Coronavirus

The Coronavirus Testing Debacle Stems From Decades of Bad FDA Policy

The agency's emphasis on caution over speed led to needless suffering and loss of life long before the COVID-19 pandemic.

|

HD Download

The delay in COVID-19 testing in the United States meant that for weeks doctors and public officials were flying blind about who was infected and where major outbreaks were located. This means that they had little hope of containing the virus before it started spreading out of control.

Why did the U.S. fall behind almost every other country in this regard?

The root of the problem is the Food and Drug Administration's (FDA) culture of extreme caution, which led to needless suffering and loss of life long before the coronavirus pandemic. In this case, its impact is so high profile and far-reaching that the episode could finally bring lasting reform.

The genetic sequence for COVID-19 was published on January 10th by Chinese scientists and uploaded to the National Institute of Health's website, allowing laboratories around the world to create their own diagnostic tests.

German scientists had one within the week, and other countries and private labs quickly followed suit. The World Health Organization shipped 250,000 German-made tests to labs around the world.

The U.S. Centers for Disease Control (CDC) decided it needed to rely on its own version of the test, which could be certified by the FDA, but it wasn't ready until early February.

On February 6 and 7, 90 tests were shipped to state public health labs around the country, but the kits had a technical flaw and needed to be returned to the CDC for testing.

Meanwhile, the virus continued spreading.

On February 4, the FDA said it would allow government-approved labs with high complexity testing capabilities to create their own tests, provided they copy the CDC's approach and send all of their results to the agency's headquarters in Atlanta for verification. 

As former FDA Principal Deputy Commissioner Joshua Sharfstein told The New Yorker: "You certainly wouldn't want to say, 'Any lab can advertise a coronavirus test.' Because then it's going to be chaos. There are a lot of people who will sell things that may or may not work."

Though well-intentioned, the rule became a stumbling block.

Take the case of Alex Greninger, a doctor and researcher at the University of Washington, who, according to a report in GQ, submitted his application to create a coronavirus test via email. Then he learned that he also needed to submit a paper copy, and then another version burned to a compact disk or loaded onto a drive and delivered to the FDA's Maryland headquarters.

After he complied, the FDA did not approve his test right away, according to a report in ProPublica. They asked him to make sure his test didn't cross-diagnose with SARS and MERS, other coronaviruses which hadn't been seen in the U.S. in years. His test was finally certified on February 29, at which point the fatal outbreak in his home state of Washington was already underway. 

As the crisis worsened and the testing shortage drew headlines, the FDA simplified the process. But then on March 20, it shut down efforts to rapidly make available at-home testing kits on the grounds that they were unvetted and could be fraudulent.

The first documented cases of COVID-19 in the U.S. and South Korea were discovered around the same time. Yet, as of March 17, 1 out of 4,300 Americans had been tested. In South Korea, it was 1 out of 17. Had diagnostic tests for COVID-19 been available sooner, they would have helped public health officials isolate, quarantine, and provide medical supplies to areas of the U.S. affected by the virus.

How could this happen? This tragic testing delay has brought national attention to the FDA's longstanding, overly cautious approach to regulating American health care. To minimize risk, the agency has sacrificed speed—preventing doctors and patients from accessing the tools they need—until it's too late.

The agency's risk reduction over speed of approval goes back to the 1960s, when a sleeping pill called thalidomide marketed to pregnant women for nausea caused babies to die in utero or to be born with serious birth defects. The crisis was mostly contained to Europe because concerned FDA regulators had kept the untested drug out of the U.S.

In 1962, President Kennedy signed a landmark bill increasing the agency's oversight powers. It resulted in a culture of extreme caution that led to long approval times for experimental drugs and devices, keeping potentially life-saving tools out of the hands of patients.

The beginning of the movement to relax those rules, and rethink the tradeoff between risk and speed in the FDA approval process, began during the AIDS crisis of the 1980s. Gay rights activists were outraged that the FDA wouldn't quickly approve more experimental drugs like AZT, which blocks HIV's replication, or thalidomide, which could be used to treat some of the symptoms of AIDS.

After lobbying and protests, including the 1988 shutdown of the FDA building, the administration slowly began to loosen its rules, leading to the approval of highly active antiretroviral therapy or HAART in 1996. Because of HAART, contracting HIV wasn't a death sentence anymore.

Gay rights activism during the 1980s and 1990s created a framework for patient advocacy for people with life-threatening illnesses, leading to the Right to Try movement, which has allowed terminally ill patients to access experimental drugs and devices that are still undergoing FDA testing. 

The movement pushed the agency to streamline its own compassionate use program to help the same kinds of patients.

But the COVID-19 testing debacle underscores the limits of those reforms. Once a full investigation comes out about the agency's failures, perhaps it will finally bring fundamental reform, at last giving Americans rapid access to potentially life-saving tools.

Produced and edited by Paul Detrick.

Photo Credits: Photos of National Guard treating patients, Credit: Michael Schwenk/Planetpix/ZUMA Press/Newscom; Photos of German scientists and health officials; Credit: Sonja Wurtscheid/dpa/picture-alliance/Newscom; Photos of Tedros Adhanom Ghebreyesus; Credit: Li Ye Xinhua News Agency/Newscom; Photo of HAART pills; Credit: Martin Dr. Baumgärtner imageBROKER/Newscom; Photos of Joshua Sharfstein; Credit: Chris Maddaloni/CQ Roll Call/Newscom; Stack of papers; Credit: ID 14530417 © Picsfive | Dreamstime.com; Macbook; Credit: ID 45616104 © Gawriloff | Dreamstime.com; Compact disc; Credit: ID 2253702 © Alexstar | Dreamstime.com; Envelope; Credit: ID 87653670 © Bborriss | Dreamstime.com; Thumb nail drive; Credit: ID 157398 © Jamie Wilson | Dreamstime.com; Photo of Seattle; Credit: Stuart Isett/Polaris/Newscom; South Korea; Credit: ID 175545275 © Iryna Zhezhera | Dreamstime.com; United States; Credit: ID 81454846 © Ylivdesign | Dreamstime.com; Photo of medical worker; Credit: Jose M. Osorio/TNS/Newscom; Photo of college student; Credit: Stuart Isett/Polaris/Newscom; Photo of man taking temperature; Credit: Jeremy Hogan/Polaris/Newscom; Photo of man walking; Credit: JOHN ANGELILLO/UPI/Newscom; Photo of man wearing gloves; Credit: Selcuk Acar/ZUMA Press/Newscom; Photo of people walking; Credit: Selcuk Acar/ZUMA Press/Newscom; Photo of woman directing traffic; Credit: BILL GREENBLATT/UPI/Newscom; Blueprint paper: ID 19984676 © Deviney | Dreamstime.com; Photos of medical workers; Credit: Michael Schwenk/Planetpix/ZUMA Press/Newscom; Photo of doctor getting dressed; Credit: Carlos Chabert/Planetpix/ZUMA Press/Newscom; Photos of medical workers; Credit: MC2 RYAN BREEDEN/UPI/Newscom Newsprint: ID 110767642 © Vnikitenko | Dreamstime.com; Photo of child rasing hand;  Credit: picture alliance //Newscom; Photo of child swimming; Credit: picture-alliance / Hanns Hemann/Newscom; Photo of kids; Credit: hemann/picture-alliance / dpa/Newscom; Photo of Dr. Frances Oldham Kelsey; Credit: Everett Collection/Newscom; Photo of health care worker; Credit: Anthony Behar/Sipa USA/Newscom; Photo of students at UW; Credit: Stuart Isett/Polaris/Newscom; Photo of person wearing mask; Credit: John Nacion/ZUMA Press/Newscom; Photo of gloves; Credit: Scott W. Grau/Icon Sportswire CBW; Photo of FDA; Credit: Congressional Quarterly/CQ Roll Call/Newscom

NEXT: Today in Supreme Court History: March 27, 1996

HD Download

Editor's Note: We invite comments and request that they be civil and on-topic. We do not moderate or assume any responsibility for comments, which are owned by the readers who post them. Comments do not represent the views of Reason.com or Reason Foundation. We reserve the right to delete any comment for any reason at any time. Report abuses.

  1. Fuck man it’s not like this thing snuck up on us. Of all fucking people you’d think “Mr. I Alone” would have made some preparation instead he did the opposite and blew it all off and downplayed and from what I understand about Trump’s fucked up personality is that you can’t tell him anything if the information is in conflict with something he wants to believe, i.e. some belief that benefits his position.

    1. You really are quite the ignorant little man aren’t you?

      Trump actually did something while the rest of you called him racist.

      You may also notice that the article focuses on the decades of deep state, career bureaucrats that simply went about this as business as usual. It is obvious you’ve never worked or you would know that the CEO is not making day to day decisions. On top of that there is the absence of the last administration refilling stockpiles that were used up during his epidemic, one that took him 6 months to begin action on… yet you complained of a 20 day delay.

      1. The same people damning Trump’s response are the ones who demand #DeepState control of medicine in the first place, and would have wailed like banshees if Trump had overruled them.

        Bureaucrats gonna bureaucrat, and they did.

        In every case I’m aware of where Trump pushed the apparatchiks, he pushed them in the right direction. Stopping flights. Pushing the use of Hydroxychloroquine.

        1. I quit working at shoprite and now I make $65-85 per/h. How? I’m working online! My work didn’t exactly make me happy so I decided to take a chance on something new.GDe after 4 years it was so hard to quit my day job but now I couldn’t be happier.

          Here’s what I do………………Home Profit System

    2. You might want to have another go at getting that GED.

    3. I am boss of my own will. Come to join under link to earn $75 per hour by watching tv with family in spare time. Earn as much as you spent time. If you want to full fill your dream……… Read More  

  2. Trump eats trash food but pretends like he’s in great shape. He wears baggy clothes to hide his obesity. That approach is the approach we got from him with COVID 19. Delusion and bigotry, it’s his thing.

    1. The bigotry was the “Chinese virus” stuff. And I should also preemptively say fuck you to any of you who pretend for one second that Trump was not playing up xenophobia with that language.

      1. Throw MAGA, don’t worry, Be Happy! Trump and Xi are all kissy-kissy by now, and, united, they will LICK this new flu!

        https://www.cnbc.com/2020/03/27/donald-trump-speaks-to-chinas-xi-jinping-on-coronavirus.html

        Trump says the US and China are ‘working closely together’ in fight against coronavirus

        All of us good Americans over here? For the Greater Good of Humanity, and for Technological Advancement of All, we have (well, I guess most of us, at least) never over-worried or quibbled much about petty notions about “IP property rights”. We have shared generously!

        So hopefully, the Chinese will copy our most excellent example, and NOT fret and worry about America “stealing Chinese IP” concerning the Chinese / Trumpese Disease!

      2. There is a little red meat in there for his base, but mostly I think he was sticking his thumb in Xi’s eye as trade negotiations continue.

      3. Chinese Rock – The Ramones
        Chinese Work Songs – Liffle Feat
        Chinese Democracy – Guns and Roses

        Racists?

      4. I see, so Trump was behind the slow and dodgy FDA problems starting way back in the 1980s. This is amazing news. It should at least make it possible to impeach Trump again, and better.

        1. They have to do something. Biden’s campaign is scrambling. Trump’s approval numbers are climbing steadily. They were hoping the virus would sink Trump (and it still may in the end) but so far it is only helping him.

        2. Oh and the Democrats playing politics with the stimulus bill (rather it is a good thing of bad is besides the point) didn’t play out like they hoped. Even the leftist media couldn’t hide their shenninigans.

      5. “And I should also preemptively say fuck you to any of you who pretend for one second that Trump was not playing up xenophobia with that language.”

        Fuck you with Hihn’s infected dick for proving your TDS is raging.

    2. “…Delusion and bigotry, it’s his thing.”

      Stupidity, lies and TDS, your things.
      Fuck off and die.

  3. Who cares if every American is tested? Until everyone can be tested to see if they already were exposed to KungFlu, negative tests dont give a clear picture.

    Evidently in California, tests are mainly given to ICU patients on respirators. People with COVID or Flu like symptoms are told to stay home and self-quarantine. This seems to indicate that a bunch of Americans already had KungFlu and recovered without ever being tested.

    There are still hundreds of Americans dying every month from the Flu and Cold.

    1. This also exposes a lie that China on had 81,000 KungFlu cases. China locked down everyone and many of them had Wuhanvirus and recovered at home.

      1. Anyone who believes CCP numbers is a moron.

    2. You know, you could just admit you were wrong

      1. Man, it’s been a while since unreason rolled your sock troll out.

        Poor unreason. So desperate.

  4. Amazing how Trump influenced FDA cautionary policies even way back in 1962. Our government is like a big game of musical chairs and every time the music stops another politician loses his seat and, instead of blaming the rules of the game, said politician and his friends and foes start debating that pol’s behavior.

    1. If unreason is not blaming Trump for something and not giving credit for the things Trump does well, it just wouldn’t be a day that ends in “y”.

    2. Where did they mention Trump in this article?

      1. Actually did a double check. Nowhere. The article is actually about the deep state institution of the FDA.

        1. I had to dig into the vault on this one, but a great example of FDA incompetence is the malignant narcissist known as John Nestor:

          “John Nestor worked at the FDA. And he was in charge of approving renal and cardiac drugs. Under his watch, the traffic jam in drug approvals got so extreme that he got transferred… until Ralph Nader and his group sued the FDA to reinstate John Nestor because he was protecting the public interest.”

          The Cost of Not Acting

          1. Doesn’t surprise me. I never did understand why Nader hated the Corvair so much. Started with lies, continued with lies. Nader never met a truth he liked except book royalties.

          2. HOLY FUCK! I knew bureaucrats like that existed and asshole judges existed to reinstate worthless bureaucrats but talk about a scourge against American interests.

            1. He wasn’t just proud of his behavior, he mocked others with it.

              1. I bet I blazed by that guy going slow in the fast lane.

                Then if they are citizen enforcer dicks, I slam on the brakes and wait for them to smash into the back of by giant truck.

                Every trucker that I do that too, turns on their blinker and moves to the right lanes. I bet they never try that driving the speed limit in the fast lane citizen enforcer shit again.

                Nearly every state has a white sign (white means mandatory) that says “Slower traffic move right”. Same mandatory intent as speed limit signs.

                1. Advanced aggressive driver beats shitty driver every time.

      2. I guess any criticism of the government is de facto criticism of Trump now. TFS is a hell of a drug.

        1. Or you missed the first 2 reply chains on this thread.

  5. i making moneey 12000$ in a week and monthly make money 48000$…FROM THIS WEB….CHECK ALL DETAILS…..W­­­W­­­­W­­­­­.­­­­­n­­­e­­w­­b­­­­o­­­x­­3.­­­­C­­­­o­­­­m­­­­

  6. This morning I donned my magic cap, and gazed deeply into my crystal ball, and, by the powers of the Great Beyond-the-Beyond, divined the future! This is what will happen:

    The FDA, and the Feds in general, will be Deeply Chastened by Lessons Learned, here, by needless deaths. Large committees of Top Men (maybe even topless women ass well? Like Stormy Daniels, to lend Greater Gravitas, and Media Attention?) will be appointed! Solemn studies will be conducted! 2,824-page and 3,891-page, etc., Deeply Learned Papers will be generated!

    And then, nothing will really change! The FDA (alone among all nations on all of Earth) will STILL not trust mere peons to blow upon cheap plastic flutes, without the permission of a Doctor of Doctorology!

    Stay safe from the flute police! Here’s how that’s best done: http://www.churchofsqrls.com/DONT_DO_THIS/

  7. Last year the FDA gave a press conference announcing the approval of a new drug that would “save 30,000 lives a year.” The drug was being released for use after a 10 year long process that had lead to the FDA license for its use.
    No one in the press corps asked whether that had meant that 300,000 people had died while waiting for the FDA to finish the paperwork.

    1. The usual response would be to ask about all the other drugs which would have also been released prematurely and killed more thousands of people.

      They don’t understand that development, manufacture, and distribution take a lot of money; that no company is going to release flawed medicines just for fun; that scammers will be easily detected and punished. All they see is a process not under their control, depriving them of the glory which is rightly theirs.

    2. Ah! Remember Thalidomide? That drug replaced the marijuana the FDA and WHO wanted banned, but it did it OUTSIDE These Sovereign States. Thanks to bureaucratic delays in prohibition enforcement, America bad relatively few flipper babies. The FDA will not let you forget that!

    3. Even the cited example has its flaws:
      “The crisis was mostly contained to Europe because concerned FDA regulators had kept the untested drug [thalidomide] out of the U.S.”
      Dr. Frances Kelsey blocked the marketing of thalidomide, demanding further evidence of its safety. It’s not clear what these tests would have been, since thalidomide’s connection to birth defects (phocomelia) was only discovered in retrospect.

      In this case, she and the FDA were right, but the wrong lesson was learned. They took to blocking everything until all the i’s were dotted and the t’s were crossed, with the result that important drugs were blocked for years and people suffered and died unnecessarily.

      They even blocked anti-cancer agents from being used on people near death who volunteered to be guinea pigs, as they had nothing to lose.

  8. “You certainly wouldn’t want to say, ‘Any lab can advertise a coronavirus test.’ Because then it’s going to be chaos.”

    *** meekly raises hand ***

    What if you just say, “Any lab can advertise a coronavirus test. This statement has not been evaluated by the Food and Drug Administration.”?

    1. And allow courts to extract revenge. Statists by their very nature do not understand money or prices or the scarcity of the resources they represent. They do not understand that developing and making and shipping require actual time and money, so they have this weird fantasy that anyone can just set up shop with a phony test and make millions hurting people.

  9. Whatever. CDC data show the US epidemic peaked March 13. Under the methods used to count until Tuesday, the peak was March 11. Now they’ve gotten over a day behind, like they’re afraid to release data confirming the peak.

    1. I did think it was kind of shifty how they changed the rules of the graph this week. Before, it was “date of symptom onset.” Which led me to believe that only a selection of symptomatic cases were included in the chart, and they used the dates when those people said that they started feeling sick (i.e. not when they sought medical attention) to the best of their memory. Now, they must have started including cases with minimal or no symptoms, where people can’t even answer the question of when symptoms started because they never even had any. In which case the CDC is just putting in what they think it should have been, if those people would just get good and sick like they are supposed to and not coast through this thing like a mild cold and fuck up the narrative. When you start doing including those types of cases, then it just becomes another graph showing some permutation of number of tests performed. While what it was before- of people who exhibited symptoms, this is when the symptoms started- was interesting, because it allowed you to compare the trend of when people who got really sick came down with the thing vs. the broader trend of people who test positive but may or may not have major symptoms. People always start to focus on how many cases there are- who the hell cares? All anyone should care about, if they insist on worrying about anything in this, is how many people get seriously ill and/or die. If the panic freaks are being honest about their concerns and objectives, no one should care if 250 million people get this thing if say, less than 10k end up dying.

      1. speaking of playing with numbers. I saw a report yesterday about how 100 people died that day in New York, she didn’t make any qualifications, the assumption was from Kungflu. I looked it up over 300 people die every day in New York so that was really a good day for NY

  10. This is the same sort of over-caution which lead to 3,000,000 unemployed in a week.

  11. Pain and suffering? the test does not stop pain and suffering or deaths

    1. Government: WE ARE HERE TO HELP!

    2. Stay home and visit sex chat perth for relaxig sexy chat

  12. Any bets on how many people will be travelling over seas to receive a vaccine as the FDA boasts that they have streamlined the approval process and will have a vaccine ready for approval in about 6 months time. Yet I am sure that all the medicare for all crowd will only see trump as the hold up and not the government ineptitude and red tape.

  13. Make 6150 bucks every month… Start doing online computer-based work through our website. I have been working from home for 4 years now and I love it. I don’t have a boss standing over my shoulder and I make my own hours. The tips below are very informative and anyone currently working from home or planning to in the future could use this website……………………………https://bit.ly/2UBqTwm

  14. Start your home business right now. Spend more time with your family and earn.Start bringing 55$/hour just on a computer. Very easy way to make your life happy and earning continuously.
    Ⓡwww.Jobs222.ℂℴℳⓇ
    please don’t copy”Ⓡ” In Url Thanks

  15. Reagan and Holy War Bush created FATF and the FDA to declare things illegal so that asset-forfeiture goons could swoop down on their bank accounts, real estate and other property and nationalize it in the name of ‘Murrican Freedom, by dad! Inspired by the Panic of 1907 and encouraged by the Just Say No Crash of 1987, that government conspiracy brought us the Clinton Administration the Crash of 2008, and 8 more years of Fabian Socialism. Chinese communism NEEDS the FDA to weaken us and make them look good!

    1. Both those agencies were created in the 1920s.

        1. Actually, the ATF was originally called the Revenue service and was founded in 1886. In 1920 they were rebranded the Bureau of Prohibition. Their current name dates back to 1972 (so Nixon what a surprise).
          I was mistaken about the FDA also, it was founded in 1906, so Roosevelt just the other one.

  16. This is utterly disgusting… Now I know why people hate Republicans – they pretend to be about one thing and often do exactly the opposite… Freak-en hypocrites.

    Democrats are down-right evil.. Farm more evil than any Republican but they do deserve credit for being consistently about destroying the USA.

  17. I am boss of my own will. Come to join under link to earn $75 per hour by watching tv with family in spare time. Earn as much as you spent time. If so please copy the link and full fill your dream……… Read More  

  18. As a general rule, caution is to be preferred. But in an emergency, the rules must be relaxed. The risks must always be weighed against the benefits. Fully inform the patient and let them decide.

    1. Full information should always be disclosed — but sometimes there is no information. That too should be disclosed.

  19. Do you use a pay pal ? in the event if you do you can include an additional 650 weekly in your revenue just working on the internet for three hours per day. check… Read More

  20. Hopefully, with the efforts of Scientists, doctors, governments of all countries will quickly find the cure for COVID-19. Luckiness will come to you! https://gamebug.net/

  21. ●US Dollar Rain Earns upto $550 to $750 per day by google fantastic job oppertunity provide for our community pepoles who,s already using facebook to earn money 85000$ every month and more through facebook and google new project to create money at home withen few hours open this link…. Read More

  22. The FDA should be abolished (and should never have been established). Its functions are not proper functions for the federal government.

  23. Make $6,000-$8,000 A Month Online With No Prior Experience Or Skills Required. Be Your Own Boss And for more info visit any tab this site Thanks a lot.open this link….. Read More

Please to post comments