In a guidance issued Wednesday, the agency said randomized, controlled trials of cancer drugs should only use placebo in cases like when surveillance is standard of care. A bioethics expert said such principles have long existed, but it was good to see them in an official guidance.
The issue of conflicts of interest has become more pressing in recent years as drug prices soar and healthcare companies reach out to the academic and policy community for advice — often with generous payments attached, ethics experts say.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Whether assisted feeding can be withdrawn was at the center of recent high-profile cases in which patients with dementia were spoon-fed against their documented wishes because they continued to open their mouths.
The final draft of the National Defense Authorization Act would give the Pentagon authority to decide when unapproved drugs and devices, referred to as agents of war in the legislation, could be used on military personnel in an emergency. This proposal is a bad idea and should be dropped.
Neither the Food and Drug Administration nor a safety panel known as an institutional review board, or an “IRB,” monitored the testing of a vaccine its creators say prevents herpes outbreaks.
The Senate approved the feel good legislation which was hotly debated at the MedCity CONVERGE conference this week.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
The Right to Try debate involving patients' right to experimental drugs is a thorny topic that will be debated by experts holding opposing viewpoints. The discussion, part of MedCity CONVERGE in Philadelphia, will be live streamed via Facebook Live on Aug. 1.
Although 33 states have passed right to try legislation aimed at helping dying people get easier access to experimental treatments, medical ethicists warn they pose worrisome risks to the health and finances of vulnerable patients.
Simple math illustrates the challenge facing U.S. taxpayers, consumers and insurers following the launch late last year of two expensive new drugs to treat hepatitis C. If all 3 million people estimated to be infected with the virus in America...
The hullabaloo around 23andMe brought to light one unresolved issue for direct-to-consumer testing companies, and now a federal advisory panel is bringing to light another: dealing with incidental findings. Incidental findings are pieces of information that are happened upon by clinicians, researchers or DTC testing companies during a test or procedure. For example, a child […]
We will highlight Build My Health's revenue practice management tools, which could help physician practices add up to $250,000 to their practices.
The director of the National Institutes of Health met with the family of Henrietta Lacks three times. Two journals delayed plans to publish a map of the HeLa genome. And now family members now will have a say in how their relative’s genetic material will be used in future research projects. NIH director Francis Collins […]
The dilemma of our age, in the words of bioethicist Dr. Ryan Nash, is asking what should be done in medical care, and not merely what can be done. “Often we’re facing innovations and technology that we can use a certain way, but a key question to ask is should we?” Nash leads the Center […]
Talk about wow. Reports out of Britain this week suggest that it could soon become the first country to allow an in-vitro fertilization technique that uses genetic material from three people. The technique in question – referred to as three-parent in vitro fertilization – involves intervention in the fertilization process to remove defective mitochondrial DNA […]
Generic drugs have been an effective cost containment solution for traditional, small molecule pharmaceuticals. As large molecule biologics proliferate and take up a growing share of medical spending, we also increasingly need cost containment. The path we’re on now in the US and Europe is to ape the experience with small molecule products by introducing [...]
“…resolve to be honest at all events; and if in your own judgment you cannot be an honest lawyer, resolve to be honest without being a lawyer.” No need to identify the authorship of the above quotation, which should be known by all discerning readers, such as those who feast on the weekly Whistleblower offering. […]