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.
Emphasis added.
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.
Emphasis added.
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.”
Emphasis added.
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”
Left Brain Right Brain 
Uhm, typo? Missing word?
Even though this is painfully clear, Mr. Wakefield has continually denied that the invention as a vaccine.
Liz Ditz,
thanks for the correction. “…was a vaccine”
Well done for slogging through the transcripts Sully [thumbs up].
And?
If he did or did not have a vaccine, what does that matter? I wish you would put this much scrutiny for Mr. Paul “For Profit” Offit. Then we may actually start getting somewhere.
I expect to see a story discussing all of the conflicts of interest with Paul Offit next. Then we can compare who has more interest in the matter.
Here you go Ken:
Q: Has Andrew Wakefield consistently lied about his vaccines patent?
A: Yes.
Q: Has Paul Offit?
A: No.
Ken,
I have repeatedly discussed Paul Offit’s patent situation. When I pointed out to Mark Blaxill and Dan Olmsted that they made some very large mistakes and that those were easily confirmed (which begs the question as to why an intellectual property expert and an investigative reporter couldn’t find the information in the first place) I was basically informed that the incorrect information would remain in place until such time as Paul Offit met their demands.
That all said, why does this matter?
Because, Mr. Wakefield failed to act ethically. He failed over and over and over. The patent and his business interest represent just a few of his failings.
He misled the public when he went into his press conference and into the public eye multiple times after that. He misled the public that his intentions were untainted by conflicts of interest.
How much publicity would Mr. Wakefield have gathered as an entrepreneur who stood to gain financially in multiple ways from his research? Besides his patent, he was also working as a consultant to the UK litigation, racking up hundreds of pounds an hour.
Let’s say that you are right and Paul Offit is horribly conflicted and is making his statements only to profit. Even though it isn’t born out by the facts, lets say it. Would that excuse Andrew Wakefield?
Wakefield changed his commentary day by day as the hearing went on, adding whatever he thought. The denials of what is clearly evident in print was the end for him as he could no longer argue he had not misled his medical team, the medical school, the University and in the end his own legal team, attempting to hide behind semantics as a defence is not a good move in a legal hearing
“attempting to hide behind semantics as a defence is not a good move in a legal hearing
Um, wouldn’t that depend on what your definition of IS is? 😉
Sorry, American joke, a reference to Clinton.
Are the transcripts and exhibits online? And if so, where?
Thanks.
Well, I guess that was an attempt at a tu quoque fallacy but Ken even failed at that. This blog has scrutinised Dr. Offit’s openly declared conflicts of interest and profit from his institution’s patent sale. What is your point exactly? Does Dr. Offit somehow own or has generated all the vasts amounts of scientific studies that demonstrate Wakefield’s fraud? Is he somehow responsible for the grotesquely unethical behaviour that Wakefield is guilty of?
I don’t expect to see your head extracted from your posterior any time soon Ken.
@Science Mom and Sullivan,
I certainly assumed (which we all know what that does) that Offit was held in a different regard on this blog and I certainly apologize for that. This was the first time I really came across anything from this blog, so please excuse the ignorance. I am glad that you all are taking a balanced approach to these issues.
For me, he has been consistent in stating that he wanted an option for the MMR vaccination. Parents SHOULD have a choice at getting these shots singularly. Where is the harm in that? Other than affecting the MMR manufacturer’s bottom line, this is still accomplishing the goal in vaccinating. Without really looking into Wakefield’s patent, I believe it was a ‘treatment’ or a single Measles vaccine. How does this make him the monster that is portrayed in the media?
By suggesting that he was bending the truth behind his intentions, are you suggesting that the results of his study were falsified?
Are you also suggesting that Brian Deer was genuine in his intentions with the witch hunt against Wakefield?
If Wakefield didn’t mention the MMR vaccine in his initial study, he would still have his license.
Ken,
Mr. Wakefield is not a “monster”. He is a former surgeon/former academic researcher who made multiple lapses in judgment and ethics. His patent activities are only one example out of many.
I’ve been meaning to write a post describing exactly this. There are so many details, so many lapses, that people often loose track of the big picture–the man was unethical. His ethical lapses put people at risk.
I’ll happily suggest the results of his study were falsified. I’m not sure he lied exactly – although he does have a track record of lying – but the results were false.
Results were not false
They were wrong. And Wakefield either knew they were wrong or he was grossly incompetent.
Or both.
Why don’t you correct us and tell us which version of the MMR vaccine Wakefield was studying. In 1988 the UK introduced three different MMR vaccines, but withdrew two in 1992. One of the kids in the case series was American to had the version introduced in 1978 in the USA. So which of the four was the study about? Provide verifiable evidence to support your answer.
@Ken – Re separate M,M and R vaccines
————-
There may be a shortage of MMR vaccine. The CDC price for MMRII vaccine in the US is 18.63 per dose. Two doses are needed. That’s really cheap for a vaccine that covers three diseases. Merck was hoping to make money on its MMRV vaccine, but it appears to cause less problems if given as MMR and V.
There isn’t a high demand in the US for separate M, M and R vaccine which is part of the reason Merck stopped making them when they ran into production issues.
Then there is the great benefit of fewer doctor visits and getting over the vaccines most likely to cause short term adverse events (the attenuated vaccines) at one time. Doing it three times, when it isn’t necessary, doesn’t benefit children.
By having separate vaccines, you are going to lower the rate of vaccine use as parents are going to pick and choose and also just have the problem of coming in for separate shots.
There’s also the problem of actually getting single disease vaccines when they aren’t normally stocked by doctors.
Finally, MMR is a way to prevent those concerned with the abortion origin of the Rubella vaccination of not vaccinating their children. The Rubella vaccination of infants is problematic in that Rubella is a very mild disease in infants. And that it isn’t given to benefit infants. It is given universally to prevent the infection of pregnant women with Rubella, because the results are often devastating. The alternative of vaccinating girls and women was tried in the UK. When compared to universally vaccinating infants in the US, the UK approach came a very poor second.
Quite simply there just isn’t a benefit in terms of safety of separate M, M and R vaccines. The only possible reason for separate vaccines would be if the Mumps strain wasn’t one that didn’t cause excess cases of aseptic meningitis. But even then, aseptic meningitis from mumps vaccine isn’t nice, but it doesn’t cause long term damage. MMRII used in Canada, the US and the UK (when available, which it isn’t now) uses Jeryl Lynnn isolates. Priorix, the only one currently available in the UK uses Schwartz strain which is based on one of the two isolates in Jeryl Lynn. Neither Jeryl Lynn nor Schwartz cause excess cases of aseptic meningitis.
Frankly, I think Hillemann’s development of MMR and its successor MMRII was a great idea.
Kev – Wakefield’s greatest sin was lying about the children were selected for the study. If he had told the truth, then no one would have paid much attention. And it wouldn’t have made into the Lancet.
The lie in the paper was important enough that Wakefield repeated in a response to question that was published in The Lancet. He also repeated it at a scientific meeting called to discuss his paper.
Wakefield maintained that the measles, and only the measles portion of MMR caused the autistic regression he has written about. So doesn’t it seem a bit hypocritical to develop a patent for the one vaccine virus that he claims causes all of this autistic regression while demonising his perceived competition? MMR sold as monovalents would also be more expensive so would increase the manufacturer’s bottom line. But there wasn’t the demand so what does that tell you?
I have no problem with stating that he intentionally falsified his results, repeatedly. His own graduate student (at the time), Nicholas Chadwick demonstrated to him that the PCR results of measles vaccine virus was contamination. Wakefield also employed the poor quality laboratory of John O’Leary’s Unigenetics to perpetuate his fraud. This isn’t how rigorous science is performed.
Why is it a witch hunt against Wakefield? Mr. Deer found an interesting story and turned out to be bigger than anyone expected. If Wakefield was so squeaky-clean and conducted himself in an ethical manner, it would be a non-story. You should be more upset at being duped by Wakefield, not at the bloke who discovered his fraud.
No, If Wakefield hadn’t committed so many ethical lapses in his quest, he would still have his license. He has only himself to blame.
“witch hunt” is a term used when the subject of the investigation is innocent, and evidence is fabricated, similar to the witches of Salem.
Mr. Wakefield was not innocent. Brian Deer uncovered this. The GMC confirmed it. The transcripts support it.
Sheldon101,
I do not believe the transcripts are publicly available. LBRB has obtained them though.
Ken:
The problem was that Wakefield advocated separating the vaccines by a year. Since the earliest a child gets any of those vaccines is when they are over a year old, that means the vulnerability to mumps or rubella is up to at least age three.
How does that work? How does offering two vials of a vaccine bring in less money than six?
The costs to prepare 3 separate vaccines are higher than to prepare a single multivalent vaccine. The viruses are all grown separately, but the final vaccine preparation has to be tested individually. That is the big cost. Test each of 3 vaccines for potency and side effects in humans, or test a single multivalent vaccine for potency and side effects.
the point is is that we already HAD the 3 single vaccines and they were being administered. Then Merck came out with the 3 in 1.. How can you believe the PHARMACUETICAL company’s claim that “there was not the demand for the single vaccines” ? They could just be telling you that. Parents pretty much go by the recommendations given by their doctor. We all know that doctors are unduly influenced by the pharmacuetical companies to PUSH a specific drug. Furthermore, you yet again bring up COST. What is the cost to society now that we have a devastating rate of autism? I mean, the arguments that is is more expensive to develop and create them singly so lets all be efficient and just do it in one shot is a lazy solution, and dangerous, especially when you are talking about something like vaccines. You are playing with peoples lives all because of the “cost” factor. Ridiculous.
It’s 20 years since Wakefield did his crap research. Time and again he’s been shown to be a liar and a charlatan. But time and again he has shown that people like Margaret Barr will repeat his lies.
Guess what–Wakefield had a huge conflict of interest while he was doing that junk science. Actually many conflicts of interest. He was a greedy scumbag. Still is. But, hey, he can always count on fans to keep him and his stories alive.
Something that has been overlooked in all of this is that Dr. Wakefield’s “treatment” for (mythical) persistent measles infections (which he presumed, despite data to the contrary, caused both autism and inflammatory bowel disease) was transfer factor.
Transfer factor – or “dialysable leukocyte extract” – has long been touted as an “immune modulator” and reportedly has the ability to “transfer” immunity from an immune animal to a non-immune animal (ergo the name).
Unfortunately, there hasn’t been a lot of research into what transfer factor actually is or in how it works – or even if it works. What little clinical research has been done on transfer factor comes from a small cadre of researchers and very little of that has been done recently. Dr. Wakefield seems to have largely taken it as a matter of faith that it would work against measles, although there appears to be only a single case series (uncontrolled, open-label use in 10 critically ill children) supporting its use.
I’m not sure that you could call transfer factor a “vaccine”, even though Dr. Wakefield used that term – erroneously – in documentation surrounding his patent. Whether or not Dr. Wakefield thought of it as a vaccine is relevant only in terms of his veracity, which needs little additional condemnation. It seems more likely that transfer factor works – again, if it works – as a non-specific pro-inflammatory agent. If that is true – and it seems to be the general consensus – it would seem to be a poor treatment for chronic inflammatory illnesses.
Thus, to Dr. Wakefield’s long list of failings we may have to add “not understanding what he was proposing to do to patients”.
Prometheus
What’s the source for the claim that Wakefield wanted the 3 vaccines separated by a year? And what exactly was he proposing?
I think he would have stuck with measles at 1 years.
I’ve just, heaven forbid, been at whale.to and seen the Mumpsvax monovalent and it too is not recommended before 12 months.http://www.whale.to/v/mumpsvax.html
I’ll guess that rubella is the same.
So measles at one year, mumps at 2 years and rubella at 3 years. So you would bring back mumps and rubella.
Prometheus,
Professor Sir Peter Lachman (http://en.wikipedia.org/wiki/Peter_Lachmann) testified at the GMC hearing. He had this to say about the transfer factor that Mr. Wakefield proposed in his patent:
“This is a completely novel and otherwise undescribed method of making transfer factor, and it goes from being merely eccentric to being totally bizarre.”
The good professor also noted:
“However, he then says that he is expanding this transfer factor. He does not claim that he is using the measles virus to immunise these cells, and indeed you cannot do that, because that is quite a difficult thing to do and needs other cells in vitro. So he is claiming that he can get these cells to make this transfer factor in what is in fact an hereditable fashion – that he somehow gets it into their genome – because otherwise by the time you have expanded them a billion times there would be nothing left. So that would suggest to me that he thinks this is an integrating virus, which with the size it is it really cannot be.
Having made this material, he then says he can amplify further what is now a protein, or a protein with a few RNA bases on it, by injecting it into a goat. If you inject it into a goat you may make antibodies to it, but you cannot cause it to replicate itself. The only proteins that are known to replicate themselves after injection into somebody are prions, and (a) I am quite sure he would not want to believe these are prions; nor is there the slightest reason to believe that there is any prion material in here. So it is very difficult just from an ordinary understanding of cell biology and molecular biology to understand how he can think he can be replicating this factor in the mouse, and get goat colostrum.”
In documents submitted to the Royal Free before the publication in the Lancet, Mr. Wakefield described transfer factors as
http://briandeer.com/wakefield/wakefield-patents.htm
having a potential use as “an agent of immunization”.
He submitted the patent without the Royal Free’s knowledge. The language about the vaccine was not something the hosptial added to broaden the scope of the patent (not that Wakefield ever said that). Mr. Wakefield had to have full knowledge of what was written.
Sheldon 101,
in the video press conference for the Lancet paper:
http://briandeer.com/wakefield/royal-video.htm
He doesn’t say to separate by a year (at least at that point in history) but to space them over time.
“Well I think it’s a very complex question. Certainly if you continue, as I would recommend to use the single vaccine, you do not incur a greater risk of those diseases in the children, so that you do not lose the benefits of vaccination if you space them over time.”
Sullivan: About the transcripts, I can’t figure out who I should contact. Drop me an email at XXXX leaving out the bananas. Thanks.
[note: I edited this to remove the email address. Sullivan]
Sheldon101:
Bad Science by Ben Goldacre, 2nd edition (paperback with Rath chapter), page 297:
Unfortunately, he did not put the source of that recommendation in the notes at the end of the book.
Apparently it was a recommendation that many anti-vax folks were taking as from Wakefield. In looking for his actual quote (which must be in a video, and I do not have the time or inclination to sit through any of them, especially the interviews with Mercola), I found a comment by Yazbak on (oh, I am going to regret this… laugh all you want… via whale.to) at http://www.bmj.com/content/329/7477/1293.1/reply#92190 :
I’m confused, you’re saying Dr Wakefield applied for patent using the institutions name, but if he was trying to make money on this, why would he put it in the institutions name? Just trying to get clarification on the implication that he was benefitting personally from this. Thanks so much!
Also, again, just trying to get my facts straight… What I’m seeing in this article is that the patent was for a treatment, but they intended on looking at it as a possible replacement vaccine in the future as part of the plan, but had no scientific research suggesting that this factor would even be able to be used a vaccine, and it was just a possibility, is that right? If so, why do you suppose he wld deny that because, playing the devils advocate here, I don’t see why this patented treatment that has “potential” to replace a vaccine (that they are claiming would be better for kids) is damning? Am I missing something?
“I’m confused, you’re saying Dr Wakefield applied for patent using the institutions name, but if he was trying to make money on this, why would he put it in the institutions name? ”
Because he was contractually obligated to. Beyond that, leaving out the fact that the patent would be assigned to his institution would invalidate the patent.
Researchers in academic institutions (such as his hospital) are paid a portion of the royalties that patents generate. So he was still in line to make money from it. He had a business plan (discussed in detail at the GMC hearing) in which he laid out his plan to profit from this invention and other aspects of his work.
“What I’m seeing in this article is that the patent was for a treatment,”
It was a patent for a vaccine and a treatment. Claim 2 of the patent is for a vaccine.
“but had no scientific research suggesting that this factor would even be able to be used a vaccine, and it was just a possibility, is that right? ”
He had no research to show it would work as a treatment either. That’s part of where he got into trouble–he tried to get that data by subjecting a disabled child to this “treatment” without ethical approval.
Wakefield claims the patent was only for a treatment. He’s lying. The patent is clearly for both a treatment and a vaccine. He started this lie before the GMC hearing. At the GMC hearing it was made public that his business plan included investigating the invention as a vaccine. So he clearly understood at the time that he was patenting a vaccine.
So the fact Paul offit the “vaccinate your child cos they’re harmless” person ….
[edited to remove anti-vaccine nonsense.
Go away “Sa Jarvis”]