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Recent Advances in Drug Discovery: Innovative Approaches and Targeted Therapeutics

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• Geethanjali institute of Engineering and Technology, keesara, Hydetabad · Science and humanities M.Sc.Ph.D

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Clinical pharmacology: Current innovations and future challenges

Affiliations.

• 1 INSERM U1042, Université Grenoble Alpes, Grenoble, France.
• 2 CHU de Grenoble, Service de Pharmacologie - Pharmacosurveillance, CIC1406, Centre Régional de Pharmacovigilance, Grenoble, France.
• 3 INSERM, PARCC, Université de Paris, Paris, France.
• 4 CIC1418 and DMU CARTE, AP-HP, Hôpital Européen Georges-Pompidou, Paris, France.
• 5 Saint-Etienne, UMR1059, Université Jean-Monnet, Saint-Etienne, France.
• 6 CHU de Saint-Etienne, Unité de recherche clinique, Innovation et pharmacologie, Saint-Etienne, France.
• 7 Theranexus, Lyon, France.
• 8 Inserm, CHU Lille, U1172 - Degenerative & vascular cognitive disorders, Université Lille, Lille, France.
• 9 Inserm, CHU Lille, Clinical Investigation Center - CIC 1403, Université Lille, Lille, France.
• 10 CIC1401, INSERM U1045, University of Bordeaux, Bordeaux, France.
• 11 CHU de Bordeaux, CIC1401, Service de Pharmacologie Médicale, Bordeaux, France.
• PMID: 34954839
• DOI: 10.1111/fcp.12747

Clinical pharmacology is the study of drugs in humans, from first-in-human studies to randomized controlled trials (RCTs) and benefit-risk ratio assessment in large populations. The objective of this review is to present the recent innovations that may revolutionize the development of drugs in the future. On behalf of the French Society of Pharmacology and Therapeutics, we provide recommendations to address those future challenges in clinical pharmacology. Whatever the future will be, robust preliminary data on drug mechanism of action and rigorous study design will remain crucial prior to the start of pharmacological studies in human. At the present time, RCTs remain the gold standard to evaluate the efficacy of human drugs, although alternative designs (pragmatic trials, platform trials, etc.) are emerging. Innovations in healthy volunteers' studies and the contribution of new technologies such as artificial intelligence, machine learning, and internet-based trials have the potential to improve drug development. In the field of precision medicine, new disease phenotypes and endotypes will probably help to identify new pharmacological targets, responders to therapies, and patients at risk for drug adverse events. In such a moving landscape, the development of translational research through academic and private partnership, transparent sharing of clinical trial data and enhanced interactions between drug experts, patients, and the general public are priority areas for action.

Keywords: connected devices; drugs; machine learning; precision medicine; translational research; trials.

© 2021 Société Française de Pharmacologie et de Thérapeutique.

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Substance Use Disorders and Addiction: Mechanisms, Trends, and Treatment Implications

Information & authors, metrics & citations, view options, insights into mechanisms related to cocaine addiction using a novel imaging method for dopamine neurons, treatment implications of understanding brain function during early abstinence in patients with alcohol use disorder, relatively low amounts of alcohol intake during pregnancy are associated with subtle neurodevelopmental effects in preadolescent offspring, increased comorbidity between substance use and psychiatric disorders in sexual identity minorities, trends in nicotine use and dependence from 2001–2002 to 2012–2013, conclusions, information, published in.

• Substance-Related and Addictive Disorders
• Addiction Psychiatry
• Transgender (LGBT) Issues

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Substance Abuse and Public Health: A Multilevel Perspective and Multiple Responses

Substance abuse has been a thorny public health concern throughout human history. Manifestly, prevention and treatment are the two main strategies commonly adopted to tackle the problem of substance abuse. They are in fact cross-disciplinary, and they relate to the various domains of heredity, biology, psychology, cognitive science, family, social development and cultural structures. This special issue, “Substance Abuse, Environment and Public Health,” has published empirical studies from different regions and countries globally to enhance the international exchange of latest views and findings on the etiology, processes and influences of substance abuse across different domains, through which a multilevel perspective is considered more helpful for analyzing its complex nature, courses and consequences. This in turn suggests the possible need to employ multiple responses dynamically and integratively in the prevention and treatment of substance abuse.

1. Introduction

It is apparent that substance abuse is a cross-disciplinary topic of research and concern [ 1 , 2 ], which involves the need to employ concomitantly various theoretical explications and empirical evidence in collaborative efforts to strive for more optimal solutions to limit its contagiousness, and to curb any direct and indirect harm [ 3 , 4 ]. Substance abuse has been described as a “chronic relapsing disease”, with extremely high relapse rates that range from 56.8% to 81.8% [ 5 , 6 ]. Recently, the United Nations reported that “(i)n 2017, an estimated 271 million people, or 5.5 per cent of the global population aged 15–64, had used substances in the previous year” ([ 7 ], p.7). This is 11.5% higher than the estimated number of substance-using people in 2012 [ 8 ]. Due to the nature of recurrence and the rising number of substance users globally, a continuing upsurge in human, social, health and economic costs in the form of substance-related violence, criminal acts, health care needs, legal orders, rehabilitative services, reduced labor productivity and judicial expenditure is evident [ 4 , 6 , 9 ]. Undoubtedly, prevention and treatment are two main intervention approaches that have been commonly adopted to tackle substance abuse [ 2 , 10 ], in which the former focuses primarily on enhancing public awareness of the dangers of substance misuse and addiction, and the latter mainly emphasizes helping substance abusers to attain complete abstinence and avoid relapse. Both prevention and treatment of substance abuse are pertinent to public health, as the two approaches need to employ a multilevel perspective to conceptualize and solve fallout generated from drug trafficking, misuse and harm [ 11 , 12 ]. This points to the need to investigate human hereditary, biological, and psychological needs, cognitive and mental conditions, social development and cultural structures simultaneously and interactively.

For a comprehensive understanding of the nature, processes and impact of substance abuse on human individuals and societies as a whole, an international exchange of the latest scholarly views and empirical research findings is needed. This special issue, “Substance Abuse, Environment and Public Health,” aims to promote international exchange of empirical academic works on substance abuse and its related concerns. It includes 14 empirical research articles and one intervention paper from Bosnia, Croatia, Hong Kong, Italy, mainland China, Norway, Poland, Singapore, South Korea, Spain, Slovenia, Sweden and the United States, and covers the topics of substance misuse and addiction amongst various social groups, different types and forms of illicit and legally approved substances and multiple research methods and designs. Importantly, the scholarly works published in this special issue are expected to present an opportunity to enhance the international exchange of cross-disciplinary research and academic inquiries in the prevention and treatment of substance abuse.

2. Substance Abuse and Different Social Groups

When researching substance abuse and its harmful effects, researchers predominantly focus on certain social groups with a higher tendency towards substance taking and misuse, such as adolescents and male adults [ 13 , 14 , 15 , 16 , 17 , 18 ]. This is valid, as they may encounter various demanding life and social challenges, expectations, interpersonal alienation and biological impulses, all of which are relevant to the triggering of their initiation into drug experimentation as a form of self-medication. Substances may also act as a comforting “soul mate” to help users evade hard realities [ 19 , 20 ]. In this special issue, Zubak et al. [ 21 ] examined the effects of scholastic factors—for example, grade point averages, school and other unexcused absences and poor behavior—in relation to illicit drug misuse (IDM) and its initiation among adolescents in Bosnia and Herzegovina. Jee et al. [ 22 ] investigated the trajectories of different smoking groups of young South Korean male adults and the implication of the habit in their atherosclerotic cardiovascular disease (ASCVD) in middle age. However, substance takers are never restricted to any specific social groups; they can be found in communities of professionals, social talents, elders and university students. Devcic et al. [ 23 ] examined socio-demographics, sports-related factors, factors of hesitation, doping-related factors, consumption of dietary supplements, knowledge of doping and predictors of doping behavior in terms of misusing performance-enhancing substances among high-level competitive swimmers in Slovenia. Wang et al. [ 24 ] investigated how gender, residential areas and study majors were related to misconceptions about antibiotic use among Chinese university students, which in turn linked to their antibiotic misuse behavior. Through the use of a community-based participatory research design, Walter et al. [ 25 ] inquired how work-related musculoskeletal disorders (MSDs) and injuries among US fishing industry workers affected their use of prescription opioids to treat their pain, which in turn exposed them to increased risk of developing substance disorders. Apparently, different social groups are equally susceptible to the risk of substance abuse and addiction [ 3 , 4 , 12 ], and this is likely to be affected by their specific personal characteristics and environmental conditions. Hence, there is a need for researchers to discover both common and unique precursors germane to different social groups which lead to their substance using behavior.

3. Substance Abuse and Its Types and Forms

Substances that are misused or abused can be categorized into two forms. These include illicit and legally approved substances of various types. The most common illicit types of substances include cannabis, amphetamines, ketamine, methamphetamines, cocaine, ecstasy and heroin [ 2 , 6 ], which are largely banned in most countries. However, marijuana products have recently been legalized and commercialized in some northern American and Western states and regions under the umbrella of “control of reasonable use,” which casts a contemplative doubt over the original intent of reducing cannabis-related criminality and public health problems; hence, more research is needed on this subject [ 26 , 27 , 28 ]. Tobacco and alcohol are two legally approved types of substances that have been widely used by different social groups across different societies and cultures [ 6 , 11 , 29 ]. Some legally prescribed drugs, such as cough medications and the antibiotics mentioned above, can also be easily misused and abused by the general public, and these too merit the further attention of researchers [ 2 , 30 ].

In this special issue, Lo et al. [ 31 ] explored how far using illicit drugs, smoking cigarettes and drinking alcohol predicted sexual misconduct among Macau youths, while simultaneously adjusting for the effects of susceptibility to peer influence and school attachment/commitment. Assari et al. [ 32 ] attempted to assess the impact of subjective and objective socioeconomic status on the cigarette smoking and alcohol use of older African Americans by controlling the effects of pertinent covariates, which included demographic factors (age and gender), living arrangement and family type, health insurance status, chronic medical conditions, self-rated health, sick days, depression and chronic pain. Muller et al. [ 33 ] investigated changes in exercise and nicotine use among 1464 Norwegian prison inmates by classifying them into harmful and non-harmful substance use pre-incarceration groups, according to the Drug Use Disorders Identification Test (DUDIT) and the Alcohol Use Disorders Identification Test (AUDIT), both of which are commonly used by healthcare practitioners and researchers to assess the severity of illicit drug and intoxicant use. Wang et al. [ 34 ] analyzed the sources of antibiotics leftovers in the home and the risk factors of keeping them in relation to antibiotic self-medication among Chinese university students. Taken together, the relationships between the use of illicit drugs and legally approved substances are complex and intertwined or mutually reinforcing [ 35 , 36 ]. They may be affected by the personal circumstances and environmental conditions of the abusers, and may cause other forms of behavioral maladjustment [ 17 , 37 , 38 ]. Nevertheless, our current understanding of this complicated phenomenon of substance abuse is limited, and so more cross-disciplinary research is again recommended.

4. Researching Substance Abuse: Methods and Designs

As has been mentioned, substance abuse is a public health concern that involves human biological and physical needs, psychosocial demands, cognitive and spiritual fulfillment, and environmental formulations. Therefore, cross-disciplinary research using different methodologies and designs is much needed to scrutinize substance abuse in respect of etiology, maintenance, consequences, abstinence and relapse. Generally speaking, empirical studies using quantitative methods are more common than research involving qualitative inquiry, analysis of secondary data and/or documentary inspection [ 16 , 39 , 40 ]. In fact, research based on a range of methods and designs is useful in enhancing our comprehension of the nature and impact of substance abuse from different perspectives. This special issue incorporates empirical studies conducted by quantitative, qualitative and documentary methods. For quantitative research designs, study findings based on a representative sample or any of the random sampling procedures are desirable, and can strengthen empirical evidence and provide greater external validity [ 41 ]. For example, Oh et al. [ 42 ] investigated whether those who had current or previous experience of facial flushing would drink for different primary reasons, compared with those who had no experience of facial flushing. The sample comprised 4590 college students who were recruited by stratified random sampling procedures proportionately in 82 colleges in South Korea. There are other empirical studies in this special issue that similarly used a representative sample [ 21 , 24 , 31 , 34 ]. However, using quantitative methods to survey empirically the attitudes and behaviors of certain health and human service professional groups is less likely to require a representative sample, and so it is necessary to use non-probabilistic sampling procedures such as quota, purposive or snowballing sampling designs. Molina-Mula et al. [ 43 ] analyzed the attitudes and perceptions of emergency and mental health nurses with regard to alcoholics. Their findings will hopefully help to develop appropriate professional and clinical responses to substance abuse.

Qualitative research methods can help reveal in-depth and formative information related to the processes and development of substance abuse. For their qualitative study, Chan et al. [ 44 ] interviewed 67 drug abusers to explore how their psychological experiences—with special emphasis on interpersonal relatedness—affected their drug taking and relapse behaviors. Walter et al. [ 25 ] used qualitative interviewing to examine knowledge of and attitudes towards opioid use among 21 fishing industry workers in the US. In addition, use of secondary data or documentary information can efficiently and objectively assist in the transition processes of substance users. For example, Asharani et al. [ 45 ] employed and analyzed recorded data from the Registry of Birth and Death, Immigration and Checkpoint Authority of Singapore to investigate the unnatural deaths of 42 treatment seekers of substance addiction between 2011–2015. Their findings provide evidence of the lethal consequences of substance abuse in an unobtrusive manner. Moreover, Chmielowiec et al. [ 46 ] examined the relationship between the mesolimbic dopamine system and addiction in a group of 299 addicted subjects and another group of 301 non-addict controls by analyzing two polymorphisms in their genes (a variable number of tandem repeats in DRD4 and DAT1), which are mainly responsible for dopaminergic transmission, representing a human reward system that is closely related to substance abuse and misuse. It is clear that research using different methods and designs is useful in fortifying and enhancing currently established concepts and knowledge of substance abuse. Therefore, more novel research methods and designs should be encouraged, so that patterns of substance abuse can be more efficiently dissected.

5. Conclusions

Substance abuse has been an issue of public health for hundreds of years [ 47 ]. Nevertheless, professionals and researchers of different domains tend to adopt a one-dimensional view based on their particular expertise when examining, explaining and trying to find solutions to this complex problem [ 10 , 48 , 49 ]. Thus, various and often competing perspectives rooted in the paradigms of heredity, biology, psychology, cognitive science, family, social development and cultural structures can exist simultaneously, thereby unwittingly compounding the problem [ 1 , 2 , 39 , 50 ]. However, as substance abuse is composed of layers of individual development, family and social influences, cultural values and environmental conditions, a multilevel perspective is needed to analyze its etiology, maintenance and consequences. Various theories and models from different scholarly paradigms at different levels of social systems should be employed concomitantly to help examine and resolve the issues as part of a dynamic and comprehensive process [ 2 , 3 , 12 ]. Employing such a multilevel perspective requires researchers and practitioners to explore the interaction of hereditary, physical, psychological, cognitive, mental, family, social, cultural and environmental factors, and to show exactly how such synergy leads to and/or maintains substance use and addiction. Doing so will help in the design of improved multiple responses to the fallout from substance abuse.

As substance abuse is never limited to particular social groups in human societies, it is essential to understand the unique psychological, personality, cognitive, socioeconomic, familial and cultural differences of various social groups, and to explore what common and unique characteristics they hold in terms of the initiation, processes and consequences of substance abuse [ 4 , 6 ]. If researchers, service practitioners, educators and policy makers were able to understand the common and unique etiological causes and stimulants that incur experimentation and the subsequent maintenance of substance abuse, more effective prevention and treatment strategies and programs could be introduced. Furthermore, because each society or nation is comprised of multiple differing social groups, a knowledge and understanding of their unique cultural and ethnic structures would be empirically useful for researchers trying to unearth the common and distinct etiological causes and stimulants of substance use and abuse. This is a largely unchartered area of research.

The abuse of different types and forms of substances may generate different levels of addiction and harm [ 2 , 51 ], which in turn may trigger distinct social maladjustment and craving behaviors [ 12 , 52 ]. Therefore, future research should discern and clarify the effects of different types and forms of substances on the progress, abstinence and relapse of addicts; this would lead to a better comprehension of the nature and impact of substance abuse. Quantitative methods and designs should be adopted to this end, in addition to other methods and designs that will broaden our perspectives on the topic. In other words, future addiction research should consider the employment of mixed-method designs to investigate the nature of different types and forms of substances and their effects on different social groups. Furthermore, the interaction between the biological, individual, family, social and cultural factors that lead to substance abuse is worthy of research, but will require more advanced methodological designs and mathematical and statistical procedures.

The processes and consequences of substance abuse can be seen to evolve in step with social, technological and cultural developments [ 4 , 39 ]. The patterns and forms of substance abuse can vary according to different social groups. Therefore, comparative and longitudinal research is more useful and insightful in helping to reveal its precarious and dynamic influences. In fact, polysubstance abuse—in which substance addicts expect to achieve higher substance-synergy effects of enjoyability by simultaneously abusing multiple types of drugs and substances—has become more common in the past decade [ 53 , 54 ]. This apparently presents an even greater challenge to treatment and healthcare services. In the face of this new phenomenon, the role of empirical research becomes more pivotal in helping to configure effective approaches and solutions.

In conclusion, substance abuse has long been a thorny public health problem, and it continues to evolve. Multiple responses supported by the employment of a multilevel research perspective are needed. Cross-disciplinary collaboration and concerted research are urgently required if we are to optimize our current strategies and remediation.

Author Contributions

T.W.L., J.W.K.Y., and C.H.L.T. conceived the topic for the Special Issue and were the guest editors. All authors have read and agreed to the published version of the manuscript.

This research received no external funding.

Conflicts of Interest

The authors declare no conflict of interest.

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Why are Genentech cancer researchers worried?

By Meghana Keshavan Sept. 27, 2024

This story first appeared in The Readout newsletter.  Sign up for The Readout  and receive STAT’s award-winning biotech news delivered straight to your inbox. 

A busy end of this week! Today, we see an approval for a new type of schizophrenia drug, we see the Biden administration back off a Medicaid proposal, and delve into what Pfizer’s withdrawal of a sickle cell drug means.

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What the withdrawal of Pfizer’s sickle cell drug means

A day after Pfizer pulled its sickle cell drug Oxbryta from the market due to safety concerns, patients and advocates are expressing shock.

The news is an embarrassment for the drugmaker, which spent $5.4 billion to purchase Global Blood Therapeutics, which developed the therapy, in 2022. But there are also questions about whether pulling the drug is the right choice.

“We have so few treatment options,” one pediatric hematologist told STAT. “Could there not be a published warning, even a ‘black box warning,’ instead of the unusual step of taking away the medicine from everybody with sickle cell disease?”

The drug was approved in 2019, but it was a controversial one — with questions swirling even then about its safety and efficacy.

CMS drops Medicaid drug price transparency plan

The Biden administration just scrapped a proposed policy that would have mandated drugmakers disclose the prices and research costs for high-cost medicines in state Medicaid programs. The decision comes after intense lobbying and legal threats from pharma companies, which saw the proposal as an overreach of government authority.

Ultimately, STAT’s Bob Herman writes, the reversal highlights how the Biden administration was not willing to take on a unified drug industry that is still separately attacking the government’s  Medicare drug negotiation program .

Cassava Sciences and former execs, facing SEC charges, agree to fines

Facing charges from the Securities and Exchange Commission for misleading claims related to a controversial Alzheimer’s drug candidate, Cassava Sciences and two of the company’s former executives have agreed to pay fines, the company announced yesterday.

The news came on the same day that the SEC filed charges against Cassava, former CEO Remi Barbier, and former senior vice president of neuroscience Lindsay Burns.

Read more from STAT’s Jonathan Wosen.  

FDA approves Cobenfy as new schizophrenia treatment

U.S. regulators yesterday approved Cobenfy — a new type of schizophrenia treatment developed by Karuna Therapeutics. It’ll be sold by Bristol Myers Squibb.

The drug has a mechanism of action that’s unique to other psychiatric medicines used to treat schizophrenia: It stimulates the muscarinic receptors in the brain to help reduce psychotic symptoms, STAT’s Adam Feuerstein writes.

Trials show that Cobenfy may improve cognition and treat negative symptoms like social withdrawal. This novel approach has fewer side effects, such as weight gain, which is a major issue with other medications. It’ll cost $22,500 each year, and some analysts project that sales could grow to $3.4 billion annually.

What led Pfizer to pull its sickle cell drug off global markets? And what cake did Adam make for all his podcast colleagues except Elaine? We talk about all that and more on this week’s episode of “The Readout LOUD,” STAT’s biotech podcast.

Our colleague Jonathan Wosen joins us to discuss the recent setbacks and wins in oncology R&D, including Genentech’s decision to shut down its cancer immunology group, and the global ambitions of Akeso, the Chinese biotech behind Summit Therapeutics’ recent positive results.

Listen here.

Dispute over Duchenne therapy highlights thorny access issues

“You spend all this time to get the FDA to approve it, and then you have to spend even more time with insurance companies to get them to approve it,” one of her doctors told STAT’s Andrew Joseph.

• Q&A: MedStar Health’s Raj Ratwani on health AI and the battle raging over regulation, STAT
• More than $800 million pledged for mpox response, African CDC says, Reuters
• Insilico Medicine, an early force in AI-driven drug R&D, lets IPO plans peter out for second year in a row, Endpoints

About the Author Reprints

Meghana keshavan.

Biotech Correspondent

Meghana Keshavan covers biotech and contributes to The Readout newsletter .

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Prediction: Eli Lilly Will Dominate the Billion-Dollar Weight Loss Drug Market for This Key Reason

• Eli Lilly’s two weight loss drugs have become blockbusters, bringing in more than $1 billion in annual revenue.
• Demand is growing in this market, but so is competition.
• Motley Fool Issues Rare “All In” Buy Alert

Eli Lilly is focusing on research and manufacturing.

Eli Lilly ( LLY -3.22% ) is a leader in one of the pharmaceutical industry's highest-growth markets: weight loss drugs. This market may increase by 16x from today's size to reach $100 billion by the end of the decade, according to Goldman Sachs Research. And right now, Lilly's two drugs prescribed for weight loss patients -- Mounjaro and Zepbound -- are bringing in billions of dollars in revenue .

But Lilly isn't alone in the market, and in the coming years, this space could become more crowded. Today, Lilly competes with Novo Nordisk , and in the future, companies like biotech giant Amgen and smaller biotech Viking Therapeutics to big pharma company Pfizer could enter the market with rival products.

These players, as well as many others, are studying candidates in clinical trials right now. But my prediction is that even when stronger competition is present, Lilly will continue to dominate this billion-dollar market -- and for one key reason.

Image source: Getty Images.

Mounjaro and Zepbound

First, let's take a quick look at why Lilly's drugs and others of the same class are so popular. Mounjaro and Zepbound are the same drug -- tirzepatide -- but Mounjaro is officially approved for type 2 diabetes, while Zepbound is approved for weight loss. However, doctors have prescribed them both to patients trying to lose weight.

There are a couple of reasons for this: Mounjaro was commercialized first, so for a time, it was the only option from Lilly. And drug shortages have been frequent, so doctors and patients had to go with whatever was available.

Mounjaro and Zepbound are dual GIP and GLP-1 receptor agonists -- they act on two hormones involved in controlling blood sugar levels and appetite. Novo Nordisk makes similar drugs, but they stimulate only the GLP-1 pathway instead of the two, like Lilly's drugs.

In any case, both have produced great results in clinical trials and the real world, and that's why doctors and patients have created demand that has surpassed supply at certain times. Since the shortages, Lilly and Novo Nordisk have taken steps to increase production -- and Lilly has invested $18 billion in manufacturing since 2020 to address the problem and generally strengthen its production abilities.

Now let's move on to my prediction. I think Lilly will dominate this market over the long term despite competition, thanks to its late-stage pipeline. Though others are working on similar drugs in pill form (today's GLP-1 drugs and dual GIP/GLP-1 drugs are injectables) -- Lilly is a step ahead of them all from a timeline perspective.

Two potential weight loss drugs on the horizon

Today, Lilly's orforglipron, a GLP-1 receptor agonist in pill form, is in phase 3 studies. The company also has another candidate in phase 3 -- an injectable called retatrutide. This potential drug could provide superior performance to today's treatments since it acts on three hormones: GIP, GLP-1, and glucagon.

With orforglipron, Lilly may offer patients the convenience of a pill rather than an injection. With retatrutide, Lilly offers the possibility of even stronger efficacy than what we've seen from today's drugs in the same class.

On top of this, Lilly has the first-mover advantage from a marketing and production perspective. Doctors and patients already are familiar with Mounjaro and Zepbound, and if they've had good experiences with those drugs, they may opt for another Lilly treatment. Newer patients may be more willing to go for Lilly's drugs after hearing so many success stories about them in the media.

As for production, as mentioned above, Lilly has been investing in more and more capabilities for quite some time. A newer entrant to the market will need time to ramp up production, distribute its product, and win over doctors and patients.

All of this means I'm optimistic about Lilly's future in this market, even as competition grows. I predict that this pharma giant will continue to hold onto its lead -- and that's great news for investors who get in on the shares today and stick with this story for the long term.

Adria Cimino has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Goldman Sachs Group and Pfizer. The Motley Fool recommends Amgen and Novo Nordisk. The Motley Fool has a disclosure policy .

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Faculty of Humanities & Social Sciences

New research into poppers highlights problematic proposed drugs policy.

Published on 23 September 2024

New research into the use of the drug poppers (alkyl nitrites) has highlighted inconsistencies in proposed changes to drug policy in the UK and how exemptions to the law impact on minority groups.

The study, published in the British Journal of Criminology today (Monday 23 September), is the first of its kind to examine who uses poppers in the UK and why. Poppers provide a cheap, short lasting headrush when used for non-medical purposes and are used as a sex aid to reduce risk of injury from anal sex and as a recreational drug.

Analysis of poppers was conducted through data collected over ten years from the independent annual English Festival Study (EFS), which includes questions on demographic characteristics, past and current alcohol and other drug use.

Statistics from the EFS highlighted that respondents who had engaged in anal sex in the last year were more than twice as likely to have taken poppers. The study showed that gay men participating in anal sex were found to be 14 times more likely to have used poppers in the past year than straight women not participating in anal sex, proving that poppers are a commonly used drug by gay men.

The legal status of poppers is currently ambiguous. This year, the Advisory Council on the Misuse of Drugs (ACMD) recommended a unique exemption for poppers from the Psychoactive Substances Act 2016 because they are used by gay and bisexual men to reduce risk of injury during anal sexual intercourse. The research in this paper has shown that poppers are more likely to be used by gay men, meaning that the proposed exemption would alleviate harm faced by this minority group.

However, the authors of the research highlight the flaws of this approach. By granting a proposed exemption for one minority group the authors state that this risks exacerbating inequalities when other drugs used by different minority groups are not given equal consideration regarding the harms resulting to them from drug controls.

The government is obliged to respond to the recommendations of AMCD reports in a timely manner, meaning that a decision will need to be made soon regarding whether or not to allow poppers to be sold as a sex aid.

Professor Fiona Measham, Chair in Criminology at the University of Liverpool, who led the study said: “We welcome consideration being given to how the Psychoactive Substances Act disproportionately affects groups with protected characteristics but are calling for that same logic to be applied to all affected groups, including by race, gender, age and class.

“While poppers have long been presumed to be used by gay men, this study now shows there is a clear association. To exempt poppers sales from legislative control because of an impact on gay and bisexual men contrasts with the vastly disproportionate impact of criminalisation of drugs on marginalised minority ethnic groups, youth and the working class. We hope that the government considers the broader issue of social justice when responding to the recommendations and takes this opportunity to review current drug policy more comprehensively.”

“Our research indicates that the government can be more ambitious in its approach to drug policy and reorient toward a social justice approach which addresses structural inequalities across society linked to the current outdated Misuse of Drugs Act.”

Professor Mark McCormack , Professor of Sociology at Aston University, added: "It’s not right that a policy of exemptions should benefit one group while ignoring the harms to other groups also with protected characteristics."

You can read the article, ‘ Poppers, the politics of exemption and the characteristics of poppers users in the annual English Festival Study, 2014–2023’ in full here.

Research quantifying “nociception” could help improve management of surgical pain

New statistical models based on rigorous physiological data from more than 100 surgeries provide objective, accurate measures of “nociception,” the body’s subconscious perception of pain.

The degree to which a surgical patient’s subconscious processing of pain, or “nociception,” is properly managed by their anesthesiologist will directly affect the degree of post-operative drug side effects they’ll experience and the need for further pain management they’ll require. But pain is a subjective feeling to measure, even when patients are awake, much less when they are unconscious. In a new study, MIT and Massachusetts General Hospital (MGH) researchers describe a set of statistical models that objectively quantified nociception during surgery. Ultimately, they hope to help anesthesiologists optimize drug dose and minimize post-operative pain and side effects.

The new models integrate data meticulously logged over 18,582 minutes of 101 abdominal surgeries in men and women at MGH. Led by former MIT graduate student Sandya Subramanian , now an assistant professor at UC Berkeley and UC San Francisco, the researchers collected and analyzed data from five physiological sensors as patients experienced a total of 49,878 distinct “nociceptive stimuli” (such as incisions or cautery). Moreover, the team recorded what drugs were administered, and how much and when, to factor in their effects on nociception or cardiovascular measures. They then used all the data to develop a set of statistical models that performed well in retrospectively indicating the body’s response to nociceptive stimuli.

The team’s goal is to furnish such accurate, objective, and physiologically principled information in real-time to anesthesiologists who currently have to rely heavily on intuition and past experience in deciding how to administer pain-control drugs during surgery. If anesthesiologists give too much, patients can experience side effects ranging from nausea to delirium. If they give too little, patients may feel excessive pain after they awaken.

“Sandya’s work has helped us establish a principled way to understand and measure nociception (unconscious pain) during general anesthesia,” said study senior author Emery N. Brown , Edward Hood Taplin Professor of Medical Engineering and Computational Neuroscience in The Picower Institute for Learning and Memory, the Institute for Medical Engineering and Science, and the Department of Brain and Cognitive Sciences at MIT. Brown is also an anesthesiologist at MGH and a Professor at Harvard Medical School. “Our next objective is to make the insights that we have gained from Sandya’s studies reliable and practical for anesthesiologists to use during surgery.”

Surgery and statistics

The research, publsihed in the Proceedings of the National Academy of Sciences , began as Subramanian’s doctoral thesis project in Brown’s lab in 2017.  The best prior attempts to objectively model nociception have either relied solely on the electrocardiogram (ECG, an indirect indicator of heart-rate variability) or other systems that may incorporate more than one measurement, but were either based on lab experiments using pain stimuli that do not compare in intensity to surgical pain or were validated by statistically aggregating just a few time points across multiple patients’ surgeries, Subramanian said.

“There’s no other place to study surgical pain except for the operating room,” Subramanian said. “We wanted to not only develop the algorithms using data from surgery, but also actually validate it in the context in which we want someone to use it. If we are asking them to track moment-to-moment nociception during an individual surgery, we need to validate it in that same way.”

So she and Brown worked to advance the state of the art by collecting multi-sensor data during the whole course of actual surgeries and by accounting for the confounding effects of the drugs administered. In that way, they hoped to develop a model that could make accurate predictions that remained valid for the same patient all the way through their operation.

Part of the improvements the team achieved arose from tracking patterns of heart rate and also skin conductance. Changes in both of these physiological factors can be indications of the body’s primal “fight or flight” response to nociception or pain, but some drugs used during surgery directly affect cardiovascular state , while skin conductance (or “EDA,” electrodermal activity) remains unaffected. The study measures not only ECG but also backs it up with PPG, an optical measure of heart rate (like the oxygen sensor on a smartwatch), because ECG signals can sometimes be made noisy by all the electrical equipment buzzing away in the operating room. Similarly, Subramanian backstopped EDA measures with measures of skin temperature to ensure that changes in skin conductance from sweat were because of nociception and not simply the patient being too warm. The study also tracked respiration.

Then the authors performed statistical analyses to develop physiologically relevant indices from each of the cardiovascular and skin conductance signals. And once each index was established, further statistical analysis enabled tracking the indices together to produce models that could make accurate, principled predictions of when nociception was occurring and the body’s response.

Nailing nociception

In four versions of the model, Subramanian “supervised” them by feeding them information on when actual nociceptive stimuli occurred so that they could then learn the association between the physiological measurements and the incidence of pain-inducing events. In some of these trained versions she left out drug information and in some versions she used different statistical approaches (either “linear regression” or “random forest”). In a fifth version of the model, based on a “state space” approach, she left it unsupervised, meaning it had to learn to infer moments of nociception purely from the physiological indices. She compared all five versions of her model to one of the current industry standards, an ECG-tracking model called ANI.

Each model’s output can be visualized as a graph plotting the predicted degree of nociception over time. ANI performs just above chance but is implemented in real time. The unsupervised model performed better than ANI, though not quite as well as the supervised models. The best performing of those was one that incorporated drug information and used a “random forest” approach. Still, the authors note, the fact that the unsupervised model performed significantly better than chance suggests that there is indeed an objectively detectable signature of the body’s nociceptive state even when looking across different patients.

“A state space framework using multisensory physiological observations is effective in uncovering this implicit nociceptive state with a consistent definition across multiple subjects,” wrote Subramanian, Brown and their co-authors. “This is an important step toward defining a metric to track nociception without including nociceptive ‘ground truth’ information, most practical for scalability and implementation in clinical settings.”

Indeed the next steps for the research are to increase the data sampling and to further refine the models so that they can eventually be put into practice in the operating room. That will require enabling them to predict nociception in real-time, rather than in post-hoc analysis. When that advance is made, that will enable anesthesiologists or intensivists to inform their pain drug dosing judgements. Further into the future, the model could inform closed-loop systems that automatically dose drugs under the anesthesiologist’s supervision.

“Our study in an important first step toward developing objective markers to track surgical nociception,” the authors concluded. “These markers will enable objective assessment of nociception in other complex clinical settings, such as the ICU, as well as catalyze future development of closed-loop control systems for nociception.”

In addition to Subramanian and Brown, the paper’s other authors are Bryan Tseng, Marcela del Carmen, Annekathryn Goodman, Douglas Dahl and Riccardo Barbieri.

Funding from The JPB Foundation, The Picower Institute for Learning and Memory, George J. Elbaum (MIT '59, SM '63, PhD '67), Mimi Jensen, Diane B. Greene (MIT, SM '78), Mendel Rosenblum, Bill Swanson, Cathy and Lou Paglia, annual donors to the Anesthesia Initiative Fund , the National Science Foundation and an MIT Office of Graduate Education Collabmore-Rogers Fellowship supported the research.

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