I’m reading through the transcripts from the General Medical Council Hearing on Andrew Wakefield and his colleagues at the Royal Free Hospital. It is long. Very long. Each day runs tens of pages (day 31 is 79 pages alone). Even beyond the bulk of the proceeding I find it difficult reading. I find it very difficult to read about the ethical lapses committed in the name of care of disabled children. Because of that, I quickly moved to a topic I have already written about and one that is less painful to discuss: the patent application Mr. Wakefield submitted on his “transfer factor”.
A thorough discussion of the patent history can be found on Brian Deer’s website. Brian Deer is the journalist who uncovered much of what the GMC was later to pronounce as ethical violations.
The patent is very clear in that it covers both the use of the transfer factor as a therapeutic agent and as a prophylaxis. In other words, Mr. Wakefield patented a treatment and a vaccine. Even though this is painfully clear, Mr. Wakefield has continually denied that the invention was a vaccine.
Day 31 of the hearing went into great detail about the patent. I was surprised to read (or had forgotten had I read before) that Mr. Wakefield applied for the patent without his hospital’s knowledge. This is very odd since the Royal Free was named as the applicant.
Below is a section from a memo, dated March 10, 1998 from Ruth Bishop to Cengiz Altan Tarhah, of University College, London (of which the Royal Free Hospital is a part).
Last summer, Andy Wakefield wrote to the School describing a patent application which he had personally filed along with Neuroimmuno Therapeutics Research Foundation (NIT). This was filed without the School’s knowledge, although in the name of the School. This application concerns the ‘transfer factor’ and Mr Wakefield asked if the School would be prepared to take on the prosecution and costs – he was (and is) meeting these himself.
Applying for a patent without approval from his institution is amazingly foolish. Aside from the obvious chutzpah, it basically invalidates the patent. For most people this would be a remarkable career mistake. While is is serious, it pales in comparison to the many other ethics violations that the GMC found Mr. Wakefield guilty of.
Let’s take a closer look at the question of whether it was Mr. Wakefield’s intent to use the invention, the “transfer factor”, as a vaccine. Mr. Wakefield submitted a business plan whereby he and the father of child 10 (the 10th child in the Lancet study) would develop the transfer factors.
In parallel with the clinical trial the company will develop a clinical diagnostic for the presence of the measles virus. It is estimated that the market for this diagnostic is about £4,000,000 per annum in the UK alone. The company will also investigate the potential of transfer factors as vaccine alternatives. An animal model trial of the value of measles specific transfer factor in preventing inflammatory bowel disease will begin upon securing funding.
Recally, Mr. Wakefield contended that the MMR was causing inflammatory bowel disease. He had plans to test his transfer factor to prevent IBD, not just to treat it.
It was a Vaccine.
Should that language be vague enough for some to still claim Mr. Wakefield didn’t intend on developing a vaccine. Here is a section from the “Strategy and Objectives” section of the business plan:
[Immunospecifics] is at present no more than a concept, but one with a unique opportunity. The strategic goal for the venture will be to achieve full regulatory approval for the use of antigen (infectious agent) specific transfer factors in a variety of clinical conditions where existing treatment regimes are either non-existent or have limited effectiveness. This strategy will permit the company to establish a clear technical and medical lead in this area with a resulting dominant market share. Paralleling the use of [transfer factors] as therapeutics will be a research programme aimed at demonstrating the value of [transfer factor] as a vaccine.
Again–a vaccine in addition to a therapy.
It was a vaccine.
A sub-heading of “Strategy and Objectives” reads: Establish the potential of the high specific active preparations as a potential measles vaccine. It just doesn’t get much clearer than that.
This study will be done in conjunction with ‘Immuno’ a subsidiary of Baxter Health Care, in Austria using simian model systems. The efficacy of the [transfer factor] will be assessed by its ability to prevent measles specific IBD during challenge experiments. ‘Immuno’ have agreed to undertake the preliminary work with the [Royal Free Hospital] at no cost, although Immuno’s contribution is estimated to be of the order of £100,000. If successful this concept will be developed further in collaboration with a major pharmaceutical company, such as Glaxo Wellcome’s Jenner Institute. The full relationship between ISB and Immuno needs to be resolved.”
They planned to develop this with someone like Glaxo Wellcome’s Jenner Institute. That would be a vaccine research group (Jenner being the inventor of the first vaccine, for smallpox, in the 18th century).
Further, the business plan included objectives:
“Medium term objectives for the venture will be: 1) to take the purified and characterised measles specific [transfer factor] through formal product registration by undertaking phase II and phase III clinical trials; 2) establish the most appropriate route for the commercial development of the product; 3) develop the potential for use of [transfer factors] as vaccine replacements; 4) introduce new anti-infectious agents TFs to the company’s product development portfolio and take them through to formal product registration.”
Vaccine replacements. Replacements. Not “we are using the name vaccine to mean a therapy”, but a replacement.
I know I’ve given the evidence a number of times in this post, but I just can’t understand why Mr. Wakefield even tries to deny his intent to develop a vaccine in the true sense of the word.
It was difficult to understand how people believed Mr. Wakefield’s story before. I will be amazed (but not surprised) that they continue to do so.
Just in case you missed it, here is one of the goals for Mr. Wakefield’s proposed company: “Establish the potential of the high specific active preparations as a potential measles vaccine”