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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.

[…]

Read the full article here.

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.”

Read the full article here

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.”

Read the full article here

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.

[…]

Read the full article here

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.

Compounded Bioidentical Hormone Therapy

Breast Cancer, Medical Treatments with Cancer Risks, , , ,

Keris KrennHrubec, Meg Seymour, & Diana Zuckerman, PhD

To avoid the risks of conventional hormone therapy, more and more women are seeking alternatives. But how safe are compounded bioidentical hormones?

When women enter menopause, their bodies produce less estrogen and progesterone. This can cause hot flashes, night sweats, insomnia and other symptoms. Hormone therapy can supplement those hormones, but it increases the risk of breast cancer and other serious diseases. What are your options if the symptoms of menopause are difficult to cope with?

In 2002, a major research study reported that FDA-approved hormone therapy can increase a woman’s risk of heart disease, breast cancer, and stroke. (For more information, please visit: Hormone Therapy and Menopause). As a result, women started to look for alternatives to conventional hormone therapy. Custom-compounded bioidentical hormone therapy (CBHT) has been marketed as more natural and safer, but does the scientific evidence support those claims?

Natural and Safe?

Many of the hormones used in conventional hormone therapy are derived from animal products. Bioidentical hormones, on the other hand, are from plants and are more similar (although not necessarily identical) to the hormones that naturally occur in the human body. However, the term “bioidentical” is misleading and has no scientific value. Bioidenticals are created in laboratories through at least 15 chemical reactions, and they are not identical to hormones produced by human bodies.[1,2] To date, no studies have shown that bioidenticals are safer than conventional hormone therapy and experts used to assume they have similar benefits and risks for patients.[3,4]

The FDA asked the National Academies of Sciences, Engineering and Medicine to form a committee that would assess whether cBHT is an adequate substitute for the traditional therapies that are FDA-approved. In 2020, the committee issued a report that there was not sufficient data to say that cBHT is a safe and effective treatment for menopause. Although some people have reported anecdotal claims that cBHT is safe and effective, these anecdotes are not scientific data.[5] 

The Pros and Cons of Compounding

Some bioidentical hormones (such as small particles of progesterone and estradiol) have been approved by the FDA,[1] but most are not. Instead, they are prescribed as a compound with ingredients that are mixed and blended by pharmacies to “create a customized medication for an individual patient”.[6,7] Since compounding is used to make individualized medication, it is not approved by the FDA. Compounding of some medications is necessary for some patients, such as patients who are allergic to one component of an approved drug or who need a particular dosage that differs from the FDA-approved medicine. However, since it is not monitored the way an FDA-approved drug is, compounded drugs are not proven to be safe or effective.[7]

Women who are considering compounded bioidentical hormones often start by getting their individual hormone levels checked through saliva or serum tests. This may create the impression that the bioidentical drugs will be customized for each patient, but research has not shown that these hormonal tests are meaningful or can ensure a safe or effective product.[1,3]

Risks Through Compounding

In addition to not being approved by the FDA as safe or effective, compounded drugs have an additional risk of being contaminated [3] or having an inaccurate dosage.[6] Either can be dangerous. Since compounded drugs are not FDA-approved, they also lack warnings on labels about possible side effects, including serious ones.[1,8] Several of the ingredients that are commonly used in bioidentical hormones – such as testosterone – have not been approved by the FDA for use for postmenopausal women.[3]

Despite these concerns, many women have been prescribed bioidentical hormones for menopause. That’s why the FDA announced in 2018 that they will expand research on compounded bioidentical hormone therapy.[9]

How Do I Know If My Hormone Therapy Has Been Compounded?

Compounded bioidentical drugs are legal if they are in response to a doctor’s prescription.[7] It is unlawful for a pharmacy to simply give you modified drugs without consent. However, even if it is legal, that doesn’t mean it will be safe or effective. If you have any questions or concerns about your hormone therapy, you should talk to your doctor or pharmacist.[10]

You can recognize FDA-approved hormone therapy by the use of brand names such as Premarin, Vagifem and Estrace. The bioidenticals micronized progesterone (brand name Prometrium) and estradiol (brand name Vivelle) have also been approved by the FDA. If your medication has been compounded, you will see terms such as estrone, estradiol, testosterone or progesterone instead of brand names. You are probably receiving CBHT if you have been asked for a saliva or serum test to establish an individualized treatment course.[1,2]

Traditional hormone therapy can be effective for menopausal symptoms, but can increase the risk of cancer and other serious diseases. Bioidentical hormones may have the same risks. You can find more information on the FDA-approved hormone therapies here.

 

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

  1. American College of Obstetricians. (2012). Compounded bioidentical menopausal hormone therapy. Fertility and Sterility, 98(2), 308-312. (reaffirmed in 2018)
  2. Gass, M. L., Stuenkel, C. A., Utian, W. H., LaCroix, A., Liu, J. H., & Shifren, J. L. (2015). Use of compounded hormone therapy in the United States: report of the North American Menopause Society Survey. Menopause, 22(12), 1276-1285.
  3. Pinkerton, J. V., & Pickar, J. H. (2016). Update on medical and regulatory issues pertaining to compounded and FDA-approved drugs, including hormone therapy. Menopause (New York, NY), 23(2), 215.
  4. National Institute on Aging. (June 2017). Hot Flashes: What Can I Do? Retrieved from: https://www.nia.nih.gov/health/hot-flashes-what-can-i-do#risks
  5. The National Academies of Sciences, Engineering and Medicine (July 2020). Report: The Clinical Utility of Compounded Bioidentical Hormone Therapy (cBHT) A Review of Safety, Effectiveness, and Use. Retrieved from: https://www.nap.edu/resource/25791/cBHT%20Consensus%20Study%20Report%20Highlights.pdf
  6. FDA (June 2018). Report: Limited FDA Survey of Compounded Drug Products. Retrieved from: https://www.fda.gov/drugs/human-drug-compounding/report-limited-fda-survey-compounded-drug-products
  7. FDA (June 2018). Compounding and the FDA: Questions and Answers. Retrieved from: https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers.
  8. FDA (June 2018). Compounding Oversight. Retrieved from: https://www.fda.gov/drugs/human-drug-compounding/compounding-oversight
  9. FDA (September 2018). FDA announces new and expanded compounding research projects. Retrieved from: https://www.fda.gov/drugs/drug-safety-and-availability/fda-announces-new-and-expanded-compounding-research-projects
  10. FDA (February 2018). Menopause: Medicines to Help You. Retrieved from: https://www.fda.gov/consumers/free-publications-women/menopause-medicines-help-you

Joint Letter Opposing Efforts to Weaken FDA’s Authority over Tobacco Products

Legislation, Policy

July 7, 2020

The Honorable Nita Lowey
Chairwoman
Committee on Appropriations
United States House of Representatives
Washington, D.C. 20515

The Honorable Kay Granger
Ranking Member
Committee on Appropriations
United States House of Representatives
Washington, DC 20515

Dear Chairwoman Lowey and Ranking Member Granger:
As your committee proceeds to mark up the Fiscal Year 2021 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations bill, we urge you to oppose any efforts to weaken FDA’s authority over cigars or any other tobacco products.

Tobacco use is the leading cause of preventable death and disease in the United States. More than 480,000 Americans die from tobacco use each year, and more than 16 million Americans are currently living with a tobacco-caused disease. With the enactment of the Family Smoking Prevention and Tobacco Control Act in 2009, Congress recognized that all tobacco products should be overseen by an agency with expertise in assessing health risks and experience promulgating science-based regulation.

Over the years, manufacturers and sellers of tobacco products have sought to exclude certain products from FDA’s authority or weaken FDA oversight of them, including through the appropriations process. Fortunately, Congress has not restricted FDA’s statutory authority. All  tobacco products pose risks to health and should adhere to science-based public health protections. As our nation confronts the COVID-19 pandemic – a pandemic that impacts the lungs and has taken the lives of more than 100,000 Americans – surely now is not the time to weaken FDA oversight of tobacco products.

Manufacturers and sellers of certain types of cigars have argued that their products should not be overseen by FDA despite the agency’s determination that there is no appropriate public health justification for exempting them. While cigar smoking is often perceived as an activity of older adults, cigars are popular among youth, particularly high school boys. Cigars are marketed in a wide array of flavors and are often inexpensive, making them especially appealing to youth. Despite industry claims to the contrary, cigar use has serious negative health risks and can lead to lung and heart diseases and numerous types of cancer. FDA has determined that all cigars are potentially addictive and that cigar use leads to approximately 9,000 premature deaths each year.

We urge you to oppose any amendments to weaken FDA’s authority over cigars including an amendment that would add language that was adopted during the Energy and Commerce Committee’s consideration of H.R. 2339, the Reversing the Youth Tobacco Epidemic Act, that would have exempted certain cigars from having to undergo a public health review by FDA. Our organizations opposed this amendment when it was added to H.R. 2339 because it would restrict an important tool FDA now has to protect public health. Despite our opposition to this amendment, we continued to support the bill because other parts of the legislation – including a prohibition on all flavored tobacco products – would substantially reduce youth tobacco use and greatly benefit public health. That would not be the case if a similar amendment were adopted by this Committee.

In passing the Tobacco Control Act, Congress wisely recognized the addictive and deadly nature of tobacco products and the critical need for manufacturers to demonstrate that new products are “appropriate for the protection of public health.” Given their risks to health, no tobacco product should be exempt from FDA product review.

We thank you for not adopting any provisions during consideration of the FY 2020 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations bill that would weaken FDA oversight of tobacco products, and we urge you to once again oppose any efforts to exempt cigars or any other tobacco products from FDA oversight during consideration of the FY 2021 bill.

Sincerely,

Action on Smoking & Health
African American Tobacco Control Leadership Council
Allergy & Asthma Network
American Academy of Nursing
American Academy of Oral and Maxillofacial Pathology
American Academy of Oral and Maxillofacial Radiology
American Academy of Otolaryngology- Head and Neck Surgery
American Academy of Pediatrics
American Association for Cancer Research
American Association for Dental Research
American Association for Respiratory Care
American Cancer Society Cancer Action Network
American College of Cardiology
American College of Chest Physicians (CHEST)
American College of Physicians
American College of Preventive Medicine
American Heart Association
American Lung Association
American Psychological Association
American Public Health Association
American Society of Addiction Medicine
American Thoracic Society
Americans for Nonsmokers’ Rights
Asian Pacific Partners for Empowerment, Advocacy and Leadership (APPEAL)
Association for Clinical Oncology
Association of Black Cardiologists
Association of Schools and Programs of Public Health
Association of State and Territorial Health Officials (ASTHO)
Campaign for Tobacco-Free Kids
Cancer Prevention and Treatment Fund
Catholic Health Association of the United States
ClearWay Minnesota
Community Anti-Drug Coalitions is America (CADCA)
COPD Foundation
Eta Sigma Gamma – National Health Education Honorary
LUNGevity Foundation
National African American Tobacco Prevention Network
National Association of County and City Health Officials (NACCHO)
National Association of Pediatric Nurse Practitioners
National Association of School Nurses
National Association of Social Workers
National Black Nurses Association
National Education Association
National Network of Public Health Institutes
Oncology Nursing Society
Parents Against Vaping E-Cigarettes (PAVe)
Society for Cardiovascular Angiography and Interventions
Students Against Destructive Decisions (SADD)
The Society of State Leaders of Health and Physical Education
The Society of Thoracic Surgeons
CC: United States House of Representatives Committee on Appropriations Members

MLB’s return plan mirrors the Bundesliga’s. The key difference? It’s in the U.S., not Germany.

In the News, News Stories & Editorials, We're In the News, , ,

Jesse Dougherty: The Washington Post, June 3, 2020

One season is ending, another is beginning, and the intersection of the two — Major League Baseball and Bundesliga soccer — shows how risky it is to restart sports in the United States right now.

On Saturday, Bayern Munich and Bayer Leverkusen will meet in the German Cup final in Berlin, capping a successful six-week schedule. Across the Atlantic Ocean and all over North America, MLB will begin summer camp during the novel coronavirus pandemic. The models for the two are similar in that, unlike the NBA, they are operating outside of a bubble, traveling between cities and having players, coaches and staff live at home.

But here’s a key difference: Germany’s response to the pandemic was much more successful — and much more proactive — than the United States’. It enabled the Bundesliga, the country’s top-tier soccer league, to resume in mid-May and handle sporadic coronavirus cases. Baseball, on the other hand, is about to make a similar attempt in a much different environment.

The United States topped 50,000 new daily cases for the first time Wednesday. That was more than a fourth of Germany’s total cases to date. Germany has had around 9,000 coronavirus deaths, and by mid-May, when soccer returned, it had almost completely flattened the curve.

“Germany was able to pull it off, but we are not Germany. Many of the markets that MLB wants to play in do not look like Germany,” said Zachary Binney, an epidemiologist at Oxford College of Emory University. “The baseline risk is much higher. So unfortunately, because of our response to covid-19, sports leagues need stricter return plans, and I don’t know that MLB has really wrestled with that yet.”

Both plans hinge on players, coaches, staff and their families being cautious and smart away from team facilities. That’s the reality of not playing inside a bubble, which the NBA will use in Florida to negate travel and limit exposure to the outside world. But MLB and the Bundesliga took near-opposite approaches for regulating off-site behavior.

MLB’s 113-page operations manual dedicated one paragraph to it, writing individuals “must exercise care,” adding that they should avoid restaurants, bars and other crowded areas. MLB left each team to craft and enforce its own policy. Four players, who spoke on the condition of anonymity to freely discuss a sensitive topic, said this is MLB’s way of avoiding responsibility should an outbreak occur.

[….]

Here is where baseball picks up this weekend, starting with testing. Before training begins, all players, coaches and staff have to take a coronavirus test and self-quarantine while awaiting results. After that, they will be tested every other day. A lab in suburban Salt Lake City will be tasked with fielding thousands of tests and turning around results in “approximately 24 hours,” according to MLB’s operations manual. There is, however, already skepticism within the sport that results will come that quickly.

Before training began in Germany, players, coaches and staff did a week-long quarantine at a hotel. They ate meals separately and, each morning, completed a questionnaire to check for possible symptoms. Testing was frequent during that period, then slowed to around twice a week during the season. The Bundesliga contracted five labs to process results and, according to news accounts, was comfortable doing so because the country wasn’t stretched for resources.

Since the Bundesliga was the first league to return, it provided a template for how to play outside of a bubble. But environmental influences serve as the trickiest element there. Baseball’s plan, while similar, is less detailed in critical areas, according to public health experts, and set to unfold where the virus is still rampant.

“The biggest risk for baseball is location,” said Diana Zuckerman, president of the nonprofit think tank National Center for Health Research. “The greatest weakness of the plan is sending teams and having teams in states where the governor is unwilling to have strict rules.”

Read the full article here