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Public Comments Regarding ACIP Meeting on December 1, 2020

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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.  

Four ways Trump has meddled in pandemic science — and why it matters

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Giuliana Viglione, Nature: November 3, 2020

As the United States votes today on who will be its next president, Donald Trump’s response to the COVID-19 pandemic looms large. One issue that resonates with the research community is the extent to which the current president and his administration have meddled with science and scientific advice during the pandemic — often with disastrous results.

Last month, a coronavirus-crisis sub-committee within the US House of Representatives released a report documenting 47 instances in which government scientists had been sidelined or their recommendations altered. And the report notes that the frequency of meddling has been increasing in the lead-up to the US election.

“It’s hard to express how unbelievably demoralizing this experience has been,” says Diana Zuckerman, president of the National Center for Health Research, a non-profit organization in Washington DC.

If Trump wins a second term, researchers fear what that could mean for public health and the scientific enterprise. If Democratic challenger and former vice-president Joe Biden wins, he’ll have his work cut out for him to restore the reputation of the US science agencies that Trump has damaged.

Nature chronicles some of the most significant cases of meddling so far, and assesses their impact.

Scientists sidelined, silenced and ignored

At a campaign rally this week, Trump suggested that if he were re-elected, he would fire much-revered and long-standing infectious-disease expert Anthony Fauci, who has led the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH), since 1984. Fauci has earned international acclaim as an adviser on HIV/AIDS to six US presidents, and is one of the most-cited researchers in the world.

This display follows a pattern of Trump attempting to silence and discredit Fauci throughout the pandemic: in May, in an unprecedented move, the administration blocked Fauci from testifying about the US pandemic response in front of the Democrat-led House of Representatives’ appropriations committee. “Never in my 30-plus years here in Washington do I recall ever a White House refusing to let an NIH expert testify before Congress,” says Zuckerman. The White House did not respond to Nature’s request for comment.

From cruise ships to asymptomatic spread: expert advice ignored

[….]

 

But Trump’s treatment of Fauci is just one example of the administration’s willingness to sideline its world-famous experts and institutions. The Centers for Disease Control and Prevention (CDC) is a world-renowned health agency and typically plays a major role in tracking and responding to outbreaks. In previous crises, its scientists have issued advice and updates directly to the public through regular media briefings. But compared with previous global-health crises, experts at the CDC have been unusually quiet during the COVID-19 pandemic, according to an analysis by the Union of Concerned Scientists (UCS) that was issued in May.

The report found that during the current pandemic, the CDC has held a much smaller proportion of press events than usual. For instance, during the H1N1 pandemic in 2009, the CDC led all but 3 of the 35 press conferences in the first 13 weeks of the pandemic. In contrast, Trump led close to three-quarters of the 69 press events during the same period of the COVID-19 outbreak. CNN reported that the lack of press briefings by the CDC on the coronavirus was due to pressure from the White House. “It is concerning that the scientists that are doing this great work are unable to talk,” says Anita Desikan, a research analyst at the UCS’s Center for Science and Democracy. The CDC did not respond to Nature’s request for comment.

[….]

In August, now-removed guidance appeared on the CDC’s website that stated that asymptomatic people no longer needed to be tested for the virus, counter to the recommendations of public-health experts. A senior CDC official told CNN that this guidance was issued “from the top down”; it was eventually reversed after public outcry. Officials outside the CDC have allegedly inserted their own documents on the CDC website in a move that Samuel Groseclose, a retired epidemiologist who spent 27 years at the agency, calls “bizarre”.

Revered public-health report delayed

The Trump administration has also attempted to meddle with a mainstay of the American public-health community: a weekly, peer-reviewed report that’s meant to facilitate the rapid release of epidemiological data. In September, Politico reported that political appointees in the Department of Health and Human Services, which oversees the CDC, had attempted to delay or halt the release of and retroactively edit the CDC’s Morbidity and Mortality Weekly Report (MMWR). Officials also demanded oversight before some results were published. The MMWR is “revered in the public-health community”, says Liz Borkowski, a public-health researcher at George Washington University in Washington DC, adding that she was “utterly horrified” to hear of the attempted meddling.

[….]

COVID treatments prematurely approved

Convalescent plasma, antibody-laden blood plasma from someone who survived COVID-19, was a promising treatment early in the pandemic. In August, the Trump administration leaned heavily on Food and Drug Administration (FDA) commissioner Stephen Hahn to issue an Emergency Use Authorization (EUA) for the treatment despite a lack of solid evidence that it helps people, as reported by The New York Times and The Washington Post. The FDA issued the EUA, making plasma available to a wide swath of the US population. But evidence from a clinical trial in India1, posted in September, suggests that the treatment has no effect on patient outcomes. Earlier in the pandemic, the agency had to revoke its authorization of hydroxychloroquine, which Trump had touted as a “game changer” for COVID-19, because it, too, was subsequently shown to be ineffectual at treating the disease.

[….]

To many public-health experts, it is clear that the Trump administration’s persistent meddling is responsible for the disastrous way in which the pandemic has unfolded in the United States. “Some of it is probably real and some of it is probably supposition,” Georges Benjamin, the executive director of the American Public Health Association in Washington DC, says of the media reports about interference. “But at the end of the day, this has been one of the worst risk-communications processes that I’ve ever seen. And I think that’s tragic.”

doi: https://doi.org/10.1038/d41586-020-03035-4

References

  1. 1.

Agarwal, A. et al. Preprint at medRxiv https://doi.org/10.1101/2020.09.03.20187252 (2020).

Read the full article here.

HEALTH CARE BRIEFING: FDA Vaccine Rules Challenged as Weak

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Brandon Lee and Alex Ruoff, Bloomberg Government: October 23, 2020

U.S. vaccine advisers questioned whether safety and efficacy standards set by Food and Drug Administration officials were high enough to warrant emergency authorization of a shot.

About two dozen outside advisers to the FDA with expertise in infectious diseases met yesterday to weigh in on agency standards that require a vaccine to work in at least 50% of people and for drugmakers to collect two months of safety data on at least half of clinical trial volunteers.

“They haven’t gone far enough” in terms of safety, said Hayley Altman-Gans, a panel member and pediatrics professor at Stanford University Medical Center.

Many panel members and outside researchers who commented during the hearing worried that if a vaccine is rushed out that later turns out to have safety problems or to be less effective than promised, it could backfire in a big way, undermining public confidence in Covid-19 vaccines for years to come.

Several panel members expressed concern that the two-month safety follow-up the FDA is calling for before a vaccine gets an emergency authorization is simply not enough. In addition to safety, it means that doctors won’t know whether a vaccine’s efficacy could fade after just a few months.

Diana Zuckerman of the National Center for Health Research told the committee the vaccine trials “have serious design flaws.”

The trials are too geared to preventing mild infections, and may not show whether they prevent severe infections and hospitalizations, she said. Longer follow up may be especially important because some of the first vaccines, including messenger RNA vaccines from Pfizer and Moderna, are based on new technologies that have never been used in an approved product. 

Read the full article here. 

FDA Panel To Lay Regulatory Groundwork For COVID-19 Vaccine

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Noel King and Sydney Lupkin, NPR: October 22, 2020

NOEL KING, HOST:

There are several COVID-19 vaccines in development. But before they are approved, they have to be safe. It’s the FDA’s job to ensure that. Today an FDA advisory panel is meeting for the first time about the coronavirus vaccine. It’ll be making recommendations based not on politically motivated timetables, but on data.

Sydney Lupkin covers the pharmaceutical industry for NPR. Good morning, Sydney.

SYDNEY LUPKIN, BYLINE: Good morning.

KING: So what is the deal with this FDA panel? Who’s on it? What are they going to be doing?

LUPKIN: Well, the FDA regularly turns to committees of outside advisers for guidance. Most often, these panels are asked to evaluate specific drugs or health products, and that helps the agency to decide whether to approve these products. Today’s meeting of the committee that looks at vaccines is going to be a little different.

KING: How?

LUPKIN: Like everything else in this pandemic, it’s a bit unusual. The big difference is that the committee isn’t going to be sifting through data for a specific coronavirus vaccine like it normally would. The meeting will be a broader discussion of how the agency should think about safety and effectiveness of these new kinds of vaccines, particularly safety. Dr. Paul Offit is a committee member who works at the Children’s Hospital of Philadelphia.

PAUL OFFIT: How robust should safety data be? How long, for example, after the first or second dose should patients be followed or participants be followed for any possible safety issue?

LUPKIN: They’ll be discussing FDA’s existing guidance to companies, which includes some of that information. They’ll also discuss how studies should continue after the first vaccine is given the green light. What do you do for patients who got a placebo once a vaccine is widely available? Of course, the FDA usually heeds the advice of these committees, but it doesn’t have to.

KING: So since there’s no vaccine to review, I would think that in ordinary times, we would not know about this meeting. It would not be news at all. It’s very clear that the FDA wants to make public that this is happening. Why do they want to do that?

LUPKIN: Well, I mean, it gives the American public a window into the process. There’s been so much discussion around whether the FDA will put politics ahead of science. So it’s important to see what’s going on. And the FDA has questions that it wants answers to. Here’s Dr. Miles Braun, a former FDA epidemiologist.

MILES BRAUN: There is a level of humility that the FDA is coming to its advisers with. And I think that’s a good thing. And if they find out they’ve missed some important things, they’ll address those.

LUPKIN: Committee members will hear presentations from scientists at the FDA, the Centers for Disease Control and Prevention and the Biomedical Advanced Research and Development Authority. The public will also have an opportunity to weigh in. Diana Zuckerman is the president of the National Center for Health Research, an advocacy group slated to speak.

DIANA ZUCKERMAN: We’ve seen the guidance of what they’re telling companies they’re supposed to be studying. Frankly, they’re not very stringent, so we are concerned about them.

LUPKIN: She hopes the meeting will delve into making sure the clinical trials are diverse, for example. She also questions whether the study approach the FDA suggested to manufacturers is long enough to assess vaccine safety.

[…]

Read or listen to the full article here. 

FDA Promises Strong Safety Standards for Covid-19 Vaccines as It Convenes Advisory Panel

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Thomas M. Burton, Wall Street Journal: October 23, 2020

SILVER SPRING, Md.—Food and Drug Administration officials gave fresh assurances Thursday that Covid-19 vaccines will undergo rigorous testing before being made widely available—a message they underscored in a meeting with outside medical experts aimed at bolstering the agency’s credibility.

“Only those vaccines that are demonstrated to be safe and effective” will be licensed by the FDA, said Marion F. Gruber, director of the FDA’s Office of Vaccines Research and Review. But some speakers and panel members raised concerns about whether the FDA’s vaccine guidelines for Covid-19 clinical trials are sufficiently rigorous.

These comments came at the first meeting of a 25-member panel of medical experts, including specialists in fields like virology, infectious diseases and biostatistics. The group, which met remotely via video-conferencing, was  established to make recommendations to the FDA on how best to assess the safety and effectiveness of vaccines.

“The FDA frequently convenes outside panels of medical experts for their advice on products,” said Peter Marks, director of the FDA’s center for biological products. “But normally panels about vaccines are watched by dozens of people. In this case, it’s watched by many thousands.”

[….]

President Trump has pushed to get a vaccine approved quickly, which has drawn concern from some public health experts and political opponents that the FDA would be under pressure to bypass usual precautions to rush a vaccine to market quickly.

FDA officials have vowed not to do so. In addition to convening the advisory panel, they have issued a set of guidelines to govern how vaccine clinical trials will be conducted and evaluated.

They also formulated a set of rigorous standards for the FDA to employ before granting what is known as an emergency-use authorization (EUA) for a vaccine. The EUA is the faster equivalent during the Covid-19 pandemic of a conventional approval by the agency.

[….]

Various speakers questioned whether the shorter EUA test period was sufficient.

“The vaccine trials have serious design flaws,” said Diana Zuckerman, president of the National Center for Health Research in Washington. In addition to the two-month period, she said FDA guidelines focus on measuring milder cases of the disease, and not the most serious cases.  

Read the full article here.

FDA Vaccine Rules Challenged as Weak at Advisory Panel Meeting

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Anna Edney and Robert Langreth, Bloomberg Business: October 22, 2020

About two dozen outside advisers to the FDA with expertise in infectious diseases met Thursday to weigh in on agency standards that require a vaccine to work in at least 50% of people and for drugmakers to collect two months of safety data on at least half of clinical trial volunteers.

“They haven’t gone far enough” in terms of safety, said Hayley Altman-Gans, a panel member and pediatrics professor at Stanford University Medical Center.

Many panel members and outside researchers who commented during the hearing worried that if a vaccine is rushed out that later turns out to have safety problems or to be less effective than promised, it could backfire in a big way, undermining public confidence in Covid-19 vaccines for years to come.

Archana Chatterjee, advisory panel member and dean of Chicago Medical School, said the public has a lot of concern about safety. Meanwhile, she added, “What we’re being asked to do is to build this plane as we fly it.”

Several panel members expressed concern that the two-month safety follow-up the FDA is calling for before a vaccine gets an emergency authorization is simply not enough. In addition to safety, it means that doctors won’t know whether a vaccine’s efficacy could fade after just a few months.

Panel member Amanda Cohn, who is chief medical officer at the National Center for Immunization and Respiratory Diseases, worried that the efficacy of vaccines that just meet the 50% threshold after two months may see reduced effectiveness a few months later if the shot doesn’t offer a long period of protection.

“Very rarely do we look at [vaccine efficacy] so shortly after completing a series,” according to Cohn, whose organization is part of the Centers for Disease Control and Prevention.

Design Flaws

The advisers weren’t alone in questioning the standards. Diana Zuckerman of the National Center for Health Research told the committee the vaccine trials “have serious design flaws.”

The two-month follow up the FDA has asked for is too short to establish how long a vaccine will work, and the trials are too geared to preventing mild infections, and may not show whether they prevent severe infections and hospitalizations, she said.

Longer follow-up may be especially important because some of the first vaccines, including messenger RNA vaccines from Pfizer Inc. and Moderna Inc., are based on new technologies that have never been used in an approved product.

The debate over the rigor of the FDA guidelines was one of two main issues debated before the committee, which heard comments from regulators, drugmakers and the public. The second questioned whether trial participants on a placebo should be advised when a vaccine is deemed to be safe and effective.

[…]

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Study finds removing breast implants improved symptoms

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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.”

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FDA Updates Breast Implant Labeling Recommendations to Help Inform Patients About Dangerous Potential Side Effects

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Beth Fand Incollingo, Cure: September 29, 2020

Makers of breast implants should supplement their labeling to include a boxed warning about health problems that can arise from the devices, along with a patient decision checklist that highlights those concerns, according to final guidance issued today by the Food and Drug Administration.

The guidance, titled “Breast Implants – Certain Labeling Recommendations to Improve Patient Communication,” recommends, but does not mandate, that manufacturers include information about two major health issues that can arise from implant use: breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and breast implant illness (BII), an autoimmune condition that can result in brain fog, fatigue, rash, and muscle or joint pain. A draft of the document was issued in 2019.

[…]

Roxane Vermeland, a breast cancer survivor who was treated for BIA-ALCL after receiving implants as part of breast reconstruction after mastectomy, was pleased to hear about the FDA’s decision.

“This is great news,” she said in a statement to CURE®. “We have been advocating hard for this, as women need to know the risks of implants up front so they can make an informed decision. The black-box warning alone is a major accomplishment for us which will truly make women think about the decision to put implants into their bodies. I am in tears as I write this.”

Guidance details

According to the guidance, the boxed warning should state that breast implants are not considered lifetime devices; the chance of developing complications increases over time; some complications will require more surgery; implants, particularly textured ones, have been associated with the development of BIA-ALCL; and implants have been associated with systemic symptoms. The checklist should note situations in which the device should not be used; considerations for a successful breast implant candidate; risks associated with surgery and BIA-ALCL; the importance of appropriate physician education, training and experience; the risk of BII; and should suggest discussion of options other than breast implants, the guidance states.

The guidance also suggests updates to the silicone gel-filled breast implant rupture screening recommendations, stating when MRIs should be conducted; inclusion of an easy-to-find description of the materials used to make the implants; and provision of patient device cards that will inform patients about what kind of implants they have, state a serial or lot number for the specific devices and include a toll-free phone number for the manufacturer.

The labeling recommendations are intended to enhance, but not replace, discussions between doctors and patients about the benefits and risks of breast implants, the FDA wrote in a press release.

Finally, the FDA has updated its guidance titled “Saline, Silicone Gel, and Alternative Breast Implants” to make it consistent with the new labeling recommendations. The FDA stated that it will continue to work with professional medical societies, patient advocacy groups and women’s health organizations to help ensure that risk information about breast implants is disseminated to patients.

“As new information has become available about the risks and complications of breast implants, it is critical that women have access to information they need to make informed decisions,” Dr. Binita Ashar, director of the Office of Surgical and Infection Control Devices in the Center for Devices and Radiological Health, said in the release. “After working with stakeholders, including patients, today we are recommending format and content changes to breast implant labeling so the information is presented in an easy-to-understand way. It is important that patients discuss the risks and benefits of breast implants with their health care provider, and we hope that these labeling recommendations will help in facilitating these discussions.”

[…]

Diana Zuckerman, president of the National Center for Health Research and its Cancer Prevention and Treatment Fund, also had a concern, pointing out that guidance from the FDA usually consists of recommendations that are not enforceable.

“That’s a big question for us,” she said in an interview with CURE®. “Because we know from experience that, if it’s a suggestion, there are just a lot of doctors who aren’t going to follow through. We think this needs to be required, and we will be working with the plastic surgeons’ medical societies to try to ensure that they urge their members in the strongest possible terms to use this checklist, either the FDA’s version of it or our version, which we think is better.”

An ongoing issue

The FDA also acted on testimony given at the March panel when it requested in July that Allergan, which was since purchased by AbbVie, issue a worldwide recall of any of its Natrelle Biocell textured implants and tissue expanders that remained on shelves. That’s because textured implants, particularly the Natrelle Biocell product line filled with either saline or silicone, have been linked with BIA-ALCL. As of Jan. 5, the cancer had been diagnosed in 733 patients and killed 36, the FDA reported Aug. 20.

“Although the overall incidence of BIA-ALCL appears to be relatively low, once the evidence indicated that a specific manufacturer’s product appeared to be directly linked to significant patient harm, including death, the FDA took action to alert the firm to new evidence indicating a recall is warranted to protect women’s health,” Dr. Amy Abernethy, the FDA’s principal deputy commissioner, said in July.

[…]

First identified about 20 years ago, BIA-ALCL is a rare type of non-Hodgkin lymphoma that arises specifically in women with implants. The FDA first warned women about BIA-ALCL in 2011.

Breast implant illness, meanwhile, seems to occur more often in women who have a personal or family history of autoimmune conditions, experts said, suggesting that more research is needed and that these women should be warned before getting implants. One expert at the 2019 hearing said that this group should opt against implants.

Jennifer Cook of Georgia, who received a diagnosis of BIA-ALCL in 2017, told the 2019 FDA panel that she received her implants as part of a clinical trial and signed a consent form stating that there was no established scientific evidence linking them with cancer. Over many years, she said, no one informed her that a risk had been established, and she found out only by watching a play on the topic at the middle school where she taught.

“I was shocked and thought I would need to reprimand the students for making false statements, and then I learned the horrifying truth,” Cook said. “Shortly thereafter, I recognized that I had symptoms. I was blindsided. I was deceived, and I don’t want anyone else to go through that.”

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How the Coronavirus Pandemic May Affect Cancer Clinical Trials

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Agata Boxe, Cancer Therapy Advisor: September 23, 2020

The health risks posed by SARS-CoV-2 to cancer patients have spurred changes in how cancer clinical trials are being conducted. Some of the alterations introduced by the National Cancer Institute (NCI) include using telemedicine visits, switching to electronic signatures for signing patient consent forms, shipping of oral medications to patients, and allowing researchers to skip collecting certain data. While the modifications may help to expand access to trials and lead to greater economic and geographic diversity of trial populations, they may also limit the amount of key information about the patient experience. Meanwhile, the pandemic itself may dissuade some groups of patients from enrolling in new trials altogether, thus negatively impacting the make-up of trial populations.

Like all other experts interviewed for this story, Hala Borno, MD, assistant clinical professor in the genitourinary oncology program at the University of California, San Francisco, was in favor of the changes that improved patient access to trials, such as the greater use of telemedicine. “In the context of a pandemic, there’s an opportunity to rethink the burdens that we place on patients and an opportunity to redesign the way in which we deliver cancer treatment in the context of the clinical trial,” Dr Borno said.

Dr Borno’s previous research showed that access to clinical trials was particularly challenging for disadvantaged social groups. Her 2018 study found that patients from lower‐income areas had to travel longer distances compared with patients from higher‐income areas to participate in cancer clinical trials. “What I observed is that patients coming from low-income neighborhoods are shouldering the largest burden of travel in order to participate in clinical research,” she said.

But the new measures may also lead to missing key information that is normally recorded during trials when they are conducted in person. Diana Zuckerman, PhD, president of the National Center for Health Research in Washington, D.C., noted potential complications with capturing the patient experience via videoconferencing compared to in-person visits. For example, it might be more difficult for researchers to notice potentially concerning symptoms that would otherwise be easy to see. “For example, if, as a doctor or researcher, I’m meeting with a patient in person, I might notice that they’re slumping in their chair or they look pale or they seem uncomfortable,” she said. “I might notice a lot of things about them that won’t necessarily be so obvious in a telehealth visit.”

Problems like bad lighting in a patient’s home may contribute to visibility issues. Children bursting into the room or a dog jumping on a patient’s lap may distract the patient from the purpose of the virtual visit. Finally, Dr Zuckerman wondered whether patients might not be as candid during online appointments as they would be during face-to-face visits about how they really feel while receiving treatment.

Jonathan Kimmelman, PhD, a professor and director of the biomedical ethics unit at McGill University in Montreal, said he wondered whether the decreased frequency of in-person interactions between patients and investigators might affect detection of adverse events.

[…]

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Do Lesbians Need Cervical Cancer Screening? What You Need to Know

Cervical Cancer & HPV, Prevention, , ,

Meg Seymour, PhD

Regular cervical cancer screening is an important way to prevent cervical cancer or detect it while it is still in the early stages and can be treated more easily.[1] Lesbians are less likely to get screened for cervical cancer than heterosexual and bisexual women, because many face barriers to accessing healthcare.[2] For example, they are less likely than heterosexual women to have a primary healthcare provider and are more likely to have negative experiences with healthcare providers, such as feeling discriminated against.[3,4] 

Another important reason why lesbians are not screened as often as other women is because many believe that they are less likely to get cervical cancer.[5] Some lesbians are erroneously told by their healthcare providers that they do not need cervical cancer screenings due to not having sex with men.[6] In fact, lesbians also develop cervical cancer and they have similar rates of cervical abnormalities to other women.[3] Cervical cancer screening is recommended for all women with a cervix, with no exceptions.[7] 

Can lesbians get cervical cancer?

Almost all cervical cancer is caused by human papillomavirus, commonly referred to as HPV.[8] HPV is the most common sexually transmitted infection (STI), and some strains of it can cause cancer.[9] HPV usually goes away by itself without causing any harm, but if it does not go away it can cause cancer. For more information about HPV and other STIs, you can read this article. (STIs are sometimes referred to as sexually transmitted diseases [STDs].)

Some lesbians believe the myth that HPV can only be transferred through men’s bodily fluids, so they falsely believe that they cannot get HPV or develop cervical cancer.[10] However, research has found that HPV can be transferred between women who are only having sex with other women[11]: through contact between genitals, oral contact with genitals, digital contact with genitals, and sharing sex toys.[12] The CDC notes that “the most reliable way to avoid transmission of STDs is to abstain from oral, vaginal, and anal sex or to be in a long-term, mutually monogamous relationship with a partner known to be uninfected.”[7] However, for those who are not interested in abstinence or who do not have a monogomous long-term partner, it is important to practice safe sex.[13] 

Additionally, many lesbians have had sex with men earlier in their lives, and they may have been infected with HPV from those male partners. It can take as much as 10-20 years for a woman to develop cervical cancer after she was first exposed to HPV,[14,15] Lesbians are able to contract HPV from either past sexual experiences with men or from current experiences with female sexual partners.  

Additional causes of cervical cancer

There is not conclusive research comparing the rate of cervical cancer among lesbians with the rate among other women. However, lesbians are more likely than heterosexual women to smoke, and smokers are twice as likely to get cervical cancer than non-smokers, because smoking makes it harder for the immune system to fight HPV.[14,16] If you are interested in information on how to quit smoking, you can read this article. 

Lesbians are also more likely than heterosexual women to have an imbalance of good and bad bacteria in the vagina that is called bacterial vaginosis[17], and researchers have found that HPV is more common among women who have bacterial vaginosis.[18] Bacterial vaginosis can sometimes lead to inflammation, causing health complications such as preterm birth or pelvic inflammatory disease. Bacterial vaginosis often does not cause any symptoms, but a common symptom is a “fishy” vaginal odor.[19]   

The bottom line

Lesbians should be sure to get the recommended cervical cancer screenings. Failure to have proper screening may delay a diagnosis of cervical cancer until the cancer has already progressed to a more advanced stage. This can lead to a greater likelihood of dying from the cancer.[20]

For more information on when women are recommended to get screenings, you can read this article. For information about HPV vaccines, 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.     Centers for Disease Control and Prevention. What Should I Know About Screening? Cdc.gov. https://www.cdc.gov/cancer/cervical/basic_info/screening.htm. Updated August 2019. 
  2.     Takemoto ML, Menezes MD, Polido CB, Santos DD, Leonello VM, Magalhães CG, Cirelli JF, Knobel R. Prevalence of sexually transmitted infections and bacterial vaginosis among lesbian women: systematic review and recommendations to improve care. Cadernos de Saude Publica. 2019; 35:e00118118.
  3.     McNair RP. Lesbian health inequalities: a cultural minority issue for health professionals. Medical Journal of Australia. 2003; 178(12):643-5.
  4.     Tracy JK, Schluterman NH, Greenberg DR. Understanding cervical cancer screening among lesbians: a national survey. BMC Public Health. 2013 Dec 1;13(1):442.
  5.     British Broadcasting Corporation. Lesbian women cervical screening myth is ‘dangerous’. Bbc.com.  https://www.bbc.com/news/health-48802285#:~:text=The%20%22dangerous%20myth%22%20that%20gay,vast%20majority%20of%20cervical%20cancers.. 2019. 
  6.     Munson S, Cook C. Lesbian and bisexual women’s sexual healthcare experiences. Journal of Clinical Nursing. 2016; 25(23-24):3497-510.
  7.     Workowski KA, Bolan GA. Sexually transmitted diseases treatment guidelines, 2015. MMWR. Recommendations and reports: Morbidity and mortality weekly report. Recommendations and reports. 2015; 64(RR-03):1.
  8.     Centers for Disease Control and Prevention. Cancers Associated with Human Papillomavirus (HPV). Cdc.gov. https://www.cdc.gov/cancer/hpv/basic_info/cancers.htm#:~:text=Almost%20all%20cervical%20cancer%20is,cancer%20is%20caused%20by%20HPV. Updated November 2019. 
  9.     Centers for Disease Control and Prevention. Genital HPV Infection – Fact Sheet. Cdc. gov. https://www.cdc.gov/std/hpv/stdfact-hpv.htm. Updated August 2019. 
  10. Curmi C, Peters K, Salamonson Y. Lesbians’ attitudes and practices of cervical cancer screening: a qualitative study. BMC Women’s Health. 2014; 14(1):2.
  11. Doull M, Wolowic J, Saewyc E, Rosario M, Prescott T, Ybarra ML. Why girls choose not to use barriers to prevent sexually transmitted infection during female-to-female sex. Journal of Adolescent Health. 2018; 62(4):411-6.
  12. Reiter PL, McRee AL. HPV infection among a population-based sample of sexual minority women from USA. Sexually Transmitted Infections. 2017; 93(1):25-31.
  13. McNair R. Risks and prevention of sexually transmissible infections among women who have sex with women. Sexual Health. 2005; 2(4):209-17.
  14. Waterman L, Voss J. HPV, cervical cancer risks, and barriers to care for lesbian women. The Nurse Practitioner. 2015 Jan 16;40(1):46-53.
  15. McGill University Division of Cancer Epidemiology. Facts about HPV. Mcgill.ca. https://www.mcgill.ca/hitchcohort/hpvfacts. 2020. 
  16. American Cancer Society. Risk Factors for Cervical Cancer. Cancer.org. https://www.cancer.org/cancer/cervical-cancer/causes-risks-prevention/risk-factors.html. Updated January 2020. 
  17. Evans AL, Scally AJ, Wellard SJ, Wilson JD. Prevalence of bacterial vaginosis in lesbians and heterosexual women in a community setting. Sexually Transmitted Infections. 2007; 83(6):470-5.
  18. Liang Y, Chen M, Qin L, Wan B, Wang H. A meta-analysis of the relationship between vaginal microecology, human papillomavirus infection and cervical intraepithelial neoplasia. Infectious Agents and Cancer. 2019; 14(1):1-8.
  19. Mayo Clinic. Bacterial vaginosis. Mayoclinic.org. https://www.mayoclinic.org/diseases-conditions/bacterial-vaginosis/symptoms-causes/syc-20352279. Updated May 2019.
  20. JK, Lydecker AD, Ireland L. Barriers to cervical cancer screening among lesbians. Journal of Women’s Health. 2010 Feb 1;19(2):229-37.