New York Magazine had a great article on the epidemic of opioid deaths and who and what is to blame.

“During the worst year of the HIV/AIDS crisis, 43,000 Americans lost their lives to the virus. In 2015, 52,000 died of a drug overdose. Never in recorded history had narcotics killed so many Americans in a single year; the drug-induced death toll was so staggering, it helped reduce life expectancy in the United States for the first time since 1993.”

The article suggests that “a great deal of blame belongs to our system of pharmaceutical patents, and the sociopathic greed that it incentivizes.” The for profit pharmaceuticals companies spend upwards of $200 million a year lobbying Congress to ensure that no profit-reducing regulations are imposed on them.

Pharmaceutical research is an expensive and uncertain endeavor therefore the government provides pharmaceutical companies with a motivation for researching new drugs — and a means of recouping losses from failed experiments — by offering those companies a temporary monopoly on newly discovered medications. This formula for pharmaceutical innovation has many downsides including legal price-gouging that patent monopolies enable and concealment of the harmful effects of their products.

“American doctors have been free to prescribe morphine and other generic opioid painkillers since the early 20th century. But they started prescribing such narcotics at drastically higher rates in the mid-1990s, when Purdue Pharma patented OxyContin, and began aggressively marketing the drug to doctors and patients.”

The problem with this focus is that there’s little evidence that treating chronic pain with opioids is effective — and a lot of evidence that it’s dangerous. The Centers for Disease Control and Prevention have concluded that there is “insufficient evidence” that opioids provide effective pain relief when taken for a period of longer than three months.

A recent study by the Center for Economic and Policy Research found that the total cost of OxyContin abuse in the U.S. between 1998 and 2007 — as measured by spending on “abuse treatment, medical complications, productivity loss (minus mortality), and criminal justice proceedings” — totaled $38.6 billion.

The CDC has also concluded that roughly a quarter of those who use opioids on a long-term basis become addicted. But you can make a lot of money selling dope to addicts; and Mundipharma has shown little deference to the CDC’s findings.

In 2007, Purdue and three of its executives pleaded guilty to federal charges of misbranding drugs — and were forced to pay a $635 million fine (a sum far lower than their profit of $35 billion). But by then, 29,600 Americans had already died of OxyContin overdoses – and the notion that opioids were a low-risk treatment for chronic pain had become widespread.

 

The Chicago Tribune reported that half of pharmacies fail to warn consumers of drug interactions and contraindications.  In the largest and most comprehensive study of its kind, the Tribune tested 255 pharmacies to see how often stores would dispense dangerous drug pairs without warning patients. Fifty-two percent of the pharmacies sold the medications without ever mentioning the potential harmful interaction, striking evidence of an industry wide failure that places millions of consumers at risk.

Pharmacists failed to catch combinations that could trigger a stroke, result in kidney failure, deprive the body of oxygen or lead to unexpected pregnancy with a risk of birth defects.

Dangerous drug combinations are a major public health problem, hospitalizing tens of thousands of people each year. Pharmacists are the last line of defense, and their role is growing as Americans use more prescription drugs than ever. One in 10 people take five or more drugs — twice the percentage seen in 1994.

The Tribune study, two years in the making, exposes fundamental flaws in the pharmacy industry. Safety laws are not being followed, computer alert systems designed to flag drug interactions either don’t work or are ignored, and some pharmacies emphasize fast service over patient safety. Several chain pharmacists, in interviews, described assembly-line conditions in which staff hurried to fill hundreds of prescriptions a day.

In the fight to protect patients from dangerous drug interactions, doctors shoulder significant responsibility. They are the ones who write the prescriptions.  However, in filling prescriptions, pharmacists are uniquely positioned to detect potential drug interactions, warn patients and prevent harm. Pharmacists themselves say that is one of their primary duties.

Carmen Catizone, executive director of the National Association of Boards of Pharmacy, said the professional standard is clear. “Anytime there’s a serious interaction, there’s no excuse for the pharmacist not warning the patient about that interaction,” he said.

 In 2012, the nonprofit Institute for Safe Medication Practices conducted a national survey of 673 pharmacists and found that nearly two-thirds worked at stores that track the time it takes to fill prescriptions. About 25 percent worked at companies that guaranteed short wait times.

In 2013, the National Association of Boards of Pharmacy called on states to prohibit, restrict or regulate company policies that measure the speed of pharmacists’ work. If pharmacists fall behind, the backlog pops up in color on their computer screens, said Chande, also a former union steward. “It’s an unreal pressure,” he said. “Your mind is kind of frantically trying to obey it.”

In response to the Tribune tests, CVS, Walgreens and Wal-Mart each vowed to take significant steps to improve patient safety at its stores nationwide. Combined, the actions affect 22,000 drugstores and involve additional training for 123,000 pharmacists and technicians.

 

 

 

 

 

The Atlantic had a great article on the recent report on life expectancy in America.  There is some good news and some bad news.  Young Americans are dying at a faster rate.  Elderly Americans are extending their life expectancy.

A pair of new studies suggest Americans are sicker than people in other developed countries. The studies suggest so-called “despair deaths”—alcoholism, drugs, and suicide—are a big part of the problem, but so is obesity, poverty, and social isolation.  Deaths from unintentional injuries, including drug overdoses, are up, rising by 10,000 since 2014 which can partly be explained by the epidemic of heroin and prescription-painkiller abuse.

American life expectancy fell by one-tenth of a year since 2014, from 78.9 to 78.8, according to a report released last week by the National Center for Health Statistics. Meanwhile, the number of years people are expected to live at 65 remained unchanged, suggesting people are falling ill and dying young.Heart disease and cancer were the most common causes, accounting for nearly half of all deaths. Still, cancer deaths are declining, while deaths from all other causes, including heart and lung diseases, strokes, Alzheimer’s, diabetes, and suicides have ticked up.

Much of the increase in mortality can be explained by obesity. However, poverty and its associated struggles, such as depression, stress, and poor nutrition, are also clearly playing a role. Americans are hit harder than other rich countries are by these forces, because of lack of preventive health care and because “the U.S. has higher income inequality and less comprehensive social safety net, so the ill-effects of poverty may take an undo toll.”

One paper published this month suggested that Americans would live nearly four years longer if the U.S. had a safety net as generous as those of European countries. Nationally, better health-care access could improve mortality rates. But if Obamacare is repealed, 30 million Americans might lose their health insurance coverage as early as January—unless, of course, Trump can create a better plan.

The Observer-Reporter had a disturbing article about Amy C. Durbin, a registered nurse from Greensboro, who worked at the assisted-living facility previously known as Golden Living Center (now known as Waynesburg Healthcare and Rehabilitation Center).

Durbin is accused of not logging prescription drug reports for medication she was supposed to be giving to patients.  Twelve charges of prohibited acts for fraudulent or omitted drug reports were filed against Durbin.

“Agent Andrew Sakmar wrote in court documents his investigation began in March after the office was notified of the nursing home’s internal investigation into medication that was unaccounted for. Durbin allegedly was not documenting medication administration properly for controlled substances, according to the criminal complaint.”

Records indicate Durbin was “withdrawing medications which were unaccounted for by documentation on pain evaluation forms and were not recorded as administered to patients on medical administration records,” the complaint said.  The medications include 40 oxycodone pills and six hydrocodone-acetaminophen pills, investigators said.

Durbin allegedly became “verbally hostile,” refusing to come into work to be questioned or tested.

The Indiana Gazette reported the guilty pleas of Lance D. Shirey and Tonya R. Shirey, the owners and operators of Shirey Personal Care Home, charged in the death of Gary Armstrong.  Armstrong died of a fentanyl overdose from his prescribed patches. In a plea agreement, each pleaded guilty to a charge of recklessly endangering another person.

In an affidavit of probable cause, the Office of the Attorney General and Department of Human Services said the keeping of medication logs and failure to recognize overdose symptoms led to the death of Armstrong on May 8, 2014.

Investigators said Lance Shirey told them he saw Armstrong chewing on something between 4:30 and 5 p.m. May 7, but assumed it was food. Tonya Shirey told DHS interviewers that Lance told her he thought it could have been a patch.

Lance Shirey told investigators he found a chewed gel patch in Armstrong’s hand between 8 and 8:30 p.m. and that the patient was slumped over. Armstrong was then put to bed unresponsive.

An aide said she and Lance and Tonya Shirey went into Armstrong’s room at 10 p.m. to change him due to a leaking catheter bag and noticed his breathing was hard and raspy and that bubbles were coming out of his mouth. The aide and Tonya Shirey discussed calling 911. The aide couldn’t find a fentanyl patch on Armstrong’s body and found a patch in his mouth, but it was erroneously believed it to be a nicotine patch.

At 1 a.m., the aide said he did not seem to be breathing and had a weak pulse. She woke Lance and Tonya Shirey, placed Armstrong on the floor and gave CPR. Medical responders stopped their rescue attempts at 1:44 a.m.

DHS said Tonya Shirey told them they had problems keeping track of Armstrong’s fentanyl patches. Investigators said they also detailed other problems with medication logs.

A doctor from Pennsylvania Toxicologists P.C. told investigators it was “gross negligence” that the personal care home failed to initiate an emergency response when he was first found unresponsive at 8 p.m. and again at 10 p.m.

The Chicago Tribune reported the significant fine totaling more than $100,000 from Continental Nursing & Rehabilitation Center nursing home after five residents overdosed on heroin inside the facility.   The residents were hospitalized and recovered, but at least two used heroin again hours after they were returned to the facility, even though they were supposed to be on close watch.  One of the two overdosed again.

The facility failed to properly monitor and treat residents with drug addictions in violation of federal and state regulations.  In addition to the overdose incidents, police were called to Continental in October 2015 when residents alerted staff to narcotics abuse inside the facility. Staff searched rooms and recovered paraphernalia for cooking and shooting drugs that they turned over to police, records show.

In a brief interview with the Tribune, Continental part-owner Moishe Gubin said he was not aware of any heroin overdoses or other problems at the facility. Continental is part of a rapidly growing, South Bend, Ind.-based nursing home operation that includes more than 50 facilities in eight states, records show.

The complex ownership and management structures employed by Gubin and his partner Michael Blisko attempt to absolve them of responsibility and accountability according testimony they gave in civil lawsuits. Gubin and Blisko own a combined 75 percent of the company operating Continental.  Continental and other facilities pay a separate consulting company solely owned by Gubin and Blisko to offer suggestions about management, nursing, billing and payroll practices.

The facility buildings are owned by subsidiaries of the partners’ real estate investment trust, called Strawberry Fields. Registered in the British Virgin Islands, Strawberry Fields recently raised $68 million on the Tel Aviv Stock Exchange to expand operations with a goal of growing by 50 percent a year, according to its public statements.

 

The Belleville News Democrat had an article about Trisha Cleveland, a nursing home employee that pled guilty after she was arrested for making false reports to get hydrocodone at a local nursing home.  Police said the Medicaid Fraud Control Bureau had been contacted in April by staff at Four Fountains Convalescent Center  regarding allegations that Cleveland diverted hydrocodone. According to their investigation, Cleveland falsely reported requests by residents for their prescribed, “as needed,” hydrocodone. Police said the residents had never asked for the medication, and that Cleveland was getting hydrocodone “for her own personal use.”

Cleveland faced one count of unlawful possession of a controlled substance in St. Clair County. The case was referred to the Attorney General’s Medicaid Fraud Bureau for prosecution, and Cleveland was sentenced to two years of felony probation and 30 hours of community service.

Hydrocodone, an opioid, is considered a Schedule II narcotic, according to the Drug Enforcement Administration.

 

The District Sentinel reported on the U.S. Department of Justice’s settlement with OmniCare, Inc. which is the nation’s largest nursing home pharmacy making billions a year.  OmniCare will pay $28 million for its role in a massive kickback scheme perpetrated by drug manufacturer Abbott Laboratories dating back six years.

“Omnicare solicited and received kickbacks from Abbott in exchange for recommending that physicians prescribe Depakote, an anti-epileptic drug manufactured by Abbott, to elderly nursing home residents,” The DOJ detailed in a press release.

Omnicare Inc. was caught accepting direct payments, lavish vacations, and sports tickets from Abbott often times disguised as “grants” or “educational funding.” The drug manufacturer also financed Omnicare’s management meetings on Amelia Island, Fla.  Abbott also gifted sporting event tickets to Omnicare executives.

Abbott Laboratories had already agreed to pay $1.5 billion in 2012 to settle civil and criminal charges stemming from its kickback operations with several pharmacies.  The allegations against Abbott Laboratories were first lodged by former employees at the company, Richard Spetter and Meredith McCoyd. Since the prior lawsuits were filed under whistleblower provisions of the False Claims Act, McCoyd will receive $3 million from the federal share of the settlement with Omnicare.

“It is disturbing that any health care corporation would pay kickbacks that corrupt the professional medical decision making process in order to pad their profits,” said Nicholas DiGiulio, the Special Agent in Charge of the Department of Health and Human Services Office of Inspector General (HHS OIG).

This is not the first time OmniCare was involved in a kickback scheme.  See prior blog here.

 

The L.A. Times had a remarkable article on the dangers of opiod drugs.  Over the last 20 years, more than 7 million Americans have abused OxyContin, according to the federal government’s National Survey on Drug Use and Health.  Oxycontin is blamed for setting off the nation’s prescription opioid epidemic, which has claimed more than 190,000 lives from overdoses involving OxyContin and other painkillers since 1999.  Before OxyContin, doctors had viewed narcotic painkillers as dangerously addictive and primarily reserved their long-term use for cancer patients and the terminally ill. Purdue envisioned a bigger market.

Purdue Pharma launched OxyContin two decades ago with a bold marketing claim: One dose relieves pain for 12 hours, more than twice as long as generic medications.  One OxyContin tablet in the morning and one before bed would provide “smooth and sustained pain control all day and all night.”  OxyContin became America’s bestselling painkiller, and Purdue reaped $31 billion in revenue.  OxyContin is a chemical cousin of heroin, and when it doesn’t last, patients can experience excruciating symptoms of withdrawal, including an intense craving for the drug.  The problem offers insight into why people become addicted to OxyContin, one of the most abused pharmaceuticals in U.S. history.

OxyContin’s impact on the practice of medicine was similarly transformative. Other drug companies began marketing their own narcotic painkillers for routine injuries. By 2010, one out of every five doctor’s visits in the U.S. for pain resulted in a prescription for narcotic painkillers, according to a Johns Hopkins University study.  OxyContin accounted for a third of all sales revenue from painkillers that year, according to industry data.

The L.A. Times investigation found:

  • Purdue has known about the problem for decades. Even before OxyContin went on the market, clinical trials showed many patients weren’t getting 12 hours of relief. Since the drug’s debut in 1996, the company has been confronted with additional evidence, including complaints from doctors, reports from its own sales reps and independent research.
  • The company has held fast to the claim of 12-hour relief, in part to protect its revenue. OxyContin’s market dominance and its high price — up to hundreds of dollars per bottle — hinge on its 12-hour duration. Without that, it offers little advantage over less expensive painkillers.
  • When many doctors began prescribing OxyContin at shorter intervals in the late 1990s, Purdue executives mobilized hundreds of sales reps to “refocus” physicians on 12-hour dosing. Anything shorter “needs to be nipped in the bud. NOW!!” one manager wrote to her staff.
  • Purdue tells doctors to prescribe stronger doses, not more frequent ones, when patients complain that OxyContin doesn’t last 12 hours. That approach creates risks of its own. Research shows that the more potent the dose of an opioid such as OxyContin, the greater the possibility of overdose and death.
  • More than half of long-term OxyContin users are on doses that public health officials consider dangerously high, according to an analysis of nationwide prescription data conducted for The Times.

The U.S. Justice Dept. launched a criminal investigation, and in 2007 the company and three top executives pleaded guilty to fraud for downplaying OxyContin’s risk of addiction. Purdue and the executives were ordered to pay $635 million. The case centered on elements of Purdue’s marketing campaign that suggested to doctors that OxyContin was less addictive than other painkillers.

While Purdue’s litigators were working in courthouses around the country to fend off civil suits, its regulatory attorneys in Washington, D.C., made a blunt admission to the FDA: The 12-hour dosing schedule is about profits.

The Boston Globe reported on the tragic and preventable death of Kenneth “Bubba” Levesque who was taking medicine to quell his cravings for heroin when he entered Braemoor Health Center last summer. Infections had forced the amputation of his lower left leg, and he needed help learning how to walk again with a prosthetic limb.

Levesque went back and forth between addiction and recovery many times over the years, and told his family that this was his wake-up call, that he was finally going to “get clean” while in the Brockton nursing home.  The employees did not consider his addiction.  Levesque’s family were repeatedly rebuffed when they asked nurses at Braemoor Health Center about the powerful narcotics Levesque was receiving.

“I got into an argument with the lady who discharged him because they were sending him onto the street with nothing. No [addiction] counseling, nothing,” his sister, Robin Levesque, said.

“We begged them for a place for Kenny to go when he was coming home,” Levesque said. “And they said, ‘I don’t know what to tell you. Go to the emergency room.’ ”

Three days after Levesque was discharged from Braemoor in March, the 43-year-old was dead from an opioid overdose, a grim ending to his stay at the nursing home. He was negligently provided escalating doses of opioid medications and no substance abuse counseling.  Most people do not understand how prescribed opiods are quite similar to heroin. Even as regulators and health experts have launched myriad initiatives to combat the opioid crisis and educate nursing home of the dangers of opiods.

Few nursing homes are prepared to identify and treat residents with a history of substance abuse, and services to care for such patients have typically not been a priority, say addiction and long-term care specialists.

“The addiction crisis is going to be in patients in every demographic, and it behooves nursing homes to learn how to take care of [these] patients,” said Dr. Sarah Wakeman, medical director of the substance use disorder initiative at Massachusetts General Hospital.

A June report from the federal Office of Inspector General found that millions of older Americans received prescriptions for commonly abused opioids last year through Medicare, the government insurance program for people over 65.

Nearly one-third of beneficiaries getting prescriptions through Medicare received at least one of these drugs. And on average, these patients each had five opioid prescriptions in 2015, the report concluded.