ACLU: standing up for discrimination and libelous statements from Wal Mart employee

Posted on April 14, 2017 by Pharmaciststeve

MSU professor files lawsuit against world’s largest retailer

http://www.abcfoxmontana.com/story/35149595/msu-professor-files-lawsuit-against-worlds-largest-retailer

BOZEMAN –  A professor at Montana State University is taking on Walmart. Court documents, filed Thursday state that MSU professor Gilbert Kolande is suing the world’s largest retailer for libel.  

Kalonde is currently working as an Assistant Professor of Technology and Education at MSU.

Court documents state in 2015, Kalonde, who was born in Zambia and is of African descent, purchased a fishing license at Walmart.

As a necessary part of obtaining a fishing license, the licensing agent, in this case the Walmart employee is required to ask for identification and occupation.

Kalonde told the Walmart employee his occupation was “faculty/professional.” However, instead of putting down his correct occupation, the Walmart employee allegedly entered “cleans toilets” into the FWP database.    

Kolande alleges the entry made was “deliberately false” and done with the purpose of exposing Kolande to “hate and ridicule.”

Bozeman is a hub for fishermen and woman, some to whom I spoke say they are shocked by the licensing agent’s alleged actions.

Bozeman resident Jack Ranieri said, “I mean, it’s an insult to say the least, where they came up with that is crazy for a college professor.”

While another Kit Williams disagreed, “Whether he has a case or not, I’m not sure. But I know that I think he should get over his own ego because I think there is a lot of good toilet cleaners and there just as much of a necessity as doctors.”

Court records show, Kolande told a faculty employee that where he’s from someone who cleans toilets is often “shunned” from society.”

Jim Taylor, Kolande’s Legal Director at the ACLU says they have tried to reach out to Walmart for a settlement.

Taylor stated, “They haven’t really responded for settlement negotiations, we have tried to resolve this in a very simple way.”

Taylor also says, in addition to the libel claim, they have filed a racial discrimination claim with the Human Rights Bureau. 

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FDA warning letter: PAPER TIGER ?

Posted on April 14, 2017 by Pharmaciststeve

FDA jumps on another Mylan plant in India, slapping it with a warning letter

http://www.fiercepharma.com/manufacturing/fda-slaps-another-mylan-plant-india-a-warning-letter

Less than two years after being slapped hard by the FDA for problems at three plants it got in its buyout of a sterile injectables specialist Agila Specialties, another Mylan plant in India has been issued a warning letter for ongoing data integrity issues.

In the warning letter, issued last week and posted by the FDA today, the agency said investigators continued to find issues with batch testing results disappearing from computers when failed tests were involved. The observations were based on an inspection of the finished pharmaceutical plant in Maharashtra, India.

In a statement today, a Mylan spokesperson said the company was working closely with the FDA to address the issues raised in the warning letter.  “Mylan has always had a deep and unwavering commitment to quality everywhere we operate.”

She noted that the plant is just one of 50 the company has and that the warning letter would not result in any supply disruptions. 

The FDA, however, noted in its warning letter that the plant had been cautioned during an inspection in 2015 about missing data.

It noted that even though the facility invalidated 101 of 139 initial out-of-specification (OOS) assay results, about 72%, employees never thoroughly investigated to find the root cause of the issues and didn’t include them in the results reported to the agency.

“Because your laboratory investigations frequently invalidate initial failures without cause, your laboratory trending excludes a large proportion of data that would otherwise alert you to problems in your laboratory system,” the FDA said, pointing out that the agency has discussed this kind of issue before.  

Further it criticized the quality control lab for not bothering to look into error signals from the HPLC computers indicating loss of data. The lab blamed the problems on power interruptions and computer connectivity problems, but couldn’t explain why they so often happened in the lab and why it didn’t bother to find a root cause.

The agency ordered Mylan to go back and document all of the missing data and figure out what impact those failed tests may have had on its drugs. It said the company needs a corrective action plan to deal with the issue so it is not repeated going forward.

In 2015, the FDA savaged three of the sterile injectables plants that it got in its $1.75 billion buyout of Agila Specialities from India’s Strides Arcolabs. It said it knew the company had only recently acquired them, but pointed out that one had been cited in a warning letter before Mylan bought it, giving the company an indication there might be manufacturing issues that needed to be addressed. Considering Mylan’s extensive experience in generic drugs, the agency said, that should have been enough for the company to get control of problems there as soon as it took over.

Related: Mylan fired workers at Agila plants after getting FDA warning letter

Mylan pledged to do better, but also went after and received from Strides a $70 million payment to help cover the costs.

Problems with data integrity have plagued many Indian drugmakers, like Sun Pharma and Wockhardt, resulting in an avalanche of FDA warning letters in the last few years.

The FDA this year issued a warning letter to a Wockhardt plant in India for issues including data integrity. It followed that up with a warning for a Wockhardt plant in the U.S. that castigated the company for not getting on top of these issues despite ongoing FDA discussions about its problems at other Mylan plants. It pointed out that the warning letter for the U.S. plant was the company’s sixth for seven Wockhardt plants, three of which have been banned from shipping to the U.S.  

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acceptance (of pain) might make the intensity of pain less important to a person’s functioning and quality of life

Posted on April 14, 2017 by Pharmaciststeve

Intensity of Chronic Pain — The Wrong Metric?

http://www.nejm.org/doi/full/10.1056/NEJMp1507136#t=article

Jane C. Ballantyne, M.D., and Mark D. Sullivan, M.D., Ph.D.

N Engl J Med 2015; 373:2098-2099November 26, 2015DOI: 10.1056/NEJMp1507136

Pain causes widespread suffering, disability, social displacement, and expense. Whether the issue is viewed from a moral, political, or public health perspective, pain that can be relieved should be relieved. Yet the most rapidly effective drugs for relieving pain — opioids — are caught up in a morass of concerns about addiction. Achieving a balance between the benefits and potential harms of opioids has become a matter of national importance.

The United States recently established a national plan to address pain, as Canada, Australia, Portugal, and Malaysia have previously done.1 This National Pain Strategy grew out of recognition by the Institute of Medicine (now the National Academy of Medicine) of the enormous burden of chronic pain in the United States. For three decades, there has been hope that more liberal use of opioids would help reduce the number of Americans with unrelieved chronic pain. Instead, it produced what has been termed an epidemic of prescription-opioid abuse, overdoses, and deaths — and no demonstrable reduction in the burden of chronic pain.2

Although the chronic-pain crisis can be attributed in part to the aging of the population, improved survival from disease and trauma, changes in disability policy, and multiple factors such as obesity that contribute to chronic ill health, the suggestion that chronic pain can and should be eliminated by opioids hasn’t helped. The National Pain Strategy concludes that current reimbursement policies, provider attitudes and training, and “myths, misunderstandings, stereotypes, and stigma” in the health care system have denied Americans the benefit of evidence-based multimodal approaches to managing chronic pain, in favor of costly interventions that don’t produce long-term benefit. Opioids are a case in point: they have good short-term efficacy, but there is little evidence supporting their long-term benefit. The National Pain Strategy emphasizes the importance of self-management and interdisciplinary treatments and recognizes that drug treatment alone has limited utility when it comes to managing chronic pain.

During the late 1980s and early 1990s, it was argued, largely on moral grounds, that opioids should be available for treating chronic pain, and physicians were persuaded that addiction to opioid treatment would be rare. Both the idea that chronic pain could be effectively and safely managed with opioids and the principles of opioid pain management were based on the successful use of these drugs to treat acute and end-of-life pain. That success was based on the “titrate to effect” principle: the correct dose of an opioid was whatever dose provided pain relief, as measured by a pain-intensity scale. The dissemination of the World Health Organization’s stepladder approach to managing cancer pain was the beginning of widespread adoption of reduction of pain intensity as the goal of drug treatment. When the Joint Commission for the Accreditation of Healthcare Organizations (now the Joint Commission) introduced a mandate that pain be recognized and treated, numerical ratings of pain intensity were chosen as the chief metric. The promotion of pain as the “fifth vital sign” was a response to that mandate.

But is a reduction in pain intensity the right goal for the treatment of chronic pain? We have watched as opioids have been used with increasing frequency and in escalating doses in an attempt to drive down pain scores — all the while increasing rates of toxic drug effects, exposing vulnerable populations to risk, and failing to relieve the burden of chronic pain at the population level. For many patients, especially those who have become dependent on opioids, maintaining low pain scores requires continuous or escalating doses of opioids at the expense of worsening function and quality of life. And for many other people, especially adolescents and young adults, increased access to opioids has led to abuse, addiction, and death.

Pain-intensity ratings aren’t necessarily a reflection of tissue damage or sensation intensity in patients with chronic pain. The intensity of chronic pain can’t be reliably predicted from the extent or severity of tissue damage, since chronic pain is not determined primarily by nociception. Functional neuroimaging studies and other prospective clinical studies have shown that what feels like the same pain is initially associated with the classic sensory “pain matrix” brain regions but is later associated with brain regions involved in emotion and reward. Thus, over time, pain intensity becomes linked less with nociception and more with emotional and psychosocial factors.3

Suffering may be related as much to the meaning of pain as to its intensity. Short-lived pain may be excruciating, but it is better tolerated and causes less suffering because it’s finite and may be necessary to attain a valuable goal, such as childbirth, healing, or athletic achievement. Persistent helplessness and hopelessness may be the root causes of suffering for patients with chronic pain yet be reflected in a report of high pain intensity. Strong support for such a relationship between the meaning of pain and the degree of suffering can be found in the relief that occurs because anxiety is reduced when the source of pain is understood, pain is no longer a threat, or effective treatment is known to be at hand.4

Many of the interdisciplinary and multimodal treatments recommended in the National Pain Strategy use coping and acceptance strategies that primarily reduce the suffering associated with pain and only secondarily reduce pain intensity. Willingness to accept pain, and engagement in valued life activities despite pain, may reduce suffering and disability without necessarily reducing pain intensity. Patients who report the greatest intensity of chronic pain are often overwhelmed, are burdened by coexisting substance use or other mental health conditions, and need the type of comprehensive psychosocial support offered by multimodal treatment approaches. Reliance on pain-intensity ratings tends to result in the use of opioid treatment for patients with mental health or substance abuse problems who are least likely to benefit from opioid treatment and most likely to be harmed by it — a phenomenon we have termed “adverse selection.”5 These patients are more likely than others to be treated long-term with opioids and sedatives, to misuse their medications, and to experience adverse drug effects leading to emergency department visits, hospitalizations, and death.

The National Pain Strategy outlines a number of initiatives to help achieve the “cultural transformation” needed to ease the burden of chronic pain in the United States. Many of these initiatives recognize that chronic pain differs from short-lived pain in its causes, psychopathology, and social meaning. Borrowing treatment principles from acute and end-of-life pain care, particularly a focus on pain-intensity scores, has had unfortunate and harmful consequences. The titrate-to-effect principle fails when pain is chronic, because our best chronic-pain treatments don’t produce an immediate or substantial change in pain intensity. Multimodal therapy encompasses behavioral, physical, and integrated medical approaches. It is not titrated to pain intensity but has a primary goal of reducing pain-related distress, disability, and suffering. When it does that successfully, a reduction in pain intensity might follow — or acceptance might make the intensity of pain less important to a person’s functioning and quality of life.

We propose that pain intensity is not the best measure of the success of chronic-pain treatment. When pain is chronic, its intensity isn’t a simple measure of something that can be easily fixed. Multiple measures of the complex causes and consequences of pain are needed to elucidate a person’s pain and inform multimodal treatment. But no quantitative summary of these measures will adequately capture the burden or the meaning of chronic pain for a particular patient. For this purpose, nothing is more revealing or therapeutic than a conversation between a patient and a clinician, which allows the patient to be heard and the clinician to appreciate the patient’s experiences and offer empathy, encouragement, mentorship, and hope.

 

Dr. Ballantyne reports receiving grants from Pfizer and being president of Physicians for Responsible Opioid Prescribing. Dr. Sullivan reports receiving grants from opioid REMS program companies and personal fees from Janssen and Relievant.

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Alabama: Alprazolam rescheduling to C-II DOA !

Posted on April 14, 2017 by Pharmaciststeve

Alabama Battle Over Alprazolam is Done. For Now.

deachronicles.quarles.com/2017/04/alabama-battle-over-alprazolam-is-done-for-now/

The battle is over! For now.

Yesterday, Alabama lawmakers blocked the proposal to move Alprazolam into Schedule II, as well as blocking the other proposed changes described in this series of client updates. See here and here. The pharmacy community in Alabama took an active role in opposing these changes. According to this article from Alabama Live, members of the Alabama Pharmacy Association opposed this change and as noted in our most recent update, the Alabama Board of Pharmacy was also encouraging pharmacists to reach out to their legislators to share their concerns. It looks like all of this hard work has paid off. Will this come back? Hard to tell, but we will continue to watch how Alabama and other states try to manage and prevent the abuse of prescription medications.

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AG Jeff Sessions: wants to enforce our laws… “Trump era of law enforcement”

Posted on April 13, 2017 by Pharmaciststeve

It has been stated that AG Session is going to “reactivate”the war on drugs.. turn back the clock to the 90’s. Except in the early 90’s there was no Americans with Disability Act and the original act was “very vague” for Congress intended for the law to be defined in our court system… which would take years.. could that have been so that the ADA and the war on drugs could co-exist ?

Back then there was no FIVE STAR RATING system for Medicare/Medicaid.. which if pts file grievances.. the vendor’s (prescriber, hospital, insurance company, pharmacy/pharmacist) could be lowered if enough grievances are filed by pts for “bad care”. To www.cms.gov – 800 Medicare.

If the prescriber lowers the pt’s chronic pain medication(s) but doesn’t increase/decrease the pt’s medication(s) for the rest of the pt’s chronic conditions… then discrimination against the pts because of their medical conditions require treatment with a controlled substances could be claimed. And a complaint can be filed with https://www.ada.gov/filing_complaint.htm     which is under AG Session’s Dept of Justice..

Elder/Senior Abuse laws are mostly at the state level.

If the prescriber claims that he/she is adopting the CDC guidelines… those guidelines are for acute pain pts… not chronic pain pts.. This means that the prescriber has adopted the CDC guidelines as their practice’s standard of care and best practices.  Failure to adhere to their own policies can be considered MALPRACTICE and can also be used to document Elder/Senior Abuse and discrimination under ADA.

Here is four quotes from the CDC opiates guidelines:

https://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm

“The guideline is intended to ensure that clinicians and patients consider safer and more effective treatment, improve patient outcomes such as reduced pain and improved function.”

“Clinicians should consider the circumstances and unique needs of each patient when providing care.”

“Clinical decision making should be based on a relationship between the clinician and patient, and an understanding of the patient’s clinical situation, functioning, and life context.”

“This guideline provides recommendations for primary care clinicians who are prescribing opioids for chronic pain outside of active cancer treatment, palliative care, and end-of-life care.”

They are using “the laws” to control what/how much medical care that pts diagnosed with subjective disease and have a medical necessity for being prescribed controlled substances…. but… there are laws on the books to protect those same pts suffering from subjective diseases from being discriminated against and/or harmed/abused.

Pts need to document what the prescribers are stating… recording audio/video… ask for a copy of the practice’s policies and procedures concerning controlled substances prescribing, or the plan of treatment that the prescriber has prepared for treating a particular pt’s disease states.

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GA Bureaucracy: With more regulation comes better outcomes.

Posted on April 13, 2017 by Pharmaciststeve

Georgia moving to regulate another industry, in the name of consumer protection

investigations.blog.ajc.com/2017/04/13/georgia-moving-to-regulate-another-industry-in-the-name-of-consumer-protection/

Georgians who need oxygen equipment, walkers, blood sugar monitors or other durable medical equipment could be impacted by legislation now awaiting the governor’s signature. But there’s debate over whether it will provide those consumers with important protections or increase medical costs by unnecessary regulations.

Under the legislation, many suppliers of durable medical equipment would have to have a state license to sell to Georgia residents. To get the license, the companies would have to have an office or place of business in Georgia. They also would have to meet state standards, such as training for all workers who deliver, maintain or repair equipment, and could be subject to other rules set by the State Board of Pharmacy.

For years, the Georgia Association of Medical Equipment Suppliers (GAMES) has lobbied for such a law. But prior versions of the bill failed after criticism that the proposals were intended primarily to protect Georgia businesses from out-of-state and internet competition.

 

Last summer, the Georgia Occupational Review Council, which reviews all bills that propose licensing of a business or profession, reported that a version of the bill then under consideration could raise costs without providing additional consumer protections.

The council also said there was no documented evidence or pattern of Georgia customers being harmed, and that Medicare and Medicaid already require suppliers to meet standards that protect customers.

But Georgia consumers now have no local agency to handle and investigate complaints about medical equipment suppliers, so there is no way of determining the number of problems people here have faced, said GAMES president Tyler Riddle.

He also said that because the state hasn’t tracked the medical equipment businesses, it doesn’t know if those who deliver the equipment to patient homes may have criminal records. “It’s kind of terrifying,” he said.

The legislation would provide state-level accountability, he said. In the medical field, he said, “With more regulation comes better outcomes.”

Only equipment prescribed by doctors and covered by Medicare, Medicaid or private insurance is covered by the legislation. Because they already monitor payment rates, Riddle said, licensing should not spike costs.

“This legislation doesn’t stop anyone from selling non-prescription items, like bedside commodes,” he also noted.

Georgia suppliers, like those nationwide, have been struggling in recent years after the federal government began competitive bidding for supplying certain durable medical equipment for people on Medicare. Under that process, Medicare establishes what it will pay based on national bid averages. Since the bidding began in 2011, Medicare says it has saved hundreds of millions of dollars.

But the industry, which has criticized the competitive bidding process as flawed, said nearly 40 percent of businesses have either closed or been sold to a national provider since bidding began.

The Georgia council last summer had reported that large national providers without bricks-and-mortar locations in Georgia have lower overhead and can offer a lower bid than in-state competitors.

Photo: City of Millville, NJ

But many states already regulate home medical equipment suppliers, and the business is primarily a local one, said Tom Ryan, president and CEO of the American Association for Homecare, an industry advocacy group. The association has found that state regulations are pro-patient and pro-small business, he said.

Often, businesses that provide equipment must conduct a home assessment, such as making sure that a home meets electrical requirements for a ventilator.

“I wouldn’t want oxygen drop-shipped to a patient’s home with an instruction sheet,” he said.

The Georgia bill was approved March 30. The governor has 30 days to approve or veto it.

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Opioids after surgery: Which patients don’t stop when they should

Posted on April 13, 2017 by Pharmaciststeve

Opioids after surgery: Which patients don’t stop when they should

http://www.foxnews.com/health/2017/04/12/opioids-after-surgery-which-patients-dont-stop-when-should.html

The first time many patients in the United States take prescription opioid painkillers is following surgery. But not everyone puts away the pills: In a new study, researchers found that 6 percent of patients continued to use the drugs for at least three months after surgery.

The researchers wanted to know more about why some people continue to use the drugs while others don’t, so they looked at the types of surgery people had. But it turned out that it didn’t matter whether someone had a major operation, such as bariatric surgery or a hysterectomy, or a minor procedure, such as varicose vein removal; there was no difference in how likely people were to continue to use opioids past the three-month mark.

However, the findings showed that the people who were more likely to continue to use the painkillers were those who smoked, drank alcohol, had certain mood disorders or had chronic pain.

The findings suggest that whether a person continues to take prescription painkillers long after his or her surgery “is not due to surgical pain but addressable patient-level” risk factors, the researchers wrote in the study.

In the study, a team of researchers led by Dr. Chad Brummett, an associate professor of pain management anesthesia at the University of Michigan Medical School, looked at data on more than 36,000 patients who received opioid painkillers after surgery in 2013 and 2014 but had not taken opioids at any point in their lives before that. The majority of the patients (80 percent) had minor surgeries, such as varicose vein removal or carpal tunnel surgery; the remaining 20 percent of the patients had major surgeries, such as bariatric surgery or surgery to remove the uterus.

The researchers found no statistically significant difference between the people who had major surgery and those who had minor operations in their likelihood to continue using opioids, according to the study.

Having ruled out the type of surgery as a predictor of who would continue to use opioid painkillers, the researchers looked to other factors.

People who smoked cigarettes, drank alcohol or had substance-abuse problems were more likely to continue taking opioids long after their surgeries, according to the study. For example, smokers were 35 percent more likely to continue taking opioids compared with people who didn’t smoke. Those who had an alcohol or substance-abuse disorder were 34 percent more likely to continue taking opioids compared with people who didn’t have one of those conditions.

In addition, people with anxiety were 25 percent more likely to continue taking opioids, the researchers found.

Finally, people who had chronic pain before their surgeries were 39 percent more likely to continue using the painkillers.

Though the study included only 36,000 patients, the researchers estimated that, based on the number of surgeries that occur in the United States each year, as many as 2 million people could start using opioids after a surgical procedure each year.

Because the study was observational, the researchers found only an association between prolonged use of opioids and certain risk factors. In other words, smoking or drinking, for example, don’t necessarily cause a person to continue to use opioid painkillers; rather the study showed that people who already smoke or drink may be more likely to do so. 

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Empathy, active listening are key to communicating with patients who have chronic pain

Posted on April 12, 2017 by Pharmaciststeve

Empathy, active listening are key to communicating with patients who have chronic pain

http://pharmacytoday.org/article/S1042-0991(17)30398-5/fulltext

As the opioid epidemic surges and the government tightens its regulatory grip on prescribing, pharmacists must walk a thin line between providing compassionate care and complying with the law—and sometimes they stumble, leaving their patients with chronic pain feeling questioned and alienated.

“That’s the problem with the CDC guidelines [for prescribing opioids]. People think the guidelines are punitive and absolute, so they go into suspicion mode. Practitioners can become zealots, and the legitimate pain patients pay the price,” Mary Lynn McPherson, PharmD, MA, BCPS, CPE, professor and executive director of advanced postgraduate education in palliative care in the department of pharmacy practice and science at University of Maryland School of Pharmacy in Baltimore, told Pharmacy Today.

Myths about pain don’t help, said Joni I. Berry, PharmD, MS, FAPhA, consultant pharmacist in Raleigh, NC. Berry advises pharmacists to revisit their understanding of pain.

“One of the biggest myths is that a health professional can tell if someone is in pain, but it’s not something you can measure like blood pressure. How someone expresses pain could be anything from tears to anxiety,” Berry said. “The bottom line is that when pain patients present a prescription, they’re no different from anyone else coming in with any other condition and any other prescription. You’re there to serve their needs, so you approach them like you would everyone else.”

The big E

Empathy is a huge part of communicating about pain successfully, said Berry. “Just letting patients know you hear them is going to help. It can defuse the situation and take your own anxiety down as well.”

One way to tap into empathy is to ask questions, said McPherson. “People in pain are happy to tell you about it. When talking about medications, I like the Dr. Phil approach. I ask, ‘How’s that working for you?’ It’s not accusing.”

Berry came to believe in the power of validation after witnessing a colleague address a patient with residual postoperative pain. “He sat down at the same level as the patient, face to face, and said, ‘You must be in a tremendous amount of pain.’ The patient stopped, teared up, and thanked him.”

Berry added that patients who are drug-seeking often don’t respond to validation. “They would keep asking for medication and keep saying they’re in pain. When you attempt to validate someone’s feelings, if the pain is real you’re probably going to stop them in their tracks.”

Active listening

When patients answer questions, their delivery is as important as the words they use, said McPherson. She suggests pharmacists ask about the “three Ps”: precipitating, palliating, and previous treatments.

“What causes the pain? What nondrug solutions relieve the pain? What other treatments has the patient tried? They should be able to answer those questions without hesitation,” McPherson said. “If they look like they don’t know what you’re talking about, that’s not a good sign.”

Pharmacists should be careful about tossing off advice, said Berry. “The patient has probably heard a million different things they can do for pain. Say you’ve noticed their medication doesn’t seem to be working, and ask if recommendations would be helpful, instead of giving information they may have already heard.”

If pharmacists suspect drug-seeking, the tough questions should be couched in terms of trying to understand the patient, McPherson added. “You could say you’ve noticed the patient is always early to fill the opioid prescription but never fills the Lyrica prescription, and ask why. There could be a legitimate reason, like a patient thinking they’re allergic to a medication when really the dose is too much.”

Even when suspicion runs high, it’s best to make the process about the patient’s health, McPherson said. “Don’t say, ‘I think you’re addicted.’ Instead, say something like, ‘Generally this medication is not used for years. I would like to discuss this with your doctor to make sure we’re doing the best job we can for you.’

“Be vigilant, because it’s our responsibility to protect patients and society by not dispensing something inappropriate, but don’t go overboard,” McPherson added. “It’s [hard] to be a legitimate pain patient today. Explore all the avenues.”

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England’s Nat Health Service has put a $$$ on the cost of a life ?

Posted on April 12, 2017 by Pharmaciststeve

Opdivo for head and neck cancer too expensive for NHS use, says NICE

https://www.thepharmaletter.com/article/opdivo-for-head-and-neck-cancer-too-expensive-for-nhs-use-says-nice

In yet another negative decision of a new cancer drug, the medicines cost-effectiveness watchdog for England and Wales has issued new draft guidance that has also come in for criticism from the Institute for Cancer Research, though the latter sees a role for Pharma to reduce the cost of drug development.

The National Institute for Health and Care Excellence (NICE) said today that it does not recommend US pharma major Bristol-Myers Squibb’s (NYSE: BMY) Opdivo (nivolumab) for the treatment of head and neck cancer. The anticipated marketing authorization for nivolumab is for treating squamous cell carcinoma of the head and neck which has progressed during or after platinum-based chemotherapy.

The NICE appraisal committee found that the evidence showed a significant improvement in overall survival rates in the short term after nivolumab. However, its value for money was considerably above that which is usually a cost-effective use of National Health Service resources.

“The committee heard that treatment options for patients in this area are limited, and it’s important to patients that treatment extends their life and improves the quality of life,” noted Professor Carole Longson, director of the Health Technology Evaluation Centre at the NICE, adding: “But the additional costs of nivolumab were considered to be very high in relation to its benefit to be recommended for routine NHS use at present.”

Consultees, including the company, healthcare professionals and members of the public are now able to comment on the draft recommendations via the NICE website until Thursday 4 May. All comments received during this consultation will be fully considered by the committee and a second draft of the guidance will be published. 

If there are no objections at that stage, NICE will publish final guidance to the NHS. Until then, NHS bodies should make decisions locally on the funding of specific treatments. 

Although the NICE draft guidance does not recommend nivolumab for treating head and neck cancer, it does state that people already receiving the drug may continue until they or their doctor thinks it’s appropriate to stop.

“Disappointing and frustrating,” says ICR expert

“It is disappointing and frustrating that today’s decision means doctors will not be able to offer this game-changing immunotherapy to patients with advanced head and neck cancer. Once it has relapsed or spread, the disease is extremely difficult to treat and options, including surgery and radiotherapy, are very limited,” said Kevin Harrington, Professor of Biological Cancer Therapies at The Institute of Cancer Research (ICR), London, and Consultant Clinical Oncologist at The Royal Marsden NHS Foundation Trust, who led the UK arm of the phase III clinical trial of nivolumab for advanced head and neck cancer.

He continued: “Nivolumab is an expensive drug but it is also the only treatment shown in a Phase III trial to improve survival for this group of patients – and it did so without worsening patients’ quality of life, and with fewer side-effects than other options. It’s crucial that talks on the drug’s availability continue and ultimately that this decision is reversed, since otherwise patients face missing out on a genuinely effective treatment simply because of cost.”

ICR chief executive Prof Paul Workman added: “This decision denies patients a genuine breakthrough treatment that makes a real difference for people with relapsed of metastatic head and neck cancer. It is another example, and a particularly stark one, of an innovative cancer therapy not being made available on the NHS because of cost. I’d urge NICE and the manufacturer to work together to reach an agreement on price so that this decision can be overturned as soon as possible.

“We need to recognize that the price of cancer drugs is much too high, and that’s particularly the case with the exciting new wave of immunotherapies. We need pharmaceutical companies to bring down the cost of drug development through smaller, more targeted trials, and to do much more to pass on the savings to patients. NICE for its part must take much greater account of innovation in its appraisal processes, to give exciting treatments like nivolumab a better chance of reaching patients.”

ICER and QALY of Opdivo

The appraisal committee concluded that the incremental cost effectiveness ratios (ICERs) for nivolumab would be above the range of £66,000 to £75,000 ($81,774-$92,925; ERG) per quality-adjusted life-year (QALY) gained compared to other treatments – considerably above that usually considered to be a cost-effective use of NHS resources (£20,000 to £30,000 per QALY gained).

The committee concluded that nivolumab met all the criteria to be considered a life-extending end-of-life treatment. The committee considered that the most plausible ICER was likely to be above £50,000 per QALY gained, and concluded that the amount of additional weight that would need to be assigned to the QALY benefits in this patient group would be too great for nivolumab to be considered a cost-effective use of NHS resources. The company has agreed a patient access scheme with the Department of Health.

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officer Joe Lloreda “made the decision to abruptly discontinue Jacobs’s Alprazolam (Xanax)

Posted on April 12, 2017 by Pharmaciststeve

Wrongful death lawsuit filed in case of man who died in Galveston jail

http://setexasrecord.com/stories/511101163-wrongful-death-lawsuit-filed-in-case-of-man-who-died-in-galveston-jail

GALVESTON – A Texas family has filed a wrongful death lawsuit in connection with the 2015 death of their son in the Galveston County Jail.

Jesse R. and Diane Jacobs filed the lawsuit in the Galveston Division of the Southern District of Texas in the death of their son, Jesse C. Jacobs.

 

The lawsuit names Mary Johnson, Boon-Chepman Benefit Administrators Inc., Soluta Inc. Soluta Health Inc., Care Here, the estate of Dr. Teresa Becker, Dr. Harry Louis Faust, Dr. Linea McNeel, Dr. Gary Beech, Kathy White (also known as Kathy Jean Jordan), Will George, Robin Bartholomew, Mellissa Faulk, Joe Lloreda, Monica McCray, Josephine Irogbu and Deborah Wiggins as defendants.

The Jacobs family is represented by the Lewis Law Group PLLC of Houston. They are seeking a jury trial.

According to court records, Jesse Jacobs, 32, died in police custody in March 2015 after his Xanax prescription was withheld from him.

The lawsuit states that he did not receive adequate medical care while he was held in the Galveston County Jail for eight days.

Jacobs reported to the jail on March 6, 2015, after pleading guilty a month earlier to DWI charges. He had received a 30-day sentence.

Court records indicate that Jacobs informed jail officials that he was prescribed and had been taking Xanax for a severe panic disorder. He also presented his bottle of prescription, with pills and a letter from his treating physician.

According to court records, the letter from Dr. Don LaGrone stated that it was “imperative” that he take the medications everyday.

The lawsuit notes that intake officer Joe Lloreda “made the decision to abruptly discontinue Jacobs’s Alprazolam (Xanax) medication without any tapering orders and failed to take steps to prevent any foreseeable withdrawal symptoms. He further failed to contact any physician regarding his possible withdrawals before denying him of his medication resulting in Alprazolam (Xanax) withdrawals.”

Three physicians that also worked at the jail – Faust, Becker and McNeel – each signed off on Lloreda’s intake order detailing the detoxification protocol and withdrawals, the suit states.

The suit also notes that on March 9, Jacobs called home and spoke to his mother on a recorded jail call. He noted that he had not seen a doctor yet, even though Faust maintained that he had. His medical chart indicates that he was feeling “irritable, difficulty concentrating, heart racing, anxious, sweating, and moisture on forehead,” with not one symptom noted to be addressed by medical personnel.

According to court records, during his detention in the jail, Jacobs’ symptoms worsened. He suffered panic attacks, including sweating, disorientation, palpitations, nausea, panic, anxiety, and terrible seizures day after day without any emergency medical attention to prevent these symptoms, until his final day in the Galveston County Jail, when he was found on the floor of his jail cell drooling and unresponsive.

After Wiggins found Jacobs in this emergency state, and before CPR emergency services were performed, or a call was made to 911 for emergency services, Wiggins left Jacobs with the deputy to return to the clinic, the suit states.

The lawsuit contends that she “retrieved ammonia caps to use on Jacobs, despite his having difficulty breathing, in an effort to confirm Jacobs was not faking, pursuant to jail policy, and summoned another nurse, Monica McCray, who also worked overnight to return with her to Jacobs’ cell,” according to the suit.

Jacobs had stopped breathing in his cell and court records note that 911 emergency services were summoned to revive him. In the interim, the suit notes that Wiggins vegan low effort chest compressions.

The suit further noted that McCray brought a crash cart, with an automatic defibrillation and attached it to Jacobs. The cart was attached and his vitals were captured. No pulse was detected and no shock was administered.

Jacobs was transported to a local hospital where he died one day later.

The suit states that jail officials and Boon-Chapman’s Soluta Health Medical Personnel refused to treat Jacobs for his seizures, except for documenting some of the seizures.

It also alleges that Jacobs suffered from withdrawal symptoms, as a result of the abrupt disruption of the medication that his body became physically dependent upon, and needed.

Moreover, court records indicate that jail officials and medical personnel ignored Jacobs’ complaints, “intentionally failed to provide medical treatment him by abruptly discontinuing his long term high dose alprazolam, and had wanton disregard, and deliberate indifference for Jesse C. Jacobs’ serious medical needs.”

Their decisions and a delay of outside emergency treatment, according to the suit, resulted in Jacobs’ death.

The lawsuit also claims that the Galveston County and Galveston County Sheriff and other defendants required the detoxification protocol action against inmates entering the jail facility by intake personnel, on a basis and standard of just “knowing it” or admission by an inmate that they are on a substance, as Jacobs did, without considering whether the individual is using the substance legally as a prescribed medication.

Further, the lawsuit claims that Jacobs’ civil rights, under the Eighth and 14th amendment of the United States Constitution “to be free from cruel and unusual punishment, to receive proper medical care, and to receive adequate medical care, while incarcerated and under the custody and control of Galveston County, at the Galveston County Jail under the supervision and control of the Galveston County Sheriff, Galveston County John Doe Jailers 1-20 and Galveston County Jail’s contracted medical providers.”

The lawsuit also contends that more than 28 medical individuals came into contact with Jacobs, and “each individual failed to address his withdrawals symptom at all, other than document them and the other two medical personnel individuals failed to adequately address the withdrawals symptoms.” It notes that the medical personnel also knew the dangers of failing to ensure that Jacobs received his medication or a suitable substitute.

The lawsuit also contends that Jacobs was placed in a violent solitary cell, where he remained until he died, and had to be revived placed on life support, only to be pronounced dead the following day.

It also claims that Jacobs was discriminated against because of his disability, anxiety disorder and was denied reasonable accommodations in the jail by Soluta Health and Boone Chapman.

The suit also claims medical negligence under the Texas Healthcare Liability Act and supervisor liability. It seeks punitive and exemplary damages against each defendant as well as compensatory general damages.

In filing the lawsuit, Jacobs’ parents, as representatives of his estate, are seeking fair compensation and also hope to prevent another the occurrence of a similar incident in any Texas jail.

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