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Mr. Deputy Speaker (Mr. Michael Morris): Under Standing Orders, items 9 to 13 on the Order Paper will be dealt with at 10 o'clock. We shall now deal with motions 14 to 18 before a suspension until 10 o'clock.
DELEGATED LEGISLATION
Mr. Deputy Speaker: With permission, I shall put together the motions relating to delegated legislation.
Motion made, and Question put forthwith, pursuant to Standing Order No. 101(6) (Standing Committees on Delegated Legislation),
Mr. Deputy Speaker:
With permission, I shall put together the questions on the deregulation orders.
Motion made, and Question put forthwith, pursuant to Standing Order No. 14A(1) (Consideration of draft deregulation orders),
On resuming--
It being Ten o'clock, Mr. Deputy Speaker put the Questions required to be put by Standing Order No. 53 (Questions on voting of estimates etc.).
Resolved,
Ordered,
Order for Second Reading read.
Question, That the Bill be now read a Second time, put forthwith, pursuant to Order [6 March] and Standing Order No. 54 (Consolidated Fund Bills), and agreed to.
Bill accordingly read a Second time.
Question, That the Bill be now read the Third time, put and agreed to.
Bill accordingly read the Third time, and passed.
PETITIONS
Mr. Simon Hughes (Southwark and Bermondsey):
I have two petitions to present, both of which are on the same subject and relate to a Bill that is to come before the other place on Friday. The first is
The petitions
The petitioners wanted the petition to be presented before the debate in the other place on Friday.
To lie upon the Table.
Mr. Mark Wolfson (Sevenoaks):
This petition is on the same subject as the previous two. I have the honour to present it on behalf of my constituent, Mrs. Lois Hainsworth, chairman of the Bahai national women's committee and of Rev. Graham St. John-Willey, director of the Action for Children Campaign, and Mrs. Sandra Khambatta, its assistant director, the other officers of those organisations and the Bahai community in the United Kingdom. This is this first of four similar volumes that hold, in all, 10,000 signatures.
The petition states:
Motion made, and Question proposed, That this House do now adjourn.--[Mr. Ottaway.]
Ms Jean Corston (Bristol, East):
I am grateful for this opportunity to raise a matter of urgent public health concern. One of the most remarkable phenomena of the past 30 years has been the increasing prevalence of foreign travel. People now travel to parts of the world that two generation ago were considered the preserve of the intrepid explorer. Before people travel, whether for holiday or business, they seek professional advice about endemic diseases in their country of destination and the medications or treatment that they should take--prophylaxis--to avoid contracting diseases. That is especially true of malaria.
Unfortunately, a more aggressive strain of malaria has emerged recently in some parts of the world, principally sub-Saharan Africa and parts of the far east. The previous prophylactics, chloroquine and paludrine were considered not to be effective enough. Another drug entered the market: mefloquine, which was marketed by Hoffman La Roche under the name Lariam.
I know someone in Bristol who took Lariam 10 months ago to travel to east Africa to finish some academic research. He was a highly competent professional and a married man with children. He was a young person with a great deal to give to the academic world. Just a few days after arriving in Nairobi, he collapsed in the street with total amnesia and was taken to hospital. He has since suffered psychotic attacks, and has had paranoid delusions and terror attacks. He cannot concentrate or work, and he cannot drive a car. His family life has been severely disrupted and he feels at the moment--at best--as though his life was on hold.
I have since discovered that he was not the only one. When he was in hospital in east Africa, he was told by a tropical diseases consultant that severe neuro-psychiatric side effects from Lariam were quite common. The consultant said that he saw hundreds of patients, and that the problem was that the symptoms could be diagnosed as a breakdown.
Following a BBC television programme last week in the west country, someone wrote to me to say that he had been a resident in east Africa, and now travelled there. When he was last in east Africa, he said, he
I have since heard many instances of Lariam poisoning. An Officer of the House approached me last summer when I was tabling parliamentary questions on the matter to say that he knew a highly competent professional woman who had taken Lariam, who, he told me, was now psychotic. I have spoken to GPs who are very concerned. I met members of the Lariam support group, which is principally based in the west country but whose members come from all over the UK. I met a highly motivated young woman police officer, who has not been able to work for nearly a year and a half because of the serious side effects.
Lariam was made the drug of first choice in 1995 for sub-Saharan Africa and parts of Asia by the malaria advisory committee, which is headed by Professor David Bradley. It is also recommended as the first choice in MIMs, which gets its information from the malaria research laboratory of the Hospital for Tropical Diseases in London. The medical advisory service for travellers abroad also suggests Lariam as the first choice. British Airways travel clinic also recommends it on the basis of advice from MASTA.
On 7 October 1991, a change was made to the product data sheet with regard to the ability to drive. The recommendation was that such a task should be avoided for three weeks following therapy, because the patient may experience dizziness, a disturbed sense of balance or a neuro-psychiatric reaction. I do not know whether this is observed, and whether people who take that drug cease to drive a car for three weeks afterwards. I do not how people who go on fly-drive holidays manage.
It is interesting to ask what advice is given to travellers on the side effects. For example, somebody from the BA travel clinic said on the "Close Up West" television programme on the BBC:
I asked a series of parliamentary questions last June, and was told by the Department of Health that revised guidelines were still being developed by the malaria advisory committee and that no publication date had been set. I assumed that the MAC was a statutory body, but it turns out to be a self-selecting volunteer group of about 40 experts, which has met eight times since 1980. I asked again in early February when the committee would report, and was told by the Minister for Health that the consultation process was "taking longer than anticipated".
A leading figure in travel health in this country who is a member of the committee has told me that she is very impatient for the new guidelines to be published, so that she can advise practice nurses, who are often the people who talk to the traveller, and that she is keen to ensure
that prophylactic drugs are taken far enough in advance so that any side effects can be ascertained. However, on BBC television on 6 March, Dr. David Bradley, the chair of the MAC, said:
It is important to ask what advice GPs give and what they say about Lariam. Dr. David Chisholm of the British Medical Association GPs committee, when asked whether he would take Lariam, said on BBC television:
When doctors working at MASTA found that the number of their clients suffering from side effects seemed to belie the one in 10,000 assertion, they conducted their own trial, and found that one in 140 were so affected by Lariam as to make them temporarily unable to carry out day-to-day activities. Hoffmann-La Roche disputes those findings. Dr. Gordon Cook says that the MASTA figure is nearer the truth, but that
A reply to a parliamentary question I tabled in July 1996 to the Secretary of State for Defence revealed that Lariam is not prescribed to service pilots and air crew, because of the possible side effects of dizziness or a distorted sense of balance. Furthermore, the Civil Aviation Authority has also stated that Lariam's
As long ago as April 1992, the WHO removed mefloquine from the recommended anti-malarial drugs list for duty troops visiting high-risk malaria areas, on the basis of its concern about neuro-psychiatric side effects. What about people such as train drivers or brain surgeons, who have jobs in which they cannot afford to suffer
dizziness, which require them to be in full command of their faculties? Those people go on holiday and take anti-malarial drugs, and the potential consequences are too awful to contemplate.
I am also concerned about the effects on children. Changes made to the precautions on the product data sheet in June 1993 included:
Dr. Gordon Cook has said that Lariam appeared to cause an especially adverse reaction in young women. I do not know to what degree Lariam has been tested on young women, or any women. They are certainly given the same dosage as men, never mind the difference in their weight ratio, and I gather that the drug was trialled on Thai soldiers.
The statutory body that assesses data and gives product licences in the United Kingdom is the Medicines Control Agency. It also monitors and evaluates reports of suspected adverse reactions. It is worth drawing an analogy with something that was called to my attention when I served on the Select Committee on Agriculture, when we found that the veterinary medicines directorate gave product licences to organophosphate dips, and it had to monitor the suspect adverse reaction. That is asking people who guarantee the safety of a product to seek evidence that they are wrong. The Agriculture Select Committee recommended that those two functions should be separated because of potential conflicts of interest; a similar recommendation should probably be made in this case.
All the information that I have sought to date from the Department of Health regarding the number and nature of trials that have been done on Lariam before and since licensing has been refused, on the basis of section 118 of the Medicines Act 1968, on the restriction on disclosure of information. That section lays down that information supplied to the licensing authority in connection with the application for, and granting and maintenance of, a product licence or clinical trial certificate must be kept in confidence by the licensing authority and its advisory bodies.
However, a book published by the MCA in 1993 called "Towards Safe Medicines" says that section 118 is intended to protect the commercial secrets of the pharmaceutical industry. It says:
There were three malaria deaths in the United Kingdom in 1990, and in the subsequent years there were 11, nine, four, 11, five, and 13 in 1996. The argument for retaining Lariam is based on the premise that the risk of not taking the drug are higher than those of suffering the side effects. There is anxiety that the MAC report may be being held
up because of the concern that malaria deaths might increase in time if people do not take Lariam, but effectiveness must be balanced with compliance. If people suffer serious side effects, they will stop taking the prophylactic. Resistance to mefloquine is already being reported in sub-Saharan Africa and the far east.
This matter has the makings of a Government health scandal. The Government are awaiting a report from a non-statutory body, which has no obligation to report, and whose chair has cast doubt on whether it will do so. The Department of Health appears to be doing nothing while purporting to wait for others to act. The Medicines Control Agency appears to be sitting on its hands because it and the Department are responsible for a failure, first to organise and prioritise the conclusions to be drawn from research and monitoring, and secondly to ensure that those priorities and conclusions are unambiguously conveyed to the public via the organisations that I have mentioned.
That the draft Courses for Drink-Drive Offenders (Experimental Period) Order 1997, which was laid before this House on 13th February, be approved.
12 Mar 1997 : Column 467
That the draft Property (Northern Ireland) Order 1997, which was laid before this House on 24th February, be approved.
That the Special Grant Report (No. 26) (HC 326), which was laid before this House on 27th February, be approved.--[Mr. McLoughlin.]
Question agreed to.
That the draft Deregulation (Provision of School Action Plans) Order 1997, which was laid before this House on 17th February 1997, be approved.
That the draft Deregulation (Occasional Permissions) Order 1997, which was laid before this House on 24th February 1997, be approved.--[Mr. McLoughlin.]
Question agreed to.
9.52 pm
That during the year ending on 31st March 1998 a number not exceeding 51,440 all ranks be maintained for Naval Service, and a number not exceeding 17,195 for Service in the Reserve Naval and Marine Forces.
Resolved,
That during the year ending on 31st March 1998 a number not exceeding 129,950 all ranks be maintained for Army Service, a number not exceeding 112,579 for Service in the Reserve Land Forces, and a number not exceeding 6,000 for Service as Special Members of the Reserve Land Forces under Part V of the Reserve Forces Act 1996.
12 Mar 1997 : Column 468
Resolved,
That during the year ending on 31st March 1998 a number not exceeding 59,100 all ranks be maintained for the Air Force Service, a number not exceeding 23,000 for Service in the Air Reserve Forces, and a number not exceeding 105 for Service as Special Members of the Reserve Air Forces under Part V of the Reserve Forces Act 1996.
Resolved,
That a sum not exceeding £215,096,760.90 be granted to Her Majesty out of the Consolidated Fund to make good excesses of certain grants for Defence and Civil Services for the year ended on 31st March 1996, as set out in House of Commons Paper No. 239.
Resolved,
That a further supplementary sum not exceeding £1,554,472,000 be granted to Her Majesty out of the Consolidated Fund to complete or defray the charges for Defence and Civil Services for the year ending on 31st March 1997, as set out in House of Commons Papers Nos. 238 and 334.
That a Bill be brought in on the foregoing resolutions: And that the Chairman of Ways and Means, Mr. Chancellor of the Exchequer, Mr. William Waldegrave, Mr. Phillip Oppenheim, Mrs. Angela Knight and Mr. Michael Jack do prepare and bring it in.
Mr. Michael Jack accordingly presented a Bill to apply certain sums out of the Consolidated Fund to the service of the years ending on 31st March 1996 and 1997: And the same was read the First time; and ordered to be read a Second time this day, and to be printed [Bill 130].
10.3 pm
The Humble Petition of the Conference of Religions of England and Wales with Action for Children campaign and other Citizens of the United Kingdom.
The second is
The Humble Petition of Citizens of the United Kingdom residing in Switzerland and elsewhere.
affirm our commitment to the principles of the United Nations Convention on the Rights of the Child which seeks to protect children from sexual exploitation;
and call upon Her Majesty's Government to seek to play an active role in bringing about concerted international action to tackle this problem and in particular to examine ways of ensuring that individuals involved in such exploitation are brought to justice within the United Kingdom;
wherefore, your petitioners pray that your honourable House do introduce legislation to ensure that citizens of the United Kingdom who commit serious sexual offences against children abroad can be prosecuted in this country.
10.5 pm
The Humble Petition of Members of the National Spiritual Assembly of the Baha'is of the United Kingdom with Action for Children Campaign and other Citizens or Residents of the United Kingdom,
To lie upon the Table.
sheweth
That we, the undersigned, hereby:
express our deep concern at continuing reports that citizens of developed nations travelling abroad may be encouraging the use of children in prostitution and pornography;
affirm our commitment to the principles of the United Nations Convention on the Rights of the Child which seeks to protect children from sexual exploitation; and
call upon Her Majesty's Government to seek to play an active role in bringing about concerted international action to tackle this problem and in particular to examine ways of ensuring that individuals involved in such exploitation are brought to justice within the United Kingdom.
Wherefore your Petitioners pray that your honourable House do introduce legislation to ensure that citizens of the United Kingdom who commit serious sexual offences against children abroad can be prosecuted in this country.
And your Petitioners, as in duty bound, will ever pray.
10.7 pm
"consulted a doctor in the Nairobi hospital who is considered to be the leading expert on Malaria in Africa and he told me that NO doctor in East Africa will recommend Lariam as they all consider it highly dangerous. I told him my doctor had recommended it and his reply was that UK doctors do not know what they are talking about. I am in the medical business and in frequent contact with doctors and I have not yet found a single doctor in Africa who will recommend Lariam."
As long ago as 1989, the World Health Organisation reported that mefloquine can cause severe mental disturbances, and that the reported side effects were a "cause for concern". Nothing to this effect was put in the product data sheet until 19 March 1996. Hoffman La Roche put out a press release on 16 March 1996 in which it blamed background depression as the cause of Lariam reaction. But the facts of acute neuro-psychiatric reactions in people with no previous history have been highlighted worldwide in many leading medical journals.
The person I know certainly has no previous neuro-psychiatric history, and was an extremely fit young man.
"There are some possible side effects that have been experienced by some people."
But surely people want to know how likely these are, how serious the effects might be, and how much testing has been done. On the BBC "Watchdog" programme, Dr. Peter Barrett--the MASTA director--said
"I have to say that personally I think I would probably tend to go for doxycycline in many of the areas where mefloquine might be used . . . I do find it difficult sometimes advising the use of mefloquine quite as widely."
Many experts also argue that Lariam may not be suitable for two to three-week holidays.
"I have no idea when we will reach a consensus or whether we will reach one at all."
It is safe to assume that there is a dispute about Lariam among acknowledged experts. The MAC held an emergency meeting on 25 March 1996, and it is right to ask whether that was because of increasing concern about neuro-psychiatric disorders. If that was when the committee last met, and if there has been no agreement nearly a year later, is the committee ever going to agree, and should not some other avenue be pursued?
"I would be reluctant to, because of the information that is reported to me and to all doctors about its safety profile and its side effects. Some of these side effects are serious and extremely unpleasant."
It must be admitted that there are disputes about the prevalence of side effects. Hoffman-La Roche has always claimed that the rate of serious side effects, defined by the company and by the WHO as leading to death, prolonged hospitalisation or significant disability, as one in 10,000. Dr. Gordon Cook, an expert on malaria at the Hospital for Tropical Diseases, has described that as "sheer nonsense".
"personal experience leads me to conclude that the true prevalence is more than that".
It would appear that wrangling over the definition of "serious" side effects may be another factor in the delay of the new guidelines that are awaited by travellers and all in the medical profession. My friend in Bristol would not be considered as suffering from serious effects according to the manufacturer, yet nearly a year later he cannot resume work.
"significant side-effect profile makes its use in aircrew inappropriate."
Surely that would lead a traveller on an aeroplane to ask, "If the pilot can't take it because it isn't safe, why should I be taking it? What is the pilot taking if he routinely flies to these areas, has stopovers and has not keeled over from malaria?"
"a statement indicating that use in children below 15 kg is not recommended."
However, a six-year-old girl died last year after suffering a severe reaction to Lariam, which she had been prescribed for a holiday in Nigeria. She developed a condition known as toxic epidermal necrolysis, which causes skin blisters and mucus in the eyes and nose. Her nails and hair fell out, and she died in intensive care.
"But where there is a safety issue the necessary information is given because the need to protect public health takes priority. Interpretation of this section is kept under review in the light of developments in the EC Single Market to enable more information about the licensing process to be made public."
An Internet trawl reveals adverse reactions and side effects reported from throughout the world.
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