Bayer, J&J settle thousands of US Xarelto lawsuits for $775 million

Bayer, J&J settle thousands of US Xarelto lawsuits for $775 million

https://www.mdlinx.com/pharmacy/top-medical-news/article/2019/03/26/7561883/

Bayer AG and Johnson & Johnson have agreed to settle more than 25,000 US lawsuits alleging that their blockbuster blood thinner Xarelto (rivaroxaban) caused unstoppable and in some cases fatal bleeding for a total of $775 million, court documents on Monday showed.

The amount will be shared equally between the two companies that jointly developed the drug. Bayer and J&J do not admit liability under the agreement.

The settlement will resolve all pending US lawsuits over rivaroxaban, which plaintiffs claimed caused uncontrollable and irreversible bleeding leading to severe injuries and even death among thousands of patients. Plaintiffs accused the drugmakers of having failed to warn about the bleeding risks, claiming their injuries could have been prevented had doctors and patients been provided adequate information.

Bayer in a statement on Monday said it continues to believe the claims are without merit. “However, this favorable settlement allows the company to avoid the distraction and significant cost of continued litigation,” the company said. Lawsuits over rivaroxaban began piling up in 2014, and the companies had so far won all six trials over rivaroxaban’s alleged bleeding risk.

J&J in a statement said it continued to believe in the safety of rivaroxaban but that the settlement was the right thing to do for patients and their doctors.

Rivaroxaban is Bayer’s best-selling drug. It contributed 3.6 billion euros ($4.07 billion) in revenue to the German group’s pharmaceutical business last year. Bayer said its share of the settlement amount will be partially offset by product liability insurance.

Bayer jointly developed rivaroxaban with J&J’s Janssen Pharmaceuticals unit, which sells the blood clot preventer under a licensing agreement in the United States. J&J reported 2018 rivaroxaban sales of $2.47 billion.

The US Food and Drug Administration approved rivaroxaban in 2011. It is prescribed for people with atrial fibrillation, and to treat and reduce the risk of deep vein thrombosis and pulmonary embolism. The companies in the past have said rivaroxaban’s warning label provides “complete, accurate, and science-based information on the medicine’s benefits and risks.”

The majority of the claims were consolidated in New Orleans federal court, where three cases were selected as so-called bellwether trials, aimed to help determine the range of damages and define settlement options. The companies won those three trials throughout 2017. J&J and Bayer were also cleared of liability in three other state court trials in 2018.

Rivaroxaban is among a class of oral blood thinners, including Bristol-Myers Squibb and Pfizer’s Eliquis (apixaban), that are alternatives to decades-old warfarin. Most of the lawsuits over apixaban have been dismissed by US judges.

A similar drug, Boehringer Ingelheim’s Pradaxa (dabigatran), also became the subject of thousands of lawsuits claiming the company understated its bleeding risk. Boehringer in 2014 reached a $650 million settlement to resolve more than 4,000 of those cases.

Why did these companies agree to make these settlements ??.. because in MY PROFESSIONAL OPINION – they are dangerous…  A number of years ago, Barb had A-Fib and her then cardiologist wanted to discharge her from the hospital on one of these “new oral anticoagulants” that – at the time – had no way to reverse of a pt started bleeding… I reluctant to allow her to be discharged on the one that could at least be reversed with dialysis  – on top of that  – the particular med he wanted her on has a LEVEL ONE DRUG INTERACTION with one or more of her other meds – LEVEL ONE is DO NOT GO THERE.

Once I got her into the PCP… I got her switched to Warfarin… our PCP really kinda of defended using these new meds but he caved to my persistence. Thru a medical procedure, Barb was able to get her A-Fib correct and no longer on Warfarin…

A few years later, I showed up with some clots and had to go on a blood thinner and our PCP – either remembered me be “hard-headed” about using Warfarin  – or he had seen the problems with these new blood thinners and never discussed me being on anything but Warfarin.  A Warfarin bleed can be quickly reversed with Vit K and while there is a new reversal agent for these blood thinners… the studies I have seen suggests that it works so slow that 17% of the pt will still BLEED OUT !

I can do home testing with a meter http://www.coaguchek.com/coaguchek_patient/landing and with Medicare and a Supplement… the cost is paid 100% and it takes maybe a total of 5 minutes to do the test

 

 

Just how important are the CIVIL ASSET FORFEITURES to the feds ?

For those who are skeptical about how important the $$$ collected by the FEDS using CIVIL ASSET FORFEITURE ACT…  here is a list from SEVEN DIFFERENT FEDERAL AGENCIES and the lists of property that was seized/confiscated by the FEDS

https://www.forfeiture.gov/

https://www.forfeiture.gov/pdf/ATF/OfficialNotification.pdf
https://www.forfeiture.gov/pdf/DEA/OfficialNotification.pdf
https://www.forfeiture.gov/pdf/FBI/OfficialNotification.pdf
https://www.forfeiture.gov/pdf/USAO/OfficialNotification.pdf
https://www.forfeiture.gov/pdf/CBP/OfficialNotification.pdf
https://www.forfeiture.gov/pdf/USPS/OfficialNotification.pdf
https://www.forfeiture.gov/pdf/USSS/OfficialNotification.pdf

 

Does it remind you of the WILD WILD WEST ?

 

Purdue Pharma, state of Oklahoma reach settlement in landmark opioid lawsuit

https://www.washingtonpost.com/national/health-science/purdue-pharma-state-of-oklahoma-reach-settlement-in-landmark-opioid-lawsuit/2019/03/26/69aa5cda-4f11-11e9-a3f7-78b7525a8d5f_story.html

Purdue Pharma and the state of Oklahoma have agreed to settle a lawsuit over the drugmaker’s role in the deadly opioid crisis, a milestone in the legal effort to force pharmaceutical companies to pay some of the costs of the epidemic, people familiar with the matter said.

The deal, which is scheduled to be announced at a news conference Tuesday, will require Purdue and the family that owns the company to pay approximately $270 million. Most of the money will fund a new center for research, education and treatment of addiction and pain at Oklahoma State University in Tulsa.

Oklahoma is free to continue its lawsuit against two other defendants and their subsidiaries — Johnson & Johnson, the 37th-largest company in the United States, and Teva Pharmaceutical Industries, an Israel-based manufacturer that focuses mainly on generic drugs. The two companies, which have asked to be tried separately from Purdue, are slated to go to trial on May 28.

Lawyers in the case and a spokesman for Purdue declined to comment ahead of the planned announcement Tuesday.

Oklahoma contends that Purdue, Johnson & Johnson and Teva bear some responsibility for thousands of opioid deaths across the state, in addition to the health care, law enforcement and treatment costs of the state’s addiction crisis. Purdue and others face similar claims in several other courts, and the first major settlement in the flood of lawsuits could help set the bar for compensation sought by hundreds of states, cities, counties and Native American tribes for the costs incurred in responding to the epidemic.

About 1,600 of those cases are consolidated in one enormous case — known as multidistrict litigation — before a federal judge in Cleveland. That action targets companies that manufactured, distributed and dispensed narcotic painkillers across the country, and those cities, towns and tribes are seeking damages in what some believe is the most complex litigation in U.S. history.

Thirty-six states have chosen to bring separate lawsuits in their own court systems, believing they have better chances there.

Purdue’s recent acknowledgment that it is considering bankruptcy as an option could influence strategy in those lawsuits; Oklahoma’s settlement ensures it will receive at least some compensation for its claims.

Under the terms of the settlement, Purdue will contribute $102.5 million to establish the new addiction center. Members of the Sackler family, who own the company but were not defendants in the case, will pay another $75 million in personal funds over five years, people familiar with the agreement said. Purdue also will provide $20 million worth of treatment drugs, will pay $12 million to cities and towns, and will cover about $60 million in pay to private attorneys from two law firms that have represented Oklahoma in the case.

The addiction center would be housed at Oklahoma State University’s Center for Wellness and Recovery and would be overseen by an independent board.

Nearly 400,000 people in the United States died of opioid overdoses between 1999 and 2017, according to the Centers for Disease Control and Prevention, including a record 47,600 in 2017. Purdue is widely blamed for helping to start the epidemic after it introduced the powerful opioid OxyContin to the market in 1996. The company allegedly persuaded doctors to prescribe — and overprescribe — the drug for a wide variety of ailments. In 2007, Purdue and three of its executives pleaded guilty to misconduct in their marketing of OxyContin and paid more $600 million in fines.

Authorities have argued that Purdue used deceptive marketing tactics and a sizable workforce of representatives to repeatedly visit physicians to sell them narcotics, assuring them that the drugs were rarely addictive. Many patients became addicted to the potent painkillers, and large amounts of the drug were diverted to the black market.

More than 2 million Americans now suffer from an opioid use disorder, according to government data. The epidemic has evolved to encompass illicit use of fentanyl, a synthetic ultrapowerful opioid that has caused a spike in overdoses and fatalities.

Three years ago, the CDC estimated the cost of the opioid epidemic at $78.5 billion for calendar year 2013. In 2017, the White House Council of Economic Advisers placed the price tag much higher, at $504 billion for 2015.

A consultant’s report that Oklahoma filed in court estimated that abating the opioid crisis in that state would cost more than $8.7 billion during the next 20 years.

Oklahoma Attorney General Mike Hunter sued the three drug companies in June 2017, and the two sides have been taking depositions and jousting over pretrial issues for nearly two years. As other cases lagged, Oklahoma judge Thad H. Balkman set a May 28 trial date, agreed to televise the proceedings live and refused drug company requests to postpone the trial. That ensured that the Oklahoma case would be the first major test of whether the companies would be forced to pay for the crisis.

According to a lawsuit filed by the state of Massachusetts, Sackler family members received nearly $4.3 billion in payouts from Purdue between 2008 and 2016. But the family-owned company has suffered heavy blows to its image in recent months as litigation has advanced. Three museums in Britain and the United States have turned down donations from the Sacklers, longtime patrons of the arts, in recent days.

And documents released in the Massachusetts lawsuit, brought by state Attorney General Maura Healey, depicted some of the Sacklers as insatiably greedy and uncaring about the human toll of their product.

“Millions of dollars were not enough. They wanted billions,” the lawsuit charges. “They cared more about money than about patients, or their employees, or the truth.”

Another Vet left being tortured by the VA & the govt that promised to take care of him

Image may contain: one or more people, people sitting, living room and indoor

It’s OFFICIAL the VA has now fully tapered my dad. His last RX is coming and that’s the end. Their intentions were all along to kill my father, even after the family begging them not to take away his pain medication. It was the VA who put my father on the pain program now they are taking away their promise to treat him.
I hold the VA and the #opioidhysteria responsible for the extreme suffering my father is going through. I will be outside the VA center everyday in protest and will shame this facility for the entire Pensacola area to see!!!!!

Another Vet left being tortured by the VA & the govt that promised to take care of him.
Please speak up and share this post, this has to end. I’m sure this woman would appreciate some help in protesting outside the VA in Pensacola as well, if anyone is in the area, contact her or stop by & show some support for those being harmed by #opioidhysteria and the false narrative being perpetuated by Andrew Kolodny, his cohorts at PROP, their PR team and the CDC & DEA who is their own personal terrorist army.
Please join the special class action lawsuit against the govt and help stop the torture! Visit www.sickofsuffering.com for more info!

 

A Federal Court Says Your Prescription Records Aren’t Really Private. The Supreme Court Might Have Something to Say About That.

A Federal Court Says Your Prescription Records Aren’t Really Private. The Supreme Court Might Have Something to Say About That.

https://www.aclu.org/blog/privacy-technology/location-tracking/federal-court-says-your-prescription-records-arent-really

When you fill a prescription at your local drug store, you would surely bristle at someone behind you peeking over your shoulder — but in a decision issued last week, a federal court in Utah said that you have no Fourth Amendment right to object when the peeker is the United States government.

You read that correctly: In a case challenging the Drug Enforcement Administration’s warrantless access to patient prescription records stored in a secure state database, the court relied in part on an outdated legal doctrine to rule that a “patient in Utah decides to trust a prescribing physician with health information to facilitate a diagnosis,” and thereby “takes the risk . . . that his or her information will be conveyed to the government.”

That’s hard to swallow — and it helps make very clear the huge stakes of our upcoming Supreme Court argument in United States v. Carpenter, which concerns the role of the so-called “third-party doctrine” in opening up all kinds of sensitive records to warrantless searches by police.

The 1970s-era doctrine says that Fourth Amendment protections afforded to certain kinds of information disappear once people voluntarily provide that information to a third party. The doctrine emerged from a pair of Supreme Court cases, one of which — Smith v. Maryland — involved a robbery suspect who argued that his Fourth Amendment rights had been violated when police recorded the numbers he dialed from his home phone without obtaining a warrant. The Supreme Court ultimately ruled that because his phone calls passed through the phone company, he lacked a reasonable expectation of privacy in the numbers he dialed, and therefore they weren’t protected by the Constitution.

This case (and its close cousin, United States v. Miller, which held there was no reasonable expectation of privacy in certain banking records held by a bank) is still on the books, and the government has leveraged it to acquire powers that were unimaginable four decades ago. Today, police can track not only the phone numbers dialed by a single suspect over a short period, but also collect reams of information about people — whether their sensitive prescription records or data about their every movement over months at a time — without ever asking a judge for a warrant based on probable cause.

That brings us back to Utah. In 1995, the state passed a law establishing a database for prescriptions of certain medications, including those that treat chronic and acute pain, anxiety disorders, gender transitions, and many more medical conditions or procedures. As of last year, the database housed more than 70 million prescription records and was growing by more than 5 million per year. To address the obvious privacy risks in maintaining this kind of database, and in response to a scandal in which a Utah detective downloaded the entire prescription histories of nearly 500 firefighters, in 2015 the Utah legislature amended its law to require law enforcement to obtain a warrant before retrieving this private medical information.

But even though the amendment made clear that sensitive prescription records should be protected by the safeguards of the warrant requirement — including a probable cause finding of criminal activity, an independent assessment by a judge, and a narrow and particular purpose — the federal government simply didn’t care. In June 2015, the DEA issued a subpoena that was never approved by a judge demanding reams of prescription records from Utah’s state database. When Utah said “get a warrant,” the agency went to court to force the state to turn them over.Last year, the ACLU and the ACLU of Utah intervened in the case on behalf of Equality Utah, an LGBTQ advocacy organization concerned about the privacy of transgender individuals who are prescribed hormones and other medications, and IAFF Local 1696, the union representing Unified Fire Authority firefighters and paramedics who have experienced concrete violations of their prescription privacy in recent years. (We also represent two individual Utahns and the patients and physicians among the ACLU of Utah’s members.)

The ACLU, on behalf of our clients — along with Utah, on behalf of all its residents — argued that the Fourth Amendment required a warrant because people have a reasonable expectation of privacy in their prescription records.

But the court disagreed, deciding that “[p]hysicians and patients do not have a reasonable expectation of privacy in the highly regulated prescription drug industry,” because a patient who gives a doctor private health information takes the risk that her prescribed treatment will be regulated by state law. In other words, because a person gives sensitive information to a third party (here, a doctor and pharmacist!), that person loses an expectation of privacy in that information — the so-called “third-party doctrine.”

While we’ve lost this round in Utah, there’s another on the horizon that may require the court in Utah to reconsider its conclusions. This fall, we’ll be arguing before the Supreme Court in Carpenter that the mere fact that an individual’s private and sensitive records reside with some third party does not, on its own, eliminate the individual’s constitutional right to privacy in those records. In that case, police collected months’ worth of cell phone location information about our client, all without a warrant.

Given how integral cell phones have become to daily life, and the amount of sensitive information they generate about us, it’s simply untenable to argue that the mere act of carrying a cell phone eliminates your Fourth Amendment right against warrantless government access to your most private information. The Carpenter case provides a historic opportunity to ensure that the protections of the Constitution don’t become obsolete in the face of advancing technology. But it’s about more than the privacy of our cell phone location records. It could also provide an opening to give our prescription data and other sensitive records the privacy they deserve. It’s about time.

 

Opioid bill ignores real problem, creates host of new ones, critics argue

https://www.watchdog.org/minnesota/opioid-bill-ignores-real-problem-creates-host-of-new-ones/article_6f73481c-4c18-11e9-bc8c-9b551bb84e55.html

A Minnesota bill seeking to establish an Opioid Stewardship Fund doesn’t address the root cause of the opioid crisis – the illegal sale of narcotics – and will only increase costs to taxpayers, insurance companies and their customers, critics argue. And while well-intentioned, it potentially could drive pharmaceutical companies out of the state, they say.

The bill, HF 400, passed the state House by a vote of 94-34 and awaits action in the Senate. If passed into law, it would create an opioid stewardship fund, an opiate product registration fee, and modify provisions related to opioid addiction prevention, education, intervention, treatment and recovery.

Rep. Tony Albright, Assistant Minority Leader, who voted against the bill, has proposed several alternatives over the years, including better access to treatment and prevention resources.

The fund’s revenue would come from fees on manufacturers and wholesalers of opioid medication. Board members of the Opioid Stewardship Fund would determine fees based on its $20 million annual budget.

But imposing arbitrary fees on pharmaceutical distributors will only increase costs for everyone and do nothing to address the opioid crisis, Grover Norquist, president of Americans for Tax Reform, argues.

HF 400 “could even make the opioid crisis worse,” Norquist says. “The legislation would impose a harmful new tax that would hurt patients in need of medicine by driving up costs directly and causing supply problems that would further hike costs and create access issues.”

Action 4 Liberty, an advocacy group that opposes the bill, argues “government should not get involved in the decision-making of prescribing pain medication from medical professionals.”

The bill dictates how much opioid pain medication a doctor can prescribe to patients who’ve had surgery or undergone a major trauma. It states, “when used for the treatment of acute pain associated with a major trauma or surgical procedure, initial prescriptions for opiate or narcotic pain relievers listed in Schedules II through IV of section 152.02 shall not exceed a seven-day supply.”

The bill also adds mandated acupuncture coverage to Minnesota health insurance plans: “health plans must cover acupuncture services for the treatment of pain and ongoing pain management.”

The new regulations are misplaced and overly burdensome, the Washington, D.C.-based advocacy organization, Citizens Against Government Waste (CAGW), argues.

“Because the opioid crisis is primarily driven by illegal narcotics like fentanyl and heroin, it would be prudent for legislators to focus their efforts on preventing those drugs from being trafficked, instead of placing further regulations and taxes on the legal pharmaceuticals that Americans use every day,” Elizabeth Wright, CAGW’s director of health policy, said.

According to a study published this month by economics professors at Union University in New York, any costs to comply will be passed on to taxpayers. When evaluating a similar opioid tax proposed in New York, the researchers found that “the proposed tax will encourage residents suffering from opioid dependence to switch to cheaper illegal opioids, including heroin and fentanyl, with increased rates of accidental overdose.”

The opioid tax would drive up prices for consumers and insurers, the researchers found, and not actually address the drug-addiction crisis.

None of these initiatives address the root of the opioid problem, critics argue.

Approximately 26,000 people died nationwide from fentanyl sold on the black market originating from China and Mexican cartels in 2017, according to a Bloomberg News report. According to Centers for Disease Control (CDC) data, the sale of illicit fentanyl poses the greatest risk in the opioid crisis.

Critics point out that because the tax demands an arbitrary amount of fees, once one fee-paying pharmaceutical company leaves the state, the rest will end up paying more, and then also might consider leaving. Suppliers would then leave the state, opponents of the bill fear, creating another crisis altogether – less access to medication.

“Taxpayers should make their voices heard and demand that policies related to the opioid epidemic are focused on the cause of the crisis, not on a political scapegoat,” Wright added.

Dr Mark Ibsen : unhappy about how a cancer survivor veteran loosing his pain meds

Under treatment of pain – ELDER ABUSE – plaintiff awarded 1.5 million by jury

http://www.mywhatever.com/cifwriter/library/eperc/fastfact/ff63.html

Title: Fast Fact and Concept #63: The legal liability of undertreatment of pain

Author(s): Warm, Eric; Weissman, David E

It is well recognized that physician’s fear of fear of regulatory scrutiny (DEA, state medical boards), is a major contributor to the problem of under treatment of pain. A recent landmark lawsuit should be a wake-up call for all physicians that this type of practice poses its own legal liability. An 85-year-old California man with metastatic lung carcinoma spent the final week of his life in severe pain. Three years after his death his children sued his doctor alleging that the physician had failed to prescribe drugs powerful enough to relieve their father’s suffering. This was one of the first U.S. cases in which a doctor has gone on trial for allegedly under-treating a patient’s pain. By a 9 to 3 vote the jury decided that the physician’s lack of attention to pain constituted elder abuse, awarding the family $1.5 million (the amount was reduced to $250,000). To win, lawyers convinced the jury that under-treatment of pain was “reckless negligence”. Until recently, lawyers would have considered such a suit un-winnable. Given politically savvy aging baby boomers, as well as the preponderance of sound scientific evidence for the proper assessment and treatment of pain, we can probably expect more such verdicts. Here are some tips for how physicians can better protect themselves from charges of under-treatment of pain?

  • Review your own practice–are you currently meeting JCAHO standards? Find out at: http://www.jcaho.org and AHQR (a.k.a. AHCPR) http://www.ahrq.gov/clinic/cpgarchv.htm pain guidelines?
  • Improve your knowledge and skills in pain assessment and treatment. (Some states, such as California, now require mandatory pain CME).
  • Learn about and utilize your local consultation resources for pain management.
  • Improve your knowledge and skills in assessing substance abuse disorders; learn about and utilize your local resources for substance abuse referrals and treatment.
  • Improve your understanding of the drug regulatory system and how it functions- learn about the common triggers for regulatory review . Go to: http://www.medsch.wisc.edu/painpolicy/ for information about federal and state regulatory laws and regulations.
  • Become active in your hospital pain improvement efforts-check with your hospital QI department and their efforts to meet the new JCAHO pain guidelines.
  • Become active with your state Cancer Pain Initiative; go to http://www.aacpi.org/ to find information about your state activities.

Ideally physicians should not use the fear of lawsuits to help guide medical care, but evidence shows that they do. In a way, this attention on improved pain management may become a silver lining in the black cloud of our litigious society.

References

Stieg RL, et al: Roadblocks to effective pain treatment. Med Clin N Amer, 1999;83(3): 809-821.

Okie, S. Doctor’s Duty to Ease Pain At Issue in Calif. Lawsuit. Washington Post.May 7, 2001; Page A03

Crane M, Treating pain: damned if you don’t? Med Economics, Nov 19, 2001, pp 67-69.

Weissman DE, Doctors, Opioids and the law: The Effect of Drug Regulations on Cancer Pain Management. Semin Oncol 20(Suppl A): 53-58, 1993.

Gilson AM, Joranson DE. Controlled substances and pain management: Changes in knowledge and attitudes of state medical regulators. Journal of Pain and Symptom Management. 2001;21(3):227-237.

Joranson DE, Maurer MA, Gilson AM, Ryan KM, Nischik JA. Annual review of state pain policies, 2000. Pain & Policy Studies Group, University of Wisconsin Comprehensive Cancer Center. Madison, Wisconsin; February 2001.

Jacox A, Carr DB, Payne R, et al. Management of Cancer Pain. Clinical Practice Guideline No. 9 AHCPR Publication No. 94-0592, Rockville, MD. Agency for Health Care Policy and Research, U.S. Department of Health and Human Services, Public Health Service, 1994.

Acute Pain Management Guideline Panel. Acute pain management: Operative or Medical Procedures and Trauma Clinical Practice Guideline. AHCPR Publication No. 92-0032. Rockville, MD. Agency for Health Care Policy and Research, US Department of Health and Human Services, Public Health Service, 1992.

Copyright and Referencing Information: Users are free to download and distribute Fast Facts for educational purposes only. Citation for referencing. Fast Facts and Concepts #63 The legal liability of undertreatment of pain. Warm E and Weissman DE. March, 2002. End-of-Life Physician Education Resource Center www.eperc.mcw.edu.

Fast Facts and Concepts was originally developed as an end-of-life teaching tool by Eric Warm, MD, U. Cincinnati, Department of Medicine. See: Warm, E. Improving EOL care–internal medicine curriculum project. J Pall Med 1999; 2: 339-340.

Disclaimer: Fast Facts provide educational information, this information is not medical advice. Health care providers should exercise their own independent clinical judgment. Some Fast Fact information cites the use of a product in dosage, for an indication, or in a manner other than that recommended in the product labeling. Accordingly, the official prescribing information should be consulted before any such product is used.

Creation Date: 3/2002

Format: Handouts

Purpose: Instructional Aid, Self-Study Guide, Teaching

Audience(s)

Training: Fellows, 1st/2nd Year Medical Students, 3rd/4th Year Medical Students, PGY1 (Interns), PGY2-6, Physicians in Practice
Specialty: Anesthesiology, Emergency Medicine, Family Medicine, General Internal Medicine, Geriatrics, Hematology/Oncology, Neurology, OB/GYN, Ophthalmology, Pulmonary/Critical Care, Pediatrics, Psychiatry, Surgery
Non-Physician: Nurses

ACGME Competencies: Medical Knowledge

Keyword(s): Addiction, Chronic non-malignant pain, Controlled substance regulations, Pain, Pain assessment, Pain treatment

Association of Tramadol With All-Cause Mortality Among Patients With Osteoarthritis

Association of Tramadol With All-Cause Mortality Among Patients With Osteoarthritis

https://jamanetwork.com/journals/jama/article-abstract/2727448

Question  Is tramadol prescription associated with a higher risk of all-cause mortality than other pain relief medications among patients with osteoarthritis?

Findings  In this cohort study that included 88 902 patients with osteoarthritis, initial prescription of tramadol was associated with a significantly increased risk of mortality over 1 year compared with initial prescription of naproxen (hazard ratio [HR], 1.71), diclofenac (HR, 1.88), celecoxib (HR, 1.70), and etoricoxib (HR, 2.04), but not compared with codeine (HR, 0.94).

Meaning  Tramadol prescription may be associated with increased all-cause mortality compared with commonly prescribed nonsteroidal anti-inflammatory drugs, but further research is needed to determine if this relationship is causal.

Abstract

Importance  An American Academy of Orthopaedic Surgeons guideline recommends tramadol for patients with knee osteoarthritis, and an American College of Rheumatology guideline conditionally recommends tramadol as first-line therapy for patients with knee osteoarthritis, along with nonsteroidal anti-inflammatory drugs.

Objective  To examine the association of tramadol prescription with all-cause mortality among patients with osteoarthritis.

Design, Setting, and Participants  Sequential, propensity score–matched cohort study at a general practice in the United Kingdom. Individuals aged at least 50 years with a diagnosis of osteoarthritis in the Health Improvement Network database from January 2000 to December 2015, with follow-up to December 2016.

Exposures  Initial prescription of tramadol (n = 44 451), naproxen (n = 12 397), diclofenac (n = 6512), celecoxib (n = 5674), etoricoxib (n = 2946), or codeine (n = 16 922).

Main Outcomes and Measures  All-cause mortality within 1 year after initial tramadol prescription, compared with 5 other pain relief medications.

Results  After propensity score matching, 88 902 patients were included (mean [SD] age, 70.1 [9.5] years; 61.2% were women). During the 1-year follow-up, 278 deaths (23.5/1000 person-years) occurred in the tramadol cohort and 164 (13.8/1000 person-years) occurred in the naproxen cohort (rate difference, 9.7 deaths/1000 person-years [95% CI, 6.3-13.2]; hazard ratio [HR], 1.71 [95% CI, 1.41-2.07]), and mortality was higher for tramadol compared with diclofenac (36.2/1000 vs 19.2/1000 person-years; HR, 1.88 [95% CI, 1.51-2.35]). Tramadol was also associated with a higher all-cause mortality rate compared with celecoxib (31.2/1000 vs 18.4/1000 person-years; HR, 1.70 [95% CI, 1.33-2.17]) and etoricoxib (25.7/1000 vs 12.8/1000 person-years; HR, 2.04 [95% CI, 1.37-3.03]). No statistically significant difference in all-cause mortality was observed between tramadol and codeine (32.2/1000 vs 34.6/1000 person-years; HR, 0.94 [95% CI, 0.83-1.05]).

Conclusions and Relevance  Among patients aged 50 years and older with osteoarthritis, initial prescription of tramadol was associated with a significantly higher rate of mortality over 1 year of follow-up compared with commonly prescribed nonsteroidal anti-inflammatory drugs, but not compared with codeine. However, these findings may be susceptible to confounding by indication, and further research is needed to determine if this association is causal.

Addiction now defined as brain disorder, not behavior issue

Addiction now defined as brain disorder, not behavior issue

Decades of research convinced American Society of Addiction Medicine to change definition

http://www.nbcnews.com/id/44147493/ns/health-addictions/t/addiction-now-defined-brain-disorder-not-behavior-issue/

Addiction is a chronic brain disorder and not simply a behavior problem involving alcohol, drugs, gambling or sex, experts contend in a new definition of addiction, one that is not solely related to problematic substance abuse.

The American Society of Addiction Medicine (ASAM) just released this new definition of addiction after a four-year process involving more than 80 experts. It is best to click here for the best addiction advice. 

“At its core, addiction isn’t just a social problem or a moral problem or a criminal problem. It’s a brain problem whose behaviors manifest in all these other areas,” said Dr. Michael Miller, past president of ASAM who oversaw the development of the new definition. “Many behaviors driven by addiction are real problems and sometimes criminal acts. But the disease is about brains, not drugs. It’s about underlying neurology, not outward actions.”

The new definition also describes addiction as a primary disease, meaning that it’s not the result of other causes, such as emotional or psychiatric problems. And like cardiovascular disease and diabetes, addiction is recognized as a chronic disease; so it must be treated, managed and monitored over a person’s lifetime, the researchers say.

Two decades of advancements in neuroscience convinced ASAM officials that addiction should be redefined by what’s going on in the brain. For instance, research has shown that addiction affects the brain’s reward circuitry, such that memories of previous experiences with food, sex, alcohol and other drugs trigger cravings and more addictive behaviors. Brain circuitry that governs impulse control and judgment is also altered in the brains of addicts, resulting in the nonsensical pursuit of “rewards,” such as alcohol and other drugs.

A long-standing debate has roiled over whether addicts have a choice over their behaviors, said Dr. Raju Hajela, former president of the Canadian Society of Addiction Medicine and chair of the ASAM committee on addiction’s new definition.

“The disease creates distortions in thinking, feelings and perceptions, which drive people to behave in ways that are not understandable to others around them,” Hajela said in a statement. “Simply put, addiction is not a choice. Addictive behaviors are a manifestation of the disease, not a cause.”

Even so, Hajela pointed out, choice does play a role in getting help.

“Because there is no pill which alone can cure addiction, choosing recovery over unhealthy behaviors is necessary,” Hajela said.

This “choosing recovery” is akin to people with heart disease who may not choose the underlying genetic causes of their heart problems but do need to choose to eat healthier or begin exercising, in addition to medical or surgical interventions, the researchers said.

“So, we have to stop moralizing, blaming, controlling or smirking at the person with the disease of addiction, and start creating opportunities for individuals and families to get help and providing assistance in choosing proper treatment,” Miller said.