APHL Receives Funding to Strengthen Public Health Laboratory Systems to Improve Food Safety

Photo showing cups of beans and seeds for testing.

FOR IMMEDIATE RELEASE

Bethesda, MD, February 8, 2024 — The Association of Public Health Laboratories (APHL) recently received an award from the US Food and Drug Administration (FDA) to help build an integrated laboratory system to advance the safety of human and animal food.

The three-year grant will enable APHL to support the critical role of state public health and agriculture laboratories in identifying, containing and preventing hazards in the food supply. APHL’s work will include assessing national testing capability and capacity; developing best practices and other guidance manuals; and offering trainings, meetings and other educational resources. APHL will also support ISO/IEC 17025 laboratory accreditation to ensure laboratories have quality management systems and testing competencies in place and can produce defensible data for regulatory and public health action, among other activities.

“Public health and agricultural laboratories are on the front lines helping assure the safety of our nation’s food supply,” said Scott J. Becker, MS, chief executive officer of APHL. “They are essential to our nation’s ability to prevent, detect and respond to outbreaks of foodborne illness. We look forward to working with FDA, state laboratories and partners to strengthen our laboratory capacity to improve food safety.”

This project is supported 100% by the Food and Drug Administration (FDA) of the US Department of Health and Human Services (HHS) cooperative agreement Number 1U2FFD008200 totaling $1.8 million.

To learn more about APHL’s food safety work, visit www.aphl.org/foodsafety.

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The Association of Public Health Laboratories (APHL) works to strengthen laboratory systems serving the public’s health in the US and globally. APHL’s member laboratories protect the public’s health by monitoring and detecting infectious and foodborne diseases, environmental contaminants, terrorist agents, genetic disorders in newborns and other diverse health threats. Learn more at www.aphl.org.

Contact: Michelle Forman at 240.485.2793 or michelle.forman@aphl.org

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FDA commissioner corrects his misinterpretation of reduced mortality

Talking about a possible plasma treatment for Covid-19, the Food and Drug Administration Commissioner Stephen Hahn misinterpreted results from the study. The study from the Mayo Clinic notes a possible 35% reduction in mortality rate, and Hahn said that if 100 people were sick with Covid-19, 35 lives would be saved.

For The Washington Post, Aaron Blake discusses why the interpretation is incorrect:

The vast majority of people who get the virus will recover with or without plasma. The 35 percent figure comes into play among those who die — a much smaller group. That would still be a huge development if borne out. But strictly speaking, the treatment would have saved about 3 out of 100 coronavirus patients, not 35. And given the smaller numbers we’re talking about, the finding is much closer to the margin of error — even as the preliminary study finds the effect to be statistically significant.

And even then, the claim doesn’t make sense. The data that he and Trump were referring to compared those receiving plasma treatments not to a control group, but between higher and lower levels of plasma treatments. The group with lower levels died at a rate of 11.9 people out of 100 died, while 8.7 percent died with higher levels.

Hahn later corrected himself.

See also Christopher Ingraham’s quick explanation of relative versus absolute risk. And this visual explainer from 2015 by NYT’s The Upshot should also be helpful in understanding the difference.

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APHL Applauds Revised FDA Policy on Serology Tests for COVID-19

Laboratory scientist performing serologic testing

FOR IMMEDIATE RELEASE

Statement by Scott Becker, CEO, Association of Public Health Laboratories

Silver Spring, MD, May 4, 2020 — “The Food and Drug Administration made the right decision by walking back its policy on serology testing for COVID-19.

“We’ve long been concerned that allowing tests on the market that have not been approved and authorized for use is a recipe for disaster. This revised policy makes a lot of sense and should have been in place over the last six weeks.

“The changes announced today bring quality and transparency back into the picture on serology. In addition, it provides important guidance on performance criteria.

“We look forward continuing to work with our partners at FDA in responding to this ongoing pandemic and protecting the health of all of our communities.”

Contact: Michelle Forman, 240-485-2793 or michelle.forman@aphl.org

 

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The Association of Public Health Laboratories (APHL) works to strengthen laboratory systems serving the public’s health in the U.S. and globally. APHL’s member laboratories protect the public’s health by monitoring and detecting infectious and foodborne diseases, environmental contaminants, terrorist agents, genetic disorders in newborns and other diverse health threats. Learn more at www.aphl.org.

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Lab Culture Ep. 21: 2019 Year in Review

Collage of photos depicting APHL's 2019 year in review

Are we already at the end of 2019?! While to many of us it felt like the year flew by, APHL staff, members and partners accomplished a LOT in an effort to protect the public’s health. In this episode, Scott Becker, APHL’s executive director, reviews some of the highlights of the year along with Gynene Sullivan, APHL’s manager of communications, who is finalizing our Annual Report.

Follow APHL on TwitterFacebook and Instagram so you don’t miss anything!

Links:

APHL: Lung Injury Response Associated with Vaping

CDC: Outbreak of Lung Injury Associated with the Use of E-Cigarette, or Vaping, Products

APHL work on opioids

Data: Elemental to Health advocacy campaign

Supporting rapid exchange of public health data is urgent, crucial and laden with challenges

APHL AIMS Platform

Lab Matters (Fall 2019): Making Data Fly

NewSTEPs Data Repository

APHL Newborn Screening Systems Quality Improvement Projects Award Recipients Announced

APHL Public Health Laboratory Fellowships

APHL Emerging Leader Program

Lab Culture Ep. 9: What is the APHL Emerging Leader Program?

CDC: US Measles Cases and Outbreaks in 2019

“Launching Whole Genome Sequencing in the Public Health Realm” Lab Matters (Fall 2013)

Accreditation for Human and Animal Food Labs

APHL Conferences

Lab Culture Extra: Progress in Sierra Leone

APHL Global Health Program: Countries we serve

Global Laboratory Leadership Programme (GLLP)

Laboratory Response Network (LRN)

Lab Culture Ep. 20: 20 Years of the Laboratory Response Network

“Two Decades of Preparedness Excellence: The Laboratory Response Network” Lab Matters (Fall 2019)

The LRN’s job is to prepare, detect and respond. But what exactly does that mean?

Strengthening Lab Biosafety & Biosecurity

“Ensuring Readiness for Rabies in Puerto Rico” Lab Matters (Spring 2019)

“Public Health System Recovery in Full Swing: Hurricane Response in Puerto Rico and the US Virgin Islands” Lab Matters (Spring 2019)

In Puerto Rico, a new molecular bacteriology lab allows better control of foodborne outbreaks

APHL Publications

“US officials identify ‘strong culprit’ in vaping illnesses” Associated Press (video interview)

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Public health laboratory response capability advanced through – and in spite of – the Zika outbreak

Public health laboratory response capability advanced through – and in spite of – the Zika outbreak | www.APHLblog.org

When a health threat like the Zika virus disappears from the headlines, public health systems may appear to have halted their work. In fact, their efforts continue behind the scenes as lessons and enhancements from the last response are incorporated into public health systems and processes to enhance ongoing surveillance and inform future responses.

The US response to the 2016 Zika virus pandemic followed this pattern of event, insights and enhancements to public health response systems. It built upon past developments, such as the creation of the Laboratory Response Network (LRN) in 1999 and introduction of expedited approval of diagnostic tests in 2009, to drive improvements that will make future responses more rapid, robust and flexible.

Below are examples of how public health laboratory response capability advanced through – and in spite of – the Zika outbreak.

Zika Tests Deployed via EUA

During the 2009 H1N1 influenza outbreak, the public health community took advantage of a tool that had not been utilized previously: the Emergency Use Authorization or EUA. Under an EUA, the Food and Drug Administration (FDA) takes steps to speed up the typically long, laborious approval process for new drugs, devices and diagnostic tests, and authorizes emergency use of the product even if it has not yet gone through normal channels of approval.

On February 26, 2016, the secretary of the Department of Health and Human Services declared Zika to be a Public Health Emergency activating the EUA mechanism for expedited Zika diagnostic testing approval. By mid-March, the FDA granted EUAs for two key Zika tests. The first, the Trioplex Real-time RT-PCR, was a polymerase chain reaction (PCR) designed to detect the virus in a patient’s blood or urine. The second, the Zika MAC-ELIA, was an immunoglobulin M (IgM) test used to locate antibodies in the blood. Because of the expedited approval process under the EUA, these tests were approved in a matter of weeks instead of months or years.

Labs Roll Out Zika Tests in Record Time

By the time the FDA issued these EUAs, the tests had already been validated or shown to be effective in detecting the Zika virus in many laboratories. This required testing large numbers of samples—not an easy task in a high-pressure situation.  But the Centers for Disease Control and Prevention (CDC) found a way. Drawing on labs with the most testing expertise, the agency redirected its teams to focus on Zika. CDC’s Dengue Branch in Puerto Rico and its office in Fort Collins worked on the rollout of the tests and provided technical support to state laboratories participating in the emergency effort.

In the meantime, state and local public health labs weren’t waiting around. They were also validating PCR and IgM tests, and training on the required methods and technology.  “This proved to be crucial,” explained Kelly Wroblewski, director of infectious diseases at APHL. “Many scientists working in public health labs were not familiar with the serologic testing methods being used. Public health laboratories had largely moved to kit-based tests and the expertise required to implement this more complex method had been lost. On top of that, many labs didn’t have the proper equipment to perform the more manual tests. Due to funding cuts over the past 15 years, the labs had lost much of the capacity they had had during the West Nile outbreak that occurred about 15 years ago.”

CDC tried to fill this gap by offering more training once it began distributing the newly validated tests to qualified labs in the LRN. It provided technical assistance to labs conducting the test to ensure that they were ready for an expected surge of samples. By January 2017, LRN labs had conducted 25,439 RT-PCR tests and 35,349 Zika MAC-ELISA tests.

Inspections Postponed to Prepare for Zika Testing

In the midst of training and testing, the Centers for Medicare and Medicaid Services (CMS), which is charged with oversight of all laboratory-developed tests (LDTs), notified LRN laboratories that inspectors would be arriving to review Zika testing procedures and documentation to ensure the accuracy of test results. Though this was CMS’ prerogative under the Clinical Laboratory Improvement Amendments (CLIA), the timing could not have been worse.

“Our members began alerting us that they were anxious about the CLIA inspectors showing up at their labs,” recalls Eric Blank, chief program officer at APHL. “They were especially concerned about preparing all the necessary documentation for the inspectors.” As it had done during the H1N1 outbreak in 2009, APHL negotiated with CMS to delay inspections until the acute crisis had passed.

Task Force Launched to Coordinate Response to Future Crises

During a public health emergency, APHL works diligently to connect public health laboratories to APHL’s federal agency partners, CDC, FDA and CMS. “The federal partners along with APHL recognized the need for an improved, collective emergency response to public health emergencies,” explains Peter Kyriacopoulos, senior director of public policy at APHL. “CDC, FDA and CMS established a new entity, the Tri-Agency Task Force for Emergency Diagnostics. When the next disease comes along, this task force will enable the nation to respond much more effectively than before.”

Wroblewski adds that the task force makes communication more routine. “Having communication channels already open will make it easier to get the response going as quickly and efficiently as possible,” she says.

Since 2016, the threat of Zika has subsided. In 2017 and 2018, there wasn’t another outbreak, but Zika will likely come back. But this time, the public health community will be ready.

“With the Tri-Agency Task Force in place, we’re much better off than we were in 2016,” says Kyriacopoulos. “Other improvements, like more efficient ways to send data electronically, are still needed. But the systems we had and the new ones we’ve introduced have strengthened communication and coordination.”

For more information about public health laboratory response to the Zika crisis, check out APHL’s book, A Complex Virus, A Coordinated Response: Public Health Labs Battle Zika.

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Interesting and important story on fecal transplants in @nytimes



This is definitely worth a read:

Drug Companies and Doctors Battle Over the Future of Fecal Transplants - The New York Times. By Andrew Jacobs. March 3, 2019.

The lead in is good:
CAMBRIDGE, Mass. — There’s a new war raging in health care, with hundreds of millions of dollars at stake and thousands of lives in the balance. The battle, pitting drug companies against doctors and patient advocates, is being fought over the unlikeliest of substances: human excrement.
The story is both interesting and includes some very important stuff going on behind the scenes that may affect the future of fecal transplants as a treatment in t. It seems that a variety of folks including those from companies who are trying to develop treatments mimicking fecal transplants are trying to get the FDA to crack down on the use of actual feces for carrying out fecal transplants.
“The first principle of medicine is do no harm, and at the moment we don’t have a long-term track record of F.M.T.’s adverse effects,” said Dr. Sahil Khanna, an associate professor of gastroenterology at the Mayo Clinic who has conducted industry-funded clinical trials on fecal transplants. “We also need to move away from transferring poo from one person to another.”
and
Drug companies, which have been struggling to funnel patients into the clinical studies that are required for F.D.A. approval, would like federal officials to restrict the stool bank’s ability to distribute fecal matter in the hope that more patients will enroll in their trials.
On the other side are those from places like OpenBiome as well as many clinicians who think that the regulation may have already gone far enough or even too far.
“It is very frustrating to see hyperregulation again ruining a good thing in health care,” said Dr. Colleen Kelly, a gastroenterologist at the Brown University medical school.
and
“I never imagined the solution to my nightmare could be so simple,” he said. “I just hope Big Pharma doesn’t make it unaffordable for the people like me.”

5 most unexpected and unique partnerships forged through the Zika response

Top 5 most unexpected and unique partnerships forged through the Zika response | www.APHLblog.org

By Kelly Wroblewski, director, infectious disease, APHL

While the US public health system has been through a number of infectious disease responses in the last decade, the Zika response was unique in both its duration and complexity. For more than 20 months (January 22, 2016 – September 29, 2017), CDC’s Emergency Operations Center was activated to respond to the US’s largest Zika virus outbreak. State and local public health departments began their responses as early as November 2015 and continue to respond today. Through the uncertainty, public health built relationships with new partners and found opportunities for unique collaborations with old partners.

APHL explores the journey in detail in our new book, A Complex Virus, A Coordinated Response: Public Health Laboratories Battle Zika. For APHL and public health laboratories, five unique and unexpected partnerships forged during the Zika response proved critical to progress on this journey. Learn about them below:

1. Vector Control

Vector control is, of course, a time-honored, if underappreciated, public health partner; after all, CDC was established in the 1940s in response to malaria. The Zika response reinvigorated those relationships as public health laboratories and vector control programs worked together on the best methods and approaches for vector surveillance (i.e., testing vectors to see if the pathogen is present) and insecticide resistance testing (testing insects to determine which sprays will be most effective). Once local transmission occurred in Florida and Texas, vector control relied on public health laboratory test results to focus mosquito control efforts on the areas where transmission was most likely to occur.

2. Maternal and Child Health and OB/GYNs

While public health laboratories may connect with maternal and child health departments for other types of testing like newborn screening, it is unusual for these groups of public health professionals to work together in response to an emerging infectious disease. Many OB/GYNs treating patients concerned about their risk of Zika infection and exposure were used to working with clinical and commercial laboratories for prenatal testing, but had never ordered a test at a public health lab. Public health labs across the country worked with their maternal and child health counterparts to ensure they had the most up-to -date information on accessing testing, knew how to correctly complete test request forms and could interpret test results to pass along to appropriate healthcare providers.

3. Commercial Laboratories

At public health laboratories, Zika testing represented a massive increase in workload. Beyond demand from patients worried about their exposure, there were multiple new tests to validate, different tests required for different patient populations and often a single specimen from which multiple laboratories needed to conduct multiple tests. In April 2016, commercial laboratories began performing Zika testing, thus distributing some of the specimen volume, taking some of the load off public health labs and offering OB/GYNs access to testing from laboratories with whom they had established relationships.

4. The Zika Coalition (So. Many. Partners.)

This group, led by the March of Dimes, was comprised of more than 70 member organizations committed to the health and wellbeing of US children and families. It was established in response to Congress’ delay in approving the Obama Administration’s emergency request for funding to respond to the Zika crisis in the US. The request was made in in February of 2016 and was not approved by Congress until that September. The Zika Coalition visited congressional offices, wrote letters and testified before the Senate Appropriations Committee advocating for and applying pressure to ensure public health got the funding necessary to respond.

5. CDC, FDA and CMS – Tri-agency Taskforce for Emergency Diagnostics

Although partnerships with the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) are neither unique nor unexpected during an infectious disease emergency response, the Zika response did change their nature with the establishment of the Tri-agency Taskforce for Emergency Diagnostics. Throughout the 20 month response, as we learned more about how the Zika virus behaved, APHL worked with these agencies to ensure that laboratories had access to the best possible tests through the emergency use authorization (EUA) process (FDA’s role), guidance on how to use those tests (CDC’s role) and assurance that the tests were being implemented in compliance with quality testing standards (CMS’s role). This taskforce remains intact for future responses.

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Farewell, Providence! APHL Annual Meeting — Days 3 and 4

Farewell, Providence! APHL Annual Meeting — Days 3 and 4 | www.APHLblog.org

After four days of fascinating speakers, networking with peers and partners from around the world, and enjoying public health jokes that only insiders would understand, the 2017 APHL Annual Meeting came to a close. It was the largest meeting yet with over 700 attendees. We are so thankful to the APHL staff, members, partners, exhibitors and speakers who made this meeting a success! See you all in Pasadena, California in 2018!

Below is a round-up of days 3 and 4.

Day 1 round-up

Day 2 round-up

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The FDA Should Only Approve Drugs Backed By Science

Here’s some Inauguration Day reading for you:

For half a century, the FDA has regulated drugs on the premise that science should show that they’re safe and effective before drug companies get to sell them. Before modern drug laws, companies filled the market with ineffective products, backed by no evidence that they worked.

As I write this week in Pacific Standard, a couple of candidates for Trump’s FDA seem to think that we should go back to that era before modern drug laws. Jim O’Neill, a venture capitalist who invests in biotech argues that as long as companies can show a drug is safe, the FDA should let patients take it “at their own risk,” regardless of whether that drug is useless.

And biomedical engineer/biotech executive Balaji Srinivasan thinks that, rather than testing drugs with clinical trials, people should just rate them the way they rate their Uber drivers. Given that people believe all sorts of insane things about what makes them healthier, this is not likely to be a way to rigorously learn whether a drug actually does something for the patients who buy – and whether its not just the drug company ripping people off.

In my piece, I explain exactly why these ideas would be bad for you. But the overarching theme is this: the problem with the two candidates, and their associate Peter Thiel (who is advising Trump on the FDA) is that they see drugs and biotech from the view of investors and startup executives. These are people who hear promising, brilliant medical ideas all the time from scientists and entrepreneurs, people who want to take fledgling ideas and turn them into therapies. That’s great, but in the end, most of these promising, brilliant ideas will in fact be wrong – and that’s why we need the FDA to protect us by weeding out the failures.


Filed under: Uncategorized Tagged: drugs, FDA, Science in Society

The FDA is not holding back effective drugs

It’s going unnoticed amidst the news of the rolling disaster that is the incoming Trump administration, but our lame duck Congress has just passed a major piece of legislation called the 21st century cures act. Scientists are happy about the extra $5 billion this bill gives to the NIH – sort of. That money has to go to specific programs, like the Precision Medicine Initiative and Biden’s Moonshot program, rather than being put into the general funds of the NIH, meaning that Congress, and not the NIH, is deciding what specific research to fund. That’s generally not a good idea, but more money toward broad research and translational initiatives like cancer and precision medicine is still a net win.

More controversial are the FDA provisions of this bill. The bill pushes the FDA to take into account other, often less rigorous types of clinical studies when it decides whether or not to approve a new drug. Some worry that this means drug companies will have more leeway to push unsafe or ineffective drugs on the market. I’m more ambivalent – there are cases (drugs for rare diseases) when double blind randomized clinical trials may not be right, and the FDA should have the flexibility to demand the best evidence appropriate to each case. If – and this is a big if as we look ahead – we trust that the FDA can stand up to industry pressure, than giving them more flexibility to follow best scientific practices is the way to go.

My bigger problem with the FDA provisions are that the premise is flawed. As I write in Pacific Standard this week, the bill’s sponsors argue that, by cutting regulations and red tape at the FDA, we’ll free new cures that are just waiting to be put into the hands of patients. That’s wrong – the FDA is not the rate limiting step here. There is no backlog of effective new drugs just waiting to be approved.

Go check out my piece for the details. The rate limiting step is the science. Medical science is hard, and diseases are understood imperfectly. If you want more effective drugs faster, we need to invest more in research.


Filed under: Follies of the Human Condition, This Mortal Coil, Uncategorized Tagged: drugs, FDA, science funding