In the recent Dateline NBC episode about Dr. Wakefield, Matt Lauer asked Dr. Wakefield about his patent activities.
As a bit of background: before Dr. Wakefield’s 1998 Lancet article was published, his hospital, the Royal Free, had submitted a patent application for an invention of Dr. Wakefield’s. The application was titled, “PHARMACEUTICAL COMPOSITION FOR TREATMENT OF IBD AND RBD”
IBD is “inflammatory bowel disease”
RBD is “regressive behavioural disease” “(also referred to as pervasive developmental disorder)”
(definitions taken from Dr. Wakefield’s Great Britain patent application 2,325,856)
As you might assume from the title, the patent has as a main thrust the idea that certain transfer factors could be used therapeutically. In other words, the main point appears to be to use this as a treatment. This does not exclude the fact that the patent also includes a claim for a classic, preventive vaccine.
The original patent application, filed June 6 1997 (before Dr. Wakefield’s first autism paper in The Lancet), is shown on Brian Deer’s website.
There are nine claims to the patent. Eight of which relate to the proposed treatment. Claim two, however, states:
The composition according to claim 1 adapted for use as a vaccine for the prophylaxis of measles virus.
Prophylaxis, of course, meaning to prevent.
The existence of such a patent application raises the obvious question of conflict of interest. In other words, was there the possibility that Dr. Wakefield’s invention could result in royalty payments to Dr. Wakefield for a vaccine? Could he profit from what amounts to a single vaccine for measles (as opposed to the combination virus MMR vaccine)?
Dr. Wakefield in a previous statement (again hosted on Brian Deer’s website):
The reference to the possible use of TF [transfer factor] to protect children against measles infection – the thrust of the Sunday Times’ conspiracy theory – was put in as an afterthought in the patent. It was entirely speculative and never pursued in any shape, manner or form.
The provisional patent filing was entirely speculative and was for a possible therapy; as such, it had no bearing on the 1998 Lancet paper.
Note that Dr. Wakefield acknowledges that his invention was claimed to be able to protect against measles infection. As we will see below, this is in direct contrast to his statements on Dateline.
Before we delve into that, I must strongly disagree with Dr. Wakefield as to whether this had bearing on the 1998 Lancet article. Part of the patent application clearly claims the use of the invention as a vaccine. Whether the invention was speculative or that the main use was as a therapy is immaterial. The appearance of a financial conflict of interest should have been reported to The Lancet, the referees, and to the press, in my opinion.
In his statement, Dr. Wakefield goes on to say:
It constituted no potential conflict until the patent was awarded.
Again, I strongly disagree. If the patent was a potential conflict of interest, so was the application. Both are a potential to profit.
Also, if the patent itself is a potential for profit, how can one justify the previous argument that the application was not a conflict since it was merely “for a possible therapy”? Again, if the language of the patent was a potential conflict due to the inclusion of the vaccine, the application was a potential conflict as well.
So, after that long introduction, what did Dr. Wakefield have to say to Matt Lauer?
Dr. Wakefield is back to denying that the invention was for a vaccine to prevent measles and is claiming it as merely a therapeutic agent.
But as we have already seen above, this is not what the patent states. This isn’t even consistent with Dr. Wakfield’s own previous comments.
Here is the section where Matt Lauer of Dateline interviewed Brian Deer on the topic:
First impression: Matt Lauer’s team messed up with the statement that the vaccine was “for the elimination of MMR”. I heard that statement as though the purpose of the Wakefield vaccine was to eliminate the MMR as a vaccine. The wording of the first sentence of the patent application is:
The present invention relates to a new vaccine for the elimination of MMR and measles virus and to a pharmaceutical composition…
I read this as the vaccine for the elimination of the MMR viruses from someone with a persistent infection of one or more of measles/mumps/rubella, not as for the elimination of the MMR vaccine itself.
It is not well worded.
The statement from the patent application that most clearly shows that it covers the invention as a vaccine is claim 2. It is short, clear and direct to the point.
The composition according to claim 1 adapted for use as a vaccine for the prophylaxis of measles virus.
This is what Dateline should have used, in my opinion.
I think the segment below clearly shows that part of the intention of the invention was as a vaccine for the prevention of measles which is purported to be safer.
Back to the interview, I think that Mr. Deer makes a key point in stressing that the patent application discussed the invention as a “safer” vaccine. This makes it more clearly a possible contender to replace the MMR vaccine as a product.
Brian Deer notes on his website:
A letter from his lawyers dated Jan 31 2005 said: “Dr Wakefield did not plan a rival vaccine.”
It is very difficult to ascertain intentions. At a very real level, what Dr. Wakefield planned is immaterial. The fact of the matter is that there was a possibility (however remote) that Dr. Wakefield could profit if the combination MMR vaccine were removed. The appearance (at least) of a potential conflict of interest was there and should have been disclosed in the paper and press conference, in my opinion.
The information I would like to see on this would be Dr. Wakefield’s lab books (or notes, as the case may be). In particular, he is reported to have applied his “transfer factor” on at least one child. Were there any tests performed (say, measles titers?) that could have been used to justify development as a vaccine? For example, measles titers?
It is also worth noting that as far as I can see, all of the patents on this potential vaccine have been abandoned. In other words, Dr. Wakefield and/or the Royal Free Hospital do not appear to have continuing financial interests in the proposed measles vaccine, or the IBD/autism therapy.
As a final word–I find it interesting that in one of the patents Dr. Wakefield states that that the autism prevalence is about 1%. This from a document dated 1998, 10 years ago. So much for that epidemic, eh?



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