Site Archives Human Research and Experimentation

Clinical Trials Neglect the Elderly


[New York Times] The randomized clinical trial, long the gold standard of medical research, supposedly provides the most reliable data regarding which drugs, devices and procedures prove effective on real patients and which don’t. But when the people enrolled in the trial are quite different from those who will actually use the drug or device [...]

Should Parents Lose Custody of Super Obese Kids?


[NYT] CHICAGO (AP) — Should parents of extremely obese children lose custody for not controlling their kids’ weight? A provocative commentary in one of the nation’s most distinguished medical journals argues yes, and its authors are joining a quiet chorus of advocates who say the government should be allowed to intervene in extreme cases.
It has [...]

Poison Pills


[The Economist] DRUG smugglers can expect harsh penalties nearly everywhere—if the drugs in question are heroin or cocaine. Those who smuggle counterfeit medicines, by contrast, have often faced lax enforcement and light punishment. Some governments deem drug-counterfeiting a trivial offence, little more than a common irritant. After all, whose spam filter does not groan with ads [...]

Rep. DeGette renews bid to pass stem-cell legislation Read more: Rep. DeGette renews bid to pass stem-cell legislation


[Denver Post]- U.S. Rep. Diana DeGette on Wednesday unveiled her latest legislative effort to support embryonic-stem-cell research.
The Denver Democrat used Craig Hospital, which is internationally acclaimed for its rehab facilities for people with spinal- cord and brain injuries, as the backdrop to introduce the Stem Cell Research Advancement Act of 2011, which she is co-sponsoring [...]

Researchers Link Deaths to Social Ills


[NYT] Poverty is often cited as contributing to poor health. Now, in an unusual approach, researchers have calculated how many people poverty kills and presented their findings, along with an argument that social factors can cause death the same way that behavior like smoking cigarettes does.
In an article published online for the June 16 issue [...]

Could another Guatemala case happen?


[Blog.Bioethics.gov]- The question was simple, the answers not.
At the Presidential Commission for the Study of Bioethical Issues today, Commission Chair Dr. Amy Gutmann, president of the University of Pennsylvania, asked a panel of international experts on bioethics whether the so-called Guatemala incident could happen again. In Guatemala, from 1946 to 1948, a U.S.-funded research experiment [...]

Medtronic’s Infuse Bone Growth Therapy


[MassDevice] A new study alleges that Medtronic’s Infuse bone growth product causes excess bone growth in the spinal canal and researchers on the company payroll covered it up.
MASSDEVICE ON CALL — Medtronic Inc. (NYSE:MDT) faces new heat over the Infuse bone growth product, this time for allegations that the therapy caused excess bone growth in [...]

France Set to Uphold Curbs on Embryonic Stem Cells


[Reuters]- France looked set on Thursday to maintain its curbs on human embryonic stem cell research after the conservative government fought off a parliamentary bid to liberalize the country’s bioethics law.
The National Assembly voted to uphold the curbs in the second reading of the new bioethics law. Conservative legislators and the Roman Catholic Church had [...]

Pfizer Says Treatment’s Study Had One Drug-Related Death


[WSJ]- Pfizer Inc. said four patients died in a clinical trial of an experimental treatment for rheumatoid arthritis, but only one was determined by the investigators to be drug-related.
The New York company added that the death rate associated with the drug, across several studies, “is within the range of rates reported for biologic therapies” for [...]

StemCells Shelves Batten Disease Program — Not Enough Patients for Trial


[Business Times]- StemCells Inc. will discontinue an early-stage clinical trial in Batten disease because it couldn’t find enough eligible patients with the rare disease.
Batten disease, also known as neuronal ceroid lipfuscinosis or NCL, is a fatal neurodegenerative disorder in children.
Palo Alto-based StemCells in 2009 completed a Phase I safety trial in six patients with advances [...]