Singularity Health Law Blog

CAN THE FDA REGULATE YOUR STEM CELLS?

In July, 2012, Rosemary N, Collyer, a United States District Court Judge for the District of Columbia, ruled that autologous stem cells re-injected into a person’ body following a acculturation of the cells with the use of another drug product shipped in interstate commerce is a “drug” subject to regulation by the U.S, Food and Drug Administration. The purpose of the re-injection is to stimulate the regrowth of bone, cartilage and other human tissue to regenerate them in lieu of joint transplants and other orthopedic surgical procedures.

 

Comparing US And UK Head And Brain Injury Compensation Law

[This is a guest post by Joanne Berry of Pannone LLP's Serious Injury Team in the UK.]

The following article provides an overview of the US and UK legal systems regarding head and brain injuries compensation, when said injuries are sustained through accidents. To make the comparison easier, the focus of this comparison will be on head injuries or brain injuries that were caused due to a road traffic accident. The aim is to provide an interesting comparison to encourage debate and discussion of the pros and cons of both systems.

PARSING PARTS: COMPENSATION FOR BONE MARROW

Yesterday, a panel of the federal 9th Circuit Court of Appeals considered a challenge to the constitutionality of the National Organ Transplant Act (the “Act”) as it relates to restricting compensation to bone marrow cell donors whose cells are extracted through apherisis. The Act prohibits the compensation of donors of body organs including specifically, bone marrow, but permits compensation for blood, sperm,  and eggs. In Flynn et al v. Eric Holder, No. 10-55643 (9th Cir. 2011), the Plaintiffs, who included a variety of persons and entities adversely affected by the difficulty of obtaining donations of bone marrow, argued that there was no rational basis for distinguishing between the donation of blood plasma and the donation of hematopoietic stem cells which are excreted from the bone marrow itself into the blood stream in thus implicating the “equal protection clause” of the Constitution.

 

TOP HEALTHCARE SYSTEMS

With the continuing devolution of U.S. health care into at least a three tiered class structure, we are left with a number of questions as to why the U.S. with all of its wealth and power is so far down the list of top health care systems.  It may perhaps be related to the growing transformation of the U.S. into “bananarepublichood,” where the growing gross disparity in income here leads to lack of access to care by large segments of the the population which adversely effects our overall averages in quality markers such as life expectancy and infant mortality.  When you have a combination of the best and the worst features of a health care system your average necessarily drops precipitously.

 

BRITS SAY MARGINAL LUPUS DRUG TOO EXPENSIVE.

Benlysta is a new Lupus drug developed by Human Genome Sciences and marketed by GaxoSmithKine.  It is the first new Lupus drug to come along in 50 years.  The others are aspirin approved in 1948 and Plaquenil, a malaria drug, and corticosteroids approved in 1955.  A United Kingdom regulator in Britain recommended that the health care system in Britain not pay for the drug because it is too expensive and marginally effective. The cost of the drug in the United States is about $35,000. per year.  In Britain, where big Pharma is a lot friendlier, it is about $15,600.

 

BAHRAIN DOCTORS PUNISHED FOR TREATING PROTESTORS.

The government wrath against the “arab spring” surfacing in Bahrain has turned its ugly face to inflicting gross criminal sentences upon doctors and other health care workers who treated protesters fleeing from Pearl Square, in the Bahrain capital, Manama.  Pearl Square used to be a rallying point for Shia protestors until the Suuni run government stuck a round hole in it. The government sentenced 18 doctors and 2 paramedics to 5 to 15 years for aiding protestors.  70% of the 525,000 citizens of Bahrain are Shia, who are systematically excluded from influence economically or otherwise