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01/03/2004
Statement from Dr Andrew Wakefield
Serious allegations have been made against me and my colleagues in relation to the provision of clinical care for children with autism and bowel disease, and the subsequent reporting of their disease.
These allegations have been made by journalist Brian Deer who has expressed, in front of witnesses, his aim of destroying me.
All but one of the allegations, which are grossly defamatory, have been shown to be baseless. One allegation remains against me personally.
That is, that I did not disclose to the Lancet that a minority of the 12 children in the 1998 Lancet report were also part of a quite separate study that was funded in part by the Legal Aid Board .
It is the Lancet's opinion but not mine that such a disclosure should have been made since it may have been perceived as a conflict of interest. This is despite that fact that the funding was provided for a separate scientific study.
It needs to be made clear that the funds from the Legal Aid Board were not used for the 1998 Lancet study, and therefore I perceived that no financial conflict of interest existed.
The Lancet defines a conflict of interest as anything that might embarrass the author if it were to be revealed later. I am not embarrassed since it is a matter of fact that there was no conflict of interest. I am, however, dismayed at the way these facts have been misrepresented.
Whether or not the children's parents were pursuing, or intended to pursue litigation against the vaccine manufacturers, had no bearing on any clinical decision in relation to these children, or their inclusion in the Lancet 1998 report.
It is a matter of fact that there was no conflict of interest at any time in relation to the medical referral of these children, their clinical investigation and care, and the subsequent reporting of their disease in the Lancet.
As far as the 1998 Lancet report is concerned, it is a matter of fact that we found and reported inflammation in the intestines of these children.
The grant of 000 was paid not me but to the Royal Free Hospital Special Trustees for my research group to conduct studies on behalf of the Legal Aid Board. These research funds were properly administered through the Royal Free Hospital Special Trustees.
The Legal Aid research grant to my group was used exclusively for the purpose of conducting an examination of any possible connection between the component viruses of the MMR - particularly measles virus - and the bowel disease in these children. This is entirely in line with other studies that have been funded by the Legal Aid Board (latterly the Legal Services Commission) and reported in the BMJ . If and when this work is finally published, due acknowledgement will be made of all sources of funding.
It is unfortunate that, following full disclosure of these facts to the editor of the Lancet, he stated that in retrospect he would not have published facts pertinent to the parent's perceived association with MMR vaccine in the 1998 Lancet report. Such a position has major implications for the scientific investigation of injuries that might be caused by drugs or vaccines, such as Gulf War Syndrome and autism, where possible victims may be seeking medical help and also legal redress.
Health Secretary John Reid has called for a public enquiry. I welcome this since I have already called for a public enquiry that addresses the whole issue in relation vaccines and autism.
It has been proposed that my role in this matter should be investigated by the General Medical Council (GMC). I not only welcome this, I insist on it and I will be making contact with the GMC personally, in the forthcoming week.
This whole unpleasant episode has been conflated to provide those opposed to addressing genuine concerns about vaccine safety with an opportunity of attacking me - an attack that is out of all proportion to the facts of the matter.
I stand by everything that I have done in relation to the care, investigation and reporting of the disease that I and my colleagues have discovered in these desperately ill children.
My family and I have suffered many setbacks as a direct consequence of this work. As a family, we consider that our problems are nothing compared with the suffering of these children and their families. For the sake of these children, this work will continue.
23/02/2004
PRESS RELEASE FROM DR PUGH
Dear Parents
In January 2003 the safety and efficacy of the vaccines used in our clinics at Elstree and Sheffield were subject to severe criticism by the Director of Public Health, Hertsmere.
It may help you to understand this issue, if you know, that the original complaint to the Health Authority came from 2 locum doctors, who had been employed at the practice for several months, whilst I was in Australia. Their contracts were terminated. They complained to the Public Health Authority stating that they had suspicions and "NO PROOF" of the matters complained of.
We mixed the vaccines in advance of the clinic, pooled the Measles vaccines into a multi-dose container and used this container of pooled vaccine during the course of the clinic, withdrawing a unit dose from the container for each child.
Needles and syringes were only ever used once and then discarded. We did the same for the Rubella and the Mumps vaccines.
The Director of Public Health, Hertsmere in collaboration with the Consultant in Communicable Diseases and others investigated our clinic and our methods and formed the opinion that there may have been loss of potency of the vaccines and / or introduction of bacterial contamination into the vaccines because of the methods we used. Their advice remains to this day the same, in accordance with Government policy, that your child should still have the MMR vaccine.
I was reported to the General Medical Council and my fitness to practice was brought into question, and as you are aware the General Medical Council have suspended my registration pending a full enquiry.
In the meantime we decided that it was of the utmost importance to have an analysis of the vaccines carried out, in order to be able to reassure parents on these important issues of potency and purity of the vaccines.
It proved difficult to find a laboratory willing and / or able to carry out the analysis, and seven such laboratories in the UK and three in the USA were approached and declined our request. After several months of negotiation we were fortunate to obtain this agreement from a Federally-approved virology laboratory in America.
The laboratory carried out the analysis using vaccines which we shipped to them from our stock of vaccines and they also used our steriliser and multi-dose containers as well as all of the other equipment used in our clinic and which the laboratory needed to carry out the analysis.
The analysis was carried out in 'open air' conditions, that is to say in ordinary room air and not in a sterile environment, in order that we could reproduce the conditions present in our clinics. The way in which the vaccines were reconstituted, pooled and stored in the refrigerator exactly copied the way in which we did these things; and vaccine was withdrawn at intervals so as to allow it to be analysed at various times for purity and potency. This also allowed air to get into the vials, exactly as would happen when doses were withdrawn to administer vaccine to children.
The manufacturer's information leaflets state that the vaccine, once reconstituted must not be used after 8 hours (Rubella and Mumps) and 6 hours (Measles). None of our vaccines were ever used after this elapsed time.
For purposes of analysis however, we decided to continue the analysis beyond these times to see what would happen to the potency and purity over a 24 hour period after reconstitution and pooling.
The result of the analysis is best understood if I quote the 'Conclusions' paragraph (Paragraph V of the report)
" The study indicates that the manipulation of the vials and vaccines under 'open air conditions' did not result in the addition of bacterial and / or fungal contaminants into the system. In addition, the vaccine preparation procedure and storage at 2-8 degrees C appeared not to have an effect on the titers [potency] which remained consistent for the 24 hour study"
In other words, the way in which we mixed and pooled and stored the vaccines did not result in any contamination, nor any loss of effectiveness of the vaccines given to your child. Of course the Public Health Authority will look at the report which we have submitted and no doubt, in the near future provide their observations upon it. At the present time their opinion remains unaltered, which is that the "vaccines given could have been less effective than normal, so their child may not be fully protected and this advice still applies".
The Public Health Authority still follows the Government policy and advises that the MMR should be given.
The Health Protection Agency states "We do not think that the results of this in-vitro study change any of the decisions that have been taken in relation to protecting public health among those who attended immunisation clinics run by Lifeline Care Limited. This is because we have documented previously that these clinics did not follow appropriate procedures when preparing and administering single vaccinations for Measles, Mumps or Rubella. Also parents were advised that the vaccine their child was given could have been less effective than normal so their child may not be fully protected and this advice still applies".
I hope that our vaccine analysis and the results will give you as parents a more balanced view of the overall situation and provide the reassurance and peace of mind that you so much deserve.
Full reprints of the analysis and the report are available from 'Choice' at www.choice.freeservers.com
Best wishes
David Pugh
Latest News 25/08/2003
We recently asked Dr Bonnett whether he would be willing to to meet with parents to discuss the Elstree case. Our correspondence is published below.
From: choice@fsmail.net [mailto:choice@fsmail.net]
Sent: Sunday, August 10, 2003 10:57 PM
To: joel.bonnet@hertsmere-pct.nhs.uk
Subject: Meeting
Dear Dr Bonnet
I do not appear to have had a response to my last email asking that you consider meeting parents to discuss the Estree case. As you may recall I founded a support group after my child was vaccinated at the Sheffield clinic. Dr Pugh came along and spoke to parents regarding the allegations and we would now like to listen to your version of events. I have contacted the helpline but unfortunately they are not able to answer a number of questions I have. Many of the parents would like to know what proof there is that the vaccines were ineffective. Also there have been reports in the media of use of out of date vaccines, diluted vaccines etc. As parents we need to gather as much information as possible in order to make informed choices regarding how to proceed.
As suggested in my last email our support group will fund the hire of the hall and sort out all of the hiring procedures. If you are able to offer us a date when you will address the parents it would be much appreciated.
Regards
Vicki Hill
Message date : Aug 19 2003, 03:48 PM
From : Bonnet Joel
To : 'choice@fsmail.net'
Copy to :
Subject : RE: Meeting
Dear Ms Hill
Thank you for your emails of 10 August and 1 August (with letter attached dated 10 July 03 from yourself and Ms Pitsh on behalf of your support group). I have been away on annual leave from end of 31 July until today, hence the delay in replying.
I am attaching a copy of the advertisement which was placed recently in newspapers together with a copy of the Questions and Answers document
prepared for the National Advice Line referred to in this advertisement.
Hopefully this Q&A answers your questions.
Dr Joel Bonnet
Director of Public Health
Hertsmere Primary Care Trust
Latest News 21/07/03
It has been reported that the government is investing in a new style computer system containing the details of every person in Britain. The medical database
will contain more than 58 million files. Doctors, police, social workers, teachers, social workers and other selected groups will apparently have access to it WITHOUT the patient's consent. Head teachers may be able to use it to check if a child joing their school has had the MMR vaccine.
Latest News 18/07/2003
The two women whose partners took them to court over their refusal to have MMR administered to their children are going for an appeal next week. We understand that the case has been rushed through and therefore the women won't have time to prepare their case thoroughly. The women are seeking supporters to join them next Thursday at The High Court, Royal Court of Justice, High Holborn London at 10am or before if you need to set up placards etc. Further details will be added as we find them out.
Press Release
SINGLE JABS FOR MEASLES, MUMPS & RUBELLA AT PRIVATE CLINICS - UP TO 40,000 CHILDREN MAY NOT HAVE BEEN PROTECTED
Children who received single immunisation injections against measles and/or mumps and/or rubella at two private clinics, one in Elstree in Hertfordshire and the other in Sheffield, may not have been protected against these diseases,
public health doctors are saying.
And children could have been put at risk of infection because of the way in which the vaccines were made up at the clinics.
A major advertising campaign is being launched today in the areas served by these two clinics to alert parents to the problem.
Public health doctors in Hertsmere and Sheffield are concerned that parents of all children who received the single vaccines should be given the opportunity to have the MMR vaccine so that they are immunised against these diseases. The
MMR vaccine is safe and can be given at any age.
Concerns about the way vaccines were made up were reported in the media in February. Both clinics were closed as they were not registered with the National Care Standards Commission.
Since then public health doctors have continued their enquiries about the clinics and believe that their original understanding that just over 1,000
patients might have been given an ineffective vaccine has now to be changed. Now the estimate is that over 10 years some 40,000 children have been vaccinated, putting all of them at some potential risk.
Dr Joel Bonnet, Director of Public Health for Hertsmere PCT, said: "We believe parents of all children who attended should be alerted to the fact that the vaccine their child received may not have protected them. This is because their child could have been immunised by a vaccine that was not made up in the usual way.
"We are recommending that all children who were vaccinated with single antigen vaccine for measles or mumps or rubella at these two clinics should be
vaccinated again and this time with MMR. Parents should see their GP about arranging this.
"Although these children may not be at immediate risk they are very likely to come into contact with the three infections, possibly at school or on holiday abroad."
Parents can ring the Elstree and Hillsborough Advice Line on 0845 850 9850 for advice.
The advice line is open Monday to Friday between 9 am and 6.30 pm and Saturday between 9 am and midday.
Further information from Jonathan Street on 020 7761 1899
Latest News - 17/06/2003
As you may be aware on Friday 13 June, a judge ruled that two youngsters had to be given the MMR vaccine against the wishes of their mothers. Both sets of parents were unable to come to an agreement regarding vaccination and therefore the matter was put into the hands of the law. This ruling is extremely worrying and it is now time that parents took some positive action. Our website offers a forum for parents to unite and to fight the restrictions being placed on our freedom of choice. We need to raise public awareness of the need for single vaccination programmes on the NHS. We were hoping to hold a sponsored toddle on Sunday 10th August in Sheffield to raise funds for further research into the triple vaccine. We hoped that parents would offer to organise toddles across the country yet we have had very little support. Over the next few days we are going to review the situation and decide whether to go ahead with this event. If you believe that you should have a choice then please do support us. If you are interested in taking part in the toddle or organising one in your local area please email us at choice@fsmail.net. If we do not take action we cannot expect to ever be given the choice that our children deserve.
Minutes From Ware Meeting 08/06/2003
On Sunday June 8th Vicki and Sharon travelled to Ware, Herts to chair a meeting with Dr Pugh and parents. Unfortunately the meeting was not as well attended as we had hoped it would be with 40 parents in attendance.
The meeting was opened by Vicki who explained that CHOICE was set up by herself and Sharon Pitsch who are just ordinary mothers. Parents were requested to sign our online petition as it is being noticed that parents are visiting the site but are not taking the time to sign. If we are to campaign for the right to have single vaccines then it is essential that we contribute to this petition. Parents need to encourage their partners, grandparents and friends to sign this petition too.
CHOICE asked for donations to help with running the website which is at this present time solely funded by Sharon and Vicki. We received 40.00 in donations from the meeting and would like to thank everybody that contributed.
The media were present at the meeting but were asked not to record it as parents were talking about individual children and therefore had a right to maintain some privacy. The press were also requested not to ask questions during the meeting as the idea of the meeting was for parents to get the opportunity to have their questions answered.
The media respected this and were able to secure interviews with Dr Pugh after the meeting.
Introduction
Dr Pugh explained that he was attending the meeting through his own personal choice as he felt that it was important that he came to explain misinformation that parents were receiving. He explained that he has been a medical practioner for over 31 years and decided to begin to administer single vaccines when faced with the decision regarding his own son's immunisation programme. Dr Pugh stated that he gave his own son single vaccines and did not administer a booster. Dr Pugh asked parents to go away and check everything that he had stated during the meeting and provided a list of useful websites to enable them to do this.
Immunity
Dr Pugh handed out 4 A4 sheets during the meeting relating to immunity testing and useful websites. A copy of these can be obtained by sending an SAE to 35 Sough Hall Avenue, Thorpe Hesley, Rotherham, S61 2QH. Using these handouts he explained that the blood tests actually measure level of antibodies. If you receive a positive result then you are immune. If you receive a negative result it simply means that the antibodies are not present at that particular moment in time yet you still can be immune. Thus the level of antibodies detected does not signify immunity. Therefore he claimed that the blood tests are not an accurate measure of immunity. The handouts back up what Dr Pugh was saying. He stated that the only way to truly see if a child is immune is to expose that child to the disease that they have been vaccinated against and to see if they contract it.
Dr Pugh stated that he had done over 30,000 single vaccine immunisations. He knew of no hospital admissions after vaccination and knew of only 2,(possibly 3) children who had gone on to contract the illness that they had been vaccinated against.
Clinics closure
The closure of the clinic was due to the non-registration with the NCSC and not to do with the vaccines being used. The NCSC is a new body and out of 10,000 clinics, 200 single vaccine clinics were not notified of the need to register. Dr Waldron and Dr Eardley reported Lifeline Care Limited after receiving notice to leave their posts. Dr Pugh read an extract from the letter. "Although we have no proof this has been happening", this quote related to using vaccines past the recommended time span.
Dr Pugh stated that it is acceptable practice to use multi vial vaccines and he quoted a piece from Direct Health 2000's literature which stated that "multi and single dose vials are used at their clinics, multidose vials are drawn up prior to morning and afternoon clinics."
Dr Bonnet complained about multi dose vials being used as it is not NHS practice.
Fraud allegation
Between 8 January and 20 February 2003, Dr Pugh performed 205 blood tests at the request of parents. 24% showed no antibodies and 76% showed antibodies.
He is accused of altering 6 out of 48 blood test results. Dr Pugh denied this and asked parents to consider why he would just change 6 and not all of them.
He returned to the police station on Tuesday 6th June to answer his bail and was re-bailed until 6th August. The police have released the practice computers.
Current discussions
Dr Pugh pointed out that there are 2 discussion going on at the moment. The first is the introduction of a quad vaccine in 2004/5 which will include chicken pox in the MMR.
The second is to make MMR compulsory for all children.
Latest news
Dr Pugh stated that parents should wait 6 to 8 weeks and he would provide them with evidence which proves that the vaccines that their children received were safe and effective. CHOICE will of course keep parents posted relating to this news.
Conclusion
Dr Pugh concluded by asking parents to go away and research what they had been told. He also asked parents not to use the triple vaccine as he believes that it is unsafe.
These minutes were checked for accuracy by Dr Pugh on Thursday 12th June
Latest News 06/06/2003
The meeting with Dr Pugh is going ahead on Sunday 8th June at 1.30pm.The venue for this meeting is Wodson Park, Ware and a map can be found by clicking here. All parents are welcome to come along and ask questions.The media will be present but are being requested not to film the meeting or to ask questions until parents have left.
Dr Pugh answered his bail on 6th June 2003 and has been re-bailed until 6th August.
24/05/2003 Elstree meeting with Dr Pugh
Since CHOICE was established we have received a number of requests from parents asking us to arrange a meeting with Dr Pugh in the Elstree area. We have decided that we can now go ahead with this if there is sufficient interest from parents. We have made contact with Dr Pugh and he is happy to attend and speak at such a meeting.
The meeting would involve a short introduction from us about CHOICE and the work that we do, the rest of the time would be dedicated to a question and answer session with Dr Pugh. As some of you will be aware we organised a similar meeting in South Yorkshire in March and it was a great success with over 140 parents attending.
We believe that this is an opportunity for parents to ask questions directly to Dr Pugh. We know that many of you have been frustrated that you have not had the opportunity to speak with Dr Pugh prior to now. We have worked hard to provide you as parents with this opportunity to have your questions and concerns addressed. We believe that you have a fundamental right to attend such a meeting.
As we both live in South Yorkshire we are going to have a long journey down to Elstree (an 8 hour round trip we believe!). We are more than happy to give up our time to organise this meeting if it is what parents want. We need you to email us at choice@fsmail.net in order to express an interest in attending.
At the moment we have a provisional date of Sunday 8th June, probably in the afternoon. It would be impossible for it to be on a weekday evening due to the distance we have to travel. If we do have enough parents declaring an interest in coming to the meeting we will book a suitable venue in the Elstree area.
Please email us if you would like to be added to the mailing list for information relating to this meeting.
Confirmation Of Sponsored Toddle Event
We have just had confirmation for the sponsored toddle event.The provisional date and time is for the 10th August at 11am, starting at Hillsborough Sports Arena, Sheffield.We have also found out there will be a fun fair in the park starting at 1pm.There will therefore be refreshments,food etc.Will be a great day out!! More details in the next few days.
Latest News 19/04/2003
Yesterday a meeting was held between the General Medical Council (GMC) and Dr David Pugh. We were contacted by the GMC who informed us that the following conditions have been placed upon Dr Pugh's registration:
1. He must not undertake any immunisation of patients.
2. He must keep a record of all patients seen, their diagnosis and treatment or treatment recommendations or clinics undertaken. This record is to be produced at any subsequent review by the committee.
3. He shall notify all current and potential employers, contractors or professional organisations at the time of application, whether for voluntary or paid work that requires registration with this council of the conditions imposed on his registration by this committee.
4. He shall notify the Interim Orders Committee Secretariat of the GMC if any new work he undertakes requires registration with the GMC.
These conditions are imposed for 18 months.
For more information about how the IOC works please visit www.gmc-uk.org/probdocs/criteria.htm
Minutes from Meeting Held on 06/03/03
Venue: Tickhill Methodist Church Hall
The meeting was organised by Vicki Hill and Sharon Pitsch. Both women had their children vaccinated at Dr Pugh's clinic in Sheffield.
Vicki and Sharon do not come from a medical background, it is important to stress that both women are ordinary mothers who were desperate for information. It is also important to stress that the only link that they have to Dr Pugh is that their children were vaccinated at his clinic. They do NOT work for Dr Pugh and have never worked for him.
The meeting was arranged so that parents could share information and offer each other support. Dr Pugh was invited to attend the meeting in order to answer parent's questions and concerns.
The venue was Tickhill Methodist Church hall. Vicki and Sharon worked hard to find a suitable venue but unfortunately many places were unwilling to offer their halls for hire as a result of the media interest in this meeting. Tickhill Methodist Church allowed the pair to hire the hall for a small cost which has been reimbursed by Dr Pugh. In order to show their appreciation to the church Vicki and Sharon organised a collection on the evening of the meeting and over 40.00 was collected.
Over 140 parents attended the meeting and it was featured on Calendar, Look North, Hallam FM, The Yorkshire Post and the Sheffield Star. Vicki and Sharon were also invited to take part in the 'Tonight' programme with Trevor MacDonald. Unfortunately they were not able to attend due to their commitment to organising this meeting. The press continue to follow this case and Vicki and Sharon now prepare to begin campaigning for the right to choose single vaccines.
Introduction
Vicki introduced the meeting welcoming all the parents to Tickhill. She stated that this was an opportunity to hear what Dr Pugh had to say. Parents were asked to respect the church hall that the meeting was taking place in and also were asked to remain calm throughout the meeting. Vicki introduced Dr Pugh
Introduction from Dr Pugh
Dr Pugh stated that there had been lots of misinformation in the press regarding the clinic. The clinics closure was not to do with the vaccines but to do with the registration forms. The body, the National Care Standards Commission was supposed to send registration forms to each clinic. 200 clinics were not sent these forms or notified about the need to register. All of the clinics offering single vaccines were in the 'forgotten' list and none of them were notified of the need to register. One clinic (Desumo) registered a couple of days late and the application was sat on for 10 months, the clinic was then closed down as it wasn't registered.
Dr Pugh is not supposed to consult with parents or the press, this could lead to prosecution and 6 months imprisonment. He stated he is taking legal action to lift this gag. Can't do any blood tests or reimmunisations until he can continue practicing.
Prior to the clinic closing Dr Pugh did 'over 300 blood tests, 93% of children were protected'. No vaccine is 100% and there will always be a small percentage of children who have no immunity. If child was ill after the vaccine this can affect immunity. It takes time to build up immunity somewhere between 3weeks and 6 months. Some parents are blood testing too early, their child may not be immune at this point in time but could build up immunity over coming weeks. Failure rate for MMR is as high as 20%, the single vaccine failure rate is 10%.
Dr Pugh told the parents he was away during the 'alleged period of June 2002 to December 2002' he was in Australia lecturing on Autistic Therapeutic Treatment. He employed 2 Doctors to run the clinic in his absence, Dr Eardley and Dr Waldon. The Doctors worked from June - December in the immunisation centre. On his return Dr Pugh gave notice to the two Doctors on 28th December. The practice was closed over Christmas although the Doctors had Dr Pugh's contact details they did not make any contact. On 2nd January of this year the Doctors refused to immunise at the clinic which was booked. They said that the clinic was too cramped. They took the next day off to get legal advice over the termination of their contract. In actual fact they went to Heartsmere Health Authority with a letter that stated that vaccines used at the clinic had been stored beyond their expiry date. These allegations have not been proved.
Dr Pugh told parents to log onto the 'World Health Organisation' website which gives a detailed account on the stability of vaccines before and after they are mixed. If you work within the guidelines the vaccines are OK. The measles vaccine has been tested and is still fully potent after 24 hours - Lifeline Care Limited used the vaccines within 6 hours.
Questions from parents
Were the vaccines contaminated?
If they had been the child would have abscess at the site of injection or would get septicaemia - bacteria growing in the blood, this would make the child very seriously ill within 1 to 3 days and they would have to be admitted to hospital for treatment with intravenous antibiotics. Dr Pugh stated that he had been immunising single vaccines since 1976 and had no reports at any time of any child being ill.
Were you registered before last year?
No, there was no requirement to be registered before that date.
You cannot practice unless registered with the General Medical Council. If there is a complaint about a clinic it is standard practice for the General Medical Council to be contacted. At the moment this is in the preliminary hearing stage where both sides can give their arguments.
Has any child contracted the diseases immunised for?
Prior to the Mail article there was no evidence of ANY child immunised by the clinic having contracted the disease they were immunised for. One parent emailed the clinic to say her child was the only child in the class not to have caught measles, and he had been immunised by Dr Pugh
Where do we get blood tests done?
Dr Pugh stated he was referring children for blood tests prior to closure. If the GP won't do the blood test (many parents stated that their GP had refused this), then there is nowhere at present. Sheffield Children's Hospital had stated to one parent that no blood test will show up the results required.
Why can't we contact the clinic? One parent said that BT had told her the phone was off the hook Also why wasn't their an answer machine message?
Dr Pugh said he accepted what she said. He has 4 lines to the office and the phones were never off the hook. The staff were constantly answering phones and any engaged signal was because they were speaking to parents. The answer machines take 30 messages and then are full.
One parent stated she faxed the office and got a response straight away.
Why didn't everyone get a letter?
There was not enough time to write to everyone so they wrote to the parents it affected. The clinic was asked to contact all the parents whose child had received the measles vaccine that was made up for multiple vaccines. Some measles vaccines were mixed individually and these were not required to be recalled. Other children received vaccines that were mixed on a larger scale for up to 20 children.
The clinic held vaccination records for every child. They record on that whether single dose or multi dose was used, this is also recorded in your child's health record book. As a rule of thumb the Drs largely used multi dose and the nurses tended to prefer single does. 1012 children were immunised using multidose vaccines.
If they anticipated the clinic was going to be particularly busy they would use multidose vaccine as it allowed them to work more quickly. Multidose was used 4 times out of 7 times at Sheffield. Prior to June the clinic never used Multidose vaccines. The Dr's who reported Dr Pugh went to him as they couldn't keep up with demand. As a result they reduced the number of vaccines they were carrying out per hour. At the Drs request they introduced the multi vaccine.
If you look in your health record the last 2 digits indicate whether your child had single or multidose vaccine. The single dose is stated by the numbers 01.
Why did you disappear?
Didn't disappear. Wanted to come back to Sheffield to meet with parents when Hillsborough Sports Arena withdrew the venue due to adverse publicity from media. The staff were searching for a new venue when the clinic closed.
How have you got single vaccines licence?
Any Dr can give any treatment that they feel is in their patients best interest.
Were your records stolen?
After the story in the Mail the clinic was inundated. Parents jammed in to find out if their child was protected. Databases were on the desk and parents started to grab at paper work. Same happened for several days. Dr Pugh went to get the records and they could not be found. Seemed that they had been taken from the clinic, this was reported to the police.
Were the vaccination affected just measles as I was emailed about rubella from Sue Hawkins?
The rubella was not in question. This email did not come from the clinic. The phones have been bugged and the emails intercepted. The rubella was not in question and had never been in question.
Will you take legal action against the 2 Doctors?
Yes
How soon are you re-opening?
When we are registered.
What advice can you give about where to continue our single vaccines?
Direct Health 2000 is the only single vaccine clinic to secure registration.
Mother gave proof of no immunity to measles from a vaccine given in March 2002
Dr Pugh stated that it was not an ELISA test that had been used. The test used was an EIA test. The ELISA test is the only one to give you the level of antibodies.
Can you give another single measles vaccine?
No problem in doing this even if the first vaccine has been a success. This is confirmed on the Dept Of Health website.
One mother stated a huge bottle was used for mumps vaccine after Dr Pugh stated it should be single bottle used
Dr Pugh stated this should have been a small bottle and needs to be clarified. Only the measles were mixed using multi dose method.
If we give another single vaccine do we have to wait 6 months?
Dr Wakefield's opinion is to leave a 6 month gap between measles and mumps. When reimmunising you can give it after one month.
Can you give triple MMR on top of single vaccines?
Dr Pugh couldn't say, only heard of one child where this had been done. If you give MMR to a child who does not have immunity in all 3 strains you are in the same position as giving the triple vaccine from the start
How many parents received letters?
3 hands raised out of 140. Dr Pugh stated that if you did not get a letter in his opinion your child's vaccine was effective.
Dr Pugh read out a letter that he sent from his clinic as part of the recall procedure.
Why didn't everyone get a letter to warn us of what was going on?
Quite simply not enough time, the clinic was fighting for survival.
Would you be willing to revaccinate and give blood tests for free if you set up again?
Yes
Are you opposed to triple vaccine?
Totally opposed.
Were vaccines stored at correct temperature?
Yes
How will you let parents know you are re-open?
We will write to the parents as we still have details.
Why didn't you put something on your website?
Has been advised that altering the website could be construed as consultation. If you wish to email him can do so on Pughlestree@aol.com
Meeting Closed
Meeting closed by Vicki Hill who thanked parents for attending. Dr Pugh spent time with every parent who wanted to see him on an individual basis looking at health records and answering questions.
Dr Pugh checked these minutes for accuracy on 9.3.03
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