Christopher Booker's Notebook
(Filed: 23/03/2003)

Drug trial multiplied infections fivefold
'Police state' in Cornwall
A perfectly legal poisoning
Moot money

Drug trial multiplied infections fivefold

A remarkable debate in the Commons on March 14 highlighted what has become an all-too-familiar scandal of our time: the ability of our government machine to protect itself against any attempt by a "whistleblower" to expose a failure of the system, however serious its implications.

In a powerful speech, Sandra Gidley, the Lib Dem MP for Romsey, used her expertise as a pharmacist to outline the case of one of her constituents, Dr Stephen Karran, a retired consultant surgeon. For eight years, he has been trying to unravel the murky story behind the misuse of a drug which put at risk the lives of hundreds of patients.

In 1988 Dr Karran, then working with Southampton General Hospital and Southampton University, was asked by Bayer, the giant German pharmaceutical firm, to test whether an antibiotic called Ciproxin could reduce the risk of surgical infection.

If it could be shown to be as effective in surgery as it was for other purposes, its sales worldwide could rise by several billion pounds.

Dr Karran's tests showed that, if Ciproxin was administered with other pre-operative drugs, these would severely impair its efficacy, putting patients seriously at risk. This was confirmed in a separate study by Professor Colin McArdle in Glasgow.

But a third, clinical trial by Dr Karran, also funded by Bayer, showed that if Ciproxin was given an hour before the other drugs, it would be safe, effective and cheap. These results were given to Bayer and to the forerunner of the Medicines Control Agency, the body which licenses drugs (and is funded by the pharmaceutical firms through the licence fees).

In 1993, as a member of the local medical ethics committee, Dr Karran saw that Ciproxin was to be tested on surgical patients in Southampton. He was astonished to discover that the MCA had given permission for a further trial, involving 850 patients in different hospitals, without inserting the vital stipulation that the drug be administered separately.

On Dr Karran's advice, this condition was imposed in Southampton, but he was shocked to find, in 1994, that it had been overruled. He eventually discovered, with difficulty, that the results were just as he feared.

Potentially life-threatening post-operative infection among patients on whom the drug was used in Southampton had soared to more than five times the normal rate, up from 5-10 per cent to 46 per cent.

The implications were alarming, and Dr Karran set out to discover how the system had failed so seriously. Had Bayer reminded the MCA of the results of the earlier tests? Why had the MCA ignored those results? Why had the results of the new trial never been published?

Why had the ethics committee's ruling that the drug should only be used well before other drugs been set aside? The head of the department suggested that nurses found it too time-consuming to give the drug separately, but hospital records showed otherwise.

For several years Dr Karran sought answers - from Bayer, from the MCA and from the hospital - to what should have been simple questions, but he met only obfuscation. He even visited Germany to raise the issue before 4,000 Bayer shareholders at their annual meeting.

Eventually he went to his MP, Sandra Gidley, whose experience as a pharmacist qualified her better than most to understand the problem. But, she told the Commons, her own repeated letters to Bayer and the MCA met such "a complete wall of silence" that, as she put it: "I smelt a rat."

As Mrs Gidley explained, there seems to be clear evidence of a complete failure of the system designed to protect patients. Not only were lives endangered; the false information given patients before their operations was in specific breach of their human rights.

And the refusal of David Lammy, a health minister, to answer any of her questions raises another, yet wider question: why has our system now become so unaccountable that a minister cannot tell the truth to the House of Commons, even when the implications for public safety are as grave as those revealed by Dr Karran?

'Police state' in Cornwall

Tony Blair and President Chirac may not have had much chance to discuss another Anglo-French rift now arousing intense anger in the South-West. This week's Fishing News carries the stark headline "Newlyn 'Like A Police State' ".

Cornish fishermen are up in arms over what seems to be a flagrant example of double standards, following draconian restrictions on cod-fishing imposed by Brussels to conserve supposedly vanishing cod stocks.

The seas around Cornwall are swarming with more cod than fishermen can remember for 30 years. Whenever a net is put down it comes up brimming with them. But so minuscule are their quotas that Cornish boats must dump hundreds of tonnes of cod dead back into the sea.

They can do nothing else because of the "reign of terror" by which the regulations are being enforced. In the words of the local fishermen's leader, Phil Trebilcock, the district's senior fisheries official, Colin George, backed by the fisheries minister, Elliot Morley, has turned Newlyn into "a police state".

Twelve boats have already had their licences suspended. When another skipper, Jonathan Turtle, suggested that a catch of £3,000-worth of cod that he and his crew could not avoid netting should be sold for Comic Relief, he was told that they must be chucked back.

What enrages the Newlyn fishermen even more, however, is the sight of a dozen French trawlers "filling their boots" with cod in the same Cornish waters and taking them back home without fear of reprisal, where they are openly advertised for sale.

But no doubt Mr Morley is proud to think he and his officials are doing their bit for "conservation" by ensuring that hundreds of thousands of pounds' worth of fish are being destroyed, along with the livelihoods of the Cornish fishermen.

A perfectly legal poisoning

Next Wednesday BBC1's The Food Police will feature Georgina Downs, a young singer who, as I reported last July, has fought a fearless campaign to expose the startling gap in the law which deprives members of the public of any protection from damage by toxic crop-sprays.

She and her parents suffered severe health problems from repeated exposure to pesticides drifting over their Sussex home and garden from the fields next door. Georgina was amazed to discover that, under EU law, the public have no right to any warning from farmers when such poisonous chemicals are used, or even to know which chemicals they have been exposed to.

When Georgina recently had a meeting with the farm minister, Lord Whitty, and his colleague Michael Meacher, she showed them a video of what her family must put up with. When asked whether he would personally find it acceptable, Whitty weakly agreed it could be "inconvenient and annoying".

The ministers promised to consider changing the law. But the fact is, as Georgina learned last year after showing her video to the Pesticides Advisory Committee, unless Brussels agrees, that there will be nothing British ministers can do about it.

Moot money

Somehow a confusion between North-East and West crept into last week's item on the chaos engulfing John Prescott's campaign for elected regional governments.

What I meant to say was that, following my earlier report on claims that the North-East Assembly is unlawfully using ratepayers' money from local councils to promote elected assemblies, Lancashire county council had commissioned a legal opinion on the use of its own contributions to the North-West Assembly (which has in fact been much less obviously promoting an elected assembly than its North-East counterpart).

When Eldred Tabachnik QC advised that funding was not lawful under the Local Government Act, Lancashire withdrew its funding. Two more councils, Cheshire and Fylde, last week followed suit.

Meanwhile the North-East Assembly's director, Stephen Barber, has assured Sunderland council that no ratepayers' money is being used to fund its promotion of an elected assembly. This money comes from central government.

But, as Neil Herron of the North-East Against A Regional Assembly has now explained to Sunderland, last July the local government minister, Nick Raynsford, specifically ruled that government funding must not be used for this purpose.

Promoting an elected assembly, Mr Raynsford wrote, "would be overtly political and is thus expressly excluded by the funding agreement". It looks like game, set and match to Mr Herron.