Site Archives clinical trials

Experimental therapies for Parkinson’s disease: Why fake it?


How ’sham’ brain surgery could be killing off valuable therapies for Parkinson’s disease.
[Nature] Peggy Willocks was 44 when she was diagnosed with Parkinson’s disease. It progressed quickly, forcing her to retire four years later from her job as a primary-school principal in Elizabethton, Tennessee. Soon, her condition had deteriorated so much that she was often [...]

New rules needed to weed out Big Pharma’s unethical ’seeding studies,’ says U bioethicist


[MinnPost]- In July, the federal government proposed new rules governing the protection of human participants in medical studies.
But as University of Minnesota bioethics professor Carl Elliott notes in a commentary published Friday in the New York Times, those rules will do nothing to protect people who volunteer for medical studies from an unethical marketing ploy [...]

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 [...]

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 [...]

FDA panel advises caution on personal genetic testing


[LA Times]- A Food and Drug Administration advisory panel said Tuesday that genetic tests directly marketed to consumers should be allowed only under a doctor’s supervision.
Personal testing, which is mainly available online from firms operating outside traditional medical institutions, can produce ambiguous or misleading results without proper analysis, panel members said.
“I would suggest that we [...]

Bioethics Panel Told No Guarantee Against Unethical Research


[Huffington Post]— Experts say that the kind of unethical medical studies that occurred half a century ago could still happen again despite more than 1,000 rules and regulations that should prevent such abuses.
Bioethicists and researchers spoke Tuesday before a presidential panel in Washington. The meeting was triggered by the government’s apology last fall for federal [...]

Eli Lilly Alzheimer’s Drug Made Patients Worse


[Forbes]-Patients taking an experimental Eli Lilly Alzheimer’s treatment worsened faster than those on placebo. The treatment also apparently caused skin cancer. Lilly says it will stop developing the drug, but will keep working on another, different Alzheimer’s treatment.
The result is another setback for Alzheimer’s research and should probably make scientists and investors think again about [...]

Glaxo to Take $3.49 Billion Litigation-Risk Charge .


[WSJ] GlaxoSmithKline PLC said it will record a £2.2 billion ($3.49 billion) charge for the fourth quarter to cover costs relating to a U.S. investigation of its marketing practices, as well as additional costs tied to consumer lawsuits over the diabetes drug Avandia.
The amount is the latest in a series of large charges the U.K. [...]

US army studies malaria vaccine


[theworld.org] Early on a cold fall morning, a dozen volunteers gathered in a waiting room at the Walter Reed Army Institute of Research outside Washington, D.C. They had come to test an experimental malaria vaccine.
The volunteers included college students, Walter Reed employees, and a 41- year-old single mother from Baltimore named Renee Krueger.
Krueger said she [...]