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Tuesday, October 18, 2022

Lilly to Acquire Akouos to Discover and Develop Treatments for Hearing Loss

 Proposed acquisition will accelerate gene therapies that aim to restore, improve, and preserve hearing for patients living with disabling hearing loss worldwide

Transaction valued at approximately $487 million plus a contingent value right for an aggregate amount up to approximately $610 million

Eli Lilly and Company (NYSE: LLY) and Akouos, Inc. (NASDAQ: AKUS) today announced a definitive agreement for Lilly to acquire Akouos, a precision genetic medicine company that is developing a portfolio of first-in-class adeno-associated viral gene therapies for the treatment of inner ear conditions, including sensorineural hearing loss.

https://finance.yahoo.com/news/lilly-acquire-akouos-discover-develop-105000897.html

J&J beats sales estimates on pharma strength

 Johnson & Johnson on Tuesday beat analysts' estimates for third-quarter sales, helped by strong demand for its cancer drug Darzalex and Crohn's disease drug Stelara.

The U.S. health care conglomerate tightened its full-year adjusted profit forecast range.

J&J is the first drugmaker and medical devices firm to report third-quarter earnings and the maintained forecast could be seen as a sign of demand resiliency.

Sales at pharmaceuticals, the company's largest unit, rose 2.6% to $13.21 billion. That beat estimates of $13.03 billion, according to six analysts polled by Refinitiv.

Sales at J&J's medical devices unit rose 2.1% to $6.78 billion on demand for contact lenses and wound-closure products. The division has been under pressure from extended lockdowns in China and a slow recovery in demand for some non-urgent surgery delayed due to COVID-19.

Total sales for the third quarter rose 1.9% to $23.79 billion, topping estimates of $23.34 billion, according to Refinitiv IBES data.

https://www.foxbusiness.com/markets/johnson-johnson-beats-sales-estimates-pharma-strength

Florida To Revoke Licenses Of K-3 Teachers Who Discuss Gender Identity, Sexuality

 The Florida Department of Education is planning to revoke or suspend the teaching licenses of K-3 teachers who discuss gender identity or sexuality with their students, according to the Washington Post, citing a new rule published by the department.

The rule, proposed in September by Education Commissioner Manny Diaz Jr., would enforce a 2021 state law that prohibits instruction on gender identity and sexuality for children in kindergarten through third grade - the Parental Rights in Education Act, colloquially known by opponents as the "don't say gay" law.

According to the rule, any teacher who "intentionally provide[s] classroom instruction" to K-3 students on those topics will face "revocation or suspension of the individual educator’s certificate, or the other penalties as provided by law."

The 2021 law already requires schools to create a system via which parents can report teacher noncompliance with the law. If a school system does not address a parent’s concerns, the law makes it easy for parents to sue and says the Florida Department of Education can launch an investigation of the district.

The rule on teachers’ licenses drew immediate condemnation from some teacher groups and LGBTQ advocates. Melanie Willingham-Jaggers, executive director of LGBTQ rights group GLSEN, said in a statement Thursday that the Florida rule “will harm LGBTQ+ students, who we know benefit by having supportive teachers and inclusive curriculum in the classroom.” -WaPo

The Dept. of Education rule was published as Hurricane Ian hit, and was first reported last Tuesday by the Progress Report.

A spokesman for the department said on Thursday evening that "it should not be surprising that educators are at risk of having their certificates sanctioned if they violate state law. The proposed amendment will change nothing for teachers who follow the law and are focused on providing high-quality classroom instruction aligned to state academic standards."


Monday, October 17, 2022

Changes in cancer therapy over 3 decades with risk of later breast cancer in female child cancer survivors

 Tara O. Henderson, MD, MPH1Qi Liu, MS2Lucie M. Turcotte, MD, MPH3et al

doi:10.1001/jamaoncol.2022.4649

Key Points

Question  Are the changes in approaches to radiation and chemotherapy treatment for children with cancer over time associated with changes in risk for breast cancer among long-term cancer survivors?

Findings  In this longitudinal cohort study of 11 550 female survivors of childhood cancer, the risk of breast cancer modestly decreased with time, which was largely associated with the decreased use of chest radiotherapy, although the risk was tempered by concurrent changes in other therapies.

Meaning  Ongoing efforts to both improve survival outcomes and minimize long-term toxic effects in the treatment of childhood cancer were associated with decreasing risk of breast cancer over time.

Abstract

Importance  Breast cancer is the most common invasive subsequent malignant disease in childhood cancer survivors, though limited data exist on changes in breast cancer rates as primary cancer treatments have evolved.

Objective  To quantify the association between temporal changes in cancer treatment over 3 decades and subsequent breast cancer risk.

Design, Setting, and Participants  Retrospective cohort study of 5-year cancer survivors diagnosed when younger than 21 years between 1970 and 1999, with follow-up through December 5, 2020.

Exposures  Radiation and chemotherapy dose changes over time.

Main Outcomes and Measures  Breast cancer cumulative incidence rates and age-specific standardized incidence ratios (SIRs) compared across treatment decades (1970-1999). Piecewise exponential models estimated invasive breast cancer and ductal carcinoma in situ (DCIS) risk and associations with treatment exposures, adjusted for age at childhood cancer diagnosis and attained age.

Results  Among 11 550 female survivors (median age, 34.2 years; range 5.6-66.8 years), 489 developed 583 breast cancers: 427 invasive, 156 DCIS. Cumulative incidence was 8.1% (95% CI, 7.3%-9.0%) by age 45 years. An increased breast cancer risk (SIR, 6.6; 95% CI, 6.1-7.2) was observed for survivors compared with the age-sex-calendar-year-matched general population. Changes in therapy by decade included reduced rates of chest (34% in the 1970s, 22% in the 1980s, and 17% in the 1990s) and pelvic radiotherapy (26%, 17%, and 13% respectively) and increased rates of anthracycline chemotherapy exposures (30%, 51%, and 64%, respectively). Adjusting for age and age at diagnosis, the invasive breast cancer rate decreased 18% every 5 years of primary cancer diagnosis era (rate ratio [RR], 0.82; 95% CI, 0.74-0.90). When accounting for chest radiotherapy exposure, the decline attenuated to an 11% decrease every 5 years (RR, 0.89; 95% CI, 0.81-0.99). When additionally adjusted for anthracycline dose and pelvic radiotherapy, the decline every 5 years increased to 14% (RR, 0.86; 95% CI, 0.77-0.96). Although SIRs of DCIS generally increased over time, there were no statistically significant changes in incidence.

Conclusions and Relevance  Invasive breast cancer rates in childhood cancer survivors have declined with time, especially in those younger than 40 years. This appears largely associated with the reduced use of chest radiation therapy, but was tempered by concurrent changes in other therapies.

https://jamanetwork.com/journals/jamaoncology/fullarticle/2797487

Experimental cancer drug could be effective in treating idiopathic pulmonary fibrosis

 Researchers have shown that the medication saracatinib shows promise as a treatment for idiopathic pulmonary fibrosis (IPF). Saracatinib worked as well or better than two approved drugs at reducing tissue scarring in preclinical models of IPF according to the study published in the American Journal of Respiratory and Critical Care Medicine. Researchers at National Jewish Health, Mount Sinai Ichan School of Medicine, Yale School of Medicine, and AstraZeneca collaborated on the research, which identified the oral therapy treatment based on a novel computational approach that analyzed several medications developed for other diseases.

“This initial research provides hope that we may soon be able to offer IPF patients another resource to treat their disease,” said Gregory Downey, MD, executive vice president of Academic Affairs at National Jewish Health and a lead author on the study. “This research is potentially an important step forward for patients with IPF. Current approved medications have variable responses and side effects.”

IPF is a progressive condition in which the lungs become scarred and breathing becomes increasingly difficult. It affects about 50,000 people in the U.S. each year and is currently incurable. In people with IPF, tiny air sacs in the lungs become damaged and increasingly scarred, making it difficult for oxygen to get into the blood.

Nintedanib and prifenidone have been previously approved by the Food and Drug Administration to slow disease progression. In evaluating 32 separate therapies, already developed for other conditions, researchers identified saracatinib as the best candidate. They discovered that saracatinib reduced fibrotic response in cells obtained from normal lung tissue as well as from IPF lung tissue. Additionally, they found that saracatinib reduced collagen and other lung scarring measures as much or more than nintedanib and prifenidone.

Following the findings, a phase 1/2 trial launched, called “STOP-IPF” that is testing saracatinib against a placebo in adults with IPF. The trial is expected to be completed in a year.

“Our primary focus is to show that saracatinib is safe in humans, and if we can show that it is safe and effective, I am hopeful that we can improve quality of life in patients,” said Dr. Downey.  

For more information on the STOP-IPF trial, contact Kaitlin Fier at 303.270.2852 or visit the National Jewish Health trial webpage.

National Jewish Health is the leading respiratory hospital in the nation. Founded 123 years ago as a nonprofit hospital, National Jewish Health today is the only facility in the world dedicated exclusively to groundbreaking medical research and treatment of patients with respiratory, cardiac, immune and related disorders. Patients and families come to National Jewish Health from around the world to receive cutting-edge, comprehensive, coordinated care. To learn more, visit njhealth.org or the media resources page.

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Less costly noninvasive test effective alternative to more costly test for colorectal cancer screening

 

  • National guidelines suggest a fecal immunochemical test (FIT) can be used as the primary noninvasive screening modality for early-stage colorectal cancer, but a significant proportion of patients still receive a more expensive alternative test called Cologuard®. 

  • Data used for national screening guidelines has shown no difference between the two tests at detecting adenoma versus colorectal malignancy. 

  • These results align with previous studies out of Japan and the Netherlands examining FIT as an appropriate screening modality that is more cost effective than other types of noninvasive colorectal screening tests.  

Commercially available noninvasive screening tests for colorectal cancer—a fecal immunochemical test (FIT) and the multi-target stool DNAtest (mt-sDNA; or Cologuard®)—are equally effective for screening patients with early-stage colorectal cancer. However, a FIT costs about one-fifth of the multi-target DNA test, according to new study results presented at the Scientific Forum of the American College of Surgeons (ACS) Clinical Congress 2022. 

Pavan K. Rao, MD, a general surgery resident at Allegheny Health Network in Pittsburgh, Pennsylvania, presented study results looking at 117,519 people in the Highmark claims database who underwent colorectal screening in 2019. Highmark is a Blue Cross Blue Shield Association insurer in four Mid-Atlantic states.   

From that group, the researchers identified 91,297 people who had noninvasive screening with either the fecal immunochemical test (FIT, n=45,487) or the DNA test (mt-sDNA, n=46,110) instead of having a routine colonoscopy.   

Key findings  

  • Among the study population that underwent colorectal screening, 45,487 (38.7 percent) had one of two commercially available FIT tests and 46,110 (39.2 percent) had the mt-sDNA test.  

  • Patients who were screened with either test presented with early disease, staged from 0 to II, at similar rates: 59.5 percent for FIT and 63.2 percent for mt-sDNA test (p=0.77).  

  • Patients within the Allegheny Health Network Oncology Registry diagnosed with colorectal cancer were matched to their claims data to determine distribution of cancer stage.  If the noninvasive test indicated signs of early disease, patients were then referred for additional testing to confirm the findings.   

  • The total annual costs for the tests were $6.47 million—$1.1 million for a FIT, or about $24 per test, and $5.6 million for mt-sDNA, or about $121 per test. Costs were calculated using Medicare reimbursement rates. 

Observations on study results  

The study followed guidelines issued by the U.S. Preventive Services Task Force (USPSTF) in 2016 and updated in 2019. Since then, the guidelines were updated again in 2021.

“Despite national guidelines suggesting that FIT be used as the primary noninvasive screening modality, we found that on review of our insurer’s claims data, a significant proportion of patients still receive a more expensive alternative test. There is substantial cost savings not only to our patients but to our health system with promoting appropriate use of noninvasive testing,” Dr. Rao said. 

“There was no difference in the clinical stage at the time of diagnosis between the two tests, which again demonstrates the clinical equipoise maintained by switching to FIT,” Dr. Rao said of the variation between the two tests.  

He added, “When you look at the national data for which the guidelines put forward, they found no difference between the two tests at detecting adenoma versus colorectal malignancy.”2 

Cost savings without compromising care  

The researchers determined that transitioning all noninvasive colorectal cancer screening to FIT would result in a $3.9 million savings annually in the study population.  

“In the current state of healthcare, we are thinking ever more about efficiency and reduction in costs while maintaining patient outcomes, and not compromising the quality of care we provide,” Dr. Rao said. “I think a colorectal surgeon or any specialist who sees appropriate patients for colorectal cancer screening can use this data to provide recommendations of alternative screening tests to patients who primarily do not want to undergo colonoscopy. We cannot only say it is appropriate from a guideline standpoint, but we’re also reducing wasteful spending in health care by appropriately using the FIT.” 

What makes this study unique is the methodology used to analyze the claims data, said study coauthor Casey J. Allen, MD, a surgical oncologist at Allegheny Health Network and an assistant professor at Drexel University College of Medicine, Pittsburgh. The researchers analyzed outcomes in the local health registry and then applied those outcomes to the claims database. “It’s not just the cost of the mt-sDNA test kit or the cost of the FIT kit multiplied by the number of members in the healthcare system,” Dr. Allen said. “It’s the full downstream costs depending on the rates of false-positive and false-negative tests and how much it costs to obtain a colonoscopy when that occurs. The cost of a screening colonoscopy in the database the researchers used was $635. 

These results support previous studies out of Japan3 and the Netherlands4 that found FIT was more cost-effective than other types of noninvasive colorectal screening tests.  

Study coauthors are Samantha Falls, DO, Stacey Shipley, BA, and Katie Farah, MD, of Allegheny Health Network, Wexford, Pennsylvania; and Patrick L. Wagner, MD, FACS, David L. Bartlett, MD, FACS, and Sricharan Chalikonda, MD, MHA, FACS, of Allegheny Health Network, Pittsburgh.  

Dr. Rao and Dr. Allen have no disclosures to report. 

Citation: Rao, PK et al. Comprehensive Cost Implications of Commercially Available Non-invasive Colorectal Cancer Screening Modalities: Results of A Large National Insurer Claims Database Analysis, Scientific Forum, American College of Surgeons Clinical Congress 2022.  

https://www.eurekalert.org/news-releases/967890

Many US women lack basic information on life after mastectomy

 As many as 50 percent of cancer patients who’ve undergone a mastectomy have elected to have breast reconstruction surgery. Yet, while breast reconstruction is a common procedure, a new national survey finds that many women may have not received adequate information to evaluate how it may impact them physically, financially and emotionally.

A new survey conducted online by The Harris Poll on behalf of the American Society of Plastic Surgeons (ASPS) among over 2,000 adults in the United States measured common myths and misconceptions about breast reconstruction surgery. While women have many choices in reconstructive breast surgery – including the option not to have the procedure – more than half of (54%) of women are unsure if there are surgical options beyond breast implants. Other results that highlighted a need for greater awareness include:

  • 62% of women do not know it is possible to regain sensation in the breast and 75% of women do not know it is possible to breastfeed after breast reconstruction. While surgical techniques allow women to regain sensation in their breasts and even allow some new mothers to breastfeed their infants, many women who were surveyed were unaware that these were possible after surgery. 
  • 73% of women are unsure if they’d be responsible for paying for the surgery, though federal law requires insurance companies to cover the cost of reconstructive surgery after a mastectomy.

“It’s important that patients receive clear information and are helped to understand all of their breast reconstruction surgery options,” said Bernard Lee, MD, MBA, MPH, President of The Plastic Surgery Foundation (The PSF). “There are still some misunderstandings around this procedure that often influence whether patients choose to even explore their treatment options. It’s important to clear up any misconceptions to provide patients the best care possible.”

Dr. Lee says it’s important that information about the surgical options is communicated concisely and effectively to patients - and that there are often preconceived notions about breast reconstruction surgery that he debunks.

“While reconstruction with breast implants is a good option for many patients seeking breast reconstruction after a mastectomy, it’s not the only option,” said Dr. Lee. “Many plastic surgeons also offer innovative microsurgical breast reconstruction procedures that use the patient's own tissue from other areas - such as the abdomen, buttock, back or thigh - to recreate a natural-looking breast. Patients need to be educated on all their options so they can make the best choice for themselves and their lives after mastectomy."

Recognizing that patients deserve accurate information to make the best decisions impacting their care, ASPS and The PSF launched the Breast Reconstruction Awareness Campaign and the annual Breast Reconstruction Awareness (BRA) Day.  

“At a time when a breast cancer patient is faced with a difficult change in their life, we want to engage, educate, and empower patients to make a choice that’s best for them, which includes knowing their breast reconstruction options. BRA Day helps us to do that,” said Lee. 

The Breast Reconstruction Awareness campaign involves informing patients, family, caregivers and media that the breast cancer loop remains open until a woman is informed of breast reconstruction options. Local BRA Day events are scheduled throughout the nation on October 19 and both the ongoing campaign and events seek to help raise funds to support research and grants in local communities and nationally.

Beyond the physical impact of mastectomy, there is an emotional component too, as women may experience a period of mourning due to the change in their body. Yet, the survey noted that nearly one third of women (29%) do not know there’s a period of emotional adjustment following breast reconstruction. As breast reconstruction patient Jen Rozenbaum can attest, it was an emotional experience every time she looked in the mirror. Rozenbaum was diagnosed with breast cancer five years ago and underwent a double mastectomy followed by eight rounds of chemotherapy and four breast reconstruction surgeries to regain what she describes as her sense of self.

“Breast reconstruction isn’t so much about the breasts as it is about the mind and how we feel as women and how we see ourselves as women,” said Rozenbaum. “For me, it made a world of difference. I couldn’t be more grateful for my surgery team who took the time to walk me through all my options and help me select the best treatment plan.”

As a photographer, Jen publicly documented her journey through breast reconstruction by turning the camera around on herself showing the reality of what a breast cancer body looks like after healing from breast cancer. Jen hoped that through sharing, she would help other women who are exploring breast reconstruction.

“I couldn’t be happier with my surgeries because I finally felt like I recognized the woman that I saw in the mirror again,” said Rozenbaum. “Online, I see so many women who are hesitant about the procedure or scared about their treatment options. I make sure to share my success story so that I can boost their confidence and empower them to take control of their bodies.”

Like Jen, the American Society of Plastic Surgeons, the largest plastic surgery specialty organization in the world, wants to help inform and empower women to best understand breast reconstruction options. The organization encourages women to consult with a board-certified plastic surgeon to learn about all of their options. This ensures that the surgeon is highly trained, employs the highest safety and ethical guidelines, and can provide the best information and guidance about any surgery options.

Survey Methodology
This survey was conducted online within the United States by The Harris Poll on behalf of The American Society of Plastic Surgeons from September 27-29, 2022 among 2,047 U.S. adults ages 18+ among whom 1,129 are women. The sampling precision of Harris online polls is measured by using a Bayesian credible interval.  For this study, the sample data is accurate to within +/- 2.8 percentage points using a 95% confidence level. For complete survey methodology, including weighting variables and subgroup sample sizes, please contact The American Society of Plastic Surgeons (ASPS).

https://www.eurekalert.org/news-releases/967725