Navigation Links
Drug Firm Disowns Liability

The German biotech firm TeGenero, the drugs company behind the clinical trial listed its potential side effects on its 12-page document prepared by Parexel. //This consent form listed a side effect which can seriously harm the immune system. The clinical trial left six volunteers fighting for their lives. The consent form the men were asked to sign, which has been obtained by The Observer, warned that a possible effect of the drug was cytokine release. This includes a massive immune reaction to a chemical as it triggers an uncontrollable response from antibodies.

It is otherwise called as a cytokine release or cytokine storm. This can be life-threatening but the form does not spell that out. It is also doubtful whether the doctor heading the trial at Northwick Park Hospital in north London verbally highlighted the specific nature of the cytokine risk to the participants. The form says that that the drug could cause a hives-like allergic reaction. The volunteers were struck down with symptoms within minutes of being injected with the drug. A string of possible side effects are listed on the form, revealed for the first time in this newspaper. The consent form says that the participants may not experience any side effects as the doses used in early human studies are always very small.

But sometimes unintended effects may be encountered during any trial with a monoclonal antibody drug, though they did not occur even at the highest tested doses in animals. The various side effects listed are immunosuppression, autoimmunity, cytokine release, and anaphylaxis. Even the Medicines and Healthcare Products Regulatory Agency (MHRA) which authorised the trial was notified beforehand that there was this risk of cytokine release. The study obtained approval from German and UK authorities.


'"/>




Page: 1

Related medicine news :

1. Ex-workers Ask HLL to Accept Liability for Mercury Deaths
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:5/26/2017)... Abilene, Texas (PRWEB) , ... May 26, 2017 , ... ... released a new publication this week that is focusing on the Peace Agreements being ... begun his Middle East sprint in a race to try to speed up peace ...
(Date:5/26/2017)... ... 26, 2017 , ... Silver Birch of Hammond, a new assisted lifestyle community, ... four acres of land at 5620 Sohl Avenue in Hammond, serves older adults who ... 125 studio and one-bedroom apartments. Each of the private apartments at Silver Birch features ...
(Date:5/26/2017)... (PRWEB) , ... May 26, 2017 , ... Rob Lowe ... An upcoming production of the series is on hiking in American. Viewers can reconnect ... of the great benefits of hiking. , Many consumers have looked for an inventive ...
(Date:5/26/2017)... , ... May 26, 2017 , ... Dr. Alex Rabinovich, ... to announce a new, informational blog post on insurance options. If a Bay Area ... plans may help save time and money. Visiting an in-network provider for a second ...
(Date:5/26/2017)... ... 2017 , ... “When the Stars Lead Home”: a poignant story of loss, ... Laura Weigel Douglas, an avid reader who lives in the Pacific Northwest with her ... Green Hills Adventure Camp. She couldn’t be more grateful. , Twelve-year old Tizzy could ...
Breaking Medicine News(10 mins):
(Date:5/26/2017)... , May 25, 2017  In response to ... , Direct Relief is working with Pfizer to ... available at no cost to community health centers, free ... providers nationwide. "Pfizer has a long-standing ... medicines and ensuring patient safety through educational activities," said ...
(Date:5/24/2017)... 24, 2017  ivWatch LLC today announced the ... Board to enable seamless integration of ivWatch,s groundbreaking ... infusion pumps and other devices. By integrating ivWatch ... to help health care customers deliver a higher ... to IV therapy. "The ivWatch OEM ...
(Date:5/23/2017)... PLEASANTON, Calif. , May 23, 2017 /PRNewswire/ ... world,s most innovative medical devices for pressure ulcer ... at the American Association of Critical Care Nurses, ... Houston May 22-25. The Leaf Patient ... designed specifically for the hospital environment.  The system ...
Breaking Medicine Technology: