Archive | January, 2011

Andrew Wakefield’s erasure from the UK medical register is complete

19 Jan

This just isn’t Andrew Wakefield’s week. Last year the General Medical Council (GMC) in the UK found Andrew Wakefield guilty of multiple counts of improper conduct. These include subjecting disabled children to invasive tests that were not in their clinical interest, placing children in a research program without first obtaining the safeguards of ethical approval, financial and commercial conflicts of interest as well as other breaches of ethical conduct.

Here is one example paragraph from the sanction of Mr. Wakefield:

With regard to nine of the eleven children (2,1, 3, 4, 6, 9, 5,12 and 8) considered by the Panel, it determined that Dr Wakefield caused research to be undertaken on them without Ethics Committee approval and thus without the ethical constraints that safeguard research. Ethical constraints are there for the protection both of research subjects and for the reassurance of the public and are crucial to public trust in research medicine. It was in the context of this research project that the Panel found that Dr Wakefield caused three of these young and vulnerable children, (nos. 3, 9 and 12) to undergo the invasive procedure of lumbar puncture when such investigation was for research purposes and was not clinically indicated. This action was contrary to his representation to the Ethics Committee that all the procedures were clinically indicated. In nine of the eleven children (2,1, 3, 4, 9, 5,12, 8 and 7) the Panel has found that Dr Wakefield acted contrary to the clinical interests of each child. The Panel is profoundly concerned that Dr Wakefield repeatedly breached fundamental principles of research medicine. It concluded that his actions in this area alone were sufficient to amount to serious professional misconduct.

The sanction includes the determination that Andrew Wakefield should have his name erased from the medical register:

Accordingly the Panel has determined that Dr Wakefield’s name should be erased from the medical register. The Panel concluded that it is the only sanction that is appropriate to protect patients and is in the wider public interest, including the maintenance of public trust and confidence in the profession and is proportionate to the serious and wide-ranging findings made against him.

Mr. Wakefield had a period of time to appeal to the High Court. I have word from Brian Deer, the journalist who first broke the story of the Mr. Wakefield’s misdeeds, that the time has passed and the erasure is now effective.

For those who want visual confirmation, here is the GMC’s registry page on Mr. Wakefield. (click to enlarge)

Bernie Marcus Sides with Autism Scientists in British Study

19 Jan

I’ve known for a while that Home Depot included autism coverage in their employees insurance benefits. I must admit I didn’t know that their co-founder was so involved with the autism community. Bernie Marcus, co-founder of Home Depot, founded an autism center in Atlanta: the Marcus Autism Center.

Well, Mr. Marcus has stepped forward during the high media attention surrounding the BMJ articles discussing research fraud by Andrew Wakefield. The story, Marcus Sides with Autism Scientists in British Study, is from Channel 11 in Atlanta:

http://c.brightcove.com/services/viewer/federated_f9?isVid=1

I admit that when I read the title of the news piece, I thought he was siding with the “scientists in the British study” as in siding with Mr. Wakefield. No, he is siding with the scientists

“You have two schools of thought, and then you should have this scientific group in the middle that doesn’t have any political agenda that just cares about the kids,” Marcus said. “I’ve tried to associate myself with that group of people that doesn’t necessarily agree or disagree.”

and

“Everything that comes back is the same,” he said. “They cannot find any connection between immunization and autism.”

Marcus has been directly involved in Autism research and treatment for more than 20 years. He founded and funded the nation’s leading center for autism treatment. Now in its 10th year, the Marcus Autism Center has already treated more than 30,000 youngsters, as well as providing family support and counseling.

It’s great to hear someone taking a stand but in a very down-to-earth, non confrontational manner.

Dowsing for Data

18 Jan

The BMJ has podcasts (something I was unaware of). This week’s edition is called “Dowsing for Data“. They have input from Tom Jefferson of the Cochrane Collaboration on a subject aside from the Wakefield articles which have been published in the past few weeks. In the second part (starting at about 11:30 into the podcast) the BMJ discusses with Brian Deer about the articles.

They discuss the history of the story, how he got started to do background work for a TV program in 2003. He discusses Mr. Wakefield’s aborted attempt to sue Brian Deer for defamation, which caused 2 years of litigation. It was during this period that Mr. Deer became more convinced that the Lancet article “could not be rationally explained”. Since the information was clinically confidential information at the time, Mr. Deer could not take the information into the public domain. This changed with the GMC hearings and, especially the hearing transcript hearings. This allowed for fact checking of Mr. Deer’s articles. He discusses how the story ended up in the BMJ. Also, the advantage of placing this in the BMJ makes it clear that a greater level of fact checking has been performed. He answers the critics who say that this is more journalism than science, questioning the placement in the BMJ. Of course, Brian Deer is a journalist, not a doctor or researcher. But, that this could be done with the accuracy and rigor of a science paper in a more narrative form.

Chatting with Seth Mnookin

18 Jan

I don’t want to call what follows an interview as:

a) I’m not that grand
b) It was more friendly than that

So what follows was a meandering email chat Seth and I had about the release of The Panic Virus (Amazon UK, US and CA) and the content in it.

KL: You mention in the book that one reason for writing it was that as a new dad you were keen to explore the issue of vaccination in relation to autism. Do you feel that you’ve come away from the writing process with a greater personal (as a dad) idea(s) of what the vax/anti-vax opposing beliefs are?

SM: Actually, I started the book before I was a father…and before my wife was pregnant. I think it was one of the reasons I was so curious about the topic: I hadn’t experienced the debate on a personal level and so I found it hard to understand how different people I respected could disagree so strongly about the facts.

I’m not sure whether this is a result of the writing/research process or of my becoming a dad, but I feel like I have an understanding of where both sides are coming from–and why they get so frustrated. I can’t pretend to know what my reaction would be if I believed that vaccines had harmed my child.

KL: Do you feel you share the sense of frustration that ‘pro-vaccine’ people have now the book is completed?

SM: That’s a hard question to answer. Overall the situation is extremely frustrating. I feel frustration that the issue has been so poorly covered by the media, and I think our handling of the story has as much as (or more than) anything else to do with where we’ve ended up. I’m also frustrated by the handful of self-anointed experts, like Bob Sears, who give the impression that heeding their (or parents’/patients’) instincts are the proper way to go about dealing with medical decisions.

But I think one of the things that makes this such an intractable issue is that there are not a lot of opportunities for people on opposing sides to sit down and have an actual, human-to-human conversation — at this point emotions are so pitched and the stakes are so high (or feel so high) that a sort of bunker mentality has set in. I was lucky: I cam to this without a horse in the race, as it were, so I was able to have what I think were open and honest conversations with people that I know disagree strenuously with the conclusions I ultimately arrived at.

KL: Thats an interesting thought. At what point in writing the book did you think ‘I know I’ve reached my own conclusions’?

SM: I don’t think there was one point at which I felt like I’d made up my mind about the issues that came up because it didn’t feel to me that there was any one single issue. It’s part of what I found interesting and bewildering about this whole thing. I went to an AutismOne conference in Chicago, and after watching a presentation by Mark and David Geier, I knew I had some real concerns about their approach to treatment. There were some other presentations I saw that I knew from the outset were just factually incorrect, and there were claims about government conspiracies to poison children that I found to be…well, I guess unconvincing is a good word to use.

But I certainly didn’t feel like I knew enough at that point to say whether some of the other treatments that came up had validity, and I didn’t feel like I could say with any confidence whether some of the theories regarding causality had any grounding in fact. There’s a lot of very complicated science involved, so when David Kirby stood in front of an auditorium and talked about mitochondrial disease and genetic susceptibility, I hadn’t done enough research at that time to know whether what he was saying made sense or not.

I did find the all-or-nothing quality to the debate to be disturbing. At AutismOne, it was made very clear to me that I’d be judged in absolutes: If I expressed skepticism about the Geiers, the assumption was that I didn’t think anything else that was being discussed at the conference had any type of validity.

I was open about this when I spoke with people. If I was interviewing someone and the Geiers came up — and I don’t mean to pick on them, but they’re a good example of this because they’re such prominent figures — I’d say that I found their approach to science unconvincing.

I think that there is, among some people at least, a feeling that it’d be better for everyone involved if that with-me-or-against-me attitude wasn’t quite so prevalent. I spoke with Jane Johnson about Andrew Wakefield’s departure from Thoughtful House after the GMC decision was released early last year. I really like Jane — she’s smart and thoughtful and very generous with her time and every time I spoke with her she made me think about things in new ways. And when I asked her why Wakefield had left she didn’t say that it had anything to do with the contents of the GMC ruling, which I really respected: There was not really any new information in the report. Instead, she said that he had become too much of a lightening rod and that Thoughtful House wanted to do more work with Texas medical authorities. I don’t want to misquote her, and these aren’t her words, but she essentially went on to say, This doesn’t all need to be about vaccines. There’s lots of other work to be done here that has nothing to do with vaccines. That’s an attitude I wish more people had.

KL: I know you didn’t set out to write a book about *autism* as such but it seems to attract authors – do you think you’ll always maintain a passing interest in the autism/vaccine issue now?

SM: I think I’ll maintain more than a passing interest in the issue. It’s hard to learn about it – and certainly hard to write about it – without become passionately involved in it, so it’s hard to imagine my not continuing to have some connection to a lot of these issues moving forward.

Increase in NIH autism projects over the past decade

18 Jan

We hear repeatedly how research interest in autism has climbed in the past decade. I was looking through the NIH database of autism research projects and I decided to check on the number of projects that the NIH has funded by year.

Here are those data: research projects by fiscal year. In the past 10 years, the number of projects funded per year has increased by about 3x or 4x.

Quantity isn’t the same thing as quality by a long shot. But I do find this very encouraging.

The NIMH Center for Collaborative Genetic Studies

17 Jan

I follow the Director’s blog at the National Institute of Mental Health (NIMH). A recent post is titled Looking forward to 2011

You probably won’t be surprised that I did a search for “autism” in the text. I only found one hit:

Genomics and Other High Throughput Technologies

What happened with computers in the last decade – faster, cheaper, better – is happening with technologies to sequence the human genome today. Once cost prohibitive, the price of DNA sequencing has dropped drastically in the past several years. Soon, whole genome sequencing will become the norm in research. With such precise methodology, this will be the year for discovering many new genetic variants associated with mental disorders. To expedite our discoveries, it will be key to share high quality data produced by these sequencing efforts and to build the computational resources to analyze the impending avalanche of data. The NIMH Center for Collaborative Genetic Studies has become the world’s largest repository for DNA samples from individuals with mental disorders and their families. In 2011, with samples from this repository, along with consortia developed with investigators around the globe, we should get our first comprehensive view of the genomic risk for autism, schizophrenia, and bipolar disorder.

emphasis added.

It’s an interesting hit. First, the director of NIMH is in a position to know what research is in the pipeline. If he says 2011 should give us our first “comprehensive view” of the genomic risk, I’m willing to bet that something will come out this year. More importantly, I was unaware of the Center for Collaborative Genetic Studies.

Leave aside the genetics part of this for the moment and just take a look through the site. It is a great idea. Making data from multiple investigations available to other researchers.

Here’s the “scientific mission”:

Scientific Mission

Given the major public health implications of identifying genes that contribute to the susceptibility for severe brain disorders, the National Institute of Mental Health (NIMH) has funded a Human Genetics Initiative. The goal of this Initiative is to study individuals affected with schizophrenia, bipolar disorder, or Alzheimer’s disease and their relatives, in order to establish a national resource of clinical/diagnostic information and immortalized cell lines for DNA extraction. These data and biomaterials are distributed to qualified investigators in the wider scientific community, for use in research on the genetic basis of these disorders. The NIMH Human Genetics Initiative is supported by the Office of Human Genetics & Genomic Resources in NIMH’s Division of Neuroscience & Basic Behavioral Science (DNBBS).

Progress in scientific understanding is best achieved by the free and open exchange of knowledge, data, and ideas. The NIMH Human Genetics Initiative was founded on the principle that timely access to primary data and biomaterials for human genetic research may stimulate research and development and maximize the benefits afforded to individuals affected with these disorders and their family members. Progress in these efforts is paralleled by growing interest throughout the scientific community in having timely access to the information and resources that may speed the understanding of disease etiology, refinement of diagnostic systems, and development of novel therapeutic agents and preventive interventions.

The autism page for the site gives a brief statement and links to the autism pages. You can see what papers have already come out of the autism consortium, including many available for download. They have data on sibling pairs, where genetic data on families with families with 2, 3, 4, even 5 ASD kids are included. They are up to revision 7 on the data. You can see what data are in the pipeline in the future releases page. There are a lot of data in the works, with a lot of it coming on line in the next year or 2.

The idea is great. I’d love to hear from researchers as to how well it really works. But the data, the raw data, are being made available to multiple researchers. There are other projects like this out there in autism research.

Salon retracts RFK Jr. article

16 Jan

In 2005, Salon published online an exclusive story by Robert F. Kennedy Jr. that offered an explosive premise: that the mercury-based thimerosal compound present in vaccines until 2001 was dangerous, and that he was “convinced that the link between thimerosal and the epidemic of childhood neurological disorders is real.”

The piece was co-published with Rolling Stone magazine — they fact-checked it and published it in print; we posted it online. In the days after running “Deadly Immunity,” we amended the story with five corrections (which can still be found logged) that went far in undermining Kennedy’s exposé. At the time, we felt that correcting the piece — and keeping it on the site, in the spirit of transparency — was the best way to operate. But subsequent critics, including most recently, Seth Mnookin in his book “The Panic Virus,” further eroded any faith we had in the story’s value. We’ve grown to believe the best reader service is to delete the piece entirely.

“I regret we didn’t move on this more quickly, as evidence continued to emerge debunking the vaccines and autism link,” says former Salon editor in chief Joan Walsh, now editor at large. “But continued revelations of the flaws and even fraud tainting the science behind the connection make taking down the story the right thing to do.” The story’s original URL now links to our autism topics page, which we believe now offers a strong record of clear thinking and skeptical coverage we’re proud of — including the critical pursuit of others who continue to propagate the debunked, and dangerous, autism-vaccine link.

Well done Salon.

Salon retracts Robert Kennedy’s “Deadly Immunity”

16 Jan

One of the worst pieces written claiming that mercury caused an autism epidemic was the piece “Deadly Immunity” by Robert Kennedy Jr. Salon.com and Rolling Stone co-published the piece. It was immediately met with criticism and corrections: multiple correction pieces were published.

Salon has decided to review the piece and decided that corrections were not enough. They’ve pulled the piece from their site. Here’s the statement.

Correcting our record
We’ve removed an explosive 2005 report by Robert F. Kennedy Jr. about autism and vaccines. Here’s why

In 2005, Salon published online an exclusive story by Robert F. Kennedy Jr. that offered an explosive premise: that the mercury-based thimerosal compound present in vaccines until 2001 was dangerous, and that he was “convinced that the link between thimerosal and the epidemic of childhood neurological disorders is real.”

The piece was co-published with Rolling Stone magazine — they fact-checked it and published it in print; we posted it online. In the days after running “Deadly Immunity,” we amended the story with five corrections (which can still be found logged here) that went far in undermining Kennedy’s exposé. At the time, we felt that correcting the piece — and keeping it on the site, in the spirit of transparency — was the best way to operate. But subsequent critics, including most recently, Seth Mnookin in his book “The Panic Virus,” further eroded any faith we had in the story’s value. We’ve grown to believe the best reader service is to delete the piece entirely.

“I regret we didn’t move on this more quickly, as evidence continued to emerge debunking the vaccines and autism link,” says former Salon editor in chief Joan Walsh, now editor at large. “But continued revelations of the flaws and even fraud tainting the science behind the connection make taking down the story the right thing to do.” The story’s original URL now links to our autism topics page, which we believe now offers a strong record of clear thinking and skeptical coverage we’re proud of — including the critical pursuit of others who continue to propagate the debunked, and dangerous, autism-vaccine link.

Two suspects in custody in LA abuse case

14 Jan

The sexual assault story out of LA continues to evolve. The LA County Sheriff’s department is posting updates on this case. They note that the first victim has been identified. Here is part of that statement:

The first victim in the videotaped sexual assaults of persons with disabilities was located on Monday. She was found by state investigators living at a residential care facility within the County of Los Angeles. Sheriff’s detectives immediately went to the facility to interview her. The 25-year old White female (Victim #1) is currently a resident of a residential care facility in the state of California. Her medical conditions have caused her to be physically defenseless; however, she was able to communicate with detectives. The young woman confirmed to detectives that years ago she had been the victim of sexual assaults at a residential care facility in the City of Los Angeles.

This had already been identified by Sheriff’s Special Victims Bureau detectives, thanks to information provided by detectives with the Los Angeles Police Department. Her interview on Monday with Sheriff’s Special Victims Bureau detectives was very emotional and painful for her. Detectives described her as very traumatized. She is being provided with victim assistance. She said she feels safe at the residential care facility where she is now living. She does not want her identity or current residence known. Sheriff’s detectives will not be releasing any information about the residence where the victim is located and are asking that everyone respect her desire for privacy and to feel safe where she now lives. In the interview, she alleged that a few years ago she was sexually assaulted by Suspect Lloyd (Suspect #1) at the residence where they both previously lived as residents.

The LA Sheriff’s department is also updating the public on the status of finding the alleged perpetrators. Two have been found so far. Suspect #1 was identified and brought in to custody. Suspect #4 is already in prison.

The booking photo of Suspect #1 Ernie Lloyd has also been provided with this update. The investigation involving Suspect Lloyd is continuing, as are many other investigative leads on several cases.

Suspect #4, Bert Hicks, is serving a sentence in state prison and is due to be released in 2012. He has not been arrested by the LASD and therefore there is no booking photo for him. His case is under active investigation by the sheriff’s department and LAPD.

Here are the two in custody:

Two suspects are still outstanding:

As noted above, the booking photo of Ernie Lloyd was made public:

According to the news source which posted the booking photo:

The informant who anonymously provided the 100 hours of videos that launched a massive sexual assault investigation, reached out to Sheriff’s Special Victims Bureau detectives on Sunday, January 9. He identified himself to detectives and agreed to meet face to face and discuss the case. The meeting took place for several hours on Sunday.

The informant explained to sheriff’s detectives that he had been given a desktop computer by a drug addict and asked to clean the hard drive. Without knowing what the videos were, he watched a portion of them. He was deeply disturbed by the videos and said what he saw made him sick. He immediately knew that he needed to report it to law enforcement, but feared for his safety. He decided that he would copy the videos onto eleven disks and send them anonymously to the Los Angeles County Sheriff’s Department, along with an anonymous explanation note. The informant still fears for his safety, which is why he does not want his identify to be released.

The Sheriffs are still looking for any information, especially that which could identify other suspects or the victims:

Information can be provided anonymously, by calling Crime Stoppers at 800-222-TIPS (8477), or by texting the letters TIPLA plus your tip to CRIMES (274637) or by accessing the Crime Stoppers website at www.lacrimestoppers.org.

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.”

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