Tag Archives: CDC

How Fauci and the NIH Got Ahead of the FDA and CDC in Backing Boosters

Sarah Jane Tribble and Arthur Allen, KHN: September 16, 2021


In January — long before the first jabs of covid-19 vaccine were even available to most Americans — scientists working under Dr. Anthony Fauci at the National Institute of Allergy and Infectious Diseases were already thinking about potential booster shots.

A month later, they organized an international group of epidemiologists, virologists and biostatisticians to track and sequence covid variants. They called the elite group SAVE, or SARS-Cov-2 Variant Testing Pipeline. And by the end of March, the scientists at NIAID were experimenting with monkeys and reviewing early data from humans showing that booster shots provided a rapid increase in protective antibodies — even against dangerous variants.

Fauci, whose team has closely tracked research from Israel, the United Kingdom and elsewhere, said in an exclusive interview with KHN on Wednesday that “there’s very little doubt that the boosters will be beneficial.” But, he emphasized, the official process, which includes reviews by scientists at the Food and Drug Administration and the Centers for Disease Control and Prevention, needs to take place first.

“If they say, ‘We don’t think there’s enough data to do a booster,’ then so be it,” Fauci said. “I think that would be a mistake, to be honest with you.”

The support for an extra dose of covid vaccine clearly emerged, at least in part, from an NIH research dynamo, built by Fauci, that for months has been getting intricate real-time data about covid variants and how they respond to vaccine-produced immunity. The FDA and CDC were seeing much of the same data, but as regulatory agencies, they were more cautious. The FDA, in particular, won’t rule on a product until the company making it submits extensive data. And its officials are gimlet-eyed reviewers of such studies.

On boosters, Americans have heard conflicting messages from various parts of the U.S. government. Yet, Fauci said, “there is less disagreement and conflicts than seem to get out into the tweetosphere.” He ticked off a number of prominent scientists in the field — including Surgeon General Vivek Murthy, acting FDA Commissioner Janet Woodcock and covid vaccine inventor Barney Graham — who were on board with his position. All but Graham are members of the White House covid task force.

Another task force member, CDC Director Rochelle Walensky, said her agency was tracking vaccine effectiveness and “we’re starting to see some waning in terms of infections that foreshadows what we may be seeing soon in regard to hospitalizations and severe disease.” As to when so-called boosters should start, she told PBS NewsHour on Tuesday, “I’m not going to get ahead of the FDA’s process.”

Differences in the scientific community are likely to be voiced Friday when the FDA’s vaccine advisory board meets to review Pfizer-BioNTech’s request for approval of a third shot. Indeed, even the FDA’s official briefing paper before the meeting expressed skepticism. “Overall,” agency officials noted, “data indicate that currently US-licensed or authorized COVID-19 vaccines still afford protection against severe COVID-19 disease and death.” The agency also stated that it’s unclear whether an additional shot might increase the risk of myocarditis, which has been reported, particularly in young men, following the second Pfizer and Moderna shots.

Part of the disagreement arose because President Joe Biden had announced that Americans could get a booster as soon as Sept. 20, a date Fauci and colleagues had suggested to him as practical and optimal in one of their frequent meetings just days before — though he cautioned that boosters would need CDC and FDA approval.

Now it appears that that decision and the timing rest with the FDA, which is the normal procedure for new uses of vaccines or drugs. And Fauci said he respects that process — but he thinks it should come as quickly as possible. “If you’re doing it because you want to prevent people from getting sick, then the sooner you do it, the better,” Fauci said.

Researchers at the NIH typically focus on early-stage drug development, asking how a virus infects and testing ways to treat the infection. The job of reviewing and approving a drug or vaccine for public use is “just not how the NIH was set up. NIH does relatively little research on actual products,” said Diana Zuckerman, a former senior adviser to Hillary Clinton and president of the nonprofit National Center for Health Research in Washington, D.C.

“It’s no secret that FDA doesn’t have the disease experts in the way that the NIH does,” Zuckerman said. “And it’s no secret that the NIH doesn’t have the experts in analyzing industry data.”

‘Data in Spades’

Yet no other infectious disease expert in any branch of the U.S. government has Fauci’s influence. And while other scientific leaders support boosters, many scientists believe Fauci and his colleagues at the NIAID — some of the world’s leaders in immunology and vaccinology, men and women in daily contact with their foreign peers and their research findings — are leading the charge.

Fauci was hard-pressed to give exact dates for when his thinking turned on the need for boosters. The past 18 months are a blur, he said. But “there’s very little doubt that the boosters will be beneficial. The Israelis already have that data in spades. They boost, they get an increase by tenfold in the protection against infection and severe disease.”

In July, Israel, which started vaccinating its population early and used only the Pfizer-BioNTech vaccine, began reporting severe breakthrough cases in previously vaccinated elderly people. Israel’s Ministry of Health announced boosters July 29. Fauci noted that Israel and — to a lesser extent — the U.K. were about a month and a half ahead of the U.S. at every stage of dealing with covid.

And once Israel had boosted its population, the Israeli scientists showed their NIH counterparts, hospitalizations of previously vaccinated people, which had been rising, dropped dramatically. Emerging evidence suggests boosters make people far less likely to transmit the virus to others, an important added benefit.

To be sure, members of the White House covid response team — including Fauci and former FDA Commissioner David Kessler — had begun preparing a timeline for boosters months earlier. Kessler, speaking to Congress in May, said that it was unclear then whether the boosters would be needed but that the U.S. had the money to purchase them and ensure they were free.

Fauci explained that “practically speaking, the earliest we could do it would be the third week in September. Hence the date of the week of September the 20th was chosen.” The hope was that would give regulators enough time. The FDA’s advisory board meeting Friday is set to be followed next week by a gathering of the CDC’s immunization advisory committee, which offers recommendations for vaccine use that can lead to legal mandates.

[….]

Real-Time Science

Scientists tracking the coronavirus are swimming in data. Hundreds of covid studies are published or released onto pre-publication servers every day. Scientists also share their findings on group email lists and in Zoom meetings every week — and on Twitter and in news interviews.

Kessler, chief science officer of the White House covid response team, said the case for boosters is “rooted in NIH science” but includes data from Israel, the Mayo Clinic, the pharmaceutical companies and elsewhere.

As Fauci put it: “Every 15 minutes, a pre-print server comes out with something I don’t know.”

The SAVE group, active since February, was organized by NIH officials who in normal times track influenza epidemics. The 60 to 70 scientists are mostly from U.S. agencies such as the NIH, CDC, FDA and Biomedical Advanced Research and Development Authority, but also from other countries, including Israel and the Netherlands.

“This is very much the basic scientists who are in the weeds trying to figure things out,” said Dr. Daniel Douek, chief of the human immunology section within NIAID.

[….]

Dr. Robert Seder, an NIH senior investigator, was in a group testing the booster theory long before America’s “Summer of Delta.” The researchers injected rhesus macaque monkeys with the Moderna vaccine for the “express purpose of looking at the immune responses over a long period of time.”

“Are they durable? And would you need to boost?” Seder said.

Matthew Frieman, a participant and associate professor of microbiology at the University of Maryland School of Medicine, said the data makes it clear that the time for boosters is approaching. Biden’s booster announcement “may have gotten ahead of the game, but the trajectory is pointing toward the need for boosters,” Frieman said. “The level of antibody you need to protect against delta is higher because it replicates faster.”

[….]

Monday, an international group of scientists led by Dr. Philip Krause, deputy chief of the FDA’s vaccine regulation office, and including his boss, Dr. Marion Gruber, published an essay in The Lancet that questioned the need for widespread booster shots at this time.

Krause and Gruber had announced their retirements from the FDA on Aug. 30 — at least partly in response to the booster announcement, according to four scientists who know them. Gruber, who will remain at the agency until later this fall, is listed as a participant in Friday’s meeting.

The Lancet paper argues that vaccine-based protection against severe covid is still strong, while evidence is lacking that booster shots will be safe and effective. University of Florida biostatistician Ira Longini, a co-author on the Lancet paper, said it would be “immoral” to begin widespread boosters before the rest of the world was better vaccinated. As the disease continues its global spread, he noted, it is likely to develop deadlier and more vaccine-evasive mutants.

Longini was also skeptical of an August study, which Israeli scientists are to present to the FDA on Friday, that NIH officials had touted as strong evidence in support of boosters. …That study found that people receiving a third dose of the Pfizer-BioNTech vaccine were 11 times more likely to be protected from covid infection than those who had gotten only two doses. But the study observed people for less than two weeks after their booster vaccinations kicked in. Biostatisticians felt it had irregularities that raised questions about its worth.

[….]

Fauci emphasized that no single study or piece of data led Biden or the members of the White House covid response team to conclude that boosting was necessary. The compilation of evidence of waning immunity combined with reams of research was a factor. Now the crucial decisions are in the hands of the regulators, awaiting the FDA and CDC’s judgment on how the nation should proceed.

“It isn’t as if,” Fauci said, “one day we’re sitting in the Oval Office saying, ‘You know, Mr. President, I think we need to boost.’ And he says, ‘Tony, go ahead and do it.’ You can’t do it that way. You’ve got to go through the process.”

To read the entire article, click here.

Study finds removing breast implants improved symptoms

Kris Pickel, AzFamily.com: October 1, 2020


PHOENIX (3TV/CBS 5) — A new study may be a game changer in the debate: Is breast implant illness real? Plastic surgeon Dr. Lu-Jean Fang designed the study involving 750 women with a diverse mix of breast implants, including silicone and saline, with shells that were either smooth or textured.

Every patient underwent a total capsulectomy. It’s a surgical procedure which removes the breast implant and all surrounding scar tissue, known as the capsules.

Prior to surgery to remove the implants, patients rated the severity of 11 symptoms commonly associated with breast implant illness, on a scale from 0 to 5.

Symptoms rated in study:

  • numbness and tingling in the extremities
  • joint and/or muscle pain
  • hair loss
  • memory loss/cognitive problems
  • dry eyes and/or blurred vision
  • chronic fatigue
  • breast pain
  • rashes and/or hives
  • food sensitivity/intolerance
  • flu-like symptoms and/or low-grade fever
  • difficulty breathing

Ten days after their implants were removed, the women rated their symptoms again and repeated the survey multiple times over the next year. The data was then analyzed by a team at Case Western University led by Dr. Corinne Wee and published in the Annals of Plastic Surgery.

After years of seeing her patients’ health improve following the removal of their breast implants, Dr. Feng says the results still came as a surprise. “I didn’t think it would be this good,” says Dr. Feng. When averaged out among the group, almost every symptom improved. Most symptoms drop to ratings considered ‘none’ or ‘mild’.

“For each one of these symptoms, there is a statistical difference so it’s not by chance anymore that they improve,” says Dr. Feng.

Researchers found health improvements happened quickly. If a woman saw improvements within the first ten days after surgery, the benefits were still present a year later. The most significant improvements happened in women who were obese or had some type of hardening of the scar tissue around the implant and who made lifestyle changes such as eating a healthy diet and exercise.

Removal of saline and silicone implants resulted in similar levels of improvements. The study notes “silicone is actually present in the shells of many saline implants.”

During years of investigations, numerous women have shared first-hand accounts with CBS 5 Investigates, saying when doctors failed to diagnose the cause of their symptoms, they were led to believe their symptoms were psychosomatic or the result of aging.

Dr. Feng says her study debunks the theory that breast implant illness is something women are imagining. “It is not in their heads,” says Dr. Feng. “This is my life’s work mainly because it’s such a simple solution. You take out the implant and all the surrounding scar tissue that houses the inflammatory reaction and the implant derived material, and the patient gets better.”

DIFFERENT THAN PREVIOUS STUDIES

For breast implants illness advocates, Dr. Feng’s study provides scientific evidence to back up claims made by tens of thousands of women.

Dr. Diana Zuckerman is President of the National Center for Health Research in Washington DC. An expert on national health policy, Dr. Zuckerman has worked for decades to get stronger warnings on the risks of breast implants. “This study absolutely confirms that there are women getting sick from their breast implants, and when their implants are taken out, they get well,” says Dr. Zuckerman.

In analyzing decades of previous studies, Dr. Zuckerman says major studies sponsored or conducted by breast implant manufacturers have a created a misleading perception surrounding the safety of implants.

Dr. Zuckerman says these studies have flaws, with the results often misrepresented. In some cases, she says, women were kicked out of studies if they got sick. She also points out it can take sometimes a decade or longer for symptoms to develop, which means studies end before some women start to experience problems.

As an example, Dr. Zuckerman cites the 10 year post-approval study by breast implant manufacturer Mentor on its MemoryGel CPG Breast Implants.

She says seven years into the study, 80% percent of the 41,000 women were no longer participating in the study.

Mentor provided CBS 5 Investigates with final data from its post-approval study showing that of  the 41,452 women enrolled in the study only 6,063 completed the study.

[…]

FDA RECOMMENDS NEW WARNINGS FOR BREAST IMPLANTS

On September 29, 2020 the FDA took their strongest steps to date to increase awareness on the risks of breast implants.

The agency is recommending labeling for breast implants include a box warning, the strongest warning by the FDA that a product carries the risk of serious injury or death.

While the FDA did not mandate manufactures include the warning, they recommended the following information be included: breast implants are not lifetime devices; are associated with the cancer of the immune system BIA-ALCL; patients have died from BIA-ALCL; patients have reported systemic symptoms such as joint pain, muscle aches, confusion, chronic fatigue, auto immune disease; and that some patients recover from the symptoms after implants are removed.

The recommendations are carefully worded to acknowledge recovery from systemic symptoms may happen after implants are removed. However, the FDA stopped short of saying the implants cause the symptoms.

The FDA is also recommending a checklist for women to be given when considering breast implants.  The checklist would outline when implants should not be used; risks of implant surgery, cancer, systemic symptoms, rupture and complications; updated screening and follow up tests, implants are not lifetime devices and alternatives to implants.

The FDA says the labeling recommendations are intended to enhance but not replace discussions between patients and their physicians.

[….]

CDC SHUTS DOWN INSURANCE COVERAGE EFFORTS

Efforts to make breast implant illness an official diagnosis covered by insurance came to a sudden stop earlier this year.

Dr. Zuckerman was among the advocates invited to speak at the CDC’s March meeting on ICD-10 codes. The codes are used to diagnose medial conditions and show insurance companies why treatment is necessary. Without the codes, insurance companies will not cover the cost of treatment.

Dr. Zuckerman planned to attend the meeting and built a presentation. She says without explanation, she was notified the agency would not be exploring the option of ICD-10 codes for breast implant illness. “I was not given a reason why, other than it was considered too controversial,” says Dr. Zuckerman.

After months of requests to the CDC asking for an explanation as to why the topic was dropped from their agenda, the agency sent an email to CBS 5 Investigates stating, “There is no definitive evidence that breast implant cause the systemic symptoms.”

The agency also provided a list of ICD-10 codes providers can use for treatment and billing covering conditions ranging from breast deformity to atrophy.

However, the current ICD codes do not cover the symptoms commonly associated with breast implant illness such as fatigue, rash, joint pain and cognitive issues.

Efforts have not stopped to get ICD-10 codes for breast implant illness. Congressman Lloyd Doggett of Texas and Congresswoman Rosa DeLauro of Connecticut sent a letter to CDC Director Dr. Robert Redfield asking for clarification on why the topic was dropped.

Their letter references a growing body of research that thousands of women have been seriously harmed by breast implants and that “women continue to be denied health insurance coverage for medically necessary implant removal.”

Representatives Dogget and DeLauro point out women who elected to undergo breast implant surgery were “unaware of the potentially serious risks.”

[….]

The agency also provided a list of ICD-10 codes providers can use for treatment and billing covering conditions ranging from breast deformity to atrophy.

However, the current ICD codes do not cover the symptoms commonly associated with breast implant illness such as fatigue, rash, joint pain and cognitive issues.

Efforts have not stopped to get ICD-10 codes for breast implant illness. Congressman Lloyd Doggett of Texas and Congresswoman Rosa DeLauro of Connecticut sent a letter to CDC Director Dr. Robert Redfield asking for clarification on why the topic was dropped.

Their letter references a growing body of research that thousands of women have been seriously harmed by breast implants and that “women continue to be denied health insurance coverage for medically necessary implant removal.”

Representatives Dogget and DeLauro point out women who elected to undergo breast implant surgery were “unaware of the potentially serious risks.”

Read the full article here