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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This story can be republished for free (details).

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.

The content originally appeared on: News Americas Now

Black Immigrant Daily News

The content originally appeared on: NBC SVG

Free HIV testing, counselling and screening are just a few of the services being offered at a Health Fair hosted by the Ministry of Health

It is being hosted at the site of the Old Treasury Building in Kingstown as part of activities to observe World Aids Day.

Chief Health Promotion Officer in the Ministry of Health Wellness and the Environment Shanika John said the activity is also being held to end the stigma and discrimination around HIV and AIDS.

https://www.nbcsvg.com/wp-content/uploads/2022/12/SHANIKA-AIDS-FAIR.mp3

Ms. John listed a number of other health services that are also available at today’s health fair.

https://www.nbcsvg.com/wp-content/uploads/2022/12/OTHER-SERVICES.mp3

Meanwhile, Director of the Health Security Unit in the Ministry of Health Wellness and the Environment Donna Bascombe is encouraging persons to visit the fair and get tested for HIV.

She said it is time to end the stigma and discrimination of the disease and to treat it like any other disease.

https://www.nbcsvg.com/wp-content/uploads/2022/12/BASCOMBE-STIGMA.mp3

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