Mr. Wakefield’s business plan as discussed at the GMC hearing.

13 Jan

As Kev has discussed, Mr. Wakefield has put out a press release denying all allegations about research fraud and an attempt to profit from the research he was engaging in. I had hoped to put this all behind us, but I thought for those interested, a more thorough discussion of Mr. Wakefield’s business venture might be appropriate here. I copy below a section of the GMC hearing testimony from Day 31. Mr Cengiz Altan Tarhan, who worked on the finance side of University College London and was brought in to discuss, amongst other things, Mr. Wakefield’s business venture.

Q I am going to be reverting to that role in more detail much later on in the story, but just so everyone knows that is a company that relates to technologies developed by the Medical School, is that correct?
A Not just the Medical School. It is the whole of the university. So it is University College London. The Medical School is a part of the university.

Immunospecifics is discussed below, but it went through name changes, including Carmel. I’ve wuoted a section of testimony below. Questions and answers in the hearing are italicized. The text of the documents is left normal.

The documents discussed involve the plan to spin-out a company from UCL to develop Mr. Wakefield’s invention (as put forth in his patent) into a therapy and as a vaccine replacement.

Q Sir, I am going to call this gentleman from now on in order to protect the confidentiality of the boy, his son, as “Dr 10”. Could we go, please, in volume 2, to page 756a. This is a letter that was sent to you before a meeting. It is from Dr Wakefield to you dated 26 February 1998.

“Re our meeting on Tuesday, 3 March 1997, please find enclosed two references for Alex Korda, our proposed Chairman. I have applied for references for Dr [10], our proposed CEO [Chief Executive Officer], and will pass these on as soon as these are available .

In addition, Dr Kirkpatrick from Denver, Colorado, will be giving a guest lecture on the use of Transfer Factor in the treatment of viral disease on the same Tuesday lunch time in the Department of Paediatric Gastroenterology. I realise that this may be of limited value to you other than reassuring you that Transfer Factor is a credible and rational alternative treatment for viral infections. Dr Kirkpatrick holds certain IPR [intellectual property rights] that may be relevant to our endeavours, and Alex Korda, [Dr 10] and I will be meeting with him to discuss this. I will feed back as soon as I have more information.”

Is that correct?
A Yes.

Q Would you go on to 797, please. That is a memo from you. I am told that is a document that needs to be put back into the bundle. Actually, sir, this is a tranche of documents which goes all the way from 797 to 816. Perhaps I can give them all to you at once so I do not do it piecemeal.

THE CHAIRMAN: I have 797a here.

MS SMITH: In that case you need 797 to precede it and then, after 797a, you go on with the rest of the documents, which go from 798 to 816. Could we go first of all, Mr Tarhan, to 797.
A Okay.

Q This is a memo from you and sent to Mr Dutton, Professor Zuckerman, Mr Blatch and Miss Bishop, dated 6 March 1998.

“Mr Wakefield and potential company proposal

Andy came to see me with two of his colleagues who expressed an interest in setting up a company and acquiring the patents from the School. I asked for some background papers on the two individuals. One is a XXX (10) and the other appears to be an entrepreneur with previous experience with start up companies and is prepared to raise funds for the company.

I have asked them to put forward what they saw as the business plan and way forward and will report back as soon as I have further information.”

Can we then go on to 798. This is your second memo, 6 March 1998, to the same people.

“Further to my memo of 4 March I have now received the attached document from [Dr 10] the Managing Director designate for Immunospecifics Biotechnologies Ltd.

Any comments would be appreciated.”

Attached to that, was there a business plan document?
A That is correct.

Q That starts at page 799. Can I just look in brief terms at the contents of that.

“Immunospecifics Biotechnologies Ltd is a new biotechnology venture specialising in the isolation, production licensing and marketing of a new range of immunotherapeutics, generically known as transfer factors. These compounds are a naturally occurring part of the human immune system and promote specific cell mediated immunity towards the target antigen.

The first clinical condition targeted will be measles virus induced inflammatory bowel disease. It is estimated that this disease costs the NHS about £15,600,000 per annum. The incidence of measles induced inflammatory bowel disease is increasing dramatically in Europe and the States. Immunospecifics … will undertake the start of a two year, double blind, phase 1 clinical trial into the effectiveness of measles specific transfer factor in the treatment of inflammatory bowel disease and an open label study into the effectiveness of the same product in ameliorating pervasive developmental disorder within 3 months of securing funding.

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.

On completion of a successful phase 1 clinical trial the company will move towards phase 2 and phase 3 trials for the measles specific transfer factor whilst introducing new potential transfer factor therapeutics to its development portfolio. Prior to the completion of this first phase trial, the company expects to have finished the laboratory development of the clinical diagnostic, completed the open label study into pervasive developmental disorder and finished the animal study into the potential of transfer factor as a vaccine.

The company is looking to raise about £2,100,000 to undertake this development programme.”

Moving on to page 800,

“THE PRODUCTS

[Immunospecifics] will specialise in the production, formulation and sale of a wide range of immunotherapeutics, generically known as transfer factors (TFs). [Transfer factors] are a naturally occurring component of the immune system which have been shown to confer antigen specific cell mediated immunity. This form of immunity is important in overcoming viral infectious agents. Many viral agents have the capacity to suppress the body’s cell mediated immune system (e.g. Human Immunodeficiency Virus). Overcoming this suppression through the introduction of an antigen specific cell mediated immunity promoter has enormous potential clinical significance.”

Then it sets out the history. Would you go on to page 801, the top of the page and second paragraph down,

“It is [Immunospecifics’] aim to use a high potency, standardised TF preparation in one of the first properly controlled clinical trials of these materials. The target conditions for the trials will be specific forms of inflammatory bowel disease (IBD) and a condition affecting children known as pervasive developmental disorder (PPD). These trials will begin within the first three months of the company’s establishment. Whilst these trials are taking place, the company will be purifying and characterising the active compounds in the TF preparation. Once isolated and characterised, the potential for this molecule as a measles specific vaccine will be evaluated in animal model systems.”

Going on to page 802 and just past the middle of the page,

“STRATEGY AND OBJECTIVES

[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.

The objectives and associated tasks for the first two years to develop the concept into a full-scale venture are summarised in the following points.”

Turning back to page 801 for a moment, Mr Tarhan, and the bottom of the page, the last paragraph reads,

“It is [Immunospecifics’] aim to undertake a phase I clinical trial of a high potency measles specific transfer factor supplied by Fudenberg’s group at a very early stage in the life of the Company.”

Would you turn now to page 804 and this is still under the heading, “STRATEGY AND OBJECTIVES” and to number 7 of 9,

“Establish the potential of the high specific active preparations as a potential measles vaccine

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.”

Going on to page 805,

“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.”

Wakefield says he’s innocent of fraud…in other news sky still blue

13 Jan

And so…

I want to make one thing crystal clear for the record – my research and the serious medical problems found in those children were not a hoax and there was no fraud whatsoever. Nor did I seek to profit from our findings.

Yeah there was. Yeah you did.

“I stand by the Lancet paper’s methodology and the results which call for more research into whether environmental triggers cause gastrointestinal disease and developmental regression in children. In fact, despite media reports to the contrary, the results of my research have been duplicated in five other countries.

Your paper was fatally flawed. Your research has never been replicated.

“It is not unexpected to see poor reporting and misinformation coming from Brian Deer, the lead reporter of the recent BMJ coverage.

Oooooh, biatchy!

But to see coverage in other media that cites Deer’s shoddy journalism in the BMJ as a final justification to claim there is no link between vaccines and autism is ludicrous.

Who did that? I think most journalists made the link between the MMR and autism, not ‘vaccines’ and autism.

The MMR is only one vaccine of the eleven vaccinations on the pediatric schedule that has been studied for causing developmental problems such as autism. That is fact, not opinion.

Studied and guess what – nothing found AJ!

Any medical professional, government official or journalist who states that the case is closed on whether vaccines cause autism is jumping to conclusions without the research to back it up.

Blah blah blah.

“I continue to fully support more independent research…

Quackery…

…to determine if environmental triggers, including vaccines, are causing autism and other developmental problems. The current rate of autism is 1 in 110 children in the United States and 1 in 64 children in the U.K. My goal has always been and will remain the health and safety of children.

No it hasn’t.

Since the Lancet paper, I have lost my job, my career and my country.

Oh stop being a primadonna. Lost your country?

To claim that my motivation was profit is patently untrue. I will not be deterred – this issue is far too important.

Yeah, you need to find a way to recoup all that lost dosh right?

L.A. authorities find first victim in videotaped sexual assaults

13 Jan

The LA Times recently had a story about sexual abuse of disabled women. Ken brought the story here to LeftBrainRightBrain in Videos show rape of disabled women, police seek help to ID attackers. CNN is now reporting that one of the victims has been identified and one suspect is in custody: L.A. authorities find first victim in videotaped sexual assaults.

Investigators have found the first victim in the videotaped sexual assaults of severely disabled women, and the woman alleges a suspect already in custody had raped her in a Los Angeles care home, authorities said.

The woman, 25, now resides in another Los Angeles County residential care facility. Her medical condition causes her to be physically defenseless, Los Angeles County sheriff’s investigators said.

Having found one of the victims, they were able to obtain information on an alleged attacker:

The woman, found by state investigators Monday, made the sexual assault allegation against Ernie Lloyd, 27, who had turned himself in Saturday following widespread media coverage of the videotaped sexual assaults and a manhunt for four suspects depicted in police sketches. Lloyd was charged with rape of a person with disabilities Saturday after he “implicated himself,” authorities said.

Once again, here are the sketches of the attackers:

Majority of Youth with Mental Disorders May Not Be Receiving Sufficient Services

13 Jan

The National Institute of Mental Health in the U.S. posts periodic science news stories. A recent article, Majority of Youth with Mental Disorders May Not Be Receiving Sufficient Services, caught my eye. I’ll quote a few paragraphs here, but it is worth following the link to the short article.

Inequities in service delivery, be it by age, gender, ethnicity, geography or other reason really bother me.

The article starts out:

A substantial proportion of youth with severe mental disorders do not receive mental health care, according to data from an NIMH-funded survey published in the January 2011 issue of the Journal of the American Academy of Child and Adolescent Psychiatry.

and here are the results:

About 36 percent of youth with any lifetime mental disorder received services, and only half of these youth who were severely impaired by their mental disorder received professional mental health treatment. The majority (68 percent) of the children who did receive services had fewer than six visits with a provider over their lifetime.

Service use was highest among those with ADHD (60 percent), and behavior disorders like conduct disorder or oppositional defiant disorder (45 percent). Among those with mood disorders such as depression or bipolar disorder, 38 percent received services, and 18 percent of those with an anxiety disorder received services. In addition, 15 percent of those with a substance use disorder received services, and 13 percent of those with an eating disorder received services.

Girls were more likely to receive services for anxiety disorders, and boys were more likely to receive services for ADHD. Racial and ethnic minorities were less likely than non-Hispanic whites to receive treatment for any mood or anxiety disorder, and less likely to receive mental health treatment in general than their white counterparts.

We as a people need to do better. Times are only getting tougher economically but we have to close the gap on inequities such as this.

The Panic Virus

13 Jan

Seth Mnookin’s book, the Panic Virus, debuted this week. Mr. Mnookin took a look at the vaccine scares and started a two year project of in-depth research resulting in this book. Not too surprisingly, much of his work relates to the autism-parent groups who promote the ideas of an autism epidemic caused by vaccines. Andrew Wakefield and the MMR scare also play a role.

The book is very well written. I believe I have spent more time than most on the subject and I still found a lot of new and interesting information in this book. Mr. Mnookin had great access. He interviewed David Kirby and Lyn Redwood, including a discussion of how the book Evidence of Harm came into being. He spoke repeatedly with Andrew Wakefield. He attended AutismOne. This is not a “Google Ph.D.” research effort. He got down into the trenches and he brings new information to light.

In many ways, the book is a discussion of how people come to believe and promote ideas that are false. Unfortunately for us, vaccine-rejectionists and parts of the autism communities present the best example of this behavior in modern history.

Mr. Mnookin brings an outsider’s eye to the story and comes down clear and decisive that there really is no debate on these issues, no real controversy. The science is in and it is clear.

He also takes journalists to task for being uncritical of the stories presented to them. There is likely no better example of this than how the press treated Andrew Wakefield and his studies, starting with the 1998 Lancet article. Even now we still see a lot of “he said/she said” type reporting on Mr. Wakefield which gives a false impression that the evidence and support for both sides is somewhat equal. Unfortunately, things are getting worse rather than better with time as media outlets downsize and science writers are let go.

This is from the press release:

Seth Mnookin—the New York Times-bestselling author of Feeding the Monster and Hard News (a Washington Post Book World “Best of 2004” selection)—delivers a real-life detective story that exposes what may well be the biggest health scare hoax of all time in THE PANIC VIRUS: A True Story of Medicine, Science, and Fear (Simon & Schuster; January 11, 2011; $26.99). Mnookin, a contributing editor at Vanity Fair with a Harvard degree in the history of science, looks at the bogus vaccine panics—which started with a single, now totally discredited paper linking the measles, mumps, and rubella (MMR) vaccine with autism—that have cost tens of millions of dollars and resulted in the deaths of an untold number of infants and children around the world.

Mnookin explains how dishonest researchers and snake-oil salesmen have taken advantage of desperate parents by perpetrating a fraud, and how the media—by ignoring facts and pretending that all points of view are equally valid—has through its irresponsible coverage fueled a controversy that never should have arisen in the first place. He explores how cultural relativism and insular online communities have blurred the distinction between facts and feelings to the point that the traditional American ethos of individualism has been transformed into one in which individualized notions of reality, no matter how bizarre or irrational, are repeatedly validated. In addition, he gives readers fresh and fascinating insights into the scientific process, the nature of knowledge, and the subconscious forces that drive much of our daily lives.

Why are we so willing to believe things that are false?

Mnookin’s interest in the anti-vaccine movement began in 2008, as a newly married man looking forward to having children, after a series of conversations with parents of young children regarding their anxiety about vaccines and autism. Much to his surprise, a significant number of this group of well educated professionals in New York City had decided to deviate from the recommended vaccination schedule for their children, despite the fact that there is overwhelming scientific consensus supporting vaccination on one side and quack doctors, New Age healers, and celebrities like Jenny McCarthy on the other. The subject took on even greater significance for Mnookin with the birth of his son in 2009.

After he began researching the issue and arrived at the conclusion that there was no evidence supporting a link between childhood inoculations and developmental disorders, Mnookin realized that this pseudo-controversy raised a series of broader questions that go to the heart of social dynamics and human cognition: Why, despite all the evidence to the contrary, do so many people remain adamant in their belief that vaccines are responsible for harming hundreds of thousands of otherwise healthy children? Why is the media so inclined to air their views? Why are so many others so readily convinced? Why are we so willing to believe things that are, according to all available evidence, false?

In an effort to answer those questions, Mnookin interviewed scientists and doctors, healers and mystics, government appointees and elected officials. He also spoke with dozens of parents who watched helplessly as their children withdrew behind a wall of autism. “The suffering of parents who feel unable to protect their children is almost impossible to describe – and helplessness only begins to cover the range of emotions they endured,” Mnookin writes. There was also guilt, resentment, bitterness, isolation, and anger: Surely someone or something was to blame for the ways in which their lives had been upended.

Every year, some two thousand parents of autistic children travel to Chicago for the annual conference of AutismOne, which claims to be the single largest producer of information about the disease in the world. What is paramount for these parents, as Mnookin discovered when he attended, is the sense of support and fellowship they receive. Nevertheless, the organization is relentlessly and virulently antivaccine, with one presenter claiming that vaccines are a “de facto selection of the genetically vulnerable for sacrifice” and calling doctors who administer vaccines the moral equivalent of “the doctors tried at Nuremberg.”

Mnookin writes: “If you assume, as I had, that human beings are fundamentally logical creatures, this obsessive preoccupation with a theory that has for all intents and purposes been disproved is hard to fathom. But when it comes to decisions around emotionally charged topics, logic often takes a back seat to what are called cognitive biases – essentially a set of unconscious mechanisms that convince us that it is our feelings about a situation and not the facts that represent the truth.” These same mechanisms – and the same rejection of the scientific method and the principles of deductive reasoning that have been the foundation of rational society and medical progress since the Enlightenment – are dangerously at work in the so-called debates about evolution and climate change, he suggests.

Brimming with vivid personalities, engaging anecdotes, authoritative science, historical sweep, and plain-English explanations, THE PANIC VIRUS is one of those rare books that entertains at the same time that it illuminates the mysteries of medicine and addresses a subject of vitally important concern to millions of parents, with life-and-death repercussions for everyone else on the planet.

Jenny McCarthy joins the defense of Andrew Wakefield

12 Jan

One of the defenses of Andrew Wakefield is that his paper doesn’t actually claim to have proven that MMR and autism are linked. You can find it in the interviews, you can find it on the Generation Rescue (Jenny McCarthy’s autism organization) website:

The mainstream media is in a frenzy over a new “study” claiming that Andrew Wakefield’s 1998 Lancet paper was fraudulent. For years, the media has mischaracterized Wakefield’s work as implicating the MMR vaccine in the autism epidemic. This was never true, as Wakefield himself wrote in the conclusion to his paper:

“We did not prove an association between measles, mumps, and rubella vaccine and the syndrome described.”

You can find it in Jenny McCarthy’s blog post on the Huffington Post:

Is that the whole story? Dr. Andrew Wakefield’s study of 12 children with autism actually looked at bowel disease, not vaccines. The study’s conclusion stated, “We did not prove an association between measles, mumps and rubella vaccine and the syndrome described [autism].”

And, they are correct. The paper does state that. And it is correct, the study did not prove any link. Which leaves us with the question: how could the press have made such a mistake as to think that the paper supported a link?

For starters, from Andrew Wakefield himself.

From the video that his employer at the time, the Royal Free Hospital put out:

DR ANDREW WAKEFIELD: I think if you asked members of the team that have investigated this they would give you different answers. And I have to say that there is sufficient anxiety in my own mind of the safety, the long term safety of the polyvalent, that is the MMR vaccination in combination, that I think that it should be suspended in favour of the single vaccines, that is continued use of the individual measles, mumps and rubella components.

He called for a suspension of the MMR vaccine at the time. Pretty strong message to send to parents.

In addition, as Jenny McCarthy tries to distance Andrew Wakefield from linking MMR and autism, let’s take a look at her own website, Generation Rescue dot com. They claim that the number one paper that supports the idea that a trigger of inflammation and the current resultant behaviors is the Wakefield 1998 study in The Lancet:

Children with neurological disorders are often suffering from severe gastrointestinal distress and inflammation. A trigger of this inflammation and the resultant behaviors is the MMR vaccine.

We cite four published studies that support this position:

Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children
Lancet 1998 Feb 28 Wakefield AJ, Murch SH, Anthony A, Linnell J, Casson DM, [University Department of Medicine, Royal Free Hospital and School of Medicine, London, UK]

Not surprisingly, the exact same text is included on the “14 studies” website, a site set up by Generation Rescue.

So, according to Generation Rescue, the Lancet article supports the position that the MMR is a trigger, even though the article itself says it doesn’t prove a link.

Generation Rescue and Jenny McCarthy have spent years putting the notion of a link between MMR and autism into the public’s mind. They have relied, heavily, upon the Lancet paper to make this assertion. And now they blame the media for propagating this idea?

Secrets of the MMR scare: How the vaccine crisis was meant to make money

11 Jan

Last week, Brian Deer published an article in the BMJ How the case against the MMR vaccine was fixed. In it he lays out how data were misreported in Andrew Wakefield’s now retracted 1998 article in The Lancet. The BMJ editors published an editorial coincident with the Deer article, Wakefield’s article linking MMR vaccine and autism was fraudulent.

In his latest article in the BMJ, Brian Deer lays out: Secrets of the MMR scare How the vaccine crisis was meant to make money

Andrew Wakefield had plans to make money. A lot of money. He created a business to produce diagnostic testing kits. He applied for a patent for a therapeutic agent and a proposed vaccine to prevent measles infections. This in addition to the money he was collecting as a paid expert to the MMR litigation in the UK.

On the diagnostic testing kit. Mr. Deer obtained the prospectus for the company that was formed to develop and market it:

“It is estimated that the initial market for the diagnostic will be litigation driven testing of patients with AE [autistic enterocolitis] from both the UK and the USA,” said a 35 page “private and confidential” prospectus, which was passed to me [Brian Deer] by a recipient.

He predicted £28,000,000 in revenue from the therapeutic and diagnostic products from his company.

Mr. Wakefield used a laboratory in Ireland, Unigenetics, headed by John O’Leary, to test tissue samples for measles virus. This is well known. Mr. Wakefield was a director of that laboratory.

The work by Unigenetics was key to the company’s success. Mr. Wakefield predicted–apparently in September 1996, before the research was completed–that Unigenetics would provide “unequivocal evidence for the presence of the vaccine derived measles virus in biopsy samples”

“Once the work of Professor O’Leary and Dr Wakefield is published, either late in 1999 or early in 2000, which will provide unequivocal evidence for the presence of the vaccine derived measles virus in biopsy samples,” the prospectus said, “the public and political pressure for a thorough, wide ranging investigation into the aetiology of the bowel conditions will be overwhelming.

“As a consequence of the public, political and legal pressures brought to bear, the demand for a diagnostic able to discriminate between wild type and vaccine derived measles strains will be enormous.”

That paper has since been discredited. First, a major attempt to replicate it failed. More importantly, Stephen Bustin, perhaps the world’s foremost expert on the methodology used (PCR), found that the Unigenetics laboratory’s methods were so seriously flawed as to make any results worthless (good summary here). Also, it was found that PCR data from Mr. Wakefield’s own research group were negative for measles virus, and that Mr. Wakefield buried those negative results.

It was because of these (and more) conflicts of interest that he was let go from the Royal Free Hospital (long before the Brian Deer investigation). Mr. Wakefield’s claim that his departure from the Royal Free was because his “research was unpopular”. Contrary to this position, the Royal Free had offered Mr. Wakefield the opportunity to prove his hypothesis.

But the paperwork does not show this. Despite all that had happened, UCL volunteered to support his work. It offered him continuation on the staff, or a year’s paid absence, to test his MMR theories. He was promised help for a study of 150 children (to try to replicate his Lancet claims from just 12) and, in return for withdrawing from the January London conference, he would be given the intellectual property free.

“Good scientific practice,” the provost’s letter stressed, “now demands that you and others seek to confirm or refute robustly, reliably, and above all reproducibly, the possible causal relationships between MMR vaccination and autism/“autistic enterocolitis”/inflammatory bowel disease that you have postulated.”

Yes, Mr. Wakefield had an offer on the table to take a year to prove his hypothesis. The Royal Free already had their doubts, and even more doubts about Mr. Wakefield’s conflicts of interest. And, yet, it would take a few more years before Brian Deer would make this public.

At first Mr. Wakefield agreed to the Royal Free’s proposal. But he never put the plan into action. When it became clear that he had no intent to follow through, he was let go from the Royal Free.

One defintion I found (the top definition at dictionary.com) defines fraud thus:

deceit, trickery, sharp practice, or breach of confidence, perpetrated for profit or to gain some unfair or dishonest advantage.

As presented last week by Mr. Deer, data were manipulated to “fix” the results of Mr. Wakefield’s research. This week’s installment discloses how Mr. Wakefield sought to profit from this work. Pretty clear to this reader that this meets the definition of fraud.

Here is how the BMJ summarized the article:

Andrew Wakefield, the disgraced doctor who claimed a link between MMR and autism, planned secret businesses intended to make huge sums of money, in Britain and America, from his now-discredited allegations.

The Wakefield scheme is exposed today in the second part of a BMJ series of special reports, “Secrets of the MMR scare”, by investigative journalist Brian Deer. Last week we revealed the scientific fraud behind the appearance of a link between the vaccine and autism. Now Deer follows the money.

Drawing on investigations and documents obtained under the Freedom of Information Act, the report shows how Wakefield’s institution, the Royal Free Medical School in London, supported him as he sought to exploit the MMR scare for financial gain.

It reveals how Wakefield met with medical school managers to discuss a joint business even while the first child to be fully investigated in his research was still in the hospital, and how just days after publication of that research, which triggered the health crisis in 1998, he brought business associates to the Royal Free to continue negotiations.

One business, named after Wakefield’s wife, intended to develop Wakefield’s own “replacement” vaccines, diagnostic testing kits and other products which only stood any real chance of success if public confidence in MMR was damaged.

Documents reveal the planned shareholdings of Wakefield and his collaborators, and how much Wakefield expected to receive personally. Financial forecasts made available for the first time today show Wakefield and his associates predicting they could make up to £28 million ($43,367,082; €33,290,350) a year from the diagnostic kits alone.

“It is estimated that the initial market for the diagnostic will be litigation driven testing of patients with AE [autistic enterocolitis] from both the UK and the USA,” said a 35 page “private and confidential” prospectus obtained by Deer, aimed at raising an initial £700,000 from investors. “It is estimated that by year 3, income from this testing could be about £3,300,000 rising to about £28,000,000 as diagnostic testing in support of therapeutic regimes come on stream.”

Deer’s investigation also reveals today that Wakefield was offered support to try to replicate his results, gained from just 12 children, with a larger validated study of up to 150 patients, but that he refused to carry out the work, claiming that his academic freedom would be jeopardised. His research claims have never been replicated.

There will be at least one more installment in this series by Brian Deer in the BMJ.

Seth Mnookin on CNN “American Morning”

11 Jan

The Panic Virus, a book by Seth Mnookin came out today. Mr. Mnooking was interviewed for CNN’s “American Morning”. I agree with much of what he has to say: the “debate” is not balanced. It’s a few people vs. a ton of data and many more people. It is good that the vaccine-autism hypothesis was tested, but it is time to move on.

http://i.cdn.turner.com/cnn/.element/apps/cvp/3.0/swf/cnn_416x234_embed.swf?context=embed&videoId=bestoftv/2011/01/11/exp.am.intv.holmes.mnookin.cnn

Timeline of MMR scare

11 Jan

From Brian Deer’s latest article in the BMJ“:

Timeline of MMR scare

October 1988: The three in one measles, mumps, and rubella vaccine is introduced to the UK after successful use in the US since 1971. Previously, single measles and rubella vaccines were used, and there was no licensed mumps vaccine

September 1992: The UK Departments of Health withdraw two brands of MMR vaccine after research shows them to be associated with a raised incidence of transient mumps meningitis, although much lower than with natural disease

January 1994: A campaign group, JABS, is launched in Wigan, Lancashire, alleging that MMR causes brain damage and other problems in children. Autism and inflammatory bowel disease are not initially claimed

March 1995: Andrew Wakefield, a researcher at the Royal Free medical school, files for a patent claiming that Crohn’s disease and ulcerative colitis may be diagnosed by detecting measles virus in bowel tissue and body fluids

September 1995: Paediatric gastroenterologist John Walker-Smith moves with most of his team from Bart’s hospital, London, to set up a service at the Royal Free

February 1996: JABS solicitor, Richard Barr, retains Wakefield, at £150 an hour, plus expenses, to support a speculative legal attack on MMR manufacturers. This contract is not publicly disclosed

July 1996: The first child is admitted to the Royal Free for research to try to show a link with MMR. The research is commissioned by, and supported with a £55000 grant from, the UK Legal Aid Board, but this is not publicly disclosed

September 1996: Wakefield and his mentor Roy Pounder meet medical school managers to discuss market projections for a new business based on purportedly diagnosing Crohn’s disease from the presence of measles virus

June 1997: Claiming that the measles virus in MMR causes problems, Wakefield files for a patent on a “safer” single measles vaccine and for products to treat both autism and inflammatory bowel disease. This, too, is not publicly disclosed

February 1998: The Lancet publishes a 12 patient case series by Wakefield and 12 others, proposing a link between MMR and a “new syndrome” of autism and bowel disease. At a press conference, he urges the use of single vaccines instead of MMR

February 1998: Just days after the press conference, Wakefield and business partners meet Royal Free medical school managers to discuss a joint company to develop products based on his MMR claims, including “a replacement for attenuated viral vaccines”

February 1999: Unigenetics is incorporated, with Wakefield and a Dublin pathologist, John O’Leary, as directors. The company is awarded £800000 by the Legal Aid Board to perform tests on samples from children seen at Walker-Smith’s Royal Free unit

December 1999: Mark Pepys, new head of medicine at the medical school, challenges Wakefield about his business scheme and puts him on notice that he must replicate his research

January 2001: The Daily Mail and other newspapers launch campaigns backing Wakefield, working with JABS, after he publishes a purported review of his evidence and repeats his calls for single vaccines

October 2001: Wakefield is asked to leave the Royal Free after failing to mount a large scale controlled study to confirm or refute his claims about MMR

December 2001: Prime Minister Tony Blair is ambushed by Wakefield supporters, who claim that his youngest son, Leo, did not have MMR. The Blairs initially decline to comment but much later deny the claim

May 2002: Amid continuing media campaigns over MMR, particularly by the Mail and Telegraph groups, the magazine Private Eye issues a special edition, written in collaboration with families that are suing vaccine manufacturers

January 2003: Vaccination among 2 year olds falls to 78.9%: below the 92% the Department of Health says is needed to maintain herd immunity. Figures in parts of inner London are half the national rates

September 2003: The Legal Services Commission stops funding for Barr’s lawsuit after barristers for the claimants report to the commission that, on the evidence, they cannot make a case that MMR causes autism

February 2004: The Sunday Times reveals that the Legal Aid Board funded the Lancet research and that many of the children were litigants. Richard Horton, the journal’s editor, rejects more serious charges against the authors, later proved by the GMC

March 2004: Ten of the 1998 paper’s 13 authors, excluding Wakefield, retract its “interpretation” section, which claimed an association in time between MMR, enterocolitis, and regressive developmental disorders

November 2004: Channel 4’s Dispatches reveals Wakefield’s single vaccine patent and that, despite Wakefield’s claims that the culprit for the disorders is measles in MMR, molecular tests in his laboratory found no trace of the virus

January 2005: Wakefield initiates libel lawsuits, funded by the Medical Protection Society, against the Sunday Times, Channel 4, and Brian Deer over Deer’s website, claiming that all allegations are false and defamatory

March 2005: Among much research rejecting any link with developmental disorders and bowel disease, research is published showing that, after MMR was discontinued in Japan, the incidence of autism diagnoses continued to rise

October 2005: In the London High Court, Mr Justice Eady refuses an application from Wakefield to freeze his libel actions and orders him to proceed to trial of Deer’s allegations against his “honesty and professional integrity”

April 2006: As measles outbreaks are reported across Britain, the first death in the UK from the disease in 14 years is reported—a 13 year old boy from the traveller community

December 2006: The Sunday Times reveals Wakefield’s personal funding from Barr to support the lawsuit over MMR: £435643 plus expenses, from the legal aid fund. Some other Royal Free doctors were also paid

January 2007: Two days after the payments from Barr are revealed, the Medical Protection Society stops funding for Wakefield’s libel actions and through him agrees to pay the defendants’ costs of about £800000 on top of its own legal bills

July 2007: At a fitness to practise hearing in London, the General Medical Council opens its case alleging serious professional misconduct by the Lancet paper’s three senior authors, Wakefield, Walker-Smith, and endoscopist Simon Murch

February 2009: The Sunday Times alleges that Wakefield “fixed” the appearance of a link between MMR and autism. He denies fraud and files a complaint with the UK Press Complaints Commission, which he later abandons

February 2009: In the United States, three test case judgments for 5000 claims based on Wakefield’s theories are handed down in federal court, rejecting the allegation that MMR can cause autism. They are upheld on appeal in August 2010

January 2010: A panel comprising three doctors and two lay members gives findings of fact on the GMC’s case, upholding dozens of charges against Wakefield, Walker-Smith, and Murch and sending all three forward for sentencing

February 2010: Six years after the matters were raised with the Lancet, the journal fully retracts the 1998 paper. Horton describes aspects of it as “utterly false” and says he “felt deceived”

May 2010: After a 217 day inquiry, the GMC panel orders Wakefield and Walker-Smith to be erased from the medical register, but notes that Murch had shown “insight” and finds him not guilty of serious professional misconduct

Fact checking the Age of Autism’s defense of Andrew Wakefield

11 Jan

The BMJ article, How the case against the MMR vaccine was fixed, has had a lot of media coverage in the United States. With that coverage has come the defense of Andrew Wakefield, by himself and a few others. As a part of the defense (arguably the bulk of the defense) has been an attack on Brian Deer, the investigative reporter who wrote the article. I say attack because the main accusation, as you will read below, is false. Easily verified as false.

Consider this, on CNN’s Anderson Cooper 360, Mr. Wakefield made the accusation:

WAKEFIELD: Well, that’s interesting you should say that, because he was supported in his investigation by the Association of British Pharmaceutical Industries, which is funded directly and exclusively by the pharmaceutical industry. So…

On CNN with Ali Valshi, Generation Rescue founder J.B. Handley made the following statement:

“The British Medical Journal is only publishing allegations from a single investigative journalist named Brian Deer, who was funded by a pharma front group for four years to investigate Andy Wakefield.”

He later states that Brian Deer was “…funded by pharmaceutical groups from the getgo”.

Where did this accusation come from?

In a blog post, Mr. Handley let’s us know how he came to this conclusion:

In fact, Deer was originally funded to investigate Andy by a front group for the Association of the British Pharmaceutical Industries, just as Andy Wakefield said. From a confidential source:

“Deer was provided with free assistance by Medico-Legal Investigations a company owned and controlled by the Association of the British Pharmaceutical Industry – I have documentation on this. MLI specialise in getting medical doctors prosecuted by the General Medical Council. And that was done before he published in The Sunday Times in Feb 2004.”

We also see the story shifting we also see the story shifting. Instead of “funded from the getgo” or “funded by a pharma front group for four years” we find that he was given “free assistance” We don’t even know how much free assistance.

An unsupported assertion is made that the company is “owned and controlled by the Association of the British Pharmaceutical Industry”.

At least we have something we can verify. A claim like this should be verified, one way or the other. So I did. I contacted Medico-Legal Investigations. I posed a simple question:

You may be aware that Brian Deer has recently published the findings of his investigations showing that Andrew Wakefield committed research fraud in his investigations into MMR and autism. In retaliation, Mr. Wakefield and his supporters are claiming that Mr. Deer is conflicted himself. As part of this, they claim:

“When Brian Deer began his investigation of Andy Wakefield, he was supported by a pharmaceutical front group”

To support this, they claim:

“Deer was provided with free assistance by Medico-Legal Investigations a company owned and controlled by the Association of the British Pharmaceutical Industry – I have documentation on this. MLI specialise in getting medical doctors prosecuted by the General Medical Council. And that was done before he published in The Sunday Times in Feb 2004.”

Can you confirm whether this statement is, in fact, true?

The response?

The statement in bold lettering is totally false. We had no idea he was undertaking this investigation until he was about halfway through. At that point, and knowing that we were the only people in Europe experienced in the investigation of research fraud and misconduct, he contacted us to seek advice on a general issue related to Ethics Committees. We had a one off meeting with him and were able to offer guidance without knowing the details of the confidential investigation. I would like to know how anyone can say we are a pharmaceutical front group – we have always retained our independence.

We have never been owned or controlled by the ABPI – that is complete and utter nonsense. We have been supported by the ABPI and, indeed, the medical Royal Colleges. In order to ease our cashflow crises (there is never enough work to cover the costs of running a business) a few pharma companies paid an annual subscription to us in return for reduced rates for training and investigations. That does not mean that we were controlled by them. I pay annual subscriptions to magazines and get cheaper copies but I do not have editorial control!

Finally we specialise in the investigation of possible fraud/misconduct in research. When we are 70% certain that we have enough evidence to prove serious professional misconduct we report the facts to the GMC who conduct an Inquiry into the allegations. We also investigate other health sector matters and if a criminal offence is disclosed we report to the police or embark upon a private prosecution through the lawyers of our clients (other statutory bodies). The protection of patients is primarily our concern.

I hope this helps

Shall we count the errors in Mr. Handley’s attack?

1) Medico-Legal Investigations had no part in the investigation. They only offered a one-off meeting on medical ethics. Medico-Legal Investigations was unaware of the specifics of Mr. Deer’s investigations.

2) Medico-Legal Investigations is not “owned and controlled by the Association of the British Pharmaceutical Industry”. Thus it is not a “front group”.

3) On top of all that, Mr. Deer was not even funded by Medico-Legal Investigations.

4) The association with Medico-Legal Investigations was a simple meeting, as Mr. Deer was over half way through his investigation. The association was not “from the get go” and was not “four years” (funded or not).

In essence, we see what Mr. Wakefield and his supporters are reduced to: a publicity campaign. Get their message out, accurate or not. Attack the source rather than address the allegations.

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