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.

 

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.

 

DOCTOR BEATS LIVER SWITCH RAP.

Dr. Richard R. Lopez, Jr., the former head of the liver transplant program at St. Vincent Medical Center in Los Angeles, received a jury verdict of acquittal against federal charges that he was engaged in a conspiracy to coverup the jump switch of an available liver over 50 patients waiting in line to a wealth Saudi.  Mr. Saud Al-Harthi, the patient who was next in line for the liver was told to go home to await word on availability. He died waiting for the call that never came.

 

THE SINGULARITY IS NEAR: When Humans Transcend Biology. by Ray Kurzweil, Viking Press, 2005.

    Recent developments in brain scanning through technological refinements of SPECT, fMRI and PET scans that monitor water, blood and/or glucose movement in the human brain to observe actual brain functioning as opposed to structure are providing a wealth of new information concerning its organization, complexity and integration.  Ray Kurzweil believes that exponential improvements in the temporal, spatial resolution and bandwidth of the human brain which is doubling each year, will successfully enable us to reverse engineer the human brains principals of operation  in the first half of this century.  This will result in that he calls the “Singularity” where machine based intelligence surpasses that of all humans combined, creating a disruptive transformation in human capability.  This capability he believes will be a billion times more powerful that all of human intelligence today.

Within several decades information based technologies will encompass all human knowledge and proficiency, ultimately including the pattern recognition powers, problem solving skills, and emotional and moral intelligence of the brain itself.

NEW MEXICO BODY PARTS CAPER.

It came up “heads” when an employee at a medical waste disposal facility called Stericycle in Kansas noticed a partially burned head and torso at disposal site.  Stericycle normally disposes of dead tissue, but this was more like raisins in the oatmeal and he quickly perceived something was wrong.  Further investigation led to the discovery of 6 additional roughly severed heads and a number of torsos in a truck outside of the facility. Shades of Alistair Cook! Cook you will remember as the genial host of Masterpiece Theater on PBS whose body was dismembered and proliferated by a gang of New Jersey body snatchers a couple of years ago.

Transplant Follies: Live Liver Lie Leads To Surgeon Indictment

It is a felony to lie to a federal government official concerning an administrative matter or process within his or her jurisdiction. Dr. Richard R.Lopez, M.D., 54, the former head of the liver transplant program at St. Vincent’s Medical Center in Los Angeles, CA was the recipient of a grand jury indictment this month for lying about and falsifying records concerning a liver transplant to federal transplant officials.  The lie was essentially to deceive the identity of the actual recipient of the liver. 

Jesse’s Brain

21 year old Jesse Adams died of a heart condition shortly after turning 21. During a renewal of his driver’s license he signed a card indicating his intent to make an anatomical gift of his body organs. Meanwhile back at the ranch Stanley Medical Research Institute (SMRI), a Maryland non-profit corporation dedicated to research of certain brain disorders had entered into a deal with the King County (Seattle, Washington) Medical Examiner to fund a pathologist position in the medical examiner’s office in exchange for the procurement of brain tissue from corpses passing through the examiner’s office- sort of a brain exchange program. Dr. Nabila Haikal was SMRI’s contribution to the examiner’s office. When Jessie died, Dr. Haikal called plaintiff, Nancy Adams, Jesse’s mother to ask for permission to take brain tissue from Jesse for research. The parties dispute the scope of the removal described, but ultimately all of Jesse’s brain ended up at SMRI while the Adams thought only a small sample would be taken. Later in a television program, the Adams learned that Jesse’s entire brain had been taken and now assert damages suffered from grief and depression.