he was dead.
The arrangement — according to interviews with Graney’s mother and girlfriend and saved Facebook messages he sent — was brokered by Daniel Cleggett, a flamboyant figure, and some would say a pillar, in the Boston-area drug recovery community. A former addict who has spent nearly a quarter of his life in jail, Cleggett has turned entrepreneur in the burgeoning treatment industry for people addicted to opioids such as heroin and prescription painkillers.
He presides over an expanding empire of treatment facilities in Massachusetts, but he has also helped recruit addicted young people from Massachusetts for drug rehab centers in South Florida, according to the patients’ families and others who know Cleggett and are familiar with the arrangements. Two of these young men, including Graney, died from overdoses in hotel rooms in the oceanside resort communities where they were sent for treatment.
Cleggett has pulled off a stunning and rapid turnaround for a man who was once homeless. He now drives a sleek, black Mercedes-Benz CLS 400 that retails for more than $65,000, and enjoys cruising his boat around Boston Harbor. Recently, he posted pictures on Facebook of him at opening day at Fenway Park in seats steps from the field, and attending a boxing match at a casino.
The 31-year-old Cleggett refers to himself on Facebook as a former “lunatic, outlaw addict” — but one who has been sober for five years and is now committed to helping others follow his path. In a brief telephone interview, Cleggett said he had no role in Graney going to Florida for treatment — despite the messages to the contrary Graney sent. He declined to answer any questions about brokering in general or his role in helping other people travel to Florida for treatment.
“I help people all day, every day. That is what I do,” he said. “I had nothing to do with whatever place he went to.”
Cleggett is just one player, albeit a prominent one, in a murky network of middlemen, often referred to as marketers or brokers, who recruit and arrange transportation and insurance coverage for desperate young men and women from the Northeast and Midwest.
Patient brokers can earn up to tens of thousands of dollars a year by wooing vulnerable addicts for treatment centers that often provide few services and sometimes are run by disreputable operators with no training or expertise in drug treatment, according to Florida law enforcement officials and two individuals who worked as brokers in Massachusetts. Cleggett refused to say whether he was paid to find customers for Florida treatment centers.
The facilities are tapping into a flood of dollars made available to combat the opioid epidemic and exploiting a shortage of treatment beds in many states. As center owners and brokers profit, many patients get substandard treatment and relapse.
The role of patient brokers in steering addicts to out-of-state treatment centers is now coming under scrutiny from law enforcement, including Massachusetts Attorney General Maura Healey, according to a spokeswoman for her office. “These recruitment operations take advantage of the desperation of people struggling with addiction to refer them to treatment centers not based on their best interest, but in order to get a commission,” Healey said in a statement. “Patients need to access safe and effective recovery options instead of being treated like paychecks.”
Such arrangements can be illegal in some cases under federal and Massachusetts law if facilities pay brokers to bring them patients and if patients are given inducements, such as free travel or insurance, to enroll in a particular treatment center.
Two people engaged in the business of recruiting addicts for Florida facilities said there are scores of people recruiting patients in Massachusetts and neighboring New England states where rates of opioid abuse are high. They spoke on the condition they not be identified for fear of prosecution.
Brokers are primarily paid in two ways, they said. One is a per-head fee — ranging from $500 to $5,000 — for each patient who successfully checks into a treatment center. In other cases, brokers get a monthly fee from a particular facility but must meet a quota of patients to collect payments as high as tens of thousands of dollars.
A change of scenery and pleasant weather are enough to entice some people to head to Florida to detox, the brokers said. However, most can’t afford it, so they are offered “scholarships,” with the patients paying nothing for their travel or treatment.
In addition to sometimes paying for patients’ flights, brokers often help them obtain private insurance, and then pay the premiums on their behalf until treatment benefits are exhausted after 60 to 90 days. The Florida centers frequently bill the private insurers at higher, out-of-network rates that can easily total $10,000 or more a week.
“They get down there, and it’s nothing more than a puppy mill for insurance billing,” said Eric Spofford, founder and CEO of Granite Recovery Centers in New Hampshire, who has learned of the brokering from the region to Florida centers from patients at his facility. “There’s no investment in helping them get better.”
When Graney, who grew up in Milton, Mass., was in Florida last summer, he repeatedly cited Cleggett as the person who arranged for his treatment in messages to four different people obtained by STAT and the Globe.
In a message to a friend on July 22, Graney wrote that after discussing with Cleggett the possibility of treatment in Florida “he had me on a plane the next day” and that it was “all free.” Two days later, Graney wrote to another friend that his treatment was free and “this kid clegget” got him insurance, misspelling Cleggett’s name. Graney then added, “they get paid 4 sendin kids down here.”
On Aug. 3, when a third friend asked him about his treatment in Florida, Graney wrote, “Yea Danny Clegget hooked it up all free.” The next day, he wrote to an acquaintance who runs sober homes in Florida. Of his insurance, Graney said, “sum1 back home sent me down here…but I didn’t pay for it.” When asked who sent him, he responded “Danny clegget.”
In a message to a fifth person, sent just hours before he died, he mentioned a second person who was involved in the arrangement of his treatment in Florida. The identity of that person could not be confirmed.
Graney’s mother, who provided the Facebook messages, and Graney’s former girlfriend said in interviews that Cleggett arranged free transportation and insurance for Graney.
Cleggett insisted in the interview that he didn’t pay for any expenses related to Graney’s treatment in Florida, including airfare and insurance — and that he had nothing to do with Graney traveling there. He refused to say whether he was working with another broker who paid those costs. Asked about Facebook and text messages with Graney, Cleggett said, “Your facts are not true.”
He said Graney was a friend and added, “It’s very unfortunate what happened with Pat.”
The relocation to Florida did little for Graney. He was bounced out of a treatment facility, and two months after arriving, he was homeless and trying to find help on his own. He fatally overdosed in a Delray Beach hotel room with a stranger he met hours earlier at a detox center that turned him away.
“My son would still be alive today if he didn’t get on that plane to Florida,” said Graney’s mother, Maureen.
Maureen and Jack Graney pose in their home in Milton, Mass. Keith Bedford/The Boston Globe
Earlier this month, at a meeting of a community group that gathers regularly to discuss solutions to the opioid crisis, Cleggett sat slumped and expressionless at the front of a room in the Holbrook, Mass., town hall. Burly with close-cropped hair, he was dressed casually in a long-sleeve checked shirt.
Cleggett is a frequent presence at such meetings. An ex-con and a businessman, he can talk the language of inmates locked up on drug-related charges and of state officials working on solutions to the opioid epidemic.
He listened for about an hour while one speaker after another talked about finding sobriety and helping others. Finally it was his turn to speak. All eyes were on Cleggett as he leaned forward over the dais and began to tell his story, loud and rapid-fire.
He told the group that he was jailed for the first time when he was 14 and spent seven of the next 12 years locked up. He was homeless. He abused alcohol and drugs.
Law enforcement records offer additional details of a long and violent criminal history. After his first brush with police at age 14, the charges were dismissed, but over the next decade, dozens more followed. On at least three occasions, he led police on high-speed chases, hitting other cars in one and careening dangerously close to pedestrians in another, court documents show.
One chase, when he was 20, occurred just hours after he was released from jail after serving a six-month sentence for assault and battery with a dangerous weapon, according to court documents.
In his mid-20s, Cleggett went to a retreat modeled on the 12-step Alcoholics Anonymous program. The treatment clicked. He was soon managing a sober house in Maine where addicts in recovery lived together. Those experiences prompted him to open similar treatment facilities in Massachusetts, he told the group in Holbrook. He now operates five facilities with 100 total beds, he said.
He recently opened a 12-step retreat in a large home in Wakefield near a lake. He has a sober home in Weymouth and two other facilities in nearby Quincy. There are many people who credit Cleggett and his facilities with helping them get sober.
Cleggett paused, seeming to fight back tears, when talking about friends dying and his current work.
“If these kids got the help I got,” he told the group, “it didn’t have to be this way.”
Patrick Graney (right) with his sister Elizabeth in 2016. Graney family
A photo of Daniel Cleggett posted on his Facebook page. Facebook
Patrick Graney’s struggle with opioids began at his junior prom at Milton High School in suburban Boston. A friend offered him OxyContin, and his life changed instantly. He was quickly hooked on the drug and dropped out of school halfway through his senior year.
Graney was a gifted athlete — a star pitcher in Little League and a high-scoring hockey player. He had a thick Boston accent and a quick wit. As he descended into a decade-long addiction to opioids, his appearance changed as he put on weight and drifted from halfway houses to homelessness.
Court records reveal a record shared by thousands of others addicted to opioids: drug and theft charges, short stints behind bars, and in and out of treatment programs.
Somewhere along the way, Graney met Cleggett, when they were both using drugs and occasionally seeking treatment. After Graney started using drugs again last year, Cleggett sent him numerous text messages offering to arrange treatment for him in Florida, said Graney’s former girlfriend, Kerri Jones. He also offered to help get Jones treatment in Florida, she said, and he had previously arranged for her relative to get treatment there.
“The way it was explained to both of us is that it is a fresh start in a new state,” she said of Cleggett’s pitch. She said Cleggett sent photographs of a facility that looked like “a five-star resort.” There were daily yoga sessions, she said he told them, and clients were given money to go the movies.
Cleggett told them everything would be paid for, Jones said. They would be in a private insurance plan — not Medicaid, the government insurance program the two had used in the past and that pays far less for treatment than commercial insurers. If anyone questioned them about their insurance, Cleggett told them to say they were unsure about the details or they were covered by their parents’ plans, she said.
Screen grab of a text conversation between Cleggett and Graney. Courtesy Maureen Graney
About three-quarters of the rehab center patients with private insurance like Graney are coming to Florida from out of state, according to law enforcement officials in Palm Beach County. The Affordable Care Act, which both mandates payment for drug treatment and makes private insurance easier to obtain for young people, has created a pot of money that’s being exploited by unscrupulous treatment centers, according to those officials.
“There will always be people dying of drug overdoses, but it doesn’t have to be exacerbated by laws intended to get people healthy that have been misused to cause more deaths,” said Dave Aronberg, the state attorney for Palm Beach County, who created a task force to investigate abuses in the treatment industry that thrives in his area.
Graney’s mother said her son told her that Cleggett was arranging free travel and insurance for his treatment in Florida. He sent her a copy of a text message from Cleggett asking for his date of birth and other information so he could book his travel. Graney then sent his mother another message from Cleggett providing the details of his flight on American Airlines from Boston to Fort Lauderdale the next day.
Graney had been in and out of facilities in Massachusetts. When he was 19, Graney’s parents borrowed $10,000 to send him for treatment at a beachfront rehab in southern California. Nothing stuck.
His family focused on keeping him alive, hoping one day he would decide that he had enough with drugs, or find a treatment facility that worked for him.
Maureen Graney was suspicious of the Florida arrangement, but there was little she could do to stop her son from going.
The Florida Recovery Group in Delray Beach, Fla. Josh Ritchie for STAT
In the end, the lure of Florida was an illusion. A van was waiting when Graney arrived at the airport and he was brought to a treatment facility called Florida Recovery Group in Delray Beach, according to insurance records as well as friends and family.
The plan was for Jones, Graney’s ex-girlfriend, to follow him there a few days later. Graney told her not to bother, she said. The facility was not what he expected, he told her. He said he was sticking it out so he wouldn’t upset Cleggett.
After a few weeks in Florida, Graney relapsed. He connected with a high school friend from Milton, who was also struggling with opioid abuse, and a girl from Massachusetts. They had no place to stay and slept on the beach. Graney then made a telephone call and was picked up by a man in a sedan, who took him back to Florida Recovery Group, according to Maureen Graney.
Although he was back at the facility, there were problems with his insurance. Graney messaged Cleggett via Facebook on Aug. 24 to find out what was going on.
“Hey Watsup buddy,” Cleggett responded when Graney reached out.
“They ask me about my insurance today cause theres no payment on it,” Graney replied. Cleggett told him he would look into it and later told him, “All set bud.”
He wasn’t. Graney’s insurance was terminated.
Jan Goodman, the CEO of Florida Recovery Group, confirmed that Graney was a patient there, after Maureen Graney signed a privacy waiver allowing him to speak to Graney’s case. He said in a statement that Graney received “an excellent level of care.” The center does not allow people to be kicked out for lapsed insurance and Graney stayed from Aug. 24 to Sept. 7, with the understanding he would pay for his treatment later, Goodman said.
Graney was ultimately discharged after it was reported that he brought heroin into the facility and gave it to another patient, who overdosed, Goodman said.
He said he had never heard of Cleggett and that the Florida Recovery Group does not use patient brokers. The center has no history of complaints filed with Florida’s Department of Children and Families.
On Aug. 29, Graney asked Cleggett via Facebook if he could send him bus money to come home. Two weeks later, when Graney was still in Florida, his mother began working to get her son home. She planned to buy him a ticket on a Greyhound bus leaving at 12:35 p.m. on Sept. 10. First, she had to find him a place to stay and booked him a room for the night of Sept. 9 at the Residence Inn in Delray Beach.
Patrick Graney, however, was struggling.
A friend of his from Boston, who spent time in jail and detox with him, was also in Florida and saw Graney around this time. Graney was in bad shape, he said, and had recently drunk kratom, a plant that is often brewed and produces opioid-like effects.
On the evening of Sept. 9, Graney went to a Delray Beach detox center seeking help. He was turned away because no beds were available, according to a police investigation of his death. He then checked into the hotel room, bringing along a man and a woman he met at the detox center. At 2:12 the next morning, the man called 911 to report Graney was unconscious on a couch with a brown liquid coming from his mouth.
The stranger attempted CPR until paramedics arrived. It was too late. Graney was dead from what the medical examiner later determined was acute cocaine intoxication. He was 30 years old.
Patrick Graney (center) with his parents. Graney family
The sunny getaway promoted by Cleggett and other brokers is hardly paradise. Palm Beach County is so packed with addiction treatment facilities that many call it the “Recovery Capital of America.”
At the Dunkin’ Donuts on Atlantic Avenue in Delray Beach, white vans carrying patients to treatment facilities pull in and out of the parking lot throughout the morning. People spill out of the vans, grabbing a quick cigarette break or a cup of coffee. They reload and head off to rehab centers in bland office parks, far from the white sand beaches and trendy restaurants and galleries.
Officials estimate that Delray Beach alone — a city of 16 square miles with 67,000 residents — has more than 800 treatment facilities. And within five miles of the city, according to one rehab operation, there are hundreds of Alcoholics Anonymous meetings every week.
Cities such as Delray Beach are a draw for out-of-state residents seeking recovery because they are walkable, the weather is warm, and the people are friendly. It’s a perfect place to come get sober — or get rich off those trying to do so.
“It’s where the money is,” said Aronberg, the state attorney. “This is a hotbed of corruption.”
The problem had become so pressing by 2016 that the state appropriated $275,000 to create a task force in Palm Beach County to go after corrupt operators, including those engaged in patient brokering. Earlier this month, two sober home owners investigated by the task force were sentenced to prison as part of a money-laundering scheme. Patients at those homes were allegedly given drugs, and female patients were sexually exploited.
Numerous centers are run by people with little expertise in substance abuse treatment or with questionable backgrounds — staffed by people like Dr. Evan Zimmer, listed in a court record last year as medical director of Bright Futures Treatment Center in Boynton Beach. That’s where Cleggett arranged for Evan McLaughlin of Plymouth, Mass., to go for treatment, according to McLaughlin’s mother, Tina, who said she paid for his travel and insurance.
Evan Mclaughlin, left, of Plymouth, Mass., died in a Florida hotel room after seeking treatment for his addiction to opioids. Facebook
Tina McLaughlin grew up with members of Cleggett’s family in Braintree, Mass. Her son was admitted on June 10, 2016, under Zimmer’s medical direction, according to a document filed as part of a heroin possession case against McLaughlin in Massachusetts.
Zimmer, a psychiatrist, had his medical license suspended for three years beginning in 2012 after numerous complaints he was possibly under the influence of drugs and alcohol, according to state medical board records.
It was the second serious sanction from the medical board. His license was revoked in 1985 after Zimmer was charged with driving under the influence of drugs following an accident, and was subsequently found to have written prescriptions in the names of patients he had no record of treating. Police found hundreds of prescription pills in his vehicle, including Valium and Percocet. He received a new license in 1991, according to board records.
Zimmer said his own experiences with addiction make him a better practitioner. He said he didn’t know how McLaughlin ended up in Florida, but added he is opposed to patient brokering. The facility’s management did not respond to a request for comment. Bright Futures has no history of complaints with the state Department of Children and Families.
Tina McLaughlin said her son initially did well after arriving in Florida. He had struggled with an opioid addiction since he was prescribed painkillers as a teenager following a hockey injury that fractured his neck. By the time he was 16, he was shooting heroin.
McLaughlin said her son was managing two sober homes, where people in recovery live together, and had just signed a contract to be a marketer for a rehab facility. She described that job as “doing what Danny does.”
“As far as I knew, he was doing great,” she said of her son.
Just after Thanksgiving in 2016, Evan McLaughlin relapsed without warning, his mother said. His body was discovered by a housekeeper in a Boynton Beach hotel room on Dec. 1. On a countertop, police found two syringes and a burnt spoon. The medical examiner determined he died from an overdose of carfentanil, a particularly dangerous opioid originally developed as a tranquilizer for large animals such as elephants.
Zimmer said McLaughlin didn’t comply with treatment in Florida and was using steroids. “The writing that was on the wall for Evan would have been on the wall regardless of where he was,” said Zimmer. “It was about who he was rather than where he was.”
Tina McLaughlin doesn’t blame Cleggett for her son’s death at age 24 and remains friendly with him.
Bright Futures Treatment Center in Boynton Beach, Fla. Josh Ritchie for STAT
Cleggett literally wears his spirituality as a sleeve. His right arm has a tattooed image of Jesus nailed to the cross. His entire back is tattooed with an elaborate illustration of Satan and Jesus arm-wrestling.
At the Holbrook meeting last month, he said he will be sober five years this summer and credited his success to following the 12-step program and finding God. He named his company A Vision from God LLC, and he is an active member of Life Community Church in Quincy and recently helped the church move into a new building.
“I used to be just a junkie convict and I handed my life over to God,” he told the group. When the meeting ended, he walked outside and drove away in his Mercedes.
Could this suggest why Legislators/Legislatures do nothing about the 100,000/yr preventable alcohol related deaths or the 450,000/yr preventable Nicotine related deaths ? Can you be part of the solution… if you are part of the problem ? Could all of the various legislatures be focusing on the “opiate epidemic” to distract from the real “epidemic” of preventable deaths because they personally could lose access to their “drug of choice” ?
Dallas police arrested the Texas House Democrat voted “Freshman of the Year” late Tuesday night for driving while intoxicated.
Officers, responding to message that a vehicle hit a tree, later learned that the allegedly drunk driver was state Representative Victoria Neave (D-Dallas).
Reportedly, she did not cooperate with law enforcement who arrived on scene. The arrest warrant described Neave, 36, as having a strong odor of alcohol, unsteady, and with bloodshot eyes and slurred speech, WFAA reported. Officers also documented the state lawmaker’s behavior as uncooperative, refusing to perform field sobriety tests, and give breath or blood samples. According to police records, Neave repeatedly told officers in slurred speech: “I love you and I will fight for you and I’m invoking my Fifth Amendment rights.”
Officers booked her into the Dallas County Jail at 3:30 a.m. (CDT) on Wednesday where she remained, waiting to see a magistrate. However, on Wednesday, shortly before 2 p.m., Neave took to social media with a public Facebook apology. She stated: “Last night, I disappointed my family, my constituents, and my supporters. I disappointed myself. I’m deeply sorry. I’m so grateful that no one was hurt. I will accept full responsibility for my actions and I will work to make this right.”
Ironically, Neave participated in a Mesquite-held event promoting safe driving on Sunday, June 4.
Screengrab credit: Twitter/@JuanDel20662323
The often outspoken freshman representative has maintained a highly visible profile during the state’s 2017 legislative session. In April, she marched in Dallas against Texas sanctuary city legislation, Senate Bill 4, which Governor Abbott since signed into law. Breitbart Texas reported she tweeted: “Eleven years ago, I marched w/my family. This time, I march as a State Representative fighting anti-immigration legislation at #txlege.”
A few weeks later, she led a hunger strike to oppose SB 4, asking other Democrat lawmakers and open border advocates to join her, as was reported by Breitbart Texas. She was also the organizer of the Dallas Women’s March and Texas House Democratic Caucus recently named her “Freshman of the Year.”
On Wednesday morning, Dallas County Democratic Party Chair Carol Donovan responded to the news of Neave’s arrest by issuing a statement:
We understand, and are thankful, that no other person was involved or injured in the accident. Nevertheless, we look forward to speaking with her regarding the facts of her case and to insure she is alright. We wish her the very best and pray for her swift recovery so that she can resume her strong representation of the citizens of House District 107.
Neave’s district encompasses East Dallas, Mesquite, and Garland. By trade, she is a lawyer with a practice in Dallas.
The National Council on Alcoholism and Drug Dependency estimates that over 23 million Americans (age 12 and older) are addicted to alcohol and other drugs. According to the Substance Abuse and Mental Health Services Administration (SAMHSA), just under 11% (2.5 million) received care at an addiction treatment facility in 2012. SAMHSA also estimates that the market for addiction treatment is about $35 billion per year.
The vast majority of addiction treatment is based either partially or entirely on the 12 Steps of Alcoholics Anonymous (AA), but is there scientific evidence to support AA as a clinical treatment? Should addiction treatment centers make enormous profits by simply funneling substance abusers into the free fellowship of AA?
These are the primary questions behind The Business of Recovery ‒ a new documentary that opened earlier tonight at the Newport Beach Film Festival. Like many documentaries, there are some startling statistics ‒ including this provocative one delivered early in the 81-minute film.
I became the Director of the Alcoholism Treatment Unit at Harvard’s McLean Hospital. I’ve probably treated a couple of thousand people who have one addiction or another. Almost all residential treatment programs in the United States are 12 Step based, so their effectiveness will depend entirely on whether 12 Step programs work and the statistics for AA are not good. It is helpful for 5‒10% and that’s a good thing. That’s 5‒10% of people who are being helped by A.A. ‒ it’s a lot better than zero percent ‒ but it shouldn’t be thought of as the standard of treatment because it fails for most people ‒ for the vast majority of people. Lance Dodes, MD ‒ Addiction Expert & Author ‒ Harvard Medical School Graduate in The Business of Recovery
As a part of the annual film festival in Southern California, the film is being shown again Tuesday evening and the producers are working toward a broader, public release later this year. The critical assessment of addiction treatment is both timely and sobering.
12 Step programs are very popular, but if you’re looking for figures and randomized trials and scientifically rigorous studies of how they work and for how many people they work ‒ you will not find those studies. You will find anecdotal evidence ‒ for people that it did work [for] ‒ but unfortunately we don’t have the scientific basis to say how many of all those people that tried a 12 Step program ‒ how many of those did not succeed. Ruben Baler ‒ Health Scientist, National Institute on Drug Abuse in The Business of Recovery
The film is timely because the market does seem poised for accelerated growth based on a number of key attributes.
A real‒estate component that can easily scale to any size ‒ including the private, single family residence (called “sober living homes” ‒ by one estimate over 10,000 in Arizona alone).
Almost no federal, state or municipal oversight for credentials or treatment pricing.
Advertised success rates of 80% (or higher) with no scientific evidence.
This last one is the most troubling since addiction is often couched in clinical terms like “disease” and “treatment.” The AMA first defined alcoholism as an illness (1956) and then a disease (1966), but there’s little scientific evidence to support a disease diagnosis. That also makes it challenging to categorize any program based on the 12 Steps of AA as clinical treatment ‒ even if there is a billing code.
AA is not really a treatment ‒ it’s a fellowship. If you go to your doctor to be treated for cancer or heart disease you expect your doctor to be doing what the science says is the best treatment available for what you have. That has not been the standard in addiction treatment. William R. Miller, PhD ‒ Emeritus Distinguished Professor University of New Mexico in The Business of Recovery
Two events last year (not included in the documentary) also signal a healthy and growing commercial industry.
The first was the merger between two iconic treatment brands ‒ the world-renowned Betty Ford Center and Hazelden (founded in 1949). The combined non‒profit entities are now simply the Hazelden Betty Ford Foundation. As with many non‒profits, there are no outside investors to satisfy, but the salaries of key execs are often in the high six‒figures (and well above averages for even practicing physicians ‒ any specialty).
The second event was the IPO last fall of AAC Holdings, Inc. ‒ which is really the first attempt at a publicly traded company exclusively for addiction treatment (the AAC stands for American Addiction Centers). The quoted price range for a 30-day “treatment plan” (again ‒ revolving largely around AA) was $15,000 to $26,000. The Hazelden Betty Ford Foundation is easily twice that amount and other, more exotic treatment facilities (often catering to celebrities in swank resort‒style locations) can easily run into the low six‒figures.
As a publicly traded company ‒ something that Betty Ford and Hazelden have both intentionally avoided ‒ AAC has already hit some significant headwinds in the form of accusations, short‒sellers and legal scrutiny. One of the reasons is that a sizable source of high‒margin revenue appears to be urine testing which can be used in high‒volume and is relatively easy to game for serial revenue and profits.
On March 3, 2015, SeekingAlpha published an article asserting, among other things, that AAC Holdings: (i) conducts unnecessary urine drug tests that contribute to its outsized margins; and (ii) lowered its provision for doubtful accounts after acquiring a revenue management company from its CEO and president’s spouses, which boosted its net income before its IPO. On this news, shares of AAC Holdings fell $3.54 per share or over 10% from its previous closing price to close at $30.37 per share on March 3, 2015, damaging investors. The Rosen Law Firm (announcing its investigation into potential securities claims on behalf of investors)
The lack of certification also supports a very low barrier to becoming an addiction treatment counselor.
There is no mandatory national certification exam for addiction counselors. The 2012 Columbia University report on addiction medicine found that only six states required alcohol and substance-abuse counselors to have at least a bachelor’s degree and that only one state, Vermont, required a master’s degree. Fourteen states had no license requirements whatsoever ‒ not even a GED or an introductory training course was necessary ‒ and yet counselors are often called on by the judicial system and medical boards to give expert opinions on their clients’ prospects for recovery. Gabrielle Glaser ‒ The Irrationality of Alcoholics Anonymous (The Atlantic)
So we developed this history of providers being people who are themselves in recovery ‒ originally with no educational requirement at all. In New Mexico, we now have a Bachelors degree required to be a substance abuse counselor and it was quite controversial to do that. I don’t know of any other life‒threatening illness where it’s controversial if you should have a college education to treat it, but it has been in the addiction field. William R. Miller, PhD ‒ Emeritus Distinguished Professor University of New Mexico in The Business of Recovery
Even the judicial system contributes to the confusion by often mandating AA attendance to offenders who arrive in court as the result of criminal charges associated with substance abuse (most commonly driving under the influence).
It is completely inappropriate and dangerous for courts to be mandating AA treatment. This amounts to malpractice. It’s medical malpractice by the judge. It’s as foolish as if the judge said to you ‘ok ‒ you have an infection ‒ I mandate that you take penicillin because I believe that’s the effective drug. Lance Dodes, MD ‒ Addiction Expert & Author ‒ Harvard Medical School Graduate in The Business of Recovery
Outside of AA, newer alternatives are also gaining broader awareness, acceptance ‒ and real scientific evidence of efficacy (JAMA meta‒analysis here).
I made the documentary One Little Pill to help spread awareness about a treatment for alcoholism that literally saved my life. It’s called the Sinclair Method and it’s based on using the FDA approved generic drug naltrexone to create an effect known as pharmacological extinction. The success rate is very high ‒ nearly 80%. I also started a non‒profit called the C3 Foundation as a more direct way to help people find the clinical information and doctors that support the use of this life saving treatment. Claudia Christian ‒ Actress
New drugs will also challenge the conventional wisdom around AA being the primary ‒ often only solution to substance abuse. There is also the very real possibility that AA is not helping people with other mental or behavioral disorders that can be easily masked by substance abuse. The AA mantra of “more meetings” could well be counterproductive to many who arrive at the fellowship with a wide range of psychological, behavioral and other clinical issues.
Ultimately, whether AA is scientifically effective ‒ for whom and how many ‒ is a secondary issue. No one argues that it has helped to destigmatize substance abuse and it definitely helps some. Unlike for-profit treatment plans, however, AA has never had fees or dues of any kind since its inception in 1935 ‒ and likely never will. The real issue then is a $35 billion a year industry that’s largely based on funneling substance abusers into the free fellowship of AA ‒ or simply providing large doses of AA meetings themselves.
To be sure, there’s a lot of hand‒waving, glitzy marketing and pseudo‒science to justify the enormous cost associated with treatment plans, but little proof of scientific efficacy. Court mandated attendance isn’t profitable, of course, but it does legitimize the process of funneling people into A.A. in ways that also benefits the industry at large.
As highlighted through several tragic stories in the documentary, family members are naturally eager to spend whatever money they have ‒ and often money they don’t have ‒ in desperate attempts to save loved ones from the harsh realities of substance abuse and addiction. Preying on this strong desire is the very real and profitable business of recovery ‒ and one that the documentary exposes with clear‒eyed and sober detail. I do hope the film finds a way to a larger public audience. There’s still so much we don’t know about substance abuse and addiction ‒ except ‒ at least according to one compelling film ‒ how to turn it into a very lucrative business.
They liberally throw around verbs and adjectives that makes one think that things are not only POSSIBLE.. but.. they suggest that bad/lethal outcomes are ABSOLUTE. They go to a area that is KNOWN for high incidents of drug/substance abuse and claim that MORE PEOPLE are DYING from pts taking the combo of certain medications.. they DO NOT STATE.. if the pts were taking the combination of medications as prescribers OR was taking more than prescribed and combining them with other substances including alcohol.
They claim that 28,000 died from opiate OD in 2014… and HALF was from prescription opiates.. SO, 14,000 died from a OD of ILLEGAL OPIATES ??
More people died from prescription drug overdoses in 2014 than any other year on record.. WHAT MEDICATIONS were involved ?? Controlled med prescriptions typically account for 15%-20% of all prescriptions… I thought this article was about the dangers of the opiate/benzo combo ? Just throw in an OBSCURE FACTOID ???
The number of patients prescribed both an opioid pain reliever and a benzodiazepine increased by 41 percent between 2002 and 2014.. SOUNDS SCARY ?… that is only a average of a 3% PER YEAR increase.. Doesn’t sound so bad now ? Our overall population increases abt 3%/yr.
This is NOT A LAW or a RULE… prescribing these two medications is still up to the prescriber and untold number of medications have a BLACK BOX WARNING from the FDA that prescribers use EVERY DAY.
Mixing prescription opioid painkillers with a class of drugs that includes popular sedatives such as Valium and Xanax can cause a fatal overdose, U.S. health officials warned Wednesday.
The U.S. Food and Drug Administration said it will require “boxed warnings” on 389 different products to inform health professionals and the public of this potentially lethal drug interaction, FDA Commissioner Dr. Robert Califf said during a media briefing.
Benzodiazepines — which include Valium and Xanax — affect the central nervous system, and are used to treat conditions like anxiety, insomnia and seizures, said Dr. Doug Throckmorton, deputy director of regulatory programs with the FDA’s Center for Drug Evaluation and Research.
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Surgeon general’s letter to clinicians in crusade against opioid abuse
If benzodiazepines are combined with opioid medications such as oxycodone (Oxycontin) and hydrocodone (Vicodin), a drug interaction can occur that could result in coma or death, Throckmorton said.
“Nearly one in three unintentional overdose deaths from prescription opioids also involve benzodiazepines,” said Baltimore Health Commissioner Dr. Leana Wen, who worked with the FDA to produce the new warning.
Products that will carry the boxed warning — the strictest one possible — will include benzodiazepines, prescription opioid painkillers such as oxycodone and hydrocodone, and cough medicines that contain opioids, the FDA said.
Combining these drugscan dangerously depress a person’s breathing and make them extremely sleepy, the FDA warned.
Califf said he heard about this threat during a recent trip to the Appalachians, a region hard hit by the prescription drug abuse epidemic.
“One thing really stood out to me, that I heard consistently from each place on our trip — benzodiazepines and opioids were an increasing threat for overdose as seen in their emergency departments,” he said.
“This rise in overdoses and deaths due to the combined use of these products isn’t new,” Califf added. “Communities have been seeing this trend for some time, but ultimately we needed data in order to act today.”
A review conducted by the FDA identified a troubling trend in which patients are often prescribed these drugs in combination, even though they can interact in dangerous ways.
The number of patients prescribed both an opioid pain reliever and a benzodiazepine increased by 41 percent between 2002 and 2014. That translates to an increase of more than 2.5 million opioid painkiller patients also receiving benzodiazepines, Throckmorton said.
“We know approximately half of concurrent benzodiazepine and opioid analgesic prescriptions were dispensed to patients on the same day and prescribed by the same health care provider,” Throckmorton said.
More people died from prescription drug overdoses in 2014 than any other year on record, according to the Centers for Disease Control and Prevention.
Opioids killed more than 28,000 people in 2014, and at least half of those deaths involved a prescription drug, the CDC says.
Doctors routinely prescribe benzodiazepines along with opioids, unaware of the potential overdose risk, Wen said.
“If a patient was in a car accident and experiencing neck pain, a clinician might prescribe opioids for the pain and benzodiazepines for muscle spasms,” she said. “A patient who is on benzodiazepines for anxiety disorder might get prescribed opioids for pain relief, and vice versa.”
Wen urged doctors to heed the new warning, and patients to review the drugs they’re taking.
“I urge patients to look inside your own medicine cabinets and ask, ‘What is this medication for? Do I need it? What are the side effects? Could there be a dangerous combination?’ “ she said. “Please speak to your doctor if you have questions or concerns.”
Pet owners warned as highly contagious dog flu spreads after dog show
