WEBVTT - The Test Market Is a Free-for-All 0:00:00.880 --> 0:00:05.880 Welcome to Prognosis. I'm Laura Carlson. It's day one hundred 0:00:07.120 --> 0:00:12.200 since coronavirus was declared a global pandemic. Today's main story 0:00:13.200 --> 0:00:16.560 in the US. We still don't have as many COVID 0:00:16.640 --> 0:00:20.680 tests as we need, and when people can get their 0:00:20.680 --> 0:00:26.960 hands on tests, they're not always reliable. But first, here's 0:00:26.960 --> 0:00:36.760 what happened in virus news today. The UK added London 0:00:36.960 --> 0:00:41.760 to its watch list of potential pandemic hotspots as coronavirus 0:00:41.880 --> 0:00:47.240 cases surge across the country. The move is fueling fears 0:00:47.280 --> 0:00:51.080 that the capital, which recorded six hundred and twenty new 0:00:51.200 --> 0:00:55.040 COVID nineteen cases on Thursday, could face the kind of 0:00:55.120 --> 0:01:00.720 local lockdown measures imposed on other cities. The no new 0:01:00.760 --> 0:01:04.920 restrictions will be put on London immediately. Its designation as 0:01:04.920 --> 0:01:09.600 an area of concern means extra testing will be made available, 0:01:09.800 --> 0:01:15.959 according to London Councils. In China, annual vaccine capacity is 0:01:16.000 --> 0:01:19.880 expected to reach six hundred and ten million doses by 0:01:20.000 --> 0:01:24.120 year end and one billion doses by the end of 0:01:26.280 --> 0:01:29.960 that's according to Jiang jongwe, an official at the National 0:01:29.959 --> 0:01:34.360 Health Commission. At a briefing in Beijing. Jang said prices 0:01:34.400 --> 0:01:38.240 will be affordable for the public, but did not give specifics. 0:01:39.480 --> 0:01:43.399 No serious cases of adverse reaction were reported yet in 0:01:43.480 --> 0:01:49.920 an emergency use program of China's innoculations, And finally, in 0:01:49.960 --> 0:01:54.040 the next few days, the world will officially record one 0:01:54.120 --> 0:01:59.080 million deaths from COVID nineteen, but the real tally might 0:01:59.120 --> 0:02:04.680 be almost double that. Actual fatalities from the worst pandemic 0:02:04.720 --> 0:02:08.320 in a century may be closer to one point eight million. 0:02:09.160 --> 0:02:12.120 The death toll could grow to as high as three 0:02:12.160 --> 0:02:16.880 million by the end of the year. Both projections are 0:02:16.919 --> 0:02:20.800 according to Alan Lopez, a laureate professor and director of 0:02:20.800 --> 0:02:25.360 the University of Melbourne's Global Burden of Disease Group. The 0:02:25.480 --> 0:02:30.320 coronavirus is rapid spread and transmission by people without symptoms 0:02:30.840 --> 0:02:34.360 mean that it has moved faster than our ability to 0:02:34.440 --> 0:02:43.680 do widespread testing. And now for today's main story, six 0:02:43.720 --> 0:02:47.919 months into the coronavirus pandemic, the US is still hamstrung 0:02:48.160 --> 0:02:53.040 by testing efforts. There simply aren't enough COVID nineteen tests, 0:02:53.680 --> 0:02:58.280 and even when there are tests available, they aren't always reliable. 0:02:59.360 --> 0:03:02.480 Here's you order, Kristin V. Brown on the free for 0:03:02.639 --> 0:03:12.000 roll that US coronavirus testing has become last month when 0:03:12.120 --> 0:03:15.840 nineteen people at a nursing home and Needham, Massachusetts, suddenly 0:03:15.880 --> 0:03:20.399 tested positive for COVID nineteen. It sent the facility into 0:03:20.440 --> 0:03:25.079 a tailspin. But North Hill Communities hadn't had any positive 0:03:25.080 --> 0:03:31.160 tests for weeks. That's North Hill CEO Ted Owens. He 0:03:31.320 --> 0:03:34.600 was especially worried because in the US, more than a 0:03:34.720 --> 0:03:38.040 third of deaths from the novel coronavirus have been connected 0:03:38.160 --> 0:03:43.000 to nursing homes. Massachusetts long term care facilities were especially 0:03:43.000 --> 0:03:48.280 hard hit emotionally. You get to the point where in 0:03:48.360 --> 0:03:52.760 the beginning, as people were dying, it was very stressful 0:03:52.800 --> 0:03:57.960 for the staff, and then things calmed down, things tapered down. 0:03:58.360 --> 0:04:00.560 He kind of got used to it, you know, you 0:04:00.640 --> 0:04:05.080 reached some sort of new normal, not completely, but you 0:04:05.200 --> 0:04:09.360 kind of adjusted to where things were. And then suddenly 0:04:10.720 --> 0:04:15.720 you go probably three weeks with no positives, and then 0:04:15.840 --> 0:04:19.960 suddenly you have nineteen positives that came out of the blue. 0:04:23.680 --> 0:04:27.039 At the height of the pandemic, dozens of staff members 0:04:27.040 --> 0:04:31.320 and residents had contracted the virus and nine residents had died, 0:04:32.360 --> 0:04:35.160 but they had figured things out and put infection control 0:04:35.160 --> 0:04:39.040 measures in place. Ted said that those positive results had 0:04:39.080 --> 0:04:42.440 instilled fear throughout the nursing home that a second wave 0:04:42.480 --> 0:04:46.000 of infection had come to the facility. But it turned 0:04:46.000 --> 0:04:48.640 out there wasn't a new wave of virus sweeping through 0:04:48.680 --> 0:04:54.360 the nursing home. The problem was the test. North Hill 0:04:54.480 --> 0:04:57.719 was one of about sixty nursing homes in Massachusetts that 0:04:57.800 --> 0:05:02.440 contracted with the Boston company called Origin. Origin is better 0:05:02.520 --> 0:05:06.440 known as a consumer DNA testing company, and not a 0:05:06.520 --> 0:05:09.919 very serious one. One of its tests actually hunts for 0:05:10.040 --> 0:05:14.360 superhero genes. But Ted didn't know any of this when 0:05:14.360 --> 0:05:18.119 he started using the company. In late June, the state 0:05:18.200 --> 0:05:22.159 ordered all nursing homes to do regular surveillance testing and 0:05:22.200 --> 0:05:24.320 gave them less than three weeks to set up a 0:05:24.360 --> 0:05:28.360 testing program. Ted doesn't know how he heard about Origin. 0:05:28.880 --> 0:05:31.440 He just knows it was a scramble to find any 0:05:31.480 --> 0:05:34.719 company that could complete the amount of testing he needed 0:05:34.720 --> 0:05:38.839 every week. At one point, the state did recommend Origin 0:05:38.880 --> 0:05:44.800 to nursing homes. My analogy is it was like, Okay, 0:05:44.960 --> 0:05:48.719 we're telling you that from now on you have to fly. Well, 0:05:48.800 --> 0:05:52.080 how do I fly? That's up to you. You figure 0:05:52.120 --> 0:05:54.560 that out. I'm just telling you what you need to do. 0:05:55.200 --> 0:05:57.640 And that's kind of what they did with the surveillance testing. 0:05:57.720 --> 0:06:01.599 They said, you need to do the surveillance testing, and 0:06:02.000 --> 0:06:03.920 it's up to you to figure out how to get 0:06:03.960 --> 0:06:08.080 it done. A few weeks into surveillance testing, when all 0:06:08.120 --> 0:06:11.760 of those positive results came back, ted thought it seemed odd, 0:06:12.600 --> 0:06:15.560 and he told the state Health Department that, but he 0:06:15.640 --> 0:06:19.200 still had to treat the results seriously. He sent the 0:06:19.240 --> 0:06:22.640 eighteen staff members who tested a positive home and asked 0:06:22.640 --> 0:06:26.120 other staff to work over time. He isolated the one 0:06:26.160 --> 0:06:29.080 resident who had tested positive, and he sent out a 0:06:29.200 --> 0:06:32.440 letter to all the family members of residents telling them 0:06:32.600 --> 0:06:37.080 what had happened. And, as you would expect, it through 0:06:37.640 --> 0:06:41.520 everyone into a panic. We were in scramble mode. So 0:06:41.640 --> 0:06:44.920 the first thing we did was we we started to 0:06:45.240 --> 0:06:50.040 do a complete audit of all our infection control procedures 0:06:50.520 --> 0:06:55.800 to try and figure out Initially, we just dissowned that 0:06:56.000 --> 0:06:58.760 somewhere there was a source of infection and we had 0:06:58.800 --> 0:07:05.120 missed it. It turned out that North Hill wasn't the 0:07:05.200 --> 0:07:08.880 only nursing home in Massachusetts going through this fire drill. 0:07:09.680 --> 0:07:13.360 The state investigation found that the company returned almost four 0:07:13.480 --> 0:07:18.200 hundred false positive results. At least eleven nursing homes were impacted. 0:07:19.600 --> 0:07:23.480 False positives are almost always the result of a laboratory error. 0:07:24.000 --> 0:07:28.320 They usually mean that somehow a sample was contaminated. This 0:07:28.480 --> 0:07:31.720 happened sometimes, but labs are supposed to have checked someplace 0:07:31.840 --> 0:07:36.000 to catch those errors. The state said the Origin didn't 0:07:37.040 --> 0:07:40.720 for ted. That meant spending tens of thousands of dollars 0:07:40.880 --> 0:07:44.480 in overtime and sick time and trying to figure out 0:07:44.520 --> 0:07:48.080 where the virus had come from. It also meant really 0:07:48.160 --> 0:07:52.520 scaring people for no reason. I think about the fear 0:07:52.600 --> 0:07:58.080 that this instills in these nine year old people who 0:07:58.120 --> 0:08:03.080 are scared to begin with about this whole thing. And 0:08:03.680 --> 0:08:08.200 you know, we spend months trying to get them to 0:08:09.480 --> 0:08:13.160 calm down, to convince them that we're doing everything we 0:08:13.200 --> 0:08:16.200 can to keep them safe, that we're following all the 0:08:16.240 --> 0:08:19.880 protocols that are sent to us by c d C, 0:08:20.640 --> 0:08:25.680 the Massachusetts Department of Public Health. Now, this wasn't the 0:08:25.760 --> 0:08:30.000 first time that Origin had run into lab issues. Last year, 0:08:30.200 --> 0:08:32.800 I reported a story in which former employees said that 0:08:32.840 --> 0:08:38.160 the company had generally troubling lab practices, including tampering with results. 0:08:38.920 --> 0:08:41.840 At the time, the company said that the former employees 0:08:41.840 --> 0:08:46.840 were disgruntled and called their accounts grossly inaccurate. A few 0:08:46.920 --> 0:08:50.280 years ago, Origin also grabbed headlines for not distinguishing a 0:08:50.280 --> 0:08:54.200 difference between DNA from a dog and DNA from a person. 0:08:55.240 --> 0:08:58.440 Origin is not even close to the only company that 0:08:58.480 --> 0:09:01.840 has had issues with its tests. Here is Davy Smith, 0:09:02.120 --> 0:09:05.120 the head of the Division of Infectious Diseases and Global 0:09:05.200 --> 0:09:09.600 Public Health at the University of California, San Diego. At 0:09:09.600 --> 0:09:12.560 the beginning of the epidemic, the CDC realized that there 0:09:12.600 --> 0:09:16.280 was going to be quality control issues, right, so they 0:09:16.280 --> 0:09:19.600 said only we could test, and that allowed them to 0:09:19.720 --> 0:09:23.040 have as much control over the quality because they knew 0:09:23.040 --> 0:09:25.280 exactly this is the one test that was done, this 0:09:25.320 --> 0:09:27.920 is how it was going to be diagnosed, and they 0:09:27.920 --> 0:09:30.800 would have all the data. So that's a very good 0:09:30.960 --> 0:09:35.360 top down quality control process. The problem was there was 0:09:35.600 --> 0:09:38.480 no way the CDC could do all the tests that 0:09:38.480 --> 0:09:42.280 were necessary, um that was needed in a pandemic. So 0:09:42.360 --> 0:09:44.480 the second thing they did was, Okay, you know what, 0:09:45.000 --> 0:09:48.880 everybody has machines in all these labs all across the country, 0:09:49.120 --> 0:09:50.920 and you can do your own tests, so we can 0:09:50.960 --> 0:09:56.000 democratize testing. So go out there and go forth and test. 0:09:57.080 --> 0:10:00.920 Amidst a massive shortage of tests, the fd a basically 0:10:00.960 --> 0:10:05.400 opened the floodgates. Making a basic COVID nineteen test in 0:10:05.480 --> 0:10:09.080 theory isn't all that difficult. A lot of labs have 0:10:09.120 --> 0:10:12.200 the equipment to do it. An Origin isn't even the 0:10:12.240 --> 0:10:15.480 weirdest company to pivot to COVID nineteen testing. There at 0:10:15.559 --> 0:10:19.320 least two companies that were previously best known for treating 0:10:19.320 --> 0:10:24.880 erectile's function that also now offer coronavirus tests. Origin did 0:10:24.960 --> 0:10:28.600 receive what's known as an emergency Youth authorization for its test, 0:10:29.080 --> 0:10:31.680 but the review process for that is just not all 0:10:31.679 --> 0:10:35.760 that rigorous, and as of last month, labs that develop 0:10:35.800 --> 0:10:38.720 their own tests like Origin won't even have to jump 0:10:38.760 --> 0:10:41.520 through that hoop. At the moment, it's a little bit 0:10:41.559 --> 0:10:45.200 of the wild West, because the demand is so great 0:10:45.280 --> 0:10:48.199 and the supply it is so small that anybody out 0:10:48.200 --> 0:10:51.680 there can make a test. You may recall other headlines 0:10:51.720 --> 0:10:55.680 about false results in recent months, including seventy seven false 0:10:55.679 --> 0:11:00.280 positives that sent the NFL spinning. The US needs more tests, 0:11:00.280 --> 0:11:03.240 but those tests just aren't all that valuable if they're 0:11:03.280 --> 0:11:07.880 not reliable, Davy said. We need better standards for internal 0:11:07.960 --> 0:11:11.160 quality control at labs, as well as a system that 0:11:11.240 --> 0:11:14.440 periodically checks to make sure labs are doing things properly 0:11:15.120 --> 0:11:18.480 rather than just responding once an issue comes up. There 0:11:18.520 --> 0:11:23.040 are always going to be contamination issues, and they're always 0:11:23.040 --> 0:11:30.040 going to be technical issues and personnel errors, and we're humans, etcetera. 0:11:30.280 --> 0:11:32.440 The trick is to be able to catch it early 0:11:33.000 --> 0:11:38.679 and to be able to have rigorous quality assurance practices 0:11:38.760 --> 0:11:41.120 that are both internal. So if I run a lab, 0:11:41.200 --> 0:11:42.839 I want to make sure that my what I give 0:11:42.880 --> 0:11:47.800 my results out are reproducible and correct, and I want 0:11:47.840 --> 0:11:50.240 to be able to have an external agency that checks 0:11:50.240 --> 0:11:53.840 all my homework. Davy said the free market is supposed 0:11:53.840 --> 0:11:57.960 to produce the best, most reliable products, but he said 0:11:58.440 --> 0:12:01.679 that is not what has happened during the pandemic. One 0:12:01.720 --> 0:12:03.760 of the things that I learned early on in this 0:12:03.880 --> 0:12:07.360 pandemic is that there wasn't if you had a task, 0:12:07.720 --> 0:12:11.160 there wasn't any competition you had. The demand for your 0:12:11.240 --> 0:12:14.720 test was so high that there was no Everybody was 0:12:14.760 --> 0:12:17.440 after you, and it didn't matter how good your quality was. 0:12:21.360 --> 0:12:24.400 The state of Massachusetts required Origin to submit a plan 0:12:24.679 --> 0:12:28.400 to fix its internal quality issues. The company is now 0:12:28.520 --> 0:12:31.240 waiting for a green light to resume testing in the 0:12:31.280 --> 0:12:35.400 state in a statement to Bloomberg Origins said that it 0:12:35.520 --> 0:12:39.920 is confident that it will resume operations soon and provide accurate, 0:12:40.160 --> 0:12:43.520 timely test results. The company said it has made a 0:12:43.559 --> 0:12:47.280 plan to address its shortcomings in the lab, including hiring 0:12:47.320 --> 0:12:51.000 outside consultants to review its processes and hiring a new 0:12:51.120 --> 0:12:54.760 vice president of operations and a director of quality assurance. 0:12:55.720 --> 0:12:59.640 The company said that is conducted more than forty thou tests, 0:13:00.080 --> 0:13:03.680 including for schools and nursing homes. It continues to sell 0:13:03.720 --> 0:13:20.080 its tests in other states. That was Kristin V. Brown 0:13:20.679 --> 0:13:23.320 and that's it for our show today. For coverage of 0:13:23.320 --> 0:13:25.960 the outbreak from one and twenty bureaus around the world, 0:13:26.320 --> 0:13:30.840 visit Bloomberg dot com, slash coronavirus and if you like 0:13:30.920 --> 0:13:33.520 the show, please leave us a review and a rating 0:13:33.880 --> 0:13:37.480 on Apple Podcasts or Spotify. It's the best way to 0:13:37.520 --> 0:13:42.640 help more listeners find our global reporting. The Prognosis Daily 0:13:42.800 --> 0:13:47.760 edition is produced by Topher foreheads Jordan Gospore, Magnus Hendrickson 0:13:47.920 --> 0:13:52.520 and me Laura Carlson. Today's main story was reported by 0:13:52.559 --> 0:13:57.960 Kristin V. Brown. Original music by Leo Sidrin. Our editors 0:13:57.960 --> 0:14:03.000 are Francesco Levi and Rick Shawn Francesco Levie is Bloomberg's 0:14:03.080 --> 0:14:15.040 head of podcasts. Thanks for listening, MHM.