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Oregon Patient Advocate can be heard tonight -08/07/2018
Posted on August 7, 2018 by Pharmaciststeve
With most OD’s on ILLEGAL OPIATES Rep McSally wants to increase tracking of legal prescriptions
Posted on August 4, 2018 by Pharmaciststeve
McSally proposes drug monitoring best-practices bill to combat nation’s opioid epidemic
Toward ending the nation’s opioid crisis in her home state and around the country, U.S. Rep. Martha McSally (R-AZ) on July 26 introduced the Prescription Drug Monitoring Program (PDMP) Best Practices Act.
“This crisis has plagued Arizona for too long,” Rep. McSally said. “We’ve taken steps to combat this epidemic but there’s still more work to be done.”
She said that’s why she introduced H.R. 6608, which would direct the U.S. Department of Justice’s Bureau of Justice Assistance to coordinate with the Centers for Disease Control and Prevention to develop best practice guidelines to bolster PDMPs, the electronic databases that track each state’s opioid prescriptions. H.R. 6608 also would simplify states’ adoption of PDMPs and establish a PDMP data-sharing pilot program for states.
“The opioid epidemic has torn apart families and ruined lives forever,” the congresswoman said, noting that 116 Americans die each day from a drug overdose.
“These victims come from every background – they are teachers, ranchers, retirees, and students,” she said. “No parent should have to bury their own child.”
Rep. McSally’s statement also pointed out that PDMPs may work as a powerful tracking tool to deter the misuse of controlled substances.
If enacted, H.R. 6608 would authorize guidance on the specific information that should be submitted to PDMPs, including the patients at the highest risk for misusing controlled substances and how to identify incorrect prescription trends. Additionally, guidance would focus on the best practices on treatment options for prescribers, and how to spot and address roadblocks to implementing the guidelines, according to McSally’s statement.
H.R. 6608, which is cosponsored by U.S. Rep. Kevin Cramer (R-ND), has been referred to the U.S. House Energy and Commerce Committee for consideration.
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Addiction to Rx Opioids Falling
Posted on August 4, 2018 by Pharmaciststeve
www.painnewsnetwork.org/stories/2018/7/14/addiction-to-rx-opioids-falling
A new report from health insurance giant Blue Cross Blue Shield highlights a little-known and rarely reported aspect of the opioid crisis: Addiction to opioid pain medication is declining, not increasing.
Blue Cross Blue Shield (BCBS) said 241,900 of its members were diagnosed with opioid use disorder (OUD) in 2017, a rate of 6.2 for every 1,000 BCBS members. The rate fell to 5.9 in 1,000 members in 2017, a decline of nearly 5 percent. The insurer said it was the first drop in the eight years BCBS has tracked diagnoses of OUD.
“We are encouraged by these findings, but we remain vigilant,” said Trent Haywood, MD, senior vice president and chief medical officer for BCBS said in a statement.
“More work is needed to better evaluate the effectiveness of treatment options and ensure access to care for those suffering from opioid use disorder.”
BCBS attributes much of the decline to a 29% drop in opioid prescriptions for its members since 2013. A longtime critic of opioid prescribing hailed the findings as a sign of change.
“It means that there’s light at the end of the tunnel,” psychiatrist Andrew Kolodny, MD, the founder and executive director of Physicians for Responsible Opioid Prescribing (PROP) told BuzzFeed.
“Unfortunately though, the genie is out of the bottle,” said Kolodny, a former medical director of the addiction treatment chain Phoenix House. “Millions of Americans are now struggling with opioid addiction. Unless we do a better job of increasing access to effective treatment, overdose deaths will remain at record high levels and we’ll have to wait for this generation to die off before the crisis comes to an end.”
Admissions for Addiction Treatment
The BCBS numbers should be taken with a grain of salt, since they include all types of opioid addiction, including those linked to heroin, illicit fentanyl and prescription opioids. A more accurate way to track addiction to opioid medication would be admissions to publicly-funded treatment facilities for “non-heroin opiates/synthetic abuse” – a category that excludes heroin, but includes hydrocodone, oxycodone, fentanyl and other painkillers.
A database maintained by the Substances Abuse and Mental Health Services Administration (SAMHSA) shows that treatment admissions for prescription opioids peaked in 2011 at 193,552 admissions and fell to 121,363 by 2015 – a significant decline of over 37 percent. It seems likely that admissions for painkiller abuse have fallen even further since 2015, as opioid prescriptions have continued to plummet, and more pain patients are abandoned or denied treatment.
The SAMHSA data also reveals another trend: While the number of people seeking treatment for painkiller, alcohol and marijuana abuse has declined, admissions to treatment facilities for heroin addiction have soared. In 2010, there were 270,564 admissions in which heroin was identified as the primary substance of abuse. By 2015, that number had grown to 401,743 admissions – an increase of nearly a third.
ADMISSIONS TO ADDICTION TREATMENT FACILITIES
- Heroin
- Rx Opioids
- Alcohol
- Marijuana
SOURCE: SAMHSA
Admissions for heroin addiction now surpass those for other substances, yet much of the nation’s spending and law enforcement resources remain targeted on opioid prescriptions. Many public health officials also cling to the myth the heroin epidemic was triggered by opioid overprescribing, even though heroin admissions outnumber painkiller admissions by a 3 to 1 margin.
“Epidemiological data show that as widely prescribed opioids became less accessible due to supply side interventions, heroin use skyrocketed,“ psychiatrist Nora Volkow, MD, director of the National Institute on Drug Abuse, recently told OpioidWatch. Volkow was an early supporter of the CDC opioid guideline, one of the first supply side interventions, a strategy that she now characterizes as “naive.”
“Expecting that declines in rates of prescribed opioids could, by themselves, stem the tide of the opioid crisis is naïve and an oversimplification of the complex nature of the crisis,” Volkow said. “Legitimate questions have been raised about whether some pain patients might now be undertreated, and whether tightened prescribing practices over the last few years has contributed to the surge in overdose deaths from heroin and especially fentanyl.”
A recent study by SAMHSA found that deaths linked to illicit fentanyl and other synthetic opioids surpassed overdoses involving pain medication in 2016. The study also found that drugs used to treat depression and anxiety are involved in more overdoses than any other class of medication.
“In 2010, there were 270,564 admissions in which heroin was identified as the primary substance of abuse. By 2015, that number had grown to 401,743 admissions – an increase of nearly a third.”
These people can’t even do SIMPLE MATH…
A INCREASE from 270,564 to 401,743 is nearly a 50% INCREASE…
IF there had been a reduction from 401,743 to 270,564 would have been a DECREASE of 30%
With these people … I wonder if 2+2 is still equal to FOUR ?
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Lexington doctor who exposed Kentucky hospital to be featured on CBS show.
Posted on August 3, 2018 by Pharmaciststeve
Lexington doctor who exposed Kentucky hospital to be featured on CBS show.
https://www.kentucky.com/news/local/crime/article216037450.html
A Lexington doctor who helped uncover a widespread false billing scheme at a Kentucky hospital will be featured on CBS’ Whistleblower Friday night.
Whistleblower, airing at 9 p.m. Friday, features stories “of heroic people who put everything on the line in order to expose illegal and often dangerous wrongdoings,” according to its website.
Friday’s episode showcases Dr. Michael Jones, who along with fellow doctors Paula Hollingsworth and Michael Rukavina in 2010 and 2011, played a key role in blowing the whistle on an alleged overbilling scheme at St. Joseph-London Hospital.
The doctors noticed when they treated patients who had heart procedures done at St. Joseph-London that the treatments had been unnecessary, according to a lawsuit they jointly filed in 2011. One patient in London had 17 unneeded heart catheterizations and another patient had 10 catheterization procedures and seven stents placed to improve blood flow near arteries that were near normal.
St. Joseph-London and some doctors who worked there were accused of submitting bills to government-funded programs such as Medicare and Medicaid for hundreds of unnecessary heart procedures.
The alleged wrongdoings occurred before St. Joseph merged with Jewish Hospital and St. Mary’s HealthCare in 2012 to form KentuckyOne Health.
The owner of St. Joseph-London agreed to pay a $16.5 million settlement, which was the second-largest ever in a health care fraud case in the federal Eastern District of Kentucky.
The settlement resolved the claims against the hospital, but several doctors who practiced at the hospital and their clinics were also sued by patients.
Jones decided to take action because the procedures were invasive and costly enough to potentially bankrupt patients.
“I saw many patients who underwent unnecessary heart procedures,” Jones said, according to a release from CBS. “I was concerned they were being done for financial gain.”
Kevin Wells had a pacemaker installed that was unwarranted. His wife, Ruth Wells, is a part of the CBS episode. She said Kevin’s heart felt like it was beating out of his chest.
“Kevin could have died,” Ruth Wells said, according to CBS. “He could have died on that table. And to think it was for something he didn’t need.”
Jones practices at Baptist Health Lexington.
A statement provided by KentuckyOne Health Friday stated the London hospital is demonstrating clear action to prevent this issue from recurring.
“In February 2011, following a months-long internal investigation, Saint Joseph London self-reported to Federal authorities instances of interventional cardiology procedures that lacked adequate documentation to support the clinical indication for the procedures. The internal investigation was launched as a result of the hospital’s own proactive and ongoing compliance reviews, and the hospital then self-reported to Federal authorities, one month prior to the whistleblower lawsuit,” according to the statement.
“Saint Joseph London also fully cooperated in all subsequent government inquiries concerning the interventional cardiology procedures,” the statement continued. “Since then, the hospital has demonstrated clear action to address and prevent this issue from recurring, including monitoring, reporting and ongoing audits that exceed governmental requirements. In fact, in 2017 Saint Joseph-London was recognized by the Accreditation for Cardiovascular Excellence as adhering to the highest quality standards for cardiovascular care.”
Interventional pain procedures
Interventional pain management can help manage some patient’s pain. Many interventional pain procedures are complex and require the use of advanced imaging techniques such as fluoroscopy, digital subtraction, angiography and computerized tomography to accurately guide needles to the proper location to treat pain.
How many pts have had ESI and other procedures that have provided little/no short or long term benefits … sometimes make things worse and there are some estimated 10 million ESI done every year and it is estimated that 5% will end up with https://en.wikipedia.org/wiki/Arachnoiditis
A very painful condition which cannot be reversed and is caused by a ESI injection where the needle penetrates the spinal cord and the ESI medication is injected into the spinal fluid. These ESI’s are normally performed by INTERVENTIONAL PAIN doctors… typically anesthesiologists.
I have read many statements from pts from numerous “pain clinics” that the pts are told that unless you submit to ESI procedures… the pts will not be provided any oral opiates for their pain.
The medication typically used Methylprednisolone is not recommended by the FDA nor the UpJohn company to be used in ESI’s.
Typically, these ESI should only be used as a diagnostic tool. If after a series of ESI and the pain is not resolved.. .then the cause of the pain is not ACUTE and is CHRONIC and does not warrant continue the administration of ESI’s.
Is the title of Interventionalist a euphemism for fraudulent care ?
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65,000 + pharmacies in the USA and they are only suing TWO CHAINS – “DEEP POCKETS LAWSUIT” ?
Posted on August 3, 2018 by Pharmaciststeve
City, county governments file suit against opioid makers, pharmacists
Several Missouri county and municipal governments, including Joplin and Jasper County, on Wednesday officially filed a lawsuit against opioid manufacturers, pharmaceutical companies and pharmacies.
The suit, filed in Missouri’s 22nd circuit court in St. Louis, alleges multiple instances of misconduct on the part of the defendants with respect to the marketing of Oxycontin, a prescription opioid, and the distribution and management of those medications. The city of Joplin and Jasper County join Jefferson, Cape Girardeau, Christian, Crawford, Greene, Iron, Stone, Taney and Washington counties as plaintiffs in the suit.
Numerous drug makers and pharmacies are named as defendants, including Walgreens and CVS, Purdue Pharma and Teva Pharmaceuticals. Jack Garvey, a St. Louis attorney representing the governments, said the defendants “flooded” Joplin and Jasper County with prescription opioids in recent years.
“These companies created a bonfire full of toxic chemicals right in Joplin and walked away from it,” he said. “And it’s spreading noxious fumes and toxic fumes all across the country; they just left and said, ‘Hey, it’s your problem.'”
A Walgreens spokesperson declined to comment, citing a company policy not to discuss pending litigation. Purdue and CVS did not immediately respond to requests for comment.
Elizabeth DeLuca, senior director of corporate communications for Teva, said the company complies with all federal and state regulations with regard to opioids, is working on non-opioid medications for pain relief and frequently coordinates with health care officials and others to prevent drug abuse.
“Teva is committed to the appropriate use of opioid medicines, and we recognize the critical public health issues impacting communities across the U.S. as a result of illegal drug use as well as the misuse and abuse of opioids that are available legally by prescription,” she said.
The Jasper County Commission has called a news conference to discuss the lawsuit. It will begin at 3 p.m. today.
This story is developing and will be updated.
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FDA Called Lax in Curbing Use of Powerful Class of Opioids
Posted on August 3, 2018 by Pharmaciststeve
FDA Called Lax in Curbing Use of Powerful Class of Opioids
https://www.managedcaremag.com/dailynews/20180803/fda-called-lax-curbing-use-powerful-class-opioids
The drugs were approved for cancer patients, but have been prescribed to patients with migraine and back pain, a New York Times investigation reveals.
A class of drugs for cancer patients experiencing “breakthrough pain,” (sudden and sharp onrushes of pain despite the use of standard round-the-clock pain medications), have been prescribed to patients with back pain and migraine, putting them at high risk for addiction, a New York Times investigation says.
The drugs contain fentanyl, a narcotic up to 50 times stronger than heroin and 100 times stronger than morphine and include Actiq and Fentora, made by Cephalon, and Subsys, made by Insys Therapeutics. The drugs are called T.I.R.F.s (for transmucosal immediate-release fentanyl).
But in what’s being described as a fox guarding the hen house blunder, the FDA in 2011 charged a consortium of drug companies making the products with regulating their use. TheTimes looked at approximately 5,000 pages of documents that researchers at Johns Hopkins University obtained through the Freedom of Information Act. They showed widespread off-label prescribing of the drugs that the FDA did not intervene to prevent.
Andrew Kolodny, MD, an opioid policy researcher at Brandeis University, told the newspaper that “if any opioids were going to be tightly regulated, it would be these. They had the fox guarding the hen house, people were getting hurt—and the FDA sat by and watched this happen.”
Janet Woodcock, MD, the director of the Center for Drug Evaluation and Research at the FDA, told the newspaper that “the information we have isn’t very good, but it seems to indicate people who aren’t cancer patients are getting this and people who aren’t opioid tolerant are getting this.”
About 115 people in the United States die every day from overdosing on opioids, according to the National Institute on Drug Abuse.
In December 2011, the FDA created a safety program overseeing the use of T.I.R.F.s. “The program required doctors to undergo training for prescribing T.I.R.F.s and to sign a form saying they understood that prescribing to other patients can be dangerous,” the Times reports. “To administer the program, the consortium hired McKesson, a large national distributor that supplies drugs, including T.I.R.F.s, to pharmaceutical retailers.”
McKeeson released a statement in the wake of the investigation saying that it was just doing its job as a third-party administrator and that it was following requirements “developed jointly by the manufacturers and the FDA with ultimate approval resting with the FDA. McKesson administers the program according to these FDA requirements.”
A majority of prescription meds are prescribed “off-label”… because in order the the pharma to get a specific indication for a particular medication they would have to complete clinical trial for the specific disease. Once the FDA approves a medication to be prescribed, it is considered “safe” for humans and doctors are allowed to prescribe the med for anything they believe will help resolve the health issues for their pts.
Neurontin/Gabapentin was originally approved to treat seizures, but today it is routinely used for neuropathy.
Just how does a pt become opiate tolerant if they are never prescribed a opiate… cancer pts do not become “opiate tolerant” just because they are diagnosed with cancer ?
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A better 1-10 pain scale
Posted on August 3, 2018 by Pharmaciststeve
A toothache is pain that occurs in or around a tooth. The pain originates from within a tooth or the surrounding gum and bone structures. One usually feels toothache pain as a constant or intermittent ache that does not go away. Temperature changes, such as exposure to cold drinks or pressure on the tooth while chewing, can stimulate a toothache. In other instances, tooth pain can arise spontaneously without any stimulation. Odontalgia is another name for a toothache.
It’s hard to ignore an aching tooth while eating or going about one’s day. Persistent pain urges us to find out how to get rid of a toothache. While bothersome, it is a way for the painful tooth or area to signal that one should seek some attention and care from a dentist before things get worse.
What causes a toothache?
Injury or trauma to the tooth or area usually cause toothaches. Injury is commonly a result of tooth decay (or cavity). People usually feel cavities when they get larger and deeper into the layers of tooth structure. Enamel is the hard, outer layer of tooth, and dentin is the softer layer beneath the enamel. Dentin is the tooth’s sensitive layer with tiny microscopic tubes that originate from the very center of the tooth. The pulp chamber (the center of the tooth) contains the pulp. The pulp is comprised of blood vessels and nerves. If decay gets past enamel into the dentin, the cavity can sometimes cause discomfort. A deeper cavity that approaches the center of the tooth will likely cause pain since there is more damage to the tooth and there is less tooth structure to insulate and protect the pulp. Localized infection between the gum and tooth (periodontal abscess) can cause toothache. A traumatic physical blow to a tooth can induce a sore tooth, as well. Prevent most tooth decay conditions easily with dentitox pro.
Other causes of toothache include the following:
- Abscessed tooth: This infection originates from within the tooth and spreads to the root and the surrounding bone.
- Damaged or fractured tooth: Fracture of a tooth can expose the sensitive dentin or even the pulp. Sometimes fractures are not obvious even though the fracture line can run deep into the tooth, causing tooth pain every time one puts pressure on it with biting or chewing (called “cracked tooth syndrome”).
- Dental work: After getting a filling or crown, the tooth can feel more sensitive. This is especially the case if the removal of tooth decay was large or deep. Dental work, although necessary, can sometimes irritate the nerve. Over time, the sensitivity can resolve if the tooth is healthy enough.
- Teeth clenching or grinding: This habit is called bruxism and is oftentimes done unconsciously and at night. Unfortunately, bruxism causes damage to teeth and sometimes irritates the nerves to the point where teeth become sensitive.
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Massachusetts opioid bill includes help for pain patients
Posted on August 3, 2018 by Pharmaciststeve
Massachusetts opioid bill includes help for pain patients
The bill on opioids that the Massachusetts Legislature approved late Tuesday contains several provisions that have nothing to do with combating opioid addiction, but instead aim to help people often seen as casualties of that fight — those suffering from chronic pain.
Spooked by worries about addiction and poorly trained in pain management, many physicians have reduced or stopped prescribing medications for pain, and some avoid pain patients altogether, advocates say. At the same time, insurance often doesn’t cover other types of treatment for pain.
“Physicians don’t know what to do for people’s pain,” said Cindy Steinberg, policy chair for the Massachusetts Pain Initiative. “They don’t want to prescribe anymore. They’re dropping people with pain from care even if they do not take opioids.”
To address this problem, the bill would establish a program through which physicians can consult a team of pain-management specialists. The experts will advise them on pain therapies and refer them to local practitioners of alternative treatments.
Another provision in the bill would require health insurers to cover the full array of pain treatments, which could include acupuncture, chiropractic, physical therapy, and maybe even massage and yoga. Before the requirement goes into effect, the Health Policy Commission would study the issue and recommend to the Department of Insurance which therapies should be required.
Asked for comment Wednesday, representatives of the Massachusetts Association of Health Plans and Blue Cross Blue Shield of Massachusetts said they would work with regulators on identifying evidence-based treatments and noted that they already cover many non-opioid treatments.
The measures to address pain were absent from the opioid bill the governor proposed and also from the version the House approved. But advocates pushed to get them in the Senate bill and they made the final version.
“I’m so thrilled,” Steinberg said. “There’s 25 million people with severe pain and 2 million with opioid use disorder in the US. It’s incredibly important that we take care of both of these groups.”
In contrast to the pain provisions, which drew little public notice, a measure requiring medications to treat opioid addiction in correctional settings kept legislators wrangling over language late into the evening Tuesday.
“For some people, they’re just uncomfortable with this notion that you give drugs to a person who has an addiction that’s chemical-based,” Senator Cindy F. Friedman, chairwoman of the Joint Committee on Mental Health, Substance Use, and Recovery, said Wednesday.
Also, correctional officials were very concerned about how to manage such a program and its costs. But Friedman said federal grant money is expected to help.
In a compromise, the bill calls for a three-year pilot program, starting in September 2019, at correctional facilities in five counties: Hampden, Hampshire, Middlesex, Norfolk, and Franklin. These facilities will provide medications that treat opioid addiction — methadone, buprenorphine (known by the trade name Suboxone), and Vivitrol, a once-a-month shot — to inmates who had a prescription when they arrived, and also to inmates 30 days before release.
“When we do this pilot, if we figure out a way to do it right, then we will do it across the board because we will know how it works,” Friedman said.
The legislation would also require the state Department of Correction, starting in April 2019, to institute a medication-assisted treatment program at four facilities: the two women’s prisons, MCI Cedar Junction, and a Plymouth treatment program for civilly committed men.
At Cedar Junction, where prisoners stay for 90 days before being assigned a permanent spot, methadone and buprenorphine would be used to help patients withdraw from opioids.
Additionally, all prisoners would get an assessment by an addiction medicine specialist 120 days before release. The specialists will establish a treatment plan that could include medications. If so, prisoners would be transferred to one of the four facilities that provide the medications.
Correctional officials have long opposed providing methadone and buprenorphine behind bars because they are opioids that can be sold or stolen for illicit use.
But Middlesex County Sheriff Peter J. Koutoujian, president of the Massachusetts Sheriffs Association, said that even though sheriffs worried about security and costs, they always wanted to offer the treatment. “It’s not a change of heart,” he said Wednesday.
The sheriffs objected to an across-the-board mandate, but welcome this pilot program intended to test the waters, he said. “We think it’s an important enough endeavor that we’re willing to step into this territory and see how it works,” Koutoujian said.
The legislation, which requires the governor’s signature before it becomes law, won praise Wednesday from the presidents of the Massachusetts Medical Society and the Massachusetts Health & Hospital Association. Dr. Alain A. Chaoui, the medical society’s president, called it “thoughtful, measured, and evidence-based.”
Other notable provisions in the bill include:
■ Requirements that hospital emergency departments initiate medication-assisted treatment for patients who are treated for overdoses.
■ A program to enable primary care doctors to remotely consult experts in addiction treatment (similar to the one for pain patients).
■ Changes to the makeup of the Board of Registration in Nursing, including that members have expertise in substance use, behavioral health, and chronic pain.
■ Requirements for electronic prescribing of controlled substances.
■ Strengthened regulatory powers governing mental health and addiction programs, including the ability to require that new licensees are equipped to care for people suffering from both addiction and mental illness.
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Opioid defendants step up giving as a costly reckoning looms
Posted on August 3, 2018 by Pharmaciststeve
Opioid defendants step up giving as a costly reckoning looms
The drug industry is dishing out millions in grants and donations to organizations in cities, counties and states that have sued the companies over the deadly U.S. opioid epidemic.
The efforts could help makers and distributors of prescription painkillers, who face hundreds of lawsuits by communities across the country, reduce their tax bills and build goodwill ahead of a potential multibillion-dollar settlement over their role in a crisis that kills more than 100 Americans a day.
The money is pouring into places that have been hollowed out by the epidemic. Wholesaler Cardinal Health Inc., for example, this year gave $35,500 to a nonprofit in hard-hit Clermont County, Ohio, where overdoses have soared for more than a decade. In all, the company has given at least $3 million to some 70 groups — some with ties to plaintiffs in the litigation.
Additionally, drug wholesaler McKesson Corp. seeded a standalone nonprofit dedicated to fighting the opioid-abuse crisis with $100 million, and distributor AmerisourceBergen Corp. started its own opioid-focused grant program. Amerisource said it is still processing most applications, and couldn’t provide details, but has announced a $50,000 grant to three Boise-area hospitals to launch a program to help patients who overdosed on opioids.
The contributions mostly began after the wave of lawsuits. They are small in comparison with the amount companies could be forced to pay in a settlement — an estimate by Bloomberg Intelligence analysts pegs that potential tab at as high as $50 billion.
“That’s the way these battles are fought these days. They’re not just fought in court,” said Richard Ausness, a University of Kentucky law professor. “If you read these complaints it just sounds awful what they did, so they’re trying to create a different narrative.”
Andrew Kolodny, a Brandeis University researcher and critic of opioid makers’ business practices, urged communities to turn down the funds. “I can certainly understand how desperate they are, but they’re taking blood money,” he said. “An element of this is public relations and they want to make it look like they are doing something about this problem.”
For cities and counties with battered law-enforcement agencies or stretched social-service programs, the benefits of having the money could outweigh any disadvantages.
“What it came down to was here’s $35,000 that we can bring more prevention programs to the kids in schools,” said Karen Scherra, executive director of the Clermont County Mental Health & Recovery Board. “Do we punish them, in effect, and not provide that service, simply because of what else is going on?”
Companies facing lawsuits regularly seek ways to influence public opinion. Researchers at Harvard Business School who studied 20 years of lawsuits against public companies found that targeted local advertising increased by 23 percent after lawsuits were filed, and that they increase the probability of a favorable outcome.
Oxycontin maker Purdue Pharma LP has positioned itself as an advocate for fighting the crisis, helping fund distribution of overdose antidote naloxone through a national sheriffs’ association. In recent weeks, the closely held company has also purchased advertising in national news outlets, including The Washington Post and The Wall Street Journal, touting its efforts to stem the crisis.
Another drugmaker named in the suits, Endo International Plc, said it is helping communities but doesn’t disclose donations by organization. Johnson & Johnson said its opioid outreach includes focusing on supporting mothers and babies, but declined to provide specific details. Teva Pharmaceuticals Industries Ltd. didn’t say whether its outreach on public health has included donations related to opioids.
Corporations can deduct or donate up to 10 percent of their annual taxable income. But a company can violate self-dealing rules if giving is seen by the Internal Revenue Service as using its charity to benefit the company, including paying debts or fines, said Marcus Owens, a partner at law firm Loeb & Loeb LLP and former director of the agency’s exempt-organizations division.
He said companies may be in a gray area for two reasons: First, a fine or debt in the opioid litigation doesn’t yet exist but is possible, but also the donations have come after they were sued and amid settlement discussions.
“That sort of coincidence might suggest self-dealing, but in order to make that a case the IRS would have to know more about how the donations were structured,” Owens said.
Alexandra Lahav, a University of Connecticut School of Law professor, said the contributions could be a tactic in settlement talks or discussions with regulators, and while the donations wouldn’t be applied dollar-for-dollar in a settlement agreement, they show goodwill on the part of the company.
“The narrative is they’ve been irresponsible and this is a way to mitigate the narrative,” she said. “What they’re probably factoring in is, if I seem less like a bad guy, then the jury is more likely to award a lower amount, the judge is more likely to rule in my favor and the regulators are more likely to go softer on me.”
Clermont County sued the three major wholesalers in December 2017. The Cardinal grant went to the Coalition for a Drug-Free Clermont County, a nonprofit whose programs, volunteers and resources overlap with the county government. The money, from a program affiliated with Cardinal’s foundation and the Ohio State University College of Pharmacy, will fund education and prevention programs through Cardinal Health’s Opioid Action Program.
Mary Makley Wolff, director of the Coalition for a Drug-Free Clermont County, said that the contribution makes sense for accountability.
“People who created the problem need to be part of creating the solution, and that means funding the solution through prevention,” she said.
Scherra credits more than $1 million in grants for a drop in the overdose rate the past two years, prior to which the rate nearly doubled from 2013 to 2015. In 2015, enough opioids were dispensed in Clermont County so that 67 doses would have gone to every man, woman and child.
County commissioner David Painter, a member of the nonprofit, initially opposed the funds and said the donation doesn’t exonerate the industry. “The source was not one that I would have looked for obviously,” Painter said. “We have a large lawsuit there.”
Drug distributors have denied claims that they failed to halt suspiciously large shipments of painkillers and helped mislead patients about the painkillers’ addictive properties.
Dublin, Ohio-based Cardinal has also bought naloxone for communities and conducted take-back programs, where it accepts unused or expired medicines anonymously. Spokeswoman Ellen Barry said grant recipients were chosen partly from how epidemic has had an impact, the location’s proximity to Cardinal operations and impact on its employees in Ohio.
“These organizations were chosen through a competitive grant process and we are proud to support the important work they are doing to combat the opioid epidemic and make a difference in their communities,” she said.
Beside its grant program, AmerisourceBergen has given grants to the Moyer Foundation, which helps children and families affected by addiction, and donated drug deactivation resources to communities. An AmerisourceBergen spokeswoman said the company has helped bring together “innovative players who can address the disease of addiction and developed philanthropic efforts” that support nonprofits and municipalities.
San Francisco-based McKesson has long provided resources for military veterans with addiction issues through the Community Anti-Drug Coalitions of America (Endo said it also supports this organization). McKesson spokeswoman Jennifer Nelson said its nonprofit, announced in March, “demonstrates our commitment to being
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DEA Delay on Marijuana research
Posted on August 3, 2018 by Pharmaciststeve
In two years, the DEA has approved zero of the 26 applications it’s received to grow cannabis for research
https://www.tucsonweekly.com/tucson/dea-delay/Content
DEA Delay
In two years, the DEA has approved zero of the 26 applications it’s received to grow cannabis for research
By Nick Meyers
In August 2016, the Drug Enforcement Administration said it would begin accepting new applications for licenses to grow cannabis for research purposes. Since then, it’s received more than two dozen applications, and not one has been approved.
For years, the only place scientists have been able to get cannabis is the University of Mississippi, and a single producer doesn’t have much incentive to grow the best quality cannabis they can.
Some scientists on the cutting edge of demonstrating cannabis’s medicinal value say they can’t even conduct their research with the product the University of Mississippi provided.
Apparently, it was enough to convince the DEA to say they were going to do something about it—then never did. The reason isn’t a secret. A year after the announcement, the DEA stopped accepting applications under a new Justice
Department head, Jeff Sessions. Even Sen. Orrin Hatch (R-Utah), one of the oldest, most conservative white guys you’re going to find in Congress, pushed Sessions on the topic when he introduced a bill to open up cannabis research.Not to be out-curmudgeoned, Sessions brushed off his questions.
Hatch’s bill, co-introduced with Sen. Brian Schatz (D-Hawaii), would have encouraged research, increased availability and required the National Institute on Drug Abuse to publish best practices for growing cannabis.
Luckily, many patients seem to discover themselves what dosage works for them, and there’s certainly no shortage of experience and knowledge in the industry from growers and scientists.
But in the absence of such a welcoming environment, those trying to legalize cannabis, or advocating new qualifying conditions, are at a loss for data to prove what they anecdotally know.
Take the Mothers Advocating Medical Marijuana for Autism, for example. They’ve petitioned the Arizona Department of Health Services to add autism to the list of the state’s qualifying conditions several times, each time being met with another excuse.
They’ve had to rely on recent research from places like Israel and South America, the first studies of their kind, to demonstrate cannabis’s effectiveness in treating autism.
The DEA tells them “there’s not enough data” or “the term’s too broad.” But these are the exact kind of defenses against expanding cannabis use that can be dispelled with more research.
And that’s what Sessions is afraid of.
The United States has come a long way since the days of absolute prohibition. Only four states hold out on any kind of cannabis legalization: Idaho, South Dakota, Nebraska and Kansas. (Nebraska has decriminalized it, though.)
Since Colorado and Washington legalized recreational cannabis in 2016, seven other states have followed, 28 have begun medical programs (many with low-THC/high-CBD oils only) and six have decriminalized it.
The trend is clear, but some people refuse to see it. While Session’s shenanigans are disappointing, and a seemingly small refusal to approve applications is a tiring setback, the argument isn’t whether to legalize cannabis, it’s when.
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