“The moral test of a government is how it treats those who are at the dawn of life, the children; those who are in the twilight of life, the aged; and those who are in the shadow of life, the sick and the needy, and the handicapped.” – Hubert Humphrey
passionate pachyderms
Pharmacist Steve steve@steveariens.com 502.938.2414
I have spoken with attorneys who have expressed an interest in possibly taking legal action against pharmacies that are refusing to fill, as written, legitimate prescriptions for opiate medication for patients suffering from chronic pain lasting 3 or more months, or suffering from pain associated with a cancer diagnosis, sickle cell disease, or palliative or nursing home care, or which are adding additional requirements in order to get those prescriptions filled.
If you are interested or just want to share your story with them, you can contact them at www.justice4painpatients.com.
Pharmacies Allege OptumRx Knowingly Paid Them Less Than Large Retail Chain Pharmacies
PHILADELPHIA, PA (May 1, 2020) – — The newest litigation against a major pharmacy benefit manager comes from a most likely source: their small business victims. Unwilling to tolerate the low reimbursements which threaten to drive them out of business, more than 50 independent pharmacies have sued pharmacy benefit manager (PBM) OptumRx, a division of UnitedHealth Group, charging the company violated state laws governing pharmacy claims reimbursement.
The lawsuit alleges that OptumRx ignored state legal requirements, unlawfully paid local pharmacies substantially less than it paid large chain retail pharmacies like CVS or Walgreens and far below what the company paid its own mail order pharmacy for the same prescriptions. The lawsuit further alleges that in many cases OptumRx knowingly reimbursed local pharmacies below their wholesale cost to acquire generic prescription drugs necessary for their patients.
PBMs administer the prescription drug portion of health insurance and self-insured plans, acting as a middleman between the insurance plan and the pharmacist. Over the last 20 years these companies have accumulated immense, unregulated power – the three largest PBMs controlling up to 80% of the healthcare market – and have utilized that power to increase prescription drug costs, decrease competition and restrict patient choice.
The PBM practice of below cost reimbursements to independent pharmacies is likely one reason why OptumRx is the most profitable component of UnitedHealth Group; the world’s largest health insurance company, with over $225 billion in annual revenues.
Plaintiffs involved in the lawsuit allege that:
PBMs dictate reimbursements without notice or negotiation, and the dictated rates are often grossly unrelated to the pharmacies’ actual wholesale costs to acquire the drugs for their patients.
Optum charges health care plans brand prices while paying pharmacies the lower generic price for each prescription. Thus, the pharmacies allege the company is arbitraging prescriptions merely by changing their classification.
Optum built a wall of secrecy around its conduct by forcing network pharmacies into confidentiality agreements that conceal the truth about Optum’s business practices – specifically how much Optum is paid by insurance plans for prescriptions, how much Optum receives in rebates from drug manufacturers, and how little Optum pays to pharmacies who actually deal with patients and dispense the drugs.
The survival of independent pharmacies in America’s healthcare system is seriously threatened by the unethical, predatory business practices of PBMs. The lawsuit brought forth by this group of small-business pharmacies seeks to break this wall of secrecy and hold Optum accountable.
The pharmacies are represented by Mark Cuker and Neal Jacobs of the Jacobs Law Group, which represents over 400 pharmacies in lawsuits pending in Federal Court in Pennsylvania. For more information about the lawsuit, contact Mark Cuker at (215) 531-8512.
My dad was a chronically I’ll patient. He was 75 and underwent multiple back surgery’s and nerve decompression along w recently broken hip and spine. He fought like hell to live but his family doctor told him due to the FDA guidelines his pain meds had to be controlled by a pain doctor. After months of waiting to get into a pain doctor he was able to get his medicine but the following visit his doctor cut him down to a 1/4 of his dosage, he was not cut down slowly. My dad suffered, he went back to see doctor the following week and doctor was only interested in giving pain shots which don’t work for my dad due to scar tissue. Doctor refused to up my dad’s pain meds even tho he told them he was suffering. Here rothwelldouglas is another interesting article for you people.
5 days after that visit my dad committed suicide.
I blame the doctor as well as whoever decided to play God and not allow proper dosages of pain meds to chronically sick people.
ANONYMOUS ** They need to hear from people WITH intractable pain and WHO are not getting the medicine they need. We are are own best spokes person. Write your governor and legislators Personally as others have done. Also, the articles you see in the magazines at doctors offices are full of misinformation and lies. Few people like you and me know what real protracted pain is and can do to a person or the family of the one suffering.
On the day before her Indiana, Pa., pharmacy closed its doors for good, Stephanie Smith Cooney filled a customer’s prescription for life-saving insulin — and lost $30 on the transaction.
It had become an all-too-familiar pattern, she said Monday as she and her staff of 11 at Gatti Pharmacy filled prescriptions and said goodbye to longtime patients one last time. In the past year, she said, fully 80% of the prescriptions they filled had generated a reimbursement payment less than the pharmacy’s cost of dispensing them.
This spring, Ms. Smith Cooney — who took over the pharmacy 10 years ago from William Gatti, son of founder Louis, and Ms. Smith Cooney’s father, David Smith — came to a crushing conclusion:
“We can’t afford to stay in business anymore.”
Like most pharmacists, Ms. Smith Cooney contracts with pharmacy benefit managers, or PBMs, who act as a middleman between a consumer’s insurance company and the pharmacy. Both UPMC Health Plan and Highmark, for example, use the Express Scripts PBM to administer their drug plans.
In January, Auditor General Eugene DePasquale echoed his earlier calls for greater transparency in how PBMs operate, asking the Pennsylvania Senate to pass legislation that would help rein in costs associated with the managers. Mr. DePasquale had previously reported that Pennsylvania taxpayers paid $2.86 billion to pharmacy benefit managers for Medicaid enrollees in 2017, a 100% increase in four years.
“Because PBMs operate as subcontractors,” his office said in a release, “they can shield important information, such as how they select which drugs are covered and whether community pharmacists are reimbursed the same amount as their affiliated chain pharmacies for the same drugs.”
For independent pharmacies like Gatti, a PBM can wield tremendous power in negotiating contracts, dictating reimbursement rates and prices the pharmacy can charge for medications.
But refusing to contract with a pharmacy benefit manager is not a practical option, as that typically means losing access to many, if not most, of their customers.
Without those contracts, “I would be selling used cars somewhere,” said pharmacist Dave Cipple, who owns seven independent pharmacies in Clarion and Armstrong counties.
Until last December, Mr. Cipple owned an eighth pharmacy in Shelocta, Indiana County, which he closed after seeing a sharp decline in reimbursement payments.
“We don’t have the clout to negotiate any reimbursements that are favorable with these folks, so that’s what happens,” he said.
He did get the final word, though: Today, a giant sign outside his vacated storefront on Route 422 shouts, “PBMs WRECKED THIS PHARMACY!”
Greg Lopes, spokesman for the PBM trade group Pharmaceutical Care Management Association in Washington, D.C., disagrees that pharmacy benefit managers are forcing independent pharmacies to close.
“Now more than ever, pharmacy benefit managers are the advocates for Pennsylvania’s consumers and health plan sponsors in the fight to keep prescription drugs accessible and affordable, and are not responsible for independent pharmacy closures,” he said.
“The fact is that there has been an increase in the number of independently owned pharmacies in Pennsylvania over the last 10 years.”
Mr. Lopes cited a March 2020 report done by two Penn State political science professors that said from 2010 to 2019, Pennsylvania saw a 14% increase in the number of independent pharmacies, to a total of 1,058 pharmacies statewide.
Not only are there more independent pharmacies nationally, the report concluded, but also as a group, their prescription profit margins had “increased slightly” between 2017 and 2018.
Patricia Epple, CEO of the Pennsylvania Pharmacists Association in Harrisburg, isn’t buying it.
“We have seen closure after closure.”
She noted the March report used data from the National Council for Prescription Drug Programs, an Arizona-based nonprofit that develops standards for pharmacy services.
The council routinely attributes a greater number of pharmacies in the state than are listed with the state board, she said. “So I am not sure if NCPDP is not removing old ones or exactly what, but something seems to be off.”
An annual digest put out by the National Community Pharmacists Association last year said Pennsylvania had 963 independent pharmacies in 2018, 95 fewer than the Penn State report had.
Ms. Smith Cooney believes she knows what’s behind the discrepancy, at least in part.
“In my experience just today, I was instructed to leave my NCPDP status active even though my status with the state board and DEA are now inactive,” she said Wednesday. “If my case is similar to others, NCPDP status would be a poor way to measure pharmacy numbers.”
Closing the pharmacy has been much more than a numbers issue for Ms. Smith Cooney.
As a young girl, she would do odd tasks at the store where her father was a pharmacist. She did her training there as a pharmacy student, then became a partner after earning her pharmacy degree and bought the business — which was founded in 1936 — in 2010.
The pharmacy offered services such as Gatti’s AutoSync RX program that allowed patients to get all of their prescriptions at one time with a phone reminder when it was time to pick them up. It also tracked late and missed refills.
“They deliver a personal service that you don’t always see in this day and age,” said Linda Mitchell, executive director of the nonprofit Downtown Indiana Inc., which works to keep the corridor of shops and restaurants vital and appealing.
Ms. Smith Cooney said they’d kept costs under control, and annual revenue had grown 10% the past year. “For all intents and purposes, we should be thriving.” But the increased revenue was not enough to offset the reduced reimbursements and still cover the pharmacy’s staffing and overhead costs.
Instead, the 2,000-square-foot storefront at the west end of Indiana’s core business district has gone dark, with the Gatti store inventory and patient files now transferred to the local Rite Aid.
“It’s definitely the end of an era for Indiana,” said Ms. Mitchell.
I am sure that a lot of pharmacists are glad they are working in a “right to work state” … there are some 25 states with this law on the books.. Businesses can fire you for any reason – or no reason – without consequences.
Pharmacists have not been paid $35 – $40/hr since the late 90’s or early 2000’s. There was a period of time 2000- 2010 when there was a severe shortage of pharmacists.. at its peak they claimed that there was 6,000 empty job slots that there was no pharmacists to fill them.
At about the same time the profession went from a 5 yr degree to a 6 yr degree program so on top of everything else we had almost NO GRADUATES ONE YEAR.
New Pharmacy schools started opening and they were getting 5-6 applicants for every available pharmacy school slot. we went from 80 odd schools till today we have abt 140 schools…. and they are now graduating 3 pharmacists for what maybe 2 available job slots..
During this time, the feds increased the limit on what students could borrow for college and in turn the colleges raised their tuition.. so students were coming out of college with larger and large student loan balances… not unusual for pharmacy grads to have $100,000 + student loan balances… of course when they started pharmacy school they were expecting to make 100,000 – 120,000/yr when they become licensed.
So now we have pharmacists – that all but the Pharmacy manager are lucky to get 30 hrs/week … so now they have a student loan more than many people have loans on their houses and going to be grossing MAYBE $60,000/yr.
So many of the pts dealing with subjective diseases and trying to get controlled substance Rxs filled and run into many of these newly graduated pharmacists with a whole lot of “book smarts” and little/no real clinical experience.. I would not be surprised for a lot of these pts to get “I’m not comfortable” filling your controlled Rxs..
But there are always independent pharmacists … where the pt will typically be dealing with the Pharmacist/owner and won’t be someone fresh out of school with the ink still wet on their license here is a link to help you find one by zip code. https://ncpa.org/pharmacy-locator
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.
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 alreadycontroversial 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 ?
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.
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.
The 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.
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.
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
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.
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
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’
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.
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).