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thedanahoward.bsky.social
Dana Howard
@thedanahoward.bsky.social
330 followers 810 following 77 posts

Assistant Professor | Bioethics and Philosophy. Views are my own and not that of my employer.

Professional website: https://sites.google.com/site/danasarahhoward/

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Art 30%
Public Health 22%
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Reposted by Dana Howard

profsecchi.bsky.social
Silvia Secchi @profsecchi.bsky.social · 1d
A pretty startling example of what 21st Century agricultural extractivism looks like in the United States.

Reposted by Dana Howard

fkearns.bsky.social
Faith Kearns, Ph.D. @fkearns.bsky.social · 2d
Interesting to see how this situation has evolved. Several of the folks quoted here attended our rural groundwater workshop earlier this year, and there was definitely strong appetite for action azwaterinnovation.asu.edu/arizona-comm...

Reposted by Dana Howard

drianweissman.bsky.social
Ian Weissman, DO @drianweissman.bsky.social · 2d
A noninvasive treatment for one of the most aggressive forms of brain cancer has been successful in animal trials. Using nanotechnology, researchers developed nasal drops that travel along the nerves of the nose into the central nervous system to fight glioblastoma.
newsnationnow.com/health/nasal...
newsnationnow.com

Reposted by Dana Howard

autonomynews.co
Autonomy News @autonomynews.co · 8d
Rep. Melanie Miller is behind a bill that advocates say would stigmatize abortion and send more clients to her nonprofit. “Crisis pregnancy center director introduces anti-abortion model legislation” is a ready-made headline—so why was this fact only a footnote?
Ohio Anti-Abortion Bill Sponsor Runs a Crisis Pregnancy Center. Few News Stories Mentioned It.
Rep. Melanie Miller is behind a bill that advocates say would stigmatize abortion and send more clients to her nonprofit.
www.autonomynews.co

thedanahoward.bsky.social
Dana Howard @thedanahoward.bsky.social · 10d
The Tuskegee trial was also described as an "unparalleled opportunity" at the time by those in power. nrs.harvard.edu/urn-3:HUL.In...
Surgeon General H. S. Cumming wrote to R. R. Moton, Director of the Tuskegee Institute: The recent syphilis control demonstration carried out in Ma- con County, with the financial assistance of the Julius Rosen- wald Fund, revealed the presence of an unusually high rate in this county and, what is more remarkable, the fact that 99 per cent of this group was entirely without previous treat- ment. This combination, together with the expected coopera- tion of your hospital, offers an unparalleled opportunity for carrying on this piece of scientific research which probably cannot be duplicated anywhere else in the world.22

thedanahoward.bsky.social
Dana Howard @thedanahoward.bsky.social · 10d
“ Rigorous analyses later showed declines not only in polio vaccination but also in routine childhood immunizations particularly among educated mothers who were most aware of the trial.”
boghuma.bsky.social BK. Titanji @boghuma.bsky.social · 10d
The planned hepatitis B birth-dose trial in Guinea-Bissau raises serious ethical concerns. Withholding a proven, life-saving vaccine from newborns to answer speculative questions is an absence of equipoise with real downstream harms for trust in vaccines.
bktitanji.substack.com/p/how-unethi...
How Unethical Research Seeds Medical Mistrust
The absence of equipoise can turn research into harm
bktitanji.substack.com

Reposted by Raffaella Ravinetto, Daniel S. Goldberg, Alan Richardson , and 1 more

boghuma.bsky.social
BK. Titanji @boghuma.bsky.social · 10d
The planned hepatitis B birth-dose trial in Guinea-Bissau raises serious ethical concerns. Withholding a proven, life-saving vaccine from newborns to answer speculative questions is an absence of equipoise with real downstream harms for trust in vaccines.
bktitanji.substack.com/p/how-unethi...
How Unethical Research Seeds Medical Mistrust
The absence of equipoise can turn research into harm
bktitanji.substack.com

Reposted by Jan W. Mueller, David Lazer, Brian Keegan , and 2 more

natematias.bsky.social
J. Nathan Matias @natematias.bsky.social · 11d
Should scientists apply to OpenAI's fund for research on AI & mental health? Should policymakers consider it a credible safety effort?

Avriel Epps & I see it as "grantwashing," and it's an insult to anyone whose loved one's death involved chatbots. We explain:

www.techpolicy.press/beware-of-op...
Beware of OpenAI's 'Grantwashing' on AI Harms | TechPolicy.Press
J. Nathan Matias and Avriel Epps say OpenAI's announced research funding is the perfect corporate action to make sure we don't find answers for years.
www.techpolicy.press

Reposted by Dana Howard

boghuma.bsky.social
BK. Titanji @boghuma.bsky.social · 11d
It is unethical to randomize children to placebo or other intervention in order to assess the efficacy of an intervention whose effectiveness and clear benefits are already supported by robust clinical trial and longterm surveillance data. I hope the outcry will halt this abominable study.

Reposted by Smith, Dana Howard

gavinyamey.bsky.social
Prof Gavin Yamey @gavinyamey.bsky.social · 11d
“NIH is in crisis, grants are being terminated, labs are closing….but they found $1.6 million for an unsolicited proposal to study whether we should delay a vaccine we’ve been safely giving for 40 years, in a country where infants are at high risk of infection”

www.cidrap.umn.edu/childhood-va...
CDC awards $1.6 million for hepatitis B vaccine study, likely to controversial Danish researchers
www.cidrap.umn.edu

Reposted by Jamie Morgan, David S. Cohen, Karen Benjamin Guzzo , and 2 more

susanrinkunas.com
Susan Rinkunas @susanrinkunas.com · 11d
NEW: Louisiana and lawyer Erin Hawley of ADF just asked a federal judge to IMMEDIATELY end telemedicine prescriptions of the abortion drug mifepristone while their lawsuit against the FDA proceeds. They cite Fifth Circuit opinion and the Comstock Act of 1873
storage.courtlistener.com/recap/gov.us...
screenshot 1/2 with some words highlighted in yellow. they are offset by asterisks below: UNITED STATES DISTRICT COURT WESTERN DISTRICT OF LOUISIANA LAFAYETTE DIVISION THE STATE OF LOUISIANA, by and through its Attorney General, LIZ MURRILL, and ROSALIE MARKEZICH, Plaintiffs, v. U.S. FOOD AND DRUG ADMINISTRATION, et al., Defendants. Case No.: 6:25-cv-01491-DCJ-DJA Judge David C. Joseph Magistrate Judge David J. Ayo PLAINTIFFS STATE OF LOUISIANA AND ROSALIE MARKEZICH’S MOTION FOR PRELIMINARY RELIEF UNDER 5 U.S.C. § 705 Plaintiffs State of Louisiana and Rosalie Markezich respectfully move under 5 U.S.C. § 705 for **an order staying or postponing the effective date of the 2023 Risk Evaluation and Mitigation Strategy that the U.S. Food & Drug Administration (FDA) issued to allow mifepristone to be dispensed remotely** (the 2023 REMS). Plaintiffs also move in the alternative under 5 U.S.C. § 705 for a preliminary injunction under Rule 65 of the Federal Rules of Civil Procedure ordering FDA to suspend or withdraw the 2023 REMS while this case proceeds. The 2023 REMS is unlawful for at least the following reasons: **First, as five Fifth Circuit judges already have indicated, the 2023 REMS is arbitrary and capricious** and an abuse of discretion in violation of the Administrative Procedure Act, 5 U.S.C. § 706(2)(A). All. for Hippocratic Med. v. FDA, No. 23-10362, 2023 WL 2913725, at *17–18 (5th Cir. Apr. 12, 2023) (Alliance I); All. for Hippocratic Med. v. FDA, 78 F.4th 210, 249–51 (5th Cir. 2023) (Alliance II), rev’d and remanded on other grounds, 602 U.S. 367 (2024) (Alliance). That is because FDA permanently removed the in-person dispensing requirement and made other changes based on sources that the agency conceded did not support its decision. docket here: https://www.courtlistener.com/docket/71544002/louisiana-v-u-s-food-drug-administration/?order_by=desc screenshot 2/2 with some words highlighted in yellow. they are offset by asterisks below: **Second, the 2023 REMS is “otherwise not in accordance with law.” 5 U.S.C. § 706(2)(A). Under 18 U.S.C. § 1462** [NOTE: THIS IS THE COMSTOCK ACT. IT'S 18 U.S.C 1461-1462], Congress prohibits the use of “any express company or other common carrier or interactive computer service” for “any drug, medicine, article, or thing designed, adapted, or intended for producing abortion.” Because a federal agency cannot permit what federal law expressly prohibits, FDA lacked authority to permanently remove the in-person dispensing requirement. For these reasons, and as set forth fully in Plaintiffs’ Complaint and supporting Memorandum of Law, interim relief is necessary and appropriate to mitigate irreparable injuries caused by the 2023 REMS. Interim relief will serve the public interest and will not harm Defendants. This Motion is made on the grounds specified in this Motion, the accompanying Memorandum of Law, the exhibits attached to this Motion, the Complaint, and the Complaint’s accompanying exhibits, as well as on such other and further oral or documentary evidence as may be presented to the Court at or before a hearing on this Motion.1 An exhibit list and a proposed order are attached. docket here: https://www.courtlistener.com/docket/71544002/louisiana-v-u-s-food-drug-administration/?order_by=desc

thedanahoward.bsky.social
Dana Howard @thedanahoward.bsky.social · 12d
🚨🚨🚨

thedanahoward.bsky.social
Dana Howard @thedanahoward.bsky.social · 12d
A clear case of "ethics dumping"
thedanahoward.bsky.social Dana Howard @thedanahoward.bsky.social · 12d
This study would be unethically to conduct in the US according to federal regulations, importantly it also goes against the International Ethical Guidelines for Health-related Research Involving Humans (CIOMS): cioms.ch/publications...

thedanahoward.bsky.social
Dana Howard @thedanahoward.bsky.social · 12d
From
From page 15 of CIOMS: "Although conventional randomized controlled clinical trials are often considered the gold standard, other study designs such as response-adaptive trial designs, observational studies, or historical comparisons can also yield valid research results. Researchers and sponsors must carefully consider whether the research question can be answered with an alternative design, and whether the risk-benefit profile of alternative designs is more favourable when compared to a conventional randomized controlled trial."

thedanahoward.bsky.social
Dana Howard @thedanahoward.bsky.social · 12d
There are, of course, other research methodologies that can learn from the fact that SOC is not available in a setting. CIOMS identifies that RCT trials that withhold SOC should be held up to extra scrutiny.

thedanahoward.bsky.social
Dana Howard @thedanahoward.bsky.social · 12d
From how I understand the ethical guidance, unless there is a local need to study the difference between birth dose and witholding birth dose, then it is unethical. You are not justified in using a population as a convenience sample just because SOC is not widely available locally.

thedanahoward.bsky.social
Dana Howard @thedanahoward.bsky.social · 12d
There is no plausible local health need that would make it ethical to conduct this study in Guinea-Bissau, but not in the US.

thedanahoward.bsky.social
Dana Howard @thedanahoward.bsky.social · 12d
CIOMS discusses the situation of when withholding established effective interventions may be appropriate in low-resource settings. The trial must be "responsive to local health needs."

thedanahoward.bsky.social
Dana Howard @thedanahoward.bsky.social · 12d
From CIOMS: "when an established effective intervention exists for the condition under investigation, study participants must receive that intervention within the trial."

thedanahoward.bsky.social
Dana Howard @thedanahoward.bsky.social · 12d
This study would be unethically to conduct in the US according to federal regulations, importantly it also goes against the International Ethical Guidelines for Health-related Research Involving Humans (CIOMS): cioms.ch/publications...

Reposted by Dana Howard

martinmckee.bsky.social
Martin McKee @martinmckee.bsky.social · 12d
Is this relevant? www.sciencedirect.com/science/arti...
What is actually the emerging evidence about non-specific vaccine effects in randomized trials from the Bandim Health Project?
www.sciencedirect.com

thedanahoward.bsky.social
Dana Howard @thedanahoward.bsky.social · 12d
New research ethics case study just dropped☹️.

Reposted by Dana Howard

Reposted by Lisa W. Fazio, Richard S.J. Tol, Dorothy Bishop , and 35 more

Reposted by Dani Rodrik, Dana Howard

arindube.bsky.social
Arin Dube @arindube.bsky.social · 18d
Why did that happen, what does it tell us, and what can we do next?

That’s what my forthcoming book, The Wage Standard, is about: how rules, norms, and power in the labor market shape who shares in growth. Coming out March 31. Pre-order here:

www.thewagestandard.com
The Wage Standard by Arindrajit Dube: 9780593471418 | PenguinRandomHouse.com: Books
“The go-to guy on minimum wage” (Nobel Laureate and New York Times bestselling author Paul Krugman) tackles one of the thorniest social issues of our times—income inequality—from...
www.thewagestandard.com

thedanahoward.bsky.social
Dana Howard @thedanahoward.bsky.social · 21d
Reposted with alt text
American Academy of Pediatrics continues to recommend hepatitis B vaccination at birth for all newborns.

Reposted by Dana Howard

tom.medsky.social
Thomas [redacted] DO @tom.medsky.social · 21d
Pediatrician perspective on recent ACIP meeting:

1. A local large hospital system has already stated that they don't plan to change their protocols. Cleveland Clinic hospitals deliver 16,000 babies per year and them making this statement is important in establishing "standard of care".
From WKYC
Excerpt from article https://www.wkyc.com/article/news/health/cleveland-doctors-concerns-federal-panel-rolls-back-newborn-hepatitis-b-vaccine-policy/95-cff0f7c7-1a90-4a2c-ada9-7431985022b8 "Vaccines, including the hepatitis B vaccine, continue to play an important role in preventing serious illness and protecting public health. We encourage patients and families to speak with their healthcare providers if they have questions about this vaccine. Extensive research and clinical trials have shown the hepatitis B vaccine is safe and most effective when the first dose is given within 24 hours of birth."

Reposted by Dana Howard

criminalerin.bsky.social
Erin Fogg says Free Link @criminalerin.bsky.social · 21d
OH THAT IS INTERESTING
Interestingly, those with household incomes of $100,000 or more were the most likely (40%) to say they’ve intentionally taken an item without scanning it. Just 17% of those making less than $30,000 said the same.

Reposted by Dana Howard

enirenberg.bsky.social
Edward Nirenberg @enirenberg.bsky.social · 21d
Perhaps most importantly, after completing an HBV vaccine series, protective responses occur in the vast majority of people.

Before we had the universal policy, we could explain about half of infant HBV infections by transmission during childbirth. The other half? We don't know.