“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
A multi-state class action complaint filed March 23 in federal court in Chicago accuses Walgreens of fraud, negligent misrepresentation and unjust enrichment in relation with the way it prices prescription drugs.
Named plaintiffs Dorothy Forth, Troy Termine, Cynthia Russo and the International Brotherhood of Electrical Workers Local 38 Health and Welfare Fund accused Walgreens of a “fraudulent and deceptive price scheme to artificially inflate the ‘usual and customary’ prices reported and used to charge” themselves and putative class members for generic drugs. The lawsuit doesn’t specify how much the plaintiffs believe Walgreens has allegedly overcharged, saying only that the amount in controversy exceeds the procedural threshold of $5 million.
According to the complaint, likely millions of individual customers who use health insurance to buy generic prescription drugs from Walgreens are paying more for certain drugs than cash-paying Walgreens customers enrolled in the company’s Prescription Savings Club, which is not a form of health insurance.
The complaint cites a Generic Pharmaceutical Association report indicating 89 percent of all prescriptions dispensed in the U.S. now are generic drugs. The plaintiffs also maintain pharmacies are not allowed to charge customers or third-party payors more for prescription drugs than its usual price.
Under the PSC, customers without insurance can buy prescription generics in tiers — $5, $10 and $15 for 30-day supplies and $10, $20 and $30 for 90-day supplies. The pricing package, per the complaint, “includes some of the most commonly used generics for cardiovascular, diabetes, pain, psychiatric illnesses, gastrointestinal disorders and other common ailments.
The complaint alleges Walgreens breaks the law by artificially inflating prices for generics on reimbursement claims submitted to third-party payors, such as Medicare, Medicaid and private insurers. The practice allegedly dates to 2007, and the action seeks either nationwide class certification or for action to be brought under fraud laws of Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Louisiana, Minnesota, Missouri, Nevada, North Carolina, Ohio, Texas and Wisconsin.
Forth, of Texas, said she bought more than 20 generic medicines at Walgreens since 2012 using Medicare Part D coverage. She said she’s overpaid at least $285 compared to what she believes she would have paid if she’d used cash and participated in the PSC. Russo, of Florida, also uses Medicare Part D and said she overpaid by $130 since 2012. Termine, of Lousiana, had a Humana policy and said he overpaid by $8 — $7.15 for one 30-day prescription and $10.89 for another, both $5 tier one drugs under the PSC. IBEW Local 38 has beneficiaries in the 15 states named in the action.
The complaint incorporated a table showing drug prices in Suffolk County, N.Y., Orlando, Fla., and Philadelphia, at Walmart, Target, Shoprite and Winn-Dixie, contrasted with the usual and customary prices Walgreens submits to third-party payors, and the PSC cash price it charges. It argues against any tolling of statute of limitations, noting that “because Walgreens affirmatively concealed its pricing scheme, plaintiffs and the class had no knowledge until recently of the alleged fraudulent activities or information which would have caused a reasonably diligent person to investigate whether Walgreens committed the actionable activities detailed herein.”
In addition to class certification and a jury trial, the plaintiffs seek monetary, compensatory, consequential, statutory treble, punitive or exemplary and general damages and injunctive relief. They say all class members “are owed at least the difference between the amount they paid and the (usual and customary) offered to the general public. “
The plaintiffs sent a copy of their complaint to attorneys general in Illinois, Louisiana and Missouri.
Representing the plaintiffs in the action are Halunen Law, of Minneapolis; Scott+Scott, Attorneys at Law, LLP, of Colchester, Conn., and New York; Lemmon Law Firm LLC, of Hahnville, La.; Whitfield, Bryson & Mason, LLP, of Raleigh, N.C.; Brandner Law Firm, LLC, of New Orleans; and Tusa P.C., of Southold N.Y.
Former addict Miller Atkinson remembers when fentanyl-laced heroin hit the streets in Cincinnati: “It started trickling in, and we were like ‘Wow, that was good, we need to get more of that.’”
CINCINNATI, OHIO—Miller Atkinson was an addict from the very first time he shot up with heroin. “I fell in love with it. Everything else fell to the wayside,” says the 24-year-old. “There was nothing that could have stopped me from getting high.”
And that’s what he did every day, for 9 months, in his family’s upper middle class neighborhood in this Midwestern city. He dropped out of the University of Cincinnati. Like other users, he built up a tolerance to heroin and needed larger doses to find euphoria. Then, about 4 years ago, a powerful new combination hit the streets here: heroin cut with fentanyl, a synthetic opiate about 100 times more potent than morphine that’s used to alleviate pain during and after surgery and in late-stage cancers. “It started trickling in, and we were like, ‘Wow, that was good, we need to get more of that,’” he says. “It was more intense.” So much so that friends who shot up with fentanyl-laced heroin started dying.
Atkinson was one of the lucky ones. After several misdemeanors and a felony heroin possession charge, he got his life back on track, and he is now studying for the law school entrance exam.
Fentanyl and its analogs are new faces of a worsening scourge. The United States consumes 85% of all the world’s natural and synthetic opiates, which in 2015 factored in 33,091 U.S. deaths, up more than 4000 from the previous year, according to the U.S. Centers for Disease Control and Prevention. Opioid overdoses have quadrupled since 1999. When average U.S. life expectancies for men and women edged downward last year, for the first time in decades, many health professionals blamed opiate abuse.
The opium poppy is no longer the starting point for many of the opiates on the street. The new compounds, often sold mixed with heroin, originate in illicit labs in China. “For the cartels, why wait for a field of poppies to grow and harvest if you can get your hands on the precursor chemicals and cook a batch of fentanyl in a lab?” says Tim Reagan, resident agent in charge of the U.S. Drug Enforcement Administration’s (DEA’s) Cincinnati office.
Two milligrams of fentanyl—just a few grains clinging to a sample vial—is a lethal dose.
AP PHOTO/CLIFF OWEN
DEA classified fentanyl as a schedule II drug decades ago, which makes it a felony to sell or use the opiate without a prescription. But in China, until recently, fentanyl was largely unregulated. In late 2015, the drug agency persuaded its Chinese counterpart to add 116 synthetic drugs to its list of controlled substances; fentanyl and several analogs were included. In response, underground Chinese labs began tweaking the fentanyl molecule, which is easy to alter for anyone with basic knowledge of chemistry and lab tools. By adding chemical groups, unscrupulous chemists have created new, unregulated variants, some of them even more potent than the original.
Public awareness of the crisis spiked last spring, after music icon Prince’s death from an overdose of fentanyl. But in the months since then, the chemical one-upmanship has deepened the opiate crisis, as new and nastier substances appear on the streets in places like Cincinnati. The fentanyl derivatives not only allow makers and dealers to elude law enforcement; they blindside public health authorities and make addiction even riskier. “It’s just going to get worse,” Reagan says.
Last July, police and scientists here were bracing for a new villain—perhaps the deadliest fentanyl cousin yet. “We were hearing about something so dastardly we had to be prepared,” recalls Lakshmi Sammarco, the coroner for Hamilton County, which includes Cincinnati. Carfentanil, an elephant tranquilizer that apparently had never been studied in humans, was showing up mixed into heroin in nearby cities and felling addicts. That month, a Canadian man was arrested in Calgary after authorities intercepted a 1-kilogram package of carfentanil labeled as “printer accessories,” which he had ordered from China. Other synthetic opiates had found their way into Ohio via Canada, so it was only a matter of time before carfentanil would make the journey as well. “We all looked at each other and said, ‘Alright, buckle your seat belts, this is going to get very bumpy,’” Sammarco says.
Fentanyl crosses the blood-brain barrier with ease. It binds to opioid receptors and floods the brain with dopamine, which creates intense euphoria but also slows the heart and depresses breathing. For most individuals, a lethal fentanyl dose is about 2 milligrams—an amount so minuscule that in a test tube it looks like a few grains of salt clinging to the glass. Carfentanil is 100 times stronger, making it about 10,000 times more potent than morphine. Crime labs keep autoinjectors of naloxone, the lifesaving opioid receptor antagonist, within reach in case their personnel are accidentally exposed to synthetic opiates.
Realizing what they were facing, Sammarco and her colleagues shifted into crisis mode, warning first responders that carfentanil overdoses could require double or triple doses of naloxone. They cautioned users not to dose up alone, and banned cops and emergency crews from testing drugs at crime scenes. (Last September, 11 police in Connecticut fell ill after accidentally inhaling fentanyl that was kicked up into the air during a drug bust.)
Then, the bomb went off. Over 6 days in late August 2016, Hamilton County saw 176 drug overdoses, primarily from carfentanil, the coroner’s office says. After the initial shock wave, use of the drug ebbed—it was simply too powerful and dangerous for addicts and dealers looking to make a quick profit. “We get a little bit of breathing room,” Sammarco says. “But we’re always waiting for the other shoe to drop.”
Hoping to stem the tide of synthetic opiates, DEA has taken the fight to China, as prolific a maker of illicit drugs as it is of legitimate chemicals. According to a U.S.-China Economic and Security Review Commission report last month, “China is a global source of illicit fentanyl and other [new psychoactive substances] because the country’s vast chemical and pharmaceutical industries are weakly regulated and poorly monitored.” In response to U.S. pressure, China has scheduled fentanyl and several other derivatives.
But enforcement is tough. Chinese labs producing the synthetic opiates play hide-and-seek with authorities. On their websites, they list fake addresses in derelict shopping centers or shuttered factories, and use third-party sales agents to conduct transactions that are hard to trace. The drugs themselves are easy to find with a Google search and to buy with a few mouse clicks. A recent check found more than a dozen Chinese sites advertising fentanyl, carfentanil, and other derivatives, often labeled as “research chemicals,” for sale through direct mail shipments to the United States. On one website, carfentanil goes for $361 for 50 grams: tens of thousands of lethal doses.
The cat-and-mouse game extends to chemistry, as the makers tinker with fentanyl itself. Minor modifications like adding an oxygen atom or shifting a methyl group can be enough to create whole new entities that are no longer on the list of sanctioned compounds. Carfentanil itself was, until recently, unregulated in China.
The coroner’s office in Cincinnati overflows with work. Lab analysts have set up shop in makeshift office spaces in the hallway. They are coping with a months-long case backlog created by the waves of new opiates washing into the region. In Hamilton County, as in many other jurisdictions, drug dealers can be charged with manslaughter when a customer overdoses and dies, but prosecutors can’t charge a dealer without verifying what he sold. To confirm that victims have overdosed on illegal opiates and to support prosecution of drug dealers, Sammarco’s team must parse the chemical composition of seized samples.
Other users can’t help, as they generally “don’t know what they’re taking,” says Tom Fallon, a lead investigator with the Hamilton County Heroin Task Force. A computer readout of one sample in the crime lab here illustrates why. The batch includes heroin, of course, but also caffeine, an antihistamine, an unidentified fentanyl compound, carfentanil, and another nasty analog, furanylfentanyl. Some recently seized batches have also been laced with ketamine, an anesthetic that has gained popularity in China as a recreational drug.
When the carfentanil wave struck, the county lab scrambled to prepare its analytical tools. One challenge was simply finding samples to compare to seized material. Veterinarians no longer use the substance, and commercial labs don’t stock it. Eventually the coroner’s office procured an expired batch from a nearby zoo. By October 2016, the county toxicology lab had fine-tuned its testing of blood and urine samples using a gas chromatograph mass spectrometer, which can find carfentanil at its smallest detectable dose. The machine shears mystery molecules into fragments, weighs them, and compares the pattern of masses to those from a known molecule. Like splitting Lego creations, breaking up the molecules produces the same pattern each time.
Canadian police seized these printer ink bottles from China full of carfentanil, which is 10,000 times more potent than morphine.
ROYAL CANADIAN MOUNTED POLICE
Another challenge with carfentanil is the dearth of literature on how much would cause a human to overdose or die, explains Bob Topmiller, Hamilton County’s toxicologist. First responders and crime lab chemists are now building a body of research on its effects. “We’re not a research lab,” he says, “but there’s a lot of information we’ve been able to obtain over the last several months that we’ve been able to share with other labs,” such as molecular structures and toxicology reports.
Like other regions around the United States coping with a tide of mystery opiates, Hamilton County gets help identifying the compounds from DEA’s own facilities, including the Special Testing and Research Laboratory, a plain building in an industrial development in Sterling, Virginia. In contrast to the Hamilton County coroner’s office, the Sterling lab is brightly lit and uncluttered. Director Jeffrey Comparin and his team have at their disposal an arsenal of detection and chemical dissection tools for identifying unknown drugs. “It’s not uncommon for us to build up a molecular model from scratch as we go,” he says. A DEA chemist demonstrates by snapping a methyl group onto a plastic model of fentanyl.
China eventually banned methylfentanyl, driving down its production and pushing it deeper underground. Its crackdown on fentanyl and several analogs in 2015 led to a marked decline in those synthetic opiates in the United States, DEA says. And last month, after extensive negotiations with DEA, China added carfentanil and three more fentanyl analogs to its list of controlled substances.
Even before China scheduled carfentanil, the scourge had begun to fade in Ohio. Sammarco expects the final toll from that analog in Hamilton County last year, after all analyses are completed, will top 70 deaths. But a new threat has appeared. Traces of an unidentified fentanyl analog have cropped up in several batches from crime scenes. Hamilton County’s scientists will search for a molecular match, add it to the list—and hope the new wave is less deadly than the last.
The Drug Enforcement Administration takes billions of dollars in cash from people who are never charged with criminal activity, according to a report issued today by the Justice Department’s Inspector General.
Since 2007, the report found, the DEA has seized more than $4 billion in cash from people suspected of involvement with the drug trade. But 81 percent of those seizures, totaling $3.2 billion, were conducted administratively, meaning no civil or criminal charges were brought against the owners of the cash and no judicial review of the seizures ever occurred.
That total does not include the dollar value of other seized assets, like cars, homes, electronics and clothing.
These seizures are all legal under the controversial practice of civil asset forfeiture, which allows authorities to take cash, contraband and property from people suspected of crime. But the practice does not require authorities to obtain a criminal conviction, and it allows departments to keep seized cash and property for themselves unless individuals successfully challenge the forfeiture in court. Critics across the political spectrum say this creates a perverse profit motive, incentivizing police to seize goods not for the purpose of fighting crime, but for padding department budgets.
Law enforcement groups say the practice is a valuable tool for fighting criminal organizations, allowing them to seize drug profits and other ill-gotten goods. But the Inspector General’s report “raises serious concerns that maybe real purpose here is not to fight crime, but to seize and forfeit property,” said Darpana Sheth, senior attorney of the Institute for Justice, a civil liberties law form that has fought for forfeiture reform.
The Inspector General found that the Department of Justice “does not collect or evaluate the data necessary to know whether its seizures and forfeitures are effective, or the extent to which seizures present potential risks to civil liberties.”
In the absence of this information, the report examined 100 DEA cash seizures that occurred “without a court-issued warrant and without the presence of narcotics, the latter of which would provide strong evidence of related criminal behavior.”
Fewer than half of those seizures were related to a new or ongoing criminal investigation, or led to an arrest or prosecution, the Inspector General found.
“When seizure and administrative forfeitures do not ultimately advance an investigation or prosecution,” the report concludes, “law enforcement creates the appearance, and risks the reality, that it is more interested in seizing and forfeiting cash than advancing an investigation or prosecution.”
The scope of asset forfeiture is staggering. Since 2007 the Department of Justice’s Asset Forfeiture Fund, which collects proceeds from seized cash and other property, has ballooned to $28 billion. In 2014 alone authorities seized $5 billion in cash and property from people — greater than the value of all documented losses to burglary that year.
In most of the seizures examined by the Inspector General, DEA officers initiated encounters with people based on whether they met certain criteria, like “traveling to or from a known source city for drug trafficking, purchasing a ticket within 24 hours of travel, purchasing a ticket for a long flight with an immediate return, purchasing a one-way ticket, and traveling without checked luggage.”
Some of the encounters were based on tips from confidential sources working in the travel industry, a number of whom have received large sums of money in exchange for their cooperation. In one case, officers targeted an individual for questioning on a tip from a travel industry informant that the individual had paid for a plane ticket with a pre-paid debit card and cash.
Most individuals who have cash or property seized by law enforcement do not dispute the seizure. There’s no right to an attorney in forfeiture proceedings, meaning defendants must foot the bill for a lawyer themselves. In many cases, forfeiture amounts are so small that they’re not worth fighting in court.
While criminal proceedings assume the defendant’s innocence, forfeiture proceedings start from the presumption of guilt. That means that individuals who fight forfeiture must prove their innocence in court.
For these reasons, many defendants don’t bother disputing forfeitures. The Inspector General’s report, however, finds that those who do often get at least a portion of their cash returned. Only one-fifth of people who had their cash seized by the DEA disputed the seizures in court. But among those who contested the seizure, nearly 40 percent ended up getting all or some of their cash returned, suggesting that the DEA’s forfeiture net ensnares many individuals not involved in wrongdoing.
In a written response to the Inspector General, the Department of Justice said it had “significant concerns” with the report, noting that global criminal enterprises launder trillions of dollars annually and calling asset forfeiture “a critical tool to fight the current heroin and opioid epidemic that is raging in the United States.”
It also took issue with the Inspector General’s analysis of the 100 DEA cash seizures it examined, saying more of them were connected with criminal activity than the report suggested.
The Inspector General stood by the report and dismissed the Department’s concerns as “assumptions and speculation.” The Drug Enforcement Administration did not respond to a request for comment.
“Nobody in America should lose their property without being convicted of a crime,” said the Institute for Justice’s Sheth. “If our goal is to curb crime, we should simply abolish civil forfeiture” and only forfeit property after a criminal conviction is obtained, she added.
AUGUSTA, Maine — Two midcoast men who suffer from chronic pain informed state officials on Tuesday that they intend to sue over a new law that limits opiate prescriptions in an effort to stem Maine’s addiction crisis if it isn’t changed.
The threatened lawsuit from lobster wholesaler Brian Rockett of Owls Head and roofer Eric Wass of Rockland could undo a law that their lawyer called an unreasonable violation of federal law. He has argued that it’s unclear whether they’re exempt from the law.
The bill passed the Maine Legislature last year with support from Gov. Paul LePage and the medical community. A spokeswoman for the Maine Department of Health and Human Services said exceptions in the law allow for individualized treatment.
Elements of the law took effect in January, but the biggest piece begins in July, when Mainers will be limited to 100 morphine milligram equivalents of opiate medication such as hydrocodone per day, with exceptions for cancer patients, those in palliative and hospice care and other special circumstances.
Most people above that mark have to be tapered down by July under the limit, one of Maine’s key policy moves last year to address the state’s opiate addiction crisis. Drug overdoses killed 378 people in 2016, setting a record for the third straight year since 2014.
In a Tuesday letter to the Maine Department of Health and Human Services notifying the state of Rockett and Wass’ intent to sue, their lawyer, Patrick Mellor, said the taper has already caused “significant bodily harm” to both men and will make them unable to work and “participate in basic life activities.”
WLBZ reported that the two men have degenerative disc disease. Before the taper, Rockett told the station that he was taking 450 morphine milligram equivalents of medication. In an interview, Mellor said his clients “are not going to be able to function” if this continues.
The men plan to seek an injunction if rules are implemented as proposed by the department, arguing that they are subject to provisions of the federal Americans With Disabilities Act and Rehabilitation Act of 1973, which allows people with disabilities to seek reasonable accommodations in policies and procedures.
Final rules for the law are set to be released on Friday and whether Rockett and Wass are subject to exemption is up for debate: In a letter to Maine legislators in February, Mellor wrote that while his clients may qualify for special treatment for palliative care or another exemption, it’s “unclear,” calling for a specific carve-out for people with chronic pain.
“There’s no villains here,” Mellor said. “We’re looking to work with the Department of Health and Human Services and the legislators to get something productive done.”
Department of Health and Human Services spokeswoman Samantha Edwards said in a statement that the state “recognizes the insidious nature of chronic pain” and in cases of chronic pain, the palliative exemption “would meet the spirit and letter of the law” and allow for individualized care.
Recently I met with a woman, a casualty of our nation’s clumsy efforts to curb its opioid crisis. Her story shows how a myopic fascination with numeric targets, which caused so much harm as our prescribing went up, is likely to cause just as much harm as it comes back down.
A 60 year-old kidney transplant recipient, she required a slew of medications to protect her transplanted kidney. She also took over 100 milligrams daily of an opioid for painful arthritis. Amid national calls to reduce opioid prescriptions, one doctor after another lowered her doses in simple 50 percent steps.
None of them documented any problem caused by her pain pills. None sought her consent. Predictably, she fell apart, as did her adherence to other medications, including ones to protect her kidney. Life spiraled out of control. Ultimately, the threat of losing her kidney compounded the uncontrolled pain of her arthritis. Whether she will keep her costly transplant, or go back on dialysis, is not yet known.
Clumsy new opioid policies are practically designed to ensure her story is not unique. The pressure on physicians is already intense. It comes from legislators, law enforcement, insurers, and leaders who equate prescribed opioids with illicit heroin.
Accordingly, doctors cut doses unilaterally and shun pain patients. Last month, two national agencies entered the fray, with the National Committee for Quality Assurance and the Centers for Medicare and Medicaid Services proposing escalate the pressure. One (CMS), will restrict insurance coverage based on dose. The other (NCQA), proposed a quality measure to flag physicians as engaged in bad practice if they let doses remain high, regardless of how well or poorly the patient is doing.
It will surprise many to learn that such plans were not endorsed by the Centers for Disease Control and Prevention (CDC) in 2016, whose review found no data to support the unilateral dose reductions that CMS and NCQA will incentivize.
In its 7th recommendation, the CDC urged that care of patients already receiving opioids be based not on the number of milligrams, but on the balance of risks and benefits for that patient. That two major agencies have chosen to defy the CDC ignores lessons we should have learned from prior episodes in American medicine, where the appeal of management by easy numbers overwhelmed patient-centered considerations.
In years past, we erred when observational data led agencies such as NCQA to demand strict control of blood sugar in all diabetes patients. Subsequent trials showed that harmed many patients, and helped only some. Similarly, millions of postmenopausal women were thrown onto estrogen because observational data suggested it prevented heart attacks. Later trials showed we were causing heart attacks, not preventing them.
Even the run-up in opioid prescribing emerged from an unhealthy enchantment with a single number, the pain score, at the expense of common sense. The cardinal lesson is this: prior to imposing simple numeric targets on all patients, we should require prospective trials showing benefit. That’s what we lack for unilateral opioid dose reductions.
As physicians today execute a hard shift on opioids, I plead for caution. Patients with chronic pain report enormous suffering, some committing suicide as they see their lives turned upside down by doctors pressured to reduce.
A rising tide of concern has emerged among academic physicians who have dedicated their work to fighting addiction, including some who worked on the CDC Guideline itself. They see that clinical practice has sprung ahead of data, that it has begun to look like someone has shouted fire in a crowded theater, creating a social stampede. This does not reflect the cautious, patient-centered care urged by the CDC.
To be sure, unrestrained opioid prescriptions are dangerous. A run-up in prescribing from 2000 through 2011 fueled a spread of addiction and overdose, sometimes to pills we prescribed, and often to opioids illicitly distributed. In 2015, 33,091 Americans died from overdose. The percentage of patients prescribed an opioid who develop addiction is hard to pin down, but the CDC estimates 0.7 percent (at lower doses) to 6.1 percent (at higher doses).
Without oversight and guidelines urging caution, more will be harmed. However, this prudent check on uncontrolled prescriptions need not create a whole new population of chronic pain patients who suffer from overly-prescriptive and oversimplified recommendations that force all prescriptions below a uniform milligram limit.
Eighty professionals, including four who worked on the CDC Guideline, signed a public letter to NCQA, raising the alarm about this entirely predictable downside of new dose-curtailing policies, as did 83 who signed a letter to CMS a few weeks ago.
Among them were leading scholars in addiction medicine, pain and health care quality improvement. We can listen to these experts, or we can let more patients suffer. Now is a good time to remember how easy numbers sometimes make for bad care.
Stefan G Kertesz, MD, is a physician in internal medicine and addiction medicine on faculty at the University of Alabama at Birmingham School of Medicine. Views expressed are his own and do not represent formal positions held by any of his employers. Follow @StefanKertesz.
SALT LAKE CITY — The American Civil Liberties Union and Utah state officials are arguing that a judge’s recommendation to allow the Drug Enforcement Administration to do warrantless searches of a prescription drug database violates people’s privacy rights, the ACLU said Monday.
Safeguards are needed for a database that contains records of prescriptions for medication like the anti-anxiety drug Xanax and the sleep aid Ambien as well as prescription painkillers, the ACLU said in a statement.
The DEA counters that access is an important tool in the early stages of the agency’s investigations.
The ACLU filed its objection Friday to a recommendation earlier this month from U.S. Magistrate Judge Dustin Pead. He said the DEA should have access to a database already in government hands.
“ACLU’s arguments are akin to a criminal defendant suggesting that the federal government must seek a warrant to obtain a defendant’s records from local police,” Pead wrote on March 13.
ACLU attorneys called that parallel off target in its reply.
“A better analogy would be to the contents of students’ private emails stored on a state university’s servers; though such files are held by a government entity, surely that fact alone does not divest them of protection under the Fourth Amendment,” they wrote in a court filing.
Utah state officials also objected to Pead’s recommendation in a separate court filing, pointing to ACLU’s reasoning.
U.S. District Judge David Nuffer will decide whether to accept the recommendations.
More than 40 states keep similar databases, but Utah recently passed a law requiring investigators to get a warrant before they search it. Utah is among the minority of states that have that requirement.
The measure was passed after two firefighters said they were wrongly charged with prescription drug fraud after a wide-ranging search of the database.
They were charged after police investigating ambulance drug thefts ran hundreds of names through the system on a hunch that it might be an inside job.
The two men were not linked to the thefts, but their relatively high number of prescriptions raised suspicion and prosecutors filed fraud charges. The case was later dropped, but still put their careers and personal lives at risk, they said.
The Utah firefighters union and a state gay-rights group joined the ACLU in the lawsuit.
The firefighters’ union said it is sympathetic to the need to curb a nationwide problem with prescription drug abuse, but that police shouldn’t have unfettered access.
In the eyes of the Drug Enforcement Administration (DEA), not all weed is created equal.
When its grown and used in its natural plant form, marijuana is an illegal and highly addictive drug with no accepted medical value, according to the agency. But when a pharmaceutical company develops a synthetic marijuana product, the DEA is more open-minded.
Last week, the DEA approved Syndros, an oral solution that contains a synthetic version of THC, the main psychoactive ingredient in cannabis. That caught the attention of marijuana reform advocates because the drug company behind Syndros, Insys Therapeutics, contributed $500,000 to a committee that last year opposed marijuana legalization in Arizona.
Insys did not respond to a request for comment.
The approval of Syndros has also raised questions about the DEA’s standards for classifying drugs under federal law. Syndros earned a Schedule 2 classification, which is significantly less restrictive than marijuana’s Schedule 1 classification. The key difference between the two schedules concerns each drug’s medical value and potential for abuse, factors that are determined by the Food and Drug Administration (FDA).
The FDA approved Syndros on July 1, according to a press release from Insys. The agency claimed the synthetic marijuana product effectively treated nausea and vomiting among chemotherapy patients, and also treated weight loss associated with AIDS.
As for its potential for abuse, the DEA noted that Syndros “is similar to that of other THC containing products such as concentrates, infused edibles, and drinks” and “can be easily manipulated to other forms that can be easily abused through inhalation and oral routes of administration.”
DEA spokesperson Melvin Patterson confirmed in an interview with ATTN: that Syndros was granted a more lenient schedule because the FDA had determined the synthetic product had medical value, whereas the agency has denied marijuana’s therapeutic benefits. That’s in spite of numerous studies finding ample evidence that natural marijuana treats the same conditions as Syndros — nausea, vomiting, and weight loss.
The DEA appears to be shifting responsibility to the FDA — despite the fact the FDA has itself raised concerns over the DEA’s scheduling standards.
In September 2016, ATTN: obtained letters from the FDA through a public records request in which the agency advised the DEA to reevaluate its scheduling system, citing the difficulty of establishing marijuana’s medical value under the current “legal and regulatory framework.”
“It’s clearly absurd that DEA would approve Big Pharma’s marijuana product while keeping Mother Nature’s original version in Schedule I,” Marijuana Majority founder Tom Angell told ATTN:.
GREENWICH — A lawsuit has been filed by the parents of a Greenwich college student who died of a heroin overdose against the manufacturer of a prescription drug they claim led to his death.
Laurence and Michelle Allen are suing the makers of Suboxone, which was used to treat a previous addiction to painkillers that their son fell into following a car accident. When the Suboxone prescription ran out, according to court papers, Bradley Allen, 19, turned to street heroin and died of an overdose in 2014.
The lawsuit filed earlier this year in U.S. District Court seeks $100 million from Indivor, the company that makes Suboxone. The lawsuit by the Allens, and others like it, is adopting a number of strategies against the narcotics industry that recall efforts to force tobacco companies to pay for the death and disease caused by cigarettes in the 1990s.
Laurence Allen, an investment banker, confirmed his participation in the lawsuit and other efforts he is engaging in to combat the scourge of opioid-addiction, but he declined to discuss specifics.
Bradley Allen, his son, appeared to be on a path toward success until pain medication changed his life after a car accident in 2010, according to the lawsuit. His doctors prescribed hydrocodone for pain management, “and at some point into his prescribed opioid regimen, he became dependent on opioid-based medication.”
In order to wean him from painkillers, Allen was prescribed Suboxone, a common treatment protocol for opioid addiction. Suboxone mimics the effects of stronger opium-based drugs, but at a lower level of intensity, and it prevents users from experiencing painful withdrawal symptoms. The Allens contend that “Brad had become completely addicted to Suboxone … he replaced one addiction with another,” according to the lawsuit.
Bradley Allen attempted to end his Suboxone usage with an intensive in-patient program in December of 2013. After being released, he returned to his family’s Greenwich home. He watched a movie with his family one evening in late January, went upstairs and took heroin. His parents found him dead the next morning at their Maple Avenue residence. The Medical Examiner’s office found that the drug had been injected.
The lawsuit claims the drug maker was aware that its product was “unreasonably dangerous and defective when used as directed and as designed.” The Allens claim Invidor failed to “disclose to the medical community” that Suboxone could cause addiction.
Lawyers representing Invidor in the case, and the Invidor media office, did not respond to numerous requests for comment by phone and email.
The Allen lawsuit is one of a number of legal challenges that big pharmaceutical companies are contending with as opioid addiction continues to plague the nation, claiming the lives of some 40 Americans every day.
Two counties in California sued five of the world’s largest narcotics manufacturers in 2014 over costs incurred to public health, but the lawsuits did not advance due to jurisdictional issues. The city of Chicago is in litigation with a drug company, Pfizer, leading to some new marketing changes. The Chicago lawsuit revealed that the big players in the painkiller industry spent $288 million on marketing in 2011, three times the 2000 amount. A number of state legislatures, governors and attorneys-general are said to be weighing the possibility of lawsuits against pharmaceutical companies around the country, and large law firms are currently soliciting clients to sue big pharmaceuticals over drug overdoses.
It might seem like a repeat of the tobacco industry litigation that led to a $246 billion settlement and strict new marketing codes on cigarettes. But a legal expert said the claims against Big Pharma have a long way to go before they come close to achieving what the tobacco lawsuits did. As of yet there have been no major pay-outs or court victories by plaintiffs against drug companies.
Lawsuits like the one filed by the Allen family will likely have to overcome two hurdles, said Jeremy Zimmermann, a product-liability specialist and an adjunct professor at the Quinnipiac University School of Law.
“There’s the question of what warnings were given to the physicians. The pharmaceutical companies are responsible for giving appropriate warnings so they can responsibly prescribe (drugs) for patients,” he said. “The key phrase in product liability is: were the warnings inadequate, to such an extent that the drug itself would be considered ‘unreasonably dangerous?’ ”
Establishing a chain of causation is another key issue in litigation, according to Zimmermann.
“He died of an overdose of heroin — he didn’t die of an overdose of Suboxone,” he said. “The question is going to be — was he caused to take the heroin because of his use of Suboxone?”
That will be for a number of expert witnesses to argue over, should the case go to trial.
The tobacco-litigation comparison is too early to make, Zimmermann said. “It’s difficult to say whether there’s going to be success or not.”
Larry Allen is working on other fronts with help from http://www.drugguardians.com to fight opioid addiction, aside from litigation. He has established the Allen Research Endowment, a non-profit venture. A goal is to promote research into developing non-addictive pain medication. Allen said he is also interested in highlighting the link between politicians and donations from pharmaceutical companies through the years.
Bradley Allen was a student at Washington College in Maryland. He was a lover of the outdoors — a skier and a boater — who played guitar and took part in a number of community-service projects, according to obituary information.
I pulled the bottom quote from a large law firm’s website in Louisville, KY. The question has to be asked… isn’t some of the verbiage from this law firm’s website that describes pt abuse would also describe how many pts that have a medical necessity to be prescribed controlled substances are being treated by a variety of healthcare professionals.
Also the question has to be asked if pts in nursing home have more rights than the rest of the population receiving appropriate care from healthcare professionals ? Many pts especially those who are home bound are as sick or sicker than some of the pts residing in a nursing home.
Why are personal injury attorneys failing to represent all pts that are being abused/neglected ?
Common Indicators of Nursing Home Abuse or Neglect
“Abuse of a nursing home resident is the intentional infliction of physical, sexual, emotional, psychological, or financial harm. Neglect, which is a form of abuse, involves withholding food, shelter, health care, or protection that a vulnerable person depends on the nursing home staff to provide.”
A top official for the Centers for Disease Control and Prevention has acknowledged that prescription painkillers are no longer the driving force behind the nation’s so-called opioid epidemic.
In testimony last week at a congressional hearing, Debra Houry, MD, Director of the CDC’s National Center for Injury Prevention and Control, said that heroin and illicit fentanyl were primarily to blame for the soaring rate of drug overdoses.
“Although prescription opioids were driving the increase in overdose deaths for many years, more recently, the large increase in overdose deaths has been due mainly to increases in heroin and synthetic opioid overdose deaths, not prescription opioids. Importantly, the available data indicate these increases are largely due to illicitly manufactured fentanyl,” Houry said in her prepared testimony before the House Energy and Commerce Committee’s Oversight and Investigations Subcommittee.
While painkillers may be playing less of a role in the overdose epidemic, Houry believes pain medication is still a gateway drug for many abusers. She cited statistics from Ohio showing that nearly two-thirds of the people who overdosed on heroin or fentanyl received at least one opioid prescription in the seven years before their deaths.
“The rise in fentanyl, heroin, and prescription drug involved overdoses are not unrelated,” Houry said. “While most people who misuse prescription opioids do not go on to use heroin, the small percentage (about four percent) who do account for a majority of people recently initiating heroin use.”
Houry also disputed reports that efforts to reduce opioid prescribing have led to increased use of illegal drugs. It was her office that oversaw the development of controversial CDC guidelines that discourage doctors from prescribing opioids for chronic pain.
DEBRA HOURY, MD
“Some have suggested that policies meant to limit inappropriate opioid prescribing have led to an increase in heroin use by driving people who misuse opioids to heroin,” Houry testified. “Recent research, however, has indicated otherwise. One study found that the shift to heroin use began before the recent uptick in these policies, but that other factors (such as heroin market forces, increased accessibility, reduced price, and high purity of heroin) appear to be major drivers of the recent increases in rates of heroin use.”
The “recent research” Houry cited was a report published in the New England Journal of Medicine in January, 2016 – a full two months before the CDC opioid guidelines were even released. She offered no evidence to support her claim that the guidelines were having no impact on heroin use.
Some Patients Turning to Illegal Drugs
According to a recent survey of over 3,100 patients by Pain News Network and the International Pain Foundation, the CDC guidelines have reduced access to pain care, harmed many patients and caused some to turn to illegal drugs for pain relief.
Over 70 percent said their opioid doses have been reduced or cutoff by their doctors in the past year. And one out of ten patients (11%) said they had obtained opioids illegally for pain relief since the guidelines came out.
“The one person I know who says the recent guidelines have helped (is) my neighbor who is a heroin dealer. He says business has quadrupled since doctors have started becoming too afraid to help people in pain,” one patient wrote.
“This has caused me far more pain and suffering in my life, and increased my stress and anxiety, and depression, because nobody seems to care that I suffer like this,” said another patient. “This has also caused me to turn to using heroin, because I have nothing left now at this point and cannot suffer like this.”
“Because people are unable to get adequate pain relief from prescribed medications due to the fear instilled to doctors by these ‘guidelines,’ most people, in my experience, are turning to heroin. This explains not only an increase in overdoses but also an increase in suicide from chronic pain patients,” wrote another.
“I found it easier to get medications through the black market than through my doctor. I spend about $1,000 per month in medications through the black market, but in the end that is less than the deductible on my insurance. And they deliver to my house!” a patient said.
“My fear right now is that I’ve been using medications I buy from a dealer. They appear to be real and thus far I’ve been OK, but I’m afraid that I may eventually hit a bad batch laced with fentanyl,” said a patient.
The DEA said at least 32 deaths in the last 18 months in Maricopa County, Arizona have been linked to fake pills laced with fentanyl that were disguised to look like oxycodone tablets. In nearly 75% of the overdoses, examiners also found dipyrone (Metamizole), a painkiller banned for use in the U.S. since 1977.
Fentanyl is a synthetic opioid 100 times more potent that morphine. It is sold legally in sprays, patches and lozenges to treat severe chronic pain.
counterfeit oxycodone (dea photo)
The DEA says illicit batches of fentanyl are being made in China and exported to Mexico, where drug dealers mix it with heroin or turn it into counterfeit medication before smuggling it into the U.S.
The DEA released detailed demographic information on the age, sex and ethnicity of the people who overdosed in Arizona. It did not say how many of the dead were patients looking for pain relief.
Class action: Walgreens charges insured, Medicare customers too much for prescription drugs
Since 2007, the DEA has taken $3.2 billion in cash from people not charged with a crime
Wikimedia – 
