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Congress Holds Off on Enabling FDA Regulation of Clinical Laboratory-Developed Tests

Supporters of the VALID Act say lobbying blitz by academic medical centers prevented its passage

In 2022, a bill before Congress titled the Verifying Accurate Leading-Edge IVCT Development Act (VALID Act) sought to change the current regulatory scheme for clinical laboratory-developed tests (LDTs) and in vitro clinical tests (IVCTs).

But even though the College of American Pathologists (CAP) and nine other organizations signed a December 12 stakeholder letter to leaders of key House and Senate committees urging passage of legislation that would enable some regulation of LDTs, the VALID Act was ultimately omitted from the year-end omnibus spending bill (H.R. 2617).

That may be due to pressure from organizations representing clinical laboratories and pathologists which lobbied hard against the bill.

The American Association for Clinical Chemistry (AACC), American Society for Clinical Pathology (ASCP), Association for Molecular Pathology (AMP), Association for Pathology Informatics, and Association of Pathology Chairs were among many signatories on a May 22 letter to leaders of the US Senate Committee on Health, Education, Labor and Pensions that described the bill as “very flawed, problematic legislation.”

The Association of American Medical Colleges (AAMC) also signed the letter, as did numerous medical laboratories and health systems, as well as the American Society of Hematology and the Clinical Immunology Society.

Emily Volk, MD

Responding to criticism of its stance on FDA oversight of LDTs, in a May 2022 open letter posted on the organization’s website, anatomic pathologist and CAP president Emily Volk, MD, said “we at the CAP have an honest difference of opinion with some other respected laboratory organizations. … We believe the VALID Act is the only viable piece of legislation addressing the LDT issue. … the VALID Act contains many provisions that are similar to policy the CAP has advocated for regarding the regulation of laboratory tests since 2009. Importantly, the current version includes explicit protections for pathologists and our ability to practice medicine without infringement from the Food and Drug Administration (FDA).” (Photo copyright: College of American Pathologists.)

Organizations on Both Sides Brought Pressure to Bear on Legislators

“University laboratories and their representatives in Washington put on a full-court press against this,” Rep. Larry Bucshon, MD, (R-Indiana) told ProPublica. Bucshon, who is also a cardiothoracic surgeon, co-sponsored the VALID Act along with Rep. Diana DeGette (D-Colorado).

The AAMC and AMP were especially influential, Bucshon told ProPublica. In addition to spending hefty sums on lobbying, AMP urged its members to contact legislators directly and provided talking points, ProPublica reported.

“The academic medical centers and big medical centers are in every state,” Bucshon said. As major employers in many locales, they have “a pretty big voice,” he added.

CAP, on the other hand, was joined in its efforts by AdvaMed, a trade association for medical technology companies, the American Cancer Society Cancer Action Network, Association for Clinical Oncology (ASCO), Association of Black Cardiologists, Friends of Cancer Research, Heart Valve Voice US, LUNGevity Foundation, and The Pew Charitable Trusts.

Discussing CAP’s reasoning behind its support of the VALID Act in a May 26 open letter and podcast, CAP president Emily Volk, MD, said the Valid Act “creates a risk-based system of oversight utilizing three tiers—low, moderate and high risk—in order to target the attention of the FDA oversight.”

While acknowledging that it had room for improvement, she lauded the bill’s three-tier risk-based system, in which tests deemed to have the greatest risks would receive the highest level of scrutiny.

She also noted that the bill exempts existing LDTs from an FDA premarket review “unless there is a safety concern for patients.” It would also exempt “low-volume tests, modified tests, manual interpretation tests, and humanitarian tests,” she wrote.

In addition, the bill would “direct the FDA not to create regulations that are duplicative of regulation under CLIA,” she noted, and “would require the FDA to conduct public hearings on LDT oversight.”

Pros and Cons of the VALID Act

One concern raised by opponents relates to how the VALID Act addressed user fees paid by clinical laboratories to fund FDA compliance activities. But Volk wrote that any specific fees “would need to be approved by Congress in a future FDA user fee authorization bill after years of public input.”

During the May 2022 podcast, Volk also cast CAP’s support as a matter of recognizing political realities.

“We understand that support for FDA oversight of laboratory-developed tests or IVCTs is present on both sides of the aisle and in both houses of Congress,” she said. “In fact, it enjoys wide support among very influential patient advocacy groups.” These groups “are very sophisticated in their understanding of the issues with laboratory-developed tests, and they do have the ear of Congress. There are many in the laboratory community that believe the VALID Act goes too far, but I can tell you that many of these patient groups don’t believe it goes far enough and are actively pushing for even more restrictive paradigms.”

Also urging passage of the bill were former FDA commissioners Scott Gottlieb, MD, and Mark B. McClellan, MD, PhD. In a Dec. 5 opinion piece for STAT, they noted that “diagnostic technologies have undergone considerable advances in recent decades, owing to innovation in fields like genomics, proteomics, and data science.” However, they wrote, laws governing FDA oversight “have not kept pace,” placing the agency in a position of regulating tests based on where they are made—in a medical laboratory or by a manufacturer—instead of their “distinctive complexity or potential risks.”

In their May 22 letter, opponents of the legislation outlined broad areas of concern. They contended that it would create “an onerous and complex system that would radically alter the way that laboratory testing is regulated to the detriment of patient care.” And even though existing tests would be largely exempted from oversight, “the utility of these tests would diminish over time as the VALID Act puts overly restrictive constraints on how they can be modified.”

CLIA Regulation of LDTs also Under Scrutiny

The provision to avoid duplication with the Clinical Laboratory Improvement Amendments (CLIA) program—which currently has some regulatory oversight of LDTs and IVCTs—is “insufficient,” opponents added, “especially when other aspects of the legislation call for requirements and activities that lead to duplicative and unnecessary regulatory burden.”

Opponents to the VALID Act also argued that the definitions of high-, medium-, and low-risk test categories lacked clarity, stating that “the newly created definition of moderate risk appears to overlap with the definition of high risk.”

The opponents also took issue with the degree of discretion that the bill grants to the US Secretary of Health and Human Services. This will create “an unpredictable regulatory process and ambiguities in the significance of the policy,” they wrote, while urging the Senate committee to “narrow the discretion so that stakeholders may better evaluate and understand the implications of this legislation.”

Decades ago, clinical laboratory researchers were allowed to develop assays in tandem with clinicians that were intended to provide accurate diagnoses, earlier detection of disease, and help guide selection of therapies. Since the 1990s, however, an industry of investor-funded laboratory companies have brought proprietary LDTs to the national market. Many recognize that this falls outside the government’s original intent for encouragement of laboratory-developed tests to begin with.

—Stephen Beale

Related Information:

The Tests Are Vital. But Congress Decided That Regulation Is Not.

Message from the CAP President on the VALID Act

Better Lab Test Standards Can Ensure Precision Medicine Is Truly Precise

Healthcare Groups Urge Congress to Pass Diagnostic Testing Reform Before Year’s End

Califf: FDA May Use Rulemaking for Diagnostics Reform If VALID Isn’t Passed

Is FDA LDT Surveillance Set to Improve as VALID Act Heads to Resolution?

Congress Needs to Update FDA’s Ability to Regulate Diagnostic Tests, Cosmetics

FDA User Fee Reauthorization: Contextualizing the VALID Act

They Trusted Their Prenatal Test. They Didn’t Know the Industry Is an Unregulated “Wild West.”

InsideHealthPolicy: Pew, AdvaMed, Others Push for VALID as Clock Ticks on Government Funding

AdvaMed Leads Letter Urging Lawmakers to Support Bipartisan Diagnostics Reform

Survey: Proposed FDA Approval of Laboratory Developed Tests Will Reduce Innovation

Though response was limited in Dark Daily’s poll, the message from respondents was overwhelmingly negative on LDT regulation by the FDA

Most respondents to a recent industry survey said that should Food and Drug Administration (FDA) approval be required in the future for laboratory developed tests (LDTs), innovation will suffer.

This conclusion echoes what opponents of the Verifying Accurate Leading-Edge IVCT Development Act (VALID Act) have argued will happen should that proposed bill become law.

In the survey, which was conducted by Dark Daily, 91% of respondents said FDA pre-market approval of LDTs would decrease clinical laboratories’ ability to bring innovative tests to market. (See Figure 1.) The other 9% felt it would have no effect on innovation. Zero of the respondents said FDA involvement would increase innovative tests.

Figure 1: “How might a requirement of FDA pre-market approval impact the ability of your lab (or a lab you work for) to bring innovative tests to market?

“Development of LDT tests has been the mission of most of the labs, and it meets the need for patient care,” noted one respondent in the survey. “Moving LDTs under FDA will create more obstacles for labs to offer the tests.”

To be fair, the survey had limited responses—34 in total. The poll went out to thousands of Dark Daily readers. We found that response rate surprising given how many labs will be affected if the VALID Act becomes law.

An LDT is a proprietary diagnostic test developed and performed by an individual clinical laboratory. In academic medical center laboratories, LDTs often address unmet clinical needs. The Clinical Laboratory Improvement Amendments of 1988 (CLIA) generally regulates LDTs.

VALID Act vs. VITAL Act Hinges on LDT Oversight

The VALID Act is a bipartisan bill that proposes FDA oversight of laboratory developed tests. The bill continues to make its way through the U.S. Senate and the House of Representatives.

A counterproposal called the Verified Innovative Testing in American Laboratories Act (VITAL Act) is also before Congress but has less momentum behind it. The VITAL Act seeks to keep LDTs under CLIA while also calling for reforms to account for modern lab tests.

See our past reporting in Dark Daily for a detailed comparison of the VALID Act and VITAL Act.

Looking at survey results, 80% “strongly disagreed” or “disagreed” that new LDT requirements, such as those found in the VALID Act, are needed. (See Figure 2.)

Figure 2: “FDA pre-market approval of LDTs should be required, as proposed in the VALID Act.”

By comparison, 65% “strongly agreed” or “agreed” with modernizing CLIA requirements for LDTs, as called for in the VITAL Act.

Those numbers shifted somewhat depending on the lab setting of the respondent. For example, just looking at commercial labs, opposition to the VALID Act remained similar, but support for modernizing CLIA jumped up to 88%. When looking at just hospitals, independent labs, and academic labs, numbers for both topics remained consistent.

When filtering the answers, the number of lab employees in a setting had little effect on survey results.

Political Battle Continues Over Laboratory Developed Tests

Clinical laboratory industry groups and others have been amassing to oppose or support the VALID Act. For example, the Advanced Medical Technology Association and The Pew Charitable Trusts are behind the bill.

However, the American Association for Clinical Chemistry, Association for Molecular Pathology, and new Coalition for Innovative Laboratory Testing are against the VALID Act.

Congress may attach the VALID Act to the authorization vote for the Medical Device User Fee Agreement V (MDUFA). At this point, discussions on MDUFA remain in congressional committees.

—Scott Wallask

Related Information:

VALID Act language

VITAL Act language

What is a laboratory developed test?

LDT Regulation: New Survey Asks Readers for Their Views About Two Bills Before Congress

MDUFA V Agreement Enables Bold MedTech Vision to Become Reality

Prosecutors Allege Ex-Theranos President ‘Sunny’ Balwani and Elizabeth Holmes Were ‘Partners in Everything, including Their Crimes’

Like Holmes, Balwani faces 12 counts of fraud and conspiracy to commit wire fraud for allegedly misleading investors, patients, and others about blood-testing startup’s technology

Clinical laboratory managers and pathologists are buckling up as the next installment of the Theranos story gets underway, this time for the criminal fraud trial of ex-Theranos President and COO Ramesh “Sunny” Balwani.

This week, jurors saw text messages between Balwani and his former business partner girlfriend, Theranos founder and CEO Elizabeth Holmes. As Dark Daily previously reported in “Two Important Aspects for Clinical Laboratories to Consider Following Elizabeth Holmes’ Conviction,” Holmes was convicted on Jan. 3 on one count of conspiracy to defraud investors and three counts of wire fraud.

In one text to Holmes, Balwani wrote, “I am responsible for everything at Theranos,” NBC Bay Area reported.

Partners in Everything, including Crime, Prosecutors Allege

According to the Wall Street Journal (WSJ), prosecutors are following the Holmes trial playbook. They focused their opening arguments on the personal and working relationships between the pair, tying Balwani to Holmes’ crimes at the Silicon Valley blood-testing startup.

As second in command at Theranos, Balwani helped run the company from 2009 to 2016. He also invested $5 million in Theranos stock, while also underwriting a $13 million corporate loan.

“They were partners in everything, including their crimes,” Assistant US Attorney Robert Leach told jurors, the Mercury News reported. “The defendant and Holmes knew the rosy falsehoods that they were telling investors were contrary to the reality within Theranos.”

Leach maintained that Balwani was responsible for the phony financial projections Theranos gave investors in 2015 predicting $990 million in revenue when the company had less than $2 million in sales.

Former Theranos President and COO Ramesh “Sunny” Balwani
Former Theranos President and COO Ramesh “Sunny” Balwani (above) is seen arriving at the federal court in San Jose, California, for the start of his federal fraud trial. Clinical laboratory leaders and pathologists who followed the trial of ex-Theranos founder and CEO Elizabeth Holmes will no doubt be interested in what can be learned from this trail as well. (Photo copyright: Jim Wilson/The New York Times.)

“This is a case about fraud. About lying and cheating to obtain money and property,” Leach added. Balwani “did this to get money from investors, and he did this to get money and business from paying patients who were counting on Theranos to deliver accurate and reliable blood tests so that they could make important medical decisions,” the WSJ reported.

Defense attorneys downplayed Balwani’s decision-making role within Theranos, pointing out that he did not join the start-up until six years after Holmes founded the company with the goal of revolutionizing blood testing by developing a device capable of performing blood tests using a finger-prick of blood.

“Sunny Balwani did not start Theranos. He did not control Theranos. Elizabeth Holmes, not Sunny, founded Theranos and built Theranos,” defense attorney Stephen Cazares, JD of San Francisco-based Orrick, said in his opening argument, the WSJ reported.

The trial was expected to begin in January but was delayed by the unexpected length of the Holmes trial. It was then pushed out to March when COVID-19 Omicron cases spiked in California during the winter.

Balwani’s trial is being held in the same San Jose courthouse where Holmes was convicted. Balwani, 56, is facing identical charges as Holmes, which include two counts of conspiracy to commit wire fraud and 10 counts of wire fraud. He has pleaded not guilty.

Holmes, who is currently free on a $500,000 bond, will be sentenced on Sept. 26, Dark Daily reported in January.

Judge Excludes Jurors for Watching Hulu’s ‘The Dropout’

During jury selection in March, some jurors acknowledged they were familiar with the case, causing delays in impaneling the 12-member jury and six alternates. US District Court Judge Edward Davila excluded two potential jurors because they had watched “The Dropout,” Hulu’s miniseries about Holmes and Theranos. Multiple other jurors were dropped because they had followed the Holmes trial in the news, Law360 reported.

When testimony began, prosecutors had a familiar name take the stand—whistleblower and former Theranos lab tech Erika Cheung, who provided key testimony in the Holmes trial. During her testimony, Cheung said she revealed to authorities what she saw at Theranos because “Theranos had gone to extreme lengths to [cover up] what was happening in the lab,” KRON4 in San Francisco reported.

“It was important to report the truth,” she added. “I felt that despite the risk—and I knew there could be consequences—people really need to see the truth of what was happening behind closed doors.”

Nevada State Public Health Laboratory (NSPHL) Director Mark Pandori, PhD, who served as Theranos’ lab director from December 2013 to May 2014, was the prosecution’s second witness. Pandori testified that receiving accurate results for some tests run through Theranos’ Edison blood testing machine was like “flipping a coin.”

“When you are working in a place like Theranos, you’re developing something new. And you want it to work. Quality control remained a problem for the duration of my time at the company. There was never a solution to poor performance,” Pandori testified, according to KRON4.

While the defense team has downplayed Balwani’s decision-making role—calling him a “shareholder”—Aron Solomon, JD, a legal analyst with Esquire Digital, maintains they may have a hard time convincing the jury that Balwani wasn’t a key player.

“There’s no way the defense is going to be successful in painting Sunny Balwani in the light simply as a shareholder,” he told NBC Bay Area. “We know that, literally, Sunny Balwani was intimately involved with Theranos, because he was intimately involved with Elizabeth Holmes,” Solomon added.

Little Media Buzz for Balwani, Unlike Holmes Trial

While the Holmes trial hogged the media spotlight and drew daily onlookers outside the courthouse, reporters covering Balwani’s court appearances describe a much different atmosphere.

“The sparse crowd and quiet atmosphere at US District Court in San Jose, Calif., felt nothing like the circus frenzy that engulfed the same sidewalk months earlier when his alleged co-conspirator and former girlfriend, Elizabeth Holmes, stood trial on the same charges,” The New York Times noted in its coverage of the Balwani trial.

The Balwani trial may not reach the same headline-producing fervor as the Holmes legal battle. However, clinical laboratory directors and pathologists who follow these proceedings will no doubt come away with important insights into how Theranos went so terribly wrong and how lab directors must act under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).

Andrea Downing Peck

Related Information:

Former Theranos President Ramesh ‘Sunny’ Balwani Begins his Defense

Jury Empaneled in Ex-Theranos Exec Balwani’s Fraud Trial

Elizabeth Holmes and Ex-Lover Balwani Were ‘Partners in Everything, including Their Crimes,’ Prosecution Alleges as His Trial Opens

Another Theranos Trial Begins, This Time Without the Fanfare

Former Theranos Employee Turned Whistleblower Testifies in Sunny Balwani Trial

Theranos Blood Machines Were Like Flipping a Coin

Leader or Follower? Defense Team Tries to Distance Former COO from Theranos

Two Important Aspects for Clinical Laboratories to Consider Following Elizabeth Holmes’ Conviction

Ex-Theranos CEO Elizabeth Holmes Will Be Free on Bail Until September 26 Sentencing Hearing for Criminal Fraud Conviction

Hospital-based Clinical Laboratory Scientist is Suing Her Former Employer After Being Fired Due to Long-Haul COVID-19 Illness

Medical laboratory employee alleges healthcare system discriminated based on her medical condition, failed to accommodate her disability, then retaliated and created hostile working conditions

What is a clinical laboratory’s obligation when an employee is infected with the SARS-CoV-2 coronavirus and does not make a speedy recovery? Medical laboratory executives should ponder this question now that a California hospital system is being sued by a 33-year laboratory employee who was terminated after missing too many workdays due to “long-haul” COVID-19 illness.

According to court documents obtained by Dark Daily, clinical laboratory scientist (CLS) Kathleen Hamada filed a lawsuit March 22 in Fresno County Superior Court alleging Community Hospitals of Central California (parent company of Community Medical Centers in Fresno, Calif., where Hamada worked):

  • Discriminated based on her medical condition,
  • Failed to accommodate her disability,
  • Retaliated in violation of medical leave laws,
  • Created hostile working conditions, and
  • Wrongfully terminated her, among other charges.

Hamada’s attorney, Amanda Whitten JD of Bryant Whitten LLP in Fresno, told The Fresno Bee that “ [California] state law allows an employee to take up to 12 weeks of leave a year to deal with a serious medical condition,” and that, “It’s also illegal for an employer to retaliate against an employee for requesting and taking that leave.”

Michelle Von Tersch, Senior Vice President of Communications and Legislative Affairs at Community Medical Centers, told the Fresno Bee in a statement that she could not comment on the pending litigation. But she added, “During the COVID-19 pandemic, Community Medical Centers expanded employee assistance programs, including extended time off for employees to care for themselves and their loved ones.”

Community Medical Centers (CMC) is a not-for-profit healthcare system in the greater Fresno area. It operates four hospitals and a cancer institute, and several long-term care, outpatient, and other healthcare facilities. CMC has more than 8,800 employees, according to a hospital fact sheet.

Was Hamada Wrongfully Discharged?

The lawsuit states Hamada worked for Community Hospitals of Central California as a clinical laboratory scientist from July 1, 1987, until Oct. 13, 2020, when she was “wrongfully discharged.” In the filing, Hamada’s attorney noted that Hamada received “good performance reviews and salary increases and was not subject to discipline for her job performance” during her more than 30 years of employment.

After Hamada became sick with COVID-19 in mid-April 2020, she followed her doctor’s recommendation and went on medical leave for roughly six weeks. However, when she returned to work in June 2020, she “still suffered from the effects of the coronavirus” and was considered a “long-haul” COVID-19 patient, the lawsuit states. As a result, her healthcare provider suggested she request “intermittent medical leave” due to her continued illness and underlying medical conditions, including diabetes, cardio-pulmonary disease, and traumatic brain injury.

Plaintiff Alleges Threats and Intimidation

The lawsuit contends Hamada’s request for additional medical leave resulted in her supervisor telling her, “you better not” file the request. In addition to this threat, the plaintiff alleges she was shunned by her supervisor and coworkers and then subjected to discipline based on attendance when she was absent from work due to her medical condition. In October, she was terminated due to violating the “employer’s attendance policy,” the lawsuit states.

The complaint outlines eight causes of action:

  • Discrimination based on medical condition, disability, or perceived disability.
  • Failure to accommodate a disability.
  • Failure to prevent discrimination and discrimination based on medical condition, disability, or perceived disability.
  • Retaliation for requesting accommodation.
  • Retaliation for exercising rights under the California Family Rights Act.
  • Wrongful termination in violation of public policy.
  • Defamation.

The California Family Rights Act provides most employees in California with the right to take up to 12 weeks of leave from work to care for themselves or family members with a serious health condition or bond with a new child.

Hamada is requesting a jury award for:

  • general damages above the jurisdictional minimum of the Court,
  • special damages,
  • punitive damages,
  • interest on lost earnings,
  • deferred compensation and employee benefits,
  • reinstatement of her job, and
  • reimbursement of attorneys’ fees.

Should Long-Haul COVID-19 Be Considered a Disability?

David Fram, JD, Director of ADA services with the National Employment Law Institute (NELI) in Golden, Colo., told the Society for Human Resource Management (SHRM) that COVID-19 “long haulers” may have a “disability” as defined under Americans with Disabilities Act of 1990 (ADA), meaning employers would have to provide accommodations.

David-Fram-JD-at-event
In an article on the Society for Human Resource Management (SHRM) website, David Fram, JD (above), Director of ADA Services with the National Employment Law Institute (NELI), said, “If someone has COVID-19 for two weeks and there are no lingering effects, he or she still could be regarded as having a disability. While an employer doesn’t have to reasonably accommodate someone it merely regards as having a disability, it must refrain from discriminating against that person.” Additionally, he noted, “An employer must not discriminate against and must reasonably accommodate someone who has an impairment that substantially limits a major life activity, which could include a COVID-19 long hauler.” (Photo copyright: National Institutes of Health.)

Are Clinical Laboratories Legally Obligated?

In the same article, S. Leigh Jeter, JD, Senior Counsel with Michael Best and Friedrich in Chicago, said, “Unfortunately, there is no bright-line test for determining whether someone is disabled for purposes of the Act.” She added, “I encourage employers to err on the side of assuming that the employee may be covered under the ADA and then consider those resulting legal obligations.”

Removal of nonessential functions of the position might be a reasonable accommodation, Jeter noted.

According to court records, the case has been assigned to Superior Court Judge D. Tyler Tharpe. A case management conference has been scheduled for July 22 in the Fresno Superior Court.

Clinical laboratory executives would be wise to follow this COVID-19-related lawsuit closely and review their employment policies to better understand their obligation toward their workers under the Americans with Disabilities Act. This case may open the door to additional lawsuits related to COVID-19 firings.

Andrea Downing Peck

Related Information:

Kathleen Hamada vs. Community Hospitals of Central California

CV-48 Notice of Case Management Conference and Assignment of Judge for All Purposes

Fresno Lab Worker Who Had Long-Term COVID Is Suing Hospital, Says She Was Fired for Illness

Comply with ADA, FMLA When Worker Is a ‘COVID-19 Long Hauler’

COVID-19 Pandemic Tied to Historically Low Influenza Cases, Leading to Uncertainty about Next Winter’s Flu Vaccine

Clinical laboratories may see increase in flu and COVID-19 specimen processing as people return to pre-pandemic social behaviors, experts predict

While SARS-CoV-2 infections continue to ravage many parts of the world, influenza (flu) cases in North America have hit a historic low. As winter approached last year, infectious disease experts warned of a “twindemic” in which the COVID-19 outbreak would combine with seasonal influenza to overwhelm the healthcare system. But this did not happen, and many doctors and medical laboratory scientists are now investigating this unexpected, but welcomed, side-effect of the pandemic.

“Nobody has seen a flu season this low, ever,” said William Schaffner, MD, Professor of Preventive Medicine in the Department of Health Policy and Professor of Medicine in the Division of Infectious Diseases at Vanderbilt University School of Medicine in Nashville, in a report from WebMD, titled, “What Happened to Flu Season?

From the start of the current flu season in September 2020, clinical laboratories in the US reported that 1,766 specimens tested positive for flu out of 931,726—just 0.2%—according to the CDC’s Weekly US Influenza Surveillance Report. That compares with about 250,000 positive specimens out of 1.5 million tested in the 2019-2020 flu season, the CDC reported. Public health laboratories reported 243 positive specimens out of 438,098 tested.

CDC-Week-15-ILI-Map-nationwide-influenza-patient-visits-below-average
The graphic above taken from the CDC’s Weekly Influenza Surveillance Report for the week ending April 17, 2021, illustrates how “Nationwide during week 15, 1.1% of patient visits reported through ILINet were due to ILI [Influenza-like Illness].” This percentage, according to the CDC, is below the national baseline of 2.6%. “Seasonal influenza activity in the United States remains lower than usual for this time of year.” (Graphic copyright: Federal Centers for Disease Control and Prevention.)

Fear of COVID-19 Linked to Fewer Flu Deaths in Children

WebMD reported that just one child in the US has died from the flu this year, compared with 195 in 2020. Why the low numbers?

Speaking to WebMD, Isaac I. Bogoch, MD, Clinical Investigator, Toronto General Hospital Research Institute (TGHRI) and Infectious Diseases Consultant and General Internist at the Toronto General Hospital, cited three likely reasons:

  • Precautions people take to avoid COVID-19 transmission, including masking, social distancing, and handwashing.
  • Reduced human mobility, including less international travel.
  • Higher-than-usual flu vaccination rates. As of February 26, the CDC reported that nearly 194 million doses of flu vaccine had been distributed in the US.

WebMD noted this could be a record, but that the CDC data doesn’t indicate how many doses were actually administered.

However, Schaffner told WebMD that efforts to keep kids home from school and away from social gatherings were likely a bigger factor. “Children are the great distributors of the influenza virus in our society,” he said. But due to fears about COVID-19 transmission, kids “weren’t even playing together, because mothers were keeping them off the playground and not having play dates.”

Repercussions for Fighting Flu Next Year

Public health experts welcomed the low flu levels, however, Politico reported that limited data about flu circulation this year could hamper efforts to develop an effective vaccine for next season’s flu strains.

“We may have a combination of low public health measures at the population level with a low effectiveness vaccine,” Lawrence Gostin, JD, University Professor at Georgetown University, told Politico. “And then, so you might have a raging flu season next year.” Gostin leads the O’Neill Institute for National and Global Health Law and serves as Director of the World Health Organization’s Collaborating Center on National and Global Health Law.

Each February, Politico explained, experts convened by the World Health Organization (WHO) look at data from the current and previous flu seasons to predict which strains are likely to predominate in the Northern Hemisphere next winter. That includes data about which strains are currently circulating in the Southern Hemisphere. The WHO uses these predictions to recommend the composition of flu vaccines. In the US, the final decision is made by an FDA advisory committee.

A similar WHO meeting in September guides vaccine development in the Southern Hemisphere.

The WHO issued this year’s Northern Hemisphere recommendations on Feb. 26. The advisory includes recommendations for egg-based and cell- or recombinant-based vaccines, and for quadrivalent (four-strain) or trivalent (three-strain) vaccines.

In a document accompanying the recommendations, the WHO acknowledged concerns about this year’s limited pool of data.

“The volume of data available from recently circulating influenza viruses, and the geographic representation, have been significantly lower for this northern hemisphere vaccine recommendation meeting than is typical,” the document stated. “The reduced number of viruses available for characterization raises uncertainties regarding the full extent of the genetic and antigenic diversity of circulating influenza viruses and those likely to pose a threat in forthcoming seasons.”

The report notes that experts identified changes in circulating Influenza A(H3N2) viruses this year, and that the changes are reflected in the new vaccine recommendation.

But Paul A. Offit, MD, who serves on the FDA’s vaccine advisory panel, downplayed worries about the vaccine. “The belief is that there was enough circulating virus to be able to pick what is likely to be the strains that are associated with next year’s flu outbreak,” he told Politico. Offit is a Professor of Vaccinology and Pediatrics at the Perelman School of Medicine at the University of Pennsylvania and Director of the Vaccine Education Center at the Children’s Hospital of Philadelphia.

Paul-Offit-MD-CHOP-University-Pennsylvania
Pediatrician and internationally recognized expert in the fields of virology and immunology, Paul A. Offit, MD (above), told Politico that the low level of flu circulation this year, along with the resulting uncertainty, “is unprecedented.” Clinical laboratories might not have noticed the severe decrease in influenza specimens sent for processing due to being hyper-focused on COVID-19 testing. But as the pandemic subsides, loss of flu testing revenues will likely become more apparent. (Photo copyright: University of Pennsylvania.)

Offit suggests that efforts to mitigate the COVID-19 outbreak could be useful to combat other infectious disease outbreaks. However, both Offit and Gostin expressed doubt about that prospect.

“I mean, could we reasonably in a winter month, wear masks just at least when we’re outside in large crowds? … Or are we comfortable having hundreds of 1000s of cases of hospitalizations for flu and 10s of 1000s [of] deaths? I suspect the answer is B. We’re comfortable with that, we’re willing to have that even though we just learned, there’s a way to prevent it,” Offit told Politico.

“Remember after the 1918 flu pandemic, most people don’t realize what happened when that was over. But what happened was the roaring ‘20s,” Gostin told Politico. “People started congregating, mingling, hugging, kissing. All the things they missed. They crowded into theaters and stadiums and went back to church. That’s what’s likely to happen this fall and that makes the influenza virus very happy.”

So, what should clinical laboratories expect in future flu and COVID-19 vaccines? That is not yet clear. One thing is certain, though. New lab test panels that test for influenza and the SARS-CoV-2 coronavirus will be arriving in the marketplace.

Stephen Beale

Related Information:

What Happened to Flu Season?

Fears of ‘Twindemic’ Recede as US Influenza Rates Stay Low

The Mystery of the Flu-COVID ‘Twindemic’ That Never Happened

The Pandemic Dramatically Reduced Flu Cases. That Could Backfire.

Recommended Composition of Influenza Virus Vaccines for Use in the 2021 – 2022 Northern Hemisphere Influenza Season

Weekly U.S. Influenza Surveillance Report

For mRNA Vaccines, COVID-19 Is Just the Beginning

How COVID Unlocked the Power of RNA Vaccines

Coronavirus Vaccine Technology Is Paving the Way for a Whole New Approach to Flu Shots

Duke Researchers Working on mRNA Flu Vaccine That Would Last Up to 5 Years

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