News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
Sign In

Looming Government Shutdown Opens Door for Congress to Possibly Pass Clinical Laboratory Bills

Two former FDA commissioners who support changing oversight of laboratory-developed tests (LDTs) say FDA’s regulatory playbook is ‘outdated’

Congress’ attempts to avoid a government shutdown due to a lack of funding presents a final chance this year for two different clinical laboratory bills to be pushed through.

The Verifying Accurate Leading-edge IVCT Development (VALID) Act and Saving Access to Laboratory Services Act (SALSA) could be added to a year-end spending package that will fund government operations. Without the spending bill, the government will shut down on Dec. 16 and not re-open until funding is appropriated.

The VALID Act proposes to move oversight of laboratory-developed tests (LDTs) to the US Food and Drug Administration (FDA). SALSA seeks to reduce lab test reimbursement cuts scheduled for Jan. 1 under the Protecting Access to Medicare Act (PAMA).

As Dark Daily’s sister publication The Dark Report, noted in “VALID and SALSA Acts Still Pending in Congress,” a standalone vote on either bill is unlikely this year. Instead, they would need to be attached to the larger spending bill. (If you’re not a subscriber to The Dark Report, check out our free trial.)

Scott Gottlieb, MD and Mark McClellan, MD

In an article for STAT, former FDA Commissioners Scott Gottlieb, MD (left), and Mark McClellan, MD, PhD (right), wrote, “The FDA is currently working from an outdated regulatory playbook that has left gaps in its oversight of safety and effectiveness and makes it more difficult to introduce new innovations. The [VALID Act] would strengthen protections for consumers and patients for both diagnostic tests and cosmetics and make it easier for manufacturers to introduce better products.” (Photo copyrights: FDA/American Well.)

Political Parties Negotiating

At press time, a draft spending bill had not yet been introduced to Congress as lawmakers from both political parties negotiate funding levels.

A source told The Dark Report that until legislators hammer out those details, add-ons such as the VALID Act or SALSA are stalled. There is no guarantee either lab measure will be added to the spending bill.

“We don’t have agreements to do virtually anything,” said Senate Minority Leader Mitch McConnell (R-KY) to reporters on Dec. 6, according to Reuters. “We don’t even have an overall agreement on how much we want to spend,” he added. Reuters reported that Democrats and Republicans in the Senate were $25 billion apart in their proposals.

Congress could also pass a continuing resolution to keep the government open for a short time, which would allow lawmakers more opportunity to negotiate.

Former FDA Chiefs Weigh In

Meanwhile, proponents of the VALID Act have publicly turned the heat up for the bill. For example, STAT recently ran two commentaries—including a joint piece from a pair of former FDA commissioners—in support of the VALID Act.

Currently, LDTs are regulated through the Clinical Laboratory Improvement Amendments of 1988 (CLIA). However, supporters of the VALID Act argue that the complexity of modern LDTs deserves more scrutiny.

“The VALID Act would create a consistent standard for all tests, regardless of the kind of facility they were developed in or made in, as well as a modern regulatory framework that’s uniquely designed for the recent and emerging technologies being used to develop tests,” wrote Scott Gottlieb, MD, and Mark McClellan, MD, PhD, in STAT on Dec. 5.

Gottlieb and McClellan served as FDA commissioners from 2017-2019 and 2002-2004 respectively. They both currently serve on various boards for biotech and healthcare companies.

Pathologists, Clinical Lab Directors Express Concerns about VALID Act

Opponents of the VALID Act contend that LDT innovation will be stifled if clinical laboratories, particularly those at academic medical centers, need to spend the time and money to go through formal FDA approval. There is evidence that working pathologists in academic settings have legitimate concerns about the negative consequences that might result if the VALID Act was passed as currently written.

In “Might Valid Act Support Be Waning in Congress?The Dark Report covered how on June 1 more than 290 pathologists and clinical laboratory directors sent a grassroots letter to a Senate committee asking for a series of concessions to be made for academic medical center labs under the VALID Act.

It is reasonable to assert that the majority of clinical laboratory professionals and pathologists are supportive of the SALSA bill, which would stop the next round of scheduled price cuts—as much as a 15% price reduction to many tests—to the Medicare Part B Clinical Laboratory Fee Schedule (CLFS). That is not true of support for the VALID Act, as currently written. Sizeable segments of the diagnostics industry have taken opposing positions regarding passage of that legislation.

For these reasons, both bills will be closely watched in coming weeks as Congress works to fund the federal government while, at the same time, incorporating a variety of other bills under the omnibus bill, which is a considered a “must pass” by many senators and representatives.

Scott Wallask

Related Information:

H.R.4128 – VALID Act of 2021

S.4449 – Saving Access to Laboratory Services Act

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

US Congress Could Punt Funding Bill into 2023, McConnell Says

VALID and SALSA Acts Still Pending in Congress

Might Valid Act Support Be Waning in Congress?

New Research Challenges Long-Held Theory about Causes of Alzheimer’s Disease, Creating the Possibility of Useful New Biomarkers for Clinical Laboratory Tests

University of Cincinnati researchers hypothesize that low levels of amyloid-beta protein, not amyloid plaques, are to blame

New research from the University of Cincinnati (UC) and Karolinska Institute in Sweden challenges the prevailing theory about the causes of Alzheimer’s disease, suggesting the possibility of new avenues for the development of effective clinical laboratory assays, as well as effective therapies for treating patients diagnosed with Alzheimer’s.

Scientists have long theorized that the disease is caused by a buildup of amyloid plaques in the brain. These plaques are hardened forms of the amyloid-beta protein, according to a UC news story.

However, in their findings published in the Journal of Alzheimer’s Disease, titled “High Soluble Amyloid-β42 Predicts Normal Cognition in Amyloid-Positive Individuals with Alzheimer’s Disease-Causing Mutations,” the researchers advanced an alternative hypothesis—that Alzheimer’s is instead caused by “depletion” of a soluble form of that same amyloid-beta protein.

“The paradox is that so many of us accrue plaques in our brains as we age, and yet so few of us with plaques go on to develop dementia,” said Alberto Espay, MD, one of the lead researchers of the study, in another UC news story. Espay is Professor of Neurology at the UC College of Medicine and Director and Endowed Chair of the Gardner Center for Parkinson’s Disease and Movement Disorders.

“Yet the plaques remain the center of our attention as it relates to biomarker development and therapeutic strategies,” he added.

Alberto Espay, MD

“It’s only too logical, if you are detached from the biases that we’ve created for too long, that a neurodegenerative process is caused by something we lose, amyloid-beta, rather than something we gain, amyloid plaques,” said Alberto Espay, MD (above), in a University of Cincinnati news story. “Degeneration is a process of loss, and what we lose turns out to be much more important.” The UC study could lead to new clinical laboratory diagnostics, as well as treatments for Alzheimer’s and Parkinson’s diseases. (Photo copyright: University of Cincinnati.)

.

High Levels of Aβ42 Associated with Lower Dementia Risk

In their retrospective longitudinal study, the UC researchers looked at clinical assessments of individuals participating in the Dominantly Inherited Alzheimer Network (DIAN) cohort study. DIAN is an ongoing effort, sponsored by the Washington University School of Medicine in St. Louis, to identify biomarkers associated with Alzheimer’s among people who carry Alzheimer’s mutations.

The researchers found that study participants with high levels of a soluble amyloid-beta protein, Aβ42, were less likely to develop dementia than those with lower levels of the protein, regardless of the levels of amyloid plaques in their brains or the amount of tau protein—either as phosphorylated tau (p-tau) or total tau (t-tau)—in their cerebral spinal fluid. P-tau and t-tau are proteins that form “tau tangles” in the brain that are also associated with Alzheimer’s.

One limitation of the study was that the researchers were unable to include Aβ40, another amyloid-beta protein, in their analysis. But they noted that this “did not limit the testing of our hypothesis since Aβ40 exhibits lower fibrillogenicity and lesser depletion than Aβ42, and is therefore less relevant to the process of protein aggregation than Aβ42.” Fibrillogenicity, in this context, refers to the process by which the amyloid-beta protein hardens into plaque.

While the presence of plaques may be correlated with Alzheimer’s, “Espay and his colleagues hypothesized that plaques are simply a consequence of the levels of soluble amyloid-beta in the brain decreasing,” UC news stated. “These levels decrease because the normal protein, under situations of biological, metabolic, or infectious stress, transform into the abnormal amyloid plaques.”

The UC News story also noted that many attempts to develop therapeutics for Alzheimer’s have focused on reducing amyloid plaques, but “in some clinical trials that reduced the levels of soluble amyloid-beta, patients showed worsening in clinical outcomes.”

New Therapeutics for Multiple Neurodegenerative Diseases

Eisai, a Japanese pharmaceutical company, recently announced phase three clinical trial results of lecanemab, an experimental drug jointly developed by Eisai and Biogen, claiming that the experimental Alzheimer’s drug modestly reduced cognitive decline in early-stage patients, according to NBC News.

Espay noted that lecanemab “does something that most other anti-amyloid treatments don’t do in addition to reducing amyloid: it increases the levels of the soluble amyloid-beta.” That may slow the process of soluble proteins hardening into plaques.

Beyond their findings about Alzheimer’s, the researchers believe similar mechanisms could be at work in other neurodegenerative diseases such as Parkinson’s disease, where the soluble alpha-synuclein protein also hardens into deposits.

“We’re advocating that what may be more meaningful across all degenerative diseases is the loss of normal proteins rather than the measurable fraction of abnormal proteins,” Espay said. “The net effect is a loss not a gain of proteins as the brain continues to shrink as these diseases progress.”

Espay foresees two approaches to treating these diseases: Rescue medicine, perhaps based on increasing levels of important proteins, and precision medicine, which “entails going deeper to understand what is causing levels of soluble amyloid-beta to decrease in the first place, whether it is a virus, a toxin, a nanoparticle, or a biological or genetic process,” according to UC News. “If the root cause is addressed, the levels of the protein wouldn’t need to be boosted because there would be no transformation from soluble, normal proteins to amyloid plaques.”

Clinical Laboratory Impact

What does this mean for clinical laboratories engaged in treatment of both Alzheimer’s and Parkinson’s patients? A new understanding of the disease would create “the opportunity to identify new biomarkers and create new clinical laboratory tests that may help diagnose Alzheimer’s earlier in the disease progression, along with tests that help with the patient’s prognosis and monitoring his or her progression,” said Robert Michel, Editor-in-Chief of Dark Daily and its sister publication The Dark Report.

Given the incidence of Alzheimer’s disease in the population, any clinical laboratory test cleared by the FDA would be a frequently-ordered assay, Michel noted. It also would create the opportunity for pathologists and clinical laboratories to provide valuable interpretation about the test results to the ordering physicians.

Stephen Beale

Related Information:

High Soluble Amyloid-β42 Predicts Normal Cognition in Amyloid-Positive Individuals with Alzheimer’s Disease-Causing Mutations

UC Study: Decreased Proteins, Not Amyloid Plaques, Tied to Alzheimer’s Disease

US News: Scientists Propose New Mechanism Driving Alzheimer’s

Scientists Propose New Mechanism Driving Alzheimer’s Disease

Alzheimer’s: Lack of Beta-Amyloid, Not Plaque Buildup, May Be the Culprit

Better Cognitive Predictor in People at High Risk of Alzheimer’s Disease

UC Study: Researchers Question Prevailing Alzheimer’s Theory with New Discovery

ABPP Amyloid Plaques’ Role in Onset of Alzheimer’s Questioned by Cincinnati University: GlobalData Reveals That ABPP Targeted by a Tenth of All Alzheimer’s Drugs

Blots on a Field? A Neuroscience Image Sleuth Finds Signs of Fabrication in Scores of Alzheimer’s Articles, Threatening a Reigning Theory of the Disease

WVXU: Does a Key Alzheimer’s Study Contain Fabricated Images?

Monkeypox Outbreak Subsides in US, Europe, But Public Health Concerns Remain

Experts cite high vaccination rates and behavioral changes among at-risk groups, but warn about complacency; clinical laboratories should remain vigilant

In July, Scott Gottlieb, MD, Commissioner of the US Food and Drug Administration (FDA) from May 2017 to April 2019, wrote an op-ed in The New York Times titled, “Monkeypox Is About to Become the Next Public Health Failure.” In it, he wrote, “Our country’s response to monkeypox has been plagued by the same shortcomings we had with COVID-19.” But has it improved? Clinical laboratory leaders and pathology group managers will find it informative to find out what has taken place since Gottlieb made his stark prediction.

The global monkeypox outbreak that emerged last spring appears to have subsided in the US and Europe, though it remains to be seen if the disease can be completely eradicated, according to multiple media reports. As of Oct. 26, 2022, the Centers for Disease Control and Prevention (CDC) reported a 7-day rolling average of 30 cases per day in the US, down from a peak of nearly 440/day in early August.

Cases are also down in cities that earlier reported heavy outbreaks. For example, the New York City Health Department reported a 7-day average of just two cases per day on Oct. 25, compared with 73/day on July 30.

And the San Francisco Department of Public Health announced on Oct. 20 that it would end the city’s public health emergency on monkeypox (MPX) effective on Oct. 31. “MPX cases have slowed to less than one case per day and more than 27,000 San Franciscans are now vaccinated against the virus,” the agency stated in a press release.

Tedros Adhanom Ghebreyesus, PhD

“Once again, we caution that a declining outbreak can be the most dangerous outbreak, because it can tempt us to think that the crisis is over and to let down our guard,” said World Health Organization (WHO) Director-General Tedros Adhanom Ghebreyesus, PhD, in an Oct. 12 global press briefing. “That’s not what WHO is doing. We are continuing to work with countries around the world to increase their testing capacity, and to monitor trends in the outbreak.” Clinical laboratories should not assume the outbreak has passed but continue to be vigilant and prepared for increased demand in monkeypox testing. (Photo copyright: ITU Pictures.)

Changing Behavior Lowers Infection Rates

In addition to high vaccination rates, public health experts have attributed the decline to behavioral changes among at-risk groups. “There were really substantial changes among men who have sex [with] men,” infectious disease physician Shira Doron, MD, of Tufts Medical Center in Boston, told ABC News.

On September 2, the CDC published the results of a survey indicating that about half of men who have sex with men “reported reducing their number of sex partners, one-time sexual encounters, and use of dating apps because of the monkeypox outbreak.”

Another likely factor is the disease’s limited transmissibility. “Initially, there was a lot of concern that monkeypox could spread widely at daycares or in schools, but, overall, there has been very little spread among children,” NPR reported.  

But citing multiple studies, the NPR story noted “that often there isn’t very much virus in the upper respiratory tract,” where it might spread through talking or coughing. “Instead, the highest levels of virus occur on sores found on the skin and inside the anus.”

These studies, along with earlier research, “explain why monkeypox is spreading almost exclusively through contact during sex, especially anal and oral sex, during the current outbreak,” NPR reported.

Monkeypox Could Mutate, experts say

Despite the promising numbers, public health experts are warning that monkeypox could remain as a long-term threat to public health. According to an article in Nature, “At best, the outbreak might fizzle out over the next few months or years. At worst, the virus could become endemic outside Africa by reaching new animal reservoirs, making it nearly impossible to eradicate.”

In addition to the limited transmissibility of the virus, Nature noted that the outbreak stems from a relatively mild form of the pathogen and is rarely fatal. As of Oct. 28, the CDC reported a total of just six confirmed deaths in the US out of a total of 28,302 confirmed cases since the first infections were reported in May.

It is possible that the virus could mutate into a more contagious form, but Nature noted that monkeypox is a DNA virus, and that they tend to mutate more slowly than RNA viruses such as SARS-CoV-2 and HIV. Nevertheless, University of Alabama at Birmingham School of Medicine bioinformatician Elliot Lefkowitz, PhD, warned that a “worrisome mutation” could arise if the outbreak continues for much longer.

Another expert, Jessica Justman, MD, infectious disease specialist, epidemiologist, and associate professor at Columbia University Mailman School of Public Health, cautioned that declining case numbers might not reflect the true prevalence of the disease.

“I have no confidence that all the people who need to be tested are being tested,” she told Nature. She expressed concerns that people could resume risky behavior if they think the danger has passed.

Another question is whether currently available vaccines offer long-lasting protection. And though reported case numbers are down in the US and Europe, they are rising in parts of Africa and South America, Nature noted.

Gottlieb’s Dire Prediction

The decline in new infections followed dire warnings last summer about the possible consequences of the outbreak. In his New York Times op-ed, former Gottlieb criticized the CDC for being slow to test for the virus. He wrote, “[I]f monkeypox gains a permanent foothold in the United States and becomes an endemic virus that joins our circulating repertoire of pathogens, it will be one of the worst public health failures in modern times not only because of the pain and peril of the disease but also because it was so avoidable.”

At the time of his writing, Gottlieb was right to be concerned. On July 29, the CDC reported a seven-day moving average of 390 reported cases per day. According to the federal agency, a reported case “Includes either the positive laboratory test report date, CDC call center reporting date, or case data entry date into CDC’s emergency response common operating platform, DCIPHER.”

Quashing the outbreak, Gottlieb estimated, would have required about 15,000 tests per week among people presenting symptoms resembling monkeypox. But between mid-May and the end of June, he noted, the CDC had tested only about 2,000 samples, according to the federal agency’s July 15 Morbidity and Mortality Weekly Report (MMWR).

As a remedy, Gottlieb called on the Biden administration to re-focus the CDC’s efforts more on disease control “by transferring some of its disease prevention work to other agencies,” including the FDA.

Perhaps his suggestions helped. Confirmed monkeypox case are way down. Nevertheless, clinical laboratory leaders should continue to be vigilant. Growing demand for monkeypox testing could indicate an increase in reported cases as we enter the 2022 influenza season, which is predicted to be worse than previous years. Dark Daily covered this impending threat in “Australia’s Severe Flu Season Could be a Harbinger of Increased Influenza Cases in US and Canada Straining Already Burdened Clinical Laboratories.”

Stephen Beale

Related Information:

Monkeypox Cases in the US Are Way Down—Can the Virus Be Eliminated?

What Does the Future Look Like for Monkeypox?

NYC Has Almost Eliminated Monkeypox. An NYU Biology Prof on What the City Needs to Reach Zero

New York and Nevada Announce First Monkeypox Deaths as Official CDC Tally Rises to Four

Monkeypox Update: FDA Takes Significant Action to Help Expand Access to Testing

Gottlieb Predicts Monkeypox Will Become Public Health Failure

Monkeypox Is About to Become the Next Public Health Failure

Australia’s Severe Flu Season Could be a Harbinger of Increased Influenza Cases in US and Canada Straining Already Burdened Clinical Laboratories

Researchers from the University of Missouri Publish New Insights into SARS-CoV-2 Omicron’s Ability to Infect and Reinfect Human Cells

Clinical laboratories continue to report positive COVID-19 tests for individuals that have been vaccinated and even previously infected with the same variant of the coronavirus

Researchers across the globe continue to study the SARS-CoV-2 coronavirus and its many variants. Their goals are to curb the spread of the disease and develop new therapies and treatments for optimal patient outcomes. Now, a study conducted by scientists at the University of Missouri (UM) provides deeper insight into the processes the virus uses to mutate and overpower the human immune system. These findings could lead to improved antivirals and clinical laboratory tests for COVID-19.

The UM team identified specific mutations occurring within the virus’ spike protein that help Omicron subvariants evade existing antibodies and create an infection. These mutations may explain why some people who have had previous COVID-19 infections and/or who are fully vaccinated continue to test positive for SARS-CoV-2, and why the virus continues to evolve.

“Omicron now has more than 130 sublineages and they have been here for quite a while. We are now just finally able to detect them and differentiate among them with this research,” said Kamlendra Singh, PhD, associate research professor in the Department of Veterinary Pathobiology at UM’s College of Veterinary Medicine, in a UM press release.

“Previous variants, including Alpha, Beta, Gamma, and Delta, contributed to many of the mutations occurring now with these Omicron variants. So, our research shows how the virus has evolved over time with new mutations,” he added.

The researchers published their findings in the International Journal of Molecular Sciences, titled, “Complex Mutation Pattern of Omicron BA.2: Evading Antibodies without Losing Receptor Interactions.”

Kamlendra Singh, PhD

“Throughout the pandemic, the [SARS-CoV-2] virus has continued to get smarter and smarter. Even with vaccines, it continues to find new ways to mutate and evade existing antibodies,” said Kamlendra Singh, PhD (above), Associate Research Professor, College of Veterinary Medicine at University of Missouri, in a UM press release. This research team’s findings may help clinical laboratories further develop their SARS-CoV-2 antibody tests. (Photo copyright: University of Missouri.)

Antibodies for One Variant, but Not for Another

The scientists began their investigation by researching online databases that track COVID-19 cases and analyzing the protein sequences from more than 10 million Omicron-related samples that were collected from around the world since November of last year.

They examined the available sequences, structures of spike/receptor and spike/antibody complexes of the samples, and then conducted molecular dynamics simulations. The team utilized 3D modeling to locate where mutations occur and created structures of the spike protein to determine how the mutations are affected by antibodies and vaccinations.

The researchers found that the Omicron variant continues to mutate and has become extremely efficient at adaptation. Reinfections are happening because many individuals do not possess the antibodies for the new subvariants that continue to develop.

“Vaccinated individuals, or those who have previously tested positive, may have the antibodies for one variant but not necessarily for any of the other variants,” Singh explained. “The various mutations may seem like only subtle differences, but they are very important.”

The UM scientists’ research shows it is possible to differentiate Omicron subvariants from each other and pinpoint how certain mutations might become problematic for patients. According to Singh, many people can be infected with multiple variants at the same time. He is hopeful that their work will make it possible for vaccines and other treatments to specifically target different strains of the virus.

Singh also believes that the coronavirus is most likely never going to disappear from society and that new variants and their sublineages will continue to appear and evolve.

“The ultimate solution going forward will likely be the development of small molecule, antiviral drugs that target parts of the virus that do not mutate,” Singh said. “While there is no vaccine for HIV, there are very effective antiviral drugs that help those infected live a healthy life, so hopefully the same can be true with COVID-19.”

Omicron Subvariants May Be Here to Stay

“I am proud of my team’s efforts, as we have identified specific mutations for various variants throughout the pandemic, and it feels good to be contributing to research that is assisting with the situation,” Singh said. “We will continue to help out, as there will surely be new variants in the future.”

Singh is also part of a team that developed a supplement called CoroQuil-Zn, which was designed to reduce a patient’s viral load after being infected with SARS-CoV-2. The drug is currently being used in parts of India and is awaiting approval from the US Food and Drug Administration (FDA).

Clinical laboratories that perform antibody testing for SARS-CoV-2 infections should be aware that the coronavirus will likely be moving among humans for many years to come. This recent research may aid in the development of new antivirals, treatments, and vaccines that target specific subvariants for the best patient outcomes.

JP Schlingman

Related Information:

Clever COVID-19

Complex Mutation Pattern of Omicron BA.2: Evading Antibodies without Losing Receptor Interactions

Spike Protein Changes Explain Repeat COVID Infections

Mizzou Research Examines Why COVID-19 Omicron Variant Is So Transmissible: ‘It Can Escape’

University of Missouri Research Team Identifies 46 Mutations Specific to the SARS-CoV-2 Omicron Variant That Could lead to Improved Clinical Laboratory Tests, Treatments, and Vaccines

Scientists Estimate 73% of US Population May Be Immune to SARS-CoV-2 Omicron Variant

Walgreens Launches Clinical Trial Business with Goal of Leveraging Consumer Data, Technology, and Nationwide Reach to Increase Racial and Ethnic Diversity in Drug Research

By partnering with drug manufacturers to connect customers with clinical trials, the retail pharmacy chain believes this new venture will be the company’s “next growth engine.”

Walgreens is launching a business to connect customers with clinical drug trials, a venture that adds another offering to the retail pharmacy giants’ growing menu of healthcare services. This new venture might also mean additional test orders for clinical laboratories and pathology groups in areas that serve Walgreens customers.

In “By 2027, Walgreens Wants 1,000 Primary Care Clinics,” Dark Daily’s sister publication, The Dark Report, reported on Walgreens’ goal of building 1,000 primary care clinics at its retail pharmacies by 2027, a move which mimics the rollout of CVS Pharmacy MinuteClinic and Walmart Health primary care clinics in their retail locations.

Now, Walgreens is attempting to further redefine the patient experience by partnering with pharmaceutical companies to find participants for clinical trials, a business that could result in more Americans from underrepresented racial and ethnic populations enrolling in drug-development trials. With 9,021 retail pharmacies in all 50 states, it is well-positioned to know which of its customers would be candidates for different clinical trials.

“Walgreens’ trusted community presence across the nation, combined with our enterprise-wide data and health capabilities, enables us to pioneer a comprehensive solution that makes health options, including clinical trials, more accessible, convenient and equitable,” said Ramita Tandon, Walgreens’ Chief Clinical Trials Officer, in a press release.

Ramita Tandon, Walgreens’ Chief Clinical Trials Officer

Ramita Tandon, Walgreens’ Chief Clinical Trials Officer, believes Walgreens can play a role in solving the issues of diversity and declining enrollment in clinical trials. “Through the launch of our clinical trials services, we can provide another offering for patients with complex or chronic conditions in their care journey, while helping sponsors advance treatment options for the diverse communities we serve,” she said in a press release. (Photo copyright: Walgreens.)

Serving the Socially Vulnerable

In an interview with Fierce Healthcare, Tandon described the clinical trials business as Walgreens’ “next growth engine” of consumer-centric healthcare solutions.

According to the company press release, “Walgreens is addressing access barriers through a compliant, validated and secure decentralized clinical trial platform built on a rigorous compliance and regulatory framework to ensure patient privacy and security. This approach leverages owned and partner digital and physical assets, including select Health Corner and Village Medical at Walgreens locations, to directly engage patients at home, virtually or in-person.”

Walgreens notes that more than half of its roughly 9,000 U.S.-based stores are in “socially vulnerable areas.”

According to the Washington Examiner, a US Food and Drug Administration (FDA) study revealed that 75% of patients who participate in clinical trials are white, while just 11% are Hispanic and fewer than 10% are Asian or black. In addition, participation in clinical trials has been declining, with 80% of trials failing to attract enough participants on time.

Tandon maintains that making the process of participating in clinical trials easier is another key to increasing diversity and participation in clinical trials.

“During the clinical trial journey, we know it’s a burden for patients to visit sites. We also know that 78% of patient-consumers in the US live within five miles of a Walgreens,” she told PharmaVoice. “If a patient can complete much of the up-front clinical trial requirements at a local Walgreens, or conduct some of the visits digitally, it would make the whole clinical trial experience that much more positive and, maybe, encourage the patient to participate in new clinical trials going forward.”

Walgreens also plans to use its treasure-trove of customer data to find potential patients for its trials business.

“Understanding this detail of customer preference and segmentation can be quite useful particularly in clinical trials, for example, to create better protocols,” Tandon told PharmaVoice. “We are sitting on so much information, but we can, and need to, do a better job of using these insights in a real-world setting, which can be translated to pharma R/D or brand management organizations. We’re all about patient-centric drug development.”

FDA Seeks Diversity in Clinical Trails

Walgreens is in discussions with several drug manufacturers as it looks to launch this new venture.

“We are working very closely with them to understand their business needs and create the solution that’s going to be sort of bespoke to their specific trial needs,” Tandon told Fierce Healthcare. “Our goal is to move that needle and start to see a larger number of US patients participating and highly diverse participants that are coming into clinical trials.”

In April, an FDA press release announced new draft guidance aimed at “developing plans to enroll more participants from underrepresented racial and ethnic populations in the US into clinical trials.”

“Despite having a disproportionate burden for certain diseases, racial and ethnic minorities are frequently underrepresented in biomedical research,” the FDA stated. “Clinical trials provide a crucial base of evidence for evaluating whether a medical product is safe and effective; therefore, enrollment in clinical trials should reflect the diversity of the population that is ultimately going to use the treatment.”

Disintermediation of Retail Pharmacies

“Walgreens has a significant opportunity to create an interconnected healthcare ecosystem where we can use the physical assets of Walgreens and connect with patients and consumers at a local level to better support healthcare and healthcare equality,” Tandon said in PharmaVoice.

This is the latest example of a billion-dollar retail pharmacy chain diversifying away from simply filling prescriptions. Two types of competitors are driving the disintermediation of retail pharmacies because they end up directing patients away from the pharmacy:

  • Amazon.com acquired PillPack and now sends, via mail, prescriptions to patients’ homes.
  • Pharmacy benefit management (PBM) companies with a business model that encourage patients to get 90 days of prescriptions at once, mailed to their home.

In both cases, retail pharmacies lose access to patients. This is what is motivating several national pharmacy chains to offer primary care within their retail pharmacies (where following an office visit with a general practitioner, the patient simply crosses the store to the pharmacy to fill his/her prescription), as well as the clinical trial matching business.

As retail pharmacy chains become an increasingly disruptive force in healthcare, clinical laboratory managers and pathologists should be preparing new strategies to meet the testing needs of a changing primary care delivery model, which likely will include lab testing being offered in nontraditional medical locations.  

Andrea Downing Peck

Related Information:

Walgreens Launches Clinical Trial Business to Address Industrywide Access and Diversity Challenges and Redefine Patient Experience

Pharmacy Retail Giant Walgreens Looks to Disrupt Clinical Trials Business

By 2027, Walgreens Wants 1,000 Primary Care Clinics

FDA Takes Important Steps to Increase Racial and Ethnic Diversity in Clinical Trials

Walgreens Opens First Clinical Trial Business to Achieve ‘Equitable’ Health Options

With Its Wealth of Patient Data, Walgreens Is Looking to Disrupt the Clinical Trial Space

;