SAN DIEGO, Nov. 28, 2022 /PRNewswire/ — On December 2, the Lennox-Gastaut Syndrome (LGS) Foundation will host its LGS Research Roundtable at the American Epilepsy Society’s (AES) annual meeting in Nashville, TN. The event will bring together over a hundred researchers, clinicians, and family members to discuss the state of medical research in LGS. Click here to learn more about how YOU can attend the Roundtable and join the discussion.
LGS Foundation Logo (PRNewsfoto/LGS Foundation)
“How we treat LGS has remained roughly the same for the last 30 years,” said Dr. Tracy Dixon-Salazar, the LGS Foundation’s Executive Director and mother of an adult living with LGS. “We try treatment after treatment, alone and in combination, and hope one of them might work. Families often refer to this as the “dartboard approach” to treating LGS. Patients with this rare disease are in desperate need of better treatment approaches.”
The LGS Research Roundtable is an initiative of the LGS Foundation that brings together LGS patient families and research experts to discuss the barriers to better research and care and to facilitate the development and implementation of solutions. Discussions from the Roundtable guide the LGS Foundation’s Cure LGS 365 Research Grants Program. Since 2013, the LGS Foundation has awarded more than a million dollars in research funding to scientists around the world.
“We are excited to gather the brightest minds tackling LGS across the globe,” said Dixon-Salazar. “And, we believe that now more than ever, that patient families and doctors working together can help find better treatment options for those with LGS.”
Talks at the LGS Research Roundtable will set the stage for a larger LGS Meeting of the Minds Conference on the same topic that will take place in September 2023.
The LGS Foundation is a nonprofit organization dedicated to improving the lives of individuals impacted by LGS through advancing research, awareness, education, and family support.
To learn more about LGS or to support the LGS Foundation’s efforts, visit www.lgsfoundation.org.
Health-equity researcher Tung Nguyen guides several anti-racism efforts at the University of California, San Francisco.Credit: Susan Merrell
Decolonizing science
Science is steeped in injustice and exploitation. Scientific insights from marginalized people have been erased, natural-history specimens have been taken without consent and genetics data have been manipulated to back eugenics movements. Without acknowledgement and redress of this legacy, many people from minority ethnic groups have little trust in science and certainly don’t feel welcome in academia — an ongoing barrier to the levels of diversity that many universities claim to pursue.
In the next of a short series of articles about decolonizing the biosciences, Tung Nguyen, who was appointed associate vice-chancellor for research inclusion, diversity, equity and anti-racism at University of California, San Francisco (UCSF) in September, offers advice for reforms in health research. Nguyen, a health-equity researcher who is also the director of the UCSF Asian American Research Center on Health, says anti-racism efforts start with engaging underserved communities and nurturing diverse trainees in health research and health care.
I studied medicine because I didn’t see health care and health research addressing the needs of the Asian community in the San Francisco Bay area — the part of California where I moved, as an 11-year-old non-English speaker, when my family emigrated from Vietnam. For the past 20 years, I’ve been doing health-equity research, focusing on cancer interventions.
In this country, the health-research world has many aspects that are anti-Asian. A lack of data on one racial identity is always a sign of racism because it essentially means that a portion of the population is invisible. For example, we know that about one-third to one-half of Asian Americans don’t speak English well enough to take a medical survey conducted in English. The ‘Asian’ responses to such a survey will include only English speakers; in addition, all of the ‘Asian’ respondents will be lumped together, despite the diversity of Asian cultures.
Lack of urgency
Although some institutions are trying to hire diverse candidates, there is a fundamental lack of urgency when it comes to addressing systemic racism. The issues I’ve mentioned are all structural problems. I think that there can be no systematic change without engaging everyone involved — from medical-department heads to members of the communities that institutions purportedly serve.
In 2020, my colleagues and I created an anti-racism task force at the University of California, San Francisco. Using a community-engagement approach, we convened a committee of 25 members, including institutional and community leaders, staff, faculty members and trainees. Over the course of a year, we solicited information throughout the university and produced a report with 160 recommendations — ranging from funding for research that investigates the structures that sustain racism, to conducting more community engagement in scholarship.
Most institutions are too top-down. I’ve learnt that the academic hierarchy is a basic challenge to doing equity work on campuses. White men tend to be over-represented among faculty members, whereas non-faculty staff members tend to include more women and under-represented minority groups. We make sure the staff and faculty members meet and are mindful of — and acknowledge — the power dynamics that exist. Otherwise, our efforts wouldn’t be inclusive.
To better diversify recruitment of study participants, in 2021, my colleagues and I created the Research Action Group for Equity, or RAGE — an acronym we deliberately chose because we are angry about the lack of minority-health data and participation, and we want to make things uncomfortable for the powers that be. RAGE works with the UCSF Clinical & Translational Science Institute to make sure that recruitment is an inclusive process. We engage community leaders who are bicultural or bilingual to provide translation support or address cultural concerns.
Decolonizing science toolkit
If my colleagues and I can diversify the health-care workforce at UCSF, we can definitely improve the economic status of diverse communities as well as the reach of biomedical research into those communities. We have a US National Institutes of Health BUILD award to address the lack of diversity among biomedical researchers. If you want minority students and trainees, you have got to go to where they are. In our case, we recruited trainees from San Francisco State University, a Hispanic-focused, minority-serving institution. We trained these junior research and health professionals to become, for example, clinical research coordinators to manage studies and conduct experiments.
This expands the job opportunities available to these trainees and diversifies participation in research. But when people talk about efforts to increase the numbers of early-career scholars from diverse backgrounds, I hate the term ‘pipeline programme’. ‘Pipeline’ implies that you have to fit into a pipeline to begin with and you come out the other end, where the system wants you to come out. Furthermore, if the pipeline is producing a steady stream of talented PhDs from under-represented communities but the system does not increase the number of senior roles these people hold, it’s not a pipeline problem. Instead, it’s a dam problem — pun intended; there are structural barriers to workplace diversity that need to be removed.
UCSF has its own continuing challenges in terms of anti-racism efforts, but the institution has been transparent. It has a dashboard that highlights racial, ethnic and gender diversity among faculty members, staff and trainees. The situation fluctuates, and the numbers have never been great for typically under-represented groups in medicine, such as Black and Hispanic people. But it’s important that the problem be visible so that we can actually improve.
It’s frustrating that successful diversity, equity and inclusivity programmes often don’t get sustained. Under-represented groups are used to people coming in with money and then leaving. I have helped to develop the AEIOU principles, which will be the foundation of my work as the newly appointed associate vice-chancellor for research inclusion, diversity, equity and anti-racism. A is for accountability and anti-racism, E is for engagement, I is for individual-centred institutional change, O is opportunity, and U is unity. These principles are key to making progress against racism. The system has to change for under-represented groups to be successful, and that requires an increase in opportunities. Oppressive structures maintain oppression by making people perceive a zero-sum game — if someone wins, someone else has to lose. To increase diversity, equity and justice, we need to quit pitting one group against another.
This interview has been edited for length and clarity.
COVID-19 vaccines and drugs were developed at “warp speed” and now experts are concerned about the US Food and Drug Administration’s (FDA) inadequate surveillance of clinical trial sites, reports an investigation published by The BMJ today.
Regulatory documents show that only nine out of 153 Pfizer trial sites were subject to FDA inspection prior to licensing its COVID-19 mRNA vaccine. Similarly, 10 out of 99 Moderna trial sites and five of 73 remdesivir trial sites were inspected, writes investigative journalist Maryanne Demasi.
Notably, the FDA received a complaint from whistle-blower Brook Jackson, about misconduct at three clinical trial sites that were testing Pfizer’s COVID-19 vaccine, while she was employed as a regional director. Jackson observed a range of problems including falsified data, unblinded patients, and inadequately trained vaccinators who were slow to follow up on adverse events. “I thought that the FDA was going to swoop in and take care of everything,” said Jackson. The FDA did not, however, inspect the trial sites in question.
Experts have criticized the FDA’s oversight of clinical trials, describing it as “grossly inadequate.” They say the problem, which predated COVID-19, is not limited to a lack of inspections, but also includes failing to proactively notify the public or scientific journals when violations are identified, effectively keeping scientific misconduct from the medical establishment.
The FDA is “endangering public health” by not being candid about violations that are uncovered during clinical trial site inspections, says David Gortler, a pharmacist and pharmacologist who worked as an FDA medical reviewer between 2007 and 2011 and then as a senior advisor to the FDA commissioner in 2019-2021.
The FDA oversees clinical research of FDA-regulated drugs and devices in the US and abroad, if the product is intended for the US market. It conducts routine visits for trials, reviews records of those sites or the institutional review boards (IRBs) that oversee trials locally and follows up on complaints of violations. The FDA does not have a target for the proportion of trial sites it inspects.
Despite the estimated hundreds of thousands of clinical trial sites in operation across the US and abroad, the FDA told The BMJ that it only has 89 inspectors for its bioresearch monitoring program, which assures the quality and integrity of data submitted to the agency in support of new product approvals and marketing applications, but that it is recruiting more inspectors to reach its yearly average of 100.
“I don’t think that it is a sufficient number of staff to do that kind of level of oversight,” says Jill Fisher, professor of social medicine at the University of North Carolina. “The FDA must have enough of a presence to dissuade investigative sites from committing fraud,” she continues.
Between March and July 2020, at the peak of pandemic restrictions, the FDA paused its site inspections and only “mission critical” inspections were carried out. However, Gortler says this was the precise time that the FDA should have ramped up its oversight, not scaled back, especially since COVID-19 products were being developed at warp speed and intended for millions of people.
The FDA told The BMJ it takes oversight of clinical trials seriously and had adapted to travel restrictions, publishing draft guidance for remote regulatory assessments, which describes virtual inspections using live streaming and video conferencing and requests to view records remotely.
The FDA has a long history of failing to adequately oversee clinical trial sites, notes Demasi. For example, a 2007 report by the Department of Health and Human Services’ Office of the Inspector General found the FDA audited less than 1{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} of the nation’s clinical trial sites between 2000 and 2005 and was highly critical of the agency because it did not have a database of operational clinical trial sites.
In response, the FDA said it created a dedicated task force and “developed new regulations and guidance further to improve the conduct of clinical trials and enhance the protection of people participating in clinical trials,” but denied The BMJ an interview with a member of the task force.
Further, a 2020 investigation by the journal Science into the FDA’s enforcement of clinical research regulations between 2008 and 2019 concluded that the agency was often light handed, slow moving, and secretive. It said that the FDA rarely leveled sanctions and when it did formally warn researchers about breaking the law, it often neglected to ensure that the problems were remedied.
Although the FDA publishes its inspection reports, they are not proactively disclosed. Nor does it typically notify journals when a site participating in a published clinical trial receives a serious warning or alert the public about the research misconduct it finds.
Demasi points to reports of insufficient staff and low morale at the FDA. Fisher says the FDA “needs to be better funded and staffed to conduct inspections. At a minimum, the agency needs to inspect sites when complaints or concerns have been filed.”
Gortler doesn’t agree, however, that the FDA is under-resourced. With a total budget of $6.1bn in 2021, he suggests the agency needs to be leaner and more efficient, with employees interested in improving public health. “Half of its budget, about $3bn, is discretionary, which means it could have hired contractors, retirees, or repurpose existing workers. It chose not to. The FDA was just yawning its way through the pandemic. The entire agency is broken.”
More information:
Maryanne Demasi et al, Investigation: FDA oversight of clinical trials is “grossly inadequate,” say experts, The BMJ (2022). DOI: 10.1136/bmj.o2628
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HENDERSON, Nev., Nov. 14, 2022 /PRNewswire/ — VolitionRx Limited (NYSE AMERICAN: VNRX) (“Volition”), a multi-countrywide epigenetics company, has announced a medical investigate examine with Oncovet, a renowned veterinary referral clinic, specializing in health care and radiation oncology.
The non-interventional research is remaining led by Dr. Jérôme Benoit, Oncovet’s Scientific Director, and will assess circulating nucleosomes of puppies and cats with cancer using Volition’s Nu.Q® Vet Most cancers Exam.
Volition’s Nu.Q® Vet Cancer Examination is a uncomplicated, uncomplicated-to-use blood take a look at currently out there for most cancers screening in canines with ongoing investigate into its use for cancer screening in cats, and ailment checking in both equally species.
Dr. Jérôme Benoit, Clinical Director at Oncovet, claimed: “Volition’s Nu.Q® Vet Cancer Examination has presently been proven to detect systemic cancers in pet dogs this sort of as lymphoma and hemangiosarcoma. We will seek to establish irrespective of whether other typical cancers that we on a regular basis see in clinic, could also be detected in pet dogs and cats by measuring circulating nucleosomes at prognosis and in the course of procedure.
“We are enthusiastic to function with the group at Volition, giving samples from 100 canine and 25 cats with a vast assortment of cancers, about the coming year. We glimpse forward to supporting Volition as the corporation expands its functions into Europe, enabling veterinarians and pet proprietors throughout the location to benefit from the Nu.Q® Vet Cancer Take a look at.”
Dr. Tom Butera, Main Government Officer of Volition Veterinary Diagnostics Growth LLC, said: “We are delighted to collaborate with Dr. Benoit and his group on this analysis research. Jérôme is very highly regarded within the veterinary oncology sector and Oncovet is very well recognized in Europe for the style and design and management of veterinary medical trials in pet dogs and cats.”
“We are hoping that this first study will be the get started of an successful, extensive-time period marriage with Oncovet, as we search for to broaden the vary of cancers that our Nu.Q® Vet Cancer Test can detect throughout diverse species. We glance ahead to sharing the final results.”
Volition is building very simple, effortless-to-use, cost-helpful blood checks to help diagnose and keep an eye on a range of lifetime-altering illnesses which includes most cancers in each individuals and animals. For extra data about Volition’s Nu.Q® technological innovation go to: www.volition.com.
Observe to editors:
Conclusions from a clinical research carried out by Volition and Professor Wilson-Robles and the staff at Texas A&M University, peer-reviewed and posted in August 2022, confirmed that:
About Volition
Volition is a multi-countrywide epigenetics company that applies its Nucleosomics™ system by way of its subsidiaries to build straightforward, quick to use, value successful blood exams to aid diagnose and watch a array of everyday living-altering health conditions including some cancers and illnesses connected with NETosis this kind of as sepsis and COVID-19. Early prognosis and monitoring have the opportunity not only to lengthen the life of patients but also to increase their quality of daily life. The exams are primarily based on the science of Nucleosomics™, which is the follow of pinpointing and measuring nucleosomes in the bloodstream or other bodily fluid – an sign that disease is existing.
Volition’s research and progress pursuits are centered in Belgium, with an innovation laboratory and business office in the U.S. and further places of work in London and Singapore.
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About Oncovet
Oncovet’s mission is to give the greatest possible welcome and cure to the clients you entrust us with. Oncovet strives for excellence and relies on the expertise of its professionals renowned at European stage, as nicely as on the staff supporting them, to present thorough care. Our services consist of medical procedures, cardiology, imaging, radiotherapy, healthcare oncology, and inside drugs. We care for individuals who appear to us from throughout Europe. For more facts, go to: www.oncovet.fr
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Louise Batchelor/Debra Daglish, Volition, mediarelations@volition.com +44 ()7557 774620
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Sensis, the biggest minority-owned advertising agency in the region accomplished its first survey on range in professional medical exploration and observed minorities grossly underrepresented in scientific trials. Even although the Fda will involve 15{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} variety in federal drug trials for acceptance, African People and Hispanics are the the very least probably to acquire section according to analysis executed by Sensis.
“Greater compensation, additional transparency, and assurances all over wellness and safety would go a very long way towards building a better degree of participation,” SensisHealth Taking care of Director Sharon Carothers, MPH, MSW said. “There is a whole lot of mistrust of institutions between Hispanics and African People in america that has formulated around hundreds of years. That is going to be tricky to overcome.”
African Americans experienced the strongest damaging affiliation with clinical trials of any team surveyed. 20-nine percent of Black respondents understood, “there are periods when specific groups were exploited in clinical studies.” Nearly a single-third of African American respondents experienced “heard unfavorable factors about health-related exploration scientific studies or medical trials.” Meanwhile, 28{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} explained they “did not want to be a guinea pig.”
“It is significant to know what perceptions are standing in your way if you hope to have an effect on significant improve,” Sensis President and Main Method Officer José Villa reported. “Changing habits normally takes time but the federal regulations don’t give drug firms quite considerably time. Concentrating on the gains, demonstrating how communities will be aided, and earning it private will all enjoy a function in impacting improve.”
About Sensis
At Sensis, we depart no 1 behind. As an built-in cross-cultural company, we connect individuals with manufacturers as a result of marketing and advertising that builds interactions across cultures. No viewers is remaining unseen, and no consumer misses out on reaching them. We are strategy-led and digital centric, driven by sturdy cross-cultural analysis, data, and insights, with the intention of enabling varied audiences to take part in and reward from the products and solutions and expert services we endorse for our shoppers. Primarily based in Los Angeles, Sensis has offices in Washington Atlanta Austin, Texas Mexico and Colombia. Agency clients incorporate AltaMed, the CDC, Scripps Investigation, Ga Lottery, Protected California, Texas Tech College, California Department of Community Health and fitness, Northern Arizona College and the U.S. Census Bureau.
