DED can be classified as aqueous deficient dry eye (ADDE),
evaporative dry eye (EDE), and mixed DED. ADDE is due to tear underproduction
by the lacrimal glands. EDE can occur due to causes related to either lid
(meibomian gland dysfunction [MGD] or blink-related) or ocular surface (mucin
deficiency and contact lens wear), resulting in abnormal lipid secretion, tear
film instability, and excessive evaporation of tears. Although EDE is considered
a leading cause of DED, ADDE can occur without obvious signs of EDE and vice
versa.

Further, iatrogenic DED could be caused by topical or
systemic drugs, contact lens wear, and ophthalmic surgical/non-surgical
procedures. Goblet cells, which produce mucins and contribute to the stability
of the tear film and immune defenses, are extremely sensitive to
toxic/inflammatory stress and are reduced in density after exposure to
iatrogenic factors. Owing to the multifactorial nature of DED, medications that
can target multiple underlying pathologies simultaneously are desirable.

Treatment goal for DED is to restore ocular surface and tear
film homeostasis. Current treatment options in the management of DED include
artificial tears or ocular lubricants, nutraceuticals, anti-inflammatory
agents, tear stimulants, autologous serum, antibiotics, and other therapies
(eg, physical treatments such as warm compresses, complementary medicines such
as herbal products, punctal occlusion, and surgical approaches).

Artificial Tears

Artificial tears, which substitute or supplement the natural
tear film, are the first line option in the management of DED. Artificial tears
improve symptoms (burning, irritation, and/or discomfort), and provide
temporary relief of dryness of the eye, but have not been shown to treat
pathophysiology of DED. Ideal artificial tears should spread uniformly and
evenly, minimize friction during blinks, have minimal visual disturbance upon
instillation, be safe/ convenient to use, and effectively improve the
signs/symptoms of DED.

Artificial tears are formulated with polymeric lubricants,
demulcents, buffering agents (compatible with ocular pH of approximately 7.5),
electrolytes, osmolality adjusting excipients, and surfactants, with/without
preservatives. Most of artificial tears are formulated to supplement either
lipid layer or aqueous layer of the tear film. However, some eye drops are
formulated as emulsions, which contain aqueous lubricants (such as
hydroxypropyl guar [HPG], polyethylene glycol [PEG], and propylene glycol [PG])
and lipid ingredients (such as phospholipid and mineral oil). Lipid-based
artificial tears have been shown to stabilize the tear film lipid layer, reduce
tear evaporation, and improve the signs of MGD and EDE.

One of the major challenges with eye drops is low retention
time. To increase the retention time, viscosity enhancing agents such as
hyaluronic acid (HA) and carboxymethyl cellulose (CMC) are incorporated in eye
drops; these agents also exhibit muco-mimetic properties and reduce desiccation
by forming a protective layer on the ocular surface. However, eye drops with
high viscosity may cause transient visual disturbances (blurred vision) and
also result in debris, leading to intolerance and non-compliance. Thus, to
overcome low ocular retention, in situ gelling chemistry is used; this is
achieved through HPG, a natural polysaccharide, that forms a viscoelastic gel
at ocular pH through cross-linking.

HPG forms the backbone in artificial tears of the SystaneTM
family (Alcon Laboratories, Inc., Fort Worth, TX, USA), which are indicated for
the temporary relief of dry eye symptoms (such as burning and irritation) and
ocular surface protection in patients with DED. Artificial tears of the
SystaneTM family include nonlipid-based (PEG/PG-HPG lubricant eye drop
[SystaneTM Original], PEG/PG-HPG-sorbitol lubricant eye drop [SystaneTM Ultra]
and PEG/PG-HPG/sodium hyaluronate (HA)-sorbitol lubricant eye drop [SystaneTM
Hydration]) as well as lipid-based (PG-HPG microemulsion lubricant eye drop
[SystaneTM Balance] and PG-HPG nanoemulsion lubricant eye drop [SystaneTM
Complete]) formulations.

In this review, Srinivasan and Williams presented the
formulation components, mechanisms of action, and the summary of literature
evidence of PG-HPG nanoemulsion lubricant eye drop (SystaneTM Complete, Alcon
Laboratories, Inc., Fort Worth, TX, USA) that is indicated for temporary relief
of symptoms of burning and irritation in DED.

PG-HPG Nanoemulsion Lubricant Eye Drops

Craig et al demonstrated the treatment of DED according to
disease subtype and severity. In a multicenter, double-masked, parallel group,
randomized controlled trial, 99 participants (mean age, 44±16 years; 64%
female) with DED were enrolled. Participants instilled either lipid-based
PG-HPG nanoemulsion drops (SystaneTM Complete) or nonlipid-based aqueous drops
(SystaneTM Ultra) ≥4 times daily for 6 months; dry eye symptomology, and tear
film and ocular surface characteristics were assessed.49 Both treatments
demonstrated sustained reduction in DED symptoms (Ocular Surface Disease Index
[OSDI], Dry Eye Questionnaire-5 [DEQ-5], and Symptom Assessment Questionnaire
iN Dry Eye [SANDE] scores) from Day 30 onwards (all p≤0.01) and decreased
superior lid wiper epitheliopathy grades from Day 60 onwards (all p≤0.01).

Further, non-invasive tear film breakup time (NITBUT), and sodium fluorescein
and lissamine green staining scores consistently improved from Day 120 onwards
in both groups (all p<0.05).49 Tear film lipid layer grades increased only with PG-HPG nanoemulsion eye drops (from Day 90 onwards); with significantly greater improvement in patients with low lipid layer thickness at baseline (lipid layer grade ≤3; p=0.01).49 Hence, both lipid-based and non-lipid-based artificial tears provided symptom relief within a month.49 Improvements in the tear film stability and ocular surface characteristics were slower than the symptomatic improvements.49 Further, both formulations showed long-term efficacy and a good tolerability profile across DED subtypes; however, improvement in tear film lipid layer grade was observed only with PG-HPG nanoemulsion drops; particularly in subgroup of patients with evaporative DED due to tear lipid insufficiency (with baseline lipid layer grade ><0.05).

Tear film lipid layer grades increased only with PG-HPG
nanoemulsion eye drops (from Day 90 onwards); with significantly greater
improvement in patients with low lipid layer thickness at baseline (lipid layer
grade ≤3; p=0.01). Hence, both lipid-based and non-lipid-based artificial tears
provided symptom relief within a month. Improvements in the tear film stability
and ocular surface characteristics were slower than the symptomatic
improvements. Further, both formulations showed long-term efficacy and a good
tolerability profile across DED subtypes; however, improvement in tear film
lipid layer grade was observed only with PG-HPG nanoemulsion drops; particularly
in subgroup of patients with evaporative DED due to tear lipid insufficiency
(with baseline lipid layer grade ≤3).

In a Phase IV, openlabel, single-arm,
multicenter trial, patients with DED (N=134; 56.6±14.8 years; 75.4% female)
instilled one drop of PGHPG nanoemulsion in each eye, twice daily for 28 days.
The instillation of PG-HPG nanoemulsion eye drops increased tear film break-up
time (TFBUT) by 1.5±2.8 seconds at 14 days; and the improvement remained consistent
through 28 days. It also improved (decreased) ocular discomfort at 14 days
(mean±SD change in visual analog scale [VAS] score, −17.3±24.80). Moreover,
subgroup analysis of patients with ADDE, EDE, and mixed DED indicated that
PG-HPG nanoemulsion was effective and well tolerated in all three types of DED.
PG-HPG nanoemulsion improved tear film stability, and signs and symptoms of DED

DED is a multifactorial condition with ADDE, EDE, and mixed
etiologies. Artificial tears are the backbone in the management of DED.
Lipid-based lubricant eye drops with viscoelastic characteristics are
beneficial in providing temporary relief of dry eye symptoms.

PG-HPG and borate components in PG-HPG nanoemulsion
lubricant eye drops form a thin viscoelastic layer that prolongs retention of
demulcent; thus, provides long-term surface hydration and moisture retention,
and ocular surface protection by improving cell barrier functions and cell
recovery, and temporary relief of symptoms in DED. Moreover, it provides tear
film stability between and during blinks owing to viscoelastic properties of
HPG. Further, PG-HPG nanoemulsion formulation helps to optimize ocular surface
coverage of lipids that is beneficial in replenishing the tear film lipid
layer. Additionally, PG-HPG nanoemulsion lubricant eye drops in the form of
multidose preservative-free system (with Novelia® bottles) is effective,
convenient, and well tolerated in DED patients who have intolerance to
preservatives with long-term eye drop use.

Clinically, PG-HPG nanoemulsion lubricant eye drops have
been shown to improve dry eye symptoms, enhance tear film stability, and lipid
layer thickness; hence, they help to restore eye surface health and provide
symptom relief in patients with DED, regardless of subtypes. Moreover, PG-HPG
nanoemulsion relieves ocular dryness and discomfort associated with daily
contact lens wear, and in prophylactic treatment of dry eye against adverse
environmental conditions.

Conversely, other lipid-based and/or liposome-based
lubricant eye drops, shown to mimic tear film composition, provide ocular surface
benefits and improve signs of dry eye; however, large-scale controlled clinical
studies are required to obtain more robust evidence on the efficacy. With over
a demi-decade of usage, PG-HPG nanoemulsion lubricant eye drops are effective,
convenient to use, and well tolerated in DED, regardless of its subtypes.

Source: Srinivasan and Williams; Clinical Ophthalmology
2022:16 https://doi.org/10.2147/OPTH.S377960

The Healthy Caribbean Coalition (HCC) continued it’s annual Caribbean Alcohol Reduction Day (CARD) webinar series with a webinar entitled The WHO Global Alcohol Action Plan 2022-2030 – Priorities for the Caribbean.  Panelists shared global and regional updates reflecting on the challenges and opportunities to build momentum around Caribbean alcohol policy within the framework of the Global Alcohol Action Plan.

The HCC and partners have held an annual Caribbean Alcohol Reduction Day for the past 6 years, under the themes and titles: The Misuse of Alcohol (2016); Drink less, Reduce Cancer (2017); Youth: Let’s talk about alcohol (2018);  Women and Alcohol (2019),  Alcohol and COVID-19 (2020) and Live Better, Drink Less: Challenges and Opportunities in the Caribbean (2021) .

This year’s webinar was entitled The WHO Global Alcohol Action Plan 2022-2030 – Priorities for the Caribbean.

The objectives of the 7th Caribbean Alcohol Reduction Day webinar were:

1. To provide an overview of the WHO Global Alcohol Action Plan 2022-2030 and implications for key stakeholders globally and regionally.
2. To provide an update on regional progress in alcohol policy development and implementation including discussion of barriers and opportunities.
3. To discuss regional priorities for alcohol policy action within the framework of the Global Alcohol Action Plan 2022-2030 in order to inform a civil society position paper targeting the region’s policymakers entitled: The WHO Global Alcohol Action Plan 2022-2030 – Priorities for the Caribbean.

The webinar took the form of a series of brief presentations followed by a panel discussion.

• Introduction: Maisha Hutton HCC Executive Director, Professor Rohan Maharaj, HCC Alcohol Policy Advisor, Professor of Family Medicine of University of the West Indies
• Presentations: Moderator, Maisha Hutton
• ‘WHO Global Alcohol Action Plan 2022-2030 – Perspectives from the Region of the Americas’  including a look at PAHO’so #LiveBetterTakeAction campaign and Pahola, PAHOs first digital specialist on alcohol use – Dr. Maristela Monteiro, Senior Advisor on Alcohol and Substance Abuse, Non-Communicable Diseases and Mental Health, PAHO
• Global Perspectives on the WHO Alcohol Action Plan 2022 – 2030 – Mr. Øystein Bakke, Global Alcohol Policy Alliance (GAPA); Senior Adviser, Alcohol, Drugs and Development FORUT, Campaign for Development and Solidarity
• Alcohol Policy in the Caribbean Update – Professor Rohan Maharaj, HCC Alcohol Policy Advisor, Professor of Family Medicine of University of the West Indies
• Jamaica National Alcohol Policy – Michael A . Tucker, Executive Director, National Council on Drug Abuse, Jamaica
• Presentation of Priorities – Maisha Hutton HCC Executive Director
• Panel Discussion: Regional priorities for alcohol policy action within the framework of the Action Plan 2022-2030: Moderator – Maisha Hutton
• Closing & Thanks: Maisha Hutton and Professor Rohan Maharaj

Maisha Hutton
HCC Executive Director

Professor Rohan Maharaj
HCC Alcohol Policy Advisor, Professor of Family Medicine of University of the West Indies

Dr. Maristela Monteiro
Senior Advisor on Alcohol and Substance Abuse, Non-Communicable Diseases and Mental Health, PAHO

Mr. Øystein Bakke
Department of Institutional Research, Northern Caribbean University, Mandeville, Manchester, Jamaica, West Indies

Michael A . Tucker
Executive Director, National Council on Drug Abuse, Jamaica

View the flyer here

The HCC and partners have held an annual Caribbean Alcohol Reduction Days (CARD) since 2016 you can find details of the other CARD days here.

The post 7th Caribbean Alcohol Reduction Day (CARD) 2022 appeared first on Healthy Caribbean Coalition.

Carissa F. Etienne on PAHO's 120th Anniversary: solidarity can help build a healthier and more hopeful future for all

Cristina Mitchell

2 Dec 2022

As a result, the National Police launched an extensive investigation into the poisoning suffered by the educators, prompting the educational district 13-02 to suspend classes until next Monday to disinfect the facility and environment, according to the center’s director. Isabel Veras is an educator.

The Ministry of Public Health was able to determine that the cause of the poisoning was herbicide, which occurred after the teachers inhaled a highly toxic substance sprayed on the campus. “We were able to contact a person who lives in front of the school, and he showed us the container in which the herbicide was supplied, which is a burner for cleaning a patio,” a source close to the investigation said.

A woman who lives near the school would have sprayed this liquid to kill the herbs in her yard, but according to the epidemiologist in charge of the Montecristi health province, she sprayed more than the recommended amount, and with the arrival of the wind, the substance entered the school and caused the poisoning. So far, 15 people, including teachers and children, have been taken to the hospital with poisoning symptoms.

The National Police are expected to look into the situation further so that the person responsible can be brought to justice if necessary.

The holiday season is beckoning, so this may be a fine time to plan a getaway or a get-together. You could also splurge on gift giving before prices rise still further. This may also be an opportunity to turn on the telly and catch up on your binge watching. Or you might want to plan the rest of your life. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …

After finding success investing in the more obviously lucrative corners of American medicine — like surgery centers and dermatology practices — private equity firms have moved aggressively into the industry’s more hidden niches: They are pouring billions into the business of clinical drug trials, Kaiser Health News writes. And a fragmented clinical trials industry has made it a prime target for private equity, which often consolidates markets by merging companies. To date, 11 of the 25 private equity firms identified by industry tracker PitchBook as the top investors in health care have bought stakes in clinical research companies.

Continue to STAT+ to read the full story…

The HC bench comprising Justice Devan Ramachandran and Justice Kauser Edappagath issued this direction as a primary step to address the issue of violence against doctors.

Suo Motu impleading the State Police Chief, the bench observed, "as a first step, in addition to the earlier directions, we are of the firm view that every incident of attack on a Doctor or a Healthcare Professional, including any other staff of the Hospital - be that Security or other - will have to be taken cognizance of by the Station House Officer of the concerned Police Station not later than one hour from the time on which it is reported to him."

"This can be under the Special Law applicable, or under the Indian Penal Code; but an FIR will be need to be registered within the afore time frame, which alone will ensure that the perpetrator/s understands that action is swift and quick," further noted the bench.

Earlier this year, the Kerala High Court had suggested the Government to consider deploying police presence in hospitals, especially in the most sensitive areas and later extend it to other hospitals as well.

Such observations had come from the High Court bench while it was considering a case related to the an attack on a nurse and a doctor at Neendakara Taluk Hospital.

Also Read: Deploy police at Hospitals to prevent Violence against Doctors: Kerala HC advice to Govt

Medical Dialogues had earlier reported that while considering the matter, the High Court had referred to the reports of 'routine' attacks on Healthcare personnel and observed that even though Kerala Healthcare Service Act 2012 has provision for strict penalties for assault against healthcare workers, the legal provision was not sufficient to stop the assaults.

Therefore, the HC Division bench comprising of Justice Devan Ramachandran and Justice Kauser Edappagath had noted back in June 2022, "No doubt, the Kerala Healthcare Service Persons and Healthcare Service Institutions (Prevention of Violence and Damage to Property) Act, 2012 provide for very stringent provisions and punishment. However, as the present case demonstrates, it is not always the best deterrent. We, therefore, have to think about placing hospitals, particularly in remote areas, under police protectional cover, more in the evenings and nights, so that the doctors and nurses can work without apprehension."

While the bench was considering these matters after almost six months, Sri.S.Gopakumaran Nair, learned Senior Counsel, instructed by Sri.S.Prashanth; and Sri.K.Anand informed the bench that for about 12 month period from June, 2021, the number of attacks recorded was in excess of 138.

Taking note of this, the bench observed, "This is certainly distressing, because, statistically, this means that there are at least 10 or 12 attacks every month."

Clarifying that the court is more concerned because despite the court orders in the past, the attacks have only increased in number. The court noted, "We are more concerned because we had been issuing orders in the past, under the hortative hope that the official system would function faultlessly; and that the citizens would also be aware of the imperative requirement to treat the Healthcare System with the respect it deserves."

"The discussions at the Bar today clearly show that, unless a sense of fear of law is instilled into the citizens, nothing can really change. Experience has shown us that citizens are not fearful of law, but of apprehension in case of misconduct or infraction," it further observed.

The bench added that prima facie it is perhaps because citizens get the impression that the processes of law are slow and that they would not be taken to task, that such recurrent occurrences happen.

"The fact that the Government Hospital System is overwhelmed and that the number of patients are escalating by the day, are common knowledge. Unless the Doctors and Healthcare Professionals are able to act in peace and calm, it would become impossible for the system itself to sustain," the bench observed at this outset.

Noting that all the stakeholders should inform the court about the steps that have been taken in this regard, the bench added, "Obviously, therefore, we require all the stakeholders, including the Government, to inform us what steps had been and have to be taken to ensure this."

Meanwhile, the Senior Government Pleader Sri S. Kannan informed the bench that every step as ordered by the HC bench earlier, including the establishment of Police Outposts in hospitals, had been implicitly adhered to by the Government. The Government counsel further submitted that the State was willing to accept any other suggestions- either by the Court or by the stakeholders in this regard.

"We also assured that the Government shares the concern of this Court qua the integrity of the Healthcare System," noted the court at this outset.

Therefore, as a first step the Court has directed the police to ensure that FIRs are lodged against the instances of attacks on doctors and healthcare professionals within one hour.

"As said above, this is only the first step and we will certainly add to this in the days to come, depending upon the inputs which are to be received from the parties in these cases," noted the court.

Suo motu impleading the State Police Chief, the bench remarked,

"We do so because, the said Authority will be the best Officer to ensure that our directions as below are effectively implemented, through necessary Circulars or such other instructions."

"In the afore perspective, we hereby order that every Station House Officer concerned, to whom, or to whose Station, a complaint of atrocity or attack or harm on any Healthcare Professional – be that Doctors, Nurses, staffs, security or such other, or against the property of a Hospital- shall be recorded as a first information and a case registered within a period of one hour from the time on which such information is obtained or gathered," read the order.

"Needless to say, swift action thereafter shall be initiated, including to apprehend the Offenders, as and when it requires so, leading to prosecution and such other, as the law warrants," it further added.

Further, requesting the State to ensure that the citizens are aware of the gravity of the offence of an attack on medical professionals, the bench added in the judgement,

"...we request them to ensure that the citizens are told, by appropriate methods, the gravity of the offence of an attack on a Hospital or a Healthcare Personnel; and the manner in which this Court proposes to deal with it in future."

To read the order, click on the link below:

https://medicaldialogues.in/pdf_upload/kerala-hc-192775.pdf

Also Read: Doctors can refuse to treat in case of Abusive, Unruly, Violent Patients, relatives: NMC Draft Medical Ethics Regulations 2022

To bring a new drug to market, the FDA requires pharmaceutical firms to perform extensive studies to demonstrate safety and efficacy, which are often expensive and time-consuming to conduct to the agency’s specifications. Getting a drug to market a few months sooner and for less expense than usual can translate into millions in profit for the manufacturer.

That is why a private equity-backed startup like Headlands Research saw an opportunity in creating a network of clinical sites and wringing greater efficiency out of businesses, to perform this critical scientific work faster. And why Moderna, Pfizer, Biogen, and other drug industry bigwigs have been willing to hire it — even though it’s a relatively new player in the field, formed in 2018 by investment giant KKR.

In July 2020, Headlands announced it won coveted contracts to run clinical trials of covid-19 vaccines, which would include shots for AstraZeneca, Johnson & Johnson, Moderna, and Pfizer.

In marketing its services, Headlands described its mission to “profoundly impact” clinical trials — including boosting participation among racial and ethnic minorities who have long been underrepresented in such research.

“We are excited,” CEO Mark Blumling said in a statement, to bring “COVID-19 studies to the ethnically diverse populations represented at our sites.” Blumling, a drug industry veteran with venture capital and private equity experience, told KHN that KKR backed him to start the company, which has grown by buying established trial sites and opening new ones.

Finding and enrolling patients is often the limiting and most costly part of trials, said Dr. Marcella Alsan, a public policy professor at Harvard Kennedy School and an expert on diverse representation in clinical trials, which have a median cost of $19 million for new drugs, according to Johns Hopkins University researchers.

Before covid hit, Headlands acquired research centers in McAllen, Texas; Houston; metro Atlanta; and Lake Charles, Louisiana, saying those locations would help it boost recruitment of diverse patients — an urgent priority during the pandemic in studying vaccines to ward off a disease disproportionately killing Black, Hispanic, and Native Americans.

Headlands’ sites also ran, among other things, clinical studies on treatments to combat Type 2 diabetes, postpartum depression, asthma, liver disease, migraines, and endometriosis, according to a review of website archives and the federal website ClinicalTrials.gov. But within two years, some of Headlands’ alluring promises would fall flat.

In September, Headlands shuttered locations in Houston — one of the nation’s largest metro areas and home to major medical centers and research universities — and Lake Charles, a move Blumling attributed to problems finding “experienced, highly qualified staff” to carry out the complex and highly specialized work of clinical research. The McAllen site is not taking on new research as Headlands shifts operations to another South Texas location it launched with Pfizer.

What impact did those sites have? Blumling declined to provide specifics on whether enrollment targets for covid vaccine trials, including by race and ethnicity, were met for those locations, citing confidentiality. He noted that for any given trial, data is aggregated across all sites and the drug company sponsoring it is the only entity that has seen the data for each site once the trial is completed.

A fragmented clinical trials industry has made it a prime target for private equity, which often consolidates markets by merging companies. But Headlands’ trajectory shows the potential risks of trying to combine independent sites and squeeze efficiency out of studies that will affect the health of millions.

Yashaswini Singh, a health economist at Johns Hopkins who has studied private equity acquisitions of physician practices, said consolidation has potential downsides. Singh and her colleagues published research in September analyzing acquisitions in dermatology, gastroenterology, and ophthalmology that found physician practices — a business with parallels to clinical trial companies — charged higher prices after acquisition.

“We’ve seen reduced market competition in a variety of settings to be associated with increases in prices, reduction in access and choice for patients, and so on,” Singh said. “So it’s a delicate balance.”

Dr. Aaron Kesselheim, a professor of medicine at Harvard Medical School, called private equity involvement in trials “concerning.”

“We need to make sure that patients” know enough to provide “adequate, informed consent,” he said, and ensure “protections about the privacy of the data.”

“We don’t want those kinds of things to be lost in the shuffle in the goals of making money,” he said.

Blumling said trial sites Headlands acquired are not charging higher prices than before. He said privacy “is one of our highest concerns. Headlands holds itself to the highest standard.”

Good or bad, clinical trials have become a big, profitable business in the private equity sphere, data shows.

Eleven of the 25 private equity firms identified by industry tracker PitchBook as the top investors in health care have bought stakes in clinical research companies, a KHN analysis found. Those companies have been involved in studies ranging from covid vaccines to treatments for ovarian cancer, Parkinson’s disease, and Alzheimer’s.

Contracted firms also analyze patient data and prepare materials to secure approval from regulatory agencies, in hopes of getting more drugs to market faster. And a big draw for investors: Clinical research companies make money whether or not a drug succeeds, making it less risky than investing in a drug company.

The number of clinical trials has exploded to more than 434,000 registered studies this year as of late November, more than triple the number a decade ago.

Still, most trial sites are physician practices that don’t consistently perform studies, according to a presentation by Boston-based investment firm Provident Healthcare Partners.

“Independent sites are being purchased by private equity, and they’re moving into larger site groups of 30, 40, and then their game plan is to roll that up into a business and then sell it again,” said Linda Moore Schipani, CEO of Clinical Research Associates, a Nashville-based company that worked on covid vaccine trials for AstraZeneca, Novavax, and Pfizer. “That’s kind of the endgame.”

Headlands is a prime example. It announced in November 2019 that it would acquire six centers in the U.S. and Canada, including three sites in Texas and Louisiana owned by Centex Studies that would help improve participation among Hispanics and African Americans.

It has made other acquisitions since then and opened new sites in areas with “extremely limited trial options,” something Blumling says distinguishes his company.

“I’m not an evangelist for private equity,” Blumling said. “The ability of KKR to be willing to invest in something that is a three- to five-year return versus a one- to two-year return is something that you won’t see out there.”

A research center in Brownsville, Texas — a stone’s throw from the U.S.-Mexico border and where 95% of the population is Hispanic or Latino — is one of several where it is partnering with Pfizer to boost patient diversity.

To recruit patients, Headlands “is really going beyond what a lot of sites do, which is social media,” Blumling said in an interview. “It’s going within churches, community fairs, really getting out into as much as possible the broader community.”

Headlands closed the Houston and Lake Charles sites because of staffing issues, Blumling said, and finished or moved their studies elsewhere. Blumling said the decision to close those locations “did not have anything to do with the speed of trials.”

Similarly, he said, Headlands is moving the McAllen site’s operations to Brownsville “because it had a larger population of trained personnel.”

“We want to continue to grow sites and do great work,” Blumling said. “If we can’t find the people in order to do that at the quality that we demand, which is at the highest level, then it doesn’t make sense to keep those sites.”

‘The Writing to Me Was on the Wall’

In 2006, Devora Torrence co-founded Centex Studies, which she described as “my little mom and pop business” in a 2021 podcast about female entrepreneurs in science. She said a flurry of interest from private equity came at the end of 2018. The appeal was evident: Drug companies were relying on bigger clinical trial networks.

“The thing is speed, getting it to market. With a bigger network, you get that speed,” Torrence said on the podcast. “The writing to me was on the wall that either I get some outside investment and scale up myself, or kind of listen to these guys and see if maybe now would be the right time to exit.”

Joining Headlands had its benefits during the pandemic because she could “lean on” its other sites with experience running vaccine trials. “Had we not gotten those … we may not still be here,” Torrence said.

Torrence, whose LinkedIn profile said she left the company in 2021, didn’t respond to messages from KHN.

Lyndon Fullen, a health care consultant and former Centex employee, said private equity provides funding that allows companies to add study sites.

“I completely support it,” he said. “If it’s about reaching that large patient population, it’s of course better to have larger groups with that funding.”

Opportunity in Long Covid

Contract research organization Parexel saw opportunity in the covid pandemic — millions of people were developing long covid after infection and there were few, if any, meaningful treatment options.

The company, which employs more than 19,000 people, was acquired in 2021 by EQT Private Equity and Goldman Sachs’ private equity arm for $8.5 billion, billions more than the $4.5 billion that private equity firm Pamplona Capital Management paid when it took Parexel private in 2017.

A growing body of research shows the debilitating effects of long covid, including a recent study of tens of thousands of patients in Scotland where nearly half had not fully recovered months later. But treatments addressing its root causes could be years away. “It’s a huge number of people,” said Dr. Nathalie Sohier, who leads Parexel’s infectious diseases and vaccines franchise. “There’s a lot of need.”

Long covid represents the promise and peril of the work to develop new drugs: Millions of patients create a potentially lucrative market for drug companies, and yet researchers and industry experts say they are reluctant to jump in. In part, that’s because “it’s not a well-defined disease, and that really makes it highly risky for companies to invest in research,” said Cecil Nick, a vice president for Parexel.

“How are we going to be able to tell the FDA that our drug works? We can’t count the number of people who died; we can’t count the number of people in the hospital,” said Dr. Steven Deeks, a University of California-San Francisco professor who is running an observational study on long covid patients.

As of August, among more than 4,400 covid studies, only 304 focused on long covid. A third of those were related to drug development, Sohier said.

Sohier said “there are few” companies in its long covid program. That hasn’t stopped Parexel from pitching itself as the ideal partner to shepherd new products, including by doing regulatory work and using remote technology to retain patients in trials. Parexel has worked on nearly 300 covid-related studies in more than 50 countries, spokesperson Danaka Williams said.

Michael Fenne, research and campaign coordinator with the Private Equity Stakeholder Project, which studies private equity investments, said Parexel and other contract research organizations are beefing up their data capacity. The aim? To have better information on patients.

“It kind of ties into access and control of patients,” Fenne said. “Technology makes accessing patients, and then also having more reliable information on them, easier.”

KHN senior correspondent Fred Schulte and Megan Kalata contributed to this report.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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Alzheimer's disease can remain undetected
until it is too late to treat. Large-scale screening programs could help to
detect early-stage disease, but current diagnostic methods are too cumbersome
and expensive. Could a simple urine test reveal if someone has early-stage
Alzheimer's disease and could this pave the way for large-scale screening
programs?

A new study published to Frontiers is the
first to identify formic acid as a sensitive urinary biomarker that can reveal
early-stage Alzheimer's disease, potentially paving the way for inexpensive and
convenient disease screening.

The
researchers tested a large group of patients with Alzheimer's disease of
different levels of severity and healthy controls with normal cognition to
identify differences in urinary biomarkers.

They found that urinary formic acid is a
sensitive marker of subjective cognitive decline that may indicate the very
early stages of Alzheimer's disease. Current methods to diagnose Alzheimer's
are expensive, inconvenient, and unsuitable for routine screening. This means
that most patients only receive a diagnosis when it is too late for effective
treatment. However, a non-invasive, inexpensive, and convenient urine test for
formic acid could be just what the doctor ordered for early screening.

Alzheimer's disease is a continuous and
concealed chronic disease, meaning that it can develop and last for many years
before obvious cognitive impairment emerges. The early stages of the disease
occur before the irreversible dementia stage, and this is the golden window for
intervention and treatment. Therefore, large-scale screening for early-stage
Alzheimer's disease is necessary for the elderly.

Urinary formic acid showed an excellent
sensitivity for early Alzheimer's screening. "The detection of urine biomarkers
of Alzheimer's is convenient and cost-effective, and it should be performed
during routine physical examinations of the elderly.

Reference:

Biomarker in urine could be the
first to reveal early-stage Alzheimer's disease; Frontiers in Aging
Neuroscience, DOI:10.3389/fnagi.2022.1046066.