The Doctor Will See You Once You Sign This Binding Arbitration Agreement

The Doctor Will See You Once You Sign This Binding Arbitration Agreement

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.”

Are this large hospital corporations setting themselves up for large discrimination lawsuits ?

FTC investigating practice of healthcare monopolization

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.

Does a practitioner’s ethnicity effect the care they provide to females ?

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.

The Day The Music Died 02/03/1959 Buddy Holly – Big Bobber – Ritchie Valens dies in plane crash

Op-Ed: Forget Second COVID Vaccine Doses for Now

Op-Ed: Forget Second COVID Vaccine Doses for Now

— It’s far more important to get first doses to as many people as possible

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.

Oral vs. IV Tylenol in the Elderly: The ‘Let’s Kick Granny Down the Stairs’ Study

Oral vs. IV Tylenol in the Elderly: The ‘Let’s Kick Granny Down the Stairs’ Study

https://www.acsh.org/news/2020/09/07/oral-vs-iv-tylenol-elderly-lets-kick-granny-down-stairs-study-15007

Sometimes studies are full of bad data. Sometimes they are just based on stupid ideas. Here’s one that manages to incorporate both flaws. Should elderly people with broken ribs be given Tylenol in pill form or IV for pain? Perhaps a salami sandwich is a better offering … since this study is full of baloney.

The anti-opioid crusade remains alive and well (unlike the pain patients who are the victims of it). Call me crazy (1), but doesn’t it seem that the “I can prescribe fewer painkillers than you” contest is still in full force?

An article on the Pain Network News site summarizes a meeting presentation of a small train wreck study entitled “Treatment With Oral Versus Intravenous Acetaminophen In Elderly Trauma Patients With Rib Fractures: A Randomized Controlled Trial” by Andrew Antill, MD and colleagues at the University of Tennessee Medical Center in Knoxville. In case you’re in the mood to blow your head off with a bazooka become educated and wish to read the entire 292 page abstract of the entire meeting, here it is. If you’re not so inclined, the study in question can be found on page 186.

What a mess. 

The title suggests that in elderly patients with fractured ribs (a very painful injury):

  • Oral and IV Tylenol work equally well in controlling pain.
  • Therefore, Tylenol pills ($0.45 per dose) should be used in place of IV Tylenol ($180.00 per dose). 

Not so fast. Aside from the cost, everything is wrong. Let’s take a look.

SUMMARY OF THE STUDY

  • The study was double-blinded and placebo-controlled. 
  • All patients (a total of 138) were 65 or older, had one or more broken ribs, and were admitted to a Level I trauma center. 
  • Patients were placed in either of two groups: 1) IV acetaminophen plus an oral placebo solution (63 patients) or IV placebo and oral solution acetaminophen (75 patients) (2).
  • The primary outcome of the study was the mean reduction in pain score after 24 hours.
  • There are more details, but I’m leaving them out. The study is so flawed that it doesn’t matter.

PROBLEMS AND MORE PROBLEMS

Right away, two doozies jump off the page:

  1. The supposition that Tylenol in any form effectively treats pain. In fact, there is plenty of evidence that it does not (See: Tylenol Isn’t So Safe, But At Least It Works, Right?).
  2. It’s really cool right now for doctors to try to use IV Tylenol in place of opioids for post-operative pain. Minor issue: It doesn’t work. (See IV Tylenol As Good As Moose Urine For Post-Op Pain Control.)

And we’re just getting started. 

You don’t need to have ESP (or ESPN) to predict that when you give a drug that does little or nothing to relieve pain that both groups in the study are going to experience the same level of non-pain relief. The Antill study claims this but offers nothing but unsuitable evidence to back up the claim. Why? Lack of any statistical significance (emphasis mine):

Results: Among the 138 trauma patients included in the study … there was no statistically significant difference between the two study groups in mean reduction in pain score at 24 hours after injury (p=.23). Mean reduction of pain scores on a 10 point scale were 3.24 in the PO acetaminophen group and 2.49 in the IV acetaminophen group.

The bolded text above only begins to tell us what a mess this thing is. First, the language is (at the very least) confusing and (at worst) intentionally misleading. Most people will read that sentence and conclude that IV and oral Tylenol work equally well in this group of patients. But this is not correct. What it really means: because the data don’t even come close to attaining statistical significance this study provides no information whatsoever about whether IV Tylenol is better, worse, or the same as the pills or that either has any effect at all. Confusing? You bet. More on this below.

Original photo: Headspace

I haven’t mentioned the study’s secondary endpoints because if the data of the primary endpoint is bad, these are far worse.

For those of you who may not be familiar with the utility of p values, the following may help. P- values are a mathematical measure of the chance that the difference between two groups, sets of results, etc. are due to chance. The lower the number the more reliable the data (at least in theory). An article by the Institute for Work & Health gives a nice simple explanation:

Mathematical probabilities like p-values range from 0 (no chance) to 1 (absolute certainty)[that the data are a result of random numbers, not a real effect]. So 0.5 means a 50 percent chance and 0.05 means a 5 percent chance.

In most sciences, results yielding a p-value of .05 are considered on the borderline of statistical significance. If the p-value is under .01, results are considered statistically significant and if it’s below .005 they are considered highly statistically significant.

Applying these criteria to the study results, the measurement of pain reduction (first column) has a p-value of 0.23, meaning that there is almost a one in four chance that the difference in the two groups is due to mathematical chance instead of real. In other words, it’s useless data. But not as useless as the rest of it. I believe we are breaking new ground in the world of uselessness. Check out these numbers…

A data table without a single statistically significant value. Zero for nine! I don’t think I’ve ever seen this before. Except for…

 

Tylenol also fails to alleviate the pain of watching the Yankees. Original photo: ESPN

 

So, by all means, let’s give useless Tylenol to old folks with cracked ribs. A splendid idea, indeed. But, nothing out of the ordinary in these days of anti-opioid madness.

COVID-19 Fatalities 16.7 Times Too High Due to ‘Illegal’ Inflation

COVID-19 Fatalities 16.7 Times Too High Due to ‘Illegal’ Inflation

https://www.greenmedinfo.com/blog/covid-19-fatalities-167-times-too-high-due-illegal-inflation

In March 2020, the CDC changed the way COVID-19 deaths are reported on death certificates, resulting in a dramatic — and possibly illegal — inflation of fatalities that drove restrictive public health policies threatening health freedom

Only 6% of COVID-19 deaths include only COVID-19 as the cause on the death certificate, according to the U.S. Centers for Disease Control and Prevention. This means for the other 94%, additional causes are listed, with an average of 2.9 additional conditions or causes of death included.[i]

“This is the most important statistical revelation of this crisis,” according to a study by the Institute for Pure and Applied Knowledge (IPAK), as it reveals that many “COVID-19 deaths” may have been due to other causes. In fact, the CDC published new guidelines on March 24, 2020, which alter the way deaths are recorded exclusively in cases of COVID-19.

The guidelines were published without peer-review or opportunity for public comment, and resulted in a dramatic and misleading inflation in “COVID-19” deaths, which would have been deemed due to other causes using the CDC’s longstanding system of data collection and reporting established in 2003. As IPAK’s report questioned:[ii]

“Why would the CDC decide against using a system of data collection & reporting they authored, and which has been in use nationwide for 17 years without incident, in favor of an untested & unproven system exclusively for COVID-19 without discussion and peer-review?”

CDC Changed Death Certificate Recording Rules for COVID-19 Only

IPAK’s report reveals a historical timeline of events showing how a number of incidents conspired to inflate COVID-19 fatality data and, in turn, justify restrictive public health policies like lockdowns, quarantines, business closures and social distancing. One key issue has to do with the way cause of death is recorded in the case of comorbidities.

In 2003, the CDC published the “Medical Examiners’ and Coroners’ Handbook on Death Registration and Fetal Death Reporting” and “Physicians’ Handbook on Medical Certification of Death.” Part I of a death certificate includes the immediate cause of death, listed in order from the official cause of death (a) down to underlying causes that contributed to death (in descending order of importance, as b, c, d).

Part II of the death certificate includes other significant conditions that are not related to the underlying causes in Part I. According to the report:[iii]

“Comorbid conditions have been listed on Part I of death certificates as causes of death per the CDC Handbook since 2003 to ensure accurate reporting can be developed. Comorbidities are seldom placed in Part II. Part II is typically the section where coroners and medical examiners can list recent infections as underlying, initiating factors.

Prior to the CDC’s March 24th decision, any co-morbidities would have been listed in Part I rather than Part II and initiating factors such as infections including the SARS-COV-2 virus, would have been listed on the last line in Part I or more commonly in Part II.”

After the March 2020 guideline change, however, comorbidities were to be listed in Part II, which meant COVID-19 could be listed exclusively in Part I:[iv]

“This has had a significant impact on data collection accuracy and integrity. It has resulted in the potential false inflation of COVID-19 fatality data and is a potential breach of federal laws governing information quality.”

New CDC Guidelines Inflate COVID-19 Deaths by at Least 16.7-Fold

The report examined COVID-19 fatalities through August 23, 2020 and compared them using the CDC’s guidelines that had been in place since 2003 and those put into place in March 2020 for COVID-19. You can see the results in their figure below, which shows, “Had the CDC used the 2003 guidelines, the total COVID-19 [fatalities would] be approximately 16.7 times lower than is currently being reported.”[v]


Image source: IPAK PHPI, COVID-19 Data Collection, Comorbidity & Federal Law: A Historical Perspective October 12, 2020, Figure 9

‘This Leaves Me Speechless’

On Twitter, investigative health journalist Nicolas Pineault wrote, “If this is accurate, this leaves me speechless.”[vi] Indeed, not only did the CDC leave no records as to how it made the decision to change how deaths are reported, but some estimates suggest they may have resulted in an inflation of COVID-19 fatalities of over 90%, while violating U.S. law:[vii]

 

“Previous reports detailed the substantial changes on how causes of death were forcibly modified by the CDC through the NVSS, and how together, both federal agencies inflated the actual number of COVID-19 fatalities by approximately 90.2% through July 12th, 2020.

We believe this deliberate decision by the CDC and NVSS [National Vital Statistics System] to deemphasize pre-existing comorbidities, in favor of emphasizing COVID-19 as a cause of death, is in violation of 44 U.S. Code 3504 (e)(1)(b), which states the activities of the Federal statistical system shall ensure ‘the integrity, objectivity, impartiality, utility, and confidentiality of information collected for statistical purposes.'”

The public health implications of an artificial inflation of COVID-19 deaths are immense, as rates of anxiety, depression[viii] and suicidal thoughts[ix] are on the rise — a direct result of restrictive COVID-19 health policies.

Only with accurate data can individuals and health officials make decisions to truly protect health, and as the report noted, “It is concerning that the CDC may have willfully failed to collect, analyze, and publish accurate data used by elected officials to develop public health policy for a nation in crisis.”[x] It’s also one more reason why now is more important than ever to take a stand for health freedom.

another “baby boomer” Do you remember these ?

Missouri man dies in hospital parking lot after being repeatedly denied care, family says

Missouri man dies in hospital parking lot after being repeatedly denied care, family says

https://www.beckershospitalreview.com/patient-safety-outcomes/missouri-man-dies-in-hospital-parking-lot-after-being-repeatedly-denied-care-family-says.html

David Bell died in the parking lot of Barnes-Jewish St. Peter’s (Mo.) Hospital during his third attempt to receive care, his wife told CBS affiliate KMOV.

Sadie Bell told KMOV she took her husband to the emergency room twice for severe chest pain the week of Jan. 8. Both times, hospital staff prescribed him ibuprofen but did not admit Mr. Bell, according to Ms. Bell. Mr. Bell, director for Central County Fire, was taken to the same hospital after having difficulty breathing at work for a third time.

When Ms. Bell arrived to Barnes-Jewish St. Peter’s Hospital, she said Mr. Bell was sitting outside in a wheelchair. She told KMOV that she asked the hospital to run tests and admit him, but they declined. 

“He said, ‘Ma’am he’s already been here twice for the same thing and we’ve already diagnosed him,'” Ms. Bell told KMOV. She said her husband died before she could take him to another hospital. 

Ms. Bell believes her husband was dismissed by physicians and staff, according to KMOV.

“Our thoughts are with the family after this loss, as well as with the entire Central County Fire & Rescue team,” a hospital spokesperson told Becker’s. “We cannot provide further comment due to patient privacy laws.” 

Chronic pain pts have “slim chance” of getting pain treatment in seeking to get admitted to a new medical practice

Nearly Half of Primary Care Clinics Won’t Take New Patients on Rx Opioids

https://www.painnewsnetwork.org/stories/2021/1/28/nearly-half-of-primary-care-clinics-wont-take-new-patients-on-rx-opioids

It is often stated that we are a “country of laws”, but what is often not mentioned is that a person cannot always find anyone/agency that is in charge of enforcing such laws … are interested in doing their job.  Often people who are trying to get some help for experiencing some “harm” because of another entity is unable/unwilling to do their job.

According to this survey, 75% of the office practices would not or may not prescribe pain meds to pts that have medical records that would document that they had been taking them, have a valid medical necessity to have them prescribed.

Being that this is survey was done via a phone call may have tainted the outcomes of the study.  Just like pharmacists will not tell pts that they stock a controlled substance(s) when they call up on the phone call to find out … claiming that they have a prescription that they wanted to get filled. Pharmacist’s logic is that they don’t want to admit stocking a particular med for fear of getting robbed.

here is a interesting article 

Can You Sue a Hospital or Doctor for Denying Medical Treatment?

Private Doctors Can Refuse to Treat

A private doctor is not subject to the provisions of EMTALA and can dismiss you as a patient at any time, for just about any reason other than discrimination, without fear of liability.

Under the Civil Rights Act of 1964, you can’t be refused treatment on the basis of your age, sex, race, sexual orientation, religion, or national origin.

Doctors in private practice are essentially small business owners and are not required to treat patients who can’t pay for their services.

A doctor can refuse to treat a patient because:

  • The doctor’s practice is not accepting new patients.
  • The doctor doesn’t have a working relationship with your health insurance company.
  • The doctor chooses not to treat patients with the illness or injury you suffer from.
  • You can’t pay for the costs of treatment.
  • You or your spouse are a medical malpractice attorney.

Your doctor can refuse to continue treating you because:

  • You haven’t paid your bill.
  • The doctor has stopped doing business with your health insurance provider.
  • You continue to exhibit drug-seeking behavior.
  • You are a disruptive patient.
  • For reasons of conscience. Reasons can include religious, contraceptive, or palliative care beliefs, or deciding not to prescribe narcotics for pain management.
  • The doctor learns you or your spouse is a medical malpractice attorney.

If your health would suffer, the doctor must continue to treat you until you’ve had time to find a new provider.

If your doctor refuses to continue to provide treatment, and as a direct result your condition worsens, you may have the basis of a medical malpractice claim.

You may have a right to care under your state’s laws. Talk to a personal injury attorney if you’re injured by a doctor’s failure to treat you.


I am not an attorney, but being able to discharge for deciding not to prescribe pain management… my question is … IS THAT A ABSOLUTE FOR THE PRACTICE ? If the prescriber has any pts that he/she is maintaining chronic pain pts on opiates… does mean that any refusal to treat or accept a new chronic pain pt is discrimination ?  Here is a chart of the effects on the human system for under/untreated pain.

South Bend pain clinic to pay $30,000 to settle discrimination claim

This discrimination case/fine was not because the pain clinic refused to accept a pt into the practice because of his/her pain but because the pt had HIV ! So apparently the DOJ only has resources to tackle discrimination toward a distinct list of disabling disease/health issues ?

Who do you believe ?