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11/14/2018 - 11:04pm
IEET Fellow S.L. Sorgner’s latest monograph, which is entitled “Brave New Human” (“Schöner neuer Mensch”), and which he was invited to write by Nicolai Publishing, was published on the 23rd of October 2018. Therein, he present his own vision of the genetic new human, the implanted new human, the digital new human, and the conceptual new human:
11/14/2018 - 9:39am

Infectious disease emergencies are opportunities to test the efficacy of newly developed interventions—for example, drugs, vaccines, and treatment regimens. Yet they raise many intertwined challenges around politics, logistics, ethics, and study design.

It is essential to advance the discussion of how such products can and should be tested while remaining consistent with the efforts of CEPI, WHO, and others who encourage development and testing of candidate vaccines in advance of emergencies.

This can help disentangle ethical from political and logistical concerns, reduce the time pressure to make a decision, and encourage rational deliberation by future stakeholders who at the time of deliberation do not know what role (which product, which field site) they may be supporting in an actual emergency.

Along with the Berkman Klein Center for Internet and Society, the Petrie-Flom Center will host a luncheon with Mark Lipsitch, Professor of Epidemiology at the Harvard TH Chan School of Public Health, on Nov. 27.  Lipsitch will discuss his work on computer simulations of vaccine trials during epidemics, as well as some of his recent work on the ethics of trials in emergencies, with the aim to stimulate discussion on the intersection of these two topics.

Registration is required to attend the lunch, but the talk will also be live-streamed here. 

The post Can Computer Simulations Enhance Vaccine Trials? appeared first on Bill of Health.

11/14/2018 - 8:56am

Even when she was gone, she was present in the patient sitting before me and in the way I was newly able to comfort and reassure her

11/14/2018 - 8:53am

Nicole Veum had been sober for nine years when she and her husband, Ben, decided to have a baby. Motherhood was something she wanted to feel. If she needed an epidural during labor, Veum told her doctor, she didn’t want any fentanyl in it. She didn’t want to feel high

11/14/2018 - 8:41am

Two years into Maribel’s recovery and treatment, David’s boss gathered his staff into his office. Don’t worry, he said, business is good. Your jobs are safe. But there would be one change: Health insurance offered through the company would soon be discontinued. It had simply become too expensive

11/14/2018 - 8:37am

The nation’s hospitals have been merging at a rapid pace for a decade, forming powerful organizations that influence nearly every health care decision consumers make. The hospitals have argued that consolidation benefits consumers with cheaper prices from coordinated services and other savings

11/14/2018 - 3:00am

Compassion & Choices today released its second video in a digital video ad campaign featuring passionate advocates of New Jersey’s Aid in Dying for Terminally Ill Act (A1504, S1072) urging the state Assembly and Senate to pass the bill before the end of year. Dec. 17 is the last scheduled voting day for the legislature.

“I've had 18 surgeries. I plan to fight my illness for as long as I can. I enjoy life,” says 61-year-old Clark resident Laurie Wilcox, LPN, who has suffered from rheumatoid arthritis for 30 years that has invaded her lung tissue and requires an oxygen tank most of the day to breathe. “At the end stage of my disease, I do not want to suffer through air hunger in the very last days of my life. Please urge New Jersey lawmakers to bring this legislation to the floor for a vote now.”...

11/13/2018 - 7:51pm

If you have found this blog useful, please vote it in the "best legal blog contest" in the "niche" category. The voting tool validates votes through LinkedIn, Twitter, or Google.

11/13/2018 - 2:20pm

By Cesar E. Montelongo Hernandez Last week a federal appeals court upheld the ruling that blocks the Trump administration from ending DACA. This means the nationwide injunction that allows DACA to remain will stay in place. Despite this, the legal battle will continue and likely head to The Supreme Court of the United States. DACA […]

11/13/2018 - 2:17pm

By Ameet Sarpatwari and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division.

Below are the abstracts/summaries for papers identified from the month of October. The selections feature topics ranging from out-of-pocket spending on orphan drugs, to a systematic review of the FDA’s exception from informed consent pathway, to the association between progression-free survival and patients’ quality of life in cancer clinical trials. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Chua KP, Conti RM. Out-of-pocket Spending on Orphan Drug Prescriptions Among Commercially Insured Adults in 2014. J Gen Intern Med. 2018 Oct 15. [Epub ahead of print]
  2. Cutler DM. Extending the User Fee Approach to Pharmaceuticals. JAMA. 2018 Oct 16;320(15):1525-1526.
  3. Feldman WB, Hey SP, Kesselheim AS. A Systematic Review Of The Food And Drug Administration’s ‘Exception From Informed Consent’ Pathway. Health Aff (Millwood). 2018 Oct;37(10):1605-1614.
  4. Hwang TJ, Gyawali B. Association between progression-free survival and patients’ quality of life in cancer clinical trials. Int J Cancer. 2018 Oct 29. [Epub ahead of print]
  5. Kesselheim AS, Woloshin S, Lu Z, Tessema FA, Ross KM, Schwartz LM. Internal Medicine Physicians’ Financial Relationships with Industry: An Updated National Estimate. J Gen Intern Med. 2018 Oct 5. [Epub ahead of print]


Photo by wp paarz/Flickr

The post Monthly Round-Up of What to Read on Pharma Law and Policy appeared first on Bill of Health.