MacroGenics final overall survival results show no statistically significant advantage

 

• Final overall survival (OS) analysis did not demonstrate a statistically significant advantage for MARGENZA over trastuzumab

• OS was greater with MARGENZA plus chemotherapy in exploratory subgroups of patients carrying a CD16A 158F allele compared to trastuzumab plus chemotherapy arm, while the OS for trastuzumab plus chemotherapy was greater than MARGENZA plus chemotherapy for the small exploratory subgroup of patients homozygous for the CD16A 158V allele

• The safety profile remains similar to what has been reported previously

https://finance.yahoo.com/news/macrogenics-announces-final-overall-survival-203000157.html

Kansas data doesn’t reflect reality as COVID-19 rips through schools

  School districts across the state independently reported hundreds of infections of COVID-19 among students and staff in the first two weeks of school, while the state’s official ledger showed just two small outbreaks.

The Kansas Department of Health and Environment’s data on school infections is unreliable because of the difficulty in tracing sources of infections and communication between the agency and local health officials. In its most recent update, the agency’s official accounting attributed just 75 new cases to outbreaks at public schools.

The number of outbreaks is actually much higher, but nobody is attempting to tally statewide numbers. Gov. Laura Kelly last week announced a new workgroup would produce a weekly report with active outbreaks, but the governor’s office didn’t say when the first report would be released. It isn’t clear whether the report will rely on the same incomplete data.

County health departments determine the source of outbreaks, but the task is made difficult by the surge in COVID-19 cases attributed to the delta variant and restrictions imposed by the Legislature last year that allow infected residents to opt out of contact tracing. Because of widespread community transmission, it can be difficult to determine whether children who test positive at school were infected there or showed up with the virus.

Craig Barnes, division manager for community health outreach and planning at the Shawnee County Health Department, said keeping track of cases at schools is complicated. The department is able to investigate just 20% of the cases countywide.

“The large number of cases coming in both via schools and the community has made investigations and contact tracing rather difficult,” Barnes said. “There are schools that have multiple cases. However, without an epidemiological link between the cases at the physical school, we would not list this as an outbreak or cluster.”

Barnes provided a hypothetical example: “Let’s say a school basketball team had a sleepover, and from that sleepover five-plus kids were infected. These would be COVID-positive students with an epidemiological linkage. However, the exposure and linkage was outside the school setting, and as such, the cluster would be the sleepover, not the school.”

It is also possible, he said, that health officials won’t recognize the link between cases and a school until much later.

KDHE provides a list of outbreaks involving five or more people within the past 14 days, and updates the list on Wednesdays. The only schools to show up on the list in recent weeks are Mount Olive Lutheran School in Overland Park, with eight cases, and USD 405 Central Elementary School in Lyons, with six cases.

“We also see the numerous news reports of entire classrooms being quarantined and schools closing,” said Matt Lara, spokesman for KDHE. “When we see these, we reach out to local health departments to find out if there is an active outbreak that we have not been notified about. Again, KDHE relies on communication and cooperation between students, teachers, staff, parents, schools and the local health departments to identify these outbreaks.”

The Wellington school district closed schools from Aug. 27 until Tuesday after more than 40 students and staff members tested positive in the first eight days of school. The Sumner County Health Department recommended closing after tracing three separate outbreaks of infections to district schools.

The Valley Center school district said 45 students and staff had tested positive for COVID-19 as of Sept. 1, up from eight a week before, the Ark Valley News reported.

Last week, the Andover school district imposed a mask mandate at public schools after 38 students tested positive for the virus, up from 19 the previous week, KWCH-TV reported.

In the Wichita school district, 194 students and 51 staff tested positive before Aug. 23, when the school board required students to wear masks. The district had 1,612 students in quarantine at that time, the Wichita Eagle reported.

In Garden City, the school district had seven cases in the first week of school, 15 the following week, and 13 on Aug. 23 alone, the Garden City Telegram reported.

In the Gardner Edgerton school district, 50 students and staff tested positive for the virus, and 200 students had to be quarantined, the Kansas City Star reported.

The Auburn-Washburn school district in Shawnee County had 47 students and three staff members test positive in the first week of school, requiring 163 students and four staff members to be quarantined, the Topeka Capital-Journal reported.

Mulvane and Ark City schools boards imposed mask mandates last week in response to an increase in the number of cases, KAKE-TV reported.

In the Turner school district in Kansas City, Kansas, 23 students and four staff members tested positive in the first week of class.

Mark Tallman, associate executive director of the Kansas Association of School Boards, said schools prepared for the school year with the hope of returning to normal. School officials didn’t want to over-respond to the rising threat of the delta variant, he said.

“No one wants to go back to mandates. No one wants to have kids in quarantine. No one wants to think about closing schools,” Tallman said. “The idea is to live as close to normal as possible to get the best possible environment.”

The governor said the new Safer Classrooms Workgroup would bring together pediatricians, family physicians, school nurses, pharmacists, school psychologists, and other health professionals to meet weekly. The group will produce a report to serve as a resource for schools, parents, media and policymakers.

The report will provide a list of active outbreaks at schools, as well as timely information about testing and masking policies, including best practices; information about vaccination clinics; and county-level data on youth vaccination status, hospitalizations, cases and deaths.

Kelly “has a crackerjack team of physicians and epidemiologist that are studying the outbreak county by county and looking at transmission in schools and how we can keep schools open,” said Kansas education commissioner Randy Watson. “That really is the key. Because everyone’s worried if this trends like last year as we get into the winter months, it may get worse. We hope not.

“So I know that the simple answer is if we can vaccinate and we can mask, we can test, we can start to diminish it. But I think that group’s going to look at a lot of things.”

https://lawrencekstimes.com/2021/09/07/kdhe-data-covid/

Whitmer calls on Michigan legislature to repeal law against abortion

 Michigan Gov. Gretchen Whitmer (D) called on the state legislature on Tuesday to repeal a decades-old state law that criminalizes abortion, which could go into effect if Roe v. Wade is overturned. 

The governor urged the Michigan legislature to abolish the state law that dates back to 1931 to ensure that women maintain the right to abortion, as reproductive rights rights activists panic that the nearly 50-year-old precedent in Roe v. Wade could be in jeopardy. Michigan’s abortion law has not been enforced because of the 1973 Supreme Court decision. 

Whitmer‘s request comes after the Supreme Court declined to block Texas’s “fetal heartbeat” law from going into effect and as the court is also slated to hear arguments for a case involving a Mississippi abortion ban next term. 

The governor called the Texas legislation “a gross violation of the constitutional right to choose.”

“If the court’s decision in the Texas case is any indication, a majority of justices are willing to throw out the constitutional right to choose that has been in place for 48 years and repeatedly upheld for decades,” the governor said in a press release. 

Whitmer declared her support for state Sen. Erika Geiss’s (D) bill that would end the 1931 law and called on state lawmakers to send it to her desk.

“Repealing the law would ensure that the right to choose, which is supported by a significant majority of Michiganders, remains a right in Michigan, even in the face of continued, relentless attacks on Roe v. Wade,” she said.

The Center for Reproductive Rights predicted that if Roe v. Wade is “weakened” or “overturned,” Michigan state legislators “will likely try to prohibit abortion.” The state courts have not yet ruled on whether the state constitution protects abortion rights.

“If Roe v. Wade is limited or overturned, it is likely that Michigan will attempt to enforce its pre-Roe ban, prohibiting abortion with only a life-endangerment exception,” the center said in a report.

Several states have passed also so-called trigger laws in recent years, which would automatically ban abortions in those states if the Supreme Court were to overturn Roe v. Wade.

Whitmer’s push to protect abortion rights in Michigan also comes ahead of the state’s 2022 gubernatorial race during an election year when abortion is expected to be a front and center issue.

Concerns have mounted over Roe v. Wade’s future after the conservative-majority Supreme Court narrowly ruled 5-4 to allow Texas’s six-week abortion ban to go into effect. 

The Texas law prohibits abortions after the fetus’s cardiac activity is detected, which can happen as early as six weeks, before many women know they are pregnant. But the legislation allows for private citizens rather than state authorities to enforce the ban and earn at least $10,000 for successful lawsuits. 

The unique legislation has captured the attention of other anti-abortion politicians in the U.S., as some consider implementing the same law in their states. 

The Supreme Court is also expected to rule on the Mississippi case that directly challenges Roe v. Wade by next summer, only months ahead of the 2022 elections. 

https://thehill.com/policy/healthcare/571105-whitmer-calls-on-michigan-legislature-to-repeal-law-against-abortion

95% of US counties now see 'high' COVID-19 transmission rate: CDC

 

© CDC

More than 95 percent of U.S. counties are now seeing “high” rates of COVID-19 transmission, according to the Centers for Disease Control and Prevention (CDC).

The CDC's COVID Data Tracker revealed on Tuesday that 95.19 percent of counties in the U.S. are seeing a “high” rate of transmission, meaning there were at least 100 new cases reported per 100,000 people in the past seven days.

Around 2 percent of counties are seeing “substantial” and “low” rates of transmission, and less than one percent of counties are seeing “moderate” rates of transmission.

The U.S. is seeing a nationwide surge in COVID-19 cases, driven largely by the highly infectious delta variant, which is more contagious than previous versions of the virus.

Dr. Anthony Fauci, President Biden's chief medical adviser, said on Sunday that the delta variant is "over 99 percent dominant."

The U.S. surpassed 40 million COVID-19 cases on Tuesday, according to data from the CDC. More than 647,000 people in the U.S. have died since the beginning of the pandemic.

The majority of recent COVID-19 hospitalizations and deaths, however, have been among unvaccinated individuals, further bolstering evidence that the shots are effective against severe illness.

Seventy-five percent of adults in the U.S. are now at least partially vaccinated against COVID-19, a milestone that was announced by a White House official on Tuesday.

More than 1.5 million shots were administered between Sunday and Tuesday, according to White House COVID-19 Data Director Cyrus Shahpar, which lifted U.S. adults above the 75 percent benchmark.

https://thehill.com/policy/healthcare/571140-95-percent-of-us-counties-now-seeing-high-covid-19-transmission-rate-cdc

Contraceptive Pill Tied to Higher Risk of Blood Clots After Knee Surgery

 The use of birth control pills appeared to boost the risk of blood clots in women undergoing simple knee arthroscopy and anterior cruciate ligament (ACL) reconstruction, a new study found.

The risk of post-surgery venous thromboembolism (VTE) more than doubled in this population (OR 2.1, P<0.001), and obesity and smoking increased the risk even more (adjusted ORs 3.05 and 4.25, respectively, P<0.001), reported Harris Slone, MD, of Medical University of South Carolina in Charleston, and colleagues in a poster presented at the American Academy of Orthopaedic Surgeons annual meeting.

The findings were previously published in the journal Arthroscopy earlier this year.

The researchers conducted their study after seeing several young, healthy women develop clots either after orthopedic surgery or between the time of an injury and the planned surgery, Slone told MedPage Today. "We know that the estrogen and progesterone in combination oral contraception pills increase the risk of clots," he said. "And we know that clots are problematic following orthopedic surgery, especially surgery around the pelvis, hip, and knee. But there has been little research to date quantifying the risk of oral contraception plus orthopedic surgery."

Miho J. Tanaka, MD, director of the Women's Sports Medicine Program at Massachusetts General Hospital in Boston, told MedPage Today that several risk factors should be taken into account, such as smoking, obesity, lack of mobility, and genetic predisposition. "All of these should be factored in, in addition to the type and duration of oral contraceptive pills, in their relationship to the development of VTE," said Tanaka, who wasn't involved in the study.

Slone and colleagues used a large healthcare database to track 64,165 female patients ages 16 to 40 who underwent simple knee arthroscopy and ACL reconstruction from 2010 to 2015. They focused on post-surgery blood clots -- both deep vein thrombosis (DVT) and/or pulmonary embolism -- that occurred within 90 days of the procedures.

They found that the risk of VTE increased with oral contraception compared with no oral contraception in all patients (OR 2.13, 95% CI 1.83-2.48, P<0.001), for those who underwent ACL reconstruction (OR 2.34, 95% CI 1.79-3.07, P<0.001), and for those who underwent non-ACL knee procedures (OR 2.02, 95% CI 1.69-2.44, P<0.001).

The risk of postoperative clots increased even more -- beyond the cumulative effect -- if patients had another risk factor in addition to use of birth control pills.

The overall risk of clots was 0.95% in patients without obesity and oral contraception use. This risk rose to 1.62% in those who were obese (adjusted OR 1.35, 95% CI 1.01-1.82, P=0.41), to 1.72% in those who used oral contraception (adjusted OR 2.12, 95% CI 1.80-2.48, P<0.001), and to 3.13% in those who had both risk factors (adjusted OR 3.05, 95% CI 1.99-4.65, P<0.001).

Among smokers, the risk of clots was 1.24% (adjusted OR 1.00, 95% CI 0.668-1.50, P=0.998), which grew to 4.04% when these patients also used oral contraceptives (adjusted OR 4.25, 95% CI 2.41-7.50, P<0.001).

"These findings suggest that patients on perioperative OCPs [oral contraceptive pills] who are undergoing these procedures should be counseled regarding their increased risk of VTE," the study authors noted in their poster. "Patients may benefit from either stopping their OCPs one month prior to surgery or consider postoperative anticoagulation when perioperative OCP use and/or other risk factors are identified."

Birth control pills seem to boost the risk of clots in the lower extremities following orthopedic procedures, but not the upper extremities, Austin Stone, MD, PhD, of the University of Kentucky in Louisville, told MedPage Today. His own 2019 study found no link between oral contraceptive use and VTE after arthroscopic shoulder surgery.

The reason for the difference in risk between upper and lower extremity surgeries isn't clear, and doesn't appear to be related to the wider use of tourniquets in surgeries in the lower extremities, said Stone, who wasn't involved in this research.

The causes of the excess risk with oral contraception are also unclear, he added, although it is well known that birth control pills can cause a hypercoagulable state. "This effect is normally negligible, but becomes relevant in the setting of lower-extremity orthopedic surgery. Several additional factors could be at play, as the study highlights, such as smoking and obesity in the setting of birth control use," he noted.

Stone said that he would counsel patients to avoid oral contraceptives before surgery if possible, since "the risk of DVT is significant." Still, he added, "we need to determine who faces the highest risk and when is the optimal time to stop oral contraceptive pills."

He recalled treating a young patient with no risk factors other than oral contraceptive use who developed a postoperative DVT despite chemical prophylaxis after a knee arthroscopy and partial meniscectomy. "Fortunately, she was OK, but the effects can be devastating," he said.

Going forward, Tanaka said, it would be helpful to understand which types of oral contraceptives pose the highest risk, since many vary in dosage and the types of hormones included.

Disclosures

Disclosures for the study authors were not available.

Stone and Tanaka reported no disclosures.

Primary Source

American Academy of Orthopaedic Surgeons

Source Reference: Traven S, et al "Oral contraceptive pills double the risk for venous thromboembolism after knee arthroscopy and anterior cruciate ligament reconstruction" AAOS 2021.

https://www.medpagetoday.com/meetingcoverage/aaos/94385

Hims & Hers Partners With Rob Gronkowski on Men’s Health Issues, Treatment

 Hims & Hers Health, Inc. ("Hims & Hers", NYSE: HIMS), the multi-specialty telehealth platform that provides modern personalized health and wellness experiences to consumers, today announced it has partnered with American professional football tight end Rob Gronkowski to bring increased awareness to men’s health topics and treatment from hair loss to mental health with a series of new advertising campaigns and social content.

"As a football player, taking care of my body for performance on the field has always been a priority. Over the years, I’ve come to realize how important it is to take that same level of care off the field. But finding the time and resources to make that commitment can be a challenge," said Rob Gronkowski. "Most men simply aren’t aware of the options available to them, or are uncomfortable having these tough conversations. I hope to contribute in bringing more positive attention to the importance of investing in your mind and your body, and ultimately prioritizing your health. Hims is a one stop shop for helping you look and feel your best, from virtual visits with healthcare providers to personalized treatments delivered to your door. This is a healthcare model that is built for making your life easier, and helping you feel amazing. That’s a mission I’m excited to be a part of."

Hims & Hers offers personalized, high-quality solutions for conditions related to primary care as well as mental health, sexual wellness, hair care and skincare to digitally native consumers. The brand’s current selection of hair care, skincare and mental health services includes access to telehealth consultations with licensed medical professionals to discuss concerns such as acne, hair loss and anxiety, as well as access to a suite of prescription products and a collection of nonprescription product options.

"A Cleveland Clinic survey found that 72% of men would rather be cleaning toilets and doing household chores than going to the doctor. Statistics like these underpin a critical gap a platform like Hims can fill for men across this country," said Co-Founder and CEO Andrew Dudum. "As one of the most authentic and talented figures in sports, we are thrilled to partner with Gronk to further educate, destigmatize and empower men to take better care of themselves. Hims is more committed than ever to tackling these issues head-on and providing men with the personalized treatments they need. This is a mission we share with Rob and as such we’re thrilled to welcome him to our family and have him on our team."

https://www.yahoo.com/lifestyle/hims-hers-partners-rob-gronkowski-160000782.html

White House Lays Out $65 Billion Pandemic Preparedness Plan

 As COVID-19 infections driven by the Delta variant continue to spike across much of the United States, stretching health care services to the limits, the White House is seeking $65 billion to lay the groundwork for future pandemic preparedness.

Over the holiday weekend, the Biden administration announced plans for a new biopreparedness initiative that is part of the ongoing Building Back Better plan. In its announcement, the White House ongoing COVID-19 pandemic that has taken the lives of more than 623,000 Americans has illustrated the seriousness of viral and biological threats. Not only has COVID-19 been responsible for more deaths than those attributed to American Civil War, but the White House also estimated the economic damage to around $15 trillion it caused to the country. 

“We must seize the opportunity to ready ourselves for the biological threats on the horizon. Investing to avert or mitigate the huge toll of future pandemics and other biological threats is an economic and moral imperative. The cost of pandemic prevention pales in comparison to the enormous cost – in lives and in economic cost – of a pandemic. It’s hard to imagine a higher return on national investment,” the White House said in its announcement.

While COVID-19 has been devastating, the White House acknowledged that the next pandemic would likely be substantially different, which means the nation must prepare to deal with any viral threat.

In the first days of his administration, President Biden directed his officials to assess the nation’s capabilities to respond to future pandemics, including the re-establishment of the National Security Council Directorate on Global Health Security and Biodefense. The White House’s plan dubbed “American Pandemic Preparedness: Transforming Our Capabilities” lays out a set of urgent needs and opportunities across five key areas that are necessary to protect the United States against biological threats. 

The first goal is to transform medical defense, including an improvement and expansion of vaccines, therapeutics, and diagnostics against known threats, and lay the groundwork for unknown pathogens, such as COVID-19 when it first appeared. Secondly, the plan calls for ensuring “situational awareness” regarding infectious disease threats. This includes early warning and real-time monitoring of these viral threats. 

The third pillar of the plan calls to strengthen the public health systems in the country, as well as internationally. The program will increase responsiveness to emergencies, “with a particular focus on reducing inequities and protecting the most vulnerable communities.” 

The fourth part of the plan is to build core capabilities, which include the production of personal protective equipment, stockpiles, supply chains, biosafety and biosecurity, and regulatory improvement. 

Lastly, the final plan calls for strong management of the mission. Likening this pandemic preparedness effort to the Moon landing, the White House said “seriousness of purpose, commitment, and accountability” will be at the forefront. 

The plan lays out spending for each pillar, including $24.2 billion to test and develop vaccines against different pathogens and improve current manufacturing and distribution capabilities. The White House will also seek $11.8 billion for the development of new therapeutics.

“Achieving these capabilities will require a systematic effort and shared vision for biological preparedness across our government. Like any ambitious endeavor… transforming our nation’s pandemic preparedness will take serious, sustained commitment and ambitious accountability,” the White House noted. “And like those efforts, it is likely to yield benefits beyond the original mission – in this case advances in human health and providing tools that could overcome health inequities and ensure equitable access to innovative products.” 

https://www.biospace.com/article/white-house-lays-out-new-65-billion-pandemic-preparedness-plan