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"Congressional investigations"
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FDA APPROVES ALZHEIMER'S DRUG AMID SAFETY CONCERNS
2023
Researchers welcome the decision, but their excitement is clouded by reports of patient deaths and that the FDA acted improperly last year when approving the first drug of this kind. Because it slows progression of the condition when taken in the early stages, lecanemab will allow individuals to have \"more time to participate in daily life and live independently\", says Joanne Pike, president and chief executive of the Alzheimer's Association in Washington DC. According to those reports, researchers think that the patients might have died because of a set of conditions known as amyloid-related imaging abnormalities (ARIA). The FDA did not hold a public advisory meeting for lecanemab before approving it. Since aducanumab's approval, Biogen and the FDA have come under further scrutiny, which has limited the treatment's roll-out.
Journal Article
Hundreds of alleged human rights abuses in US immigration detention centres, report finds
2025
A new report has catalogued hundreds of alleged human rights abuses in US immigration detention centres, including physical and sexual abuse, mistreatment of pregnant women, and inadequate medical care.1 The report, prepared by the office of Democrat senator Jon Ossoff, said that it had received or identified 510 “credible reports” of human rights abuse against individuals held in immigration detention centres since 20 January 2025. For the report, Ossoff’s team interviewed correctional staff, law enforcement officials, attorneys, detainees and their family members, doctors, and nurses. McLaughlin added that Senator Ossoff or his staff members had never been denied access to any ICE facilities. 1 Ossoff J. The abuse of pregnant women and children in US immigration detention. 30 Jul 2025. https://www.ossoff.senate.gov/wp-content/uploads/2025/08/250721_Pregnancy_Report_v7.pdf 2 Singh M, Craft W, Witherspoon A. How Trump has supercharged the immigration crackdown—in data.
Journal Article
Health experts welcome Brazil COVID-19 inquiry findings
According to the report, “the constant minimization of the severity of COVID-19, the creation of ineffective mechanisms for the control and treatment of the disease, the lack of political coordination, the lack of educational campaigns on the importance of non-pharmacological measures, personal behavior against these measures, and the omission and delay in the acquisition of vaccines were some of the conducts of the head of the Federal Executive Branch that unquestionably attacked public health and administrative probity.” According to Cesar Eduardo Fernandes, president of the Brazilian Medical Association, the report was ample, investigating “everything that should be investigated, and addressing all the points that raised doubts and concerns. According to the Congressional report, none of the emails were answered by the Bolsonaro administration. According to Fernandes, part of the damage done with misleading statements and mismanagement of the pandemic by the Bolsonaro Government is likely to be permanent.
Journal Article
Conducting quantitative synthesis when comparing medical interventions: AHRQ and the Effective Health Care Program
by
Gartlehner, Gerald
,
Ismaila, Afisi
,
Wilt, Timothy J.
in
Bias
,
Comparative Effectiveness Research - methods
,
Confidence intervals
2011
This article is to establish recommendations for conducting quantitative synthesis, or meta-analysis, using study-level data in comparative effectiveness reviews (CERs) for the Evidence-based Practice Center (EPC) program of the Agency for Healthcare Research and Quality.
We focused on recurrent issues in the EPC program and the recommendations were developed using group discussion and consensus based on current knowledge in the literature.
We first discussed considerations for deciding whether to combine studies, followed by discussions on indirect comparison and incorporation of indirect evidence. Then, we described our recommendations on choosing effect measures and statistical models, giving special attention to combining studies with rare events; and on testing and exploring heterogeneity. Finally, we briefly presented recommendations on combining studies of mixed design and on sensitivity analysis.
Quantitative synthesis should be conducted in a transparent and consistent way. Inclusion of multiple alternative interventions in CERs increases the complexity of quantitative synthesis, whereas the basic issues in quantitative synthesis remain crucial considerations in quantitative synthesis for a CER. We will cover more issues in future versions and update and improve recommendations with the accumulation of new research to advance the goal for transparency and consistency.
Journal Article
Donanemab: Conflicts of interest found in FDA committee that approved new Alzheimer’s drug
by
Lenzer, Jeanne
,
Brownlee, Shannon
in
Alzheimer Disease - drug therapy
,
Alzheimer's disease
,
Antibodies, Monoclonal, Humanized - therapeutic use
2024
A new drug for Alzheimer’s disease is causing excitement despite excess deaths, missing safety data, questionable efficacy, and financial conflicts of interest among the “independent” advisory panellists who recommended approval. Jeanne Lenzer and Shannon Brownlee report
Journal Article
PENALIZING COMPLIANCE: THE CASE FOR PAYING CHAPTER 13 TRUSTEES IN THE EVENT OF PRE-CONFIRMATION DISMISSAL
2024
Standing trustees provide a critical function of fairness in chapter 13 bankruptcy, but a jurisdictional split regarding their fees means that trustees in multiple circuits are not paid for a large percentage of their work. Under Ninth and Tenth Circuit precedents, standing trustees may not collect the percentage fee when the debtor's case is dismissed before confirmation. This creates a different result for standing trustees as opposed to single-case trustees, hurts debtors and creditors, creates adverse incentives, and even constitutional conundrums. Permitting some debtors to enjoy the benefits of chapter 13 without paying their fair share creates a system where standing trustees must work on their cases, potentially for extended periods of time. Further, trustees risk going uncompensated if the debtor decides he wants to leave chapter 13 or refuses to propose a viable plan for confirmation. When these debtors do not pay the trustee fee, the trustee must find another source to fund her office operations. Thus, trustees resort to increasing their percentage fee to compensate for these losses, meaning other debtors must pay more to use chapter 13 and unsecured creditors get a lower payout. The Ninth and Tenth Circuit approaches further create nonsensical incentives where debtors are motivated to draw out the confirmation process as long as possible with no intention of confirming their plan to avoid paying the trustee fee. It also creates an incentive for trustees to confirm plans regardless of their feasibility, working counter to their role as a keeper of fairness in chapter 13. Additionally, by only awarding trustees their fees in the event of confirmation, a constitutional issue arises due to the trustee's role as a quasijudicial officer. This Comment untangles the various approaches courts have taken in awarding trustee fees in the event of pre-confirmation dismissals and delves into the harmful consequences of the Ninth and Tenth Circuit precedents. This Comment argues that standing trustee compensation in chapter 13 should not be denied merely because a debtor's proposed plan does not pass confirmation muster. Such an approach creates absurd and undesirable outcomes across the board in the chapter 13 system. Rather, courts should endorse the approach of other bankruptcy and district courts that allow for payment of standing chapter 13 trustee fee awards regardless of plan confirmation status. Even better, Congress should settle the issue by crafting a simple amendment to the Bankruptcy Code that resolves this issue entirely.
Journal Article
MODY: History, genetics, pathophysiology, and clinical decision making
by
BELL, Graeme I
,
FAJANS, Stefan S
in
Bell, Graeme I
,
Biological and medical sciences
,
Body Weight
2011
Starting with known diabetic patients from the Diabetes Clinic, I recruited their apparently healthy and asymptomatic first-degree relatives (parents, brothers, sisters, and children) for routine oral glucose tolerance tests (OGTTs). The initial objectives were 1 to define the normal range for the OGTT, 2 to attempt to unmask the potential diabetic subjects who manifest normal glucose tolerance by the standard OGTT and determine whether the diabetogenic activity of cortisone could be used to uncover a subclinical defect in the metabolism of glucose, and 3 to carry out periodic follow-up over many years of the apparently healthy first-degree relatives of diabetic patients.
Journal Article
Covid-19 originated in Wuhan lab, alleges Republican congressional report
2024
“Four years after the onset of the worst pandemic in 100 years, the weight of the evidence increasingly supports the lab leak hypothesis,” concludes the Republican majority report of the House Select Subcommittee on the Coronavirus Pandemic.1 “Today, a zoonotic origin and lab accident are both plausible, as is a ‘hybrid’ scenario reflecting a mixture of the two,” the Democratic minority report concludes. The Republican report suggested that the virus was designed during “gain of function” research and that China’s armed forces were developing viruses for military use at Wuhan. Proc Natl Acad Sci U S A 2022; 119: e2211107119. 10.1073/pnas.2211107119 36173950 9 Office of the Director of National Intelligence.
Journal Article
Protecting Africa's children from extreme risk: a runway of sustainability for PEPFAR programmes
by
Stover, John
,
Hillis, Susan
,
Imai-Eaton, Jeffrey W
in
Abortion
,
Acquired immune deficiency syndrome
,
Adolescent
2025
PEPFAR (President's Emergency Plan for AIDS Relief), a landmark US foreign health policy, is recognised for saving 26 million lives from HIV. PEPFAR investments have also had life-saving impacts for children across sub-Saharan Africa through childhood HIV prevention, care, and treatment, ensuring 7·8 million babies were born HIV-free, supporting 13 million orphaned and vulnerable children, and protecting 10·3 million girls from sexual abuse. In this Health Policy, we review data from UNAIDS, UNICEF, World Bank, Violence Against Children Surveys, SPECTRUM model data, and Population-based HIV Impact Assessments; synthesise PEPFAR reports; conduct in-depth interviews; search PubMed for programme effectiveness evidence; and review economic reports. PEPFAR support is associated with substantial collateral benefits for the USA and Africa, including a four-fold increase in export of US goods to Africa, and US$71·6 billion in total goods trade between the USA and Africa in 2024. PEPFAR-supported countries in Africa are committed to ownership of HIV responses by 2030—overall, PEPFAR-supported countries in sub-Saharan Africa have progressively increased their co-financing of their health systems through domestic government and private expenditure from $13·7 billion per year in 2004 to $42·6 billion per year in 2021. The feasibility of a 5-year transition to country-led sustainability is supported by evidence of innovative cost-saving models of delivery, including through faith-based and community-based organisations, and high return-on-investment for PEPFAR programmes. There are also collateral benefits of PEPFAR for US and Africa national security and health security, for example, reducing forced migration and increasing capacity to control emerging transborder infectious disease threats. Risks in sub-Saharan Africa remain acute: one in five girls (younger than 18 years) experience rape or sexual assault; one in ten children (younger than 18 years) are orphaned; and a child (younger than 15 years) is estimated to die from AIDS every 7 min. Without continued PEPFAR programmes, models predict that by 2030, an additional 1 million children will become infected with HIV, 0·5 million additional children will die of AIDS, and 2·8 million children will additionally become orphaned by AIDS. There is now an opportunity for a transformational partnership between the USA and Africa, to accelerate domestic government co-financing, private-sector investments, and charitable foundations. A 5-year progressive runway of transition can occur through continued authorisation of PEPFAR programmes, which can lead to the end of AIDS for children and families, an historic achievement.
Journal Article
HUGE SCIENCE-FUNDING BILL PASSES US SENATE WITH CHINA FOCUS
2021
[...]the bill, once aimed largely at helping the United States to maintain its status as a global leader through direct funding for research and development, now includes amendments aimed at preventing China from stealing or benefiting from US intellectual property - a development that scientists fear could threaten international collaborations. \"Even if it weren't for the competition with China, the American people deserve the benefits that come from these kinds of investments of taxpayer money,\" says Neal Lane, a science-policy researcher with the Baker Institute for Public Policy at Rice University in Houston, Texas, who is a former NSF director. The directorate would act as a hub for translating fundamental scientific discoveries into commercial technologies. Because the NSF's budget had risen only incrementally since the agency's inception 70 years ago, many researchers and policy experts were elated to see renewed interest.
Journal Article