Health officials call for access to unpublished studies during drugs trials

Email this article to a friend

Printable Version

Articles Related to This Article: • Psychiatric Drugs: Chemical Warfare on Humans - interview with Robert Whitaker • The great direct-to-consumer prescription drug advertising con: how patients and doctors alike are easily influenced to demand dangerous drugs • The raw (and ugly) truth about the war on drugs Support NaturalNews advertisers - Advertise with NaturalNews Help support NaturalNews with health books and educational programs from Truth Publishing: • Swine Flu Advanced Preparedness • 8 Weeks to Vibrant Health • Raw In Ten Minutes (recipes) • How to Halt Diabetes in 25 Days ... and much more.

(NaturalNews) A recent drug trial that almost killed six volunteers is being investigated by volunteers who are intent on preventing a repeat of the near-tragedy. The volunteer scientists are part of a group of British-government appointees led by Professor Gordon Duff.

The group has called for tighter controls to ensure no danger signals are missed in the run up to a trial. Specifically, the volunteer group emphasized the requirement to collect safety information from unpublished clinical studies. In addition, information and advice from independent specialist experts should be provided, according to Prof. Duff.

The experimental drug TGN 1412 was given to six men at Norwick Park Hospital in north London this past March. As a result, all men suffered a large variety of side effects -- including pain, vomiting and organ failure. One of the men was described as looking like "the elephant man" after his head became swollen.

Another one of the men lost part of his fingers and toes through a frost-bite reaction to the experimental drug, which was developed by the German biotech company TeGenero. TGN 1412 was designed to treat rheumatoid arthritis, leukemia and multiple sclerosis.

TeGenero's experimental TGN 1412 was meant to subtly "re-tune" the immune system -- but instead, the drug sent the immune systems in the six men into overdrive. Although laboratory and animal tests suggested the drug was safe, all six men almost died from the drug's side effects.

The working group established by Prof. Duff published an interim report in July, and this week's final recommendations broadly confirm the earlier findings -- but call for more changes relating to the medicine's regulator, the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA has been accused of being too lax in its decision to approve the TGN 1412 trial in an effort to get the drug to market faster.

Duff's report specifically states that the MHRA should take independent advice -- possibly from an expert advisory group or medicines commission -- into account in the future before considering approval of all drugs.

###

Share

Get articles like this delivered to you FREE in our popular email newsletter

Related CounterThink Cartoons:

Related Articles: • Psychiatric Drugs: Chemical Warfare on Humans - interview with Robert Whitaker • The great direct-to-consumer prescription drug advertising con: how patients and doctors alike are easily influenced to demand dangerous drugs • The raw (and ugly) truth about the war on drugs	Take Action: Support NaturalNews.com Email this article to a friend Share this article on: NewsVine | digg | del.icio.us Permalink to this article: http://www.NaturalNews.com/021292_drugs_health_drug_studies.html Reprinting this article: Non-commercial use OK, cite NaturalNews.com with clickable link. Embed article link: (copy HTML code below): <a href = "http://www.NaturalNews.com/021292_drugs_health_drug_studies.html">Health officials call for access to unpublished studies during drugs trials</a>