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Comparison of Acupuncture and Therapy as Treatments for Cancer Survivors with Insomnia

Meg Seymour, PhD and Nina Zeldes, PhD, National Center for Health Research


Most cancer patients experience insomnia,[1] which is defined as having trouble falling and/or staying asleep. Most cancer patients with insomnia are prescribed sleep-aid medications as treatment,[2] which can have unpleasant side effects, such as memory problems and health risks.[3]  In fact, studies show that people who take sleep medication more often are more likely to develop many types of cancer (You can read this article for more information). Fortunately, in 2019, cancer researchers at Memorial Sloan Kettering found that there are safer and possibly more effective treatments for cancer patients’ insomnia: acupuncture, as well as a type of  therapy specifically developed for treating insomnia, called Cognitive Behavioral Therapy for Insomnia (CBT-I).

Acupuncture is a traditional Chinese treatment where a trained acupuncturist places special needles into the skin at specific points at the body, which are associated with different aspects of health. There are certain places on the body that acupuncturists place needles in order to treat sleep problems, as well as pain.

CBT-I is a type of therapy that uses several different approaches to treat insomnia. It uses methods such as “cognitive restructuring,” which trains patients to reduce anxious thoughts in ways that make it easier to fall asleep. Another strategy is “sleep restriction,” in which patients primarily stay in bed for sleeping, not for watching TV, reading, or other activities. The goal is to associate being in bed with sleeping, not thinking about issues that can interfere with sleeping.

Comparing acupuncture and therapy as insomnia treatments

Acupuncture and cognitive behavioral therapy had previously been proven effective for insomnia. For example, CBT-I had previously been shown to reduce insomnia among cancer survivors,[5] and acupuncture has been found to be effective for insomnia patients without cancer.[6] The goal of the 2019 study was to compare these two treatments for insomnia among cancer survivors, to determine which was more effective. 

The study compared the two treatments in 160 cancer survivors whose insomnia was severe enough that they were diagnosed with insomnia. Participants were randomly assigned to receive either 10 sessions of acupuncture treatment over 8 weeks, or 7 sessions of CBT-I over the course of 8 weeks. The researchers measured the severity of the participants’ insomnia, as well as other symptoms such as pain and anxiety. Participants’ symptoms were measured before they began treatment, right after completing the 8 weeks of treatment, and every four weeks up to 20 weeks after they finished the treatment. Measuring symptoms at these different times compared how effective the treatments were in both the short-term and the long-term.

Which treatment was most effective? 

The researchers found that both treatments were effective at reducing insomnia, and they also helped patients reduce their use of sleep aids, even at 20 weeks after finishing treatment. About 25% of patients were using at least one prescription sleep aid at the beginning of the study, but only 17% used the medication 20 weeks after treatment. CBT-I was slightly more effective than acupuncture at reducing insomnia symptoms and improving overall sleep quality, as well as reducing the amount of time it took to fall asleep and reducing the number of times participants woke up in the night. 

Twenty weeks after completing treatment with CBT-I, participants fell asleep an average of 24 minutes faster, and those who received acupuncture fell asleep an average of 11 minutes faster than before they started treatment. That might not seem like much benefit, but it is comparable to the small benefit of sleeping pills.[7] After treatment, both groups stayed asleep for longer at night. However, those who received acupuncture stayed asleep even longer than those who received CBT-I. Right after completing treatment, participants who had acupuncture treatment slept for an average of 62 more minutes a night, 27 more minutes than those who were treated with CBT-I. After 20 weeks, those who received acupuncture still slept 51 minutes more than before treatment, which was 5 and a half minutes more than those treated with CBT-I. That is much more additional sleep than is typical of sleeping pills.[7]

However, this difference in the effectiveness of the two treatments was only true for men. The two treatments were equally effective at reducing overall insomnia severity in women. The researchers also found that CBT-I was only more effective among White participants, highly educated participants, and those with lower pain levels. Otherwise, the two treatments were equally effective. 

In addition to evaluating insomnia severity, the researchers also measured participants’ fatigue, anxiety, depression, and overall quality of life as measured by mental and physical health. The two treatments were equally effective at improving those symptoms.

The bottom line

Both acupuncture and CBT-I helped reduce insomnia symptoms in cancer survivors, but CBT-I was more effective for men, Whites, highly educated participants, and those with lower pain levels. The researchers concluded that CBT-I should be used as the first line of treatment for cancer-related insomnia, but pointed out that patients might find it difficult to find CBT-I treatment. Unfortunately, there are few trained CBT-I therapists, but acupuncture is a good alternative. In addition, acupuncture was more effective for the treatment of short-term pain than CBT-I. 

Despite the shortage of well-trained CBT-I therapists, the availability of online therapy can help those who are interested get access to this treatment. For more information on online therapy, you can read this article. 

 

All articles are reviewed and approved by Dr. Diana Zuckerman and other senior staff.

The National Center for Health Research is a nonprofit, nonpartisan research, education and advocacy organization that analyzes and explains the latest medical research and speaks out on policies and programs. We do not accept funding from pharmaceutical companies or medical device manufacturers. Find out how you can support us here.

 

References 

  1.     Savard J, Ivers H, Villa J, et al. Natural course of insomnia comorbid with cancer: an 18 month longitudinal study. Journal of Clinical Oncology. 2011; 29(26):3580–3586.
  2.     Berger AM, Matthews EE, Kenkel AM. Management of sleep-wake disturbances comorbid with cancer. Oncology. 2017 Aug 16;31(8).
  3.     Kripke DF. Hypnotic drug risks of mortality, infection, depression, and cancer: But lack of benefit. F1000Res. 2016;5:918.
  4.     Garland SN, Xie SX, DuHamel K, Bao T, Li Q, Barg FK, Song S, Kantoff P, Gehrman P, Mao JJ. Acupuncture versus cognitive behavioral therapy for insomnia in cancer survivors: a randomized clinical trial. JNCI: Journal of the National Cancer Institute. 2019; 111(12):1323-31.
  5.     Johnson JA, Rash JA, Campbell TS, et al. A systematic review and metaanalysis of randomized controlled trials of cognitive behavior therapy for insomnia (CBT-I) in cancer survivors. Sleep Medicine Review. 2016;27:20–28.
  6.     Yin X, Gou M, Xu J, et al. Efficacy and safety of acupuncture treatment on primary insomnia: a randomized controlled trial. Sleep Medicine. 2017;37:193–200.
  7. Carr, T. The Problem With Sleeping Pills. Consumer Reports.com. https://www.consumerreports.org/drugs/the-problem-with-sleeping-pills/. Updated December 2018.

A C.D.C. analysis describes anaphylaxis after people have received the Pfizer-BioNTech vaccine as ‘rare’

Roni Caryn Rabin


Any site that administers the currently authorized vaccines must be prepared to recognize and treat a severe allergic reaction that may occur, though it is “a rare outcome,” federal health officials said.

Of the nearly 2 million Americans who received coronavirus vaccinations developed by Pfizer and BioNTech during a 10-day stretch last month, 21 experienced a serious and potentially life-threatening allergic reaction called anaphylaxis, federal health officials said Wednesday.

Although the risk is ten times higher than the risk for anaphylaxis after a seasonal flu vaccine, officials described the reaction as “a rare outcome.”

The rate of anaphylaxis following vaccination was estimated to be 11.1 per million doses administered, compared with 1.3 cases of anaphylaxis per million doses of influenza vaccine administered, officials said.

“We know that safety is one of the public’s biggest concerns about the Covid vaccine,” said Dr. Nancy Messonnier, director of the National Center for Immunization and Respiratory Diseases at the Centers for Disease Control and Prevention.

“The anaphylaxis rate may seem high compared to the flu vaccine, but I want to reassure you: This is still a rare outcome.”

Any site that administers the vaccine must be prepared to recognize and treat a severe allergic reaction that may occur, federal health officials said. And though there is less information about reactions to the Moderna vaccine than to the Pfizer-BioNTech vaccine, Dr. Messonnier said, “At this point we really don’t have enough data to say there’s any difference in the risks, so the recommendations apply to both.” Recipients who experience anaphylaxis after receiving the first dose of the vaccine should not receive the second dose, officials said.

Other than the anaphylaxis reactions, which occurred shortly after vaccination, “Our vaccine safety systems haven’t picked up any worrisome signals,” Dr. Messonnier added. “The known and potential benefits of the Covid vaccine outweigh the risk of getting Covid-19.”

The C.D.C.’s analysis of adverse reactions, published on Wednesday, included only those to the Pfizer-BioNTech vaccine administered between Dec. 14 and Dec. 23.

[…]

The vast majority of anaphylaxis reactions — 90 percent — occurred in women, who made up slightly more than half of vaccine recipients. A surprising number of those who went into anaphylaxis — 14 of the 21 — had never experienced an anaphylactic reaction prior to receiving the vaccine, and four had no known allergies at all.

Of the 21 who had reactions, 20 had recovered or been discharged home, and information was lacking on one individual. Nineteen were treated with epinephrine, and four were hospitalized, including three in intensive care. Seventeen were treated in an emergency department.

The C.D.C. said it was still investigating another seven reports of anaphylaxis following the vaccine, which have not been confirmed. The Vaccine Adverse Event Reporting System also identified 83 cases of nonanaphylaxis allergic reactions after the Pfizer-BioNtech vaccination; these people developed symptoms like rash and mild respiratory symptoms within a day of receiving the vaccine.

Among the 21 vaccine recipients who experienced anaphylaxis, 17 were known to have allergies to a variety of triggers, including foods, insects, pets and medications. The median time for anaphylactic reaction was 13 minutes after immunization, but one patient developed the reaction two and a half hours afterward.

Patients with known allergies have been warned to bring an epinephrine injector when they get vaccinated, and providers have been advised to keep patients with allergies for observation for 30 minutes following inoculation.

The new information is disconcerting, said Diana Zuckerman, president of the National Center for Health Research.

“The flaw in the system is that there was a small number of people who had a reaction 30 minutes or later,” she said. “It’s one thing to say everybody should hang around for 15 minutes. But the range was up to 150 minutes, and people aren’t going to hang around that long.”

To read entire article, see https://www.nytimes.com/live/2021/01/06/world/covid-19-coronavirus

Congressman calls for FDA to continue vaccine trials

D’Andre Henderson, ABC News: December 29, 2020.


WASHINGTON, D.C. (WRIC) — Americans are hopeful that the COVID-19 vaccines will make 2021 a better year than 2020. However, there are concerns that Pfizer and Moderna will stop their clinical trials and immediately treat everyone in their placebo group.

Some scientists, doctors and now a Congressman argues that can be dangerous because they said there is still so much unknown about the vaccines.

Rep. Llyod Doggett of Texas wrote a letter to the Food and Drug Administration (FDA) urging for the clinical trials to continue.

“the continuation of clinical trials is critical to our understanding of the efficacy and length of immunity the vaccines offer,” Doggett wrote.

In the letter, Doggett said while the initial results received from Pfizer and Moderna are showing positive results, it’s not definitive given the limited data.

[…]

“Clinical trials have suffered from a lack of diverse participant enrollment and evaluation of subpopulations,” Doggett said. “Including individuals with comorbidities, children, pregnant and breastfeeding patients, long-term care residents and individuals with diverse racial and ethnic backgrounds.”

Diana Zuckerman, President of the National Center for Health Research, a non-partisan think tank in Washington D.C., agrees that the clinical trials should continue. She said healthcare workers who volunteered for the clinical trials should have immediate access to the vaccine if they want it.

“Like most public health experts, I’ve been very concerned that Pfizer and Moderna told the FDA that they want to stop their clinical trials of the COVID vaccine and instead immediately inoculate everyone in their placebo groups,” Zuckerman said. “While I understand the desire to reward the clinical trial volunteers for their service, it would be a huge loss of information from a public health point of view. Losing the placebo group means we’d have no way to scientifically determine which of the vaccines – if any — have 95% efficacy rates that last more than 2 or 3 months. Or how long the vaccine works on people over 75.”

Zuckerman added the people who volunteer for the clinical trials shouldn’t be vaccinated before those in priority groups such as teachers, essential workers, etc.

“Since many of the study volunteers are young and healthy, it also seems unfair for them to “cut in line” for a vaccine while healthcare workers and others at high risk are still waiting their turn,” she said.

[…]

Read the full article here

Covid-19: Should vaccine trials be unblinded?

Jeanne Lenzer, BMJ: December 29, 2020.


The lack of planning for how to treat participants in covid-19 vaccine trials is a bad precedent, with the loss of potentially valuable safety and efficacy data, say research experts. Jeanne Lenzer reports:

 

In October the US Food and Drug Administration issued non-binding guidance to manufacturers of covid-19 vaccines urging them to devise a method to allow volunteers in their studies’ placebo arms to receive the vaccine while also maintaining the integrity of ongoing scientific data collection.1 Emergency use authorisation was not “grounds for stopping blinded follow-up,” said the agency.23

The companies say they have an ethical obligation to unblind volunteers so they can receive the vaccine. But some experts are concerned about a “disastrous” loss of critical information if volunteers on a trial’s placebo arm are unblinded.45

To try to tackle the problem the FDA invited Steven Goodman, associate dean of clinical and translational research at Stanford University, for a recommendation that could balance the right of volunteers to find out whether they were in the placebo arm and the simultaneous need to preserve scientific data.

Goodman recommended a study design endorsed by Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases: a blinded crossover study in which placebo recipients would be given the vaccine, and vice versa.235 That would ensure that all volunteers receive the vaccine but would be unaware of which shot they received at which time. This would allow ongoing surveillance of safety issues and more time to observe any waning effects of the vaccine and the possible need for booster doses.

But the companies said that the demands of a blinded crossover design were “onerous” and might not be feasible.6 And even before the FDA advisory committee meeting on Moderna’s vaccine on 17 December, the company notified volunteers that they could learn their status if they chose to receive the vaccine.

Pfizer also sent a letter to its trial participants one week after its vaccine was authorised on 10 December.7 It told them that, on request, they could learn whether they were in the placebo arm so they could receive the vaccine as it became available and according to recommendations of the US Centers for Disease Control and Prevention.

Asked by The BMJ whether the FDA had set any baseline requirements for the companies regarding the removal of blinding, the agency declined to answer, referring the journal to the respective companies for their plans.

Pfizer told The BMJ that the “move from the placebo group to the vaccine group would be completely optional, and participants would be encouraged to remain blinded throughout the full study duration.” Moderna failed to respond to several requests for comment.

Loss of data

Diana Zuckerman, president of the National Center for Health Research, told The BMJ that the FDA could have demanded that companies use the blinded crossover design for them to win full approval for their vaccines. She said that failure to do that meant the loss of future reliable data, which is especially concerning given that preliminary data are insufficient to determine efficacy.

“I’m especially concerned that Pfizer’s vaccine trials included only five people aged 75 and older who were diagnosed with covid-19, with an unspecified number of those defined by Pfizer as severe cases,” she said. “That makes it impossible to determine how effective the vaccine is for frail elderly patients.”

Although the FDA has granted the vaccines emergency use authorisation, to get full licence approval two years of follow-up data are needed. The data are now likely to be scanty and less reliable given that the trials are effectively being unblinded.

Consumer representative Sheldon Toubman, a lawyer and FDA advisory panel member, said that Pfizer and BioNTech had not proved that their vaccine prevents severe covid-19. “The FDA says all we can do is suggest protection from severe covid disease; we need to know that it does that,” he said.

He countered claims, based on experience with other vaccines, six weeks of follow-up was long enough to detect safety signals. Six weeks may not be long enough for this entirely new type of “untested” [mRNA] vaccine, Toubman said.

Goodman wants all companies to be held to the same standard and says they should not be allowed to make up their own rules about unblinding. He told The BMJ that, while he was “very optimistic” about the vaccines, “blowing up the trials” by allowing unblinding “will set a de facto standard for all vaccine trials to come.” And that, he said, “is dangerous.”

Footnotes

  • Correction: On 30 December we amended the final paragraph to clarify Steven Goodman’s comment.

This article is made freely available for use in accordance with BMJ’s website terms and conditions for the duration of the covid-19 pandemic or until otherwise determined by BMJ. You may use, download and print the article for any lawful, non-commercial purpose (including text and data mining) provided that all copyright notices and trade marks are retained.

https://bmj.com/coronavirus/usage

References

  1. Food and Drug Administration. Emergency use authorization for vaccines to prevent covid-19: guidance for industry. 2020. https://www.fda.gov/media/142749/download.
  2. Food and Drug Administration. Vaccines and Related Biological Products Advisory Committee meeting December 10, 2020. 2020. https://www.fda.gov/media/144245/download.
  3. Food and Drug Administration. Vaccines and Related Biological Products Advisory Committee December 17, 2020 meeting briefing document. 2020 https://www.fda.gov/media/144434/download.
  4. WHO Ad Hoc Expert Group on the Next Steps for Covid-19 Vaccine Evaluation. Placebo-controlled trials of covid-19 vaccines—why we still need them. N Engl J Med2020. doi:10.1056/NEJMp2033538.
  5. Weiland CZ. Noah. Many trial volunteers got placebo vaccines. Do they now deserve the real ones? New York Times. 2 Dec 2020. https://www.nytimes.com/2020/12/02/health/covid-vaccine-placebo-group.html.
  6. Karlin-Smith S. Covid-19 vaccine sponsors want US FDA to find alternatives for control-arm data after first EUA. Pink Sheet. 2020. https://pink.pharmaintelligence.informa.com/PS143143/COVID-19-Vaccine-Sponsors-Want-US-FDA-To-Find-Alternatives-For-Control-Arm-Data-After-First-EUA.
  7. Tanne JHCovid-19: FDA panel votes to approve Pfizer BioNTech vaccine. BMJ2020;371:m4799.  doi:10.1136/bmj.m4799 pmid:33310748 FREE Full TextGoogle Scholar 

Read the full article here

NCHR Statement by Dr. Diana Zuckerman at FDA Covid Vaccine Advisory Committee

October 22, 2020


I’m Dr. Diana Zuckerman, president of the National Center for Health Research. Our center scrutinizes the safety and effectiveness of medical products, and we don’t accept funding from companies that make those products, although I’ve personally inherited stock in Johnson & Johnson. My expertise is based on post-doc training in epidemiology and as a faculty member and researcher at Vassar, Yale, at Harvard. I’ve also worked at HHS, the U.S. Congress and White House.

We’ve heard today that the agencies are doing many things right, but the vaccine trials have serious design flaws. The standards set in FDA guidances and the study protocols make it likely that vaccines that will be authorized or approved won’t achieve what the public and policy makers expect. Instead, these vaccines will only be proven to reduce the risk of mild infections but not proven to reduce the risk of hospitalization, ICU use, or deaths.

The major flaws are as follows:

  • The FDA’s proposed primary endpoint is defined as symptomatic Covid-19 that can include only 1 very mild symptom, such as a mild cough or sore throat – as long as the person has tested positive.
  • FDA’s requirement of at least 2 months median follow-up after vaccination or placebo is too short to study efficacy.  Even if a person is exposed during that time, we don’t know the correlates of protection and so we need a longer follow-up to know how long an effective vaccine remains effective.  We can’t rely on post-market studies for that information, because once a vaccine is on the market, many people in the placebo control group will switch to a vaccine.
  • We don’t know whether diversity of study participants will be achieved in terms of age, race, or co-morbidities, especially for people who are exposed to the virus.
  • The requirement of at least 5 serious Covid-19 cases in the placebo group is completely inadequate for 2 reasons:
    • Serious Covid-19 cases are too loosely defined, and could include a case of mild Covid-19 if the patient has a blood oxygen saturation under 93%. But thousands of otherwise healthy Americans have levels below that.
  • Even if the definition were more stringent, such as requiring hospitalization or death, and even if there were no such cases among the vaccinated patients, the absolute difference in disease between 0 and 5 serious cases would not be clinically meaningful to individuals and could easily have occurred by chance.

The American public has been told for months that life can go back to normal when we have a vaccine.  It isn’t FDA’s job to achieve that overly optimistic goal for any vaccine, but it is FDA’s job to make sure that a vaccine has meaningful benefits for the health and lives of most Americans, and especially those most at risk.

Testimony of Dr. Diana Zuckerman of NCHR before the FDA Advisory Committee on Pfizer COVID Vaccine

December 10, 2020


I’m Dr. Diana Zuckerman, president of the National Center for Health Research.  Thank you for the opportunity to speak today.

Our center scrutinizes the safety and effectiveness of medical products, and we don’t accept funding from companies that make those products. My expertise is based on post-doc training in epidemiology and as a previous faculty member and researcher at Vassar, Yale, and Harvard, and a fellow in bioethics at University of Pennsylvania.  I’ve also worked at HHS, the U.S. Congress and the White House.  

Today I will focus on 2 major concerns and how to improve the data:

#1:  The 2 month median follow-up is too short, so it’s essential that the randomized controlled trial be continued, to learn about long-term safety and efficacy.

#2:  There’s a lack of diversity in COVID cases:  There were 0 Black cases in the vaccine group, and only 7 Black cases in the placebo group.  

There were 0 cases who are ages 75+ in the vaccine group, 5 in placebo group  

We need more cases in these groups in order to understand the efficacy.  I’m concerned that conclusions will be inappropriately drawn, as when an article in the Wall Street Journal article included a chart saying the vaccine was 100% effective in Blacks.

THERE are also too few severe cases to draw conclusions:

There were only 4 severe cases after the 2nd dose:  3 of which were in the placebo group.  Not all these cases required hospitalization.  In summary, there are too few severe cases to draw conclusions about whether the vaccine prevents severe COVID.

Long-term care patients were not included in the study.  About 800 people ages 75 and older were in the study but only 5 were cases (all of them placebo).

We want to save their lives, but how can we ensure informed consent to nursing home patients with no data?  How many frail elderly or their family members can make an informed decision based on so little information?

We need longer-term data to fully understand if benefits outweigh the risks for frail patients and all races/ethnicities, and for everyone else as well.  That’s why it is essential that FDA ensure the continuation of the randomized controlled trial.

In conclusion, EUA is not approval and it should have more restrictions than approval would have:

  • FDA should require continuation of the RCT while targeting EUA to priority populations, especially healthcare workers.  Study participants in the placebo group should not “jump the queue.”  Continuing the RCT for at least a few more months will make an important difference in knowledge.
  • EUA should not allow off-label use, and celebrities and others should not be allowed to jump the queue.  Off label use could occur when urgently needed under FDA’s Expanded Access program.
  • FDA should delay access to vaccines by placebo group unless they are in priority populations.  I am concerned about the blinded crossover proposal, because if the vaccine is effective very long-term, such as 9 months or a year, we would lose that information if placebo participants were crossed over after just 3-9 months.   Blinded crossover would only provide useful information if the efficacy doesn’t last long.  Let’s hope that isn’t true. 

Dr. Diana Zuckerman’s Testimony on Moderna’s COVID Vaccine Before the FDA Advisory Committee

December 17, 2020.


I’m Dr. Diana Zuckerman, president of the National Center for Health Research.  Thank you for the opportunity to speak today.

Our center scrutinizes the safety and effectiveness of medical products, and we don’t accept funding from companies that make those products. My expertise is based on post-doc training in epidemiology and as a previous faculty member and researcher at Vassar, Yale, and Harvard, and a fellow in bioethics at University of Pennsylvania.  I’ve also worked at HHS, the U.S. Congress and the White House.

Today I will focus on 3 major concerns:

#1:  The 2 month median follow-up is too short, so Moderna’s proposal to immediately unblind and offer to vaccinate the entire placebo group should be rejected.

#2:  Moderna made a good effort to include a diverse group of participants, but only 4 COVID cases were in Black patients, and there were even fewer in other racial groups.  We can’t assume that the vaccine was highly effective in demographic groups with so few cases because just 1 Covid case in the vaccinated group would have greatly reduced the efficacy rate.

The data on cases for participants with co-morbidities was slightly more substantial, with 24 placebo cases and only 1 vaccinated case

#3  I’m glad to see that unlike Pfizer, Moderna provided info on the total number of  participants who reported 1 or more adverse events.  That’s important.  Unfortunately, the total of severe systemic adverse events after the 2nd dose was over 17% for vaccinated group compared to 2% for the placebo group.

There are also too few severe cases to draw conclusions:

There were 30 severe cases after the 2nd dose, and none were in the vaccine group.  This is a strong finding.  However, only 9 of the severe cases required hospitalization; 12 involved the questionable criteria of at least slightly low blood oxygen saturation.

Long-term care patients were not included in the study.  About 1300 people ages 75 and older were in the study, almost half of them vaccinated, but only 3 were cases (all of them placebo).  Only 15 cases were in patients over 65.

We want to save their lives, but with no data it’s not possible to provide useful informed consent to nursing home patients.  That puts a tremendous burden on those patients and their family members to decide whether or not to be vaccinated.

We need longer-term data to fully understand the benefits and risks for different types of patients.  The vaccine is clearly effective, but does that last 2 months, 4 months, or a year?  We need to know that, and that’s why it is essential that the blinded randomized controlled trial is continued.

In conclusion, EUA is not approval, and it should have more restrictions than approval would have.  The EUA should be targeted to priority populations, because if the EUA applies to all adults, celebrities and others who are well-connected will cut in line.  We’ve already seen that this week.

Other people could apply for the vaccine under FDA’s Expanded Access program.

We need at least 1 year of blinded, randomized, controlled data.  We agree with Dr. Goodman’s proposal that FDA should delay access to vaccines by members of the placebo group unless they are in priority populations.  Blinded crossover has limitations because it can’t control changes in the community spread of the virus, but it is better than not continuing a blinded controlled study, if continuing the current study is not possible.

How Effective Is the Mask You’re Wearing? You May Know Soon

A CDC division is working with an industry standards group to develop filtration standards — and products that meet them will be able to carry labels saying so.

Sheila Kaplan, The New York Times: December 16, 2020


More than 100,000 varieties of face masks are currently for sale. They come in silk, cotton and synthetics; with filters and without; over-the-head and over-the-ears. They have sparkles and sunflowers; friendly greetings and insults; cartoon characters and teeny reindeer.

What they don’t have is a label that shows how well they block infectious particles, an omission that has frustrated public health officials during the coronavirus pandemic. Those experts note that there is a big range in the effectiveness of various designs, and some barely filter out particles at all.

“The most fundamental, basic question is, What is the safest mask and how do I assure that I have that, and my family members and children have that?” said Fran Phillips, who stepped down in August from her post as deputy health secretary of Maryland. “It’s so startling that we are here in this moment and we don’t have that information.”

That may change soon. A division of the Centers for Disease Control and Prevention is working to develop minimum filter efficiency standards, and labels showing which products meet them, for the vast and bewildering marketplace for masks and other face coverings.

The National Institute for Occupational Safety and Health, a division of the C.D.C. known as NIOSH, has been quietly writing guidelines with an industry standard-setting organization, ASTM International (formerly the American Society for Testing and Materials), that are expected to be made public next month.

“By having a standard in place you will be able to know what level of protection is being achieved and you’ll have a consistent way of evaluating these products,” said Maryann D’Alessandro, director of the NIOSH National Personal Protective Technology Laboratory.

Since the pandemic began, there has been little federal oversight of masks and other face coverings. Both the Food and Drug Administration and the C.D.C. have some authority over the industry. The F.D.A., which regulates medical devices, shares authority with NIOSH for oversight of N95 respirators, which are the most protective devices available. But most of the masks the general public wears are just pieces of cloth and don’t come under any regulatory oversight.

Sales of masks took off after the F.D.A. issued an emergency measure in April that said in part that the agency would not take action against companies selling them to the general public. At the same time, however, the F.D.A. also noted that these products “may or may not meet fluid barrier or filtration efficiency levels.” That warning didn’t hurt the market, and some critics now blame the F.D.A. for the poor quality of many of the products being sold.

“There were many things the F.D.A. could have done to improve the situation, especially after research started coming out about which masks worked and which didn’t,” said Diana Zuckerman, president of the National Center for Health Research, a nonprofit health policy group. “F.D.A. could have issued a guidance that masks should be fitted, at least two layers of cloth, not made of stretchy materials, etc. Instead, there was a free-for-all.”

The effectiveness of masks can range “from 0 to 80 percent, depending on material composition, number of layers and layering bonding,” said Dale Pfriem, president of Protective Equipment Consulting Services and a member of the standards development working group addressing mask guidelines.

[…]

Read the full article here https://www.nytimes.com/2020/12/16/health/covid-masks-effectiveness.html

FDA Panel Reviewing Pfizer Vaccine Leaves Out Some Experts Who Raised Concerns

David Hilzenrath, Project on Government Oversight: December 9, 2020.


When an FDA advisory committee meets tomorrow to review Pfizer’s coronavirus vaccine, the lineup of committee members will look different from the group that met in October to begin the committee’s discussion of coronavirus vaccines.

Four people who participated in the earlier meeting as temporary committee members, including experts who raised questions and expressed concerns about the testing process, do not appear on the “draft roster” of panelists the FDA has posted for tomorrow’s meeting.

Meanwhile, there will be new faces. The FDA has added 10 temporary committee members who did not participate in the earlier meeting.

The changes in the lineup raise concerns, Diana Zuckerman, president of the National Center for Health Research, said in answer to questions from the Project On Government Oversight (POGO).

Zuckerman said experts might have been excluded to avoid tough questions about Pfizer’s data.

“It is not unusual for temporary members of FDA Advisory Committees to change, but seems surprising since the issues they are considering at the Oct meeting and tomorrow are so similar,” Zuckerman said by email.

Zuckerman’s organization analyzes the safety and effectiveness of pharmaceuticals and other medical products.

POGO asked the FDA whether the disappearance of some people from the advisory committee lineup had anything to do with any questions, concerns, or opinions they have expressed. In response, an FDA spokesperson did not directly answer.

The FDA routinely supplements advisory committees with temporary voting members, including “scientists or medical personnel whose expertise may not be represented by the fixed voting membership,” the FDA spokesperson said by email. “Many times, committees need to invite experts who are unrelated to the knowledge and expertise spelled out in the committee charter if a medical product or topic for discussion calls for a specific need for a particular expert,” the spokesperson added.

That does not seem to explain why the FDA would drop temporary voting members it selected to participate in the October meeting. At that meeting, without evaluating any particular vaccine, the committee advised the FDA on how in general it should approach experimental coronavirus vaccines.

Dr. Luigi Notarangelo, an expert on clinical immunology at the National Institute of Allergy and Infectious Diseases, was not invited to participate in the December 10 FDA advisory committee meeting on Pfizer’s coronavirus vaccine. He served as a temporary committee member when the panel met in October and minced no words then as he expressed general concerns about the testing of coronavirus vaccines.

[….]

POGO recapped his commentary at the October meeting in a November 2 story, “FDA Whitewashes Warnings About Coronavirus Vaccine Trials.”

As POGO reported:

Dr. Luigi Notarangelo, a committee member who is a chief researcher at the National Institutes of Health, minced no words as he articulated several of the critiques.

Notarangelo said measures of vaccine effectiveness included in an FDA document the committee was asked to review have two problems.
“First of all, they really are biased—skewed towards mild disease,” he said. “Mild disease may not mean very much.”
“The other problem with those efficacy measures is that most of them are really subjective,” he said. “And I think that’s a major concern. I mean, we’re relying basically upon reporting from the subjects without any objective validation of what they’re reporting.”

At the time, Notarangelo was not commenting specifically on Pfizer’s data.

Another person who served as a temporary member on October 22 but does not appear on the roster for tomorrow is Kathryn Holmes, a professor emerita in the Department of Immunology & Microbiology at the University of Colorado School of Medicine.

“One of the things I have not heard much about during this conversation is infection,” Holmes said at the October meeting. “I’d like to see how we could actually be measuring infection rather than just mild disease. … We should be looking to see what can prevent infection because that is the rubric which would prevent spread through the community most effectively and that is what would protect our elderly as well.”

Holmes could not be reached for comment for this story.

Another person who participated in the October meeting but is not slated to participate tomorrow is Dr. Michael Nelson, president of the American Board of Allergy and Immunology and a physician at Walter Reed Army National Military Medical Center.

At the October meeting, Nelson said “more real-time data might be needed.”

Nelson also noted that, when the acting chair of the committee summarized members’ comments, he omitted “a lot of concern” about an aspect of how vaccine effectiveness was being measured—whether it was focused inordinately on preventing milder cases.

Read the full article here

Public Comments Regarding ACIP Meeting on December 1, 2020

Diana Zuckerman, Ph.D., on behalf of the National Center for Health Research


Thank you for the opportunity to express my views on behalf of the National Center for Health Research regarding the priorities for allocation of initial supplies of the COVID-19 vaccines. Our center is a nonprofit think tank that scrutinizes the safety and effectiveness of medical products, and we do not accept funding from companies that make those products. My expertise is based on post-doctoral training in epidemiology and public health and more than 30 years of health policy expertise, including my previous employment at the U.S. Department of Health and Human Services, the U.S. Congress, and the White House.

If a COVID-19 vaccine is authorized through an EUA or approved by the FDA, we support prioritizing allocation to healthcare workers, paid and unpaid, and especially those in contact with patients. We agree that people working at long-term care facilities should be included with other healthcare workers. We also support the sub-prioritization considerations for healthcare workers that were specified by Dr. Sara Oliver at the December 1 meeting.

We support prioritizing healthcare workers because they are at clear risk of infection and also have the knowledge to make an informed decision about whether to be vaccinated. Protecting them against infection also protects their patients. We emphasize that healthcare workers should have the choice of whether or not to get the vaccine; it should not be required for a vaccine that is authorized rather than approved by the FDA.

Although we agree that people living in long-term care facilities are clearly at the greatest risk of severe reactions to COVID-19, including death, we are concerned about the lack of data on those types of patients, or any patients over 65 years of age. According to the Reactogenicity chart presented by Dr. Oliver, data are available for only 10 community-dwelling patients in that age group in the Moderna study and only 12 patients in the Pfizer study. It is not clear whether these are the total number of individuals who were vaccinated in those age groups, or the total number in studies published so far. Either way, that is not enough information for older adults living in long-term care facilities to make an informed decision about whether or not to get the vaccine, or for family members or physicians to help make that decision. It is essential that more patients over 65, and preferably more frail elderly patients, be carefully studied in the randomized clinical trials prior to a massive vaccination distribution to tens of thousands of patients. Such data should not take more than a few months to add to existing studies.

Patients in these facilities should not be pressured to be vaccinated.  They should make an informed decision influenced by their personal preference and specific risk of infection.  We are especially concerned that the vaccine might be less effective for older patients and that the pain and fatigue that was reported in the reactogenicity data for younger and older patients could be especially debilitating to long-term care patients, many of whom would not be at high risk of exposure if the employees at their facility have been vaccinated.