FDA
Utilizing AI and Social Media Analytics to Discover Adverse Side Effects of GLP-1 Receptor Agonists
Bartal, Alon, Jagodnik, Kathleen M., Pliskin, Nava, Seidmann, Abraham
Adverse side effects (ASEs) of drugs, revealed after FDA approval, pose a threat to patient safety. To promptly detect overlooked ASEs, we developed a digital health methodology capable of analyzing massive public data from social media, published clinical research, manufacturers' reports, and ChatGPT. We uncovered ASEs associated with the glucagon-like peptide 1 receptor agonists (GLP-1 RA), a market expected to grow exponentially to $133.5 billion USD by 2030. Using a Named Entity Recognition (NER) model, our method successfully detected 21 potential ASEs overlooked upon FDA approval, including irritability and numbness. Our data-analytic approach revolutionizes the detection of unreported ASEs associated with newly deployed drugs, leveraging cutting-edge AI-driven social media analytics. It can increase the safety of new drugs in the marketplace by unlocking the power of social media to support regulators and manufacturers in the rapid discovery of hidden ASE risks.
How a drunk dial from a friend led to paralyzed man becoming Neuralink's patient zero - five months later he is playing Mario Kart with his mind
A mid-day drunk-dial from a friend has changed one man's life forever. Noland Arbaugh, 29, rose to fame after being revealed as Neuralink's first patient to receive its brain chip, but it all started when his friend called slurring his words in September. Arbaugh was paralyzed eight years ago during a diving accident. The friend called Arbaugh to tell him about Elon Musk opening up human trials and urged him to apply and even helped him fill out the form. Just five months after he was approved for the Neuralink trial, Arbaugh had a cutting edge brain chip embedded in his skull.
Congressman slams FDA for ignoring 'troubling evidence' about Elon Musk's Neuralink and allowing brain chip to be implanted in humans - despite botching experiments on monkeys
Lawmakers have slammed the Food and Drug Administration for ignoring'troubling evidence' of Elon Musk's Neuralink practices and pushing the brain chip to human trials. Rep. Earl Blumenauer (D-Oregon) penned a letter to the FDA, criticizing the agency for not expecting the company's long list of animal abuse allegations that span back to at least 2019. The Democrat cited 2022 reports that described employees' complaints of'hack jobs' of animal experiments due to a rushed schedule, causing needless suffering and deaths. The open letter also stated'these alleged failures to follow standard operating procedures potentially endangered animal welfare and compromised data collection for human trials.' Blumenauer is now demanding the FDA explain how it reconciled reports of such lapses with its decision to authorize Neuralink's human trial.
Neural Network-Based Processing and Reconstruction of Compromised Biophotonic Image Data
Fanous, Michael John, Costa, Paloma Casteleiro, Isil, Cagatay, Huang, Luzhe, Ozcan, Aydogan
The integration of deep learning techniques with biophotonic setups has opened new horizons in bioimaging. A compelling trend in this field involves deliberately compromising certain measurement metrics to engineer better bioimaging tools in terms of cost, speed, and form-factor, followed by compensating for the resulting defects through the utilization of deep learning models trained on a large amount of ideal, superior or alternative data. This strategic approach has found increasing popularity due to its potential to enhance various aspects of biophotonic imaging. One of the primary motivations for employing this strategy is the pursuit of higher temporal resolution or increased imaging speed, critical for capturing fine dynamic biological processes. This approach also offers the prospect of simplifying hardware requirements/complexities, thereby making advanced imaging standards more accessible in terms of cost and/or size. This article provides an in-depth review of the diverse measurement aspects that researchers intentionally impair in their biophotonic setups, including the point spread function, signal-to-noise ratio, sampling density, and pixel resolution. By deliberately compromising these metrics, researchers aim to not only recuperate them through the application of deep learning networks, but also bolster in return other crucial parameters, such as the field-of-view, depth-of-field, and space-bandwidth product. Here, we discuss various biophotonic methods that have successfully employed this strategic approach. These techniques span broad applications and showcase the versatility and effectiveness of deep learning in the context of compromised biophotonic data. Finally, by offering our perspectives on the future possibilities of this rapidly evolving concept, we hope to motivate our readers to explore novel ways of balancing hardware compromises with compensation via AI.
Safety Cases: How to Justify the Safety of Advanced AI Systems
Clymer, Joshua, Gabrieli, Nick, Krueger, David, Larsen, Thomas
As AI systems become more advanced, companies and regulators will make difficult decisions about whether it is safe to train and deploy them. To prepare for these decisions, we investigate how developers could make a 'safety case,' which is a structured rationale that AI systems are unlikely to cause a catastrophe. We propose a framework for organizing a safety case and discuss four categories of arguments to justify safety: total inability to cause a catastrophe, sufficiently strong control measures, trustworthiness despite capability to cause harm, and -- if AI systems become much more powerful -- deference to credible AI advisors. We evaluate concrete examples of arguments in each category and outline how arguments could be combined to justify that AI systems are safe to deploy.
Auditing Fairness under Unobserved Confounding
Byun, Yewon, Sam, Dylan, Oberst, Michael, Lipton, Zachary C., Wilder, Bryan
A fundamental problem in decision-making systems is the presence of inequity across demographic lines. However, inequity can be difficult to quantify, particularly if our notion of equity relies on hard-to-measure notions like risk (e.g., equal access to treatment for those who would die without it). Auditing such inequity requires accurate measurements of individual risk, which is difficult to estimate in the realistic setting of unobserved confounding. In the case that these unobservables "explain" an apparent disparity, we may understate or overstate inequity. In this paper, we show that one can still give informative bounds on allocation rates among high-risk individuals, even while relaxing or (surprisingly) even when eliminating the assumption that all relevant risk factors are observed. We utilize the fact that in many real-world settings (e.g., the introduction of a novel treatment) we have data from a period prior to any allocation, to derive unbiased estimates of risk. We demonstrate the effectiveness of our framework on a real-world study of Paxlovid allocation to COVID-19 patients, finding that observed racial inequity cannot be explained by unobserved confounders of the same strength as important observed covariates.
Are they REALLY taking AI seriously? Biden's flagship artificial intelligence safety lab is found to be riddled with black mold, pests and a leaky roof
With only a modest 10 million budget to help regulate an industry of billionaires, Biden's new AI safety lab is now struggling with just the safety of its own facilities. 'Chronic underfunding' of the National Institute of Standards and Technology (NIST), the federal lab that will house the new US AI Safety Institute, has produced black mold, leaky ceilings, and a dead technician crushed by a concrete slab, reports say. Despite calls from scientists and entrepreneurs who have described'the risk of extinction from AI' as on par with'pandemics and nuclear war,' GOP deficit hawks in Congress pushed for a 10-percent budget cut to NIST -- and Biden approved. One former senior NIST official reported seeing'Home Depot dehumidifiers or portable AC units all over the place' bought by staff to help dry and slow the mold. Another reported indoor incessant leaks during rainy weather that required staff to'tarp up' critical electronic equipment.
VQSynery: Robust Drug Synergy Prediction With Vector Quantization Mechanism
Wu, Jiawei, Yan, Mingyuan, Liu, Dianbo
The pursuit of optimizing cancer therapies is significantly advanced by the accurate prediction of drug synergy. Traditional methods, such as clinical trials, are reliable yet encumbered by extensive time and financial demands. The emergence of high-throughput screening and computational innovations has heralded a shift towards more efficient methodologies for exploring drug interactions. In this study, we present VQSynergy, a novel framework that employs the Vector Quantization (VQ) mechanism, integrated with gated residuals and a tailored attention mechanism, to enhance the precision and generalizability of drug synergy predictions. Our findings demonstrate that VQSynergy surpasses existing models in terms of robustness, particularly under Gaussian noise conditions, highlighting its superior performance and utility in the complex and often noisy domain of drug synergy research. This study underscores the potential of VQSynergy in revolutionizing the field through its advanced predictive capabilities, thereby contributing to the optimization of cancer treatment strategies.
Evaluating and Correcting Performative Effects of Decision Support Systems via Causal Domain Shift
Boeken, Philip, Zoeter, Onno, Mooij, Joris M.
When predicting a target variable $Y$ from features $X$, the prediction $\hat{Y}$ can be performative: an agent might act on this prediction, affecting the value of $Y$ that we eventually observe. Performative predictions are deliberately prevalent in algorithmic decision support, where a Decision Support System (DSS) provides a prediction for an agent to affect the value of the target variable. When deploying a DSS in high-stakes settings (e.g. healthcare, law, predictive policing, or child welfare screening) it is imperative to carefully assess the performative effects of the DSS. In the case that the DSS serves as an alarm for a predicted negative outcome, naive retraining of the prediction model is bound to result in a model that underestimates the risk, due to effective workings of the previous model. In this work, we propose to model the deployment of a DSS as causal domain shift and provide novel cross-domain identification results for the conditional expectation $E[Y | X]$, allowing for pre- and post-hoc assessment of the deployment of the DSS, and for retraining of a model that assesses the risk under a baseline policy where the DSS is not deployed. Using a running example, we empirically show that a repeated regression procedure provides a practical framework for estimating these quantities, even when the data is affected by sample selection bias and selective labelling, offering for a practical, unified solution for multiple forms of target variable bias.
Prognostic Covariate Adjustment for Logistic Regression in Randomized Controlled Trials
Li, Yunfan, Sabbaghi, Arman, Walsh, Jonathan R., Fisher, Charles K.
Randomized controlled trials (RCTs) with binary primary endpoints introduce novel challenges for inferring the causal effects of treatments. The most significant challenge is non-collapsibility, in which the conditional odds ratio estimand under covariate adjustment differs from the unconditional estimand in the logistic regression analysis of RCT data. This issue gives rise to apparent paradoxes, such as the variance of the estimator for the conditional odds ratio from a covariate-adjusted model being greater than the variance of the estimator from the unadjusted model. We address this challenge in the context of adjustment based on predictions of control outcomes from generative artificial intelligence (AI) algorithms, which are referred to as prognostic scores. We demonstrate that prognostic score adjustment in logistic regression increases the power of the Wald test for the conditional odds ratio under a fixed sample size, or alternatively reduces the necessary sample size to achieve a desired power, compared to the unadjusted analysis. We derive formulae for prospective calculations of the power gain and sample size reduction that can result from adjustment for the prognostic score. Furthermore, we utilize g-computation to expand the scope of prognostic score adjustment to inferences on the marginal risk difference, relative risk, and odds ratio estimands. We demonstrate the validity of our formulae via extensive simulation studies that encompass different types of logistic regression model specifications. Our simulation studies also indicate how prognostic score adjustment can reduce the variance of g-computation estimators for the marginal estimands while maintaining frequentist properties such as asymptotic unbiasedness and Type I error rate control. Our methodology can ultimately enable more definitive and conclusive analyses for RCTs with binary primary endpoints.