#pharmaceuticals and drug trials

[reasonsforhope]

“A new U.S. law has eliminated the requirement that drugs in development must undergo testing in animals before being given to participants in human trials.

Animal rights advocates have long pushed for such a move, and some in the pharmaceutical industry have argued that animal testing can be ineffective and expensive...

Signed by President Biden in December as part of a larger spending package, the law doesn't ban the testing of new drugs on animals outright.

Instead it simply lifts the requirement that pharmaceutical companies use animals to test new drugs before human trials. Companies can still test drugs on animals if they choose to.

There are a slew of other methods that drugmakers employ to assess new medications and treatments, such as computer modeling and "organs on a chip," thumb-sized microchips that can mimic how organs' function are affected by pharmaceuticals.

But Aliasger Salem, a professor at the University of Iowa's College of Pharmacy, told NPR that companies opting to use these alternative testing methods as a replacement for animal testing must be aware of the methods' limits to ensure their drugs are safe.

"The companies need to be aware of the limitations of those technologies and their ability to identify or not identify potential toxicities," Salem said.

"You don't want to shift to systems that might not capture all of the types of toxicities that have been seen in the past without ensuring that the methods that you have will capture that."

An FDA spokesperson told NPR that it will "implement all applicable provisions in the omnibus and continue to work with stakeholders to encourage the development of alternative testing methods."

This year's federal budget also includes $5 million for a new FDA program aimed at reducing animal testing by helping to develop and encourage industry to adopt new product testing methods, the spokesperson said.”

-via NPR, 1/12/23

[clinfinite]

Clinical Development Solutions

In the rapidly evolving field of healthcare, clinical development plays a crucial role in bringing novel treatments and therapies to patients worldwide. Clinical Development Solutions (CDS) is at the forefront of this exciting journey, pioneering innovative approaches to accelerate the development and approval of life-saving drugs and medical devices. With a dedicated team of experts and cutting-edge technologies, CDS is committed to transforming the landscape of clinical research and improving patient outcomes.

At CDS, we understand the challenges and complexities of clinical development. Our comprehensive suite of solutions is designed to address these challenges head-on, providing tailored strategies and support throughout the entire drug development lifecycle. From early-phase clinical trials to post-marketing studies, we offer a wide range of services that enable pharmaceutical and biotech companies to navigate the regulatory landscape efficiently and effectively.

One of the key strengths of CDS lies in our expertise in clinical trial design and optimization. We work closely with our clients to design robust and scientifically rigorous trials that generate high-quality data while minimizing risks. By leveraging our extensive knowledge and experience, we can identify the most appropriate patient populations, endpoints, and study designs to maximize the chances of success. Our statistical and data management teams ensure that the collected data is accurate, reliable, and compliant with regulatory requirements.

In addition to trial design, CDS also excels in patient recruitment and retention strategies. We understand the importance of enrolling a diverse and representative patient population to ensure the generalizability of study results. Through our innovative patient-centric approaches, such as digital recruitment platforms and targeted engagement campaigns, we connect with potential study participants and enhance their overall trial experience. By fostering strong relationships with patients and investigators, we improve retention rates and reduce dropout rates, ultimately leading to faster and more reliable study results.

CDS is at the forefront of adopting emerging technologies to drive efficiency and innovation in clinical development. We harness the power of big data analytics, artificial intelligence, and machine learning to uncover valuable insights from complex datasets. These advanced analytics enable us to identify trends, predict outcomes, and optimize trial protocols, thus accelerating the development timeline and reducing costs. Our investment in digital health technologies and wearable devices further enhances data collection and remote monitoring capabilities, enabling more flexible and patient-friendly trial designs.

In the realm of regulatory affairs, CDS provides comprehensive support to ensure compliance with global regulations and standards. Our regulatory experts have in-depth knowledge of regional requirements, including those of the FDA, EMA, and other regulatory authorities worldwide. From preparing regulatory submissions to managing post-marketing safety surveillance, we guide our clients through every step of the regulatory process, ensuring timely approvals and post-approval compliance.

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In conclusion, Clinical Development Solutions is a leading provider of innovative solutions in clinical development. Through our expertise, technology-driven approaches, and commitment to patient-centricity, we strive to transform the drug development landscape and improve patient outcomes. By partnering with CDS, pharmaceutical and biotech companies can navigate the complexities of clinical research with confidence, bringing new therapies to patients faster and more efficiently. Together, let us shape the future of healthcare through innovation and collaboration.

[clivaldatabase]

The Role of Placebos in Clinical Trials

The use of placebos in clinical trials is a powerful tool for advancing medical research, but it must be handled with care to address ethical concerns. By ensuring informed consent, minimizing deception, and balancing risks and benefits, researchers can ethically and effectively use placebos to develop new and better treatments.

[carnageacorn]

.

actually in this space im going to say. in one scene early in infinite jest two brothers are talking about the way their mom has acted after their father's suicide. the first brother asks if she's even sad he's dead. and the other says: there are 2 ways to make a flag be half-mast. you can lower the flag halfway, or you can double the height of the pole. he says: she's plenty sad, i bet. anyway that bit has fundamentally changed the way i think about displays of grief.

[market-insider]

Clinical Trials : Holistic Exploration of the Current State and Future Outlook

The global clinical trials market size is expected to reach USD 123.5 billion by 2030, expanding at a CAGR of 6.49 from 2024 to 2030, according to a new report by Grand View Research, Inc. An increase in the volume and complexity of clinical trials has been witnessed lately, which plays an important role in the R&D of new drugs and products. The market witnessed a decline of 6% in 2020 owing to the COVID-19 pandemic. However, the market is projected to recover from 2021 onwards. In addition, clinical trials have become increasingly costly, adding to the overall cost of developing a drug.

Clinical Trials Market Report Highlights

The phase III clinical trials segment dominated the market with a 53.3% share in 2023. This can be attributed to the complexity of this phase

The interventional studies segment dominated the market in 2023. It is one of the most prominent methods used in clinical trials in the study design segment owing to the increasing demand for the intervention for clinical trials by researchers

North America held 50.3% of the market share in 2023. Favorable government initiatives and the presence of a large number of players in the U.S. that offer advanced services are responsible for market growth

Asia Pacific region is anticipated to grow at the fastest CAGR over the forecast period owing to the increasing patient pool and cost-efficient services.

For More Details or Sample Copy please visit link @: Clinical Trials Market Report

The increasing need for developing new drugs for chronic diseases, such as cancer, respiratory disorders, diabetes, cardiovascular diseases, and others, is creating immense pressure on the healthcare industry. The COVID-19 pandemic and the increasing demand for developing a suitable treatment are driving the market. The high number of people affected by the disease further depicts an increasing need for therapeutics & vaccines. Currently, there are 288 therapeutics and 106 vaccines under development, out of which, nearly 7.0% of therapeutics are in Phase IV, 21.0% in Phase III, and 43.0% & 13.0% in Phase II & Phase I, respectively.

The pandemic has resulted in the global disruption of traditional onsite clinical trials. Hence, regulatory bodies worldwide have undertaken various initiatives for fast-tracking clinical trials for the development of innovative solutions. One such instance is Solidarity, an international clinical trial launched by the WHO to find effective treatment against COVID-19. Although the pandemic has forced many medical device & drug developers to revise the approach to such crises, integrating best practices within clinical trial procedures & adapting to virtual trials, which can support the continuous development of therapeutics.

ClinicalTrials #HealthcareResearch #MedicalInnovation #DrugDevelopment #PatientRecruitment #Biopharmaceuticals #ClinicalResearch #RegulatoryCompliance #DataManagement #PatientEngagement #PrecisionMedicine #TherapeuticTrials #CROs #ClinicalResearchOrganizations #GlobalHealth #ClinicalStudyDesign #PharmaceuticalIndustry #BiotechResearch #ClinicalEndpoints #HealthTechIntegration

[afeelgoodblog]

The Best News of Last Year - 2023 Edition

Welcome to our special edition newsletter recapping the best news from the past year. I've picked one highlight from each month to give you a snapshot of 2023. No frills, just straightforward news that mattered. Let's relive the good stuff that made our year shine.

January - London: Girl with incurable cancer recovers after pioneering treatment

A girl’s incurable cancer has been cleared from her body after what scientists have described as the most sophisticated cell engineering to date.

2. February - Utah legislature unanimously passes ban on LGBTQ conversion therapy

The Utah State Legislature has unanimously approved a bill that enshrines into law a ban on LGBTQ conversion therapy.

3. March - First vaccine for honeybees could save billions

The United States Department of Agriculture (USDA) has approved the world’s first-ever vaccine intended to address the global decline of honeybees. It will help protect honeybees from American foulbrood, a contagious bacterial disease which can destroy entire colonies.

4. April - Fungi discovered that can eat plastic in just 140 days

Australian scientists have successfully used backyard mould to break down one of the world's most stubborn plastics — a discovery they hope could ease the burden of the global recycling crisis within years. 

5. May - Ocean Cleanup removes 200,000th kilogram of plastic from the Pacific Ocean

The Dutch offshore restoration project, Ocean Cleanup, says it has reached a milestone. The organization's plastic catching efforts have now fished more than 200,000 kilograms of plastic out of the Pacific Ocean, Ocean Cleanup said on Twitter.

6. June - U.S. judge blocks Florida ban on care for trans minors in narrow ruling, says ‘gender identity is real’

A federal judge temporarily blocked portions of a new Florida law that bans transgender minors from receiving puberty blockers, ruling Tuesday that the state has no rational basis for denying patients treatment.

7. July - World’s largest Phosphate deposit discovered in Norway

A massive underground deposit of high-grade phosphate rock in Norway, pitched as the world’s largest, is big enough to satisfy world demand for fertilisers, solar panels and electric car batteries over the next 50 years, according to the company exploiting the resource.

8. August - Successful room temperature ambient-pressure magnetic levitation of LK-99

If the claim by Sukbae Lee and Ji-Hoon Kim of South Korea’s Quantum Energy Research Centre holds up, the material could usher in all sorts of technological marvels, such as levitating vehicles and perfectly efficient electrical grids.

9. September - World’s 1st drug to regrow teeth enters clinical trials

The ability to regrow your own teeth could be just around the corner. A team of scientists, led by a Japanese pharmaceutical startup, are getting set to start human trials on a new drug that has successfully grown new teeth in animal test subjects.

10. October - Nobel Prize goes to scientists behind mRNA Covid vaccines

The Nobel Prize in Physiology or Medicine has been awarded to a pair of scientists who developed the technology that led to the mRNA Covid vaccines. Professors Katalin Kariko and Drew Weissman will share the prize.

11. November - No cases of cancer caused by HPV in Norwegian 25-year olds, the first cohort to be mass vaccinated for HPV.

Last year there were zero cases of cervical cancer in the group that was vaccinated in 2009 against the HPV virus, which can cause the cancer in women.

12. December - President Biden announces he’s pardoning all convictions of federal marijuana possession

President Joe Biden announced Friday he's issuing a federal pardon to every American who has used marijuana in the past, including those who were never arrested or prosecuted.

------

And there you have it – a year's worth of uplifting news! I hope these positive stories brought a bit of joy to your inbox. As I wrap up this special edition, I want to thank all my supporters!

Buy me a coffee ❤️

Merry Christmas and Happy New Year!

[veeru619143]

NewLife Medicals: Your Trusted Global Clinical Research Organization

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But why should you trust NewLife Medicals?

NewLife Medicals: Active Pharmaceutical Ingredient Manufacturers

Active pharmaceutical ingredients (APIs) are the heart of any medicine, responsible for its therapeutic effects. At NewLife Medicals, we are more than just API manufacturers. Quality, affordability, and ultra-precision define our API manufacturing. We utilize state-of-the-art technology and rigorous quality checks to ensure the synthesis of high-quality APIs.

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Clinical trials form the backbone of drug development – but they can be complex and costly. Simplify and economize your clinical testing experience with our unparalleled clinical research organization. Our seasoned team of research professionals are committed to delivering high-quality, timely, and ethically sound clinical research.

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[naamahdarling]

Maybe it isn't that I actually hate medical professionals? They just suck and are weird sometimes, and a lot of them shouldn't be practicing, but I don't hate them as a group, like, personally.

What I hate is their ability to make my life harder in ways that are often completely opaque to me, and a lot of the crap things they do are not really possible to challenge. And I hate the fact that holding them responsible fort dogshit behavior in any way that will actually benefit me is almost always impossible.

And I also hate the fact that they have to do stupid things sometimes because that's how the system is set up, and those things sometimes mean patients actually get harmed. They aren't fond of that part either! They don't want the system to be the way it is! But they don't have a choice, so sometimes people like me get forced by bureaucracy into doing things that are re-traumatizing. And I can't imagine that feels good for them at all, knowing that their patients are sometimes only "consenting" because that bureaucracy will not let them be helped in any other way. Which isn't consent at all. I imagine that must be pretty traumatizing for them, too, sometimes.

If it were easier to actually access medical care without tremendous delays in this country right now I would have much less trouble finding providers who are good at what they do and are not horrible people, and who have clinic staff who can do their fucking job.

Oh and I also don't appreciate how evasive and unwilling to commit they are out of fear of being held to an answer that turns out to be inaccurate, but I can't make an informed decision about my own care unless they give me at least some information about probabilities and trajectories and typicalities. Genuinely, how the fuck am I supposed to navigate that shit. I get that some patients are really fucking difficult, but I should be able to get a special stamp on my file or something that says I understand that sometimes medicine isn't an exact science and the best answers that my doctors can give may not always prove to be accurate in the long term. I know they don't like being in that situation either.

A lot of medical professionals are fucking assholes, and unfortunately the ones who are not are still hamstrung by a system set up to actively prevent people from getting care.

I miss my old doctor. He gave no shits about anything that wasn't the patient. He prescribed scheduled meds based on what the patient needed and not based on fear of consequences potentially being imposed on him by the punitive patient-hostile drugs-are-bad moral panic machine developed to force suffering people into buying more dangerous drugs off the street in order to prevent far fewer people from maybe getting high off of drugs that at least weren't laced with lethal substances. (The purpose of a system is what it does.) Did he get sanctioned and become locally unhireable? Unfortunately yes he did. Does he now provide concierge care to rich people? Yes he does. He found a way to make it work, God bless him.

Everything about the medical system in this country is fucked. Hospitals, doctors, nurses, pharmacies, pharmacists, pharmacy techs, phlebotomists, clinic administrative staff, insurance companies, medical schools and schooling, licensing boards, drug advertising to both providers and patients, pharmaceutical reps, researchers, research, publishing, medical trials, pharmaceutical companies, manufacturers and distributors, medical equipment, charting software, billing and billing codes, diagnostic criteria, charity and low income services, accessible transportation, home care, the lack of independent individual patient advocates, dietitians and nutritionists, access to physical and occupational therapy and physical and occupational therapists, the massive bigotry of every kind rampant in every corner of the medical field, social work, senior care and assisted living, deprioritization of informed consent and harm reduction, disability applications, inaccessibility of medical records, especially psychiatric notes which are specifically allowed to be withheld from patients, lack of continuity of care for disadvantaged people, care that is equitably accessible to disabled people, telemedicine, patient portals, phone systems, clinic hours, every single aspect of inpatient and outpatient psychiatry, facility security, all sorts of things going on with therapists who are nevertheless probably the least malicious group of people in this entire charade, aaaaaand patients themselves.

Also hospital toilets that are too tall and make it literally physically impossible for me to poop while I'm there waiting for somebody to come out of surgery. I just needed to take a crap, guys. You didn't need to make the toilets so tall that my feet didn't even touch the floor. It is very clean but there is no shitting for short people at St Francis.

[clinfinite]

[clivaldatabase]

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[transmutationisms]

do you feel like SSRIs are mostly pseudoscience? I'm not sure if I should be open to trying them or avoid them at all costs since I'm not sure if they even work or if they will mess me up permanently

a preliminary note that i don't find the category 'pseudoscience' to be useful & would classify SSRI research more as 'methodologically shoddy science' or 'ideologically slanted' or 'part of a centuries-long effort on the part of psychiatrists to secure themselves professional prestige by claiming neurobiological etiologies where none are shown to exist' &c &c. imo the notion of 'pseudoscience' is itself pretty positivistic, ahistorical, and ideologically noxious (particularly apparent in any analysis of epistemological imperialism).

that aside: you raise two major issues with SSRIs, namely whether they work and whether they will cause you harm.

efficacy of SSRIs is contested. a 2010 meta-analysis found that in patients with mild or moderate depressive symptoms, the efficacy of SSRIs "may be minimal or nonexistent", whilst "for patients with very severe depression, the benefit of medications over placebo is substantial". a 2008 meta-analysis found a similar distinction between mildly vs severely depressed patients, but noted that even in the latter population, drug–placebo differences were "relatively small" and argued that the differences between drug and placebo in severely depressed patients "seems to result from a poorer response to placebo amongst more depressed patients" rather than from a greater efficacy of SSRIs. a 2012 meta-analysis found some SSRIs consistently effective over placebo treatments, but several authors disclosed major relationships with pharmaceutical companies. a 2017 meta-analysis concluded that "SSRIs might have statistically significant effects on depressive symptoms, but all trials were at high risk of bias and the clinical significance seems questionable" (emphasis added) and that "potential small beneficial effects seem to be outweighed by harmful effects".

when evaluating any of this evidence, it is crucial to keep in mind that studies on antidepressant trials are selectively published—that is, they are less likely to be published if they show negative results!

A total of 37 studies viewed by the FDA as having positive results were published; 1 study viewed as positive was not published. Studies viewed by the FDA as having negative or questionable results were, with 3 exceptions, either not published (22 studies) or published in a way that, in our opinion, conveyed a positive outcome (11 studies). According to the published literature, it appeared that 94% of the trials conducted were positive. By contrast, the FDA analysis showed that 51% were positive.

meta-analyses are not immune to this issue, either. in addition to the problem that a meta-analysis of a bunch of bad studies cannot magically 'cancel out' the effects of poor study design, the authors of meta-analyses can and do also have financial interests and ties to pharmaceutical companies, and this affects their results just as it does the results of the studies they are studying. according to a 2016 analysis of antidepressant meta-analyses,

Fifty-four meta-analyses (29%) had authors who were employees of the assessed drug manufacturer, and 147 (79%) had some industry link (sponsorship or authors who were industry employees and/or had conflicts of interest). Only 58 meta-analyses (31%) had negative statements in the concluding statement of the abstract. Meta-analyses including an author who were employees of the manufacturer of the assessed drug were 22-fold less likely to have negative statements about the drug than other meta-analyses [1/54 (2%) vs. 57/131 (44%); P < 0.001]. [...] There is a massive production of meta-analyses of antidepressants for depression authored by or linked to the industry, and they almost never report any caveats about antidepressants in their abstracts. Our findings add a note of caution for meta-analyses with ties to the manufacturers of the assessed products.

so, do SSRIs work? they are certainly psychoactive substances, which is to say, they do something. whether that something reduces depressive symptoms is simply not known at this point, though it is always worth keeping in mind that the 'chemical imbalance' narrative of SSRIs (the idea that they work by 'curing' a 'serotonin deficiency' in the brain) has always been a profitable myth. look, any medical treatment throughout history has been vouched for by SOME patients who report that it helped them—no matter how wacky it sounds or how little evidence there was to support it. this can be for a lot of reasons: placebo effect, the remedy accidentally treating a different problem than it was intended for, the symptoms coincidentally resolving on their own. sometimes the human body is just weird and unpredictable. sometimes remedies work. i'm sorry i can't give you a more definitive answer about whether SSRIs would help you.

as to potential risks: these are significant. SSRIs can precipitate suicidal ideation, a risk that has been consistently downplayed by pharmaceutical companies and studies. SSRIs are also known to contribute to sexual dysfunction and dissatisfaction, again a risk that is minimised and downplayed in much of the literature and in physician communication with patients. further (known) side effects range through emotional blunting, glaucoma, QT interval prolongation, abnormal bleeding & interaction with anti-coagulents, platelet dysfunction, decreases in bone mineral density leading to increased risk of osteopenia and osteoporosis, jaw clenching / TMJ pain, risk of serotonin syndrome when used in conjunction with other serotonergic substances, dizziness, insomnia, headaches, the list goes on.

i don't mean to sound alarmist; all drugs have side effects, some of the ones above occur rarely, and you may very well decide the risk is acceptable to you to take on. i would, though, always encourage you to do thorough research into potential side effects before starting any drug, including an SSRI. more on SSRI side effects in david healy's books 'pharmageddon', 'let them eat prozac', 'the antidepressant era', and 'the creation of psychopharmacology'; 'pillaged' by ronald w maris; and 'the myth of the chemical cure' by joanna moncrieff.

in addition to the above, SSRIs are known to come with a risk of 'discontinuation syndrome'—that is, chemical withdrawal when stopping the drug. this, too, is often downplayed by physicians; many still deny that it can even happen. some patients don't experience it at all, though i can tell you purely anecdotally that SSRI withdrawal was so miserable for me i simply gave up on quitting for over a year, despite the fact that at that point i was already thoroughly experienced with chemical withdrawals from other, 'harder' drugs. again, i am not telling you not to go on SSRIs if you decide these risks are worth it to you! i simply think this is a decision that should always be made with full knowledge (indeed, this is a core, though routinely violated, principle of medical 'informed consent').

ultimately this is not a decision anyone should make for you; it's your body and mind that are at stake here. as always i think that anyone considering any kind of medical treatment should have full knowledge about it and should be making all decisions freely and autonomously. i am genuinely not pushing any agenda 'for' or 'against' SSRIs, only against prescription of them that is done carelessly, coercively, or without fully informing patients of what risks they're taking on and what benefits they can hope to see.

[covid-safer-hotties]

also preserved on our archive

by Rowan Walrath

Public and private funding is lacking, scrambling opportunities to develop treatments

In brief Long COVID is a difficult therapeutic area to work in. It’s a scientifically challenging condition, but perhaps more critically, few want to fund new treatments. Private investors, Big Pharma, and government agencies alike see long COVID as too risky as long as its underlying mechanisms are so poorly understood. This dynamic has hampered the few biotechnology and pharmaceutical companies trying to develop new medicines. The lack of funding has frustrated people with long COVID, who have few options available to them. And crucially, it has snarled research and development, cutting drug development short.

When COVID-19 hit, the biotechnology company Aim ImmunoTech was developing a drug for myalgic encephalomyelitis/chronic fatigue syndrome, better known as ME/CFS. As more people came down with COVID-19, some began to describe lingering problems that sounded a lot like ME/CFS. In many cases, people who got sick simply never seemed to get better. In others, they recovered completely—or thought they had—only to be waylaid by new problems: fatigue that wouldn’t go away with any amount of rest, brain fog that got in the way of normal conversations, a sudden tendency toward dizziness and fainting, or all the above.

There was a clear overlap between the condition, which patients began calling long COVID, and ME/CFS. People with ME/CFS have a deep, debilitating fatigue. They cannot tolerate much, if any, exercise; walking up a slight incline can mean days of recovery. Those with the most severe cases are bedbound.

Aim’s leaders set out to test whether the company’s drug, Ampligen, which is approved for ME/CFS in Argentina but not yet in the US, might be a good fit for treating long COVID. They started with a tiny study, just 4 people. When most of those participants responded well, they scaled up to 80. While initial data were mixed, people taking Ampligen were generally able to walk farther in a 6 min walk test than those who took a placebo, indicating improvement in baseline fatigue. The company is now making plans for a follow-on study in long COVID.

Aim’s motivation for testing Ampligen in long COVID was twofold. Executives believed they could help people with the condition, given the significant overlap in symptoms with ME/CFS. But they also, plainly, thought there’d be money. They were wrong.

“When we first went out to do this study in long COVID, there was money from . . . RECOVER,” Aim scientific officer Chris McAleer says, referring to Researching COVID to Enhance Recovery (RECOVER), the National Institutes of Health’s $1.7 billion initiative to fund projects investigating causes of, and potential treatments for, long COVID. McAleer says Aim attempted to get RECOVER funds, “believing that we had a therapeutic for these individuals, and we get nothing.”

Instead of funding novel medicines like Ampligen, the NIH has directed most of its RECOVER resources to observational studies designed to learn more about the condition, not treat it. Only last year did the agency begin to fund clinical trials for long COVID treatments, and those investigate the repurposing of approved drugs. What RECOVER is not doing is funding new compounds.

RECOVER is the only federal funding mechanism aimed at long COVID research. Other initiatives, like the $5 billion Project NextGen and the $577 million Antiviral Drug Discovery (AViDD) Centers for Pathogens of Pandemic Concern, put grant money toward next-generation vaccines, monoclonal antibodies, and antivirals for COVID-19. They stop short of testing those compounds as long COVID treatments.

Private funding is even harder to come by. Large pharmaceutical companies have mostly stayed away from the condition. (Some RECOVER trials are testing Pfizer’s COVID-19 antiviral Paxlovid, but a Pfizer spokesperson confirms that Pfizer is not sponsoring those studies.) Most investors have also avoided long COVID: a senior analyst on PitchBook’s biotech team, which tracks industry financing closely, says he isn’t aware of any investment in the space.

“What you need is innovation on this front that’s not driven by profit motive, but impact on global human health,” says Sumit Chanda, an immunologist and microbiologist at Scripps Research who coleads one of the AViDD centers. “We could have been filling in the gaps for things like long COVID, where pharma doesn’t see that there’s a billion-dollar market.”

The few biotech companies that are developing potential treatments for long COVID, including Aim, are usually funding those efforts out of their own balance sheets. Experts warn that such a pattern is not sustainable. At least four companies that were developing long COVID treatments have shut down because of an apparent lack of finances. Others are evaluating a shift away from long COVID.

“It is seen by the industry and by investors as a shot in the dark,” says Radu Pislariu, cofounder and CEO of Laurent Pharmaceuticals, a start-up that’s developing an antiviral and anti-inflammatory for long COVID. “What I know is that nobody wants to hear about COVID. When you say the name COVID, it’s bad . . ., but long COVID is not going anywhere, because COVID-19 is endemic. It will stay. At some point, everyone will realize that we have to do more for it.”

‘Time and patience and money’ Much of the hesitancy to make new medicines stems from the evasive nature of long COVID itself. The condition is multisystemic, affecting the brain, heart, endocrine network, immune system, reproductive organs, and gastrointestinal tract. While researchers are finding increasing evidence for some of the disease’s mechanisms, like viral persistence, immune dysregulation, and mitochondrial dysfunction, they might not uncover a one-size-fits-all treatment.

“Until we have a better understanding of the underlying mechanisms of long COVID, I think physicians are doing the best they can with the information they have and the guidance that is available to them,” says Ian Simon, director of the US Department of Health and Human Services’ Office of Long COVID Research and Practice. The research taking place now will eventually guide new therapeutic development, he says.

Meanwhile, time marches on.

By the end of 2023, more than 409 million people worldwide had long COVID, according to a recent review coauthored by two cofounders of the Patient-Led Research Collaborative (PLRC) and several prominent long COVID researchers (Nat. Med. 2024; DOI: 10.1038/s41591-024-03173-6). Most of those 409 million contracted COVID-19 and then long COVID after vaccines and antivirals became available. That fact undercuts the notion that the condition results only from severe cases of COVID-19 contracted before those interventions existed. (Vaccination and treatment with antivirals do correlate with a lower incidence of long COVID but don’t prevent it outright.)

“There is that narrative that long COVID is over,” says Hannah Davis, cofounder of the PLRC and a coauthor of the review, who has had long COVID since 2020. “I think that’s fairly obviously not true.”

The few biotech companies that have taken matters into their own hands, like Aim, are often reduced to small study sizes with limited time frames because they can’t get outside funding.

InflammX Therapeutics, a Florida-based ophthalmology firm headed by former Bausch & Lomb executive Brian Levy, started testing an anti-inflammatory drug candidate called Xiflam after Levy’s daughter came down with long COVID. Xiflam is designed to close connexin 43 (Cx43) hemichannels when they become pathological. The hemichannels, which form in cell membranes, would otherwise allow intracellular adenosine triphosphate (ATP) to escape and signal the NLRP3 inflammasome to crank up its activity, causing pain and inflammation.

InflammX originally conceived of Xiflam as a treatment for inflammation in various eye disorders, but after Levy familiarized himself with the literature on long COVID, he figured the compound might be useful for people like his daughter.

InflammX set up a small Phase 2a study at a site just outside Boston. The trial will enroll just 20 participants, including Levy’s daughter and InflammX’s chief operating and financial officer, David Pool, who also has long COVID. The study is set up such that participants don’t know if they’re taking Xiflam or a placebo.

Levy says the company tried to communicate with NIH RECOVER staff multiple times but never heard back. “We couldn’t wait,” he says.

Larger firms are similarly disconnected from US federal efforts. COVID-19 vaccine maker Moderna appointed a vice president of long COVID last year. Bishoy Rizkalla now oversees a small team studying how the company’s messenger RNA shots could mitigate problems caused by new and latent viruses, including SARS-CoV-2. But Rizkalla says Moderna has no federally funded projects in long COVID.

Federal bureaucracy has slowed down research in other ways. When long COVID appeared, Tonix Pharmaceuticals was developing a possible drug called TNX-102 SL to treat fibromyalgia. The two conditions look similar: they’re painful, fatiguing, and multisystemic, and fibromyalgia can crop up after a viral infection.

But it wasn’t easy to design a study to test the compound in long COVID. Among other issues, the US Food and Drug Administration initially insisted that participants have a positive COVID-19 test confirmed by a laboratory, like a polymerase chain reaction test, to be included in the study. At-home diagnostics wouldn’t count.

“We spent a huge amount of money, and we couldn’t enroll people who had lab-confirmed COVID because no one was going to labs to confirm their COVID,” cofounder and CEO Seth Lederman says. “We just ran out of time and patience and money, frankly.”

Tonix had planned to enroll 450 participants. The company ultimately enrolled only 63. The study failed to meet its primary end point of reducing pain intensity, a result Lederman attributes to the smaller-than-expected sample size.

TNX-102 SL trended toward improvements in fatigue and other areas, like sleep quality and cognitive function, but Tonix is moving away from developing the compound as a long COVID treatment and focusing on developing it for fibromyalgia. If it’s approved, Lederman hopes that physicians will prescribe it to people who meet the clinical criteria for fibromyalgia regardless of whether their condition stems from COVID-19.

“I’m not saying we’re not going to do another study in long COVID, but for the short term, it’s deemphasized,” Lederman says.

Abandoned attempts Without more public or private investment, it’s unclear how research can proceed. The small corner of the private sector that has endeavored to take on long COVID is slowly becoming a graveyard.

Axcella Therapeutics made a big gamble in late 2022. The company pivoted from trying to treat nonalcoholic steatohepatitis, a liver disease, to addressing chronic fatigue in people with long COVID. In doing so, Axcella reoriented itself exclusively around long COVID, laying off most of its staff and abandoning other research activities. People in a 41-person Phase 2a trial of the drug candidate, AXA1125, showed improvement in fatigue scores based on a clinical questionnaire (eClinicalMedicine 2023, DOI: 10.1016/j.eclinm.2023.101946), but Axcella shut down before it could get its planned 300-person follow-on study up and running.

The fate of AXA1125 may be to gather dust. Axcella’s former executives have moved on to other pursuits. Erstwhile chief medical officer Margaret Koziel, once a champion of AXA1125, says by email that she is “not up to date on current research on long COVID.” Staff at the University of Oxford, which ran the Phase 2a study, were not able to procure information about the planned Phase 2b/3 trial. A spokesperson for Flagship Pioneering, the venture firm that founded Axcella in 2011, declined to comment to C&EN.

Other firms have met similar ends. Ampio Pharmaceuticals dissolved in August after completing only a Phase 1 study to evaluate an inhaled medication called Ampion in people with long COVID who have breathing issues. Biotech firm SolAeroMed shut down before even starting a trial of its bronchodilating medicine for people with long COVID. “Unfortunately we were unable to attract funding to support our clinical work for COVID,” CEO John Dennis says by email.

Another biotech company, Aerium Therapeutics, did manage to get just enough of its monoclonal antibody AER002 manufactured and in the hands of researchers at the University of California, San Francisco, before it ended operations. The researchers are now testing AER002 in a Phase 2 trial with people with long COVID. Michael Peluso, an infectious disease clinician and researcher at UCSF and principal investigator of the trial, says that while AER002 may not advance without a company behind it, the study could be valuable for validating long COVID’s mechanisms of disease and providing a proof of concept for monoclonal antibody treatment more generally.

“[Aerium] put a lot of effort into making sure that the study would not be impacted,” Peluso says. “Regardless of the results of this study, doing a follow-up study now that we’ve kind of learned the mechanics of it with modern monoclonals would be really, really interesting.”

‘A squandered opportunity’ In 2022, the NIH’s National Institute of Allergy and Infectious Diseases (NIAID) put about $577 million toward nine research centers that would discover and develop antivirals for various pathogens. Called the Antiviral Drug Discovery (AViDD) Centers for Pathogens of Pandemic Concern, the centers were initially imagined as 5-year projects, enough time to ready multiple candidates for preclinical development. The NIH allocated money for the first 3 years and promised more funds to come later.

The prospect excited John Chodera, a computational chemist at the Memorial Sloan Kettering Cancer Center and a principal investigator at an AViDD center called the AI-Driven Structure-Enabled Antiviral Platform. Chodera figured that if his team were able to develop a potent antiviral for SARS-CoV-2, it could potentially be used to treat long COVID as well. A predominant theory is that reservoirs of hidden virus in the body cause ongoing symptoms.

But Chodera says NIAID told him and other AViDD investigators that establishing long COVID models was out of scope. And last year, Congress clawed back unspent COVID-19 pandemic relief funds, including the pool of money intended for the AViDD centers’ last 2 years. Lawmakers were supposed to come through with additional funding, Chodera says, but it never materialized. All nine AViDD centers will run out of money come May 2025.

“When we do start to understand what the molecular targets for long COVID are going to be, it’d be very easy to pivot and train our fire on those targets,” says Chanda from Scripps’s AViDD center. “The problem is that it took us probably 2 years to get everything up and going. If you cut the funding after 3 years, we basically have to dismantle it. We don’t have an opportunity to say, ‘Hey, look, this is what we’ve done. We can now take this and train our fire on X, Y, and Z.’ ”

Researchers at multiple AViDD centers confirm that the NIH has offered a 1-year, no-cost extension, but it doesn’t come with additional funds. They now find themselves in the same position as many academic labs: seeking grant money to keep their projects going.

Worse, they say, is that applying for other grants will likely mean splitting up research teams, thus undoing the network effect that these centers were supposed to provide.

“Now what we’ve got is a bunch of half bridges with nowhere to fund the continuation of that work,” says Nathaniel Moorman, cofounder and scientific adviser of the Rapidly Emerging Antiviral Drug Development Initiative, which houses an AViDD center at the University of North Carolina at Chapel Hill.

“This was a squandered opportunity, not just for pandemic preparedness but to tackle these unmet needs that are being neglected by biotech and pharma,” Chanda says.

Viral persistence Ann Kwong has been here before. The virologist was among the first industry scientists trying to develop antivirals for hepatitis C virus (HCV) back in the 1990s. Kwong led an antiviral discovery team at the Schering-Plough Research Institute for 6 years. In 1997, Vertex Pharmaceuticals recruited her to lead its new virology group.

Kwong and her team at Vertex developed a number of antivirals for HCV, HIV, and influenza viruses; one was the HCV protease inhibitor telaprevir. She recalls that a major challenge for the HCV antivirals was that scientists didn’t know where in the body the virus was hiding. Kwong says she had to fight to develop an antiviral that targeted the liver since it hadn’t yet been confirmed that HCV primarily resides there. People with chronic hepatitis C would in many cases eventually develop liver failure or cancer, but they presented with other issues too, like brain fog, fatigue, and inflammation.

She sees the same dynamic playing out in long COVID.

“This reminds me of HIV days and HCV days,” Kwong says. “This idea that pharma doesn’t want to work on this because we don’t know things about SARS-CoV-2 and long COVID is bullshit.”

Since January, Kwong has been cooking up something new. She’s approaching long COVID the way she did chronic hepatitis C: treating it as a chronic infection, through a start-up called Persistence Bio. Persistence is still in stealth; its name reflects its mission to create antivirals that can reach hidden reservoirs of persistent SARS-CoV-2, which many researchers believe to be a cause of long COVID.

“Long COVID is really interesting because there’s so many different symptoms,” Kwong says. “As a virologist, I am not surprised, because it’s an amazing virus. It infects every tissue in your body. . . . All the autopsy studies show that it’s in your brain. It’s in your gut. It’s in your lungs. It’s in your heart. To me, all the different symptoms are indicative of where the virus has gone when it infected you.”

Kwong has experienced some of these symptoms firsthand. She contracted COVID-19 while flying home to Massachusetts from Germany in 2020. For about a year afterward, she’d get caught off guard by sudden bouts of fatigue, bending over to catch her breath as she walked around the horse farm where she lives, her legs aching. Those symptoms went away with time and luck, but another round of symptoms roared to life this spring, including what Kwong describes as “partial blackouts.”

Kwong hasn’t been formally diagnosed with long COVID, but she says she “strongly suspects” she has it. Others among Persistence’s team of about 25 also have the condition.

“Long COVID patients have been involved with the founding of our company, and we work closely with them and know how awful the condition can be,” Kwong says. “It is a big motivator for our team.”

Persistence is in the process of fundraising. Kwong says she’s in conversations with private investors, but she and her cofounders are hoping to get public funding too.

On Sept. 23, the NIH is convening a 3-day workshop to review what RECOVER has accomplished and plan the next phase of the initiative. Crucially, that phase will include additional clinical trials. RECOVER’s $1.7 billion in funding includes a recent award of $515 million over the next 4 years. It’s not out of the question that this time, industry players might be invited to the table. Tonix Pharmaceuticals’ Lederman and Aim ImmunoTech’s McAleer will both speak during the workshop.

The US Senate Committee on Appropriations explicitly directed the NIH during an Aug. 1 meeting to prioritize research to understand, diagnose, and treat long COVID. It also recommended that Congress put $1.5 billion toward the Advanced Research Projects Agency for Health (ARPA-H), which often partners with industry players. The committee instructed ARPA-H to invest in “high-risk, high-reward research . . . focused on drug trials, development of biomarkers, and research that includes long COVID associated conditions.” Also last month, Sen. Bernie Sanders (I-VT) introduced the Long COVID Research Moonshot Act, which would give the NIH $1 billion a year for a decade to treat and monitor patients.

It’s these kinds of mechanisms that might make a difference for long COVID drug development.

“What I’ve seen a lot is pharma being hesitant to get involved,” says Lisa McCorkell, a cofounder of the PLRC and a coauthor of the recent long COVID review. “Maybe they’ll invest if NIH also matches their investment or something like that. Having those public-private partnerships is really, at this stage, what will propel us forward.”

Chemical & Engineering News ISSN 0009-2347 Copyright © 2024 American Chemical Society

[im-not-an-object-ok]

For three months this year, I bled nearly every day. My doctor doesn’t know why. Google doesn’t know why. The condition is simply called “postmenopausal bleeding,” and medicine’s best guess as to the cause is that the postmenopausal hormone-replacement therapy I started last November suddenly made my endometrium, the lining of the uterus, “unstable.” All scientific knowledge added up to “If it’s still happening in six months, get back in touch.” (I’m still bleeding intermittently, and I don’t know why.) This is the kind of massive medical shrug that anyone with female anatomy has probably encountered.

Despite major advances for women over the past 100 years—the invention of the contraceptive pill, greater access to safe abortions—much of female biology is still woefully underserved by science. There are reasons for this, most notably the historical exclusion of women from medical and pharmaceutical trials, partly because our awkward hormone cycles were thought to skew results. There’s also the fact that some scientists still project findings from research on men onto women, seeming not to realize that women aren’t just small men: Women are different down to the cellular level, meaning that many of our immune responses, experiences of pain, and symptoms (including, for instance, those that accompany a heart attack) may be different from men’s. Are you having a nasty, unexpected side effect from your medication? That could be because most drugs were developed with male bodies in mind. A 2020 review of 86 common medications, including antidepressants, cardiovascular drugs, and painkillers, found that women were likely routinely overmedicated and suffered adverse reactions nearly twice as often as men.

The lagging science is particularly apparent when it comes to periods and female hormones more generally—the subject of the anthropologist Kate Clancy’s new book, Period, a scientific and cultural history that purports to tell the “real story of menstruation.” Clancy’s book makes clear that a lack of data is to blame for many of the ills that women and girls face concerning their reproductive health, like doctors’ failure to diagnose painful conditions such as endometriosis.

My severe endometriosis was discovered only when I was 41, accidentally. For decades, I had been given prescription-strength painkillers, and my doctor never seemed to wonder whether the amount of pain I was in was abnormal. When I published an essay about my menopausal depression in 2018, a deluge of women wrote to tell me that when they were going through something similar, their doctors had told them they were imagining their brain fog or panic attacks, or had put them on antidepressants that didn’t work because many depression drugs are inadequate to treat the symptoms of fluctuating estrogen.

[afeelgoodblog]

The Best News of Last Week

1. ‘We are just getting started’: the plastic-eating bacteria that could change the world

In 2016, Japanese scientists Oda and Hiraga published their discovery of Ideonella sakaiensis, a bacterium capable of breaking down PET plastic into basic nutrients. This finding marked a shift in microbiology's perception, recognizing the potential of microbes to solve pressing environmental issues.

France's Carbios has successfully applied bacterial enzyme technology to recycle PET plastic waste into new plastic products, aligning with the French government's goal of fully recycling plastic packaging by 2025.

2. HIV cases in Amsterdam drop to almost zero after PrEP scheme

According to Dutch AIDS Fund, there were only nine new cases of the virus in Amsterdam in 2022, down from 66 people diagnosed in 2021. The organisation claimed that 128 people were diagnosed with HIV in Amsterdam in 2019, and since 2010, the number of new infections in the Dutch capital has fallen by 95 per cent.

3. Cheap and drinkable water from desalination is finally a reality

In a groundbreaking endeavor, engineers from MIT and China have designed a passive solar desalination system aimed at converting seawater into drinkable water.

The concept, articulated in a study published in the journal Joule, harnesses the dual powers of the sun and the inherent properties of seawater, emulating the ocean’s “thermohaline” circulation on a smaller scale, to evaporate water and leave salt behind.

4. World’s 1st drug to regrow teeth enters clinical trials

The ability to regrow your own teeth could be just around the corner. A team of scientists, led by a Japanese pharmaceutical startup, are getting set to start human trials on a new drug that has successfully grown new teeth in animal test subjects.

Toregem Biopharma is slated to begin clinical trials in July of next year after it succeeded growing new teeth in mice five years ago, the Japan Times reports.

5. After Decades of Pressure, US Drugmaker J&J Gives Up Patent on Life-Saving TB Drug

In what can be termed a huge development for drug-resistant TB (DR-TB) patients across large parts of the world, bedaquiline maker Johnson and Johnson said on September 30 (Saturday) that it would drop its patent over the drug in 134 low- and middle-income countries (LMICs).

6. Stranded dolphins rescued from shallow river in Massachusetts

7. ‘Staggering’ green growth gives hope for 1.5C, says global energy chief

The prospects of the world staying within the 1.5C limit on global heating have brightened owing to the “staggering” growth of renewable energy and green investment in the past two years, the chief of the world’s energy watchdog has said.

Fatih Birol, the executive director of the International Energy Agency, and the world’s foremost energy economist, said much more needed to be done but that the rapid uptake of solar power and electric vehicles were encouraging.

---

That's it for this week :)

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[hold-him-down]

Belleview Chapter Two (Part B): Felix

Notes: mostly low-level med whump

Belleview: Chapter 1, Chapter 2 (Part A)

TW: Institutionalized slavery, Med Whump, Med Exam, References to Noncon, Noncon touch, Dubcon Medical Care, References to Human Experimentation

✥ ✥ ✥

They expected him to die soon. Lincoln knows this, without prejudice, as well as he knows anything else about this place. Even if the handler had not introduced Felix with the caveat that they had recently ceased all medical intervention, Lincoln could put the pieces together by looking for twenty seconds at the handlers’ notes from the last few days.

According to the available records, during Felix’s first several months at Belleview, he went no longer than three days between ‘projects,' often with multiple projects stacked on top of each other. Lincoln has not yet researched every experimental tool or drug or procedure that Felix was a part of, partly because some of them were classified and the DOH had yet to access the details, and partly because, in the cases where Lincoln was able to identify the critical components of the trials, his stomach had bottomed out early and he had wound up six hours deep in case files trying to sort out exactly how this had happened.

After Felix's first nine months, they had slowed down with him. There was a three week break wherein Felix was not assigned to any long-term trial before he was pulled again, for what would have been the final time. It was a medical test for a hallucinogenic training drug that lasted nearly two months before abruptly terminating two weeks prior, when, to Lincoln’s best guess, the site had received guidance to stop any majorly illegal activities.

Felix appeared to have been neglected since then. According to the handlers’ notes, he had accessed only two meals a day, a few glasses of water, and, if someone took pity on him, was afforded some assistance in showering and using the toilet. If he didn’t, or couldn’t, eat what was given to him, he would go without eating. “That was part of the gag,” the handler said. “We couldn’t… well, we couldn't actively aid in their... uh, it was technically not allowed. But there came a time when we were asked to let them ride out the end. If they didn't eat, they didn't eat.”

There will come a time, Lincoln thinks now, that Felix will be asked to testify to what happened at this site. There will come a time where some semblance of justice will be served, at least to those who partook in the darkest corners of the system. He will see to it that Felix is afforded that chance.

He takes a breath and enters the small cell, which will need to be repurposed into a bedroom over the next day or so. Felix lays on the floor on his side, curled up as tightly as his frail body will allow. He doesn’t open his eyes at their approach.

“We call him Felix because he’s always smiling,” the handler said. He doesn’t smile now. Even in sleep, he looks scared. He’s covered in bruises, with dried blood smeared across his legs and torso. Lincoln had not caught that earlier, but it couldn’t be new. He’s pale. He swallows, and his body tenses for a moment before he settles back into sleep.

“He’s not actually happy, though,” the handler continued. “He flirts with everyone he sees, just trying to find someone to take him home, we think. He’ll do anything you ask him to, as long as he can understand it. The last couple weeks he’s been up and down, though.”

He’s shaking, and it’s not the light tremble of a scared boy who’s seen too much, but a deep, uncontrollable movement that possibly points to deeper issues.

Lincoln thinks through the side effects of the drug trials. The head of that project, Dr. Michael Gletzer, Ph.D, was a leading researcher in the country, highly sought after by pharmaceutical companies and the former Dean of Medicine at the University of Florida. He is available to speak at length regarding his research. He is not currently under arrest, and, to Lincoln’s understanding, has been cooperative with questioning. He will have to speak to the doctor, and he dreads it.

Lincoln watches Felix sleep for a moment, and the reality of what these men have gone through crashes over him. It’s a crushing weight, and he lets himself feel it for only a moment before he shuts it down and takes a breath, then makes a cautious approach.

“Grab him a blanket?” Lincoln asks quietly. From behind him, Philip moves to the cabinet and begins rummaging through its drawers. Lincoln kneels down next to Felix, his hand hovering over his body. He hesitates to make contact.

“Felix,” Lincoln says. He’s gentle when he finally allows his fingers to graze Felix’s shoulder. Felix’s eyes flutter open, although they are slow to seek out Lincoln. His features are uniformly lined with exhaustion, and Lincoln, for a moment, regrets waking him.  “Hi,” Lincoln whispers.

Felix blinks slowly and tries to sit, but even in that movement, it is clear that his body is failing. He struggles to get his hands under himself, and when offered support, he accepts it without any clear indication that he is aware he’s been touched at all. Still, he looks down at himself and takes an almost unnoticeable inventory of his condition. Philip approaches and drapes a blanket over his lap, and Felix offers a tiny smile in return.

“My name is Lincoln Prescott,” Lincoln says. “Do you remember me? From earlier?”

Felix watches his mouth, his expression tight.

“It’s okay if you don’t,” Lincoln continues. “I’m a doctor, I’ve been assigned to Belleview by the Department of Health.” There is little evidence that Felix hears him at all, but he continues the well-rehearsed speech. “As of 9:00 this morning, the contracted worker system is no longer active in the United States,” he continues.

“I don’t think he’s following,” Philip says from next to him. Lincoln nods.

He’s right, of course. “We are working on finding all of the residents of Belleview stable homes to stay in while the infrastructure is built for you to live independently,” he says anyway. “In the meantime, we’re going to stay here as a group and get you all some help, alright?”

Felix nods. 

“Can you tell me your name?”

There is no response, although Felix’s eyes search Lincoln’s, studying him intently.

Lincoln asks Felix how he feels, if he’s hungry, when he ate, how old he is. Felix doesn’t respond. The question hovers just out of reach, whether Felix can and doesn’t speak, or whether he cannot at all. According to the handler, he hasn’t spoken since returning from the most recent drug trial. Prior to that, though, there were no notable concerns with his speech, hearing, or comprehension. Best case scenario, it’s a trauma response and can be worked through down the line. Worst case is that there is irreversible damage to either his brain (most likely), or individual elements of communication (highly unlikely). Both are worth exploring.

Layered upon this, there are the issues of his physical responses. He startles easily but does not pull away. He blinks slowly. His hands are slow to find the blanket and hold onto it. His eyes are red, his skin has a kind of translucent hue. He expected Felix to require more substantial diagnostic testing than they’re able to offer, and it is clear to him that a trip to the hospital for scans is unavoidable.

As Philip sets up the admission forms on the tablet, Lincoln pulls a pair of blue latex gloves on. Felix almost instantly responds, which is ultimately a good sign, as hard as it is to address in the moment. The tremors that run through his body have taken a sort of panicked edge.

“It’s alright,” Lincoln says. “I’m just gonna look at you, okay? We’re here to help.”

Felix is cooperative as Lincoln takes one of his hands. He squeezes it once then turns it over, examining the bruising and scarring from months of drug use. He runs his thumb across one of the most prominent, likely the site of a long-term IV port.

“Let’s get this off you,” Lincoln says. He is cautious as he presses his fingers under the front of the collar, his touch light as he seeks the release mechanism. When he finds it, and the collar clicks free and falls into his hands, he is both relieved that it was simple enough, and horrified by what he sees. Dark bruises form where the clip sat, with deeper gashes toward the back of his neck where the plasticky-metal dug in during, what had to be, violent altercations. Lincoln runs his fingers along the lines there, but Felix does not react.

He takes his vitals, he does as thorough an exam as he can. There’s a very tender spot on the side of his head, and with the other potential signs of concussion, it shouldn’t be ruled out. Felix is especially jumpy when Lincoln runs his hand down his spine and over his ribs. Some are broken. Felix holds his left arm more gingerly, so Lincoln is careful as he looks checks it. Still, as Lincoln turns it over, Felix cries out, his whole body tense for only a second before he forcibly relaxes. 

“I’m sorry,” Lincoln whispers. Somewhere along the line, tears have formed in Felix’s eyes, and they now threaten to spill. Lincoln isn’t sure exactly how much willpower it takes him to keep them in, only that he does. As soon as his arm is released, Felix cradles it to his chest. 

“Can I look at your back?” Lincoln asks, gentle but assertive in repositioning him.

He’s extremely underweight, with too many vertebrae and too much rib instantly visible. A thick scar runs across one side of his abdomen and circles around his side. There are other scars, less visible ones that almost would be missed by the naked eye, but they’re there. 

Felix doesn’t make a sound when Lincoln examines lower. He watches the wall with a sort of sad detachment as Lincoln runs his fingers gingerly over some swelling in his lower back, then guides him onto his side.

“Almost done,” Lincoln says. “Tell me if you need me to stop, okay?” 

There is no answer, which Lincoln does not mistake for permission, but accepts at face value. He monitors Felix’s breathing, the cadence of the tremors that roll through him, his posture. Philip kneels in front of him, holding his hand and watching his face for signs of extreme duress. It’s the best they can do.

Here, the damage is obvious. Lincoln notes both bruising and tearing, with a slew of fluids, presumably belonging to both Felix and the handlers, dried onto his skin. Lincoln’s stomach turns over as he cleans him up, muttering whatever words of encouragement he can come up with.

The further into this they go, the more Lincoln questions the plan. The likelihood that even in a full service hospital, he would be equipped to manage this, is slim. He pulls off the gloves and helps Felix to sit, then drapes the blanket around his shoulders. 

“You okay?” Lincoln asks. Felix looks very, very far from okay, but the worst is over.

Felix brings his hand up to rest on Lincoln’s arm and squeezes it. It isn’t exactly confirmation of understanding, nor is it a show of okayness. Lincoln would be doing him a disservice by writing the action off as either. But it’s something close to it, he thinks. Lincoln smiles and covers his hand with his own and squeezes it again.

“We’ll get you better, okay?” he says. “Philip’s going to help you get cleaned up, get some food and water in you, set you up with an IV and some medicine to make you feel better.” There’s no recognition in his eyes, but Lincoln continues. “While you get showered, we’ll get you a bed and a TV, or some books, or anything you need.”

Extricating himself from Felix’s grip is a little harder than it was getting into it, but once he’s free, he stands, and Felix’s eyes track his movements. 

“N… n…” Felix reaches after him as he steps toward the door, and Lincoln pauses, turning. There is true panic, for the first time, in his expression. He wants to show you he can still be of use, the handler said. He wants you to pull him.

“Felix,” Lincoln whispers. “I’ll be back for you, alright? I promise you, I will come back." He takes a step toward the door, and the tears that threatened to spill earlier come back in full force. “I need to go check on your friend,” Lincoln says, although there is almost no chance at this point that Felix understands. He kneels down and tries to smile, but he thinks it probably doesn't land. “Philip will stay with you and get you cleaned up.”

He mutters instructions to Philip, and seconds later, he is in the hallway, his forehead pressed into the wall while he takes that whole interaction and locks it into a very, very tight box in the back of his mind. 

He is in good hands. He will be okay. He is not alone, and he is not going to be left to die, and Lincoln will spend the next four weeks making sure that he knows it.

✥ ✥ ✥

Belleview Taglist:

@pigeonwhumps @peachy-panic @whump-cravings @pirefyrelight @i-eat-worlds

@taterswhump @squishablesunbeam @inpainandsuffering @distinctlywhumpthing @just-a-whumping-racoon-with-wifi

@handsinmotion @whumps-and-bumps