Andrew Wakefield patented pregnant goat cure for autism while stoking MMR scare

This page is research from an investigation by Brian Deer for the UK's Channel 4 Television and The Sunday Times of London into a campaign linking the MMR children's vaccine with autism. | Go to part I: The Lancet scandal | Go to part II: The Wakefield factor

As Andrew Wakefield pursued a crusade against MMR, what parents didn't know is that, with the Royal Free's medical school, he was filing a string of patent applications - in the UK, the US, Europe, Canada, Australia and worldwide - claiming to have discovered a competitor vaccine to MMR and treatments, possibly "a complete cure" for inflammatory bowel disease and autism. But the products were based on a fringe theory of transfer factors - developed by controversial eccentric Hugh Fudenberg - and depended on the recruitment of mice and pregnant goats. Below is the Royal Free recipe, extracted from the Wakefield patent applications:

Example 1 - Preparation of DLE

Measles virus-specific TF is made from lymphocytes of BALB/c mice immunised by live or killed virus or an antigen derived from such measles virus.  Isolated cells are freeze-thawed and, following micropore filtration the filtrate is added to an immunologically virgin human lymphoblastoid cell line.  One cell is serially expanded 10-fold with killed measles virus and interleukin-2, to a billion cells.  Measles virus specific TF preparations are made from this expanded cell population.

Cell lysis, dialysis using a 12,500 molecular weight cut-off and a series of concentration procedures results in a TF preparation containing TF and lysozyme.  The molecular weight of each preparation used is between 1,800 and 12,000.  Appropriate biological markers eg lysozyme (MW 11,000), horse myoglobulin (MW 17.7 KD) and human antibody light chains (MW 22 KD) are used as controls to ensure both the recovery of TF and absence of materials greater than 12,000 MW in the final preparation (viruses are hundreds of millions in molecular weight, and reverse transcriptase of retroviruses is 59 KD).

The TF preparation is standardised for potency (vide infra).

The ability of TF to stimulate further TF production, and the cross-species reactivity of TF are subsequently exploited in order to produce large amounts of concentrated TF at low cost.  This is achieved by injecting the TF preparation into pregnant goats 3 times prior to delivery. Colostrums are collected during the first 3 days post-delivery and TF preparations were made from these by micropore filtration excluding molecules >12,500 mol wt.  Following freeze thawing and lyophilising x 3 the preparation is tested for potency as described below and standardised at 200 South Carolina units/ml.

Elsewhere, the patents describe the "dose regimen":

One to up to ten, but preferably three or four capsules (20 S.C. units per capsule) per day should be ingested.