CALLING FOR AN IMAPARTIAL INVESTIGATION INTO THE MHRA & REC

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) Promoting Openness, Full Disclosure, and Accountability http://www.ahrp.org/cms/

"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 one 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 will have no credibility with the public.

Contact: Vera Hassner Sharav
212-595-8974
veracare@ahrp.org