Good morning. On the docket today: a lot of positive coronavirus antibody tests in New York, the effects of the pandemic on patients without the virus, and a delay on a controversial Alzheimer’s drug.
One in five tested New Yorkers has coronavirus antibodies
The pulse
In an announcement on Thursday, New York Governor Andrew Cuomo said that 21% of the 1300 people in New York City tested for coronavirus antibodies had tested positive.
That’s a lot…
It really is, if the number is accurate. A positive antibody test suggests that a patient has or has had COVID-19. All-told, 3000 people across the state of New York were tested and 14% tested positive for antibodies, raising the possibility that close to 2 million people in the city and 3 million people in the state have been infected. As of April 24th, 250,000 cases have been confirmed in New York.
What’s the implication?
Obviously, this test suggests that a lot more people have the disease than we have been able to identify. The good news, though, is that if the test is accurate, it means that the death rate is significantly lower than we expected.
Can we trust this data?
You may remember from Tuesday’s Pulse that antibody testing in the wake of the pandemic has been less than reliable. New York has its own tests that state officials have been working to validate over the past weeks. The state’s health commissioner claims that this “strong” test is reliable enough to determine infection and antibody-driven immunity.
Other officials are less optimistic. NYC’s head of disease control noted that antibody tests are prone to false negative and false positive results, leading to “significant voids” in the science.
Bottom line it for me.
It’s likely that a lot more people have coronavirus than we suspected, meaning that the disease has been more infectious and less lethal than initially believed. However, until we are able to completely trust and validate our testing methods, it is difficult to use these results to drive policy decisions.
Source: The New York Times
It’s not just coronavirus patients who are struggling to receive care
The pulse
COVID-19 has taken over the entire health system, endangering the lives of those without the disease. New surveys reveal that fear of infection is causing some non-COVID-19 patients to delay seeking crucial care while others don’t even have the option of being treated.
What life-saving care is being delayed?
COVID-19 anxiety is likely dissuading patients from visiting emergency rooms. A study published earlier this month from nine hospitals across the U.S. revealed that ER visits for heart attacks dropped by 40% in the month of March and overall ER visits in New York City have halved.
Is it possible that people are just having fewer emergencies?
Experts think it’s unlikely – in fact, many predict that a combination of stress, unhealthy eating habits, and less exercise due to staying at home would actually increase cardiovascular events such as heart attacks and strokes.
What’s happening to these patients who are staying at home instead of going to the hospital?
Physicians are worried that some of the patients who could be saved in the ER are instead dying at home, presumably avoiding the hospital out of fear of contracting the coronavirus. Others may suffer from permanent neurologic or cardiac damage as a heart attack or stroke goes untreated for a longer period of time. Nobody knows how many cases like this are happening, but these patients are coming to be known as the “hidden victims” of the pandemic.
Who else is being affected?
Care is being rationed, even for patients who do seek it. One in four cancer patients have reported delays in their treatment because of coronavirus. Organ transplants have been cut by a third and clinical trials that may provide life-saving drugs are being halted worldwide.
Final Thoughts:
While these patients struggling to receive care may not be counted in the COVID-19 death tolls, they illustrate the far-reaching effects the pandemic has had on the healthcare system.
The launch of a controversial Alzheimer’s drug gets delayed
The pulse
Pharma giant Biogen announced that its Alzheimer’s drug aducanumab will not be submitted for FDA approval until the summer. The submission was originally slated for “early 2020.”
Why the delay?
You may remember that Biogen was plastered over the news earlier this year when they hosted a conference that led to the “superspreading” of COVID-19 in Massachusetts. According to Al Sandrock, the company’s head of R&D, Biogen is still feeling the ill-effects of the conference, as employees involved with aducanumab submission have been infected.
Biogen leadership added, however, that compiling the analyses for the drug data required by the FDA was “complex” and “taking more time” than they had foreseen.
What’s aducanumab, and why is its data complex?
Aducanumab works to remove plaques in the brain that some people believe to accelerate the progression of Alzheimer’s. In March 2019, Biogen announced that the much-anticipated drug had failed, citing data that showed no benefit over placebo. In October, however, Biogen dramatically revived aducanumab, explaining that additional data and a new statistical analysis proved the drug’s efficacy.
This reversal was surprising, unprecedented, and particularly impactful in the Alzheimer’s space, where treatments are few and far between. If the data is accurate, it’s a positive sign for patients, but some experts chalk the reversal up to nothing more than statistical manipulation.
What happens next?
Analysts have been struggling for more than a year with what to make of Biogen and aducanumab. If aducanumab succeeds, it’ll become a go-to drug for many of the 5.5 million Americans with Alzheimer’s. But it’s unclear whether the true cause of this latest delay is a doubt over the data that revived the drug in the first place. The FDA will have a critical decision to make whenever Biogen eventually submits for approval.
Rapidfire
The U.S. Department of Health and Human Services is facing criticism over the decision to name Brian Harrison head of the U.S. Pandemic Task Force. Reuters reports that Harrison has no formal education in public health and previously worked as a labradoodle breeder. No, Brian, that does not count as lab experience.
Study results from Gilead’s remdesivir trial in China were inadvertently leaked. Though remdesivir, the antiviral being tested as a COVID-19 treatment, has seemed promising, the leaked results seem to suggest no benefit for patients. It’s surprising news after a positive data signal earlier this week. The Chinese study was stopped early and the full report has yet to be published.
Three lions, five tigers, and two cats (oh, my!) have tested positive for COVID-19 in NY. Some people have been wondering how the felines have been able to get tested amidst ongoing testing shortages for humans. If you ask us, this has Carole Baskin and Big (Cat) Pharma written all over it.
You asked, we answered
On Tuesday, we gave you the opportunity to submit your questions from the week’s healthcare news. We received a flurry of requests and weren’t able to address all of them. We’ll be answering one per week: keep submitting and we’ll get your questions answered on future Fridays!
This week, Fiona from New York asked:
Can you tell us more about daridorexant, the new insomnia drug? How is it different to what’s currently available?
Currently, three of the most popular sleep aids — Ambien, Sonata, and Lunesta — work by increasing the effects of GABA, a molecule which helps broadly inhibit signals in your brain so that you can go to sleep. The problem is, those sedating effects can last up to 14 hours, so people might feel groggy or out of it the next day. Daridorexant works in a different way: it blocks the effects of a molecule called orexin that normally helps you stay awake. Instead of causing an “Ambien hangover,” daridorexant combats insomnia for a shorter amount of time, allowing people to be more alert the next day.
It’s been a roller-coaster week of coronavirus testing and data readouts. We’ll be back at it next Tuesday: don’t forget to share and sign up below to get the news straight to your inbox.
Have a great weekend,
Mrinal and Serena