bioethics.net News Update - Human Research/Subjects

Malaria vaccine study will infect volunteers with the parasite

Thu, 06 Mar 2008 12:00:00 EST

Researchers say they'll only use a strain of malaria that responds to existing drugs. They say the testing in the US will help them better pick vaccine candidates to test in children in Africa.

UK bill would allow cloning without consent

Sun, 03 Feb 2008 11:55:02 EST

The bill would allow researchers to create cloned embryos from tissues donated for other research -- and without the express permission of the donors.

Questions raised about release of cholesterol drug data

Tue, 15 Jan 2008 09:35:18 EST

The results of a study that found the drug Zetia to not provide any benefit to patients weren't released publicly for almost two years after the study ended. The delay has raised questions about whether the companies behind the drug sat on the results for financial reasons.

Black Americans still wary of medical research

Tue, 15 Jan 2008 09:30:38 EST

A study in the journal Medicine reports that black Americans are less likely than whites to enroll in clinical trials. Experts worry the lower rates of participation could hinder attempts to reduce health disparities.

Cancer patients as lab rats

Sun, 16 Dec 2007 11:19:53 EST

The slow pace of research on the use of drug cocktails to treat cancers has prompted some patients to take up testing new combinations themselves.

Federal judge throws out case against VA

Tue, 11 Dec 2007 08:31:10 EST

The widows of five veterans had filed suit against the VA after their husbands had been fraudulently enrolled in clinical trials for cancer drugs at the Stratton VA Medical Center in Albany, NY.

Court documents detail string of lapses at VA hospital

Mon, 10 Dec 2007 12:28:03 EST

The documents from a pending class action suit lay out the story of a research program run amok at the Stratton Veterans Affairs Medical Center in Albany, NY. Transgressions included falsified test results, fraudulent certifications, pressured patients and a seemingly total lack of oversight.

Breast cancer risks have been underestimated

Tue, 27 Nov 2007 11:15:33 EST

A reformulation of the model used by the National Cancer Institute found that the old method almost always underestimated the risk to African-American women, especially those 50 and older. The researcher behind the model says the results are prompting him to develop alternative models for other ethnic groups.

Participants Left Uninformed in Some Halted Medical Trials

Tue, 30 Oct 2007 07:15:20 EDT

Drug and medical device makers will not be forced to disclose the results of clinical trials on some products that never reached the marketplace.

Gene Therapy for 'Lorenzo's Oil' Boys

Tue, 30 Oct 2007 07:14:40 EDT

Doctors use gene therapy to treat two boys with the rare nervous disorder made famous in the film "Lorenzo's Oil".

Muscular Dystrophy Trial to Start

Sat, 20 Oct 2007 11:00:23 EDT

Scientists in London are beginning a gene therapy trial which they hope will extend the lives of patients with muscular dystrophy.

US Laws Tightened to Improve Drug Safety

Mon, 01 Oct 2007 07:03:53 EDT

A new US law will require clinical trials to be registered, their results placed in a public database, and better monitoring for adverse events after drugs hit the market.

Report Assails FDA Oversight of Clinical Trials

Fri, 28 Sep 2007 05:49:17 EDT

The Food and Drug Administration does very little to ensure the safety of the millions of people who participate in clinical trials, a federal investigator has found.

FDA Weighs Flexibility in Trials of Heart Treatment

Fri, 21 Sep 2007 06:57:05 EDT

A panel of experts said federal regulators should relax restrictions on which patients are included in clinical trials of a widely used treatment for a common heart malfunction.

Role of Gene Therapy In Death Called Unclear

Tue, 18 Sep 2007 07:28:35 EDT

Postmortem tests on an Illinois woman who died mysteriously in July after getting an experimental gene treatment show no evidence that she was killed directly by the genetically altered viruses she was given.