healthcare biggest problem: accidental patient deaths caused by medical errors

Ignored As An Election Issue, Deaths From Medical Errors Have Researchers Alarmed

https://www.forbes.com/sites/leahbinder/2018/11/09/ignored-as-an-election-issue-deaths-from-medical-errors-have-researchers-alarmed/#268d65a8653d

We learned Tuesday that health care is a big concern for voters, with exit polling from CNN, NBC and other major outlets showing 40 percent of Americans picked health care as their most important issue. Yet neither political party is taking on health care’s most visceral problem: accidental patient deaths caused by medical errors. 

Medical errors are the third leading cause of death in America. More than 500 people likely died of avoidable medical errors on Election Day alone. This horrendous problem first drew a national spotlight 18 years ago, when the Institute of Medicine published a report suggesting upwards of 100,000 Americans died each year from preventable medical errors. Since then, advances in measurement have revealed an even higher estimated body count. A 2016 analysis suggested preventable patient deaths likely total more than 250,000 a year and an analysis by our organization, conducted by Johns Hopkins, estimates employers waste $8,000 per inpatient admission on the costs of avoidable errors.

The November issue of influential peer-reviewed policy journal Health Affairs is devoted to the latest patient safety science, and it contains plenty of bad news. Nurses – our first line of defense in hospitals – do not believe we have made enough progress reducing medical errors, with 35 percent  giving their own workplace an unfavorable rating for patient safety. Medication errors are a persistent problem, and researchers are now investigating a new category of safety concerns: diagnostic errors that affect at least 12 million patients a year, with 4 million suffering serious harm. One study found serious problems with psychiatric patients’ safety, including a long list of serious abuse complaints obtained only through a Freedom of Information Act request.

Fortunately, there is also evidence that some medical professionals are learning cutting-edge techniques to address patient safety challenges.

For instance,  engineers are modeling data analytics to hardwire better quality into the health care environment. In addition, researchers are looking at the built environment for solutions that will better routinize important safety practices like hand hygiene at the patient bedside. One study offers a nuanced perspective on communication practices that help address complications as early as possible and there are new recommendations for using technology to address medication errors. In another study, researchers implemented a system that tracks errors in real time, so they can be addressed before they do further harm. The technology even predicts patients who are at highest risk of future error in order to head off future problems. Lastly, a case study from South Carolina found that a checklist used in the operating room lowers the patient death rate—but it takes more resources than anyone ever imagined to make it work.

Many hospitals have made progress in addressing medical errors, including reducing infection rates and other hospital-acquired problems. And thanks to a remarkable little federal agency that Congress continually threatens to de-fund—the Agency for Healthcare Research and Quality (AHRQ)—we now have significant research on best practices for improving patient safety.

At a briefing by Health Affairs this week, researcher Thomas Gallagher suggested that the biggest hurdle preventing hospitals from improving patient safety is transparency – medical professionals simply do not want to admit mistakes.  This challenge becomes increasingly evident as we try to account for the bodies harmed by medical errors.

We rely on antiquated systems for counting incidences of mistakes and problems, and when better systems come along, we don’t use them for reporting. A new study by University of Michigan Medical School researchers underscores this problem. The Centers for Medicare & Medicaid Services (CMS) publicly reports the frequency of severe pressure ulcers by hospital or hospital system. Pressure ulcers are bedsores that have progressed to open wounds affecting cartilage or even bone. They should never happen. Medicare monitors these ulcers through claims data, but the study suggests this method may undercount them by a factor of 10 or more. CMS uses chart review, not claims data, to monitor other bedsores. The study suggests this method catches about 20 times more incidences compared to claims data. This raises many questions. Why are claims data so inaccurate? After all, claims are bills, so theoretically they should be more accurate. And why isn’t Medicare using the most advanced possible method of tracking this important issue?

The sad reality is that we have only just begun to understand the depths of the patient safety problem, and it is likely worse than what we’re seeing. A recent survey of seriously ill people and their families by The Commonwealth Fund, The New York Times and Harvard’s T.H. Chan School of Public Health, found that one quarter of patients suffered a serious medical error. No other industry tolerates a one-in-four failure rate. Even daredevils won’t take that level of risk.

It is heartening to know so many clinicians and researchers are working to address these problems, but they need more support from our leaders. We know elected officials aren’t paying attention. How?  My organization grades hospitals on safety and finds no difference in the report cards of red states and blue states.

We cannot develop effective solutions without knowing where we currently stand. Congress can help, starting with increased funding for AHRQ and for measurement enterprises such as the National Quality Forum that help us understand the full scope of the problem. Patient safety is a critical health care issue for every American, because none of us ever knows the moment when we will face an urgent health problem that will land us in the hospital. So all of us want hospitals to succeed.

I run an organization called The Leapfrog Group with a membership of highly impatient business leaders fed up with problems with injuries, accidents, and errors in hospitals. I can’t stand the sight of blood but I’ve worked in healthcare over 20 years, including a rural hosp…

Patient Abandonment Cases: What You Need To Know

Patient Abandonment Cases: What You Need To Know

www.theexpertinstitute.com/patient-abandonment-cases-what-you-need-to-know/

Patient abandonment is a serious, yet often overlooked, form of medical malpractice. Generally, patient abandonment occurs when a physician terminates medical treatment without a justifiable excuse or reasonable notice so that the patient can find a replacement physician. Most studies on medical malpractice claims in the United States do not specifically isolate instances of patient abandonment, so there is  little concrete data on this phenomenon. A study conducted on the rates of medical malpractice lawsuits in the United States between 1992 and 2014 found that misdiagnosis, surgical errors, and treatment-related mistakes are the most common types of claims, respectively. However, how exactly patient abandonment fits within these claims is not stated.

Unlike the more common medical malpractice claims, which involve a specific action taken by a physician, patient abandonment occurs more by the omission of proper conduct. This does not mean that a physician is susceptible to a patient abandonment claim each time a doctor-patient relationship is terminated. However, a clear understanding of its definition and legal implications can help form a medical malpractice claim or defense.

What Constitutes Patient Abandonment (And What Doesn’t)

Patient abandonment cases are very fact-specific and the exact legal definition varies state-to-state. The general elements of patient abandonment claims are:

  • 1) There was an established doctor-patient relationship
  • 2) The physician abandoned the patient while medical attention was needed
  • 3) The abandonment occurred abruptly, preventing the patient from finding a replacement physician
  • 4) The patient suffered an injury as a direct result of the abandonment

In order to effectively evaluate a potential patient abandonment claim, the first question one must ask is whether there existed a doctor-patient relationship. While this element might seem intuitive, there is more to this question than meets the eye. A doctor-patient relationship is typically created when “professional services of a physician are rendered to, and accepted by, another person for the purposes of medical or surgical treatment.” See Cygan v. Kaleida Health, 51 A.D.3d 1373, 1375 (2008). However, the law also recognizes circumstances in which the existence of a physician-patient relationship is implied by circumstances. “An implied physician-patient relationship can arise when a physician gives advice to a patient, even if the advice is communicated through another health care professional.” See Thomas v. Hermoso, 110 A.D.3d 984, 985 (2013); See Pizzo-Juliano v. Southside Hosp., 129 A.D.3d 695, 697 (2015) (held that a doctor-patient relationship existed between plaintiff and the hospital’s on-call plastic surgeon, who was unavailable to treat the patient and decided on the phone that the injuries could be treated by a physician’s assistant).

There are instances, however, that can circumscribe the relationship from a legal perspective. Some physicians may provide a written statement to their patient during an initial visit that states the visit is only for evaluation purposes and does not guarantee entry into the physician’s practice.  Likewise, in limited examination contexts, such as volunteering at health fairs or providing informal medical advice on websites, a disclaimer may be provided which states that the examination or offered information does not constitute an ongoing doctor-patient relationship.

Once a formal relationship between the physician and patient has been established, whether the termination was appropriately handled must be examined. Importantly, termination of the doctor-patient relationship can be a completely unilateral decision on the part of the doctor. Physicians are not obligated to treat each and every patient in perpetuity. However, physicians cannot terminate the relationship during a time when medical treatment is necessary and/or the patient cannot be immediately transitioned to another doctor. For example, in an emergency, a doctor cannot deny treatment to a patient on the grounds of an outstanding medical bill. Likewise, a physician cannot be unreasonably unresponsive to a patient. Even if a physician does not intend to terminate the relationship, it is still considered abandonment if the physician makes themselves unavailable for a prolonged period of time. Depending on the particular circumstance, a physician may be found to have abandoned their patient by taking a vacation without notifying their patients or arranging for emergency coverage; being unresponsive to a patient’s questions in email or other correspondence; failing to follow up with a patient after surgery or prescribing a new medication; or failing to provide treatment to the patient by a specified time.

The patient’s necessity for medical treatment also goes hand-in-hand with whether reasonable notice was given to provide the patient with the opportunity to find replacement care. For example, a doctor cannot abruptly shut down their medical practice without making arrangements to ensure that her patients have alternative care. However, doctors are under no obligation to personally find their patients replacement physicians. It may be difficult to find physicians that practice in the same sub-specialties within the same area. Also, some doctors may not be keen on recommending a patient that was particularly discourteous or troublesome to their colleagues. All a physician is required to do is to give adequate notice to the patient (30 days in most states) to the patient and support the transition to alternative care, which may include providing records or engaging in a discussion with the new doctor.

There are numerous reasons that a physician may terminate their relationship with a patient that do not constitute patient abandonment. If a doctor knows that he does not possess the requisite skill or knowledge to handle a patient’s particular issues, they are under no requirement (nor is it preferable) to continue treatment. If a patient does not follow the doctor’s orders, which includes being chronically late to appointments or not taking the necessary prescribed medications, termination may be warranted. As long as the termination is done in an appropriate manner, such action does not constitute abandonment.

What Do The Experts Say?

Like any other medical malpractice action, patient abandonment cases require the use of a medical expert to establish the standard of care and deviation of that standard by the defendant. Experts may also be required prior to filing suit. Rule 3012-a of the New York Civil Practice Law and Rules requires that all medical, pediatric, and dental malpractice complaints be accompanied by a certificate of merit stating that the plaintiff’s attorney has consulted with at least one physician and has concluded that there is a reasonable basis for the commencement of the action. Medical expert affidavits are also typically used throughout motion practice. However, there are occasions in the cases of patient abandonment in which an expert affidavit is not necessary. “Common sense and ordinary experience and knowledge, such as is possessed by laymen, without the aid of medical expert evidence, might properly suggest that the condition of the plaintiff at the time that he was abandoned by the defendants was not compatible with skillful treatment.” See Mevorah v. King, 303 A.D.2d 657, 657–58, 756 N.Y.S.2d 794, 795 (2003).

That being said, medical experts are typically needed to set forth the consequences of the physician’s abandonment within the context of the patient’s specific facts and circumstances and to establish whether the alleged abandonment represented a departure from the acceptable medical practice. The status of a patient’s condition is necessary to determine whether a physician effectively terminated the relationship. For example, a patient who had undergone heart surgery and requires a multitude of follow-up appointments is vastly different from a patient who visited a doctor once to treat a cold. Thus, a medical expert in the particular field as the defendant doctor is important to establish whether the termination occurred during a time when medical treatment was necessary and if, under the circumstances, the timing and notice was unreasonable.

Aetna: was proud of the three medical directors who denied coverage

Jury delivers $25.5 million ‘statement’ to Aetna to change its ways

https://www.cnn.com/2018/11/10/health/aetna-verdict-oklahoma-orrana-cunningham/index.html

An Oklahoma jury has awarded $25.5 million to the family of a cancer patient denied coverage by Aetna, with jurors saying that the insurer acted “recklessly” and that the verdict was meant as a message for Aetna to change its ways.

The award is believed to be the largest verdict in an individual “bad faith” insurance case in Oklahoma history, one court observer said, and could have major ramifications across the country for a form of cancer treatment called proton beam therapy.
The case revolved around the 2014 denial of coverage for Orrana Cunningham, who had stage 4 nasopharyngeal cancer near her brain stem. Her doctors wanted her to receive proton beam therapy, a targeted form of radiation that could pinpoint her tumor without the potential for blindness or other side effects of standard radiation.
Aetna denied her coverage, calling the therapy investigational and experimental.
Orrana and her husband, Ron Cunningham, a retired Oklahoma City firefighter, had been together since 1987. He was determined to do whatever it took to get the love of his life the treatment she needed. The couple mortgaged their dream home and set up a GoFundMe page to help pay the $92,082.19 to get the therapy her doctors had prescribed at the MD Anderson Cancer Center in Texas.
However, Orrana died May 30, 2015, at the age of 54, in part from a viral infection that reached her brain.
Ron Cunningham said this week’s verdict was vindication for the suffering his wife went through. She had filed the initial paperwork to sue Aetna, saying that if her case helped save the life of one person, it would be worth it.
“My wife started the case, and I’m just finishing the fight,” he said. “We did her proud. My wife wanted to make sure that it got out. Her comment was ‘if we could just save one person.’
“As far as the money, I’d give it all back to spend just one more day with her.”
Aetna attorney John Shely said in closing arguments that the insurance giant was proud of the three medical directors who denied coverage, even turning to thank them as they sat in the front row of the courtroom, according to jurors and other witnesses in court.
It was a message that didn’t sit well with the 12 jurors, who found that Aetna “recklessly disregarded its duty to deal fairly and act in good faith with the Cunninghams.”
“I just felt like Orrana Cunningham was failed at every turn,” forewoman Ann Schlotthauer said.
She said the verdict “was definitely a message to Aetna. We discussed that in jury deliberations — that we wanted to make a statement. We wanted to make a point and get their attention.”

‘Aetna needed to pay’

Schlotthauer said it was clear from expert testimony that proton beam therapy was not experimental at all. She said jurors were turned off by one Aetna medical director who acknowledged handling 80 cases a day and by the fact that all three medical directors acknowledged they spent more time preparing for the lawsuit than on Orrana’s medical case.
Schlotthauer said she believed that Aetna’s medical directors “rubber-stamped” the denials without doing their due diligence. “No one was looking at her specific case,” she said. “That’s where we decided that obviously they were in breach of contract and should’ve paid for that treatment. It was medically necessary in her situation.
“I hope [the verdict] does result in huge changes,” she said. “I hope it results in Aetna re-evaluating how they evaluate appeals and requests.”
Juror Ora Dale cried and hugged Cunningham after the trial. She was one of two jurors who believed the monetary award should’ve been much higher than the $25.5 million handed down.
“I just wanted to let him know that I was on his side,” Dale said. “Those medical directors did not exhaust every measure like they said that they did. They did not spend enough time on her claim. It just kept getting denied and denied.
“Aetna needed to pay. They were in the wrong, and he deserved everything that he was asking for.”
Cunningham had another encounter in court. He said Shely, Aetna’s lead attorney, walked up to him and congratulated him after the verdict before telling him he’d lose on appeals.
Cunningham was an Oklahoma City firefighter when the Alfred P. Murrah building was bombed on April 19, 1995, killing 168 people and wounding hundreds more in one of the deadliest terror attacks in American history. The day after the bombing, he was assigned to comb through the wreckage of the day-care center on the second floor to search for bodies of children. He said he would spray corpses with Lysol to prevent the spread of bacteria.
He’d seen the worst of the worst. But little could’ve prepared him for that encounter with Aetna’s attorney in the courtroom. He said he stood, stunned, trying to grasp what he’d just heard.
“That showed how callous these people are,” he said.
Shely did not respond to a request for comment.
Aetna, the nation’s third-largest insurer, declined to comment on the encounter but maintained that it acted appropriately in denying coverage in this case, saying there is a “lack of clinical data supporting proton therapy for treating nasopharyngeal tumors.”
“While we have no comment on the ruling, juror motives or a potential appeal, we do want to make it clear that the proper steps under the health plan were followed in this instance,” Aetna said in a written statement. “As our chief medical officer noted in a post earlier this year, it’s never easy to tell an individual or family that a treatment or procedure is not approved — it’s the hardest thing we have to do.
“However, our guiding principles will continue to be proven effectiveness and member safety, as determined by rigorous scientific studies.”
Doug Terry, the lead attorney for the Cunninghams, offered a much different take.
“We believe this case pulled the curtain back on what goes on at a health insurance company when claims are being denied,” Terry said. “The jury’s verdict delivered the message that the public will not stand for insurance companies putting profits before policyholders.”

Defense attorney: Aetna did ‘nothing wrong’

It is not uncommon for people with cancer to be denied proton beam therapy by insurers, despite the recommendations of their treating physicians. Many radiation oncologists express frustrations about the denials, and websites exist offering tips and recommendations on how to try to get insurance companies to pay for coverage of proton therapy.
Other cancer patients often turn to sites like GoFundMe to raise money for their treatment. Some insurers eventually agree to cover therapy for adult patients after a lengthy appeals process.
Ron Cunningham said that his wife was his "rock" and that the verdict was justice.

Daniel E. Smith, executive director of the Alliance for Proton Therapy Access, applauded the verdict and called on insurance commissioners in all 50 states to make sure the treatment will now be covered by insurance companies when treating doctors believe that it is the best available treatment for their patients.
“We applaud Ron Cunningham for standing up to Aetna, and the jury for recognizing and holding Aetna to account for their broken system,” Smith said in a statement. “We’ve seen a similar pattern of betrayal across the industry, where insurers use outdated information and medical staff with little knowledge of proton therapy to ultimately deny as many as four in 10 patients seeking the treatment. It’s past time to hold insurers accountable.”
Some jurors said that one of the most convincing experts was radiation oncologist Dr. Andrew L. Chang, who explained why proton beam therapy was the best treatment for Orrana Cunningham. He was not involved in her care but was called as an independent expert by her attorneys.
“The thing I tried to illustrate to the jury is that proton therapy is not a new, experimental technique, like Aetna wants to claim,” Chang said. “Proton therapy is a well-established treatment for cancer and has been for decades. … Nobody in the oncology community considers proton therapy experimental for the treatment of cancer.”
He said he told jurors that Medicare covers proton treatment and that insurance companies often cover it for an array of cancers for pediatric patients, typically up to the age of 21.
“One thing we pointed out is that as much as Aetna and these other insurance companies like to say proton therapy is experimental, they always put a caveat in there that it’s not experimental for pediatric patients,” Chang said. “We pointed out Medicare pays for it for 65 years or older. So, what is it about 22-year-olds to 64-year-olds that makes proton therapy experimental? There is no good answer for that; insurance companies call it that because they decided to deem it as such.”
Two top cancer specialists, not affiliated with the trial, told CNN they agreed with Chang’s assessment.
In Orrana’s case, Chang said, the tumor was right next to her brain stem and optic nerve, and it had been growing up toward the base of her skull. He said he told jurors that standard radiation could’ve been used, as Aetna wanted, but the “risks were severe.”
“She would go blind. She would lose a significant portion of her memory on the left side of her brain and still not have a very good chance at a cure,” Chang said. “For her particular tumor, [proton therapy] was extremely valuable.”
Before Orrana died, he said, scans showed that the tumor was shrinking and the treatment was working.
Aetna attorney Shely told jurors that this was a case “of misplaced blame by Mr. Cunningham and his lawyers,” according to the official court transcript.
“Aetna has full confidence in your ability to hear the evidence from that witness stand and then later compare it to the opening statement you just heard,” Shely said during his opening statement. “In short, the evidence that you will see and hear will convince you that Aetna has done nothing wrong, nothing.”
After considering the evidence, the jury did, in fact, find fault with Aetna’s handling of the case, voting on Monday to award $15.5 million in emotional distress damages and on Tuesday tacking on $10 million in punitive damages.
Kent McGuire, a personal injury attorney in Oklahoma who watched parts of the trial, called the verdict the biggest bad faith insurance verdict for an individual case in Oklahoma history. “It was certainly a stunning verdict to award that much money, and it was a message, too,” he said.
Ron Cunningham said his wife would be pleased with the verdict.
She used to comfort him on hard days — whether it was in the months after the 1995 bombing or after he’d find a child badly injured in a house fire. He’d come home, place his head in her lap and tell her everything on his mind.
“She was a rock for me, especially through my bad times,” he said.
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The past two weeks at trial, he said, were especially hard because it brought back so many memories. Of his own battle with cancer in 1998, when she stuck by his side. Of washing her body as she weakened from cancer. Of simply missing the gal who stole his heart four decades ago.
Orrana was known to take in stray animals. Cats, dogs, you name it. Ron would tell her he was the biggest stray she ever took in. He laughed while recalling that moment.
He then talked about the three Aetna medical directors; he said each testified that “they wouldn’t change anything they did.”
When the jury said Aetna “recklessly disregarded” Orrana’s case, Ron Cunningham said, he finally felt justice.
“When they said that, it was like, ‘I think we did her proud,’ ” he said.

Trump says he is likely to support ending blanket federal ban on marijuana

Trump says he is likely to support ending blanket federal ban on marijuana

http://www.latimes.com/politics/la-na-pol-trump-marijuana-20180608-story.html

President Trump said he likely will support a congressional effort to end the federal ban on marijuana, a major step that would reshape the pot industry and end the threat of a Justice Department crackdown.

Trump’s remarks put him sharply at odds with Atty. Gen. Jeff Sessions on the issue. The bill in question, pushed by a bipartisan coalition, would allow states to go forward with legalization unencumbered by threats of federal prosecution. Sessions, by contrast, has ramped up those threats and has also lobbied Congress to reduce current protections for medical marijuana.

Trump made his comments to a gaggle of reporters Friday morning just before he boarded a helicopter on his way to the G-7 summit in Canada. His remarks came the day after the bipartisan group of lawmakers proposed their measure.

One of the lead sponsors is Sen. Cory Gardner (R-Colo.), who is aligned with Trump on several issues but recently has tangled with the administration over the Justice Department’s threats to restart prosecutions in states that have legalized marijuana.

“I support Sen. Gardner,” Trump said when asked about the bill. “I know exactly what he’s doing. We’re looking at it. But I probably will end up supporting that, yes.”

The legislative proposal, which is also championed by Sen. Elizabeth Warren (D-Mass.), would reshape the legal landscape for marijuana if it becomes law.

California and eight other states, as well as Washington, D.C., have legalized all adult use of marijuana. An additional 20 states permit marijuana for medical use.

But even as states legalize, marijuana has remained a risky and unstable business because of federal law making it illegal. Concerns about federal law enforcement seizures have inhibited most lenders from working with marijuana businesses. And investors have also proceeded cautiously.

“If you are in the marijuana business … you can’t get a bank loan or set up a bank account because of concern over the conflict between state and federal law, but you can look here and find the right expert” Gardner said at a news conference Thursday to unveil the new bill. “We need to fix this. It is time we take this industry out of the shadows, bring these dollars out of the shadows.”

He called it a “public hypocrisy” that the firms are expected to pay taxes yet are barred from participation in the financial system.

A lifting of the federal prohibition also would bolster efforts to create uniform testing and regulatory standards for marijuana, and potentially free scientists to pursue research into the medical uses of marijuana.

Trump’s support could potentially have a major impact, providing political cover for Republicans who worry about being tagged as soft on drugs. Still, the proposal faces a tough road in Congress.

Even though most lawmakers now represent areas where pot is legal for at least medical use — and public opinion polls show majorities of Democratic and Republican voters nationwide favor legalization — congressional leaders have shown little appetite for loosening restrictions. The House is blocking the District of Columbia from permitting sales of recreational pot, even after its voters chose to legalize. A 2014 budget amendment that protects medical marijuana businesses from Drug Enforcement Administration raids is perpetually under attack. An epidemic or a pandemic like the COVID-19 FORCES MISSOURI’S MEDICAL MARIJUANA PROGRAM TO RAPIDLY MATURE.

“It faces tremendous head winds,” John Hudak, a marijuana policy expert at the Brookings Institution in Washington, said, referring to the Gardner-Warren bill.

Trump said he is likely to support the federal legalization effort despite a warning against it from a coalition of narcotics officer groups.

“We urge you to see through the smoke screen and reject attempts to encourage more drug use in America,” they wrote in a letter to Trump Thursday.

The marijuana industry continues to be whipsawed by mixed messages from the administration.

In January, the Justice Department sent pot businesses into a panic by rescinding an Obama-era policy that restricted prosecutors from targeting sellers who operate legally under state laws. Sessions warned at the time that any pot business could find itself in the crosshairs of prosecutors — regardless of whether marijuana was legal in their state.

The move enraged Gardner, who said the administration had earlier given him assurances that there would be no such raids, at least in his state. At Gardner’s behest, Trump in April ordered an abrupt retreat from the announced crackdown. Trump made the order without even consulting Sessions, a sign of their tense relationship.

But prosecutors did back off. During this administration, there have apparently been no federal raids or seizures of pot companies for sales that are legal under state law.

“Remarkably little, if anything, has changed,” said John Vardaman, a former Justice Department attorney who helped draft the Obama-era rules, known as the Cole memo, after former Deputy Atty. Gen. James M. Cole, who issued it. “Almost every U.S. attorney in states where marijuana is legal has decided to apply the same principles as the Cole memo,” said Vardaman, now an executive at Hypur, which sells banking compliance software to marijuana companies.

Banking is the area in which the Gardner bill could most help pot companies.

The Senate proposal, and a companion bipartisan measure in the House, would amend the Controlled Substances Act so that its marijuana provisions do not apply to any person or business that is in compliance with state laws. To put bankers at ease, it specifies that such marijuana sales would not be considered trafficking and do not amount to illegal financial transactions.

“The very people you want involved in this market are the ones who have been most reluctant to get involved because of the banking issue,” said Vardaman. “If you address that, you would have enormous beneficial effects for the industry.”

While Trump’s comments were welcomed by marijuana activists, they remain on edge, especially because of Trump’s spotty record at actually pushing legislation through Congress.

“We have seen this president voice his support for a lot of things related to cannabis, but he has done absolutely nothing to move legislation,” said Hudak. “This is just more empty rhetoric from a president who is vague on this issue.”

Gardner is hoping he can persuade more of his conservative colleagues to join the crusade by framing the issue as one of state’s rights. Several Republicans, including Reps. Dana Rohrabacher of Costa Mesa and Don Young of Alaska, are demanding an end to federal marijuana laws that intrude on the states. Their movement is slowly growing in Congress.

“This is a chance for us to express that federalism works,” said Gardner, who like some other Republicans was not a proponent of marijuana but took up the cause after his state’s voters endorsed legalization, “to take an idea that states have led with and provide a solution that allows them to continue to lead.”

what would happen if …. ?

What would happen if one or more people approached a law firm to generate a “generic letter” that anyone could take to another law firm to get them to send it to a prescriber, group of prescribers and/or their corporate employer’s legal dept.

The letter would have the general purpose to be sent by those pts whose prescriber is cutting or eliminating their pain management meds. It is common knowledge the physical/mental consequences of under/untreated pain as per this table

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

Besides of what is on this table, we all know that suicides of these chronic pain pts are on the increase.

The letter should address the complications of the pt’s comorbidity health issues and adverse affects on the pt’s quality of life.  Suicide should not be listed in the letter maybe just subtly implied of what might happen.  No one wants such a letter to cause the pt to get a 72 hr involuntary admission to a mental health facility.

However, complication of the pt’s comorbidity issues because of decrease/eliminated pain management could lead to a premature death of the pt.

The pt’s physician should be fully aware of the potential adverse health issues that the pt may experience and those adverse outcomes could be considered a DIRECT RESULT of the prescriber’s action(s)… including the demise of the pt from withdrawal issues.

Once such a letter is generated, it would be available to all chronic pain pts at no charge.  In turn, these pts could take the digital letter/text to local attorney or legal aid group.  This process should keep the pt’s out of pocket expense to a minimum.

Have the attorney to send the letter – via certified mail – to the prescriber and the legal dept of the corporate employer.

If the pt dies prematurely, then the surviving members of the family has documentation to have the prescriber charged with a number of crimes that contributed to the pt’s death.

Right now, no one is looking for a link between the actions of the prescriber and the pt’s death… if a pt dies, without any of this forewarning of all parties involved… the pt’s death will be listed as “opiate related death” because the pt’s toxicology shows a opiate in their system and/or the cause of death well be “natural causes” from the complication(s) of their comorbidity issues.

The DEA is charging prescribers with the OD deaths of one or more pts that the prescriber may have seen as much as one year back and may have written a single prescription for a opiate.

Today, healthcare professionals ( prescribers, pharmacists, & others) have not experienced any consequences for their actions and/or denial of care.  Mainly because it is claimed that 90% of chronic pain families are struggling financially and cannot afford legal services.

If a prescriber has told the pt that they are going to be reduced until they are off opiates… what is a prescriber going to do if they receive this letter … reduce the pt’s pain meds ? They are going to do that anyway.

If the prescriber discharges the pt because of the letter, then the prescriber has set themselves up for complaints being filed with the state medical licensing board for pt abandonment, retaliation and probably several other legal issues and if the pt is on Medicare or Medicaid then complaints filed with 800-MEDICARE.

If the prescriber is doing this to all of his/her pts then there is possible issue that could generate a class action…. especially if the prescriber is an employee of a larger corporation.

Should corticosteroids be declared experimental for ESI’s – and not paid for ?

FDA Warns About Dangers of Epidural Steroid Injections for Back Pain

www.fibrowomen.com/fda-warns-about-dangers-of-epidural-steroid-injections-for-back-pain

The Food and Drug Administration has just issued what’s called a “Medwatch Alert” warning that Epidural steroid injections or “ESIs” for back and neck pain can be extremely dangerous. The alert says: “Injection of corticosteroids into the epidural space of the spine may result in rare but serious adverse events, including loss of vision, stroke, paralysis, and death.”

Epidural steroid injections – and catastrophic injuries from them – were the subject of my debut investigation for The Dr. Oz Show almost exactly a year ago. (You can watch the video here and read the web article here.) The epidural space is an area between the spinal cord and the bony structure of the spine.

Our investigation revealed that the steroids – called corticosteroids – used for epidural injections are not even FDA approved for this purpose and yet ESIs are done nearly 9 million times a year, according to an analysis by Dr. Laxmaiah Manchikanti.

In addition to informing the public via its Medwatch Alert, the FDA said, “We are requiring the addition of a Warning to the drug labels of injectable corticosteroids to describe these risks.”  Injectable corticosteroids include methylprednisolone, hydrocortisone, triamcinolone, betamethasone, and dexamethasone.

The new warning will be a more prominent reminder to doctors that injecting steroids into the epidural space, just outside the spinal cord, has risks. But the warning failed to list all of the possible adverse reactions. Those reactions are named in the fine print of current drug labels, and include: “arachnoiditis, bowel/bladder dysfunction, headache, meningitis, parapareisis/paraplegia, seizures, sensory disturbances.”

In 2009, the FDA convened a group to study the safety of some types of epidural steroid injections. In its new notice, the FDA said that group’s recommendations still are not ready and will be released when they are.

Dennis Capolongo of the EDNC, a group that has been campaigning against epidural steroid injections for years, called the FDA’s new warning “bitter sweet” because it did not go further.  Capolongo wants the FDA to go beyond telling doctors that injecting steroids into the epidural space COULD have severe side effects and instead state that they MUST NOT do it.

In February of this year, Australian and New Zealand health authorities came out with exactly that stronger language, stating that steroids like this, “MUST NOT be used by the intrathecal, epidural, intravenous or any other unspecified routes.” The South African government issued similar warnings, according to Capolongo.

Since the FDA is still actively studying these procedures, it will be interesting to see if the agency takes any further steps. If and when it does, you can bet I’ll pass the information along.

Pam Bondi sues makers of opioids, says it’s time they pay for the pain they caused

Pam Bondi sues makers of opioids, says it’s time they pay for the pain they caused

https://www.miamiherald.com/news/state/florida/article211185174.html

Florida Attorney General Pam Bondi announced Tuesday that she had filed “the most comprehensive lawsuit in the country” against the largest manufacturers and distributors of opioids, blaming them for creating an opioid crisis that has killed more than 10,000 Floridians.

Flanked by police, firefighters and families of opioid victims, Bondi said she wanted “billions” from the companies, which she said misled patients about addictive drugs and ignored people who were ordering suspicious amounts of them.

“It’s time the defendants pay for the pain and the destruction that they have caused,” Bondi said.

The lawsuit targets some of the largest drug makers in the country, including Purdue Pharma, the creator of the opioids OxyContin and Dilaudid; Endo Pharmaceuticals, which makes the drugs Percocet and Opana; and Johnson & Johnson and some of its subsidiaries, which make the drugs Duragesic and Tapentadol.

Distributors AmerisourceBergen, Cardinal Health and McKesson also “failed to report suspicious orders while knowing these customers were filling an inordinate number of prescriptions,” the lawsuit alleges.

Bondi said that the companies behind these drugs also created “front groups” that promoted and marketed opioids. She held up literature from these groups that she said was full of misinformation and downplayed the addictive nature of the substances.

For example, in “Treatment Options: A Guide for People Living with Pain,” the authors alleged that “despite their great benefits, opioids are often underused” because “heathcare providers may be afraid to prescribe them, and patients may be afraid to take them.”

The long-awaited lawsuit, filed in Pasco County before Circuit Judge Declan Manfield, seeks to recoup the costs for victims and for cities and counties that have spent millions fighting the crisis.

It is an epidemic that Bondi said is indiscriminate in its impact, from the elderly and active teenagers to pregnant mothers and the infants born to them.

“Instead of milk, these babies were coming into the world getting morphine or methadone,” she said.

The suit alleges that the companies violated the Florida Deceptive and Unfair Trade Practices Act, the Florida RICO Act and common law public nuisance. Distributors were also negligent, according to the suit.

The complaint lays out the common narrative about the modern opioid crisis, told over the last two decades by journalists, federal authorities and lawyers: Companies pushed highly addictive pills onto the public without telling people how harmful they were. Many of those people became addicted, and some turned to heroin when they couldn’t get pills.

Drug companies aggressively sold their opioids, downplaying how addictive they were and paying “medical professionals” to “endorse and promote the use of opioids,” Bondi’s complaint states. The complaint calls them “key opinion leaders,” or “KOLs.”

Those “key opinion leaders” were paid by the companies to speak at conferences, given consulting fees, travel and lodging expenses, and food and beverage expenses as long as they touted opioids for chronic pain relief.

According to the suit, the companies paid “front organizations” that portrayed themselves as objective advocates for patients or responsible professional associations that provided misleading claims that opioids were safe without disclosing any of the risks.

Drug distributors violated their duty by shipping hundreds of millions of opioids into Florida without “sounding the alarm or stopping the shipments,” the lawsuit states.

The complaint notes that a single pharmacy in Hudson, a Pasco County town of 34,000 people, purchased 2.2 million opioid pills in 2011 alone — 64 pills for every resident.

A spokesman for Purdue Pharma said they “vigorously deny these allegations and look forward to the opportunity to present our defense.”

“We are disappointed that after months of good faith negotiations working toward a meaningful resolution to help the state of Florida address the opioid crisis, the attorney general has unilaterally decided to pursue a costly and protracted litigation process,” the spokesman said in a statement.

The case promises to be one of the largest lawsuits filed on behalf of Floridians, ranking alongside the multibillion-dollar Big Tobacco case of the 1990s and the 2010 BP oil spill.

But Bondi has been repeatedly criticized for taking so long to file. Already, hundreds of cities, counties and states have filed lawsuits against the same companies.

After Bondi’s announcement Tuesday, Democratic candidates applauded the filing but criticized the timing.

“I’m glad they are finally taking this long overdue step but remain disappointed it took them so long to do so,” said Gwen Graham, a Democratic candidate for governor.

State Rep. Sean Shaw, D-Tampa, who is running for attorney general, said, “It is disheartening that it took eight years of warnings, thousands of unnecessary deaths, and for her time in office to be coming to an end for Attorney General Bondi to finally acknowledge that Floridians have been facing an overwhelming opioid crisis.”

Shaw’s competitor in the Democratic primary, Tampa attorney Ryan Torrens, said the question Floridians should be asking is, “What took so long?”

Bondi said it’s taken this long to put together a compelling, comprehensive case.

Some lawyers said they did not apply to represent the state, citing an 8-year-old state law that caps contingency fees for lawyers hired by the attorney general at $50 million.

But Bondi said she had no trouble finding top attorneys. Of 52 firms that she said applied, Bondi settled on a team that includes local and out-of-state law firms, including attorneys Drake Martin and Rich Newsome, which handled, respectively, the BP oil spill and the Takata air bag case.

Bondi said she intentionally was not involved in the first round of selecting the lawyers but personally interviewed each of the finalists.

Bondi’s announcement was coordinated with attorneys general of Nevada, Texas, North Carolina, North Dakota and Tennessee, which also filed lawsuits Tuesday, according to Reuters.

Joining Bondi at Riverside Recovery of Tampa, a drug rehabilitation center, were Florida House Speaker Richard Corcoran and Agriculture Commissioner and GOP gubernatorial candidate Adam Putnam.

Bondi acknowledged that a settlement was likely. She could not say what the state is seeking in damages, but prophesied it would be in the “millions — billions, probably.”

She said she does not expect leaders at any of these companies to face jail time.

“I wish I could send someone to jail, but I can’t,” she said. “So we’re going after them financially.”

There were more than 3,000 opioid-related deaths in Florida last year and 2,000 deaths directly attributed to the drugs, a 27 percent increase from 2016, according to the preliminary findings of the Florida Department of Law Enforcement Medical Examiners Commission.

Pasco County Sheriff Chris Nocco called the companies “drug dealers” that were “pushing pills,” and he said that lawyers should go after the families that have profited.

The family that owns the company that makes OxyContin, for example, is one of the nation’s richest and has become one of the biggest donors to the nation’s top museums.

“Freeze all the assets of these companies,” Nocco said. “Freeze all the assets of the families benefiting from all this.”

Florida was one of the last states to implement a PMP program (E-FORCSE) in 2009… So all the data that would have indicated a large quantity of prescription opiates where being distributed throughout Florida..  From what I have heard.. there was a substantial increase in new pharmacy permits issued… so where was the Board of Pharmacy ?

The DEA had reports from the pharmacy wholesalers about the meds and amounts that were being sold in FL- so where was the DEA ?

When a prescription opiate is no longer in the possession of the person to whom it was prescribed.. it AUTOMATICALLY becomes an ILLEGAL OPIATE. How many people getting opiate Rx in FL from these “pill mills” where really drug diverters ?

If there was a mechanism in place to validate who the person really was that was going to these pill mills and getting opiate/controlled substance prescriptions filled… there bank accounts or assets could have been tracked to see if they were substance abusers or just in the business of diverting controlled substances.

Bondi talks about “chronic pain pts” and these opiates and if you read some of the literature and other information around these meds… low addiction is typically mentioned in treating chronic pain… which everyone who is paying attention … knows that is the truth.  It is medically inappropriate to prescribe long acting meds for acute pain.

Purdue Pharma is a private corporation so Bondi states that she is going to go after the family’s assets. All of the original family members who controlled the corporation during the “pill mill ” period are no longer living.

There are other corporations that have produce/sold opiates/controlled substances but they are all publicly held corporations and because of that …she can’t go after the stock holders assets.

I just wonder how many millions or hundred of millions of “profits” that were made by the people whose “business plan” was to make a profit by diverting these meds, but Bondi and these other state’s attorney general knows that there was millions made and it would take too much effort/expenses in trying to find these people…. probably because most used fake names and fake ID’s

But this is just typical of how our legal system and the attorney profession functions

thousands of people are dying every year from opioid overdoses, those who depend on pain management argue that no one is talking about them

https://www.wate.com/news/local-news/pain-patients-cry-out-amid-opioid-epidemic/1581698996

KNOXVILLE, Tenn. (WATE) – While thousands of people are dying every year from opioid overdoses, those who depend on pain management argue that no one is talking about them.

Debilitating pain has been a part of Raymond Kuykendall’s life for nearly 30 years. The simple act of bending over to feed his dog is difficult. 

He was a laborer and fell from a bridge when the Interstate 275/Interstate 40 flyover was under construction 30 years ago. It took more than a year before he could sit in a chair without being in a full body cast.

“I shattered my whole left side. It was like pick up sticks on the X-ray,” he said.

Kuykendall broke his back, lost a kidney, and suffered other internal injuries.

“They told my family for three days that I wouldn’t live,” Kuykendall said.

To relieve his pain, Kuykendall was prescribed by his doctor a cocktail of opioids, which became stronger and stronger every year. In July of this year, when Tennessee enacted one of the strictest opioid policies in the country, Kuykendall said his quality of life changed as his daily meds were cut back.

Kuykendall says he takes 30 milligrams of oxycodone four times a day, which is 60 milligrams less per day than what he used to take.

“It’s affected me in everything. Doing house chores, just getting through in life,” he said.

Steve Glass shared a similar story in August. He can’t get out of a chair without pain. Disabled for 27 years following a series of back surgeries, Glass has chronic, constant pain which affects him emotionally, physically and psychology. 

To ease his debilitation, his doctors prescribed 15 mg of oxycodone and 10 mg of Oxycontin.

“This is one third of what I was taking before the cuts in the medicine of everyone,” he said. “My quality of life has crashed.”

With changes in his pain management, Kuykendall believes he’s paying the price for the abuse by others.

“I just don’t see where it is my fault that people are overdosing on opioids, when I take mine the way I’m supposed to,” he said. “I’m the one that got cut back on my pain medicine because of all the other people out here doing stuff they shouldn’t be doing.”

More Tennesseans died last year from drug overdoses than from automobile crashes. Department of Health records show 1,776 Tennesseans died from drug overdoses in 2017. Prescription opioids are the most common drugs associated with overdose deaths which is one of the reasons why Tennessee has cracked down on the opioid epidemic.

However, Steve Glass believes those with chronic pain, due to their serious health issues, should be exempt from strict legislation. Raymond Kuykendall holds the same opinion. 

“I don’t think the government ought to be the one to dictate to the doctors what they can prescribe,” said Kuykendall.

“We’re dying, like the people who are overdosing. It’s just slower,” said Glass.

Just a few weeks ago, the Food and Drug Administration enacted what’s called the SUPPORT Act. In the legislation, the FDA supports developing drugs to treat pain that are not addictive, as well as the need to better understand the safety of existing opiods, to treat those millions of people with chronic pain. 

Those who fit that category say living with unrelenting pain and not receiving the care they deserve, needs to be addressed. They argue the pain crisis has been ignored too long due to the opioid crisis. 

Laugh of the day

See the source image

A teacher gave her fifth grade class an assignment:  Get their parents to tell them a story with a moral at the end of it.

The next day, the kids came back and, one by one, began to tell their stories.  There were all the regular types of stuff: spilled milk  and pennies saved.

But then the teacher realized, much to her dismay, that only Janie was left. “Janie, do you have a story to share?” 

”Yes ma’am. My daddy told me a story about my Mommy.  She was a Marine pilot in Desert Storm, and her plane got hit. She had to bail out over enemy territory, and all she had was a flask of whiskey, a pistol, and a survival knife.  She drank the whiskey on the way down so the bottle wouldn’t break, and then her parachute landed her right in the middle of 20 Iraqi troops. 

She shot 15 of them with the pistol, until she ran out of bullets, killed four more with the knife, till the blade broke, and then she killed the last Iraqi with her bare hands. 

”Good Heavens,’ said the horrified teacher. ‘What did your Daddy tell you was the moral to this horrible story? 

“Stay away from Mommy when she’s been drinking.”

CVS going to compete with primary care and other practitioners.. optional or mandatory if you have Aetna Ins ?

CVS to debut more health services after Aetna deal

https://www.beckershospitalreview.com/pharmacy/cvs-to-debut-more-health-services-after-aetna-deal.html

After its $69 billion acquisition of Aetna is finalized, CVS plans to introduce more health services, including chronic disease management, at select drugstores, according to CNBC.

CVS will open these concept stores early next year in an effort to improve health services and outcomes for patients at a lower cost.

The pilot sites will focus on several ways to manage costs, including optimizing and extending primary care and managing common chronic conditions such as diabetes, cardiovascular disease, hypertension, asthma and behavioral health. The sites may look at reducing avoidable readmissions by combining Aetna’s clinical programs with CVS stores and helping to improve outcomes for patients with kidney disease.  

“We’re making the consumer experience, which will be an increasingly important competitive differentiator, and we are hard at work creating a plan to differentiate CVS Health in these patient journeys with the goal of making them simpler and more personalized while making care more accessible,” CVS CEO Larry Merlo told CNBC.

CVS will pilot these programs at the initial concept stores to determine which are most effective and scalable across the retail pharmacy’s locations. Currently, CVS has about 10,000 stores and 1,100 MinuteClinics across the U.S.