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As Blood Shortage Deepens, Time to Accept the Evidence –End Deferral Period for Gay and Bisexual Blood Donors
Jeffrey A. SingerIn mid ‐January, twenty‐two Democratic U.S. Senators sent a letter to Secretary of Health and Human Services Xavier Becerra and Acting Food and Drug Administration Commissioner Janet Woodcock, urging the FDA to abandon its policy of requiring sexual abstinence by gay and bisexual men for at least three months before they can donate blood. A separate letter to the Secretary and Acting Commissioner, signed by four Democratic members of the U.S. House of Representatives was sent the same day. Earlier this week Utah State Senator Derek Kitchen (D ‑Salt Lake City) introduced SJR11, a ...
Source: Cato-at-liberty - March 4, 2022 Category: American Health Authors: Jeffrey A. Singer Source Type: blogs

Early CAR-T Therapies Produced Long Term Remission in Some Cases
Much of what we'd like to know about cancer therapies takes a long time to emerge. Only now is the long term data available for the first CAR-T immunotherapies aimed at forms of leukemia in which cancerous cells are clearly and distinctly marked by characteristic surface features. The field has long since expanded, and researchers are at present trying to adjust CAR-T in order to apply this form of treatment to solid cancers. Long term remission is not the same as a cure, as cancer is a disease in which it remains challenging to say whether or not a few remnant cancer cells await a return at some future time. If one can ma...
Source: Fight Aging! - February 10, 2022 Category: Research Authors: Reason Tags: Daily News Source Type: blogs

Fight Aging! Newsletter, February 7th 2022
In this study, we used accelerometer measurements (1) to examine the association of physical activity and mortality in a population-based sample of US adults and (2) to estimate the number of deaths prevented annually with modest increases in moderate-to-vigorous physical activity (MVPA) intensity. This analysis included 4,840 participants. Increasing MVPA by 10, 20, or 30 minutes per day was associated with a 6.9%, 13.0%, and 16.9% decrease in the number of deaths per year, respectively. We estimated that approximately 110,000 deaths per year could be prevented if US adults aged 40 to 85 years or older increased th...
Source: Fight Aging! - February 6, 2022 Category: Research Authors: Reason Tags: Newsletters Source Type: blogs

First Xenotransplantation of Engineered Porcine Organs to Human Patients
Sourcing organs from genetically engineered pigs is one of the options under development for the production of organs on demand for patients who need transplants. Ethically, growing organs from cells would be a better option, but we live in a world in which animals are widely seen only as tools to be used and consumed; one might hope that our descendants will grow to be better than us in that regard. Major surgery is a high risk undertaking in older people, and the best of all options would be to find ways to spur controlled regrowth and repair in native tissues. That remains more of an aspirational goal at this point, and...
Source: Fight Aging! - February 4, 2022 Category: Research Authors: Reason Tags: Daily News Source Type: blogs

A Popular Science Overview of the State of Development for Epigenetic Clocks
The development of rejuvenation therapies is haphazard and inefficient in part because measuring rejuvenation is costly, uncertain, and slow. On the one hand, rigorous and convincing data is needed to persuade conservative, risk-averse regulators and sources of funding to support work on rejuvenation at all. Further, cost-effective early guidance on whether one approach is better or worse than another is needed in to order to avoid a great deal of effort directed towards programs that cannot produce sizable outcomes for health. With this in mind, the research community is in search of a way to rapidly assess biologi...
Source: Fight Aging! - January 28, 2022 Category: Research Authors: Reason Tags: Medicine, Biotech, Research Source Type: blogs

Government Must Not Assign Scarce COVID Therapies By Race
Walter OlsonI ’ve got a piece inThe Dispatch this morning. Excerpt:Governments around the country have been directing medical providers to allocate potentially lifesaving COVID therapies among patients on the basis of race, a policy that is almost certainly unconstitutional as well as morally open to question. …For those late to this controversy, here ’s a few examples of how the preferences work. In dispensing the scarce kind of monoclonal antibody that is known to retain broad effectiveness against COVID, for example, the Minnesota Department of Healthprescribed a point system in which BIPOC [bl...
Source: Cato-at-liberty - January 25, 2022 Category: American Health Authors: Walter Olson Source Type: blogs

What Tobacco Control Rules Would an Ethically Responsible FDA Implement (If the White House Let It)? − Would a Nicotine-Reduction Rule Pass Muster?
Eric Lindblom (Georgetown University), What Tobacco Control Rules Would an Ethically Responsible FDA Implement (If the White House Let It)? − Would a Nicotine-Reduction Rule Pass Muster?, SSRN (2021): The U.S. Food and Drug Administration (FDA) has not yet used... (Source: HealthLawProf Blog)
Source: HealthLawProf Blog - January 21, 2022 Category: Medical Law Authors: Katharine Van Tassel Source Type: blogs

Industrial Policy Fails Another (Rapid) Test
Scott LincicomeIt was good to see President Biden finallyacknowledge yesterday what anyone in America with a school ‐age child, job in a front ‐facing industry, or overseas travel plans has known for months: U.S. policy regarding COVID-19 testing has been a piping hot mess. What the president didn ’t mention, however, was that the administration’s most recent plan for at‐home rapid tests — announced in December in response to extreme public frustration about empty drug store shelves and long testing lines — was actually Biden’ssixth promise to subsidize and plan our way to testing ab...
Source: Cato-at-liberty - January 20, 2022 Category: American Health Authors: Scott Lincicome Source Type: blogs

Be Prepared
I was in fact a Boy Scout, and that was our motto. We had a creed and an oath as well, which were more controversial, but the motto carries over into the realm of public health very well. Preparedness is a major obsession of public health planners and advocates, but it ' s hard to maintain because people get complacent and politicians don ' t want to raise the taxes and spend the money for preparedness in between crises.Covid-19 has demonstrated what fools we are in that regard. Now JAMA has a theme issue on pandemic preparedness and response, including some prognostications about how we can live with this going forward, a...
Source: Stayin' Alive - January 18, 2022 Category: American Health Source Type: blogs

Senators Are Right to Seek End to Three ‐Month Celibacy Requirement For Gay and Bisexual Blood Donors
Jeffrey A. SingerTwenty ‐two Democratic U.S. senatorssent a letter today to Secretary of Health and Human Services Xavier Becerra and Acting Food and Drug Administration Commissioner Janet Woodcock urging the FDA toend its policy of deferring blood donations from men who have sex with men until 3 months after the last sexual encounter. The senators argued it is not compatible with the scientific evidence and needlessly prevents people from donating blood, especially at a time such as now, when there is a national blood shortage. In 2020 alone, the Red Cross had to cancel almost2700 blood drives due...
Source: Cato-at-liberty - January 13, 2022 Category: American Health Authors: Jeffrey A. Singer Source Type: blogs

FDA Finally Grants Patients Access to Molnupiravir
Jeffrey A. SingerYesterday the Food and Drug Administration gave emergency use authorization (EUA) to the antiviral drugPaxlovid,more than a month after its manufacturer, Pfizer, submitted its application. This pill, if taken within the first few days of a COVID-19 infection, has been found to be 89 percent effective in preventing progression of the disease to hospitalization. Clinical trials found no patients takingPaxlovid died from the virus.Seventy ‐four days ago, Merck applied for an EUA for its antiviral molnupiravir. If taken in the first few days of COVID infection it is 30 percent effective in preventing ...
Source: Cato-at-liberty - December 23, 2021 Category: American Health Authors: Jeffrey A. Singer Source Type: blogs

Hostage Crisis Ends On Day 73 —American Patients Now Have Access to One Antiviral Pill
Jeffrey A. SingerEarlier this week I wrote about foot ‐dragging by the Food and Drug Administration regarding approval of two highly effective antiviral pills. With the omicron variant of COVID-19 rapidly spreading throughout the population, infecting both vaccinated and unvaccinated, these pills becomes even more important.Merck applied to the FDA for Emergency Use Authorization (EUA) of its antiviral molnupiravir on October 11, 2021 —73 days ago. The drug was approved for emergency use in the U.K. on November 4. It is 30 percent effective in preventing COVID infections (including the omicron variant) from progr...
Source: Cato-at-liberty - December 22, 2021 Category: American Health Authors: Jeffrey A. Singer Source Type: blogs

Why MDMA-assisted psychotherapy may become an FDA-approved treatment for PTSD within 2 years
This article was originally published on The Conversation. To Learn More: Study: Psychedelics can promote neural plasticity in the prefrontal cortex and expand pathways for mental health FDA-approved, Cybin-sponsored clinicial trial to measure ketamine’s impact on the brain via Kernel Flow neuroimaging helmet The post Why MDMA-assisted psychotherapy may become an FDA-approved treatment for PTSD within 2 years appeared first on SharpBrains. (Source: SharpBrains)
Source: SharpBrains - December 21, 2021 Category: Neuroscience Authors: The Conversation Tags: Brain/ Mental Health antidepressants Cannabidiol cannabis CBD Ecstasy MDMA MDMA-assisted psychotherapy neural plasticity Physical assault post-traumatic-stress-disorder psilocybin PTSD Sexual assault street drugs substance-ab Source Type: blogs

American Patients Held Hostage Day 71
Jeffrey A. SingerThe new omicron variant is the most contagious variant of COVID-19 yet to emerge. Cases of omicron aredoubling every 1.5 to 3 days, as the virus quickly spreads throughout the U.S. While the delta variant is still the dominant variant in this country, omicron is on track to replace it. The Centers for Disease Control and Preventionreported late today that the omicron variant is responsible for 73 percent of recent COVID-19 cases in the U.S.The Pfizer and Moderna mRNA vaccines remain effective against omicron but aremuch less effective than with earlier variants. Evidence shows 2 doses of the mRNA vacci...
Source: Cato-at-liberty - December 20, 2021 Category: American Health Authors: Jeffrey A. Singer Source Type: blogs

Two Small Pharma Firms Join The Struggle To Give Women Access to OTC Birth Control Pills
Jeffrey A. SingerTheNew York Timesreports today that two small oral contraceptive makers, Cadence and HRA Pharma, have been seeking to make their birth control pills over ‐the‐counter since 2016. The Food and Drug Administration has taken five years “dialoguing” with the pharmaceutical firms but has yet to give them “clearance” to formally apply for the switch. TheTimes article cites an FDA spokesperson as saying the agency hopes to reach a decision within 10 months of the companies submitting a formal application.As I have writtenhere, birth control pills are available over ‐the‐...
Source: Cato-at-liberty - December 14, 2021 Category: American Health Authors: Jeffrey A. Singer Source Type: blogs