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Sunday, August 9, 2020

Internists, others urge med schools to waive the MCAT for 2021 cycle

The American College of Physicians (ACP) is “strongly encouraging” medical schools to waive the Medical College Admission Test (MCAT) requirement for students applying for admission in 2021 in response to the “unique challenges” posed by COVID-19.
ACP, which represents 163,000 internal medicine (IM) physicians, subspecialists, IM trainees and fellows, and medical students, issued a position statement Wednesday asking schools instead to rely on holistic review.
The Association of American Medical Colleges (AAMC), on the other hand, issued an open letter to MCAT takers Thursday saying the only fair option this year is continuing the test.
In its paper, ACP says that students of color and those of lower socioeconomic status are disproportionally affected by the fallout from COVID-19 in testing, including having to travel to distant testing centers. Mandating the tests, ACP says, will further increase those disparities.
ACP president Jacqueline W. Fincher, MD, told Medscape Medical News the push for the paper originated from advocacy from their student members.
But she said the circumstances called for a united voice from the entire organization, saying that requiring the test in this unprecedented time is simply not fair to all.
Fincher noted that some testing sites are closing or suddenly changing the number of students they can handle, which has led to massive confusion, frustration, and anxiety. Some students have had their testing dates pushed back repeatedly or have had to take the test in a different state.
“Students at higher risk for COVID may be put in unsafe situations,” she said. Having to get a hotel the night before or after the test is not economically feasible for all, she added.
She said ACP has been told that “at least 75% of schools” are still requiring the MCAT, which means some may not be able to make application deadlines this fall.
“You’re talking about students not having complete medical school applications, which means they wait another whole year,” she said.

Other Organizations Support Waiving Tests

The American Medical Women’s Association (AMWA), with about 3000 members, including medical students, issued a similar statement on Wednesday.
AMWA, however, asks that the MCAT “be optional for the current cycle and that applicants planning on retaking the MCAT be allowed to blind their previous scores.”
If barriers to taking the test persist, AMWA says, “the MCAT should continue to be optional.”
The American College of Perioperative Medicine, which includes healthcare providers, patients, healthcare executives, pharmaceutical and medical device representatives, payers, and employers, on Thursday also voiced its support for an MCAT-optional plan.
Students for Ethical Admissions (SEA), a group of undergraduate students, has been lobbying for waiving the MCAT for months. The group sent a three-part plea to the AAMC last month asking for: “waiving the MCAT for this current cycle, delaying the application, and a further commitment to communicating with pre-med applicants to induce changes that will benefit everyone involved in this process.”
An SEA representative, who spoke to Medscape Medical News but requested anonymity for fear of negative consequences, said she found out Thursday her test date had been moved a third time, this time to September.
She said SEA was encouraged by the support of the larger organizations’ announcements.
“They are our mentors and inspiration and definitely people we have looked up to since we went into medicine, so having their input is really meaningful to us especially since we are a newer organization.”
The SEA student said Hurricane Isaias this week has added another layer of challenge for some: getting to testing sites as well as studying without power.
“Students are still required to take the exam this weekend on the East Coast but we are getting reports that [power] outages are still relevant and playing a big part all the way from North Carolina up to Maine,” she said.
Saba Ayla Bagewadi, MD, an independent pediatrician in Chicago, tweeted her support for waiving the MCAT on Thursday, saying, “Pre-med students are studying in their cars during power outages, and risking their lives to venture out during a pandemic, all so they can take the MCAT. This needs to stop. #WaiveTheMCAT”
Bagewadi applauded the medical organizations for stepping up.
She told Medscape Medical News, “Larger institutions have the responsibility to advocate for what is right in times like this. It should help pre-medical students who are in this precarious position.”

AAMC Responds

Late Thursday afternoon, the AAMC issued its latest response in the controversy.
AAMC President and CEO David J. Skorton, MD, and Joseph E. Kerschner, MD, chair of the board of directors, said they are balancing equally important responsibilities: implementing safety protocols to keep students safe while taking the test and at the same time supporting schools in helping select a qualified and diverse future physician workforce.
They rely heavily on data, the letter states, and there have been few negative instances.
“Since May, 43,000 individuals have taken the exam in testing centers around the nation. As of Aug. 5, 2020, we’ve received reports or information directly from four MCAT examinees about COVID-19 infections: one of these examinees tested positive for COVID-19 12 days before the exam but did not disclose this information; one reported experiencing symptoms during the exam; and two reported developing symptoms within a week following their exams,” according to the letter.
Skorton and Kerschner write that an MCAT-optional plan is not fair because 37,000 of the 50,000 expected applicants have already sent their scores to medical schools.
Although online testing may be an option in future years, they say, current technology cannot guarantee legitimate results or reliable internet access.
“Therefore, to make the process as fair as possible in this difficult and challenging year and to preserve the integrity of the exam, the MCAT will continue to be administered in testing centers under strict safety protocols for the current admissions cycle,” they write.
Fincher and Bagewadi have disclosed no relevant financial relationships.

Kodak loan deal on hold after allegations

The U.S. International Development Finance Corp. says it is holding up a loan agreement with Eastman Kodak (NYSE:KODK) to produce drugs that could be used to fight the coronavirus until allegations of insider trading are cleared.
“Recent allegations of wrongdoing raise serious concerns,” DFC said late Friday in a tweet.
Last month, the government agency signed a letter of intent that could provide the former photography company a $765M loan to help pay for factory changes needed to make pharmaceutical ingredients in short supply in the U.S.
But last week, Democrat U.S. senators asked the SEC to investigate whether insider trading laws had been broken, citing “unusual trading activity” before the deal was announced, and the SEC reportedly has launched a probe.

Saturday, August 8, 2020

Gene therapy biotech Freeline prices upsized IPO at $18 high end

Freeline Therapeutics, a Phase 1/2 biotech developing gene therapies for hemophilia and rare diseases, raised $159 million by offering 8.8 million shares at $18, the high end of the range of $16 to $18. The Stevenage, UK-based company offered 1.5 million more shares than anticipated. At pricing, Freeline Therapeutics commands a fully diluted market value of $636 million.
Freeline Therapeutics plans to list on the Nasdaq under the symbol FRLN. J.P. Morgan, Morgan Stanley, Evercore ISI and Wedbush PacGrow acted as lead managers on the deal.

Lilly’s sintilimab shows treatment benefit in first-line lung cancer

Following up on their initial announcement in January, Eli Lilly (NYSE:LLY) and China development partner Innovent Biologics (OTCPK:IVBIY) announce detailed results from a China-based Phase 3 clinical trial, ORIENT-11, evaluating the combination of PD-1 inhibitor Tyvyt (sintilimab), Alimta (pemetrexed) and platinum chemo for the first-line treatment of patients with nonsquamous non-small cell lung cancer (NSCLC) without sensitive EGFR mutation or ALK rearrangement.
The data were presented virtually at the World Conference on Lung Cancer Presidential Symposium.
The addition of Tyvyt to Alimta and chemo resulted in a statistically significant improvement in progression-free survival (PFS) compared to placebo + Alimta + chemo. At a median follow-up of 8.9 months, median PFS in the Tyvyt arm was 8.9 months compared to 5.0 months in the comparator arm with almost 52% less risk cancer progression or death (hazard ratio = 0.482) (p<0.00001).
The objective response rate (ORR) in the Tyvyt group was 51.9% compared to 29.8% in the comparator group with a shorter median time to response (1.51 months vs. 2.63 months).
No new safety signals were observed.
Another Phase 3, ORIENT-12, evaluating Tyvyt and chemo in first-line metastatic squamous NSCLC was also successful.
China’s National Medical Products Administration approved Tyvyt in December 2018 for classical Hodgkin lymphoma patients who have received at least two prior lines of therapy.

Asymptomatic SARS-CoV-2 infections

Diana C Buitrago-Garcia, Dianne Egli-Gany, Michel J Counotte, Stefanie Hossmann, Hira Imeri, Aziz Mert Ipekci, Georgia Salanti, Nicola Low

Decreased SARS-CoV-2 rates in persons with recent non-COVID-19 vaccinations

Colin Pawlowski, Arjun Puranik, Hari Bandi, AJ Venkatakrishnan, Vineet Agarwal, Richard Kennedy, John C O’Horo, Gregory J Gores, Amy W Williams, John Halamka, Andrew D Badley, Venky Soundararajan

Povidone-Iodine Shows Rapid In Vitro Virucidal Activity Against SARS-CoV-2

August 8, 2020

Abstract

Introduction

As of 22 June 2020, Severe Acute Respiratory Syndrome (SARS)-coronavirus (CoV)-2 has infected more than 8.95 million people worldwide, causing > 468,000 deaths. The virus is transmitted through respiratory droplets and physical contact from contaminated surfaces to the mucosa. Hand hygiene and oral decontamination among other measures are key to preventing the spread of the virus. We report the in vitro virucidal activity of topical and oral povidone-iodine (PVP-I) products against SARS-CoV-2.

Methods

Suspension assays were used to assess the virucidal activity of PVP-I against SARS-CoV-2. Products were tested at a contact time of 30 s for virucidal activity. Viral titres were calculated using the Spearman–Kärber method and reported as median tissue culture infectious dose (TCID50)/mL.

Results

All four products [antiseptic solution (PVP-I 10%), skin cleanser (PVP-I 7.5%), gargle and mouth wash (PVP-I 1%) and throat spray (PVP-I 0.45%)] achieved ≥ 99.99% virucidal activity against SARS-CoV-2, corresponding to ≥ 4 log10 reduction of virus titre, within 30 s of contact.

Conclusion

This study provides evidence of rapid and effective virucidal activity of PVP-I against SARS-CoV-2. PVP-I-based products are widely available for medical and personal use for hand hygiene and oral decontamination, and could be readily integrated into coronavirus disease, COVID-19, infection control measures in hospital and community settings.
Key Summary Points
Why carry out this study?
To generate evidence of PVP-I virucidal activity against SARS-CoV-2, the virus that causes COVID-19 disease.
With no definitive treatment or vaccine available as yet for COVID-19, effective infection control measures are needed to limit virus spread.
Previous studies showed the efficacy of PVP-I products against similar viruses (SARS-CoV, MERS-CoV) and a range of other viruses, but PVP-I has not yet been directly tested against SARS-CoV-2.
What was learned from the study?
All four tested PVP-I products demonstrated ≥4 log10 reduction of SARS-CoV-2 titres, corresponding to a ≥ 99.99% kill rate, with a contact time of 30 s. This shows the rapid virucidal activity of the PVP-I products against SARS-CoV-2.
PVP-I-based disinfectants are already widely available and could be readily integrated into existing infection control protocols in both hospital and community settings.