I sense a clinical study designed to reach a predetermine conclusion

Posted on February 28, 2019 by Pharmaciststeve

FDA takes fresh look at whether opioids are effective for chronic pain

www.bangordailynews.com/2019/02/26/national-politics/fda-takes-fresh-look-at-whether-opioids-are-effective-for-chronic-pain/
Lenny Bernstein and Laurie McGinley, Washington Post •

The Food and Drug Administration will require drug companies to study whether prescription opioids already on the market are effective in quelling chronic pain – another step in the government’s efforts to rein in use of the narcotics that spawned the drug epidemic.

Some studies already indicate that opioids are ineffective for pain beyond 12 weeks and many experts say long-term use can cause addiction, by prompting patients to build up tolerance to the drugs and seek higher doses. But conclusive, controlled research is scarce.

A finding of ineffectiveness in more rigorous studies supervised by the FDA could allow the agency to change the labeling on some opioids, impose special rules for prescribing, dispensing and taking them and even prohibit their use in some cases, according to FDA Commissioner Scott Gottlieb.

“We are going to impose a mandate on existing products . . . to answer the question that people have been posing for years: whether you have declining efficacy, and whether that declining efficacy can lead to addiction,” Gottlieb said in an interview.

But at least one longtime critic of the FDA’s response to the opioid crisis expressed frustration with the move. Andrew Kolodny, director of Physicians for Responsible Opioid Prescribing, said the FDA already has all the research it needs – and authority under existing law — to tighten restrictions on the use of opioids for chronic pain by changing instructions for how they should be prescribed.

Here we go again,” Kolodny said in an interview. “That’s exactly what the FDA said to us in 2013. . . . Five years later, we don’t have the studies and another FDA commissioner says ‘we’re going to do the studies.’ “

Gottlieb said the new research is aimed at all immediate, long-acting and extended-release opioid tablets taken by patients outside of health-care settings. It would cover products already on the market and new applications, Gottlieb said. It would not include painkillers used short-term inhospitals, for instance. Opioid painkillers were originally intended for the severe pain of cancer and end-of-life care, but beginning in the late 1990s, drug companies helped persuade doctors to offer them for a wide variety of less serious conditions.

Each manufacturer would be required to sponsor unbiased, controlled research of its opioid products, likely at universities, he said.

The FDA also is mandating a second study, Gottlieb said, to determine whether opioids can actually cause users to become more sensitive to pain, a condition known as “hyperalgesia.” Preparations for that research by a consortium of companies are farther along and it should start soon, he said.

In 2013, after Kolodny’s group complained that opioids should be labeled unsafe and ineffective for chronic pain, the FDA ordered similar research, including an attempt to determine whether painkillers cause hyperalgesia. Gottlieb said those studies were difficult to carry out because, at the time, the FDA had authority only to require post-market studies of safety, rather than effectiveness.

On Sunday, the CBS program “60 Minutes” explored the FDA’s decision in 2001 to allow long-term use of OxyContin despite the lack of research showing it was safe and effective. Gottlieb conceded that “it’s regrettable we didn’t do this many years ago.”

The vast majority of opioid prescriptions written in 2017 were for generic versions of the drugs. The research would be required only of companies that produce brand-name narcotics; generic producers would be required to adopt the same changes.

The FDA acquired the authority to demand the effectiveness research in a section of the Support for Patients and Communities Act. passed in October. Previously, Gottlieb said, the FDA could order only safety studies of drugs on the market, but the new power allows for effectiveness studies as well.

He said drug companies will soon be informed of the new requirement. A spokesman for Purdue Pharma, the company that pleaded guilty in 2007 to deceptive marketing of opioids, declined to comment. A spokeswoman for the industry lobbying group, the Pharmaceutical Research and Manufacturers of America, did not return an email seeking comment.

Gottlieb has previously said the FDA must take a more active role in battling the opioid crisis, which killed 47,600 people via overdoses in 2017. In November, when the FDA’s approval of a powerful new opioid, Dsuvia drew criticism, he said he would seek authority to consider an opioid’s benefits and harm to public health, its risk of being diverted to abusers and whether it has unique benefits before deciding on future applications.

After peaking in 2012 at more than 255 million, the number of opioid prescriptions written annually has declined sharply to 191.2 million in 2017, according to the Centers for Disease Control and Prevention, and overdose deaths from prescription narcotics leveled off as well. Still opioid overdose deaths are six times higher than they were in 1999, with more users succumbing to heroin and, in recent years, illicit fentanyl.

how do you design a study that measures a SUBJECTIVE SYMPTOM ?  With pts that could have highly variable opiate metabolism rates. With pt activity that could dramatically effect the effectiveness of the medication studied.  With intensity of pain that will naturally vary hour to hour …day to day… What will the conclusion if one or two percent of the pts are considered to have developed a substance abuse behavior or addiction… there are written psychological tests that could “weed out” such pts that are potentially dealing with the mental health disease of addictive personality.  To what level of pain is the goal to have the pt reach ?

Of course, if the pts that are to be included in this clinical study… they could be selected on criteria that will cause the study to produce a outcome that will not support the long term use of opiates to treat chronic pain.

Filed under: General Problems | 6 Comments »

Another story of HOW MUCH IS A LIFE WORTH ?

Posted on February 28, 2019 by Pharmaciststeve

No photo description available.PBM Delays for Cancer Drugs May Risk Lives, Warn Oncologists

https://www.medscape.com/viewarticle/909623

The patient had metastatic kidney cancer, and his oncologist was seeking to treat him with sunitinib malate (Sutent, Pfizer), a preferred first-line oral therapy. But the patient’s pharmacy benefit manager (PBM) refused to cover the cost of the medication. The PBM told the oncologist that the patient’s kidney must first be removed.

However, the patient’s surgeon had already determined that the patient was not a surgical candidate, owing to the extent of his disease and to coexisting medical conditions.

For 3 months, the oncologist — in concert with the surgeon — attempted to win approval for the oral medication. For those 3 months, the patient with metastatic cancer did not receive treatment.

In the end, the PBM relented, and the patient received the medication.

Dr Michael Diaz

It’s not clear in this case whether the delay altered the course of the patient’s disease, said Michael Diaz, MD, a medical oncologist at Florida Cancer Specialists and Research Institute, St. Petersburg, who is president of the Community Oncology Alliance (COA). But a 3-month delay when time is limited is concerning: a recent trial found that for patients with metastatic renal cell carcinoma who were not suitable candidates for surgery and who were taking sunitinib, the median overall survival was 18.4 months.

Not only was the 3-month delay an emotional strain for the patient, but the oncologist, the pharmacist, and other staff who were involved spent a lot of time on the appeal — time that could have been spent caring for patients, said Diaz.

More importantly, the PBM “made a medical decision without having seen the patient,” Diaz pointed out.

The PBM does not have the same liability as the physician on record. “They have no repercussions on their end — and yet they’re making medical decisions,” he noted.

The COA has been collecting similar stories from oncologists for several years, as it has become increasingly apparent that PBMs — who generally act as middlemen between insurers and healthcare providers — are having a major impact on cancer patients’ lives and on how oncologists deliver care. The PBMs are also making it more difficult for in-office pharmacies to survive.

Delays Can Be the Difference Between Life or Death

Prior authorization is the bane of many specialties, but in oncology, the delays can mean the difference between life or death. Turnaround times for authorizations are increasing, and the process has become more complicated, said Melissa Dillmon, MD, chair of the oncology division at the Harbin Clinic, a large multispecialty facility in Rome, Georgia.

It can take 2 to 3 weeks to get an oral medication to patients, she pointed out.

“From the patient’s perspective, the effects of the PBMs are dramatic,” she said.

Dr Melissa Dillmon

A 3-week delay for a woman with metastatic breast cancer is “heartbreaking to watch,” she said, especially “when you know [the drug] is sitting on your pharmacy shelf down the hall and you can’t give it to her.”

Dillmon recounted the case of a patient with glioblastoma who needed temozolomide (Temodar, Merck). A lifelong sailing enthusiast, he’d been offered a berth on a trip from Catalina to the Panama Canal. Because of delays related to the PBM, his medication did not come before he was to leave for the trip. “He missed his trip of a lifetime,” she said.

Patient Was “Hoping to Die”

Fred Divers, MD, hematologist/oncologist with Genesis Cancer Center, Hot Springs, Arkansas, said that he has noticed an increase in delays.

Dr Fred Divers

He recounted the case of a patient with metastatic colorectal cancer who always received filgrastim (Neupogen, Amgen) with chemotherapy and who had been receiving self-inject syringes from the Genesis in-house pharmacy.

At some point, the PBM for the patient’s insurance company decided that prefilled syringes were not covered but that vials — the use of which involved the patient’s drawing her own blood — would be covered. But they still required preauthorization.

That change was not communicated to Divers, who ordered the usual prefilled syringes.

Five days later, the patient had still not received filgrastim. Her white blood cell count began to fall. Divers — who was notified of the PBM denial on day 6 — then ordered individual vials and syringes. But that order too was denied because that form of filgrastim also needed prior authorization.

Ten days after the patient received chemotherapy, she finally got the medication, but by then, her white blood cell count was 0.1 and she’d been lying on the floor at home with fever, diarrhea, and vomiting, said Divers.

The patient told him: “I was just hoping I would go ahead and die.”

PBM Defends Prior Authorization

When asked to respond to oncologists’ various concerns about PBMs, the industry — represented by the Pharmaceutical Care Management Association (PCMA) — said clinicians just didn’t like losing money. “Clearly, some oncologists prefer Medicare Part B’s fee-for-service approach to paying for prescription medications, which according to the Medicare Payment Advisory Commission (MedPAC) gives providers ‘incentives for use of higher-priced drugs when lower priced alternatives exist,’ ” Greg Lopes, a PCMA spokesman, told Medscape Medical News.

The PBM industry defends prior authorization. “When more affordable, clinically appropriate treatment options are available, employers, unions, and public programs choose to use prior authorization to lower costs and improve patient safety,” said Lopes, the PCMA spokesman. “Payers and pharmacy benefit managers use teams of doctors to develop prior authorization standards to ensure patient safety,” he said. “These standards determine which drugs are appropriate, with the ultimate objective of promoting the appropriate use of medications,” he said.

Change in Landscape

The change in landscape is being driven by several factors. The PBM market has been dominated by three heavyweights: CVS Caremark, Express Scripts, and OptumRX. Their monopolistic-like power will soon become even greater.

UnitedHealth Group owns OptumRx; CVS has merged with Aetna and already owns the PBM CVS/Caremark; Cigna owns Express Scripts; Anthem has developed its own PBM, IngenioRx; and Humana owns a PBM.

In 2019, five insurers — Anthem, Cigna, CVS Health, Humana, and UnitedHealth — will control both health insurance and pharmacy benefits for more than 125 million Americans in private insurance plans, Medicare, and Medicaid, according to a report published by Axios.

The rise of oral cancer drugs has given PBMs a new opportunity. In the past, when the majority of cancer treatments involved infusions, PBMs did not come into play. But with oral drugs — which are covered under drug plans, including for Medicare — PBMs are the go-to entity for payers trying to ensure the best bang for their buck.

PBMs say they are helping clients reduce drug costs. Express Scripts, for instance, reported that in 2018, its commercial clients’ drug spending rose 0.4%, the lowest increase in 25 years. This was accomplished in part by “guiding plan members to effective, lower-cost therapies and by securing deeper discounts from manufacturers and pharmacies,” the company said. Spending for Medicare Part D plans decreased by 0.3%. Unit costs declined by 1.4%, while utilization increased 1.1%, which means that Express Scripts made “medication more accessible for beneficiaries,” said the PBM.

Divers said he isn’t buying it. PBMs drive costs up by taking money from insurers and exacting rebates and fees from drugmakers and pharmacies, he said. “They basically extort both sides of the equation,” Divers told Medscape Medical News.

Dr Barbara McAneny

“I do not see any value that comes from the PBMs,” said Barbara McAneny, MD, president of the American Medical Association (AMA), who is a medical oncologist/hematologist in Albuquerque, New Mexico.

There’s often one drug that’s head and shoulders better than the other/ Dr Barbara McAneny

In oncology, “there’s often one drug that’s head and shoulders better than the other,” McAneny told Medscape Medical News. “Trying to negotiate which one we’re going to use is ridiculous and doesn’t add any benefit.”

Steering Patients to PBM Networks

Oncologists said PBMs are making it harder for patients to get medications, through a variety of tactics — including denying coverage of drugs dispensed through a practice’s in-house pharmacy and instead requiring patients to go to a specialty pharmacy of the PBM’s choice.

It is not just a matter of steering patients to their networks, commented several oncologists interviewed by Medscape Medical News. “The PBMs are very interested in getting rid of all of the physician office pharmacies,” said McAneny.

Lisa Day, CPhT, a certified pharmacy technician with Ventura County Hematology Oncology Specialists in Ventura, California, said the use of outside pharmacies creates huge delays. In house, it might take 24 hours for a patient to receive a medication. But jumping through the hurdles required by the PBMs and using outside specialty pharmacies — a process that Day assists with — takes at least a week, and sometimes a month or longer.

“During that time, we’ve had patients say, ‘Forget it, I’m going on hospice,’ ” Day told Medscape Medical News.

The five-physician Ventura practice opened its in-house pharmacy in 2007 so as to be more of a full-service provider. The practice belongs to a buying group and gets favorable pricing, but it only makes a tiny profit on the drugs it dispenses, said Day. The pharmacy staff can make sure that patients get medications in hand, answer questions, call before appointments to see whether they need a refill — all in a familiar, comfortable environment. “There’s a lot more to it than a potential profit,” said Day.

In oncology, patients “look toward us to be there for them, and ultimately, after years of chemotherapy and treatment, and sometimes seeing them every day or once a week, we become their family,” Day said.

PBMs have been chipping away at the practice’s dispensing ability since 2011, she said. That was when Express Scripts said Ventura could no longer dispense to non-Medicare patients who were clients of Tricare because it did not have a proper ratio of specialty to maintenance medications. Then, in 2016, CVS Caremark said it would not contract with Ventura because it did not meet Medicare Part D dispensing requirements. A team of lawyers got CVS to back off.

In October 2018, OptumRx notified the pharmacy that it would no longer be a contractor unless it modified its hours so as to be open 12 hours a day on weekdays and 4 hours each weekend day. It also had to be accredited by two organizations — URAC and the Accreditation Commission for Health Care (ACHC). There was a long list of additional requirements, including having 24-hour-a-day counseling available. Ventura was given a month to comply.

The oncology practice through its attorneys challenged the requirements. It was able to negotiate a deal that allows for single accreditation through ACHC and that enables Ventura to satisfy the hours and counseling requirements by having a physician on call. Ventura now has until June 2019 to comply.

“We are doing whatever it takes because we need to take care of our patients,” said Day, who noted that her pharmacy now fills only 30% of patients’ prescriptions, down from about 70%.

Wrong Medication, Wrong Dose

Divers and his colleagues in Arkansas essentially shut down the Genesis in-house pharmacy in the face of pressure — such as dual accreditation requirements — from PBMs. Genesis recently joined the American Oncology Network, an administrative services and contracting group that gives Genesis access to RX to Go, a specialty pharmacy at Florida Cancer Specialists.

RX to Go has jumped through all the PBM hoops but is within an oncology practice. It also has direct access to the Genesis patient records, said Divers. The PBM-favored specialty pharmacies “don’t have access to the patient record, so they are in the dark,” he said.

It also means that they do not keep up on changes in dosing or a switch to a different medication. A $14,000 bottle of pills sent to the patient might not ever be used, said Divers, adding, “This happens all day every day.”

The RX to Go pharmacy lets the oncologist track how the pharmacy is serving the patient. “I can see when their drug is shipped,” Divers said.

At the Harbin Clinic in Georgia, the oncology division started its in-office pharmacy in 2011, when oral cancer drugs started coming to the fore.

The revenue from the dispensing pharmacy lets the clinic cover the cost of back office staff, who educate and counsel patients, help with copay support, and navigate through insurance and reimbursement issues, explained Dillmon, chair of oncology for the clinic.

Harbin continues to operate its pharmacy, but usually loses the prescription to a PBM’s chosen specialty pharmacy after the initial dispensing, she said. Even so, Harbin wants to continue its pharmacy operation, she said.

“Oral oncology drugs require almost more safeguards and oversight than intravenous therapies,” said Dillmon, who is also chair-elect of the American Society of Clinical Oncology’s Government Relations Committee.

AMA president McAneny agreed. Oral chemotherapy is still chemotherapy, and there is potential for significant side effects, she said. Patients may be more likely to skip doses or delay taking them because they are not in the clinic.

If oncologists are “pulled out of the loop” by the PBMs, “it makes a mess out of our ability to manage those patients,” McAneny said. “It increases our burden in trying to figure out if the patient actually did get the drug, and it decreases the adherence for the drug, which is key in cancer therapy,” she said.

DIR Fees — Pay to Play?

Oncologists are particularly mystified — and upset — about direct and indirect remuneration (DIR) fees.

Those fees exist only in Medicare Part D; the fees are paid to the PBM as a means of decreasing costs for the Part D plan sponsor. The fees can include rebates from drugmakers, subsidies, price concessions, or performance-based price concessions from pharmacies.

According to a PBM industry–commissioned report, DIR fees saved the Part D program and its beneficiaries $20.4 billion in 2017.

The fees helped reduce the federal government’s costs in 2017 by $17 billion. Medicare beneficiaries may see premiums decrease by 30% during the next decade, thanks to the DIR fees, according to the report.

The pharmacy DIR fees — which is what oncology practices pay — accounted for a small portion of the total DIR fees in 2017, said the report. But “its impact on Part D program costs may be larger, in that it typically encourages pharmacies to meet contractual ‘pay-for-performance’ standards based on measures such as the generic dispensing rate.”

These standards are often all but impossible to meet and frequently don’t even pertain to oncology practice — such as rating the practice on how well it educates patients on diabetes or hyperlipidemia — said oncologists interviewed by Medscape Medical News.

“It has nothing to do with the service the pharmacy is providing,” said Diaz.

DIR fees became more noticeable in 2016 when some PBMs and Part D plans began assessing retroactive fees on the basis of these largely irrelevant quality metrics, according to a COA report.

Specialty pharmacies — such as those in oncology practices — have a 2% to 5% profit margin on the medications they dispense, “with no additional reimbursement received for the comprehensive patient care services critical to ensuring optimal patient clinical outcomes,” said the COA. The DIR fees can range from 3% to more than 5% of the drug’s cost and “can thus wholly eradicate any profits” and “in many instances actually result in specialty pharmacies losing money when dispensing their medications,” the COA pointed out.

“When you’re talking about up to 12% of the cost of the transaction, that’s making it more and more difficult for our pharmacies to provide these medications to our patients,” Diaz, the COA president, told Medscape Medical News.

“They took $300,000 out of my practice last year that I cannot afford,” said McAneny. The retroactive fees meant that for many of the drugs sold by her practice, reimbursement ended up being less than what was paid for the therapies. “This is not the best business model out there,” McAneny told Medscape Medical News.

Day agreed, noting that in many cases, her pharmacy is not making any profit on PBM-controlled prescriptions.

The fees are ostensibly based on performance metrics, but many oncologists say they are a “pay-to-play” payment. The DIR fees are required to participate in a network, said Divers. “It’s kind of like the mafia, where you pay Fat Tony for protection, but you get no protection,” he told Medscape Medical News.

The fees aren’t itemized, and there’s no specific description of what they cover. The practice just receives a notice that the money will be withdrawn to cover the fees. “And they’re all retroactive, so you have no idea how to plan for those ahead of time,” he said.

His practice is still paying DIR fees from its now-shuttered in-house pharmacy. The latest notice was for $69,000 for June and July of 2018. He has estimated that with Genesis’ previous volume of 100 to 200 prescriptions a month, that amounts to almost $2000 per prescription paid back to the PBM.

“How is that justifiable?” asks Divers.

Dillmon said DIR fees “make no sense.” From what she can tell, they are payment to the PBM “for the privilege of providing medication to their patients.” She, too, has had trouble planning around the DIR fees. Because they are retroactive, “it’s hard to know whether you’re winning or losing,” said Dillmon.

Despite claims by PCMA that premiums are being reduced, Medicare beneficiaries may be harmed by the DIR fees. Day noted that beneficiaries’ copay for medications is a percentage of the drug’s cost. PBMs have been increasing the net price of the drug to include the DIR fees, which means ultimately, the patient copay is based on a higher price, said Day.

Dillmon said she worried about patients, too. “The Centers for Medicare & Medicaid Services has to look at whether the PBMs they are using are truly saving money and whether the Medicare beneficiaries are being harmed,” she said.

Congress has been taking a closer look at drug pricing but may not specifically go after PBMs, said Diaz. However, he said, “I believe there is interest on both sides of the aisle in drafting legislation that will protect patients, not necessarily regulating PBMs,” he said.

“It’s all about the patients,” Diaz said.

In the meantime, oncologists will be left trying to figure out how to operate in an increasingly PBM-dominated world.

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What is the value of a human life ? United Health < $2000 ?

Posted on February 28, 2019 by Pharmaciststeve

[Photo: Carrie Ann Lucas looks at the camera commandingly as she sits for a photo.]

Carrie Ann Lucas, Disability Rights Activist and Attorney, Dies Following Denial From Insurance Company

www.rewire.news/article/2019/02/25/carrie-ann-lucas-disability-rights-activist-and-attorney-dies-following-denial-from-insurance-company/

Carrie Ann Lucas was instrumental in getting the Colorado legislature to pass the “Family Preservation for Parents with Disability Act,” which aims to ensure that parents with disabilities are not discriminated against by the child welfare system.

On Sunday, the disability community lost one of its most dedicated advocates. Carrie Ann Lucas, 47, was a beloved mother and nationally recognized attorney who lived in Windsor, Colorado. She was also a professional colleague, mentor, and a dear friend.

“Carrie Ann Lucas, a disability rights attorney who pioneered representation for parents with disabilities, died after an arbitrary denial from an insurance company caused a plethora of health problems, exacerbating her disabilities and eventually leading to her premature death,” read a February 24 post on her Facebook page.

Lucas, who had a rare form of muscular dystrophy, used a power wheelchair and a ventilator. She also had low vision, was hard of hearing, and had type 1 diabetes. As she documented on her personal blog in January 2018, Lucas became ill with a bad cold. According to her Facebook page, her health insurer,

UnitedHealthcare, refused to pay for a specific medication she needed, owing to its cost of $2,000.

Consequently, she had to take a different and less-effective medication, which caused deleterious reactions. Lucas’ health rapidly declined, resulting in numerous hospital stays over the last year and the loss of her ability to speak. The obituary on her Facebook noted, “United Healthcare’s attempt to save $2,000 cost over $1 million in health care costs over the past year.” More importantly, Lucas’ friends and family argue, it cost her her life.

Access to health care was always a top priority for Lucas. Indeed, as a member of ADAPT, a grassroots group of disability rights activists, Lucas gained national attention in June 2017 after staging a multiday protest inside the office of Sen. Cory Gardner (R-CO). The group was fighting Republican attempts to repeal the Affordable Care Act (ACA). Doing so would have resulted in decreased Medicaid funding and would have jeopardized services and supports that allow people with disabilities to live in their communities. “This issue is just too critically important for my own independence and that of my children so I felt like it was time to do more,” Lucas told Rewire.News at the time.

Eventually, the protesters were arrested, which Lucas live-streamed on Facebook. She was the last protester to be arrested and was cited with trespassing and interference with a police officer because she refused to tell the arresting officers how to use her power wheelchair.

Lucas dedicated nearly two decades to fighting for the rights of other disabled parents. This began after a social worker told her that because of her disability, she could not adopt her niece Heather, who was in foster care. Ultimately, she convinced the judge that she was capable of doing so. She went on to adopt three more children with disabilities: Asiza, Adrianne, and Anthony.

Lucas took the anger she felt about the bias she encountered and decided to attend law school. After graduating, Lucas was awarded a prestigious Equal Justice Works fellowship to create a program to protect the rights of parents with disabilities. This program initially started within the Colorado Cross-Disability Coalition; Lucas later founded Disabled Parents Rights, one of the only organizations in the country devoted to fighting for the rights of parents with disabilities. Most recently, she worked at the Colorado Office of Respondent Parents’ Counsel, where she trained other Colorado attorneys on how to represent disabled parents.

Lucas was also instrumental in getting the Colorado legislature to pass the Family Preservation for Parents with Disability Act, which aims to ensure that parents with disabilities are not discriminated against by the child welfare system. Speaking to Rewire.News about this bill in May 2018, Lucas explained, “In my parent defense practice, between 75 and 80 percent of my clients in child protection cases had a disability. Oftentimes disabled parents are not receiving the accommodations they are entitled to. Too often decisions are made to prevent a child from going home, without providing parents a fair opportunity to parent,” There are now efforts under way to rename this bill the “Carrie Ann Lucas Act.”

Lucas was also active in her community and ran for Windsor Town Board in 2017. Although she lost the election, she remained politically active.

Lucas’ service will be held in Windsor on March 1. A moment of silence was held in her honor Monday morning in Colorado on both the House and Senate floors. Denver Mayor Michael B. Hancock also offered his condolences on Twitter: “Sending my condolences to the friends and loved ones of Carrie Ann Lucas. She was an unapologetic advocate for human rights and spent her life fighting for the voiceless. She will be missed.”

Lucas recognized that the health-care system was broken and fought hard to ensure that all people had access to appropriate and affordable care. Her untimely death must remind us that there is so much more work to be done.

UNITED HEALTH is the insurance company that is the one endorsed by: See the source image

 

 

Filed under: General Problems | 1 Comment »

Rare Disease facts for Rare Disease Day 2019

Posted on February 27, 2019 by Pharmaciststeve

No photo description available.

Filed under: General Problems | 1 Comment »

Patient lawsuit against IDSA and insurers moves forward in Texas

Posted on February 27, 2019 by Pharmaciststeve

Patient lawsuit against IDSA and insurers moves forward in Texas

www.lymedisease.org/idsa-lawsuit-pfeiffer/

A federal lawsuit that may just validate the pain of thousands of Lyme disease patients – and the flaws in prevailing tests and treatments — is moving ahead in a Texas courthouse, despite attempts to kill it.

The lawsuit’s progress is a big development in the decades-old struggle of patients whose post-treatment conditions – involving myriad neurological, cognitive, musculoskeletal, and cardiac symptoms — have long been misdiagnosed and minimized. Patients have hence had to seek out-of-pocket treatment from physicians who risk their licenses providing it.

The suit, Torrey v. Infectious Diseases Society of America et al, aims to change that, and, make no mistake, is a serious challenge to the Lyme status quo (see my article from 2017).

In the crosshairs of the case are six major architects and proponents of the guidelines that have dogmatically ruled Lyme disease care for two decades: Raymond J. Dattwyler, John J. Halperin, Eugene Shapiro, Leonard Sigal, Allen Steere, and Gary P. Wormser. (A seventh, Robert Nadelman, died in 2018.)

Beyond that A-list of Lyme actors, the lawsuit also accuses eight insurers of conspiring with the IDSA and the Lyme architects to advance treatment protocols that limited care options to the 25 named plaintiffs, two deceased, for whom the protocols did not work.

The companies are Blue Cross And Blue Shield Association, Anthem, Inc., Blue Cross And Blue Shield Of Texas, Aetna Inc., Cigna Corporation, Kaiser Permanente, Inc., United Healthcare Services, Inc., and Unitedhealth Group Incorporated.

Here’s what will happen shortly

A hearing on a second motion to dismiss the case will be held on March 11, at 2 p.m., at the U.S. Federal Courthouse, 500 North State Line Avenue, Texarkana, Texas. [Note: this story was edited on 2/19 to reflect the hearing’s recent date change.]

The suit, whose lead plaintiff is Texas resident Lisa Torrey, already survived one motion to dismiss. (See below.)

I’d encourage people who are invested in the outcome of the case to attend. Lyme patients have been portrayed, wrongly, as deluded, unpleasant and aggressive for a long time. Show them who you really are: Informed, concerned, intensely interested, and respectful of the court’s crucial role. Now’s the time.

Here’s what’s happened so far

The judge in part granted and in part denied a previous motion to dismiss the case.

In favor of the IDSA-insurers side, the judge agreed that the lawsuit did not sufficiently describe the alleged fraud that it maintains was committed by the defendants under the Racketeer Influenced and Corrupt Organizations Act (RICO).

The court, however, ruled the patients’ side could redraft the complaint under RICO. A request for an extension to do that will be among the issues considered at the March 12 hearing.

But the motion to dismiss was largely decided in favor of patients, including on the crucial assertion that the defendants violated anti-trust statutes under the Sherman Act.

As the judge put it, summarizing the case, “Defendants [as alleged] engaged in a conspiracy to unreasonably restrain trade in the relevant market—the Lyme disease treatment market—by paying large consulting fees to the IDSA Panelists to pass the IDSA guidelines which deny the existence of chronic Lyme disease and establish the standard that all Lyme disease is cured with short-term antibiotics.”

Insurers then were able to deny claims, and doctors who treated outside the guidelines were marginalized in what became a monopolistic marketplace, the suit maintains.

In upholding the suit’s anti-trust assertion, the judge wrote: “Plaintiffs have sufficiently alleged that, in the absence of the IDSA, there would be competition among doctors for the treatment of chronic Lyme disease and competition among insurance carriers for coverage for such treatments. Similarly, Plaintiffs have alleged that Defendants’ adoption of the IDSA guidelines and standard of care for the testing, diagnosis and treatment of Lyme disease has harmed patients and doctors nationwide. … The Court finds a nationwide geographic market has been properly alleged.”

All of this, of course, must be proven at trial.

There’s more

Beyond this, the judge granted the plaintiffs’ request for discovery, but so far it has been limited only to documents from four years before the lawsuit’s filing. The judge wrote, in reference to whether the court has jurisdiction to order discovery: “The Court finds that Plaintiffs have pointed to enough evidence preliminarily establishing personal jurisdiction over the IDSA Panelists to warrant jurisdictional discovery. Specifically, Plaintiffs point to the declarations provided by each of the IDSA Panelists in which each doctor attests to having visited Texas for professional purposes during the relevant time periods. …Moreover, Plaintiffs have established that the IDSA Panelists’ research and professional activities focus primarily on Lyme disease.” In a filing Friday, the Torrey lawyers called the four-year timeframe “arbitrary.”

Here’s what is pending

Among the issues that the hearing will consider is whether, essentially, to put chronic Lyme disease on trial. A motion by Anthem, Inc., the IDSA, and what is termed the “Doctor Defendants” asks the court to have all plaintiffs submit to independent medical examinations, or IMEs, by a Texarkana-based infectious diseases physician.

Their motion, which has been challenged by the plaintiffs’ attorneys, states: “The Lyme Claimants allege that they have suffered debilitating injuries because they have been denied appropriate medical treatments for so-called ‘chronic Lyme disease,’ allegedly due to an unlawful conspiracy among the Defendants to monopolize the treatment of Lyme disease. … Nearly all of the Lyme Claimants allege that they still suffer from the disease today and many claim that they are currently disabled or otherwise unable to work due to their illness. … (W)hether they currently or have ever suffered from Lyme disease, the severity of their symptoms, and whether those symptoms are attributable to Lyme disease or some other cause, are at the heart of this case and were put into controversy by the Lyme Claimants themselves. Well-prepared, peer-reviewed studies have established that as many as 88% of patients who have been told they have ‘chronic Lyme disease’ either do not have – or, in many cases, never have had – Lyme disease in any form.”

To support their assertion, the IDSA defendants cite an article on chronic Lyme disease by Duke University physician of pediatric medicine, Paul Lantos, which cites much of the Doctor Defendants’ research.

And finally…

The hearing will also take up another request related to whether the patients are truly ill and with what.

The IDSA is seeking emails written by them – including any in which the words Lyme appear coupled with antibiotic, literate, chronic, claim*, cover* and den* (presumably meant to refer to claimed/claimant, coverage, denied or denial). Emails with the initials IDSA are also sought.

In its motion, the IDSA asserts: “Defendants’ email requests seek information relevant to the claims and defenses in this action. In the Complaint, Plaintiffs assert that they ‘suffer debilitating injuries’ and that such injuries impact them on a daily basis, including cognitive deficits, fatigue, and memory loss, resulting in a multitude of alleged harms, including the loss of careers, homes, and the ability to function. … Plaintiffs’ communications about their condition go to the heart of corroborating or refuting their allegations about their conditions and the harms that they allege they have suffered.”

The calendar for the lawsuit lists June 24, 2019 as the start of a jury trial in Torrey v. IDSA et al. Stay tuned.

Mary Beth Pfeiffer, an investigative journalist, is author of the acclaimed book, “Lyme: The First Epidemic of Climate Change.“

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Family of local veteran who died plans to sue Jacksonville nursing home

Posted on February 27, 2019 by Pharmaciststeve

 

https://www.actionnewsjax.com/news/investigates/family-of-local-veteran-who-died-plans-to-sue-jacksonville-nursing-home/925183454

JACKSONVILLE, Fla. – The family of a local veteran plans to sue a Jacksonville nursing home, after a Florida Department of Children and Families investigation found evidence his death was related to inadequate supervision and neglect.

Tom Edwards, the attorney for York Spratling’s family, described the 86-year-old as an honorable man who died in an undignified way after a stay at Consulate Health Care in Jacksonville.

“They were not providing the care that they were being paid thousands of dollars a month to provide,” Edwards said.

Action News Jax obtained the DCF investigation into Spratling’s death.

The report says he developed an infection in his groin, which staff first documented on Feb. 16, 2017, but it wasn’t mentioned again until Feb. 21 – despite on nurse’s account that “you could smell it from the door.”

According to the report, doctors diagnosed Spratling with gangrene and amputated his genitals. He died a short time later.

“Why this nursing home let this go on and didn’t react sooner is absolutely beyond reason,” Edwards said.

Investigators found evidence to support a finding that Spratling’s death was related to inadequate supervision and medical neglect.

Action News Jax discovered previous problems reported at Consulate Health Care Jacksonville.

In 2015, health inspectors found staff wasn’t conducting required assessments of residents.

In 2016, reports show deficiencies in the number of required nursing staff.

“This is truly our hope and our prayer that this is going to change the way this nursing home is handling their patients,” Edwards said.

Edwards said the family does plan to sue.

We reached out to Consulate Health Care for comment and are waiting to hear back.

Last year, the Agency for Health Care Administration threatened to shut down 55 of the company’s Florida facilities; Consulate Health Care worked out an agreement with the state to keep them open.

Consulate Health Care is the largest nursing home provider in Florida.

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‘Effectively-organized-up or quilt-up?’ Horsham drugmaker performs one-man military in opposition to FDA in opioid crisis – Philly.com

Posted on February 27, 2019 by Pharmaciststeve

www.worldweeklynews.com/2019/02/24/effectively-organized-up-or-quilt-up-horsham-drugmaker-performs-one-man-military-in-opposition-to-fda-in-opioid-crisis-philly-com/

Edwin Thompson, the president of a pharmaceutical company in Horsham, Pa., didn’t abet encourage when he confirmed up at an FDA advisory committee assembly final June to chat about opioids.

“The root motive of the opioid epidemic is the illegal FDA approval of opioids for the therapy of chronic wretchedness,” Thompson said, urging a “no” vote on a drug into consideration that summer season afternoon, in a lodge ballroom true starting up air Washington, D.C.

“Your particular person vote and committee recommendation,” he added, “will tell us in the event you’re the elegant-up committee or the quilt-up committee.”

Thompson modified into as soon as no licensed critic. His firm manufactured opioids. And as the opioid epidemic claims tens of thousands of lives yearly – extra than 47,000 in 2017 – Thompson has waged a marketing and marketing campaign on the company that approves the highly efficient painkillers.

In a slew of petitions to the FDA, his firm has attacked the regulator’s methodology as scientifically “mistaken,” to the level of being unlawful. He has named the FDA in a complete lot of court docket cases, and even proposed his have original opioid to the company – one, he argued, that “embodies a new way” to reducing the different of abuse. The FDA rejected it.

In December, his firm, Pharmaceutical Manufacturing Study Companies and products, filed suit in opposition to the FDA one more time, this time for denying its original drug application.

Thompson declined requests to sit down for an interview for this narrative. Nonetheless he despatched the Inquirer a link to a preview of a60 Minutessection, pickle to air Sunday evening, significant of the approval and marketing and marketing of opioids for long-term mutter. Frail FDA commissioner David Kessler suggested this technique: “The rigorous extra or less scientific evidence that the company ought to be counting on isn’t any longer there.”

A spokesperson for60 Minutesconfirmed that Thompson can even appear in the portion.

One of Thompson’s most vital arguments is that the FDA doesn’t have medical evidence that’s unprejudiced ample, as required by law, to label an opioid as safe for chronic mutter – an approval carried by treatment akin to Purdue Pharma’s OxyContin. (Purdue on Friday defended the medical trials for OxyContin as the “gold same old” in the 1990s.) Nor, he says, does the company have the evidence for “abuse-deterrent” labeling, which device that a drug is extra tough to crush, dissolve, chortle, or inject.

At some level of the advisory assembly final June, Sharon Hertz, the FDA’s director of the division overseeing painkillers, insisted that opioids work for chronic wretchedness. “This total debate about absence of evidence … has truly long past exclusively too a long way, and patients are at the second being harmed because of the a total breakdown in scientific pondering,” she said, fixed with a transcript.

Thompson isn’t any longer by myself in anxious sure FDA-permitted claims for opioids.

“Abuse-deterrent is admittedly a marketing and marketing term,” said Diana Zuckerman, president of the Nationwide Heart for Health Study, which has advocated, as a replace, for extra particular phrasing, esteem crush-resistant. “The FDA has fallen into the lure of the utilization of terms that are truly promotional in nature.”

The Nationwide Academies of Sciences, Engineering, and Medicine produced an intensive opioid-abuse squawk in 2017. The explore, subsidized by the FDA under dilapidated commissioner Robert Califf, trudge that “on hand evidence doesn’t beef up the long-term mutter of opioids for administration of chronic non-cancer wretchedness.”

Instead, the squawk learned, evidence indicates that taking opioids over the long-term places patients at “increased risk” of constructing opioid-mutter dysfunction, and overdosing.

Alongside the vogue, Thompson has received beef up from one other determine who has in most cases disagreed with the FDA: Raeford Brown, chair of the FDA’s advisory committee on analgesic and anesthetic drug products. Brown submitted a letter to the court docket in one of Thompson’s court docket cases, asserting when it came to “abuse-deterrent” opioids, the company “pressed the committee to search out out about and fabricate choices per data that modified into as soon as incomplete.” There are at the second eight abuse-deterrent opioids in the marketplace.

As for the utilization of opioids for chronic wretchedness, Brown, a pediatric anesthesiologist, wrote there modified into as soon as “never any great evidence” for this kind of advise. The company’s insistence on that labeling, he said in the letter, “is straight linked to substandard prescribing of opioids to patients.”

“They don’t ceaselessly prefer your complete knowledge,” Brown said of the FDA. “And one of the significant data they don’t must hear about,” he suggested the Inquirer, “is the details Mr. Thompson items to them in these repeated petitions.”

Thompson has labored in the pharmaceutical alternate for extra than 40 years. Pharma companies outsource a great deal of aspects of researching and making treatment, and that’s where the firm Thompson primarily based comes into play. PMRS provides manufacturing products and services for four FDA-permitted treatment and “a great deal of developmental and investigational treatment,” fixed with court docket filings.

Since a minimal of April 2016, and as no longer too long in the past as November, Thompson has attended FDA advisory committee meetings on opioids, where he’s joined the ranks of members of the public, who are each and every allowed a short time to discuss. In most cases he has talked in the jargon of stories, medical trial outcomes, and approval histories, and at other times, in the blunt language of death counts.

In March 2017, committee members had been speaking about security concerns linked to Endo Pharmaceuticals’ opioid Opana ER. It had been linked to IV abuse and the spread of HIV and one other sickness. When it modified into as soon as Thompson’s time to philosophize, he said his firm manufactured Opana ER, and had “intensive journey” testing abuse-deterrent formulations.

Then he suggested the committee that “an unskilled person can with out trouble extract Opana ER to excessive purity level … the utilization of time and again on hand solvents and instruments.” He knocked one explore of the drug’s abuse-deterrent properties as “clearly invalid.”

Asked after the assembly if he risked upsetting Endo or other drug companies, Thompson suggested the alternate outlet Pink Sheet: “I modified into as soon as targeted on having unprejudiced science and unprejudiced practices in squawk. I wasn’t targeted on the other components.” Nonetheless Thompson also wouldn’t verify to the publication whether he modified into as soon as working with other companies on abuse-deterrent medications. (Three months later, the FDA requested that Endo take Opana ER off the market, and the firm, which has its U.S. headquarters in Malvern, agreed.)

Thompson’s technique can appear puzzling. If his purpose is to catch his original drug application permitted, he has long past about asking for the FDA’s blessing whereas also blasting the company’s route of as “hypothetical” and lacking scientific merit.

Additionally, if Thompson’s purpose is to manufacture an even bigger case relating to the system for approving opioids — or to alter that system exclusively — he has chosen a luxurious way. It prices about $2 million to file such an application with out a waiver, no longer to claim the prices of the court docket cases he has filed. And courts are inclined to defer to the company on questions of science, says Sara Koblitz, an attorney on FDA components.

“It’s a strange tactic to take, which true highlights that he’s attempting to manufacture a level,” said Koblitz, who has blogged about Thompson’s litigation. “All of this reveals he’s attempting to catch attention from FDA ,and most likely the public.”

In comparison to what’s in the marketplace, Thompson argued that his product’s claims may per chance be “extra restricted” and as a replace put together tips on opioid prescribing published by the Centers for Disease Protect an eye on and Prevention. He wants his label to claim it’s for acute wretchedness, no longer chronic. And he wants the label to squawk “abuse-deterrent properties have not any longer been confirmed,” paperwork squawk.

His industry “refuses to be portion of the self-discipline,” a firm filing to the FDA acknowledged, despite the truth that which device pursuing a drug application that is “most decidedly no longer a favored space to take with FDA nor alternate.”

The company has countered Thompson at nearly every pass. In October, the FDA denied PMRS’s original drug application – asserting the firm submitted insufficient, or no data, on abuse-deterrence, and that it modified into as soon as proposing a “false and deceptive” drug label.

The FDA also denied the firm’s request for a listening to on the matter, asserting PMRS’s “apt and policy objections” to the FDA’s technique to opioids didn’t justify a listening to. “The company continues to take a form of steps to deal with the public health crisis created by opioid abuse and the ensuing addiction and death,” the justify acknowledged.

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Hoorah Robert D. Jr. Rose and the fourteen civilians suing our government over barbaric practices!

Posted on February 26, 2019 by Pharmaciststeve

Filed under: General Problems | 7 Comments »

Dr. Maurice Gregory talks about opioid

Posted on February 26, 2019 by Pharmaciststeve

WEB EXTRA: Dr. Maurice Gregory talks about opioid

https://www.lasvegasnow.com/news/local-news/web-extra-dr-maurice-gregory-talks-about-opioid/1809337569

LAS VEGAS – Las Vegas physician Doctor Maurice Gregory talks with I-Team reporter George Knapp about his concerns regarding the anti-opioid movement and how it’s impacted the quality of life for patients who need long-term pain management.

Dr. Gregory was featured in the I-Team story last week about Nevada doctors testifying before the legislature on how the opioid crackdown has adversly impacted patients. Although opioid prescriptions are down, overdose deaths continue to rise.

Filed under: General Problems | 2 Comments »

Another dead due to under/untreated pain ?

Posted on February 26, 2019 by Pharmaciststeve

See the source image

Another death due to an MD tapering/removing patient from opiate med. Her husband posted this on her Facebook page. I am FB friends with Carla but he didn’t make in the post shareable. Here’s the post: “My name is Larry Larry E. HowardLarry E. Howard Howard and it is with a heavy heart I lost my wife of 28 yrs of a heart attack. I believe to the pain she was suffering and had been for 30yrs. She was the Love of my life and always will be. Her pain patient family meant the world to her. IT’S just her heart could not take it anymore. She was the best part of me and I am lost without her. But I know she would say get a pair and keep fighting. Thank you all for helping her through all the very hard times she had until end. I thank you to for the Love we recei

https://www.pharmaciststeve.com/?p=20995

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