WEBVTT - The Problem With Antibody Tests 0:00:03.320 --> 0:00:08.440 Welcome to Prognosis. I'm Laura Carlson. It's day fifty seven 0:00:08.680 --> 0:00:13.640 since coronavirus was declared a global pandemic. Our main story. 0:00:14.480 --> 0:00:19.760 Perhaps you've heard of antibody tests. These tools, different from 0:00:19.800 --> 0:00:24.239 COVID nineteen tests, which look for an active infection, can 0:00:24.280 --> 0:00:28.479 help determine whether you've had the virus and recovered. The 0:00:28.560 --> 0:00:33.159 federal government deemed them so important that it loosened regulations 0:00:33.400 --> 0:00:36.960 to get a bunch of them produced quickly, but that 0:00:37.479 --> 0:00:41.639 led to a flood of shady tests. Now the government 0:00:41.680 --> 0:00:46.280 is trying to tighten up again. But first, here's what 0:00:46.400 --> 0:00:55.480 happened today. It's a report that's become familiar. The number 0:00:55.520 --> 0:01:00.280 of Americans filing for unemployment benefits topped three million for 0:01:00.360 --> 0:01:05.800 a seventh straight week. The consistently high numbers suggest there's 0:01:05.920 --> 0:01:09.360 little relief in sight for the economy. Since the coronavirus 0:01:09.360 --> 0:01:14.319 began closing restaurants, factories, and offices from coast to coast 0:01:14.680 --> 0:01:19.520 in mid March, initial jobless claims totaled three point one 0:01:19.600 --> 0:01:23.399 seven million in the week ending May second, according to 0:01:23.400 --> 0:01:27.759 a Labor Department report released today that brought the seven 0:01:27.760 --> 0:01:33.640 week total to about thirty three point five million, and 0:01:33.800 --> 0:01:37.520 yet another move to make air travel safer. A new 0:01:37.600 --> 0:01:42.039 policy will require all US airport security screeners to start 0:01:42.120 --> 0:01:47.480 wearing masks. The Transportation Security Administration will announce the rule 0:01:47.560 --> 0:01:51.160 as soon as today, according to two people familiar with 0:01:51.200 --> 0:01:55.600 the discussions. The move comes as a government and industry 0:01:55.600 --> 0:02:00.000 working group considers a broader requirement that everyone entering an airport, 0:02:00.400 --> 0:02:04.600 including all employees and passengers, must also cover their faces. 0:02:05.560 --> 0:02:08.320 More than five hundred t s A screeners have tested 0:02:08.360 --> 0:02:12.680 positive for COVID nineteen, including six who died. According to 0:02:12.720 --> 0:02:17.840 the agency's website, The agency had left mask use voluntary 0:02:17.880 --> 0:02:22.720 for months. The coronavirus has caused people with other health 0:02:22.760 --> 0:02:27.000 conditions to delay their normal medical care. That has caused 0:02:27.000 --> 0:02:31.200 a surprise windfall for health insurers. In response, some of 0:02:31.240 --> 0:02:34.880 the US's biggest for profit insurers will give money back 0:02:34.960 --> 0:02:39.919 to customers and cut some upfront costs. United Health Group, 0:02:40.200 --> 0:02:44.160 the nation's largest insurer, said it will rebate premiums to 0:02:44.240 --> 0:02:48.560 some commercial customers and way of cost sharing for Medicare members. 0:02:49.720 --> 0:02:52.920 It's part of a one point five billion dollar pandemic 0:02:52.919 --> 0:02:58.880 assistance program. Separately, Signal Core said it's pharmacy unit will 0:02:58.919 --> 0:03:01.240 cap the costs of some drugs for people who have 0:03:01.400 --> 0:03:07.239 lost health insurance. Earlier this week, Humana Incorporated announced it 0:03:07.280 --> 0:03:10.840 would wave cost sharing for Medicare members to see primary 0:03:10.880 --> 0:03:16.000 care doctors for the rest of the year. France will 0:03:16.120 --> 0:03:20.960 roll back lockdown measures, joining countries including Germany, Italy and 0:03:21.000 --> 0:03:25.120 the Netherlands in easing restrictions as the economic pain from 0:03:25.160 --> 0:03:29.800 the coronavirus intensifies. France is preparing to go back to 0:03:29.840 --> 0:03:34.480 work and reopen schools starting on Monday, in a gradual 0:03:34.560 --> 0:03:40.560 process designed to avoid a second wave of infections. Even 0:03:40.560 --> 0:03:43.080 though more than one hundred and forty thousand people have 0:03:43.200 --> 0:03:46.880 died in Europe, the region's leaders are feeling pressure to 0:03:47.000 --> 0:03:51.320 return to normality. They are trying to walk a fine 0:03:51.400 --> 0:03:57.280 line between reactivating the economy and avoiding a renewed outbreak, 0:03:57.840 --> 0:04:01.560 and finally, one luxury brand as a winner. Amid the 0:04:01.640 --> 0:04:07.240 stock market carnage, Peloton Interactive shares hit another record high 0:04:07.560 --> 0:04:11.920 after reported its third quarter results. The company's high end 0:04:12.000 --> 0:04:16.320 exercise bikes and video fitness subscriptions have soared in popularity 0:04:16.800 --> 0:04:20.600 as fit people with high disposable incomes are forced into 0:04:20.600 --> 0:04:30.320 their homes and Jim's are shut down, and now our 0:04:30.360 --> 0:04:36.800 main story. Antibody tests are suddenly everywhere. Those tests measure 0:04:36.839 --> 0:04:41.280 whether someone contracted the virus in the past. They help 0:04:41.360 --> 0:04:45.000 policymakers understand how the virus spreads and whether measures to 0:04:45.040 --> 0:04:49.080 contain the virus are working. In some cases, it's been 0:04:49.120 --> 0:04:52.359 floated that they could help determine who has immunity to 0:04:52.360 --> 0:04:55.960 the virus and could therefore be allowed to return to work. 0:04:57.480 --> 0:05:01.560 Federal regulators relaxed guidelines to make it easier for companies 0:05:01.600 --> 0:05:04.920 to produce these tests, but this has allowed for a 0:05:04.960 --> 0:05:09.040 flood of unreliable and sometimes fraudulent tests to be offered 0:05:09.080 --> 0:05:14.440 to consumers. Now, Bloomberg reporter Kristen V. Brown reports the 0:05:14.520 --> 0:05:20.640 government is trying to control the mess. When the first 0:05:20.680 --> 0:05:24.440 antibody tests were coming online in mid March, the US 0:05:24.520 --> 0:05:29.279 Food and Drug Administration did something pretty remarkable. The agency 0:05:29.320 --> 0:05:32.160 said manufacturers wouldn't have to jump through any of the 0:05:32.279 --> 0:05:35.800 usual regulatory hoops. The tests could just go straight to 0:05:35.839 --> 0:05:41.120 market without any authorization. Suddenly there were ads for antibody 0:05:41.160 --> 0:05:46.360 tests everywhere. We have identified helpers of tests who are 0:05:47.000 --> 0:05:50.560 inappropriately marketing them. Many of them are marketing them for 0:05:50.760 --> 0:05:54.799 use at home. That was never permitted under a policy 0:05:54.880 --> 0:05:58.960 unless authorized by the FDA. Jeffrey Sharon is the director 0:05:59.000 --> 0:06:01.680 of the Center for Device is and Radiological Health at 0:06:01.680 --> 0:06:04.560 the f d A. It's his job to oversee things 0:06:04.640 --> 0:06:08.120 like performance and safety of tests. Some are marketing them 0:06:08.279 --> 0:06:12.080 as being authorized by the agency when they're not. We're 0:06:12.160 --> 0:06:17.039 making other claims. We've also have detained fraudulent test kits 0:06:17.080 --> 0:06:21.800 that have been attempted to have been imported into the US. Unfortunately, 0:06:21.800 --> 0:06:26.320 there are people who take advantage of any circumstance and 0:06:26.400 --> 0:06:29.359 people who are taking vantage with the pandemic, and we 0:06:29.400 --> 0:06:32.400 are trying to be pic joint in going after those 0:06:32.480 --> 0:06:36.479 perfect trators. There have been reports of companies doing things 0:06:36.520 --> 0:06:39.320 like advertising that their test can tell you whether you're 0:06:39.360 --> 0:06:43.600 immune to COVID nineteen. For the record, scientists are still 0:06:43.720 --> 0:06:47.120 unclear on whether having the virus once makes you immune 0:06:47.160 --> 0:06:50.880 to it in the future. Now the FDA is changing 0:06:50.920 --> 0:06:54.520 its policies to curb the release of these shady tests. 0:06:54.839 --> 0:06:57.599 FDA Commissioner Stephen Hans as tests will now need to 0:06:57.600 --> 0:07:01.840 get authorization from the agency for going to market. As 0:07:01.880 --> 0:07:05.160 I've said many times throughout this pandemic, every step this 0:07:05.279 --> 0:07:08.719 agency has taken in our approach to COVID nineteen has 0:07:08.720 --> 0:07:12.160 been a careful balancing of risks and benefits. We are 0:07:12.160 --> 0:07:15.960 striving to anticipate and meet the constantly evolving public health 0:07:16.000 --> 0:07:20.280 needs of this unprecedented public health emergency. That's why the 0:07:20.400 --> 0:07:23.720 FDA issued enough state to our COVID nineteen policy on 0:07:23.800 --> 0:07:32.560 antibody tests. There is another reason why the FDA changed course. 0:07:33.040 --> 0:07:36.680 It's bigger than just fraudulent tests advertise on social media. 0:07:37.800 --> 0:07:41.840 Unreliable tests could be prevented policymakers from getting a good 0:07:41.880 --> 0:07:45.360 sense of how widespread the virus is. Major studies on 0:07:45.360 --> 0:07:50.120 the topic have gotten blowback. For example, one Stanford University 0:07:50.120 --> 0:07:53.560 study used antibody tests to conclude that as many as 0:07:53.680 --> 0:07:57.840 four percent of local people had contracted the virus. Critics 0:07:57.880 --> 0:08:01.880 were skeptical that those tests were accurate it. Another study 0:08:02.040 --> 0:08:07.160 analyzed fourteen antibody tests and found only three produced consistently 0:08:07.240 --> 0:08:14.240 reliable results. Anibody tests are just complicated to design. For example, 0:08:14.400 --> 0:08:17.120 if a test isn't fine tuned, it could accidentally pick 0:08:17.200 --> 0:08:20.560 up on antibodies from a different virus and mistake it 0:08:20.600 --> 0:08:24.520 for COVID nineteen. Eric Toble is the director of Scripts 0:08:24.560 --> 0:08:28.920 Research Translational Institute. He says this is a problem because 0:08:28.920 --> 0:08:33.479 policymakers need accurate information when deciding how to roll back restrictions. 0:08:34.080 --> 0:08:36.880 We're trying to reopen, We're trying to get some semblance 0:08:36.960 --> 0:08:40.920 back to pre COVID world, and that has been the 0:08:40.960 --> 0:08:43.719 idea is, oh, well, I can screen people for the 0:08:43.760 --> 0:08:45.679 antibody and if they have it, we can just go 0:08:45.720 --> 0:08:48.120 back to work and back to life. Well, it turns 0:08:48.160 --> 0:08:52.160 out that could be a recipe for trouble because currently 0:08:52.320 --> 0:08:56.080 the false positive rates are you know, two three on 0:08:56.120 --> 0:08:58.760 these tests doesn't sound like much, but it could be 0:08:58.800 --> 0:09:03.280 actually a real troubleing factor. Health officials also worried that 0:09:03.360 --> 0:09:07.439 testing for antibodies could give people a false sense of safety. 0:09:07.559 --> 0:09:10.160 We haven't yet determined whether people become immune to the 0:09:10.240 --> 0:09:13.440 virus after they've had it. The FDA cracked down on 0:09:13.480 --> 0:09:18.720 antibody tests after scientists and lawmakers spent weeks raising the alarm. 0:09:18.760 --> 0:09:22.480 The tests have become so infamous for their murky results 0:09:22.520 --> 0:09:25.480 that last week the White House even suggested that we 0:09:25.480 --> 0:09:27.760 should be using two of them at the same time 0:09:27.920 --> 0:09:31.960 to check the results against each other. But Eric says 0:09:32.000 --> 0:09:35.800 even the f d recent actions won't be enough. A 0:09:35.800 --> 0:09:38.240 lot of the tests that have gotten through the FDA, 0:09:38.400 --> 0:09:40.920 or not even gone through the FDA are based on 0:09:40.960 --> 0:09:44.760 twenty or thirty people, which is, you know, just grossly inadequate. 0:09:45.640 --> 0:09:48.200 Right now, there just isn't enough data to assess the 0:09:48.280 --> 0:09:51.360 quality of most tests. The good news though, is that 0:09:51.400 --> 0:09:54.360 better tests are coming, and people like Eric are really 0:09:54.440 --> 0:09:57.520 excited about some of them. In the meantime, if you 0:09:57.559 --> 0:09:59.960 see an ad for a test that promises to tell 0:10:00.040 --> 0:10:03.480 you whether you have coronavirus immunity, don't take the bait. 0:10:09.920 --> 0:10:14.520 That was Bloomberg's Kristen V. Brown and that's our show today. 0:10:15.320 --> 0:10:18.000 For coverage of the outbreak from one and twenty bureaus 0:10:18.040 --> 0:10:23.880 around the world, visit Bloomberg dot com slash coronavirus and 0:10:24.040 --> 0:10:26.480 if you like the show, please leave us a review 0:10:26.720 --> 0:10:30.720 and a rating on Apple Podcasts or Spotify. It's the 0:10:30.760 --> 0:10:33.840 best way to help more listeners find our global reporting. 0:10:35.240 --> 0:10:38.840 The Prognosis Daily edition is hosted by Me Laura Carlson. 0:10:39.559 --> 0:10:43.200 The show was produced by Me Tophor Foreheads, Jordan Gospore, 0:10:43.600 --> 0:10:49.200 and Magnus Hendrickson. Today's main story was reported by Kristin V. Brown. 0:10:50.240 --> 0:10:55.120 Original music by Leo sidran Our editors are francesco Levy 0:10:55.320 --> 0:10:59.920 and Rick Shawn. Francesco Levy is Bloomberg's head of podcasts. 0:11:00.640 --> 0:11:01.480 Thanks for listening.