CDC Colludes with Teachers Unions

 

The cat is out of the bag. If you wondered if the CDC was getting its Covid -19 guidelines from anywhere other than science, the answer has just been revealed.

Jon Levine, writing in The New York Post, says, “The American Federation of Teachers lobbied the Centers for Disease Control and Prevention on, and even suggested language for, the federal agency’s school re-opening guidance released in February.” The emails were obtained through a Freedom of Information Act request by the conservative watchdog group Americans for Public Trust and provided to The Post.

To refresh your memory, in February, new CDC Director Dr. Rochelle Walensky announced CDC study results confirmed it was safe for schools to reopen even before teachers were vaccinated.

In an article published January 26th in the Journal of the American Medical Association (JAMA), three researchers from the CDC found “little evidence that schools have contributed meaningfully to increased community transmission” of the coronavirus. The CDC researchers looked at more than 90,000 students in 11 North Carolina districts and found that only 32 students and staff members were infected in school, while 773 got infected during the same period out of school. The science was clear; reopening schools was safe for children and teachers.

Dr. Walensky announced these findings to the press and recommended reopening of the schools. She said, “Vaccination of teachers is not a prerequisite for safe reopening of schools.” But when the press asked questions about her statement with White House press secretary Jen Psaki, she replied Dr. Walensky was speaking “in her personal capacity” and not as the Director of the CDC.

This made little sense at the time. As the Director of the CDC, Dr. Walensky always speaks in an official capacity. But her conclusions about the study and her recommendations would not become official CDC guidelines. Now we know why.

The teachers unions would not tolerate the reopening of the schools without more money and more time for teachers to be vaccinated. Never mind that the science did not support the need for these things.  The New York Post article explains what happened next.

Levine says, “The documents show a flurry of activity between CDC Director Dr. Rochelle Walensky, her top advisors and union officials – with Biden brass being looped in at the White House – in the days before the highly anticipated February 12 announcement on school re-opening guidelines.”

An email from AFT senior director for health issues, Kelly Trautner, reads, “We were able to review a copy of the draft guidance document over the weekend and were able to provide some initial feedback to several staff this morning about possible ways to strengthen the document. We believe our experiences on the ground can inform and enrich thinking around what is practicable and prudent in future guidance documents.” She described the AFT as a “thought partner” with the CDC.

Levine writes, “With the CDC preparing to write that schools could provide in-person instruction regardless of community spread of the virus, Trautner argued for the inclusion of a line reading “in the event of high community-transmission results from a new variant of SARS-CoV2, a new update of these guidelines may be necessary.” This exact language appeared on page 22 of the final CDC guidance.”

The AFT also demanded special remote work concessions for teachers “who have documented high-risk conditions or who are at increased risk for Covid-19,” and that similar arrangements should extend to “staff who have a household member” with similar risks. This also made it into the final text.

Dr. Walensky clearly changed her tune after the White House, and the AFT, intervened. Even liberal CNN anchor Jake Tapper was amazed when interviewing Dr. Walensky just a few days later on February 14. Tapper asked, “Can you point to any scientific reason for students in the United States not to return to in person classes tomorrow?”

Walensky dodged the question with this response, “If you’re in middle school or high school we would advocate for virtual learning for that group. . . We really don’t want to bring communicable disease into the classroom.” She repeatedly refused to offer a scientific explanation for the re-opening avoidance.  She said, “We all know that mask breaching is among the reasons that we have transmission within schools when it happens. Somewhere around 60% of students are reliably masking. That has to be universal. So, we have work to do.”

This clearly is a statement not supported by the CDC’s own scientific studies. Yet Walensky allowed herself to be used by the White House – and now we know the teachers unions – to further their agendas. This White House supports teachers unions – but not scientific studies. I suspected as much in earlier posts (CDC Director Caves to Politics, CDC Credibility Gone), but now we know for sure. It’s time to stop looking to the CDC or this White House for scientific guidance on the coronavirus pandemic.

Risk v. Benefits in Drug Treatments

 

How much risk are we willing to accept for better health? This important question must be answered every day of our lives. It must be answered by everyone who decides whether or not to get the Covid vaccine. But often the government won’t let us decide. They believe they know better.

This issue has become front and center in the public debate as the Biden administration pulled the Johnson & Johnson Covid vaccine off the market because of rare blood clotting cases observed in less than one in a million vaccine recipients. Many scientists and doctors questioned this decision since the risks didn’t seem to outweigh the benefits. The six women out of over seven million Americans who received the J & J vaccine were all in the child-bearing age range and may have been on contraceptive medications that can cause the same complications. Further investigation will answer these and other questions, but should the rest of the population be denied this life-saving vaccine for the sake of so few?

As the government “pauses” to investigate the J & J vaccine, another important decision is in the making regarding new treatment for Alzheimer’s disease. More than six million Americans suffer from Alzheimer’s disease, according to The Wall Street Journal editorial board. This number is expected to soar as the baby-boomer generation gets older. Any family touched by this disease knows the heartache of progressive memory loss, abnormal behavior, and inability to perform everyday tasks.

While the cause of this disease is unknown, brain scans show the buildup of amyloid plaque and tangles of tau proteins, which typically begins decades before patients show cognitive problems. Hypertension, obesity, diabetes, smoking, poor sleep and the APOE4 gene variant put people at higher risk. While some medications can temporarily improve memory, attention, or mood, none slow the neurological and cognitive degeneration.

The search for effective treatment of this dread disease has intensified. Some 10 to 20 clinical trials on Alzheimer’s drugs have been initiated each year since 2008. Aducanumab, a monoclonal antibody drug, is the first disease-modifying medicine to show efficacy. It works by targeting specific molecules on the amyloid to clear plaque. While more than 25 trials on medicines employing this strategy have ended in failure, the manufacturer, Biogen, has learned from their mistakes.

The company used PET scans, normally used to follow cancer treatments, to screen trial participants to ensure they had Alzheimer’s – rather than other forms of dementia and were not in advanced stages of the disease. This filtered out patients who wouldn’t benefit from the drug treatment. As a result, a late-stage trial showed a high-dose treatment removed 71% of the plaque build-up after 18 months and also had a significant impact on disease progression. After 78 weeks of treatment, patients receiving a high dose were 84% less of a burden to care givers than were the controls. They showed a 91% smaller decline in the ability to prepare a meal and 39% smaller reduction in capacity to discuss current events.

This exciting news was met with skepticism because of the long history of failed Alzheimer’s medicines. The skeptics cite a second concurrent late-stage trial by Biogen that indicated aducanumab didn’t have a statistically significant benefit on symptoms. But Biogen reviewed these results and discovered a likely reason for the different outcomes. The two trials had nearly identical designs, but patients in one received the high dose longer, and the benefits increased with time.

Biogen worked with FDA scientists to analyze the discrepancies between the two trials. The FDA noted in June 2019 that the evidence from the positive trial could be “considered exceptionally persuasive.” Biogen applied in July for drug approval. Many physicians and groups that work with Alzheimer’s patients have urged the FDA to approve the drug. To date this has not happened.

Why is it taking so long for approval of this significant breakthrough in Alzheimer’s treatment?

The simple answer is the inefficiency of the FDA. The FDA empaneled a group of scientists to advise it in November – none of whom specialize in treating Alzheimer’s disease patients. They accused Biogen of massaging the data to favor approval. They urged the FDA to require Biogen to conduct another trial – which could take five or more years.

Three of the panelists wrote in the Journal of the American Medical Association to suggest that the FDA’s “unusual degree of collaboration” with Biogen could have “potentially compromised” its objectively. Ironically, this degree of “collaboration” was responsible for the rapid development of the Covid-19 vaccines under the Trump administration. Could it be that the current FDA, under the Biden administration, is pushing back for political reasons?

Imagine your reaction if your spouse is suffering from early Alzheimer’s disease and you know there is a potential new drug for treatment that could substantially reverse the disease? What harm could be done to someone who is rapidly deteriorating before your eyes, especially when there is no other known treatment? A similar situation arose recently with the development of Sarepta’s drug for Duchenne’s muscular dystrophy and an extended-release opioid by Zogenix.

The FDA has an important role to play in the development of new pharmaceuticals. They must weigh the risks v. benefits in any new treatment. The current climate of the FDA seems to outweigh risks and neglect potential benefits, especially in the case of diseases without other known effective treatments. The impact of success could be substantial, not only in the lives of those families impacted, but also in healthcare system savings that would easily reach the hundreds of billions of dollars.

The WSJ editors say, “The U.S. may be on the cusp of an Alzheimer’s breakthrough, and the FDA’s first duty is to patients.”

 

What do you believe? Let me know your reactions.

Masks Only for the Vulnerable

 

Wearing masks has become a part of the culture; not just here in America, but around the world. When will this end? Will it ever end?

Those questions are increasingly on the minds of everyone who dares to think beyond the CDC guidelines. Scott Gottlieb, former FDA commissioner, says it’s time to stop wearing masks outdoors. I would question whether there was ever a reason to wear masks outdoors.

The theory on wearing masks is they stop the spread of the virus and protect the wearer from contracting the virus. Since the virus is known to spread by droplets, and not aerosols, the only reason to wear a mask is to prevent people from coughing or spitting in others’ faces. Good airflow outdoors makes this nearly impossible. Other data tells us the spread of the virus requires contact with an infected person for up to 15 minutes. This is more likely indoors and has always contradicted regulations that limited outdoor activities.

Dr. Gottlieb says it’s time to revisit rules on masking and distancing in low-risk outdoor settings like parks and sports venues. Easing these rules would move more activity outdoors, which reduces viral transmission. States are beginning to lift restrictions on the size of outdoor gatherings. Texas, New Hampshire, and Florida governors have led the way; Rhode Island and others plan to follow in May.

But the CDC is lagging behind. They still prescribe social limits while outside. Many governors are reluctant to get ahead of the CDC for fear of a political backlash. About half of states still require people to wear face coverings in all public settings.

We hear the phrase “follow the science” when it suits the political agenda, but not when it doesn’t. Consider a well-known study conducted in China last spring. Researchers traced 318 outbreaks to figure out the chains of transmission. In only one of 318 outbreaks did the initial cases come from contact while outside. The rest originated inside homes or on mass transit.

Another study found that the risk of transmission indoors was about 19 times as high as in open-air environments. Yet the CDC’s guidance says only that “masks may not be necessary when you are outside by yourself away from others.” Another CDC document advises people outside to “stay at least six feet apart from people who don’t live with you” and “limit your time around others.” This is particularly strange since the “six feet social distancing” guideline was revised to three feet weeks ago when studies showed there is no significant difference in the spread of the virus between three and six feet.

I have written in earlier posts that the credibility of the CDC has been lost (see CDC Credibility Gone). They are not even following their own Covid-19 studies because the White House wants to keep us in a state of fear.

When are masks really needed?

It’s time to talk plainly about the wearing of masks. Masks are for the vulnerable. If you’re not among the vulnerable, you don’t need to wear a mask. Who are the vulnerable? Here is a list of the vulnerable:

  • Elderly people who have not been vaccinated
  • Middle age to young adults who have health conditions such as obesity, diabetes, heart disease, pulmonary disease, or immunocompromised conditions such as active treatment of cancer – who have not been vaccinated

 

If you have been fully vaccinated – received both shots of the Pfizer or Moderna vaccines and have waited at least 14 days – you have full protection. If you have received the one Johnson & Johnson vaccine shot and have waited 14 days – you are fully protected. If you have contracted the Covid-19 virus infection and survived – you have natural immunity. If you are a child under the age of 16 – you have essentially no risk from Covid-19. (see Masking Children While Censoring Covid Information) If you are in one of the above categories, there is virtually no risk to you from Covid-19. In the extreme unlikelihood that you contract the virus, the course of your disease is sure to be mild.

It’s time to stop wearing masks unless you are vulnerable. People who continue to wear masks outdoors are simply displaying their fear, ignorance, or utter obedience to liberal politicians and ideology. Wearing masks indoors will continue to be necessary as long as businesses and public buildings demand it, but pushing back against this orthodoxy is needed if we are ever to regain our freedom.

In my office, I began by not wearing a mask even while patients wore theirs. I wasn’t afraid since I knew how the virus was transmitted and I was careful not to touch my face. Later, I began wearing a mask to make patients more comfortable. But since I’ve been vaccinated, I’ve chosen to stop wearing a mask again, telling patients they need not fear me. I hope my example will give others the freedom to stop wearing their masks if they, too, have been vaccinated.

At a time when the government is pleading for more Americans to get vaccinated, it makes sense to demonstrate the freedom that vaccination brings. Of course, that might mean giving up the political leverage of spreading fear. Maybe that’s just what these mask mandates are all about.