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Monday, May 4, 2020

Routine cancer screenings have plummeted during the pandemic

As it became clear in March that the coronavirus was tearing through the U.S., federal health officials and cancer societies urged Americans to delay their routine mammograms and colonoscopies. The public has heeded those recommendations — and that’s helped lead to an apocalyptic drop in cancer screenings, according to a white paper released Monday by the electronic medical records vendor Epic.
Appointments for screenings for cancers of the cervix, colon, and breast were down between 86% and 94% in March, compared to average volumes in the three years before the first Covid-19 case was confirmed in the U.S., the Epic data show.
The paper provides only a snapshot of the overall picture — the company’s records cover just a fraction of all cancer screenings — but they help reveal the magnitude of the gaps in care resulting from the pandemic. Although there is debate about whether certain preventive cancer screenings actually save lives, many researchers fear that deadly cancers could go undetected if screening appointments that would have normally happened in recent weeks are not soon rescheduled.
Epic Cancer Screenings in U.S.
Epic
The data suggest there is reason to be concerned that cancer screenings may not rebound even as some states begin to reopen their economies. The Epic researchers found an elevated rate of cancellations of cancer screening appointments even in the days before mid-March, when counties began issuing stay-at-home orders and the American Cancer Society and the Centers for Disease Control and Prevention recommended that people delay non-urgent outpatient care.
“We’re also fairly convinced that even once they lift the lockdowns, we’ll still see the concerned patients a little bit more reluctant to go in,” Epic President Carl Dvorak told STAT. “Truthfully, it doesn’t take much to talk a person out of going in for a colonoscopy.”
Epic looked at data from 2.7 million patients in the U.S. whose records showed that they had at least one screening for cervical, breast, or colon cancer between 2017 and 2019. The data cover 190 hospitals spread across 39 health systems in 23 states.
Although there’s always seasonal variability in how many people go in for cancer screenings — appointments generally spike after Breast Cancer Awareness Month in October — the Epic researchers found that the plunge during the pandemic period went well beyond what could be expected under normal variation.
Breast and cervical cancer screenings fell by 94% in March compared to the 2017-2019 averages, while colon cancer screenings dropped by 86%, the researchers found. Dvorak, who commissioned the research, said he was “shocked” by the scale of that drop-off.
The Epic numbers follow a similar data release last week from the San Francisco-based health tech company Komodo Health, which analyzed the billing records of 320 million patients in the U.S. Komodo found that screening for cervical cancer was down 68% from March 19 to April 20, compared to the previous 11 weeks and a comparable period last year. Tests for cholesterol, diabetes, and active and recurrent cancers were down, too, with the sharpest declines in Covid-19 hotspots like New York and Massachusetts.
Cancer screenings generally take place at doctor’s offices and at diagnostic centers run by larger health systems. There’s been variability in how these facilities have responded to the pandemic: Some have closed their doors altogether, while others have stayed open for emergencies or maintained a skeleton crew of staff.
Epic did not draw any conclusions in its research about why a small fraction of screenings continued in recent weeks, Dvorak said. It’s possible, though, that some of those may have represented people who were especially worried about their cancer risk, such as a woman who found a large lump in her breast, or people who were less concerned about getting infected with the virus by going into the clinic.
As doctor’s offices and health systems begin to go back to relatively normal operations, Dvorak said he hopes that the research can help Epic’s customers develop a strategy for booking people who may have delayed recommended cancer screenings, such as by prioritizing calls to people at high risk of cancer due to past irregular screenings or a family history.
Epic doesn’t have any immediate plans to try to publish its findings on a preprint server or in a medical journal, but Dvorak said the company hopes to partner with its health system customers so they can do research on health outcomes associated with Epic’s data.
Dvorak said his team also plans to mine Epic’s data to see if it substantiates anecdotes that the company has been hearing from its customers, such as reports that brain surgeries have declined or that there’ve been more emergency amputations for people with diabetes.
Routine cancer screenings have plummeted during the pandemic, medical records data show

Collateral damage occurs when doctors and patients wear ‘Covid-19 blinders’

My friend Mina had a stroke at home while an infectious disease pandemic raged around her. As a physician, I was blindsided. Not just by her stroke, but by the collateral damage of this pandemic: delayed diagnosis and treatment for severe medical illnesses at the cost of trying to prevent exposure to the virus that causes Covid-19.
Part of the problem is seeing everything through a coronavirus lens. There are catastrophic risks when doctors and patients wear Covid-19 blinders.
Mina is at high risk for developing complications from Covid-19 because she is 70 years old and has multiple sclerosis and heart disease. One day her left leg suddenly became weak and she fell twice. Alarmed, she phoned her neurologist, who told her that her multiple sclerosis was likely becoming more symptomatic.
Normally, symptoms like sudden weakness in a leg or arm would be evaluated in a doctor’s office or emergency department with a physical exam and brain MRI to see if they were due to a stroke or seizure. Mina’s medical center, however, had recently reported new Covid-19 cases. To avoid exposing her to the virus, her neurologist advised her to stay home and to monitor her symptoms.
Two days later she developed difficulty speaking and smiling on one side of her face. With the new symptoms and another call to her neurologist, we all agreed that she needed an MRI.
It revealed that Mina had experienced a stroke. Instead of getting treatment right away, which is the standard of care for stroke — “time is brain” stroke specialists often say — it was only days later that she received the vital medications, referrals to physical and speech therapy, and evaluations of her neck and brain.
There are widespread reports of fewer visits in emergency departments and doctors’ offices for strokes, heart attacks, and routine medical care. Across the U.S., 911 calls have fallen by 20% to 35%. Spain has seen a nearly 40% reduction in emergency procedures for heart attacks during the Covid-19 crisis. Outside of emergency care, overall outpatient visits for routine medical conditions are down by 30%, including virtual visits. And in a survey across 49 states, only 7% of primary care physician practices reported scheduling preventive visits as a high priority.
Stroke, heart disease, cancer, and lung diseases — among the leading causes of death in the U.S. — have not gone away just because Covid-19 has emerged. Patients and doctors are potentially missing or ignoring worrisome symptoms unrelated to Covid-19 and not addressing them. Interrupting care for patients with chronic conditions can lead to disastrous outcomes.
While the nation understandably focuses its hospitals’ preparedness for the surge of Covid-19 patients, much of the pandemic response occurs in outpatient settings and increasingly through telemedicine. Efforts by doctors and nurses to triage patients to the safest settings to reduce risk of Covid-19 transmission is more important now than ever before. Many primary care practices have transitioned more than 60% of in-person visits to telemedicine, with 40% of doctors and staff mostly using telephones and 23% using video visits.
Mina’s story, however, reveals an overwhelming unpreparedness of our nation’s outpatient centers to care for high-risk patients during this pandemic. Doctors are struggling to decide if our patients’ chances of surviving are better if they stay home or go to the hospital.
Physicians have been given limited guidance for making the nuanced decisions required to treat patients who don’t have Covid-19 but who are both clinically complex and at high-risk for complications if they developed the infection. The absence of standardized guidelines for using telemedicine or the infrastructure to deliver care at home can lead to delayed diagnosis and treatment. Even though Mina had help to navigate the medical system, she experienced this delay. For others without such assistance, delays of care can be damaging — even deadly.
Patients’ fears compound these complex decisions. My colleagues and I weekly receive calls from patients with symptoms that would normally require an emergency department or office visit. Take Craig, a 67-year-old with a history of heart attacks, who called me to report that he was experiencing chest pain and was worried about another heart attack. Under normal circumstances, I would have told him to go to the closest emergency department. But he refused to go to a hospital under any circumstances after his friend was diagnosed with coronavirus. These fears are real, common, and affect patients and their doctors. While Craig is an engaged patient who proactively called me, giving me a chance to intervene, I know that there are many others who avoid communicating symptoms with their doctors out of fear.
Along with uncertainty about deciding whether to risk the possibility of exposing patients to the coronavirus, doctors’ fear of becoming infected themselves can change how they practice medicine. This anxiety is fueled by not knowing if their teams can prevent them from becoming ill. In early April, 58% of doctors and staff in primary care practices lacked personal protective equipment, and more than 30% of them expressed frustration with constantly changing or conflicting guidelines. With little access to protective gear, confusion about who needs it, and stories of health care workers getting sicker due to higher exposure, doctors are becoming more willing to implement telemedicine.
We urgently need strategies for the complex scenarios that doctors now face to balance care for non-Covid-19 conditions with the desire to protect their patients from being exposed to the virus that causes it. Developing new approaches to care for patients in the time of Covid-19 may reduce future waves of collateral damage with losses that could be as significant those from the virus itself.
Virtual care can help reach many patients, but most medical centers do not yet have the infrastructure in place to fully support highly efficient telemedicine. In addition to providing telemedicine-enabled devices, medical centers must have systems to identify and prioritize which patients will benefit from them the most. For example, they can distinguish their patients who are at high risk of becoming sick using predictive analytic models, may engage in using technology, and could be taught how to use telemedicine tools.
Even though some new clinical guidelines are being released during the pandemic, medical teams require more guidance on how to implement telemedicine. Doctors can benefit from help deciding which scenarios warrant a video, phone, or in-person visit. Remote visits also could be supplemented using home-based lab collection and home monitoring devices to provide information on blood pressure, blood oxygen levels, blood sugar, heart rhythms, and perform audible lung and heart exams.
Even with advanced remote monitoring, some patients will still need in-person evaluation. Emergency care is essential for patients who are critically ill, even with the risk of Covid-19 exposure. That is especially true for patients who face challenges accessing telemedicine. In a survey of primary care physicians, 72% said they have patients who are unable to access telehealth because they do not have access to a computer, smartphone, or the internet. These patients may need help learning how to use telemedicine devices or in-person evaluations such as those available through hospital-at-home and home-based primary care programs.
Fully connecting with patients who live with chronic conditions will require the U.S. to bolster its ambulatory infrastructure and financing. Primary care stimulus packages could help support the expansion of the hospital-at-home approach, along with home-based primary care and remote monitoring services. Similarly, an expansion of Medicaid would cover broad medical care for the newly uninsured and those with pre-existing conditions.
While it will take time to develop deliberate guidance, the nation needs urgent action to mitigate patients’ and doctors’ anxiety and hep remove the Covid-19 blinders to prepare for the collateral damage of non-Covid-19 medical conditions.
Reshma Gupta, M.D., is an internal medicine physician and medical director for value and population care with University of California Health in Sacramento, Calif. She thanks Dr. Reena Gupta for her input on this essay.
Collateral damage occurs when doctors and patients wear ‘Covid-19 blinders’

FDA tightens rules on COVID-19 tests aimed at corralling bad actors

The FDA now expects COVID-19 antibody testmakers to submit requests for emergency use authorization of their assays within 10 days of test validation, backing away from its “highly flexible” stance in mid-March not requiring the application if the manufacturer notified the agency that it was selling the test and affirmed that it was validated and labeled as unapproved.
The FDA temporarily lowered the bar in order to facilitate nationwide access to testing but some opportunists have taken advantage of the situation with substandard products, including an electronics salesman hawking an unauthorized home test kit and a former doctor convicted in a fraudulent gold-peddling scheme.
In a statement, the agency says, “Flexibility never meant we would allow fraud. We unfortunately see unscrupulous actors marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of Americans’ anxiety.”
https://seekingalpha.com/news/3568338-fda-tightens-rules-on-covidminus-19-tests-aimed-corralling-bad-actors

Ayala Sets IPO at 3.33 Million Shares; Sees Pricing at $14-$16

Ayala Pharmaceuticals Inc. on Monday said it expects to sell 3.33 million shares at between $14 and $16 apiece in its planned initial public offering.
At the $15 midpoint of that range, the Wilmington, Del., clinical-stage oncology company said it expects net proceeds of about $44.4 million, or roughly $51.3 million if the underwriters exercise their option to buy an additional 500,000 shares.
Ayala said it will use the proceeds to advance its AL101 and AL102 product candidates, which it is developing for patients suffering from rare and aggressive cancers.
Novartis AG currently holds a 7.2% stake on Ayala, while Bristol-Myers Squibb Co. owns roughly 6.4%, according to a filing with the Securities and Exchange Commission.
Ayala said it will have about 12.6 million shares outstanding after the IPO, assuming exercise of the overallotment option, for a valuation of about $189.2 million at the $15-a-share midpoint.
The company said it has applied to list its shares on the Nasdaq Global Market under the symbol AYLA.

https://www.marketscreener.com/BRISTOL-MYERS-SQUIBB-COMP-11877/news/Bristol-Myers-Squibb-Ayala-Sets-IPO-at-3-33-Million-Shares-Sees-Pricing-at-14-16-Each-30534694/

BAYER AG: Bernstein gives a Buy rating

In a research note published by Gunther Zechmann, Bernstein advises its customers to buy the stock. The target price is lowered from EUR 86 to EUR 88.
https://www.marketscreener.com/BAYER-AG-436063/news/BAYER-AG-Bernstein-gives-a-Buy-rating-30533098/

GLAXOSMITHKLINE: Goldman Sachs gives a Buy rating

In his latest research note, analyst Keyur Parekh confirms his positive recommendation. The broker Goldman Sachs is keeping its Buy rating. The target price is increased from GBp 1900 to GBp 2060.
https://www.marketscreener.com/GLAXOSMITHKLINE-9590199/news/GLAXOSMITHKLINE-Goldman-Sachs-gives-a-Buy-rating-30533112/

CytoDyn down as CEO sells stock while touting COVID-19 drug

CytoDyn (OTCQB:CYDY -8.8%) is under early pressure on the heels of a report from STAT’s Adam Feuerstein questioning management’s motives behind its aggressive promotion of leronlimab for the treatment of COVID-19 patients.
The company has released a blizzard of press releases (~26 since the first of March) while CEO Nader Pourhassan has appeared on a range of financial news shows touting the potential of the CCR5 inhibitor to treat the respiratory infection. Two studies are underway, one in mild-to-moderately ill patients and one in critically ill patients.
The stock broke out on March 27 after it announced that four COVID-19 patients with respiratory complications treated with leronlimab experienced near-normal immune profiles with improved cytokine levels. Shares have rallied three-fold since then.
A regulatory filing posted on Thursday, April 30, disclosed the potential sale of up to ~46.4M common shares by current investors, including 2.0M shares by Mr. Pourhassan pursuant to warrant exercises. He also apparently plans to sell an additional 2.8M shares, trimming his ownership stake by half.
https://seekingalpha.com/news/3568282-cytodyn-down-9-ceo-sells-stock-while-touting-covidminus-19-drug