Viewpoints: Lessons On The FDA’s Fuddling Of Statistics; Vaccine Trials Need To Include Children
Opinion writers weigh in on these public heath issues and others.
The New York Times:
The F.D.A. Commissioner’s Fuzzy Math
On Monday night, Dr. Stephen Hahn, the commissioner of the Food and Drug Administration, addressed inaccurate and misleading remarks he made in a news conference the previous evening. Dr. Hahn had initially claimed that plasma from recovered Covid-19 patients — what’s known as convalescent plasma — could save 35 out of every 100 people who contract the disease. As he has since explained on television and Twitter, his initial assessment conflated two different things: relative risk reduction (that is, how much a treatment reduces the risk of death in one group of patients compared to a different group) and absolute risk reduction (that is, how much a treatment reduces the risk of death in a group of patients compared to the rest of the population who didn’t get the treatment). (8/25)
The Washington Post:
It’s Time To Start Testing Potential Covid-19 Vaccines On Children
In the 1950s, a fearful America eagerly awaited a vaccine that would help end the scourge of polio. In April 1954, a trial of a vaccine developed by Jonas Salk, which enrolled 1.8 million children, began in McLean, Va. Just one year later, researchers announced that the vaccine was safe and effective, and a national program of mass vaccination began. By 1964, polio had almost been eradicated from the country. Almost 70 years later, a fearful America eagerly awaits a vaccine to fight against the novel coronavirus. The first large-scale trials of vaccine candidates have just begun, and hopes are high that one or more will prove safe and effective. But unlike for polio, most of these trials are enrolling only adults, so they will provide no evidence on the safety, effectiveness or dosing of the vaccines in children. Without data from children, the Food and Drug Administration is unlikely to approve the vaccines for pediatric use. This possibility is unacceptable. (Steven Joffe, 8/25)
Bloomberg:
The U.S. Needs Fast New Tests For Covid-19
Federal officials have had eight months since the new coronavirus arrived in the U.S. to work out how to test for Covid-19 well enough to get to grips with the pandemic. They’ve failed. As a result, schools, hospitals and other institutions can’t adequately trace or anticipate outbreaks, or stop contagious people from infecting others. Efforts to reopen the economy will falter until this problem is solved. (8/25)
The Wall Street Journal:
Trump’s Unforced Drug Error
One goal of the Republican convention this week is to make voters nervous about the Democratic Party’s new “socialism.” The pity is that the GOP is damaging its own case against a government takeover of health care with President Trump’s enthusiasm for price controls on drug prices. Monday night’s convention featured a young woman named Natalie Harp who credited Mr. Trump with her ability to access a treatment for bone cancer. She touted the Administration’s “right-to-try” law that affirms that desperately ill patients can petition companies for drugs that haven’t cleared the Food and Drug Administration. (8/25)
Stat:
Messaging About Covid-19 Is Wrong, So Americans Aren't Listening
Americans are being asked to adopt simple precautions that science has shown will help our nation slow the spread of the pandemic and, in turn, restore our economy and lives to something resembling normalcy. But it seems that, more than in any other country, the message isn’t getting through. This, I believe, is as much a reflection of the failure of those delivering the message — medical professionals, government officials, and the media — as of those ignoring it. (Shira Doron, 8/26)
The Hill:
We're United In An Effort To End The FDA's Dog Testing Mandate
They say if you want a friend in Washington, get a dog. Today lawmakers on both sides of the aisle are finally returning the favor, working together to eliminate the Food and Drug Administration's (FDA) outdated, burdensome and inhumane dog testing mandate. (Louise Linton, 8/25)
USA Today:
Oklahoma Sooners' COVID-19 Situation Casts Doubt On 2020 Season
As we inch closer and closer to season openers, there seem to be more and more doubts about whether college football can actually happen amid this pandemic. Universities across the country have welcomed students back to campus and started in-person learning only to reverse course within days, moving all classes online and even sending some students home. (Jenni Carlson, 8/25)
Louisville Courier -Journal:
Kentucky Derby With No Fans Is Right Call
With concerns mounting from medical experts about the rapid spread of COVID-19, the company Friday relented and gave up its ambitious but faulty plan to allow fans at the Kentucky Derby. It made little sense to bring 23,000 people from all over the world to Kentucky in the middle of a coronavirus pandemic that continues to sicken and kill vulnerable people across the nation and our commonwealth.(8/21)
Atlanta Journal Constitution:
Local Control Can’t Work With Virus Without Boundaries
If the state of Georgia responded to hurricanes the way it has to coronavirus, it would hand out umbrellas and promise sunny skies. Nowhere has this reliance on genial bromides and lack of hands-on leadership been more acute than in Georgia’s response to COVID-19 and schools. The burden of figuring out how to keep students and teachers safe has fallen on local school chiefs, who have no deadly pandemic playbook and face politicized and polarized debates in their communities over the severity of COVID-19 and the efficacy of masks. (8/25)
