Examination of Witnesses (Questions 160-179)|
THURSDAY 24 JUNE 1999
160. We will probably come back to you later
on with some specific questions about your experiences because
obviously you have exercised your right to go through the procedures.
As a Committee, I think we are interested in why you feel the
procedures have not worked in your circumstances. Can I thank
you for the moment? We will certainly come back to you in a moment
(Mr Elder) The reason why they have not worked and
they will not work is because it is an internal investigation,
from start to finish.
161. Your key concern is that external mechanisms
ought to be introduced in some way?
(Mr Elder) They have to be. There can be no question
162. Ms Pappenheim, would you like to say a
little bit more about your own concerns? Can you keep them reasonably
precise and relate them to our terms of reference? We are anxious
to learn from the experiences of you and your colleagues, the
patients you represent, in looking at what we recommend as to
changes that might be brought in by the government.
(Ms Pappenheim) I will start by briefly outlining
that haemophilia is a very rare condition. It is an inherited,
life-long condition, a bleeding disorder, and the major effect
of it is internal bleeding which, if untreated, will damage joints
and is life threatening. The situation that we are here to speak
about today is the one that has arisen from the use of blood products
to treat people with haemophilia for their condition. That treatment
began in the late sixties and went on through the seventies and
eighties. During that time, those blood products were contaminated
with HIV and hepatitis A, B and C. The effect of that is that
over 95 per cent of the patient group treated during that era
were infected with combinations of those viruses. We have had
a long term problem with that treatment, leading in this instance
to infection of this patient group who already had a serious,
life-long, medical condition. They have been infected with two
life threatening viruses through their NHS treatment. It is important
to state that in 1985 and 1986 viral inactivation procedures were
put in place to prevent future transmission of HIV and hepatitis
through blood products, but we still know that there are viruses
such as TTV, which is a recently identified one, and hepatitis
A, which actually escaped that inactivation process. We cannot
be entirely confident to this day that blood products are 100
per cent safe, because we already know that some viruses are escaping
the inactivation processes. What has happened as a result of the
HIV and hepatitis C infection, which is what we primarily want
to focus on, is that by the time inactivation was put in place,
as I said earlier, over 95 per cent of the patient group treated
had been infected. 4,800 people with haemophilia have been infected
with hepatitis C and of those 1,200 were also infected with HIV.
Many have lost their lives. Over 700 have died of AIDS already
and at least 90 have died of hepatitis related liver disease.
Of course, we now have a patient group of survivors who are still
struggling with the consequences. Hepatitis C has a far longer
progression than HIV. It is a 20 to 40 year progression, but in
its end stages it damages the liver and leads to liver cirrhosis
and liver cancer. Treatments for both of those viruses, as you
will appreciate, are very complex and difficult, particularly
for the groups of patients who have haemophilia, HIV and hepatitis.
The treatment prospects are really very uncertain and treatments
in themselves have massive side effects which can be completely
disabling. To summarise the end results, many of these patients
have had seriously impaired health and still have declining health
today. They have suffered actual loss of earnings as a result
of course because many, many have had to give up work and are
no longer able to continue work because of that. Also, they are
suffering the stigma of living with these viruses. What we really
wanted to highlightand this is where we get on to the meat
of your inquiryis the fact that there have been no effective,
national procedures to pick up on this widespread treatment failure
that took place over a long period of time. Unlike other countriesand
we can look at Canada and Irelandwhere people also suffer
the effects of contaminated blood, the governments in those countries
have undertaken inquiries to establish exactly what happened,
what might have been done, what the impact has been and, very
importantly, to learn lessons for the future. In this country,
there has been no systematic investigation. It has been piecemeal
and I think one of the strongest issues to be raised today is
that picking up the pieces from this disaster has been largely
left to self help. Patients have formed themselves into self help
groups where they have tried to share information and find out
about how to live with these viruses. The Haemophilia Society
as a charity has been left very much in the role of trying to
provide support, information and advice but there has been no
systematic approach to actually ensuring that every single infected
patient has been correctly identified, tested, treated and followed
up. One of the things we want to flag up very, very strongly is
that the previous government undertook a look back study of patients
who had been infected with hepatitis C through transfusions. There
were obvious reasons for doing that, because they had to find
them, but an assumption was apparently made that all haemophilia
patients would be located, tested, treated and counselled by their
haemophilia centres. You can see from the evidence that we have
presented hereand you can talk to many, many of our members
to find outthat they have not all been correctly identified,
tested, treated, advised and counselled. We have in here a case
history of a young man of 28 who has only within the last ten
months, although it is believed he has been infected with hepatitis
C for 17 years, been properly tested and told about his condition.
Obviously, one of the sources of anguish and anger for our patient
group is that, because there was no systematic approach to locating,
testing and advising everyone, some people lived with very dangerous
viruses which they could transmit, without being given information
that would allow them to protect those closest to them, to avoid
sexual transmission to partners and to make lifestyle changes,
for instance those with hepatitis C, who should have known that
drinking alcohol is not a good thing for their health. You will
see from the evidence that we have presented that the approach
to the follow up has been haphazard. Certainly we are not here
today to blame clinicians and nurses working in haemophilia because
I think one of the points we would like to flag up is that this
disaster has had a terrible impact on doctors and nurses as well.
Many have seen their entire patient group at a particular haemophilia
centre die and become seriously ill. That has been traumatic and
stressful for them. We are certainly not here to make an attack
but what we are here to do is to flag up the issue of whose responsibility
was it. Was it sufficient to allow individual clinicians to advise
patients off their own bat, because this is what has happened
to a couple of individuals we know. Fortunately, they were warned
by a doctor or a nurse who was in a position to know the medical
research and had warned them that there was contamination in the
blood product. Should it have been left to individual clinicians,
doctors and nurses like that? Was it the responsibility of the
Department of Health? Was it the responsibility of the professional
medical bodies representing those clinicians? I think what our
patient group feels is that they have been let down by all and
that there has been no attempt to take the comprehensive approach
to picking up the pieces of this disaster. Obviously, that is
one of the lessons that we hope would be learned. We would hope
that today, with increased emphasis on clinical governance, with
the existence of the National Institute of Clinical ExcellenceI
stress "hope" because we do not know this; we do not
know that if such a thing happened tomorrow action would be any
different, but I think I cannot express strongly enough the loss
of confidence, the anger, the disappointment of this particular
patient group who have been infected through their treatment and
have not had adequate redress.
163. I appreciate that your group has had very
significant health problems and has suffered enormously because
of the problems you have outlined extremely succinctly and very
well. Do you feel as though this should never have happened at
all or do you feel that, the infection with viruses having happened,
it should have been handled differently? I am not quite sure where
your complaint is. Is it that it should have been stopped in some
way; it should never have happened, or is it that, having happened,
the response was wrong?
(Ms Pappenheim) It is a very complicated issue because
we are obviously looking at a patient group with a serious medical
condition. For those with severe haemophilia, treatment was essential.
However, there is an issue of people who had mild haemophilia
who may only have required treatment perhaps two or three times
in a lifetime and some of the particular anger of those patients
is that they feel that, had they been told of the risks of accepting
blood products for a condition which they might have overcomethey
could have gone home and they could have sat with ice packsthere
were other ways, if you had mild haemophilia, of tackling the
problems. Clearly that kind of issue might not apply when you
have severe haemophilia so one of these issues is about why there
was not advice and information at the time to allow patients to
make an informed choice about accepting treatment if there was
164. You think the medical knowledge was there
but it was not being given to the patients? There is clearly a
possibility that the medical knowledge was wrong or the medical
knowledge just was not available, but you are saying the medical
knowledge was there but it was not being applied?
(Ms Pappenheim) We are looking at a long period from
the beginning of the seventies, when blood products began to be
widely used, right the way up until 1985/1986 when inactivation
processes were implemented. Obviously, medical and scientific
knowledge was evolving throughout that time. In the case of hepatitis
C, it was known only as a non-A, non-B virus in the seventies,
but it was known to exist. Signs were coming through. They were
being reported on in the medical literature, so there was an evolving
state of knowledge which could have been flagged up. This is where
we are raising the question again about was it the responsibility
of an individual clinician who had read the medical research to
say, "I would like to warn you about this". Was it the
responsibility of the Department of Health to issue a circular
to say, "Only treat in certain circumstances"? Was it
the responsibility of the royal colleges? These are some of the
questions that our patients are still asking today. That is one
set of questions. The other is why there has still been no adequate
follow up action, why no redress. There is really very little
that the courts can do to resolve this problem and seeking justice,
seeking recompense, has come down to campaigning and lobbying
by patients within the patient group of the Haemophilia Society.
This is very starkly contrasted with other countries where they
have done an inquiry; they have uncovered the facts; they have
put the picture together. Certainly they have responded, as in
Ireland, very close at hand, by providing at least some form of
financial recompense for the loss that these people have sustained.
I think the point on that which we really want to flag up very
strongly for this Committee is that this patient group have been
told many times that they are allegedly the victims of non-negligent
harm. The question we want to raise is what should be done in
a situation where you have a large number of patients who have
apparently suffered the effects of non-negligent harm, where we
are being told that action through the courts will not work and
the government has been at great pains to distance itself from
responsibility because it continues to refer to this as inadvertent
and non-negligent harm.
165. There is clearly a difference between no
full compensation, which is one aspect which you are perfectly
right to press for if that is what you want. The alternative is
compensation for damage donein other words, by a named
individual, a hospital or a trust. Are you saying that you wish
to take action against named individuals who have treated people
wrongly, or are you saying that you would like full compensation
from the government for sufferers of this disease?
(Ms Pappenheim) I think we want the government to
take action because there has been a very unequal response. We
are dealing particularly with two viruses, as we have said in
our submission, HIV and hepatitis C. In terms of HIV, quite rightly
after considerable pressure, after campaigning, after 900 people
with haemophilia and HIV went to court in a mass action, the previous
government in 1987/1988 set up a financial assistance scheme.
That was never described as compensation because the government
distanced itself and accepted no responsibility. Money that was
provided was on an ex gratia basis in recognition of a tragedy.
However, the patients with hepatitis C, of whom there are now
some 3,000, have not been addressed in the same way. Our very
strong view is that this is a completely unequal response. It
is unjustifiable to have divided the patient group. It has caused
immense anger and anguish. Hepatitis C clearly is a different
virus to HIV, but it has extreme health consequences; it carries
stigma, it is disabling and it has created actual financial loss
for people unable to work. Going back to your question, we feel
that the previous government made a partial response after massive
public pressure and pressure in the courts. They set up a financial
assistance scheme to provide some measure of recompense for HIV.
One of the reasons that they were forced to do that was because
of the dramatic progression of HIV. Deaths were happening at the
rate of one a week. It is perhaps both the misfortune and fortune
of those with hepatitis C that their virus did not progress. It
is a much longer progression, but for a number of reasonsthat
may be one of themthey were not included in that original
focus. It is that group who are still left struggling with the
health consequences and left asking time and time again why has
the government such an unequal response to a group of patients
who have all been infected through the same type of treatment,
used in the same era for the same condition. That is the point
which we really want to flag up. There seems to be no justification
for responding partially, and quite rightly, to those with a devastating
virus, HIV, but leaving aside completely those with hepatitis
166. You said that blood products might not
be safe today and the inactivation process might not affect a
couple of viruses. Do you feel that patients today are being warned
of those risks?
(Ms Pappenheim) I think patients today are incredibly
alert and haemophilia patients have become one of the best informed
patient groups out there, because of this experience. Therefore,
we provide information on the existence of TTV, for instance.
There is a constant described by the Department of Health as "theoretical"
risk of CJD because, as you will be aware, there is no screening
test for CJD. Whilst blood products are obviously massively safer
than they were in the era we are talking about now, there is no
guarantee of 100 per cent safety and they still carry that theoretical
risk of CJD. This is the reason why, as a patient group, we have
campaigned for access to synthetic recombinant treatment which
really should be a choice for all patients so that they can avoid,
albeit a theoretical risk, an unknown, unquantified risk of other
blood borne viruses.
167. If you were not warning patients, would
you feel there was adequate warning being given to patients?
(Ms Pappenheim) That is a difficult question to answer.
It will depend very much on the stance of individual clinicians
and nurses and how proactive they are in discussing treatment
options. I think the point we have flagged up in our evidence
is that, with regard to HIV and hepatitis particularly, over the
period after the infection, for instance, tests were carried out
on patients without their consent; they were not given information
on the result in many cases. One would hope that things have moved
on, but we are still talking about, even in the last couple of
weeks, patients in touch with the Society who are only just getting
the results of their tests for these viruses and quite clearly,
once given the results, were not given a full counselling or information
session on what the implications are, not least the fact that
they are highly unlikely to be able to get mortgages and life
assurance again. It is not only a health impact; it is your whole
life that will be affected.
168. Dr Peart, can I bring you in to say a little
more about the background to your group? Obviously, I have personally
met a number of your colleagues. Can you explain to my Committee
colleagues broadly the concerns that you have as a group, as they
tie into our terms of reference for the areas we are examining?
(Dr Peart) I am very much aware that, because of the
very long term, wide ranging and very complex nature of the benzodiazepine
problems, some of my written submission was outside the remit
of this inquiry, but I have prepared a statement in which I have
attempted to distil it to be consistent with the terms of reference
and some of the definitions in the Oxford English Dictionary.
In the interests of time and because of my drug induced cognitive
impairment, I would very much like, with the Committee's permission,
to read this statement. I think it will serve to produce a much
more precise statement, one with greater content, and be much
169. So long as it is not too long.
(Dr Peart) It will be less than the previous speaker.
The adverse clinical incident I wish to talk about is 40 years
of misprescribing, misdiagnosis and mistreatment. In the late
1970s, Professor Lader of the Institute of Psychiatry warned that
the biggest medical epidemic of the 1980s was in the making. This
has happened. A much better way of describing the whole incident,
I believe, is it is simply chemical rape of the body, mind and
soul. Investigation of this incident has been very limited. It
is limited to medical publications on a worldwide basis, but these
are very restricted in scope and there have been very few epidemiological
studies. The CRM issued guidelines for drug data sheets in 1980
and the CSM published guidelines for prescribing in 1988. The
Institute of Psychiatry also published a similar set in the same
year. the outcome of these investigations was at best to have
a very marginal impact. Questions like what happened, why did
it happen, why is it ongoing have largely been unanswered. Another
important question is simply why have there been so few investigations.
I think the answer must be associated with vested interests. From
the 1960s onwards, patients bombarded their doctors with complaints
about these drugs. By the late 1970s, independent authorities
had estimated about one million people were addicted to these
drugs. This figure has remained about the same to this day. It
is of interest to not that for valium, the most widely used of
these drugs, only 16 reports of addiction were received by the
MCA via the yellow card system. That is from 1963 to 1996. The
usefulness and effectiveness of this system must be in grave doubt
when massive under-reporting of drug adverse reactions has been
going on for so long. One point is clear. The system does not
work for the patient, but it appears to work hand in glove with
170. Could you explain who you specifically
regard as the vested interests? Are you talking about the drug
(Dr Peart) Very much so the drug companies but, to
quite a large extent, the Committee of Safety of Medicines and
the MCA and also, as I will elaborate on, the medical profession
itself, the prescribers. Decades of little or no response to patients'
complaints were finally picked up by the media. This no doubt
forced the hand of the CSM into issuing guidelines in 1988. Patients,
tired of stonewalling by their prescribers, were reluctant to
take action against them because, like any addict, they wanted
to safeguard their access to and supply of their drugs. Instead,
thousands of letters of complaint were written to the drug companies,
the CSM, the MCA, the Department of Health, the BMA, the GMC,
MPs and ministers. Most patients simply wanted recognition, acceptance
and treatment of the problem. As this was not forthcoming, many
finally resorted to legal action. Others, like myself, tried to
get access to their medical records. I was refused access by my
GP on the grounds that he needed permission from all of the doctors
who treated me.
171. Is this since the law changed with regard
to access to medical records?
(Dr Peart) That was in about 1988.
172. It predates the recent legislation.
(Dr Peart) Probably, but the interesting point on
this issue is that one of the psychiatrists, the major one who
treated me, simply replied to my doctor stating that all communication
should be via the Medical Defence Union. I therefore started legal
action myself and joined the action group against the drug companies.
This legal action really was a disaster from beginning to end
and it confirmed that the English legal system is incompetent
and incapable of running group actions for medical negligence.
Over £15 million was spent, not a penny going to the claimants.
It turned out simply to be a money making machine for members
of the legal and medical professions. Briefly, the reasons for
its failure include defence tactics to run up the claimants' costs,
bias by the presiding judge, Mr Justice Kennedy, a strong conflict
of interest by our own case experts who are also prescribersthey
were very hostile to both claimants and to the generic experts
who were supposedly briefing them. Many sufferers have tried to
obtain state benefits, including disability living allowance,
because of the very long term and debilitating adverse reactions
to these drugs. Few have succeeded due to the refusal of prescribers
to recognise and diagnose problems caused by these drugs. A sick
note quoting benzodiazepine addiction is an absolute rarity. The
few who get benefits like DLA are granted them for reasons other
than the causei.e., it is the symptoms of the problem like
depression and agoraphobia. It is interesting to note that the
DLA handbook in 1988 contains no reference to prescription drug
addiction. The phraseology used for other addiction rules out
the inclusion of the iatrogenic addiction. The biggest barrier
to patients obtaining recognition, acceptance and treatment for
this problem is the prescribers themselves, those whose clinical
judgment, I might add, created the problem in the first place.
Voluntary support groups get little or no cooperation from doctors.
They refuse to display information in surgeries or give verbal
information to patients. Most surgeries, if not all, have lists
of benzodiazepine users and databases and it would be very easy
for prescribers to notify patients of support and voluntary organisations.
By definition, relatives and carers are in the same boat. They
are unable to be supportive and in many cases their actions are
destructive because they are aided and abetted by misinformation
from prescribers. There appears to be a lack of will to open up
and to do something about this problem by statutory sector services.
Quite often, health authorities are keen to work within government
guidelines and directions from the Department of Health and with
the voluntary sector, but the inward looking stance by the statutory
services, especially the National Health Service, means the response
to complaints is very much one of a statement of "it is up
to the clinical judgment of the prescribers". This mantra
is taken up by the prescribers, by the National Health Service,
by the MCA and other authorities. It does seem that the old precept
"first do no harm" has been turned on its head.
173. That was very helpful and clear. Thank
you. I am interested to know whether you feel and whether the
group of people that you represent feel that these drugs have
any place at all in the treatment of people with mental health
problems or mental illness; and whether there are perhaps other
people who have received this kind of medication who would say
that it has actually made a positive difference to the quality
of their lives. I know it is very difficult to be objective.
(Dr Peart) I believe, and many of our members believe,
that within the current guidelines they are of significant value.
That is for very short term use and for quite serious conditions.
I do know of people who fit into that category and they would
certainly make such a statement. I think there is another aspect
to these drugs which is seldom addressed and that is a very wide
ranging individual sensitivity to the drugs. Some people can take
the drugs and within a matter of days, or certainly a week, they
can become addicted to them. Others can go for many months and
only very slowly develop dependency or addiction. It is an issue
that, right the way through from clinical trials to the prescriber,
does not seem to be addressed at all.
174. What you are saying is that there will
be groups of people who have a similar condition where doctors
may feel it appropriate to prescribe this form of medication,
but no regard has been taken in the past in terms of factors connected
with individual. The doctor has looked at a group of people. They
seem to have similar symptoms. Therefore, this kind of medication
would appear to be the most appropriate intervention and most
appropriate response, but really beyond that there has not really
been any attempt to look at anything else connected with the individual
or their history, their likelihood to become dependent or addictive.
Is that what you are saying?
(Dr Peart) Very much so and very strongly so. In fact,
once patients become addicted and hooked on these drugs the prescribers
invariably continue to treat the symptoms rather than looking
at any original problem. The treatment ends up by being one, like
polypharmacy, of treating symptoms only, ignoring the original
175. Is it your view that, based on research
and evidence, it is possible for doctors to identify easily those
people who it would be, in terms of the balance of risk, unwise
to prescribe this medication for?
(Dr Peart) No, I am not of that opinion at all because
the probability of any individual becoming addicted to these drugs
is not dependent upon the individual characteristics or problems.
It is simply a biochemical problem. All aspects of addiction can
basically be explained in terms of biochemistry and the nature
of the drug.
176. You have said that you feel in some cases
it is appropriate for doctors to prescribe this medication?
(Dr Peart) For short term use, yes.
177. You have also said that you are concerned
that maybe there are some people, even in the short term, who
can become addicted?
(Dr Peart) Yes.
178. What I am a bit unclear about is, based
on your experiences, do you feel doctors can be expected to identify
those people who are likely to become addicted, even after a short
period of time of being on that medication?
(Dr Peart) I do not think that doctors can pre-predict
or predict. I believe that most doctors should be able to diagnose
the symptoms of dependence as soon as they occur, whether after
one or two weeks or after six or seven months.
179. Your contention is that basically once
that becomes clear very quickly what has happened over the years
is that doctors have avoided dealing with that and have just continued
(Dr Peart) Yes, irrespective.