The U.S. Food and Drug Administration posted a video:

Los medicamentos de receta pasan por muchos pasos y fases importantes antes de que los aprobemos. Las investigaciones, los datos y la evidencia deben demostrar que el medicamento es seguro y eficaz para el uso previsto. Aprenda más sobre el proceso de aprobación de la FDA de principio a fin.

Para obtener más información sobre el papel de la FDA en la regulación y la aprobación de medicamentos, visite nuestro sitio web en www.fda.gov/drugs/information-consumers-and-patients-drug...

Vea esta serie de tres partes: www.youtube.com/playlist?list=PL0AE2C851E6968546

The U.S. Food and Drug Administration posted a video:

Quizás sepa que la FDA es responsable de aprobar los medicamentos nuevos, como medicamentos de receta, genéricos, biosimilares y de venta libre, y de garantizar que esos medicamentos sean seguros, de alta calidad y funcionen como se supone que deben hacerlo. Pero nuestro trabajo no termina ahí. Continuamos monitoreando la seguridad y calidad de los medicamentos aprobados en los años venideros. Aprenda más sobre nuestro papel en la regulación de estos medicamentos.

Para obtener más información sobre el papel de la FDA en la regulación y la aprobación de medicamentos, visite nuestro sitio web en www.fda.gov/drugs/information-consumers-and-patients-drug...

Vea esta serie de tres partes: www.youtube.com/playlist?list=PL0AE2C851E6968546

The U.S. Food and Drug Administration posted a video:

¿Qué son los biosimilares? Los biosimilares son un tipo de medicamento que se usa para tratar una variedad de afecciones, como enfermedades crónicas de la piel y los intestinos, artritis, diabetes, afecciones renales, degeneración macular y algunos tipos de cáncer. Un biosimilar es un tipo de medicamento biológico. La mayoría de los medicamentos biológicos se elaboran usando fuentes vivas, como células animales, bacterias o levaduras. Debido a que en su mayoría provienen de fuentes vivas, todos los tipos de productos biológicos tienen diferencias menores que ocurren naturalmente entre los lotes de producción. Así como los medicamentos de marca tienen versiones genéricas, los biológicos originales pueden tener biosimilares. La cuidadosa revisión de datos, estudios y pruebas por parte de la FDA ayuda a garantizar que los productos biosimilares brinden los mismos beneficios de tratamiento que el producto biológico original aprobado por la FDA. Los biosimilares pueden brindarle más acceso a tratamientos importantes y también pueden ahorrarle dinero, dependiendo de su cobertura de seguro. Se han aprobado muchos biosimilares diferentes y se esperan aún más. Para obtener más información, visite www.fda.gov/biosimilars

The U.S. Food and Drug Administration posted a video:

La FDA monitorea continuamente datos en tiempo real de pacientes, fabricantes de medicamentos y profesionales de la salud, incluyendo informes de reacciones adversas a los medicamentos de receta. Según estos datos, podemos actualizar las etiquetas de los medicamentos o, en casos excepcionales, solicitar la retirada del mercado. Aprenda más sobre el proceso de la FDA para el monitoreo continuo de los medicamentos aprobados.

Para obtener más información sobre el papel de la FDA en la regulación y la aprobación de medicamentos, visite nuestro sitio web en www.fda.gov/drugs/information-consumers-and-patients-drug...

Vea esta serie de tres partes: www.youtube.com/playlist?list=PL0AE2C851E6968546

The U.S. Food and Drug Administration posted a video:

Quizás sepa que la FDA es responsable de aprobar los medicamentos nuevos, como medicamentos de receta, genéricos, biosimilares y de venta libre, y de garantizar que esos medicamentos sean seguros, de alta calidad y funcionen como se supone que deben hacerlo. Pero nuestro trabajo no termina ahí. Continuamos monitoreando la seguridad y calidad de los medicamentos aprobados en los años venideros. Aprenda más sobre nuestro papel en la regulación de estos medicamentos.

Para obtener más información sobre el papel de la FDA en la regulación y la aprobación de medicamentos, visite nuestro sitio web en www.fda.gov/drugs/information-consumers-and-patients-drug...

The U.S. Food and Drug Administration posted a video:

Los medicamentos de receta pasan por muchos pasos y fases importantes antes de que los aprobemos. Las investigaciones, los datos y la evidencia deben demostrar que el medicamento es seguro y eficaz para el uso previsto. Aprenda más sobre el proceso de aprobación de la FDA de principio a fin.

Para obtener más información sobre el papel de la FDA en la regulación y la aprobación de medicamentos, visite nuestro sitio web en www.fda.gov/drugs/information-consumers-and-patients-drug...

The U.S. Food and Drug Administration posted a video:

La FDA monitorea continuamente datos en tiempo real de pacientes, fabricantes de medicamentos y profesionales de la salud, incluyendo informes de reacciones adversas a los medicamentos de receta. Según estos datos, podemos actualizar las etiquetas de los medicamentos o, en casos excepcionales, solicitar la retirada del mercado. Aprenda más sobre el proceso de la FDA para el monitoreo continuo de los medicamentos aprobados.

Para obtener más información sobre el papel de la FDA en la regulación y la aprobación de medicamentos, visite nuestro sitio web en www.fda.gov/drugs/information-consumers-and-patients-drug...

On December 3, a federal appeals court ruled against one of the FDA’s untouchable restrictions on industry—thou shalt not promote the off-label use of pharmaceutical products. An industry that is little interested in constitutional law suddenly finds itself talking about the First Amendment and whether, and on what grounds, the case will be appealed. Meantime, the court’s decision left FDA Matters torn between cheering and booing. Patients are poorly served if their doctor is prescribing drugs without being able to tap into all sources of relevant knowledge. However, permitting off-label promotion undercuts the incentive for companies to thoroughly investigate the safety and efficacy of a drug for a second or third use.

The proposed American Privacy Rights Act (APRA) has taken its first step U.S. House legislative process with several issue disagreements becoming more evident. On May 23, the U.S. House Committee on Energy and Commerce Subcommittee on Data, Innovation and Commerce approved the updated APRA, advancing the bill to full committee consideration. Just prior to the […]

The New York legislature passed two bills on June 7, 2024 directed at children’s use of online technologies – the Stop Addictive Feeds Exploitation (SAFE) for Kids Act (S7694) that restricts access to addictive algorithmic feeds and the New York Child Data Protection Act (S7695) that bans sites from collecting, using, sharing or selling personal […]

Agencies with healthcare clients in pharmaceuticals, healthcare services, digital health apps, or health-related connected devices such as wearables should take note that the Federal Trade Commission (FTC) final rule updating its Health Breach Notification Rule (HBNR) that took effect on July 29, 2024. The FTC considers a breach to include a covered entity’s unauthorized disclosure […]

Two former board chairs of the Coalition for Healthcare Communication (CHC) were named as the Medical Advertising Hall of Fame (MAHF) 2025 inductees – Sharon Callahan, former Chief Client Officer at Omnicom Health Group (OHG), and Nick Colucci, former Chairman and CEO of Publicis Health/COO of Publicis Groupe North America. The inductees will be honored […]

It is often said that medicine is both an art and a science. In an imperfect world this is both inevitable and desirable. But it is extremely important that the two should not be confused with each other. In particular, because the “science” side of the equation has achieved overwhelming prestige and authority, it is...

Click here to continue reading...

<p> <b>BIOSIMILAR RED TAPE ELIMINATION ACT (S2305):</b><br /> <b><i>Weakening FDA Regulatory Standards for Biosimilars, Undermining Physician Confidence and Jeopardizing Patient Health</i></b><br /><b>31 October 2024&nbsp;|&nbsp;</b><b><a href="https://youtu.be/X6-dYZ7fjhM" target="_blank">WATCH REPLAY</a></b></p>

<p> <b>23rd Regulatory Affairs Conference 202</b><b>5</b><br /> <b>27</b><b>‒</b><b>28 February 2025</b><br /> Hilton Amsterdam Airport Schiphol<br />Amsterdam, The Netherlands</p>

<p>In October 2024, China based Bio-Thera Solutions&nbsp;(Bio-Thera)&nbsp;and Hungary’s Gedeon Richter announced they have reached an exclusive commercialization and license agreement for BAT2206, a biosimilar candidate to&nbsp;Johnson &amp; Johnson’s Stelara (ustekinumab).</p>

The government implied wholesalers had more personal protective equipment in stock than was the case during the first wave of the COVID-19 pandemic, the Healthcare Distribution Association has said.

Some 180 women were prescribed valproate, a medicine used to treat epilepsy and bipolar disorder, during their pregnancy within a 2.5 year interval, NHS data has revealed.

Community pharmacies will receive an estimated 12 referrals from the Discharge Medicines Service per year.

Researchers around the world are working at record speed to find the best ways to treat and prevent COVID-19, from investigating the possibility of repurposing existing drugs to searching for novel therapies against the virus.

The General Pharmaceutical Council has said most candidates living in countries with a two-hour or more time difference from the UK will be able to apply to sit the registration assessment at home.

Around half of Wales’ community pharmacies have expressed interest to health boards in providing COVID-19 vaccinations as part of the national programme.

A new type of drug that targets chemotherapy directly to cancer cells reduces the risk of death from the most common type of bladder cancer by 30%, a phase III trial in the New England Journal of Medicine has suggested.

By Arthur O. Tzianabos, PhD, CEO of Lifordi Immunotherapeutics, as part of the From the Trenches feature of LifeSciVC As the biotech industry continues to pick up steam, I have been getting a number of phone calls from folks in

The post Stars and Scars… Some Lessons Learned About Leadership appeared first on LifeSciVC.

Novartis recently announced the acquisition of Mariana Oncology, an emerging biotech focused on advancing a radioligand therapeutics platform, for up to $1.75 billion in upfronts and future milestones. The capstone of its three short years of operations, this acquisition represents

The post Mariana Oncology’s Radiopharm Platform Acquired By Novartis appeared first on LifeSciVC.

By Jonathan Montagu, CEO of HotSpot Therapeutics, as part of the From The Trenches feature of LifeSciVC As Boston’s weather has started its turn from the frigid darkness that is a northeast winter to the longer days and lighter conditions

The post Has Spring Sprouted New Growth in Immuno-Oncology? appeared first on LifeSciVC.

By Ivana Magovčević-Liebisch, CEO of Vigil Neuroscience, as part of the From The Trenches feature of LifeSciVC In the last decade, our industry has made great strides in combating cancer by harnessing the body’s own immune system. As it was

The post Neuro-Immunology: The Promise Of A Differentiated Approach To Neurodegenerative Disease appeared first on LifeSciVC.

By Peter Tummino, CSO of Nimbus Therapeutics, as part of the From The Trenches feature of LifeSciVC  “Over the next five to 10 years, our goal is to become a company that’s leading the world in personalized medicines, a company

The post Medicinal Chemistry In The Age Of Artificial Intelligence appeared first on LifeSciVC.

An AllTrials report for the House of Commons Science and Technology Select Committee this week has found that 33 NHS trust sponsors and six UK universities are reporting none of their clinical trial results, while others have gone from 0% to 100% following an announcement from the Select Committee in January that universities and NHS […]

A judge in New York has ruled that hundreds of clinical trials registered on ClinicalTrials.gov are breaking the law by not reporting results. The ruling came in a court case launched against the US Department of Health and Human Services by two plaintiffs, a family doctor and a professor of journalism. The case focused on […]

Even by the already-painfully-embarrassingly-low standards of clinical trial enrollment in general, patient enrollment in cancer clinical trials is slow. Horribly slow. In many cancer trials, randomizing one patient every three or four months isn't bad at all – in fact, it's par for the course. The most
commonly-cited number is that only 3% of cancer patients participate in a trial – and although exact details of how that number is measured are remarkably difficult to pin down, it certainly can't be too far from reality.

Ultimately, the cost of slow enrollment is borne almost entirely by patients; their payment takes the form of fewer new therapies and less evidence to support their treatment decisions.

So when a couple dozen thousand of the world's top oncologists fly into Chicago to meet, you'd figure that improving accrual would be high on everyone’s agenda. You can't run your trial without patients, after all.

But every year, the annual ASCO meeting underdelivers in new ideas for getting more patients into trials. I suppose this a consequence of ASCO's members-only focus: getting the oncologists themselves to address patient accrual is a bit like asking NASCAR drivers to tackle the problems of aerodynamics, engine design, and fuel chemistry.

Nonetheless, every year, a few brave souls do try. Here is a quick rundown of accrual-related abstracts at this year’s meeting, conveniently sorted into 3 logical categories:

1. As Lord Kelvin may or may not have said, “If you cannot measure it, you cannot improve it.”

• Abstract e15572: Inadequate data availability on clinical trial accrual and its effect on progress in cancer research

Probably the most sensible of this year's crop, because rather than trying to make something out of nothing, the authors measure exactly how pervasive the nothing is. Specifically, they attempt to obtain fairly basic patient accrual data for the last three years' worth of clinical trials in kidney cancer. Out of 108 trials identified, they managed to get – via search and direct inquiries with the trial sponsors – basic accrual data for only 43 (40%).

That certainly qualifies as “terrible”, though the authors content themselves with “poor”.

Interestingly, exactly zero of the 32 industry-sponsored trials responded to the authors' initial survey. This fits with my impression that pharma companies continue to think of accrual data as proprietary, though what sort of business advantage it gives them is unclear. Any one company will have only run a small fraction of these studies, greatly limiting their ability to draw anything resembling a valid conclusion.

• Abstract TPS6645: Predictors of accrual success for cooperative group trials: The Cancer and Leukemia Group B (Alliance) experience

CALGB investigators look at 110 trials over the past 10 years to see if they can identify any predictive markers of successful enrollment. Unfortunately, the trials themselves are pretty heterogeneous (accrual periods ranged from 6 months to 8.8 years), so finding a consistent marker for successful trials would seem unlikely.

And, in fact, none of the usual suspects (e.g., startup time, disease prevalence) appears to have been significant. The exception was provision of medication by the study, which was positively associated with successful enrollment.

The major limitation with this study, apart from the variability of trials measured, is in its definition of “successful”, which is simply the total number of planned enrolled patients. Under both of their definitions, a slow-enrolling trial that drags on for years before finally reaching its goal is successful, whereas if that same trial had been stopped early it is counted as unsuccessful. While that sometimes may be the case, it's easy to imagine situations where allowing a slow trial to drag on is a painful waste of resources – especially if results are delayed enough to bring their relevance into question.

Even worse, though, is that a trial’s enrollment goal is itself a prediction. The trial steering committee determines how many sites, and what resources, will be needed to hit the number needed for analysis. So in the end, this study is attempting to identify predictors of successful predictions, and there is no reason to believe that the initial enrollment predictions were made with any consistent methodology.

2. If you don't know, maybe ask somebody?

• Abstract 8592: Strategies to overcome barriers to accrual (BtA) to NCI-sponsored clinical trials: A project of the NCI-Myeloma Steering Committee Accrual Working Group (NCI-MYSC AWG)
  
• Abstract 1596: Rapid online feedback to improve clinical trial accrual: CODEL anaplastic glioma (AG) (NCCTG/Alliance N0577) as a model

With these two abstracts we celebrate and continue the time-honored tradition of alchemy, whereby we transmute base opinion into golden data. The magic number appears to be 100: if you've got 3 digits' worth of doctors telling you how they feel, that must be worth something.

In the first abstract, a working group is formed to identify and vote on the major barriers to accrual in oncology trials. Then – and this is where the magic happens – that same group is asked to identify and vote on possible ways to overcome those barriers.

In the second, a diverse assortment of community oncologists were given an online survey to provide feedback on the design of a phase 3 trial in light of recent new data. The abstract doesn't specify who was initially sent the survey, so we cannot tell response rate, or compare survey responders to the general population (I'll take a wild guess and go with “massive response bias”).

Market research is sometimes useful. But what cancer clinical trial do not need right now are more surveys are working groups. The “strategies” listed in the first abstract are part of the same cluster of ideas that have been on the table for years now, with no appreciable increase in trial accrual.

3. The obligatory “What the What?” abstract

• Abstract 6564: Minority accrual on a prospective study targeting a diverse U.S. breast cancer population: An analysis of Wake Forest CCOP research base protocol 97609

The force with which my head hit my desk after reading this abstract made me concerned that it had left permanent scarring.

If this had been re-titled “Poor Measurement of Accrual Factors Leads to Inaccurate Accrual Reporting”, would it still have been accepted for this year’s meeting? That's certainly a more accurate title.

Let’s review: a trial intends to enroll both white and minority patients. Whites enroll much faster, leading to a period where only minority patients are recruited. Then, according to the authors, “an almost 4-fold increase in minority accrual raises question of accrual disparity.” So, sites will only recruit minority patients when they have no choice?

But wait: the number of sites wasn't the same during the two periods, and start-up times were staggered. Adjusting for actual site time, the average minority accrual rate was 0.60 patients/site/month in the first part and 0.56 in the second. So the apparent 4-fold increase was entirely an artifact of bad math.

This would be horribly embarrassing were it not for the fact that bad math seems to be endemic in clinical trial enrollment. Failing to adjust for start-up time and number of sites is so routine that not doing it is grounds for a presentation.

The bottom line

What we need now is to rigorously (and prospectively) compare and measure accrual interventions. We have lots of candidate ideas, and there is no need for more retrospective studies, working groups, or opinion polls to speculate on which ones will work best.  Where possible, accrual interventions should themselves be randomized to minimize confounding variables which prevent accurate assessment. Data needs to be uniformly and completely collected. In other words, the standards that we already use for clinical trials need to be applied to the enrollment measures we use to engage patients to participate in those trials.

This is not an optional consideration. It is an ethical obligation we have to cancer patients: we need to assure that we are doing all we can to maximize the rate at which we generate new evidence and test new therapies.

[Image credit: Logarithmic turtle accrual rates courtesy of Flikr user joleson.]

[Fair Warning: I have generally tried to keep this blog separate from my corporate existence, but am making an exception for two quick posts about the upcoming DIA 2013 Annual Meeting.]

Improving Enrollment in Pediatric Clinical Trials

Logistically, ethically, and emotionally, involving children in medical research is greatly different from the same research in adults. Some of the toughest clinical trials I've worked on, across a number of therapeutic areas, have been pediatric ones. They challenge you to come up with different approaches to introducing and explaining clinical research – approaches that have to work for doctors, kids, and parents simultaneously.

On Thursday June 27, Don Sickler, one of my team members, will be chairing a session titled “Parents as Partners: Engaging Caregivers for Pediatric Trials”. It should be a good session.

Joining Don are 2 people I've had the pleasure of working with in the past. Both of them combine strong knowledge of clinical research with a massive amount of positive energy and enthusiasm (no doubt a big part of what makes them successful).

However, they also differ in one key aspect: what they work on. One of them – Tristen Moors from Hyperion Therapeutics - works on an ultra-rare condition, Urea Cycle Disorder, a disease affecting only a few hundred children every year. On the other hand, Dr. Ann Edmunds is an ENT working in a thriving private practice. I met her because she was consistently the top enroller in a number of trials relating to tympanostomy tube insertion. Surgery to place “t-tubes” is one of the most common and routine outpatients surgeries there is, with an estimated half million kids getting tubes each year.

Each presents a special challenge: for rare conditions, how do you even find enough patients? For routine procedures, how do you convince parents to complicate their (and their children’s) lives by signing up for a multi-visit, multi-procedure trial?

Ann and Tristen have spent a lot of time tackling these issues, and should have some great advice to give.

For more information on the session, here’s Don’s posting on our news blog.

The articles identified through the search had to match the corresponding trial in terms of the information registered at ClinicalTrials.gov (i.e., same objective, same sample size, same primary outcome, same location, same responsible party, same trial phase, and same sponsor) and had to present results for the primary outcome. 

So it appears that a reviewed had to score the journal article as an exact match on 8 criteria in order for the trial to be considered the same. That could easily lead to exclusion of journal articles on the basis of very insubstantial differences. The authors provide no detail on this; and again, that would be easy to verify if the study dataset was published. 

The reason I harp on this, and worry about the matching methodology, is that two of the authors of this study were also involved in a methodologically opaque and flawed study about clinical trial results posted in the JCO. In that study, as well, the authors appeared to use an incorrect methodology to identify published clinical trials. When I pointed the issues out, the corresponding author merely reiterated what was already (insufficiently) in the paper's Methodology section.

I find it strange beyond belief, and more than a little hypocritical, that researchers would use a public, taxpayer-funded database as the basis of their studies, and yet refuse to provide their data for public review. There are no technological or logistical issues preventing this kind of sharing, and there is an obvious ethical point in favor of transparency.

But if the authors are reasonably close to correct in their results, I'm not sure what to make of this study. 

The Nature article covering this study contend that

[T]he [ClinicalTrials.gov] database was never meant to replace journal publications, which often contain longer descriptions of methods and results and are the basis for big reviews of research on a given drug.

I suppose that some journal articles have better methodology sections, although this is far from universally true (and, like this study here, these methods are often quite opaquely described and don't support replication). As for results, I don't believe that's the case. In this study, the opposite was true: ClinicalTrial.gov results were generally more complete than journal results. And I have no idea why the registry wouldn't surpass journals as a more reliable and complete source of information for "big reviews".

Perhaps it is a function of my love of getting my hands dirty digging into the data, but if we are witnessing a turning point where journal articles take a distant back seat to the ClinicalTrials.gov registry, I'm enthused. ClinicalTrials.gov is public, free, and contains structured data; journal articles are expensive, unparsable, and generally written in painfully unclear language. To me, there's really no contest. 

Carolina Riveros, Agnes Dechartres, Elodie Perrodeau, Romana Haneef, Isabelle Boutron, & Philippe Ravaud (2013). Timing and Completeness of Trial Results Posted at ClinicalTrials.gov and Published in Journals PLoS Medicine DOI: 10.1371/journal.pmed.1001566

• How to Catalyze a Clinical Trial - My inaugural post introducing the blog and its purpose
• Video: Predicting Referral Conversion in Clinical Trial Advertising - A somewhat technical but very important topic, how to visualize and model the “real time” results of recruitment advertising at the sites.
• The Crystal Ball is on the Fritz - What to do with a broken enrollment feasibility process, and how asking will never be as good as measuring

• The New Breed of Clinical Trial Matchmakers - A (hopefully pretty complete, thanks to knowledgeable commenters) listing of services looking to match interested patients to clinical trials
• Rethinking Patient Enrollment, in One Graphic - The perils of predictability in site-based enrollment
• Seize the Data! Will Big Data Save Us from Ourselves? - My take on what I consider to be the large and serious obstacles in the way of “Big Data” solutions for patient recruitment

Please take a look, and I will see you back here soon.

[Photo credit: detour sign via Flikr user crossley]

The good folks down at eyeforpharma have asked me to write a few blog posts in the run-up to their Patient Centered Clinical Trials conference in Boston this September. In my second article -Buzzword Innovation: The Patient Centricity “Fad” and the Token Patient - I went over some concerns I have regarding the sudden burst of enthusiasm for patient centricity in the clinical trial world.

Apparently, that hit a nerve – in an email, Ulrich Neumann tells me that “your last post elicited quite a few responses in my inbox (varied, some denouncing it as a fad, others strongly protesting the notion, hailing it as the future).”

In preparing my follow up post, I’ve spoken to a couple people on the leading edge of patient engagement:

• Abbe Steel, CEO of HealthiVibe, which is focused on bringing greater patient input into the earliest stages of trial design through focus groups and patient surveys
• Casey Quinlan, co-founder of Patients for Clinical Research, which aims to be a force in patient education and engagement for clinical trials

In addition to their thoughts, eyeforpharma is keenly interested in hearing from more people. They've even posted a survey – from Ulrich:

To get a better idea of what other folks think of the idea, I am sending out a little ad hoc survey. Only 4 questions (so people hopefully do it). Added benefit: There is a massive 50% one-time discount for completed surveys until Friday connected to it as an incentive).

So, here are two things for you to do:

1. Complete the survey and share your thoughts
2. Come to the conference and tell us all exactly what you think

Look forward to seeing you there.

[Conflict of Interest Disclosure: I am attending the Patient Centered Clinical Trials conference. Having everyone saying the same thing at such conferences conflicts with my ability to find them interesting.]

Maybe those pesky sites are good for something after all. 

It's been six years since Pfizer boldly announced the launch of its "clinical trial in a box". The REMOTE trial was designed to be entirely online, and involved no research sites: study information and consent was delivered via the web, and medications and diaries were shipped directly to patients' homes.

Despite the initial fanfare, within a month REMOTE's registration on ClinicalTrials.gov was quietly reduced from 600 to 283. The smaller trial ended not with a bang but a whimper, having randomized only 18 patients in over a year of recruiting.

Still, the allure of direct to patient clinical trials remains strong, due to a confluence of two factors. First, a frenzy of interest in running "patient centric clinical trials". Sponsors are scrambling to show they are doing something – anything – to show they have shifted to a patient-centered mindset. We cannot seem to agree what this means (as a great illustration of this, a recent article in Forbes on "How Patients Are Changing Clinical Trials" contained no specific examples of actual trials that had been changed by patients), but running a trial that directly engages patients wherever they are seems like it could work.

The less-openly-discussed other factor leading to interest in these DIY trials is sponsors' continuing willingness to heap almost all of the blame for slow-moving studies onto their research sites. If it’s all the sites’ fault – the reasoning goes – then cutting them out of the process should result in trials that are both faster and cheaper. (There are reasons to be skeptical about this, as I have discussed in the past, but the desire to drop all those pesky sites is palpable.)

However, while a few proof-of-concept studies have been done, there really doesn't seem to have been another trial to attempt a full-blown direct-to-patient clinical trial. Other pilots have been more successful, but had fairly lightweight protocols. For all its problems, REMOTE was a seriously ambitious project that attempted to package a full-blown interventional clinical trial, not an observational study.

In this context, it's great to see published results of the TAPIR Trial in vasculitis, which as far as I can tell is the first real attempt to run a DIY trial of a similar magnitude to REMOTE.

TAPIR was actually two parallel trials, identical in every respect except for their sites: one trial used a traditional group of 8 sites, while the other was virtual and recruited patients from anywhere in the country. So this was a real-time, head-to-head assessment of site performance.

And the results after a full two years of active enrollment?

• Traditional sites: 49 enrolled
• Patient centric: 10 enrolled

Even though we’re six years later, and online/mobile communications are even more ubiquitous, we still see the exact same struggle to enroll patients.

Maybe it’s time to stop blaming the sites? To be fair, they didn’t exactly set the world on fire – and I’m guessing the total cost of activating the 8 sites significantly exceeded the costs of setting up the virtual recruitment and patient logistics. But still, the site-less, “patient centric” approach once again came up astonishingly short.
Krischer J, Cronholm PF, Burroughs C, McAlear CA, Borchin R, Easley E, Davis T, Kullman J, Carette S, Khalidi N, Koening C, Langford CA, Monach P, Moreland L, Pagnoux C, Specks U, Sreih AG, Ytterberg S, Merkel PA, & Vasculitis Clinical Research Consortium. (2017). Experience With Direct-to-Patient Recruitment for Enrollment Into a Clinical Trial in a Rare Disease: A Web-Based Study. Journal of medical Internet research, 19 (2) PMID: 28246067

More people are getting cancer in their 20s, 30s, and 40s, and surviving, thanks to rapid advancement in care. Many will have decades of life ahead of them, which means they face greater and more complex challenges in survivorship. Lourdes Monje is navigating these waters at age 29.

Sudan's civil war has displaced 10 million citizens. Here are profiles of two young people from the most vulnerable groups: an unaccompanied minor caring for twin brothers, a woman who was raped.

Magnetic resonance imaging (MRI) has revolutionized healthcare by providing radiation-free, non-invasive 3-D medical images. However, MRI scanners often consume 25 kilowatts or more to power magnets producing magnetic fields up to 1.5 tesla. These requirements typically limits scanners’ use to specialized centers and departments in hospitals.

A University of Hong Kong team has now unveiled a low-power, highly simplified, full-body MRI device. With the help of artificial intelligence, the new scanner only requires a compact 0.05 T magnet and can run off a standard wall power outlet, requiring only 1,800 watts during operation. The researchers say their new AI-enabled machine can produce clear, detailed images on par with those from high-power MRI scanners currently used in clinics, and may one day help greatly improve access to MRI worldwide.

To generate images, MRI applies a magnetic field to align the poles of the body’s protons in the same direction. An MRI scanner then probes the body with radio waves, knocking the protons askew. When the radio waves turn off, the protons return to their original alignment, transmitting radio signals as they do so. MRI scanners receive these signals, converting them into images.

More than 150 million MRI scans are conducted worldwide annually, according to the Organization for Economic Cooperation and Development. However, despite five decades of development, clinical MRI procedures remain out of reach for more than two-thirds of the world’s population, especially in low- and middle-income countries. For instance, whereas the United States has 40 scanners per million inhabitants, in 2016 there were only 84 MRI units serving West Africa’s population of more than 370 million.

This disparity largely stems from the high costs and specialized settings required for standard MRI scanners. They use powerful superconducting magnets that require a lot of space, power, and specialized infrastructure. They also need rooms shielded from radio interference, further adding to hardware costs, restricting their mobility, and hampering their availability in other medical settings.

Scientists around the globe have already been exploring low-cost MRI scanners that operate at ultra-low-field (ULF) strengths of less than 0.1 T. These devices may consume much less power and prove potentially portable enough for bedside use. Indeed, as the Hong Kong team notes, MRI development initially focused on low fields of about 0.05 T, until the introduction of the first whole-body 1.5 T superconducting scanner by General Electric in 1983.

The new MRI scanner (top left) is smaller than conventional scanners, and does away with bulky RF shielding and superconducting magnetics. The new scanner’s imaging resolution is on par with conventional scanners (bottom).Ed X. Wu/The University of Hong Kong

Current ULF MRI scanners often rely on AI to help reconstruct images from what signals they gather using relatively weak magnetic fields. However, until now, these devices were limited to solely imaging the brain, extremities, or single organs, Udunna Anazodo, an assistant professor of neurology and neurosurgery at McGill University in Montreal who did not take part in the work, notes in a review of the new study.

The Hong Kong team have now developed a whole-body ULF MRI scanner in which patients are placed between two permanent neodymium ferrite boron magnet plates—one above the body and the other below. Although these permanent magnets are far weaker than superconductive magnets, they are low-cost, readily available, and don’t require liquid helium or to be cooled to superconducting temperatures. In addition, the amount of energy ULF MRI scanners deposit into the body is roughly one-thousandth that from conventional scanners, making heat generation during imaging much less of a concern, Anazodo notes in her review. ULF MRI is also much quieter than regular MRI, which may help with pediatric scanning, she adds.

The new machine consists of two units, each roughly the size of a hospital gurney. One unit houses the MRI device, while the other supports the patient’s body as it slides into the scanner.

To account for radio interference from both the outside environment and the ULF MRI’s own electronics, the scientists deployed 10 small sensor coils around the scanner and inside the electronics cabinet to help the machine detect potentially disruptive radio signals. They also employed deep learning AI methods to help reconstruct images even in the presence of strong noise. They say this eliminates the need for shielding against radio waves, making the new device far more portable than conventional MRI.

In tests on 30 healthy volunteers, the device captured detailed images of the brain, spine, abdomen, heart, lung, and extremities. Scanning each of these targets took eight minutes or less for image resolutions of roughly 2 by 2 by 8 cubic millimeters. In Anazodo’s review, she notes the new machine produced image qualities comparable to those of conventional MRI scanners.

“It’s the beginning of a multidisciplinary endeavor to advance an entirely new class of simple, patient-centric and computing-powered point-of-care diagnostic imaging device,” says Ed Wu, a professor and chair of biomedical engineering at the University of Hong Kong.

The researchers used standard off-the-shelf electronics. All in all, they estimate hardware costs at about US $22,000. (According to imaging equipment company Block Imaging in Holt, Michigan, entry-level MRI scanners start at $225,000, and advanced premium machines can cost $500,000 or more.)

The prototype scanner’s magnet assembly is relatively heavy, weighing about 1,300 kilograms. (This is still lightweight compared to a typical clinical MRI scanner, which can weigh up to 17 tons, according to New York University’s Langone Health center.) The scientists note that optimizing the hardware could reduce the magnet assembly’s weight to about 600 kilograms, which would make the entire scanner mobile.

The researchers note their new device is not meant to replace conventional high-magnetic-field MRI. For instance, a 2023 study notes that next-generation MRI scanners using powerful 7 T magnets could yield a resolution of just 0.35 millimeters. Instead, ULF MRI can complement existing MRI by going to places that can’t host standard MRI devices, such as intensive care units and community clinics.

In an email, Anazodo adds this new Hong Kong work is just one of a number of exciting ULF MRI scanners under development. For instance, she notes that Gordon Sarty at the University of Saskatchewan and his colleagues are developing that device that is potentially even lighter, cheaper and more portable than the Hong Kong machine, which they are researching for use in whole-body imaging on the International Space Station.

Wu and his colleagues detailed their findings online 10 May in the journal Science.

This article appears in the July 2024 print issue as “Compact MRI Ditches Superconducting Magnets.”

For people with diabetes, glucose monitors are a valuable tool to monitor their blood sugar. The current generation of these biosensors detect glucose levels with thin, metallic filaments inserted in subcutaneous tissue, the deepest layer of the skin where most body fat is stored.

Medical technology company Biolinq is developing a new type of glucose sensor that doesn’t go deeper than the dermis, the middle layer of skin that sits above the subcutaneous tissue. The company’s “intradermal” biosensors take advantage of metabolic activity in shallower layers of skin, using an array of electrochemical microsensors to measure glucose—and other chemicals in the body—just beneath the skin’s surface.

Biolinq just concluded a pivotal clinical trial earlier this month, according to CEO Rich Yang, and the company plans to submit the device to the U.S. Food and Drug Administration for approval at the end of the year. In April, Biolinq received US $58 million in funding to support the completion of its clinical trials and subsequent submission to the FDA.

Biolinq’s glucose sensor is “the world’s first intradermal sensor that is completely autonomous,” Yang says. While other glucose monitors require a smartphone or other reader to collect and display the data, Biolinq’s includes an LED display to show when the user’s glucose is within a healthy range (indicated by a blue light) or above that range (yellow light). “We’re providing real-time feedback for people who otherwise could not see or feel their symptoms,” Yang says. (In addition to this real-time feedback, the user can also load long-term data onto a smartphone by placing it next to the sensor, like Abbott’s FreeStyle Libre, another glucose monitor.)

More than 2,000 microsensor components are etched onto each 200-millimeter silicon wafer used to manufacture the biosensors.Biolinq

Biolinq’s hope is that its approach could lead to sustainable changes in behavior on the part of the individual using the sensor. The device is intentionally placed on the upper forearm to be in plain sight, so users can receive immediate feedback without manually checking a reader. “If you drink a glass of orange juice or soda, you’ll see this go from blue to yellow,” Yang explains. That could help users better understand how their actions—such as drinking a sugary beverage—change their blood sugar and take steps to reduce that effect.

Biolinq’s device consists of an array of microneedles etched onto a silicon wafer using semiconductor manufacturing. (Other glucose sensors’ filaments are inserted with an introducer needle.) Each chip has a small 2-millimeter by 2-millimeter footprint and contains seven independent microneedles, which are coated with membranes through a process similar to electroplating in jewelry making. One challenge the industry has faced is ensuring that microsensors do not break at this small scale. The key engineering insight Biolinq introduced, Yang says, was using semiconductor manufacturing to build the biosensors. Importantly, he says, silicon “is harder than titanium and steel at this scale.”

Miniaturization allows for sensing closer to the surface of the skin, where there is a high level of metabolic activity. That makes the shallow depth ideal for monitoring glucose, as well as other important biomarkers, Yang says. Due to this versatility, combined with the use of a sensor array, the device in development can also monitor lactate, an important indicator of muscle fatigue. With the addition of a third data point, ketones (which are produced when the body burns fat), Biolinq aims to “essentially have a metabolic panel on one chip,” Yang says.

Using an array of sensors also creates redundancy, improving the reliability of the device if one sensor fails or becomes less accurate. Glucose monitors tend to drift over the course of wear, but with multiple sensors, Yang says that drift can be better managed.

One downside to the autonomous display is the drain on battery life, Yang says. The battery life limits the biosensor’s wear time to 5 days in the first-generation device. Biolinq aims to extend that to 10 days of continuous wear in its second generation, which is currently in development, by using a custom chip optimized for low-power consumption rather than off-the-shelf components.

The company has collected nearly 1 million hours of human performance data, along with comparators including commercial glucose monitors and venous blood samples, Yang says. Biolinq aims to gain FDA approval first for use in people with type 2 diabetes not using insulin and later expand to other medical indications.

This article appears in the August 2024 print issue as “Glucose Monitor Takes Page From Chipmaking.”

Last month when Google introduced its new AI search tool, called AI Overviews, the company seemed confident that it had tested the tool sufficiently, noting in the announcement that “people have already used AI Overviews billions of times through our experiment in Search Labs.” The tool doesn’t just return links to Web pages, as in a typical Google search, but returns an answer that it has generated based on various sources, which it links to below the answer. But immediately after the launch users began posting examples of extremely wrong answers, including a pizza recipe that included glue and the interesting fact that a dog has played in the NBA.

Renée DiResta has been tracking online misinformation for many years as the technical research manager at Stanford’s Internet Observatory.

While the pizza recipe is unlikely to convince anyone to squeeze on the Elmer’s, not all of AI Overview’s extremely wrong answers are so obvious—and some have the potential to be quite harmful. Renée DiResta has been tracking online misinformation for many years as the technical research manager at Stanford’s Internet Observatory and has a new book out about the online propagandists who “turn lies into reality.” She has studied the spread of medical misinformation via social media, so IEEE Spectrum spoke to her about whether AI search is likely to bring an onslaught of erroneous medical advice to unwary users.

I know you’ve been tracking disinformation on the Web for many years. Do you expect the introduction of AI-augmented search tools like Google’s AI Overviews to make the situation worse or better?

Renée DiResta: It’s a really interesting question. There are a couple of policies that Google has had in place for a long time that appear to be in tension with what’s coming out of AI-generated search. That’s made me feel like part of this is Google trying to keep up with where the market has gone. There’s been an incredible acceleration in the release of generative AI tools, and we are seeing Big Tech incumbents trying to make sure that they stay competitive. I think that’s one of the things that’s happening here.

We have long known that hallucinations are a thing that happens with large language models. That’s not new. It’s the deployment of them in a search capacity that I think has been rushed and ill-considered because people expect search engines to give them authoritative information. That’s the expectation you have on search, whereas you might not have that expectation on social media.

There are plenty of examples of comically poor results from AI search, things like how many rocks we should eat per day [a response that was drawn for an Onion article]. But I’m wondering if we should be worried about more serious medical misinformation. I came across one blog post about Google’s AI Overviews responses about stem-cell treatments. The problem there seemed to be that the AI search tool was sourcing its answers from disreputable clinics that were offering unproven treatments. Have you seen other examples of that kind of thing?

DiResta: I have. It’s returning information synthesized from the data that it’s trained on. The problem is that it does not seem to be adhering to the same standards that have long gone into how Google thinks about returning search results for health information. So what I mean by that is Google has, for upwards of 10 years at this point, had a search policy called Your Money or Your Life. Are you familiar with that?

I don’t think so.

DiResta: Your Money or Your Life acknowledges that for queries related to finance and health, Google has a responsibility to hold search results to a very high standard of care, and it’s paramount to get the information correct. People are coming to Google with sensitive questions and they’re looking for information to make materially impactful decisions about their lives. They’re not there for entertainment when they’re asking a question about how to respond to a new cancer diagnosis, for example, or what sort of retirement plan they should be subscribing to. So you don’t want content farms and random Reddit posts and garbage to be the results that are returned. You want to have reputable search results.

That framework of Your Money or Your Life has informed Google’s work on these high-stakes topics for quite some time. And that’s why I think it’s disturbing for people to see the AI-generated search results regurgitating clearly wrong health information from low-quality sites that perhaps happened to be in the training data.

So it seems like AI overviews is not following that same policy—or that’s what it appears like from the outside?

DiResta: That’s how it appears from the outside. I don’t know how they’re thinking about it internally. But those screenshots you’re seeing—a lot of these instances are being traced back to an isolated social media post or a clinic that’s disreputable but exists—are out there on the Internet. It’s not simply making things up. But it’s also not returning what we would consider to be a high-quality result in formulating its response.

I saw that Google responded to some of the problems with a blog post saying that it is aware of these poor results and it’s trying to make improvements. And I can read you the one bullet point that addressed health. It said, “For topics like news and health, we already have strong guardrails in place. In the case of health, we launched additional triggering refinements to enhance our quality protections.” Do you know what that means?

DiResta: That blog posts is an explanation that [AI Overviews] isn’t simply hallucinating—the fact that it’s pointing to URLs is supposed to be a guardrail because that enables the user to go and follow the result to its source. This is a good thing. They should be including those sources for transparency and so that outsiders can review them. However, it is also a fair bit of onus to put on the audience, given the trust that Google has built up over time by returning high-quality results in its health information search rankings.

I know one topic that you’ve tracked over the years has been disinformation about vaccine safety. Have you seen any evidence of that kind of disinformation making its way into AI search?

DiResta: I haven’t, though I imagine outside research teams are now testing results to see what appears. Vaccines have been so much a focus of the conversation around health misinformation for quite some time, I imagine that Google has had people looking specifically at that topic in internal reviews, whereas some of these other topics might be less in the forefront of the minds of the quality teams that are tasked with checking if there are bad results being returned.

What do you think Google’s next moves should be to prevent medical misinformation in AI search?

DiResta: Google has a perfectly good policy to pursue. Your Money or Your Life is a solid ethical guideline to incorporate into this manifestation of the future of search. So it’s not that I think there’s a new and novel ethical grounding that needs to happen. I think it’s more ensuring that the ethical grounding that exists remains foundational to the new AI search tools.

In the United States alone, more than 100,000 people currently need a lifesaving organ transplant. Instead of waiting for donors, one way to solve this crisis in the future is to assemble replacement organs with bio-printing—3D printing that uses inks containing living cells. Scientists in Israel have found that origami techniques could help fold sensors into bio-printed materials to help determine whether they are behaving safely and properly.

Although bio-printing something as complex as a human organ is still a distant possibility, there are a host of near-term applications for the technique. For example, in drug research, scientists can bio-print living, three-dimensional tissues with which to examine the effects of various compounds.

Ideally, researchers would like to embed sensors within bio-printed items to keep track of how well they are behaving. However, the three-dimensional nature of bio-printed objects makes it difficult to lodge sensors within them in a way that can monitor every part of the structures.

“It will, hopefully in the future, allow us to monitor and assess 3D biostructures before we would like to transplant them.” —Ben Maoz, Tel Aviv University

Now scientists have developed a 3D platform inspired by origami that can help embed sensors in bio-printed objects in precise locations. “It will, hopefully in the future, allow us to monitor and assess 3D biostructures before we would like to transplant them,” says Ben Maoz, a professor of biomedical engineering at Tel Aviv University in Israel.

The new platform is a silicone rubber device that can fold around a bio-printed structure. The prototype holds a commercial array of 3D electrodes to capture electrical signals. It also possesses other electrodes that can measure electrical resistance, which can reveal how permeable cells are to various medications. A custom 3D software model can tailor the design of the origami and all the electrodes so that the sensors can be placed in specific locations in the bio-printed object.

The scientists tested their device on bio-printed clumps of brain cells. The research team also grew a layer of cells onto the origami that mimicked the blood-brain barrier, a cell layer that protects the brain from undesirable substances that the body’s blood might be carrying. By folding this combination of origami and cells onto the bio-printed structures, Maoz and his colleagues were able to monitor neural activity within the brain cells and see how their synthetic blood-brain barrier might interfere with medications intended to treat brain diseases.

Maoz says the new device can incorporate many types of sensors beyond electrodes, such as temperature or acidity sensors. It can also incorporate flowing liquid to supply oxygen and nutrients to cells, the researchers note.

Currently, this device “will mainly be used for research and not for clinical use,” Maoz says. Still, it could “significantly contribute to drug development—assessing drugs that are relevant to the brain.”

The researchers say they can use their origami device with any type of 3D tissue. For example, Maoz says they can use it on bio-printed structures made from patient cells “to help with personalized medicine and drug development.”

The origami platform could also help embed devices that can modify bio-printed objects. For instance, many artificially grown tissues function better if they are placed under the kinds of physical stresses they might normally experience within the body, and the origami platform could integrate gadgets that can exert such mechanical forces on bio-printed structures. “This can assist in accelerating tissue maturation, which might be relevant to clinical applications,” Maoz says.

The scientists detailed their findings in the 26 June issue of Advanced Science.

Surgical stitches that generate electricity can help wounds heal faster in rats, a new study from China finds.

In the body, electricity helps the heart beat, causes muscles to contract, and enables the body to communicate with the brain. Now scientists are increasingly using electricity to promote healing with so-called electroceuticals. These electrotherapies often seek to mimic the electrical signals the body naturally uses to help new cells migrate to wounds to support the healing process.

In the new study, researchers focused on sutures, which are used to close wounds and surgical incisions. Despite the way in which medical devices have evolved rapidly over the years, sutures are generally limited in capability, says Zhouquan Sun, a doctoral candidate at Donghua University in Shanghai. “This observation led us to explore integrating advanced therapeutics into sutures,” Sun says.

Prior work sought to enhance sutures by adding drugs or growth factors to the stitches. However, most of these drugs either had insignificant effects on healing, or triggered side-effects such as allergic reactions or nausea. Growth factors in sutures often degraded before they could have any effect, or failed to activate entirely.

The research team that created the new sutures previously developed fibers for electronics for nearly 10 years for applications such as sensors. “This is our first attempt to apply fiber electronics in the biomedical field,” says Chengyi Hou, a professor of materials science and engineering at Donghua University.

Making Electrical Sutures Work

The new sutures are roughly 500 microns wide, or about five times the width of the average human hair. Like typical sutures, the new stitches are biodegradable, avoiding the need for doctors to remove the stitches and potentially cause more damage to a wound.

Each suture is made of a magnesium filament core wrapped in poly(lactic-co-glycolic) acid (PLGA) nanofibers, a commercially available, inexpensive, biodegradable polymer used in sutures. The suture also includes an outer sheath made of polycaprolactone (PCL), a biodegradable polyester and another common suture material.

Previously, electrotherapy devices were often bulky and expensive, and required wires connected to an external battery. The new stitches are instead powered by the triboelectric effect, the most common cause of static electricity. When two different materials repeatedly touch and then separate—in the case of the new suture, its core and sheath—the surface of one material can steal electrons from the surface of the other. This is why rubbing feet on a carpet or a running a comb through hair can build up electric charge.

A common problem sutures face is how daily movements may cause strain that reduce their efficacy. The new stitches take advantage of these motions to help generate electricity that helps wounds heal.

The main obstacle the researchers had to surmount was developing a suture that was both thin and strong enough to serve in medicine. Over the course of nearly two years, they tinkered with the molecular weights of the polymers they used and refined their fiber spinning technology to reduce their suture’s diameter while maintaining strength, Sun says.

In lab experiments on rats, the sutures generated about 2.3 volts during normal exercise. The scientists found the new sutures could speed up wound healing by 50 percent over the course of 10 days compared to conventional sutures. They also significantly lowered bacteria levels even without the use of daily wound disinfectants, suggesting they could reduce the risk of post-operation infections.

“Future research may delve deeper into the molecular mechanisms of how electrical stimulation facilitated would healing,” says Hui Wang, a chief physician at Shanghai Sixth People’s Hospital.

Further tests are needed in clinical settings to assess how effective these sutures are in humans. If such experiments prove successful, “this bioabsorbable electrically stimulating suture could change how we treat injuries in the future,” Hou says.

The scientists detailed their findings online 8 October in the journal Nature Communications.

Imagine you’re a baby cocoa plant, just unfurling your first tentative roots into the fertile, welcoming soil.

Somewhere nearby, a predator stirs. It has no ears to hear you, no eyes to see you. But it knows where you are, thanks in part to the weak electric field emitted by your roots.

It is microscopic, but it’s not alone. By the thousands, the creatures converge, slithering through the waterlogged soil, propelled by their flagella. If they reach you, they will use fungal-like hyphae to penetrate and devour you from the inside. They’re getting closer. You’re a plant. You have no legs. There’s no escape.

But just before they fall upon you, they hesitate. They seem confused. Then, en masse, they swarm off in a different direction, lured by a more attractive electric field. You are safe. And they will soon be dead.

If Eleonora Moratto and Giovanni Sena get their way, this is the future of crop pathogen control.

Many variables are involved in the global food crisis, but among the worst are the pests that devastate food crops, ruining up to 40 percent of their yield before they can be harvested. One of these—the little protist in the example above, an oomycete formally known as Phytophthora palmivora—has a US $1 billion appetite for economic staples like cocoa, palm, and rubber.

There is currently no chemical defense that can vanquish these creatures without poisoning the rest of the (often beneficial) organisms living in the soil. So Moratto, Sena, and their colleagues at Sena’s group at Imperial College London settled on a non-traditional approach: They exploited P. palmivora’s electric sense, which can be spoofed.

All plant roots that have been measured to date generate external ion flux, which translates into a very weak electric field. Decades of evidence suggests that this signal is an important target for predators’ navigation systems. However, it remains a matter of some debate how much their predators rely on plants’ electrical signatures to locate them, as opposed to chemical or mechanical information. Last year, Moratto and Sena’s group found that P. palmivora spores are attracted to the positive electrode of a cell generating current densities of 1 ampere per square meter. “The spores followed the electric field,” says Sena, suggesting that a similar mechanism helps them find natural bioelectric fields emitted by roots in the soil.

That got the researchers wondering: Might such an artificial electric field override the protists’ other sensory inputs, and scramble their compasses as they tried to use plant roots’ much weaker electrical output?

To test the idea, the researchers developed two ways to protect plant roots using a constant vertical electric field. They cultivated two common snacks for P. palmivora—a flowering plant related to cabbage and mustard, and a legume often used as a livestock feed plant—in tubes in a hydroponic solution.

Two electric-field configurations were tested: A “global” vertical field [left] and a field generated by two small nearby electrodes. The global field proved to be slightly more effective.Eleonora Moratto

In the first assay, the researchers sandwiched the plant roots between rows of electrodes above and below, which completely engulfed them in a “global” vertical field. For the second set, the field was generated using two small electrodes a short distance away from the plant, creating current densities on the order of 10 A/m². Then they unleashed the protists.

With respect to the control group, both methods successfully diverted a significant portion of the predators away from the plant roots. They swarmed the positive electrode, where—since zoospores can’t survive for longer than about 2 to 3 hours without a host—they presumably starved to death. Or worse. Neil Gow, whose research presented some of the first evidence for zoospore electrosensing, has other theories about their fate. “Applied electrical fields generate toxic products and steep pH gradients near and around the electrodes due to the electrolysis of water,” he says. “The tropism towards the electrode might be followed by killing or immobilization due to the induced pH gradients.”

Not only did the technique prevent infestation, but some evidence indicates that it may also mitigate existing infections. The researchers published their results in August in Scientific Reports.

The global electric field was marginally more successful than the local. However, it would be harder to translate from lab conditions into a (literal) field trial in soil. The local electric field setup would be easy to replicate: “All you have to do is stick the little plug into the soil next to the crop you want to protect,” says Sena.

Moratto and Sena say this is a proof of concept that demonstrates a basis for a new, pesticide-free way to protect food crops. (Sena likens the technique to the decoys used by fighter jets to draw away incoming missiles by mimicking the signals of the original target.) They are now looking for funding to expand the project. The first step is testing the local setup in soil; the next is to test the approach on Phytophthora infestans, a meaner, scarier cousin of P. palmivora.

P. infestans attacks a more varied diet of crops—you may be familiar with its work during the Irish potato famine. The close genetic similarities imply another promising candidate for electrical pest control. This investigation, however, may require more funding. P. infestans research can be undertaken only under more stringent laboratory security protocols.

The work at Imperial ties into the broader—and somewhat charged—debate around electrostatic ecology; that is, the extent to which creatures including ticks make use of heretofore poorly understood electrical mechanisms to orient themselves and in other ways enhance their survival. “Most people still aren’t aware that naturally occurring electricity can play an ecological role,” says Sam England, a behavioral ecologist with Berlin’s Natural History Museum. “So I suspect that once these electrical phenomena become more well known and understood, they will inspire a greater number of practical applications like this one.”

The teachings of Mahatma Gandhi were arguably India’s greatest contribution to the 20th century. Raghunath Anant Mashelkar has borrowed some of that wisdom to devise a frugal new form of innovation he calls “Gandhian engineering.” Coming from humble beginnings, Mashelkar is driven to ensure that the benefits of science and technology are shared more equally. He sums up his philosophy with the epigram “more from less for more.” This engineer has led India’s preeminent R&D organization, the Council of Scientific and Industrial Research, and he has advised successive governments.

What was the inspiration for Gandhian engineering?

Raghunath Anant Mashelkar: There are two quotes of Gandhi’s that were influential. The first was, “The world has enough for everyone’s need, but not enough for everyone’s greed.” He was saying that when resources are exhaustible, you should get more from less. He also said the benefits of science must reach all, even the poor. If you put them together, it becomes “more from less for more.”

My own life experience inspired me, too. I was born to a very poor family, and my father died when I was six. My mother was illiterate and brought me to Mumbai in search of a job. Two meals a day was a challenge, and I walked barefoot until I was 12 and studied under streetlights. So it also came from my personal experience of suffering because of a lack of resources.

How does Gandhian engineering differ from existing models of innovation?

Mashelkar: Conventional engineering is market or curiosity driven, but Gandhian engineering is application and impact driven. We look at the end user and what we want to achieve for the betterment of humanity.

Most engineering is about getting more from more. Take an iPhone: They keep creating better models and charging higher prices. For the poor it is less from less: Conventional engineering looks at removing features as the only way to reduce costs.

In Gandhian engineering, the idea is not to create affordable [second-rate] products, but to make high technology work for the poor. So we reinvent the product from the ground up. While the standard approach aims for premium price and high margins, Gandhian engineering will always look at affordable price, but high volumes.

The Jaipur foot is a light, durable, and affordable prosthetic.Gurinder Osan/AP

What is your favorite example of Gandhian engineering?

Mashelkar: My favorite is the Jaipur foot. Normally, a sophisticated prosthetic foot costs a few thousand dollars, but the Jaipur foot does it for [US] $20. And it’s very good technology; there is a video of a person wearing a Jaipur foot climbing a tree, and you can see the flexibility is like a normal foot. Then he runs one kilometer in 4 minutes, 30 seconds.

What is required for Gandhian engineering to become more widespread?

Mashelkar: In our young people, we see innovation and we see passion, but compassion is the key. We also need more soft funding [grants or zero-interest loans], because venture capital companies often turn out to be “vulture capital” in a way, because they want immediate returns.

We need a shift in the mindset of businesses—they can make money not just from premium products for those at the top of the pyramid, but also products with affordable excellence designed for large numbers of people.

This article appears in the November 2024 print issue as “The Gandhi Inspired Inventor.”

Acadia Pharmaceuticals did not disclose the buyer of the priority review voucher. The biotech received the voucher last year alongside the regulatory decision that made its drug Daybue the first FDA-approved treatment for the rare disease Rett syndrome.

The post Acadia Pharma Sells Voucher for Speedier FDA Drug Review for $150M appeared first on MedCity News.

Three ways health plans can engage, connect with, and delight their pregnant members to nurture goodwill, earn long-term trust, and foster loyal relationships that last.

The post Pregnant and Empowered: Why Trust is the Latest Form of Member Engagement appeared first on MedCity News.