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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.

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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

Don’t even think about it. Image: Pxhere

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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.

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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.” 

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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.

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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 ?

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