U.K. - Company Knew of the Catastrophic Risk--so did the British Medicines Autho

[Guest guest]

SSRI-Research@

Sun, 09 Apr 2006 17:34:32 -0000

[sSRI-Research] AHRP - Company Knew of the Catastrophic

Risk--so did the British Medicines Authority

 

 

 

 

 

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting Openness, Full Disclosure, and Accountability

http://www.ahrp.org/cms/

 

FYI

 

" 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. Anaphylaxis could occur

any time you encounter any new drug, cosmetic or even foodstuff in a

restaurant (peanuts and shellfish are famous for causing it). "

 

That statement appears on the TGN1412 Informed Consent document (a

copy of the single page " possible side effects " was received by AHRP).

 

In the " possible side effects " section, the consent document begins by

assuring volunteers: " no significant side effects have been seen in

animal studies...Expert advice from immunologists has been sought in

designing the protocol to minimize risks. "

 

The document goes on to disclose the " very unlikely " possibility of

" immunosuppression " " autoimmunity " and " cytokine release " which is

described as " (causing hive-like allergic reaction). "

 

As TGN1412 documents are made public, it is apparent that UK

government officials of the Medicines and Healthcare Products

Regulatory Agency (MHRA) did not tell the truth when they declared (in

their interim report) that the catastrophic recation by all six

previously healthy volunteers who suffered a " cytokine storm " (or

massive autoimmune reaction) almost the instant they were exposed to

this monoclonal antibody was " unpredicted biological action of the

drug in humans is the most likely cause of the adverse reactions. "

 

The UK Observer reveals: " It emerged this weekend that the Medicines

and Healthcare Products Regulatory Agency (MHRA) which authorised the

trial was notified beforehand that there was this risk of cytokine

release. TeGenero did tell the agency of a previous incident

involving a similar drug which had provoked a serious adverse reaction

in human volunteers. "

 

Approval of the experiment violated the principles of the Nuremberg

Code that stipulated that an experiment such as TGN1412 could ONLY be

performed if the human subjects were investigators themselves:

" No experiment should be conducted where there is an a priori reason

to believe that death or disabling injury will occur; except, perhaps,

in those experiments where the experimental physicians also serve as

subjects. " Nuremberg Code, principle #5

 

Britons are calling for " a fully impartial investigation not only of

the MHRA but of the Research Ethics Council for allowing six

(previously perfectly healthy) volunteers to enter into a potentially

lethal clinical trial. "

 

Indeed, the MHRA handling of the catastrophic experiment validates the

conclusion of a major parliament report exactly one year ago in April

2005: House of Commons Health Committee The Influence of the

Pharmaceutical Industry Fourth Report of Session 2004-05.

 

The committee expressed concerns about the MHRA evaluation of clinical

trials, identifying the overly cozy relationship between the

regulator and the pharmaceutical industry, recommending that the MHRA

needs to play a greater role during the early stages of drug

development.

 

" The organisation, process and techniques of the MHRA are focused on

bringing drugs to market fast, " parliamentarians found.

 

" The organisation has been too close to the industry, a closeness

underpinned by common policy objectives, agreed processes, frequent

contact, consultation and interchange of staff.

 

" We recommend that more research be undertaken into the adverse

effects of drugs, both during drug development and medicines licensing. "

 

See:

http://www.publications.parliament.uk/pa/cm200405/cmselect/cmhealth/42

/42.pdf

 

An investigation by the MHRA of itself makes a mockery of independent

checks and balances--and will have no credibility with the public.

 

 

Contact: Vera Hassner Sharav

212-595-8974

veracare <veracare

 

http://observer.guardian.co.uk/uk_news/story/0,,1750055,00.html

 

 

 

 

 

Drug-Free School Zone? Just Say NO to Prozac for Children.