Another Child Devloped Cancer: SCID Trials Suspended – ABC Tue, 14 Jan 2003 ABC News reports that the FDA suspended 30 gene therapy trials after a second child developed leukemia. So far, two boys who had undergone the experimental gene therapy treatment for immunodeficiency, “bubble boy disease” — or SCID–developed…
Recent developments in gene transfer research: risk and ethics Mon, 10 Jan 2005 An analysis by Dr. Jonathan Kimmelman, in the British Medical Journal provides an illuminating, clearly articulated discussion about the ethical dilemmas that challenge gene transfer experiments – essentially a kind of human genetic engineering involving somatic cells,…
Bad Medicine – Editorial – Guardian UK Sat, 12 Jun 2004 New York State Attorney General, Eliot Spitzer, is being recognized as a hero on both sides of the Atlantic. That’s because, unlike FDA officials, he knows how to use a “smoking gun” to affect change in corporate practices to…
July 26, 2002 Cancer Trials: 60% to 70% of subjects are children – Wall Street Journal The Wall Street Journal reports that there is a shortage of people volunteering to test experimental cancer drugs. “Overall, only 3% to 4% of cancer patients participate in trials. Most of those participants are…
Risks: Drugs / Vaccines / Trials / Treatment Evidence of antidepressant harm Oct 14, 2005: Andrew Finkelstein Letter to Dr. Russell Katz, Director, Neuropharmacological Drug Products, FDA about FDA’s Failure to Warn about Neurontin-Suicides Aug 29: FDA Response to Utah Court Must Be Truthful Re: Zoloft / SSRI Suicidal Risks…
"UK regulators did not receive findings that might have warned them of damage TGN1412 could do."
“The Drug Trial That Went Wrong” is an investigative report by Chanel 4 (UK) about the circumstances surrounding the near fatal drug trial testing the safety of TGN1412, a monoclonal antibody drug, conducted in March 2006 at London’s Northwick Park Hospital. [1] http://news.bbc.co.uk/go/pr/fr/-/1/hi/health/5377226.stm It airs momorrow.
"As long as we continue to manipulate biology in new ways, we probably cannot prevent all such events from occurring. We must do what we can to minimize risk, but the future health of the world population demands that we not let adverse events put an end to medical progress."
A study published in The Journal of the National Cancer Institute, found that advanced chemotherapy put patients at far greater
risks of harm than adverse effect reports from clinical trial data reveal.
"Risks of anaphylaxis applies to all studies at PAREXEL, with drugs at every stage of development, and the staff are well trained in anticipation of this (unlikely) possibility.
A front page report in The New York Times provides additonal information about the catastrophic TGN1412 medical experiment in which 6 previously healthy volunteers were intravenously injected with monoclonal antibody in a highly risky procedure.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has released an interim report about the near fatal clinical trial of the monoclonal antibody, TGN1412, stating:
