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Narcan is a drug that is is given to heroin addicts who Overdose. Only 5% of people who Overdose do so on prescribe prescription drug. Most of these people are dying from the underlying disease, not the medicines. Tax-papers fund these follies. 10 million w painful disease who will never use x $150 is 5 billion wasted.
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JATH educational contortion continuing to research the origins of why pres drugs have become the focus of the opioid epidemic, present since the end of the civil war. We have found the watershed paper, published by Lenard palazzi, a supporter of the PROP, a small group of radial ideologists, who believe no one should have access. The Palazzi 2006 article switched because of the opioid crisis from heroin to prescription drugs, inciting docs instead of heroin drug dealers. This paper is severely flawed and was presented in its flawed status, to the Joe Biden senate committee in 2008, it has remained invalid since that time.
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https://makeamericansfreeagain.com/
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https://www.medpagetoday.com/neurology/opioids/91060
Medicare beneficiaries were increasingly likely to have long-term opioid therapy stopped in recent years and medication changes often were abrupt, not tapered, an observational study showed. This blog also shows how to get Suboxone online for treating opioid addiction.
Long-term opioid discontinuations among Medicare Part D beneficiaries increased by 49% from 2012 to 2017 and most were rapid, “falling off a cliff” drug changes, reported Michael Barnett, MD, MS, of Harvard T. H. Chan School of Public Health and Brigham and Women’s Hospital in Boston, and co-authors.
The proportion of abrupt opioid discontinuations increased over time, from 70.1% in 2012 to 81.2% in 2017 (P<0.001), they wrote in the Journal of General Internal Medicine.
Patients on long-term opioid therapy “face significant stigma and misunderstanding in the current healthcare system,” Barnett said. “There are many reports of patients being indiscriminately discontinued from their medications, but little data to investigate these concerning reports,” he told MedPage Today.
“The vast majority of long-term opioid users whose therapy was discontinued had an extremely rapid, abrupt taper that was far outside of guideline recommendations,” Barnett added. “It would have been concerning to find that, say, one in four long-term opioid users had abrupt cessation of their therapy but we found that it was most, even among those with very high daily doses of opioids.”
The CDC and FDA have published cautions against abrupt tapering, citing it as dangerous to patient health, noted Beth Darnall, PhD, director of the Stanford University Pain Relief Innovations Lab, who wasn’t involved with the research.
This study highlights the pervasiveness of poor tapering practices occurring from 2012-2017 and the extent of pain care disparities, she observed. “As of 2017, these alarming trends continued to increase,” Darnall told MedPage Today. “There is a desperate need for improved healthcare and safety measures for people with chronic pain taking prescribed opioids so they are not subjected to unethical and dangerous practices.”
The CDC’s 2016 guideline for chronic pain opioid prescribing prompted a big focus to reduce overprescribing. Some state agencies and insurance companies used the guideline to push hard dose limits and abrupt tapering, which the CDC later said was inconsistent with its recommendations.
“In 2018, a group of us authored a letter to HHS calling for urgent action against forced and abrupt opioid tapering,” Darnall said. “In 2019, HHS issued guidance for patient-centered opioid tapering that promotes consensual tapering practices.”
In their study, Barnett and co-authors looked at claims for a 20% sample of Medicare beneficiaries on long-term opioid therapy for at least 1 year, defined as four or more consecutive quarters with more than 60 days of opioids supplied in each quarter from January 2011 through December 2017. People with a cancer diagnosis besides skin cancer and hospice patients were excluded, as were people on an average daily dose of 25 morphine milligram equivalents (MME) or less during their initial 12-month long-term opioid therapy period.
Most (70.3%) long-term opioid users in the study were eligible for Medicare due to disability. Mean age was 60 and 58% were women.
Long-term opioid discontinuation was defined as at least 60 consecutive days without opioids supplied. The researchers evaluated whether discontinuation was tapered or abrupt by comparing patients’ daily MME dose in the last month of therapy to their average daily dose in a baseline period of 7 to 12 months before discontinuation. By the last month of therapy, patients with abrupt discontinuation had at least a 50% reduction in their baseline average daily dose.
The study identified 258,988 long-term opioid therapy users; of these, 17,617 (6.8%) discontinued therapy. Adjusted rates of discontinuation increased from 5.7% of users in 2012 to 8.5% in 2017. Increases in annual discontinuation rates were similar for people on lower (26-90 MME, 5.8% to 8.7%) and higher (more than 90 MME, 5.3% to 7.7%) doses.
People eligible for Medicare because of disability had a greater increase in the probability of discontinuing opioids from 2012-2017 (adjusted rates 5.9% to 9.2%, 56% relative increase) compared with people not eligible due to disability (5.2% to 7.0%, 35% relative increase, P<0.001 for interaction).
While it was common for patients on lower daily MME doses to have long-term opioids stopped rapidly, the majority of patients on very high doses — even over 200 MME — who stopped also had an abrupt discontinuation, Barnett and co-authors reported.
“We need more education and support for patients on long-term opioid therapy to taper in a clinically rational way and maintain excellent continuity of care with their pain management team,” Barnett said.
The study had several limitations, the researchers noted. Data represent Medicare beneficiaries only, predominantly the disabled Medicare population, and may not apply to other people. The intended tapering strategy for these patients wasn’t known and it’s possible the data reflect a bias toward abrupt discontinuation.
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As it buys up medical practices, private equity is popularizing a favored Wall Street cost-cutting tactic—and stripping patients of rights.
https://www.bloomberg.com/news/features/2020-12-28/the-doctor-will-see-you-once-you-sign-this-binding-arbitration-agreement
Last year, Jessie Harrell went to see her gynecologist for a routine appointment. She’d been seeing Dr. Tim Baird for 14 years, ever since she showed up at the hospital in labor five weeks early. He’d been on call that morning, and she’d been reassured by his calm demeanor, even as he delivered her first child via an emergency cesarean section.
But this time, right before Harrell’s visit, a staff member in Dr. Baird’s office in Jacksonville, Fla., called and asked her to watch a video on the medical group’s website. She clicked a link and saw an attractive actress in an immaculate office explaining a new policy. All of Dr. Baird’s patients, Harrell learned, needed to sign a form agreeing to “binding arbitration,” a legal concept that meant she was waiving her right to a jury trial in the event of medical malpractice.
When she objected, the woman on the phone told her she could see Dr. Baird one more time, but she’d have to find a new practice after that. In the exam room the doctor began as he always had, by asking Harrell about her two daughters. He was apologetic about the new requirement but said it was out of his hands. His office and dozens of other locations in his medical group had been sold to Lindsay Goldberg, a New York-based private equity firm with more than 100 physician offices and surgery centers across Florida. This was the new reality, he said, whether he liked it or not.
Harrell was heartbroken, and not just because she trusted Dr. Baird. Harrell is a lawyer—she has her own appellate firm in Jacksonville—so giving up a constitutional right would’ve been bad enough. What made it even worse was that she recognized every page of the agreement the office was asking her to sign. In 2016 she’d successfully argued a case that involved a woman who’d sued her gynecologist, a doctor with a large group called Women’s Care Florida, after signing an almost identical form.
It was a horrible story: Her client, who had symptoms of early labor, arrived late to an appointment and was turned away, with the doctors’ office rescheduling for four days later. A day before the new appointment, she gave birth to a stillborn baby. Under normal circumstances, the patient would’ve been able to go through the state’s legal process, which meant either agreeing to arbitration or moving to trial. Women’s Care, though, insisted on enforcing the binding arbitration agreement, which meant she (as well as her husband and then-unborn child) had already given up their rights.
Harrell and a colleague, Bryan Gowdy, had argued during the appeal that the Women’s Care agreement was unenforceable under state law. The Florida Supreme Court sided with them, saying the agreement was void. And yet somehow here it was again. In the three years since she’d won, Women’s Care had been bought by Lindsay Goldberg, which then bought Dr. Baird’s practice, too. The medical group had continued using the form—in the hope, she guessed, that even an unenforceable arbitration agreement would be enough to dissuade a malpractice victim from suing.
It was an outrage, she thought, as she walked out of Dr. Baird’s office. “Why would I agree to that after hearing the Supreme Court say it was unfair to patients?” Harrell asked in a Zoom interview with Bloomberg Businessweek from her home. In the background, Archer, a rescue greyhound who once raced under the name Miami Hurricane, lazed on a white sofa. Harrell’s face tightened as she spoke. “People shouldn’t be put in this take-it-or-leave-it position after having been shown a five-minute video on arbitration propaganda.”
The argument for arbitration hinges on the rising costs imposed by malpractice lawsuits, which some policymakers and doctors say have made medicine more litigious and led to worse care. One in three babies in the U.S. is delivered via C-section, a procedure that, compared with vaginal delivery, is more expensive for patients, requires a longer recovery period, and carries higher risks of infection and blood loss—but which is less likely to result in a lawsuit if complications occur during labor, at least according to the American Congress of Obstetricians & Gynecologists. The group has said that limiting physician liability would cause C-section rates to drop.
Advocates of arbitration contend that it’s a sensible alternative to resolving disputes in a trial. Arbitration, they say, frees doctors to treat patients more holistically and to worry less about how a treatment decision might play with a jury. But it has also helped enable a trend that has very little to do with patients’ well-being: the rise of private equity in medicine. Over the past decade, almost 4,000 independent clinicians in women’s health have come under private equity ownership, according to a study published in August in the Journal of the American Medical Association. The figure is likely much higher, according to the study’s authors, but the deals aren’t uniformly disclosed.
The Covid-19 pandemic, during which doctors’ offices shut down temporarily and furloughed staff, is only accelerating this trend. The average medical office’s revenue has dropped 32% this year, according to a survey released in November by the American Medical Association, even as rates for malpractice coverage have gone up by as much as 30%. Private equity firms, on the other hand, raised billions from investors this year and have been buying up struggling practices on the cheap.
The private equity playbook involves acquiring practices in fields such as dermatology, gastroenterology, and obstetrics and rolling them up into enormous medical networks with hundreds of doctors’ offices and thousands of individual doctors under a single brand. For these big practices, arbitration may be especially useful. Jury trials, even in the era of tort reform, can still lead to awards in the tens or even hundreds of millions of dollars for plaintiffs. Juries, understandably, are likely to have less sympathy for a well-capitalized Wall Street owner than for a grieving mother who’s been treated poorly.
In arbitration, the plaintiff (in this case the patient) and the defendant (the owner of the medical practice) each pick an arbitrator. The third arbitrator is generally a neutral party, and the trio’s decisions are usually final. The process can be much faster than a jury trial, which can mean lower legal fees. Crucially for private-equity-owned medical groups, arbitration is almost always conducted in private, which means that big brands can avoid the negative publicity that comes with a lawsuit. Jury trials, on the other hand, are a matter of public record. When malpractice verdicts are rendered, patients can use that information to figure out which doctors to avoid and which ones to seek out.
Arbitrators are usually lawyers or retired judges, but they don’t have to follow legal precedent, and they don’t necessarily even need to explain their decisions. They also, critics say, have an incentive to favor corporate defendants because arbitrators generally want to get rehired and, as a result, tend to come up with lower payouts. In cases in which arbitrators side with a malpractice victim, awards can be strictly limited. By law in Florida, the maximum pain-and-suffering award in arbitration is $250,000 for each person filing a claim.
Of course, speed and privacy can make arbitration appealing to plaintiffs as well, and the decision to seek arbitration is usually voluntary—and occurs after malpractice. By contrast, binding arbitration agreements, which patients have to sign before receiving any care, have historically been seen as infringement of their rights. Since the early 2000s the American Arbitration Association and the American Bar Association have said their members shouldn’t participate in these kinds of cases.
But the financial industry has long embraced binding arbitration—especially when setting employment policies, a trend that critics say has been used to cover up decades of discrimination and sexual harassment—and has helped fuel the rise of the practice in medicine. Over the past few years, agreements like the one Harrell’s client signed have become pervasive in admission packages for nursing homes, another business popular with investors. Lawyers and insurance brokers say they’re also starting to show up in plastic surgery, women’s health, and other industries that private equity investors are consolidating.
The insurance industry has encouraged this trend by offering better terms to physician groups that can get their patients to preemptively waive their right to a jury trial. The former chief medical officer of Women’s Care Florida, John Murphy, lists under “Key Achievements” on his LinkedIn page that binding agreements have lowered the OB-GYN group’s liability insurance costs 20% a year. “The fact that they discount insurance tells you what’s going on,” says Thomas Edwards, a malpractice attorney in Jacksonville. “They know it will reduce or eliminate awards even in cases where somebody committed malpractice.”
This binding arbitration isn’t necessarily good for doctors, who often care about their reputations and their relationships with patients more than they care about improving profits or preserving the brand equity of their investor-owners. Arbitration agreements can turn patients off, and some physicians say they’d prefer the option of fighting charges in court if they’re accused of wrongdoing, giving them a chance to clear their name publicly. “Arbitration has the real potential to remove some of the rights providers have under a more traditional insurance policy,” says Peter Reilly, who leads the North American health-care practice for insurance broker Hub International Ltd. “There’s some value there if you get a reduced premium, but I’m not sure it’s in the physician’s best interest.”
Women’s Care started as a small obstetrics and gynecology practice in 1998 in Tampa, but by the time Harrell took it to appellate court in 2015, it had expanded to include 27 practices in the Tampa Bay area and elsewhere in Central Florida. Harrell had started her career at a big corporate firm, Foley & Lardner, where she spent seven years as a commercial litigator, defending claims against Walmart Inc., Bank of America Corp., and other companies. The job was life-altering financially for Harrell, who was the first in her family to go to college, but it was hardly fulfilling, and she eventually left for Creed & Gowdy, a smaller appellate firm in Jacksonville that specializes in, among other things, personal injury cases that wind up in federal or state appeals court.
Working for victims was gratifying, and arguing appeals was an intellectually rigorous process that played to her strengths. Her client in the Women’s Care case, Lualhati Crespo, had clearly been mistreated, as Harrell saw it. Crespo had been denied care, then was denied her legal rights, because she’d signed the agreement. “Doctors take the Hippocratic Oath to ‘Do no harm,’ and that puts them in a position of trust,” Harrell says. “You’re relying on them for advice when you step through that door. And then you go in, and you’re led to believe that if something goes wrong, arbitration is going to be best for you. I feel like they are betraying the trust of their patients.”
As she studied the case, Harrell says her sense of indignation grew. Her parents hadn’t been able to afford health insurance, and she frequently had to skip checkups. In college, after seeking treatment for migraines, she discovered she had about 10 cavities. “I really have an appreciation for medicine, because I haven’t always had access to it,” she says.
During oral arguments, Florida Supreme Court Justice Barbara Pariente noted that the binding arbitration agreement presented patients with a false choice. A Florida statute says if both parties don’t agree on arbitration, they can go to trial. The agreement Crespo had signed said she and Women’s Care could agree to go through either the state’s arbitration process or a separate binding arbitration with rules set by the medical group—but a trial was not an option. It reminded the judge of the song Hotel California: “You can check out any time you like, but you can never leave.” In a 5-to-2 decision, the court noted that Florida already had laws designed to prevent frivolous suits and said the Women’s Care agreement was “clearly favorable to one party.” (Women’s Care appealed to the U.S. Supreme Court, which declined to hear the case.)
It was over—or at least that’s what Harrell thought when she read the Florida decision, feeling a sense of pride at having won her first case before the state’s highest court. But three years later she found herself walking into Dr. Baird’s office carrying a copy of the decision under her arm, streaked with yellow highlighter.
Lindsay Goldberg had bought Women’s Care in September 2017, nine months after the ruling. Since then, Women’s Care had rapidly expanded—to the point that its providers now deliver 1 out of every 10 babies in the state. As it acquired more practices, including the one in Jacksonville’s Southside neighborhood where Harrell went, each group adopted the binding arbitration form, requiring all of its 500,000 patients in Florida to sign.
Surprisingly, even though the document is not legally enforceable, there’s nothing preventing the company from asking patients to sign it and refusing to treat them in the future if they don’t, according to more than a dozen legal experts interviewed for this story. “It’s not illegal, but it raises serious questions about what message you are sending to patients,” says Andrew Bolin, a defense attorney in Florida. “Women who sign the form will assume it’s enforceable.” That means, he says, that many who feel they’ve received substandard care won’t even consider hiring a lawyer. And even if they do try to find one, some attorneys may be unfamiliar with the court decision and choose not to take their case because of the agreement. As Harrell puts it, the practice “is tricking people into giving up their legal rights.”
Lindsay Goldberg declined requests for an interview but provided a statement on behalf of Women’s Care Enterprises. The private equity firm noted that Women’s Care has used binding arbitration agreements for more than 15 years. “These programs were instituted by and have always been developed solely by the physicians who own their practices,” the statement reads. “These physicians are committed to providing the highest quality patient care in an incredibly challenging legal environment for independent medical practitioners.”
It’s unclear how many other private-equity-backed groups use binding arbitration, because patient forms are generally kept private. They are well known to doctors, though, who see the agreements as part of a larger pattern in which investors roll up practices and then cut costs frantically in an effort to groom the business for sale, generally to an even larger company. A Businessweek investigation published in May found that some private-equity-owned medical practices buy cheaper, and sometimes substandard, medical supplies and hire providers who aren’t as well trained as doctors, such as nurse practitioners and physician assistants, to do work that would traditionally have been performed by an M.D. When all this results in substandard care, the arbitration agreements are in place to limit liability.
On Dec. 7, PE Hub, a trade magazine, reported that Lindsay Goldberg had agreed to sell Women’s Care Enterprises, which also owns other women’s health groups in Kentucky and Southern California, to BC Partners, an even larger investment firm based in London. At least one of the groups in California also uses binding arbitration, though Women’s Care says the agreement was in place before Lindsay Goldberg invested. BC Partners didn’t respond to requests for comment.
Harrell has since found a new doctor who left Women’s Care and doesn’t use binding arbitration agreements. “There’s nothing inherently wrong with investors buying medical firms, as long as doctors can practice the way they always had,” she says. But, she continues, “what seems like a business decision can affect patient care if it’s using this position of trust that doctors have to mislead patients to do something that’s not in their best interest.”
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https://doctorsofcourage.org/ftc-investigating-practice-of-healthcare-monopolization/
Many, if not most of us who have been the subject of investigations and prosecutions have been lead down this road by large healthcare systems that appear to feel threatened by you. Many of us who don’t quite fit the mold or that have refused to cooperate have been subjects of sham review by these systems or just plane bad publicity. The FTC is now probing into the larger mergers. Called the Merger Retrospective Program. It has sent orders for 6 years worth of claims to Cigna, United Healthcare, Anthem, Florida Blue, Aetna, and Health Care Service Corporation.
The FTC is looking to access the impact of Physician consolidation, including Physician practice merger and hospital acquisition of Physician practices between the periods of 2015-2020. This will allow the FTC to access the impact of healthcare facility consolidation. The FTC hopes to learn more about how mergers impact competition and “proper functioning of healthcare markets”. They will be examining inpatient and outpatient data in 15 states. The pandemic has resulted in an increase in mergers. Previous research has shown that mergers drive up cost without increase in quality or patient experience. FTC chair Joseph Simons states that “Merger retrospectives are a powerful way of engaging in critical self-examination to see if our antitrust enforcement is working correctly.”
Anyone who has been paying attention as to what has been going on in various communities throughout our country for the past 8-10 yrs. We live in a ONE HOSPITAL COUNTY… with a population of abt 85,000. This local hospital, about 10 yrs ago , started buying up local office practices. In around 2013 we were told that our multi prescriber office was been sold to the hospital. Our PCP told us that in the previous year that he had seen more pt visits than ever before and he brought home $40,000 less the previous year. They were a fairly “high tech office” they were one of the very first offices to implement EHR several years before but apparently the cost of the “back office” where all the billing took place was taking its told on their bottom line.
IMO, nothing really changed in how the office functioned in seeing and taking care of pts. About 5 yrs later, we were informed that our hospital system was “merging” with a MAJOR HOSPITAL SYSTEM in a near by large city in a adjacent state.. Within a year or so, things started to change in and around out county. Apparently the “merger” was actually a sale because our local hospital now bears the name of the LARGER HOSPITAL that they merged with.
Then all the practices and the hospitals implemented a major hospital software system. Two of the prescribers in the practice that dealt with pediatrics were asked to move on and the practice that had a separate waiting room for “sick kids” … was gone and the whole waiting area and reception area was remodeled.
In Nov 2019, Barb experiences some unexplained shortness of breath and our PCP recommended that she be admitted to the local hospital for at least <24 hr observation. Now our PCP could no longer see his pts when they were in the hospital… the hospital now had a staff of 20 HOSPITALISTS. and below is the post that I made about that encounter.
I have never updated that original post…. I filed a complaint with the QIO ( https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityImprovementOrgs )
Which a entity that oversees how hospitalized Medicare pts are treated.. The QIO reviewer’s report basically “ripped this doctor a new one”… so I took that report and filed a complaint with the Indiana AG office … a few months later I get a copy of the letter sent to at least the doctor and perhaps his hospital employers basically stating that this is A WARNING – DON’T DO IT AGAIN.
Over a year as pasted and from people I know who work in/around the hospital states that he had not changed his opiophobic ways.
The entire point is as these hospital systems merge and getting larger… they are most likely accumulating “deeper pockets/ cash reserves”… Deep pockets is what law firms go after and these large hospital systems tend to put out systemic edicts in how their practitioners will practice medicine…. prescribe or not prescribe certain medications or groups of medications – think controlled substances.
If one prescriber is force reduction in medications used for chronic pain medications, most likely many/most/all practitioners within the hospital system are doing the same, because of a policy and procedure edict coming from the corporate suite… initiated by the CFO or legal dept. That means that hundreds or thousands of pts are being discriminated against because of their medical necessity for a certain category of meds.
I get the sense that numerous law firms are “sniffing around the chronic pain community” they are trying to figure out a game plan… healthcare discrimination at this level has never happened before and all the health issues that are being discriminated against are subjective diseases… there are no lab tests to determine the severity of a individual’s condition.
Here is a link to all the ill effects to human beings having to deal with under/untreated pain… it is quite extensive and many effects can be LETHAL https://www.pharmaciststeve.com/?p=20995
IF any pt talks to a law firm, never let them go down the path of talking about MAL PRACTICE… Malpractice is when something goes accidentally and the pt is harmed. With forced reduction of pain and other meds… that is an INTENTIONAL HARM that is being caused to the pt. That has nothing to do with MALPRACTICE.
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https://www.medpagetoday.com/blogs/marty-makary/91029
Tragically, only 62% of COVID-19 vaccines distributed in the U.S. have been administered. One reason for the slow rollout: states and some hospitals are holding back vaccines for scheduled second doses. But to save more American lives and beat back the threat of new variants, we should use the entire current vaccine supply to offer a first dose to all seniors and high-risk people before we administer second doses.
Data are mounting to show that one dose can be highly effective in the short term. In the Pfizer vaccine trial results, there was 91% protection in the first 7 days after the second dose, a period in which the second dose has not yet kicked in. The 91% efficacy observed at 4 weeks is entirely attributable to the first dose.
We also got news on Jan. 13 from Johnson & Johnson’s phase I/IIa vaccine trial two weeks ago. It affirmed a scientific principle often seen with vaccines — that immunity naturally increases in the second month. In the New England Journal of Medicine article by Sadoff et al., neutralizing antibodies were observed in 90% of participants by day 29 to 100% by day 57 after receiving the J&J vaccine.
The second dose may actually be more effective when it’s delayed. “Generally, a longer gap between vaccine doses leads to a better immune response,” Andrew Pollard, director of the University of Oxford’s vaccine group, told The BMJ. He pointed to the HPV vaccine, where a one-year gap between doses yields stronger immunity than a one-month gap. He also pointed out that in the AstraZeneca/Oxford vaccine trials, the immune response was about three times greater when the second dose was given at 2-3 months versus 4 weeks. Similarly, a multinational study found that the first dose of the Moderna vaccine had 80% efficacy and that a delay of 9-12 weeks “could enhance the program effectiveness and prevent additional infections, hospitalizations, and deaths, compared to a 4-week interval between the doses.”
Put simply, in the midst of a horrific war with thousands of Americans dying each day, would you rather give 50 people 95% protection or 100 people 80%-90% protection?
That’s why the U.K. has already recently issued official guidance recommending that people wait closer to 12 weeks to get their second vaccine dose.
Yet the U.S. medical establishment has been oddly dismissive of the immunity attributable to the first dose and the broader strategy of maximizing first doses before administering second doses. This rigidity is consistent with the track record of U.S. scientists refusing to participate in the RECOVERY trial because it did not meet the elaborate standards the U.S. scientists insisted upon. U.K. doctors eventually completed the trial without U.S. participation and established steroids as a standard of care for COVID patients.
Finally, we must remember that the ultimate endpoint is death, not just infection. To date, there are no reports of anyone who has died of COVID-19 because they missed or delayed their second vaccine dose. Partial immunity appears to have the ability to reduce the severity of illness. People in academic ivory towers often speak with a denial that there is severe rationing of healthcare. Right now, we are rationing like crazy. The data are now clear on how we should ration the life-saving vaccine doses. As the data accumulate, we must be willing to evolve our strategy.
To be clear, people who receive an initial vaccine dose should get a second dose with the Pfizer and Moderna vaccines — but not while we are severely supply-constrained and 3,000 Americans die each day. Holding back vaccines for second dose reservations leaves more seniors as sitting ducks in this deadly war because they can’t get any vaccine.
Unfortunately, the FDA has a policy of not being fully transparent with vaccine data. They don’t release the entire vaccine application to the public as they should once they receive an application. That prevents smart people from weighing in on what they should do and it allows the FDA to function at turtle speed. Much of the efficacy data for the first dose was only made public once all the vaccine trial data was made public after the FDA authorized the vaccine.
When I first reviewed the vaccine data to look at the effectiveness of the first dose, I felt like a lone wolf going on television suggesting to hold off on second doses as long as we were severely supply-constrained. But since then, a growing chorus of leading physicians have advocated for the same approach.
On Sunday, Michael Osterholm, PhD, MPH, a member of the Biden administration’s COVID task force, said, “We still want to get two doses in everyone, but I think right now, in advance of this surge, we need to get as many one-doses in as many people over 65 as we possibly can.” This comment made waves since it was in sharp contrast to what the old guard medical establishment was saying. The new CDC director, Rochelle Walensky, MD, MPH, quickly upheld the two-dose on-time position when she said only in “rare circumstances” should one wait as long as 6 weeks after the first dose.
Ashish Jha, MD, MPH, and Bob Wachter, MD, were some of the first people to suggest that delaying the second dose may be a better strategy to vaccinate more people. They floated the idea in the Washington Post as something to consider (in classic academic discussion fashion), with a pre-emptive disclaimer that smart people will disagree and that their position is not a “no-brainer.” I replied that it is both a “no-brainer” and a “brainer.”
We just need to move fast to implement the idea into policy. On a personal level, I’m encouraging patients I see, friends, and family to hold off on the second vaccine dose for the benefit of vulnerable Americans. As I detailed in MedPage Today, as someone at a very low personal risk of COVID mortality and a very low risk of acquiring or transmitting the virus in the hospital, I will not be taking the vaccine until every high-risk American has been offered it first.
Our national vaccine strategy should also acknowledge the current disconnect between the scientific ivory tower and the real-world. In the real world, there is a massive vaccine grab, dominated by the wealthy and connected. As the Miami Herald reported this week, Fisher Island, Florida, the wealthiest zip code in the U.S., has a vaccination rate of 51% while nearby Opa-locka, where 40% of the population lives in poverty, has 2% of their population vaccinated. How can we justify denying Opa-locka residents a first dose when Fisher Island residents are getting a second? Prioritizing first doses at a time when we are supply-constrained could help reduce the racial and socioeconomic divide that vaccine greed is increasing by the minute.
We should also remember our country’s vaccine journey. This past summer, we all waited intently to see if a vaccine could meet the stated goal of being at least 50% effective. Imagine our reaction then if a company suddenly announced that a single-dose vaccine was found to be 80%-90% effective at 4 weeks. We’d say that’s a home run! If someone were to later add that giving the same vaccine a second time would increase the efficacy level by four percentage points, we’d probably say let’s just get everyone one dose and then talk about getting people a second dose.
It’s time the medical establishment and federal and state governments have the courage to take a hard look at the data and make a bold wartime decision, even if it rattles an older framework.
The race to beat new variants is on. The longer COVID-19 circulates unabated, the more opportunity it has to mutate and morph into new strains that may not be encompassed by our current vaccines. In order to save as many American lives as possible and optimize our chances of crushing the new variants, we need to ration our scarce vaccine supply more wisely. To date, the allocation has been erratic, wasteful. It’s also been oddly blind to those with natural immunity from prior COVID-19 infection. Let’s be guided by science and have the humility to change our approach to protect as many vulnerable people as we can.
Some scientist friends have told me not to talk about the high effectiveness of the first dose publicly because people might hear that information and decide not to get the second dose. But in principle, I believe we should not hide data from the public in hope of steering them with partial information. Second doses should be administered after every high-risk American, regardless of race or income, has been offered a first dose.
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