A Proposed Lottery System to Allocate Scarce COVID-19 MedicationsPromoting Fairness and Generating Knowledge

Posted on July 4, 2020 by Pharmaciststeve

A Proposed Lottery System to Allocate Scarce COVID-19 MedicationsPromoting Fairness and Generating Knowledge

https://jamanetwork.com/journals/jama/fullarticle/2767751

 

On May 1, 2020, the US Food and Drug Administration (FDA) issued an Emergency Use Authorization for the unapproved drug remdesivir to treat hospitalized patients with severe coronavirus disease 2019 (COVID-19). The authorization was based on a preliminary report from a randomized clinical trial in 1063 patients that found that remdesivir shortened the median time to recovery from 15 days to 11 days.1 Anticipating immediate worldwide demand, the maker of remdesivir, Gilead Sciences, donated 1.5 million doses of remdesivir to countries affected by the pandemic, including the US, which received 607 000 doses (enough to treat approximately 100 000 patients). However, the US and other countries have 2 major problems related to this drug. First, the supply of remdesivir is insufficient to treat all eligible patients, which has required hospitals to ration the drug.2 Second, there remain major gaps in knowledge about the efficacy of remdesivir, including whether it reduces mortality and what subgroups of patients may benefit the most.

These problems are not specific to remdesivir or to the current pandemic: governments and health systems will predictably encounter situations during pandemics in which novel therapeutics are in short supply and knowledge about their harms and benefits is limited. Promising results from clinical trials of convalescent plasma,3 monoclonal antibodies, or other experimental drugs will put pressure on the FDA to emergently authorize use in the face of incomplete knowledge about efficacy and insufficient supply. Without careful planning, the rollout of such emergency authorizations risks unfair drug allocation and missed opportunities to learn more fully about the effects of these medications.

When there is an insufficient supply of newly approved antiviral agents (including remdesivir), the drug should be allocated to patients using a lottery system overseen by state health departments. In this model, states would create a central registry into which hospitals report the demographics and clinical outcomes of all patients entered into the lottery, including those who are not allocated the drug. This approach could simultaneously accomplish fair allocation (via the lottery) and rapid learning, because the lottery creates a natural experiment4 that achieves random allocation in which some patients receive the drug while others do not; researchers can use the lottery’s registry to assess the effectiveness of the scarce drug.

Critique of the US Response to the Remdesivir Shortage

The initial federal and state allocation of remdesivir has 2 major problems: unfair allocation of the drug to patients and missed opportunities to generate new knowledge that could reduce morbidity and mortality. After a largely unsuccessful attempt by the US Department of Health and Human Services (DHHS) to distribute remdesivir to hospitals across the country, the DHHS delegated this responsibility to state health departments.5 Some states provided no guidance to hospitals about how to select among eligible patients when the supply was insufficient for all patients, whereas others provided guidance that is ethically problematic.

For example, the New Jersey Remdesivir Advisory Committee advised that “remdesivir [should] be used in eligible patients on a first-come, first-served basis.” Similarly, the Minnesota Department of Health created 2 tiers of priority based on the severity of patients’ respiratory failure, then instructed hospitals that “no courses…should be held in reserve for future use. All courses should be immediately allocated.” First-come, first-served approaches disadvantage patients with poor health care access, such as individuals with disabilities who require special travel arrangements to reach the hospital. These approaches also render states unable to accomplish important ethical goals of public health, such as prioritizing patients most likely to benefit, or mitigating the disproportionate effects of COVID-19 on disadvantaged groups and essential workers.

The second major problem with the US government’s response is the absence of a plan to use the government’s supply of remdesivir to gain additional knowledge about its effectiveness. The FDA’s Emergency Use Authorization for remdesivir requires hospitals to report only serious adverse events that are potentially attributable to remdesivir. This minimal reporting requirement misses an opportunity to collect outcome data that would shed light on several pressing questions, such as whether remdesivir has an overall mortality benefit and whether certain clinical subgroups are more likely to benefit than others (eg, patients with mild vs severe hypoxemia).

A Centralized Lottery System

The allocation of scarce COVID-19 drugs should occur via a lottery system overseen by individual state health departments. Oversight by states, rather than the federal government, is appropriate because medical practice is regulated by states and because states have local health officers who could coordinate such activities. As part of participating in the lottery, health systems would report information on all patients entered into the lottery, not just those who ultimately receive the drug.

In practical terms, implementing a central lottery system would be relatively straightforward. States would determine the lottery’s baseline treatment probability for individual patients based on the number of available courses of remdesivir and epidemiological projections of the number of cases expected in the state over the period the supply of drug is supposed to last. When treating clinicians in a hospital identify a patient who is eligible to receive remdesivir, rather than appealing to a hospital-based committee for allocation of the drug, they would instead make the request to the state health department via telephone or an online portal. The clinicians would provide demographic and clinical information about the patient, which would be entered into a registry covering the entire state. A state health officer or designee would verify that a patient meets eligibility requirements for remdesivir, conduct the lottery using a random number generator, and inform the treating clinicians whether the patient can receive remdesivir. If so, the state would authorize the release of the drug to the patient. To achieve rapid distribution, the drug could be held in numerous regional locations across the state. Hospitals would report patients’ clinical outcomes at death or hospital discharge to the registry, which could be made available to researchers for analysis after enough patients are included.

Although the purpose of the lottery is to fairly distribute a scarce public resource, a secondary benefit is that the lottery creates randomization, which balances known and unknown confounders across patients who receive or do not receive remdesivir. In essence, the lottery creates a natural experiment that could be leveraged by researchers to make causal inferences about the effect of a factor outside their control (eg, the medication lottery) on patient outcomes in a situation resembling an actual experiment.4 Research leveraging previous lotteries in society has yielded important scientific insights, such as the Vietnam Draft Lottery and the effect of military service on lifetime income.6

Conducting the lottery at the state level, rather than having many individual hospitals conduct hospital-level lotteries, could allow rapid accrual of a large number of patients, providing greater statistical power to assess the effectiveness of remdesivir among clinical subgroups. If needed, researchers could pool data from multiple states to enhance statistical power.

There is precedent for using the occurrence of drug scarcity to advance scientific knowledge. The first published randomized clinical trial occurred in similar circumstances in the late 1940s. Small nonrandomized studies of streptomycin for pulmonary tuberculosis had yielded encouraging but inconclusive results; manufacturing challenges limited the amount of streptomycin that the British government could procure such that not all patients in need could receive it.7 Therefore, a team led by Bradford Hill used randomization to fairly allocate the scarce streptomycin and to rigorously evaluate its efficacy, which ultimately proved effective in reducing mortality from pulmonary tuberculosis.8

A major advantage of lottery systems is that even though they introduce randomness, they need not provide the same chances to all patients. Instead, to achieve public health goals, states can use a weighted lottery to give increased priority to certain groups, such as those most likely to benefit and those who have been disproportionately harmed by the pandemic. For example, the Commonwealth of Pennsylvania recently endorsed a weighted lottery system developed at the University of Pittsburgh that gives increased chances to receive the scarce treatment to essential workers and individuals from economically disadvantaged areas.9 A strength of a central lottery, compared with hospital-level lotteries, is efficiency. State-level lotteries could significantly decrease the administrative burden for the thousands of hospitals in the US that would otherwise need to develop and administer a scarce drug allocation protocol.

Response to Potential Criticisms

Administering the centralized lottery would require additional effort by state agencies. However, the time and expense to do so is relatively small compared with the magnitude of potential benefit derived from a program that ensures fair allocation and allows greater knowledge about the drug’s effectiveness. The data obtained from the lottery are not immune to the weaknesses of natural experiments, such as lack of blinding, but there are accepted strategies to mitigate the weaknesses, such as relying on outcomes that are unlikely to be influenced by knowledge of treatment (eg, mortality).4 Some may assert that the proposed lottery would require patient-level consent for research. However, the lottery is not a research maneuver; it is a public health intervention to fairly allocate a scarce resource that creates a type of natural experiment.

Conclusions

If state health departments had instituted lotteries with registries to allocate the first shipments of remdesivir in May 2020, substantially more information about the effectiveness of remdesivir would likely be available now. Implementing central lotteries paired with registries of clinical outcomes could simultaneously allow fair allocation of scarce COVID-19 medications and facilitate knowledge generation that could reduce morbidity and mortality during the pandemic.

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8% of Opiate OD’s: were from pharma grade opiates – about 10 OD’s/day

Posted on July 4, 2020 by Pharmaciststeve

Prescriptions Are Down, but Overdoses Are Up — Is That Progress?

https://www.cato.org/publications/commentary/prescriptions-are-down-overdoses-are-progress

President Trump recently spoke at the annual Prescription Drug Abuse and Heroin Summit in Atlanta, touting “pretty amazing” progress in combating the overdose crisis afflicting the country and expressing pride in government efforts to reduce the total number of opioids prescribed, claiming a 34 percent drop in total opioid prescriptions during his time in office.

The number of opioid prescriptions might be coming down, but overdose deaths continue to mount, with the Centers for Disease Control and Prevention provisional report showing over 46,000 opioid‐​related deaths in the 12 months ending April 7, 2019, 60 percent of which involved illicit fentanyl. Thirty‐​two percent involved heroin.

If this rates as “pretty amazing” progress then the president is grading on a steep curve. If he wants to really see progress, the focus of drug policy must move away from the number of pain killers prescribed and over to harm reduction.

Patients in pain grow desperate as doctors are terrorized into under‐​prescribing pain medication, fearing arrest and prosecution. State regulators, licensing boards and even pharmacies and insurers have misinterpreted and misapplied the already controversial 2016 CDC opioid prescribing guidelines which were meant to be “voluntary [guidelines] rather than prescriptive standards.”

This misapplication has resulted in chronic pain patients being abruptly tapered off of their medication, leading some in desperation to turn to the black market or resort to suicide. It has gotten so bad that during the same week of the drug summit the CDC issued a “clarification,” stating their guidelines were never intended to encourage abrupt tapering.

The government’s own data show no correlation between the prescription rate and non‐​medical opioid use or opioid use disorder. That’s why we need harm reduction, which seeks to reduce the physical dangers that come from nonmedical drug use in a dangerous black market fueled by drug prohibition.

In the states where we have seen improvements in mortality rates, it is because those states have begun to employ harm reduction. Ohio and Massachusetts, for instance, have greatly proliferated needle exchange programs and widely distribute the overdose antidote naloxone. They have also expanded the number of licensed methadone treatment clinics. Needle exchange programs are endorsed by the CDC and the Surgeon General and have been proven to reduce the spread of HIV and hepatitis; now many of them hand out naloxone to people along with clean needles. Unfortunately, unlike Ohio and Massachusetts, many states still have anti‐​paraphernalia laws that prohibit needle exchange programs.

Harm reduction strategies are beginning to reap rewards. Ohio’s Cuyahoga County, for instance, reported 560 overdose deaths in 2018 compared with 727 in 2017. Overdose deaths dropped by four percent during the same year in Massachusetts. But much of harm reduction requires action on the federal level.

President Trump should push reform of regulations on methadone clinics, buprenorphine prescribing and other forms of what is called Medication Assisted Treatment, so that more primary care providers can treat more patients. In the UK, Canada and Australia, primary care physicians are permitted to treat addicts with methadone in their offices, but in the U.S., addicts must seek treatment at heavily regulated clinics approved by the Drug Enforcement Administration and this restricts their availability. And providers are still limited by quotas on how many addicts they can treat at any given time with buprenorphine.

The president should seek a repeal of the federal “Crack House Statute” that doesn’t allow our major cities to establish safe consumption/​overdose prevention sites, which have saved so many lives in more than 120 cities in Europe, Canada and Australia. He should have the FDA make naloxone available off‐​the‐​shelf to increase its availability and legalize cannabis so it can be used to treat pain and can undergo trials as a Medication Assisted Treatment

Drug overdoses and abuse are not confined to the U.S. The problem exists in much of Europe, in Canada and in Australia. But death rates in those countries are dwarfed by those in the U.S. and that’s largely because harm reduction strategies have been widely adopted in most of the rest of the developed world since the 1980s.

President Trump can set a new precedent — and make historic progress — by being the president who shifts the strategy from a war on drugs to a war on drug‐​related deaths.

10 deaths/day… but while they claim that these deaths are from pharma opiates..  there seems to be no further facts… how many of those 10 OD’s were from legally obtained pharma opiates ?  Pharma opiates are only “legal” if they are in the possession of pharma, wholesaler, pharmacy, pts to whom they were prescribed..  If they are in the possession of anyone else… they AUTOMATICALLY BECOME AN ILLEGAL OPIATE.

Prescription bottles/labels will have the following statement: Federal law  prohibits the transfer of this med to any person other than the patient to which it was prescribed.

So what percent of those 10 OD’d per day where illegal obtained , whatever that number is… the remaining OD’s may have been a death of despair (suicide). Self harm (suicide) from legally prescribed opiates would suggest that the pt was not getting adequate pain management .. for many reason.. like the prescriber was limiting their daily MME’s to some arbitrary limit.  You have a CRPS pts who is a ultra fast metabolizer… there is no way that a arbitrary MME/day are going to properly manage their pain… and this disease is referred to as the “suicide disease”.  Under/untreated pain could lead to anxiety and depression and cause suicidal idealization.  Suicide tends to be a rather impulsive act… the result of a “final straw” to a person that is already dealing with suicidal idealization.  In reality, those deaths labeled as OD’s could not be from a on going abuse of those meds by the person that has a legal prescription. If there is no suicide note or if there was and SOME HOW the note disappears…  their death and their death certificate cannot be properly defined ?

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administration of the drug hydroxychloroquine makes hospitalized patients substantially less likely to die

Posted on July 3, 2020 by Pharmaciststeve

administration of the drug hydroxychloroquine makes hospitalized patients substantially less likely to die.

https://www.foxnews.com/politics/hydroxychloroquine-helped-save-coronavirus-study

Researchers at the Henry Ford Health System in Southeast Michigan have found that early administration of the drug hydroxychloroquine makes hospitalized patients substantially less likely to die.

The study, published in the International Journal of Infectious Diseases, determined that hydroxychloroquine provided a “66% hazard ratio reduction,” and hydroxychloroquine and azithromycin a 71 percent reduction, compared to neither treatment.

In-hospital mortality was 18.1 percent with both drugs, 13.5 percent with just hydroxychloroquine, 22.4 percent with azithromycin alone, and 26.4 percent with neither drug. “Prospective trials are needed” for further review, the researchers note.

“Our results do differ from some other studies,” Dr. Marcus Zervos, who heads the hospital’s infectious diseases unit, said at a news conference. “What we think was important in ours … is that patients were treated early. For hydroxychloroquine to have a benefit, it needs to begin before the patients begin to suffer some of the severe immune reactions that patients can have with COVID.”

A statement from the Trump campaign hailed the study as “fantastic news.”

“Fortunately, the Trump Administration secured a massive supply of hydroxychloroquine for the national stockpile months ago,” a statement read. “Yet this is the same drug that the media and the Biden campaign spent weeks trying to discredit and spread fear and doubt around because President Trump dared to mention it as a potential treatment for coronavirus.”

It added: “The new study from the Henry Ford Health System should be a clear message to the media and the Democrats: stop the bizarre attempts to discredit hydroxychloroquine to satisfy your own anti-Trump agenda. It may be costing lives.”

The findings, conservatives said, highlighted efforts by media partisans to undermine confidence in the drug simply to undercut the president.

“So fewer people died because they took the drug @realDonaldTrump  suggested…. Thank you, POTUS for doing the right thing even in the face of a DC culture attacking you no matter what you do,” wrote former Acting Director of National Intelligence Richard Grenell.

The Federalist’s Sean Davis added: “Media and incompetent corrupt government officials lied to you about social distancing. They lied to you about hydroxychloroquine. They lied to you about risks to children and the general population. They lied not to help you, but to control you, and they’re not going to stop.”

At a March 19 White House briefing, Trump had remarked: “Now, a drug called chloroquine, and some people would add to it, hydroxychloroquine, so chloroquine or hydroxychloroquine … [has] shown very encouraging, very, very encouraging early results.” The president acknowledged that the drug may not “go as planned” and that more testing was needed, but that “we’re going to be able to make that drug available almost immediately.”

That statement prompted immediate mockery from journalists.

“Trump peddles unsubstantiated hope in dark times,” read a March 20 “analysis” by CNN’s Stephen Collinson. Saying Trump was “adopting the audacity of false hope” and embracing “premature optimism,” Collinson charged that “there’s no doubt he overhyped the immediate prospects for the drug” because the FDA had not provided an explicit timeline on approving the drug to treat coronavirus.

The media onslaught continued. “Trump is giving people false hope of coronavirus cures. It’s all snake oil,” read one Washington Post headline. Added the Post’s editorial board: “Trump is spreading false hope for a virus cure — and that’s not the only damage.”

“The most promising answer to the pandemic will be a vaccine, and researchers are racing to develop one,” the paper insisted, although it is not staffed with medical experts. “Mr. Trump’s inappropriate hype has already led to hoarding of hydroxychloroquine and diverted supplies from people with other maladies who need it. His comments are raising false hopes. Rather than roll the dice on an unproven therapy, let’s deposit our trust in the scientists.”

President Donald Trump speaks during a visit to Fincantieri Marinette Marine, Thursday, June 25, 2020, in Marinette, Wis. (AP Photo/Evan Vucci)

USA Today’s editorial board was similarly aggressive and mocking, writing, “Coronavirus treatment: Dr. Donald Trump peddles snake oil and false hope.”

“There are no approved therapies or drugs to treat COVID-19 yet, but the president hypes preliminary chloroquine trials at White House briefing and unproven remedies on Twitter,” the paper wrote, just days before the FDA would approve the drug.

Communications strategist Drew Holden flagged these and numerous other examples of media misinformation on the matter in a lengthy Twitter thread.

Salon, Holden noted, called Trump’s hope in the new treatment his “most dangerous flim-flam: False hope and quack advice.”

The New Yorker pondered “The Meaning of Donald Trump’s Coronavirus Quackery,” observing that Trump’s “pronouncements are a reminder, if one was needed, of his scorn for rigorous science, even amid the worst pandemic to hit the U.S. in a century.”

Michael Cohen, a Boston Globe columnist, urged networks to stop airing Trump’s coronavirus press briefings because he was spreading “misinformation” about a potential cure.

And, NBC News complained, “Trump, promoting unproven drug treatments, insults NBC reporter at coronavirus briefing.”

The New York Times’ Kurt Eichenwald reported that a “Louisiana MD” on the “front lines of the COVID-19 fight” had told him that “Hydroxychloroquine doesn’t work” and that “amateurs who dont [sic] understand research” were driving up demand for the drug. (“Count me skeptical of your source here, Kurt,” Holden wrote.)

Vox mocked Trump’s “new favorite treatment” for the drug and said the evidence is “lacking” that it works.

Medical journal retracts study of hydroxychloroquineThe media retreated somewhat from this narrative as more positive evidence emerged.

“Malaria Drug Helps Virus Patients Improve, in Small Study,” The New York Times reported in April, adding: “A group of moderately ill people were given hydroxychloroquine, which appeared to ease their symptoms quickly, but more research is needed.”

Michigan Gov. Gretchen Whitmer, a Democrat, went from threatening doctors who prescribed the drug with “administrative action” to requesting that the federal government ship her state some. Other state leaders have followed suit, including Nevada Gov. Steve Sisolak, also a Democrat.

And, an international poll of thousands of doctors rated hydroxychloroquine the “most effective therapy” for coronavirus.

The Food and Drug Administration halted the emergency use authorization for the drug earlier this month, saying preliminary data showed it wasn’t effective. Research into its possible applications to treat coronavirus, however, has continued.

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Opiate Rxs at all time low… opiate OD’s up 42 percent in THREE MONTHS…

Posted on July 3, 2020 by Pharmaciststeve

Cries for help’: Drug overdoses are soaring during the coronavirus pandemic

https://www.washingtonpost.com/health/2020/07/01/coronavirus-drug-overdose/

Suspected overdoses nationally jumped 18 percent in March, 29 percent in April and 42 percent in May, data from ambulance teams, hospitals and police shows.

Anahi Ortiz, a medical examiner in Columbus, Ohio, and her staff recently moved into a facility three times the size of their old office. They’re already out of space.
Anahi Ortiz, a medical examiner in Columbus, Ohio, and her staff recently moved into a facility three times the size of their old office. They’re already out of space. (Ty Wright/For The Washington Post)
By

July 1, 2020 at 9:00 a.m. EDT

The bodies have been arriving at Anahi Ortiz’s office in frantic spurts — as many as nine overdose deaths in 36 hours. “We’ve literally run out of wheeled carts to put them on,” said Ortiz, a coroner in Columbus, Ohio.

In Roanoke County, Va., police have responded to twice as many fatal overdoses in recent months as in all of last year.

In Kentucky, which just celebrated its first decline in overdose deaths after five years of crisis, many towns are experiencing an abrupt reversal in the numbers.

Nationwide, federal and local officials are reporting alarming spikes in drug overdoses — a hidden epidemic within the coronavirus pandemic. Emerging evidence suggests that the continued isolation, economic devastation and disruptions to the drug trade in recent months are fueling the surge.

Because of how slowly the government collects data, it could be five to six months before definitive numbers exist on the change in overdoses during the pandemic. But data obtained by The Washington Post from a real-time tracker of drug-related emergency calls and interviews with coroners suggest that overdoses have not just increased since the pandemic began but are accelerating as it persists.

Suspected overdoses nationally — not all of them fatal — jumped 18 percent in March compared with last year, 29 percent in April and 42 percent in May, according to the Overdose Detection Mapping Application Program, a federal initiative that collects data from ambulance teams, hospitals and police. In some jurisdictions, such as Milwaukee County, dispatch calls for overdoses have increased more than 50 percent.

When the pandemic hit, some authorities hoped it might lead to a decrease in overdoses by disrupting drug traffic as borders closed and cities shut down. The opposite seems to be happening.

As traditional supply lines are disrupted, people who use drugs appear to be seeking out new suppliers and substances they are less familiar with, increasing the risk of overdose and death. Synthetic drugs and less common substances are increasingly showing up in autopsies and toxicology reports, medical examiners say.

Social distancing has also sequestered people, leaving them to take drugs alone and making it less likely that someone else will be there to call 911 or to administer the lifesaving overdose antidote naloxone, also known as Narcan.

Making matters worse, many treatment centers, drug courts and recovery programs have been forced to close or significantly scale back during shutdowns. With plunging revenue for services and little financial relief from the government, some now teeter on the brink of financial collapse.

Even before the pandemic, experts note, the nation’s infrastructure for helping people with substance use disorders was underfunded and inadequate. Without government intervention, local officials and drug policy experts warn, overdoses and deaths will continue to climb during the pandemic and the existing system will be inundated.

What’s needed, advocates say, is emergency funding to keep afloat treatment programs, recovery centers and needle-exchange programs. Medical associations have also urged federal officials to relax restrictive barriers to opioid treatments such as buprenorphine and called for wider distribution of naloxone.

President Trump and conservatives have repeatedly cited the possible rise of overdoses and suicides when calling for states and businesses to hurry their economic reopening. Yet, of the nearly $2.5 trillion approved for emergency relief, Congress and the Trump administration have designated only $425 million — barely more than a hundredth of 1 percent — for mental health and substance use treatment.

“If it weren’t for covid, these opioid deaths are all we’d be talking about right now,” said Natalia Derevyanny, spokeswoman for the medical examiner’s office in Cook County, Ill., which includes Chicago.

Last year, the Cook County medical examiner recorded 473 overdose deaths from January to June. This year, the total through May reached 656, with more than 400 additional suspected overdoses pending investigation and toxicology reports. The county’s forensic staff — already inundated by the flood of coronavirus deaths — has added shifts and longer hours to deal with the incoming corpses from both crises.

“One epidemic began,” Derevyanny said, “but the other one never stopped.”

he lonely silence

At a time when they are needed most, some treatment centers and addiction clinics have begun closing programs.
At a time when they are needed most, some treatment centers and addiction clinics have begun closing programs. (Salwan Georges/The Washington Post)

Addiction is a disease of isolation.

“It’s when you feel alone, stigmatized and hopeless that you are most vulnerable and at risk,” said Robert Ashford, who runs a recovery center in Philadelphia and has been in recovery for seven years. “So much of addiction has nothing to do with the substance itself. It has to do with pain or distress or needs that aren’t being met.”

As the pandemic has pushed massive doses of fear, uncertainty, anxiety and depression into people’s lives, it has cut off the human connections that help ease those burdens.

Steven Manzo, 33, lost his job at an Irish pub in Mount Clemens, Mich., after it was forced to close just before St. Patrick’s Day. From the apartment he rented above the bar, he described the disquiet welling up inside of him, with nothing to do but stand on the balcony and watch the empty street below.

“Everything looks normal, but it doesn’t feel normal. I live downtown with bars and restaurants and nobody is here,” he said on March 20. “We have no idea how long it will be.”

Manzo spent much of his early 20s struggling with a heroin addiction. It took huge effort — and the help of family members, co-workers and two treatment programs — for him to turn his life around. He secured a job as a cook and bartender and discovered a gift for making customers laugh.

The pandemic took it all away, he said.

Two weeks after Manzo talked to a Washington Post reporter about his sudden unemployment, he was found dead in his apartment from an apparent overdose.

Steven Manzo, who was in recovery, felt adrift amid the pandemic. Bored, he purchased cocaine and heroin with a friend. He was found dead in his apartment. (Family photo)
Steven Manzo, who was in recovery, felt adrift amid the pandemic. Bored, he purchased cocaine and heroin with a friend. He was found dead in his apartment. (Family photo)

His mother, JoAnne Manzo, fought back tears as she described the rainy night she drove to her son’s apartment to recover his body.

Talking to his friends, she tried to piece together his last moments. He and a younger friend — also in recovery — had been drinking that weekend and got bored. They bought $40 worth of cocaine and heroin, telling themselves they would use just that one time. Shortly after midnight, Manzo saw his friend out the door. Manzo’s body was discovered two days later, sprawled out on the kitchen floor not far from his five guitars and drum set.

“He was clean for eight years. He would always tell me, ‘My trigger is depression. That is my trigger,’ ” his mother said.

The virus, she believes, took away one of the strongest forces in Manzo’s life — the presence of people who loved him. “If he had still been working, he would have been able to fight that urge, because he was busy. He loved that job. He loved people.”

Reasons for the rise

Shutdowns left nearly 1 in 4 Michigan workers jobless, with tourist spots such as Detroit's American Coney Island closing. (Nick Hagen for The Washington Post)
Shutdowns left nearly 1 in 4 Michigan workers jobless, with tourist spots such as Detroit’s American Coney Island closing. (Nick Hagen for The Washington Post)

Michigan — where Manzo died — now ranks third in the United States for the highest unemployment rate, with 1 in 5 workers out of a job. Nationwide, more than 20 million are unemployed as the nation faces its worst economic crisis since the Great Depression.

Research has established strong links between stagnating economies and increases in suicides, drug use and overdoses. In recent years, economists Anne Case and Nobel Prize-winner Angus Deaton have dubbed such increasing fatalities in declining blue-collar communities “deaths of despair.”

For months, the Trump administration and several governors have seized on such research as their central argument for reopening states and businesses at any cost.

“We have to reopen — for our health,” Health and Human Services Secretary Alex Azar wrote recently in a Post op-ed. “The economic crisis brought on by the virus is a silent killer.” As evidence, Azar cited a study suggesting that for every one percentage point increase in the unemployment rate in past recessions, the opioid death rate appears to increase by more than 3 percent.

But in an interview, the lead researcher behind that study rejected Azar’s premise as a misuse and an oversimplification of his data.

Many factors — not just job loss — trigger opioid use, said Alex Hollingsworth, a health economist at Indiana University. “Don’t use opioid deaths as a reason to reopen.”

Hollingsworth and other economists, including Case, who spearheaded much of the research on “deaths of despair,” point out that their findings are based on previous recessions that were wildly different from this one.

One big difference is how suddenly this downturn occurred — causing tens of millions of Americans to lose their jobs almost overnight. Deaths of despair normally occur after years of hardship. The pandemic has also introduced unprecedented disruptions into individual habits and society, making it difficult to foresee the exact effect.

But the biggest objection to such arguments — that tie the declining economy to an inevitable increase in overdoses — is the implied assumption that nothing can be done to avert it.

The focus, many economists and health experts agree, should be on finding safe and sustainable ways to reopen the economy, while increasing access and funding for mental health and substance use care.

“We need to multitask as a society,” said Nora Volkow, director of the National Institute on Drug Abuse, a federal research agency.

The problem is a lack of political will, said Alex H. Kral, an epidemiologist at the nonprofit research institute RTI International.

“We may not have a vaccine for covid, but we actually have very effective treatments for opioid use disorder,” Kral said. “We have medication and proven interventions. It doesn’t have to play out the way we fear it will.”

‘Cries for help’

A van waits to transport a body from the morgue in Columbus, Ohio, to a funeral home. “There’s just so many” bodies, the medical examiner said.
A van waits to transport a body from the morgue in Columbus, Ohio, to a funeral home. “There’s just so many” bodies, the medical examiner said. (Ty Wright/For The Washington Post)

Before the pandemic hit, national efforts to stem the opioid crisis were just starting to show progress.

In January, the Centers for Disease Control and Prevention released 2018 data showing a slight decline in fatal overdoses for the first time in 28 years. But decades into the opioid epidemic, federal and state agencies still lack a system to collect overdose data in real or near-real time.

The closest thing that exists comes from the Overdose Detection Mapping Application Program, which receives county-level data from emergency agencies. Since it began in 2017, ODMAP has forged agreements with a patchwork of about 3,300 agencies in 49 states that voluntarily provide data.

Of the counties participating, 62 percent have reported increased overdoses since March. And among counties that took part in the program last year and this year, data provided to The Post by ODMAP show a 42 percent increase in May.

Ortiz, the coroner in Columbus and surrounding Franklin County, said that she and her staff just moved this year into a facility three times the size of its old office so they could handle exactly this kind of added volume. They’re already out of space.

“There’s just so many. And the bodies absolutely can’t go on the floor, out of respect for the decedents,” she said. “We’re trying to borrow carts that emergency management was saving for hospitals and the possible covid surge.”

Ortiz and more than half a dozen other coroners nationwide described a dangerous trend from recent years that has accelerated during the pandemic: dealers mixing long-standing narcotics such as heroin and cocaine with much more powerful synthetic drugs, including fentanyl and carfentanil.

The American Medical Association recently issued a warning, citing reports from officials in 34 states about the increased spread of such synthetic drugs and rising overdoses.

Sandy Rivera, an emergency medical technician in Union City, N.J., said she saw an abrupt change in May in the types of cases her ambulance was responding to.

For weeks, it had been almost all respiratory illnesses and cardiac arrests related to the coronavirus. Then, suddenly, nearly half her cases became overdoses and suicide attempts, a ratio she has never encountered in 15 years working on ambulances.

“One night, that’s all I had,” Rivera said. One patient took a bottle of Tylenol. Another took medication that belonged to her children. An elderly patient had been drinking and swallowed 10 pills of Benadryl.

“They were cries for help,” she said.

Kate Yoder, deputy chief of investigations, is among the staff members confronting a surge of autopsies in Columbus, Ohio.
Kate Yoder, deputy chief of investigations, is among the staff members confronting a surge of autopsies in Columbus, Ohio. (Ty Wright/For The Washington Post)

Shuttered doors

At a time when they are needed most, some treatment centers and addiction clinics are struggling to stay solvent and have begun closing programs.

In May, Austin Recovery Network, the oldest addiction treatment provider in Texas, shuttered its clinics. “It is only a matter of time until we run out of money,” the board of the nonprofit organization told staff members.

Lynn Sherman, chairman of the treatment provider’s board, said the decision to close the clinics was “hard as hell.”

The organization is still holding online support groups and running a shelter for parents and children, Sherman said, but, she added, “I don’t think our area will have enough capacity in the future to provide the help that’s needed.”

Even as Austin Recovery Network shut down its residential treatment programs for adults, it has seen an increase in people walking into its offices, begging for detox treatment and a place to stay amid the pandemic.

In normal times, most nonprofit behavioral health centers operate on extremely thin margins and rely on reimbursements from major government health programs such as Medicaid and Medicare and grants from local government.

During the pandemic, they have struggled to treat patients, leading to severe drops in reimbursement, said Chuck Ingoglia, president of the National Council for Behavioral Health, which represents 3,326 treatment organizations. In a recent survey, 44 percent of the council’s members said they will run out of money in the next six months.

Many are bracing for deeper cuts in the coming year, as states grapple with budget crunches.

“Mental health and substance use programs are often the first thing cut,” said Tami Mark, a drug policy researcher at RTI International. “The last recession decimated behavioral health funding so badly it took them 10 years just to get back to previous levels.”

‘Failures of the system’

When the Democratic-controlled House passed a $3 trillion coronavirus relief bill in May, the legislation, dubbed the Heroes Act, designated $3 billion for mental health and substance use disorders programs — seven times more than the amount Congress approved in March.

But the White House and Republicans have declared the bill dead on arrival, leaving it unclear whether any additional funding will go toward programs for mental health and substance use disorders.

“We as a society often have a tendency to stigmatize and blame those who use drugs,” said Ashford, the recovery center director in Philadelphia. “But if overdoses really increase during this pandemic, it will be because of failures of the system.”

Since her son’s death, JoAnne Manzo has asked herself the same question over and over: What exactly happened? “I know in my heart he did not want to take his life,” she said.

On Friday, she finally received the official death certificate. Under cause of death, it said: “acute fentanyl and cocaine.”

The autopsy took nearly three months because county officials were overwhelmed with covid-19 cases. The pandemic also made it impossible to hold a funeral, so she had her son’s body cremated.

JoAnne Manzo took the ashes and put a small portion into a heart necklace she now wears every day.

She knows how lonely her son felt during the last days of his life. Since his death, she has tried to keep him as close as possible.

If you or someone you know is struggling with addiction, the Substance Abuse and Mental Health Services Administration can help you locate treatment at www.findtreatment.gov or at this free helpline: 1-800-662-HELP (4357).

Filed under: General Problems | 9 Comments »

Hillary used “bleach-bit” on her computer.. Kamala doing similar thing to her WIKIPEDIA page ?

Posted on July 3, 2020 by Pharmaciststeve

There’s a War Going On Over Kamala Harris’s Wikipedia Page, with Unflattering Elements Vanishing

https://theintercept.com/2020/07/02/kamala-harris-wikipedia/

California Democratic Sen. Kamala Harris is widely seen as a frontrunner for a spot on the ticket with presumptive nominee Joe Biden, with vetting well underway. 

Presidential vetting operations have entire teams of investigators, but for the public, when the pick is announced, the most common source for information about the person chosen is Wikipedia. And there, a war has broken out over how to talk about Harris’s career. 

At least one highly dedicated Wikipedia user has been scrubbing controversial aspects of Harris’s “tough-on-crime” record from her Wikipedia page, her decision not to prosecute Steve Mnuchin for mortgage fraud-related crimes, her strong support of prosecutors in Orange County who engaged in rampant misconduct, and other tidbits — such as her previous assertion that “it is not progressive to be soft on crime” — that could prove unflattering to Harris as the public first gets to know her on the national stage. The edits, according to the page history, have elicited strong pushback from Wikipedia’s volunteer editor brigade, and have drawn the page into controversy, though it’s a fight the pro-Harris editor is currently winning.   

In 2016, The Atlantic published an article about Wikipedia edits and how a burst of activity could foreshadow Hillary Clinton’s vice presidential pick, noting that Virginia Sen. Tim Kaine’s page had seen significantly more edits than any other candidate’s in the weeks leading up to the announcement. The article also cited a 2008 Washington Post report about Sarah Palin’s Wikipedia page seeing more than 65 edits in the hours leading up to John McCain’s announcement.

Last month, a Reddit user remembered this Atlantic piece and wrote a Jupyter script to see which 2020 vice presidential contender had the most edits in a span of three weeks: Harris had 408, Stacey Abrams had 66, Sen. Elizabeth Warren had 22, and Sen. Amy Klobuchar had four. Another Redditor pointed out that a majority of Harris’s edits were coming from a single person.

Harris has been working to distance herself on the national stage from her prosecutorial record in California, which has increasingly become a political liability, while taking a lead on Democratic police reform legislation after the killing of George Floyd and Breonna Taylor. During the 2020 primary, she branded herself as a “progressive prosecutor” and shifted left on issues like health care and climate change. But the most drastic gap is between her current messaging on crime and her past.  

A section in her bio that detailed her decision not to prosecute Mnuchin for financial fraud, despite recommendations from her staff attorneys, has also been deleted: 

In 2013, Harris did not prosecute Steve Mnuchin‘s bank OneWest despite evidence “suggestive of widespread misconduct” according to a leaked memo….In 2017, she said that her office’s decision not to prosecute Mnuchin was based on “following the facts and the evidence…like any other case”. In 2016, Mnuchin donated $2,000 to her campaign, making her the only 2016 Senate Democratic candidate to get cash from Mnuchin, but as senator, she voted against the confirmation of Mnuchin as Secretary of the Treasury.

A section on an Ethics Commission finding Harris guilty of a campaign spending violation during her San Francisco district attorney race has also been deleted. A line about Harris traveling to Israel and the West Bank in November 2017, where she met with Israeli Prime Minister Benjamin Netanyahu, was removed altogether.

The Wikipedia user, who goes by the username “Bnguyen1114,” has made hundreds of edits to Harris’s page throughout the last several months, often getting into fights over the proposed edits with other Wikipedia editors, who pointed out that the language was getting pulled directly from press releases and campaign literature. “You seem to have gone through a database of press releases from Harris’s office, cataloging every single one and adding it to the article,” one Wikipedia editor said. “That is not how we write encyclopedic articles.”

On June 11, the Wikipedia user removed this section referencing the Orange County scandal from the page, saying that they were proofreading for length: 

Later that year, Harris appealed a judge’s order to take over the prosecution of a high-profile mass murder case and to eject all 250 prosecutors from the Orange County District Attorney’s office over allegations of misconduct by Republican D.A. Tony Rackauckas. Rackauckas was alleged to have illegally employed jailhouse informants and concealed evidence. Harris noted that it was unnecessary to ban all 250 prosecutors from working on the case, as only a few had been directly involved, later promising a narrower criminal investigation. The U.S. Department of Justice began an investigation into Rackauckas in December 2016, but he was not re-elected.

In her first bid for public office, Harris embraced a “tough-on-crime” approach in the San Francisco district attorney race and unseated Terence Hallinan, who was considered one of the “most left-wing politicians in the country.” Under Hallinan, the district attorney’s office focused on rehabilitative justice initiatives instead of incarceration, which led to the lowest felony conviction rates of any county in California. 

Related

In Her First Race, Kamala Harris Campaigned as Tough on Crime — and Unseated the Country’s Most Progressive Prosecutor

While campaigning in the Mission District, SF Weekly reported at the time, Harris slammed Hallinan for failing to prosecute anti-war protesters for property destruction. “It is not progressive to be soft on crime,” she said.

On June 8, the Wikipedia user removed this quote from the page, saying that the changes made were “minor edits for length.” 

In a paragraph about Harris announcing a new state law requiring law enforcement agencies to collect statistics on how many people are shot, seriously injured, or killed by police officers throughout the state, the user removed the following sentence: “Harris was later criticized by criminal justice advocates for her measured approach.” 

This user also tried to make edits to the “Bernie Bro” Wikipedia page, a term that refers to the persistent myth that Bernie Sanders’s presidential campaign had a monolithic base of support concentrated only among young white men. 

According to the user’s edit history, they tried to remove a paragraph explaining that although Sanders’s base skewed white in 2016, the Vermont senator actually had the most diverse base of any of the Democratic presidential candidates.

Harris’s most fervent online supporters, or stans, call themselves the “KHive.” Though members of the KHive are excited by the prospect of Harris, a daughter of Indian and Jamaican immigrants, shattering another glass ceiling, they also cite her policy positions as a reason for their support. They generally consider her background as a prosecutor to be a political strength.

Filed under: General Problems | 3 Comments »

CVS is Destroying the Profession of Pharmacy: Part 5!

Posted on July 3, 2020 by Pharmaciststeve

CVS is Destroying the Profession of Pharmacy: Part 5!

https://pharmacistactivist.com/2020/July_2020.shtml

I wanted to focus this issue of The Pharmacist Activist on the positive events and experiences that we have cause to appreciate and honor during the celebration of our country’s Independence Day on July 4. However, parades and fireworks for July 4 have been canceled, as are my initial plans for this issue. COVID-19, riots, and destruction of statues dominate the national news, and much of the attention of Pharmacists is focused on the continued evil and tyranny of chain pharmacy executives, PBMs, and health insurance companies. I do not have any influence over COVID-19, riots, and destruction of statues, but some respect my concerns and ideas about Pharmacy, and this is where I will direct my attention.

I had planned to “pause” my series of commentaries about CVS with Part 4 that was published in the June 15 issue. However, the continuing evil and fraud of CVS makes this an inopportune time to stop this series. In addition, the triple threat of CVS as a drugstore, PBM, and health insurance company (not even including Omnicare) is unique and amplifies its evil and tyranny. Thus, Part 5! I wish to assure the Pharmacists at Walgreens, Walmart, Rite Aid, as well as the besieged Pharmacists at other chains, that I am not ignoring them because they are also victims of their employers and others. Future issues of The Pharmacist Activist will address matters such as Walgreens’ termination of Pharmacist Maurice Shaw because he did comedy shows (not in the store), the scandal of Walmart management’s preventing its Pharmacists from intervening in situations that resulted in opioid overdoses and deaths, and Rite Aid’s continued stonewalling with respect to important healthcare issues.

The media

As much as I wish we could get more media coverage of the exceptional services and counseling many Pharmacists provide for patients, and also more recognition for the dangerous error and abuse-preventing interventions and heroic participation of Pharmacists in COVID-19 experiences, these types of public recognition are only rarely provided. There is, however, much greater media attention being given to closures of independent pharmacies, dangerous, deplorable working conditions and fraud in chain pharmacies, and errors and potency/quality-jeopardizing shipping conditions for medications by mail-order pharmacies. Even though many of these experiences reflect negatively on our profession of Pharmacy and some pharmacists who are part of the problem instead of part of the solution, this media attention must be continued and extended.

There are an increasing number of heroes in the media who have provided excellent and continuing coverage of the above concerns. Most prominent in this recent media coverage are Marty Schladen and his colleagues at the Columbus Dispatch (Ohio) and Ellen Gabler of the New York Times (NYT). Ms. Gabler’s two front-page stories in the NYT several months ago regarding CVS and other chain pharmacies have “gone global.” I am probably unaware of important coverage provided by some others in the media and I would request readers to provide pertinent information to me at the email address below.

A primary reason for my focusing this editorial on CVS is the article that was published on June 26 in The Philadelphia Inquirer (Stacey Burling; page A4) titled, “Pennsylvania to pay CVS to test care homes.” The article begins with the following statements:

“The Pennsylvania Department of Health announced this week that it will pay CVS Health up to $9.5 million to test 50,000 residents and staff members of the state’s 693 nursing homes for the coronavirus. That’s about a quarter of the 80,000 residents and 115,000 staff the state says are in nursing homes.”

At a later point in the article it is noted:

“The new testing program will be undertaken by Omnicare, a CVS company, which will administer the tests. The state expects a turnaround time of 72 hours, Wardle (the Department of Health spokesman) said,”

I find it remarkable that CVS, the company that can’t provide sanitary and safe conditions for immunizations in many of its own stores, can find a way to conduct 50,000 tests in 72 hours. It is amazing what $9.5 million can buy, but I don’t expect the test results to be accurate/reliable, and we can only hope that the tests being used are not the same ones that have been discovered to give many false-positive results. If the Pennsylvania Department of Health is going to pay millions to CVS/Omnicare to test these individuals, it should work with and pay independent pharmacists to provide the influenza immunizations, and COVID vaccine when it is developed and becomes available, to individuals in the care homes.

In response to this article, I sent an email message to Ms. Burling (the reporter), and sent copies to some Pennsylvania health officials and pharmacy leaders. I was pleased that Ms. Burling responded very quickly and we had a productive series of messages in which she raised several excellent questions to which I was also able to respond. I highly commend her for her willingness to engage in communication and to explore these issues further.

Communication with Ms. Burling (June 26, 2020)

Dear Ms. Burling:

The very superficial reporting in your story is extremely disappointing (“Pennsylvania to pay CVS to test nursing home residents and staff for coronavirus”). The following questions should be asked:

  1. Were independent community pharmacists in the communities in which the nursing homes are located offered the opportunity to do this testing? If not, why not?
  2. Did the Department of Health request bids for this agreement worth up to $9.5 million that has been awarded to CVS Health?
  3. Are you and the Department of Health aware that Omnicare and CVS Health “are defendants in a federal lawsuit alleging that hundreds of thousands of drugs were improperly dispensed to senior housing residents over a period of years?” Why are companies that are being sued by the Federal government awarded contracts in Pennsylvania?
  4. Are you and the Department of Health aware of the information that investigations in Ohio, West Virginia, and Pennsylvania (see Auditor General Eugene DePasquale’s report) have revealed about the secretive, highly suspicious (I would say fraudulent) government (i.e, taxpayer)-funded prescription benefit programs that pharmacy benefit managers (PBMs) such as CVS Caremark are administering?
  5. Are you and the Department of Health aware that the monopolistic, anticompetitive, and alleged fraudulent practices of CVS/Caremark/Aetna/Omnicare/etc. are crushing independent pharmacies to the point that many have been forced to close, resulting in pharmacy deserts in many areas of the state in which it is not sufficiently profitable for CVS to have a pharmacy?
  6. Why is the Department of Health awarding a contract to a Rhode Island-based company rather than to independent pharmacists who live in their communities and are committed to serve the residents in their communities?
  7. If you, like myself, are a resident of Pennsylvania, why are taxes we pay being sent to out-of-state companies rather than to support local pharmacies that are being forced out of business by companies like CVS?
  8. You report that the Department of Health “will pay CVS Health up to $9.5 million to test 50,000 residents and staff members of the state’s 693 nursing homes for the coronavirus,” and that, “That’s about a quarter of the 80,000 residents and 115,000 staff the state says are in nursing homes.” Independent pharmacists should be provided the opportunity to conduct the tests for the remaining patients, and compensated accordingly. Will that be done?

Response of Ms.Burling:

Some of these are good questions. Mine to you is this: Do independent pharmacies have the capacity to quickly send their staff into nursing homes and test residents and staff throughout the state?

My response:

Thank you for your fast response. You also have a good question. Although I am not in the best position to respond for the independent pharmacists, they are located throughout the state (to a much greater degree than Omnicare) and I would like to think they could provide such testing on a timely basis. Dr Levine’s (the Secretary of Health) order was issued on June 9 and the target date for completion is July 24. That should provide adequate time for independent pharmacists to participate.

I am interested in learning which of my questions you consider to be the “good” ones and whether you will try to obtain answers. Thank you.

Response of Ms. Burling:

There was considerable repetition in your questions. I thought the first two were especially important. The others are more philosophical. Should the state have a preference for local, independent companies even if they cost more? (Obviously, I don’t know they’d cost more, but I think they easily could because CVS can get economies of scale and they can’t.) I don’t know whether PA typically looks for companies without the kind of legal record you mention.

The problem I see with trying to give work like this to multiple, local entities is that it requires multiple contracts and a different kind of vetting. I’m not saying that’s not doable, but I can imagine that it could work against efficiency. Also, to my knowledge, going into other facilities to do testing is not something that local, independent pharmacies normally do so they wouldn’t necessarily have the infrastructure to do it.

I did send your questions to the spokesman for the health department. He hasn’t responded yet.

My response:

Thanks for identifying the repetition in my questions and which ones are more philosophical. As a writer and editor myself (www.pharmacistactivist.com), I always appreciate learning from the writing and editing skills of others.

Although you anticipate that local, independent companies might cost more, I appreciate your recognizing you don’t know that even though CVS might have economies of scale. I do not know the comparative data either, but I fully expect that it would be less expensive for the Department of Health and the citizens of Pennsylvania to use local independent pharmacists for these services. I feel very confident in this expectation because I am aware, without the benefit of specific data, of how CVS builds huge profits for itself into secretive agreements that are not available for public review. This is a primary part of the reason for which Omnicare and CVS Health are defendants in a federal lawsuit. I would suggest that is a story in which the Inquirer should also be interested rather than it being viewed as a philosophical question.

Although you identify multiple reasons for excluding independent pharmacists from being engaged in this service for the Commonwealth, I am able to identify a larger number of better reasons for using independent pharmacists, starting with the fact that numerous independent pharmacists already have working relationships with many nursing homes in the provision of medications and consultant services for their residents. I believe that you have received the comments from Pat Epple, the CEO of the Pennsylvania Pharmacists Association, that independent pharmacists “have also asserted that while in discussing the testing issue, Omnicare tried to ‘steal’ the rest of their business, as several facilities have reported.” When those allegations are confirmed, CVS and Omnicare should be disqualified from participating in this program and prosecuted.

Comments from CVS pharmacists (continued)

The messages and experiences I receive from CVS pharmacists are too numerous to publish most of them but selected examples follow:

“A pharmacist was supposed to dispense a prescription for liquid propranolol for a 3-year old girl. The mom who is a family friend called me hysterical because the medication looked different. I told her to promptly return to CVS and demand to see the stock bottle and the color of its contents. It turns out it was the wrong medication – she does not know the name of the medication that was given in error for her daughter, but she was angry and frightened and burst into tears after realizing how serious a situation this was. She asked me what people do if they don’t know a pharmacist personally to ask these questions. She is supposed to get a call from the district manager. I told her to emphasize that CVS needs to increase staffing levels pronto! I also told her to go public with this but she is afraid to do so as she is a business owner in town.”

“A few years ago we were required to view the hard copy of each order we verify. This includes the original fill and all the refills on the prescription. I have personally caught mistakes on the 6th or 7th refill meaning that the patient had received the wrong drug or dose for 6 months. A couple of years ago the system stopped prompting us to review the original hard copy after the first refill. We are now told by management that we should view the original only if we had reason to believe there was a patient safety issue. We are now being monitored on every scan or step when filling orders. We are being counseled or written up for under performance if they catch us going back to view the hard copy when not prompted.”

“It is making me and other pharmacists very angry when we have to stay and finish other tasks after our shift has ended. There is no end in sight as to how many extra hours they want us to stay and catch up with duties besides filling prescriptions. Most pharmacists do not get a 40-hour week. When we have our salary cut in mid-year and we are asked to stay and work extra and not get paid, it is too much to handle.”

“CVS has done much to destroy what pharmacists were trained to do. You teach students and provide them with so much knowledge. Then CVS takes us and tries to brainwash us.”

“Phone calls have become a nuisance or harassing situation for many customers. We have become one of the worst telemarketers. Wells Fargo got into a lot of trouble years ago for opening accounts and selling goods that their customers did not need.”

“When we request additional staffing we are told we are experienced pharmacists and need to work smart. We are also told that he (district leader) has dozens of applications from pharmacists waiting to take our job.”

“I have been encouraged to keep an ear out for ‘struggling independents’ during COVID-19 who may ‘benefit from a buyout.’ That broke my heart and angered me deeply.”

“I recently had a call from a deaf patient and through the audio service she used, she begged us to please stop calling and filling prescriptions she did not need. I also have family and friends contact me and ask, “what can I do to stop CVS from filling these prescriptions I do not need?'”

“A neighbor told me that his doctor told him he kept getting faxes for 90-day refills that he did not request. The doctor informed him that this is taking away time that he should be spending with his other patients.”

In addition to local and national media, I am also hearing from attorneys. CVS has enough ill-gained wealth to pay any amount to confidentially settle lawsuits regarding deaths and other consequences resulting from errors, but it is concerned about negative publicity and tries to suppress it, as has occurred with respect to a recent suicide in a CVS store. There will be a Part 6 in this series.

Daniel A. Hussar
danandsue3@verizon.net

How to find a independent pharmacy by zip code   CLICK HERE

 

CVS Places Consumers at Risk of Harm, And is Destroying the Profession of Pharmacy! – PART 1

CVS Places Consumers at Risk of Harm, And is Destroying the Profession of Pharmacy! – PART 2

CVS is Destroying the Profession of Pharmacy – PART 3*

CVS is Destroying the Profession of Pharmacy – Part 4

CVS is Destroying the Profession of Pharmacy: Part 5!

CVS is Destroying the Profession of Pharmacy: Part 6

Filed under: General Problems | 1 Comment »

keep America GREAT AGAIN

Posted on July 2, 2020 by Pharmaciststeve

Filed under: General Problems | 7 Comments »

Kroger cleared for at-home COVID-19 test

Posted on July 2, 2020 by Pharmaciststeve

Kroger cleared for at-home COVID-19 test

https://storebrands.com/kroger-cleared-home-covid-19-test

The Food and Drug Administration has granted Emergency Use Authorization for Kroger’s at-home COVID-19 test that will begin with availability to frontline associates across the Kroger company and expand after that to other organizations.

Kroger Health, the healthcare division of Kroger, developed the Kroger COVID-19 Test Home Collection Kit to be a way to test workers at home in concert with a telehealth consultation to improve the quality of the collection process.

Working with Gravity Diagnostics, a full-service clinical laboratory located in Covington, Ky., Kroger Health plans to rapidly expand the availability of the home collection kits to other companies and organizations in the coming weeks, with a goal of processing up to 60,000 tests per week by the end of July.

For now, the tests are for associates, but as Kroger Health has worked to make testing sites available and working to serve customers in underserved areas, it seems possible to expand to more patients.

“Kroger Heath remains committed to helping people live healthier lives through our multi-disciplinary team of licensed, trained and experienced healthcare providers,” said Colleen Lindholz, president of Kroger Health. “Over the past few months, Kroger Health has been providing Americans with access to COVID-19 testing through community test sites across the country; however, we’ve observed some individuals do not have access to transportation or live near these community testing locations. To help ease this burden and provide greater accessibility, we will be offering a home testing solution to our associates first followed by other companies and organizations.”

Kroger outlined the following as keys to how the home kit works:

  • The home collection is performed under the supervision of a licensed healthcare professional. The process is simple and is available at no cost to eligible patients who meet established clinical criteria for likely COVID-19 infection or exposure;
     
  • Patients will be provided access to a website where they will answer screening questions, input their organization’s benefit code and an individual code, like an employee ID, and complete a clinical assessment. If a patient qualifies, a healthcare professional will issue a prescription and the home collection kit is shipped to their home within 24-48 hours;
     
  • The home collection kit includes a nasal swab, transport vial, instruction sheet, prepaid shipping label, and packing materials for return shipment of the sample to the laboratory;
     
  • Upon receipt of the home collection kit, a healthcare professional guides the home collection process via telehealth – a two-way video chat. The direct observation helps to ensure the proper technique is used for sample collection;
     
  • The patient will then overnight ship their sample to the laboratory for processing, which on average will take 24-48 hours;
     
  • At the laboratory, the collection undergoes a molecular diagnostic test – a test which detects parts of the SARS-CoV-2 virus and can be used to diagnose active infection with the SARS-CoV-2 virus;
     
  • If test results are negative for an active infection, results are released to the patient’s electronic medical record portal. Alternatively, patients may be called if they do not consent to use of the portal. For a patient whose test result is positive, a healthcare professional will contact them via phone to provide a recommended course of care; and
     
  • Test results will only be accessible to the patient and only shared with their organization if the patient authorizes the release of his or her results. All results are reported to government health agencies as required by law.

“As our country experiences an increase in COVID-19 cases, physical distancing, wearing protective masks and testing remains paramount to flattening the curve,” said Jim Kirby, senior director of Kroger Health. “We know flexible, accessible testing options like home solutions that leverage telehealth technology are critical to accelerating America’s reopening and recovery.”

The Kroger Health COVID-19 Test Home Collection Kit will initially be available in Arizona, Colorado, Georgia, Indiana, Kansas, Kentucky, Michigan, Montana, Nevada, New Mexico, Ohio, Tennessee, Utah and Virginia. Additional states will be added in the coming weeks.

 

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MN: bureaucrats pass law that pharmas have to provide – FREE OF CHARGE – insulin or fined upto $600k/month

Posted on July 2, 2020 by Pharmaciststeve

Why so many people at the Capitol are so pissed off about the drug industry’s lawsuit against Minnesota’s new emergency insulin program

https://www.newsbreak.com/news/0PV2NyWt/why-so-many-people-at-the-capitol-are-so-pissed-off-about-the-drug-industrys-lawsuit-against-minnesotas-new-emergency-insulin-program

From the day they introduced it to the day it passed the Minnesota Legislature, backers of a bill to provide insulin to diabetics who can’t afford the hormone said it wouldn’t draw a lawsuit from drug makers.

Citing assurances from unnamed industry executives, those proponents of the bill, which relies on the companies’ existing patient assistance program charities instead of substantial fees on drug companies, was less of a lawsuit magnet. In April, the DFL-controlled Minnesota House approved the bill by 111-22. The Senate responded with a vote of 67-0.

They were wrong.

On Tuesday night, just hours before the Alex Smith Insulin Affordability Act was to take effect, the Pharmaceutical Research and Manufacturers of America — the industry trade group better known as PhRMA — filed suit to get the new law declared unconstitutional.  “A state cannot simply commandeer private property to achieve its public policy goals,” states the suit, which names the Minnesota Board of Pharmacy and MNsure as defendants. “Because the Act takes private property for public use without paying just compensation, it is unconstitutional and should be enjoined.” 

Walz’s reaction: ‘What the hell?’

Minnesota’s plan, brokered by Republicans in the state Senate, relies on existing patient assistance programs run by pharmaceutical companies like Eli Lilly, Sanofi and Novo-Nordisk. Only if the companies refused to participate in the program do they face fees or fines: $200,000 per month for six months, and increasing to $400,000 per month for the next six. After a year of non-participation, fines go to $600,000 a month.

The suit does not ask for a temporary injunction against the act taking effect, and Gov. Tim Walz and Lt. Gov. Peggy Flanagan stressed at a press conference on Wednesday that the program was still available for those who need it.  A 90-day supply can be received either through a pharmacy or directly from the manufacturer’s patient assistance program. No more than a $50 copay can be charged for that three month supply. Those same diabetics can then apply for longer-term supplies by verifying income eligibility through MNsure.

Walz called Wednesday “one of the most enjoyable days” as governor because the new law resulted from the advocacy of diabetics and their families. The law is named for Alec Smith, who died three years ago after rationing his insulin after aging off his parent’s health insurance. Walz declared Wednesday “Alec Smith Day” in Minnesota. His parents, Nicole Smith-Holt and James Holt, Jr., accepted the proclamation from Walz.

But the lawsuit put something of a damper on the celebration. The plan had been sold as a compromise with the industry, and advocates had to swallow hard to accept it, making the news of the suit galling to some. Flanagan found out about the suit Tuesday night via social media and told Walz about it the same night. His reaction: “What the hell?”

On Wednesday, Flanagan said of the drug industry: “They may continue fighting, but so will we. And we have the advantage of being right.”

Gov. Tim Walz
MinnPost photo by Peter Callaghan
Gov. Tim Walz called Wednesday “one of the most enjoyable days” as governor because the new law resulted from the advocacy of diabetics and their families.

James Holt said his family is outraged by the lawsuit, but said he thinks it was filed because other states were looking at Minnesota as a potential model for similar programs. “They’re scared,” Holt said. 

State Sen. Matt Little
State Sen. Matt Little

Sen. Matt Little, DFL-Lakeville, said the industry has only itself to blame for the law since they are the ones who continued to impose large increases in the price of insulin, which created the unaffordability problem. He also had a message for the industry in their fight against advocates like Alec Smith’s parents and Concordia University student Alexis Stanley, all of whom were instrumental in getting the legislation passed. “I do not like your odds.”And Attorney General Keith Ellison said he will fight the lawsuit. “Today — the very day that our state finally put Minnesotans’ lives ahead of drug companies’ profits — Big Pharma is telling Minnesotans that their obscene profits come before your lives,” he said. “My office and I will defend it with every resource we have.”

Industry: insulin price increases aren’t our fault

The lawsuit challenges the law under both the takings clause and the commerce clauses of the U.S. Constitution. “If Minnesota believes that, despite the insulin manufacturers’ affordability programs, there is a need for further action to help some Minnesota residents obtain insulin, it could have created a state‐run program in which it purchases insulin from PhRMA’s members and distributes it to residents in need,” the suit states. “But instead of using public funds to address a matter of public concern, Minnesota chose to enact a law that effects per se takings of the manufacturers’ property without compensation, so that the state can achieve its policy objectives at no expense to its taxpayers.

“In addition to being forced to give away their insulin for free according to the state’s terms, manufacturers will also incur significant expenses in developing and administering the Continuing Safety Net Program and Urgent Need Program.”

The suit also blames health plans and pharmacy benefit managers for cost increases of insulin and other drugs and seeks to have the industry’s legal costs covered by the state.

Both Democrats and Republicans criticized the industry’s decision to file suit. “PhRMA is missing the mark by wasting time and money on this lawsuit. Minnesotans would be far better off if the pharmaceutical industry would focus on fairness in pricing,” said Sen. Michelle Benson, R-Ham Lake, the chair of the Senate’s Health and Human Services Finance and Policy Committee. “You shouldn’t have to be a powerful government or a special interest group to have access to fair prices. All Minnesotans want to be treated fairly.”

Senate Majority Leader Paul Gazelka also said he was disappointed with the suit. “Senate Republicans remain committed to providing emergency insulin for those in crisis no matter what happens with this poorly timed lawsuit,” the East Gull Lake Republican said.

And Little took issue with one of suit’s key arguments:  “The cost of producing insulin is so low that to say this is taking is gonna be really tough for them,” he said.

Did PhRMA mislead lawmakers?

DFL Rep. Mike Howard of Richfield dubbed the industry “soulless” for filing suit and said he thinks PhRMA misled the Senate GOP backers of the compromise that eventually became the law. “Everything about this process has shown that there is ill intent by the pharmaceutical industry,” he said. “They have not been honest; they have not been clear; they have not been straightforward; they have not been willing to come before a committee to show their face. The reason that things are confusing is by design.”

Yet the industry did raise constitutional issues with the program when it testified on the program in March. “The majority of our concerns would be around clarifying any constitutional issues we have,” Sharon Lamberton, deputy vice president for PhRMA, said at the time. “We are concerned with how manufacturers would be compensated for the insulin product, which would be a takings clause of the 5th amendment concern.”

Before that meeting, Sen. Scott Jensen, R-Chaska, said he was comfortable that the industry would let the proposal become law without challenge, largely because it didn’t impose huge licensing fees — around $38 million per year — to fund it, as the version of the program proposed by House DFLers did. “The pharmaceutical manufacturers don’t like the bill, they may even today be opposing the bill,” Jensen said before the first hearing on the compromise bill. “But they will come along and they are saying yes to this. This is not something where we’ll have to say, ‘Oh my stars it’ll end up in court.’”

State Sen. Scott Jensen
State Sen. Scott Jensen

On Wednesday, Jensen said: “I think we knew there was a risk. But we’d done so much stakeholder work that I thought everyone was comfortable. As they saw movement toward the Senate bill, they made it very clear this was their preference,” Jensen said. “The intensity of their concern was very mild and was popping up less and less often. I felt that at the table we’d reached a high comfort level.”Jensen now thinks the Legislature should look at changing the program to limit its takings clause implications. One idea would be to use other funds for the 30-day emergency program, which now requires the industry to compensate or provide insulin to pharmacies to replace what was distributed to diabetics. Jensen proposed using the health care access fund, which is paid for via a tax on health care providers.

But such a proposal is unlikely to win support in the DFL-controlled House and Walz, given their belief that any costs should be borne by the industry that made insulin unaffordable.

Lija Greenseid, an advocate who is the mother of a diabetic daughter, said she favors imposing a fee on the industry for that portion of the program.

Greenseid said she believed Jensen and Sen. Eric Pratt, R-Prior Lake, who first proposed using the patient assistance programs as the basis for the state’s plan, when they told her they were convinced the Senate’s version would not be challenged in court. “I think Sen. Jensen needs to be held accountable, either for some miscommunication from PhRMA or that it was all about politics; they needed to sweep this away in an election year,” she said. “If that was the plan, it backfired because this looks very bad.”

Little was even more critical of the Senate GOP’s management of the issue. “I believe there’s a possibility here that we have to face that (PhRMA) told GOP members they wouldn’t sue on this because their argument — that it was unconstitutional — was actually stronger against the Senate version” of the proposal. 

The license fee that House DFL members had proposed to fund the program is legal and constitutional, Little said. “They wanted to avoid a license fee because they knew they couldn’t beat that in court,” he said of insulin makers. “I think we have to face the reality that they did this on purpose.”

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Coronavirus: Rand Paul, Dr. Fauci debate when to reopen schools amid COVID-19 pandemic

Posted on July 1, 2020 by Pharmaciststeve

Sen. Rand Paul delivered an emotional statement during Tuesday’s Senate hearing on safely returning to work and school amid the COVID-19 pandemic, stating data has shown that “young children rarely spread the virus,” and that some countries who have reopened schools amid the pandemic have not had surges in virus cases. Dr. Anthony Fauci, the top infectious disease expert in the U.S. said that he “strongly” agrees with Paul that the country needs to “do whatever we can to get the children back to school.” For more info, please go to http://www.globalnews.ca Subscribe to Global News Channel HERE: http://bit.ly/20fcXDc Like Global News on Facebook HERE: http://bit.ly/255GMJQ Follow Global News on Twitter HERE: http://bit.ly/1Toz8mt Follow Global News on Instagram HERE: https://bit.ly/2QZaZIB #GlobalNews #coronavirus #COVID19

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