NO BABIES, JUST MAD COW DISEASE

Alasdair Palmer discovers an appalling saga of cover-up

and confusion involving infertile women, plundered corpses, the Department of Health and multinational drug companies

'IF THEY had told me they were going to inject me with a drug derived from the pituitary glands of human corpses, I don't think I would have gone through with it. I was desperate to have a child, but not that desperate.' Patricia McKay, a woman of 48 who looks at least ten years younger, sipped a cup of herbal tea. 'But no one told me a thing about what I was getting. I was just told the drugs would help me to ovu- late properly, and that would increase my chances of getting pregnant. I trusted the doctors, who didn't seem interested in explaining anything more.'

Because her own doctor didn't tell her, Mrs McKay does not know for certain whether or not she was injected with the serum derived from human corpses. If she wasn't, she will have nothing to worry about. If she was, the treat- ment might kill her. For she then stands a chance a chance no expert is able to quantify, but all recog- nise as real — of develop- ing Creutzfeld Jakob Disease (CJD).

There are some possibilities so horrible that merely contemplating them sends shiv- ers down the spine. Death from CJD is cer- tainly one of those. 'It feels a bit like someone has put a gun to my head and won't tell me if it's loaded with bullets or blanks,' Mrs McKay said. 'The only way I can find out is when they pull the trigger.'

Patricia McKay is one of hundreds of women in a state of more or less perpetual anxiety about the existence of those bullets. Like them, she first became aware of the gun at her head last September, when announcements were made on the radio and television: the Department of Health was eager to contact women who may have been treated with a fertility drug derived from pituitary glands. Those who had been treated were at risk of developing CJD. The announcement suggested that women who wanted more information, or coun- selling, should contact a help-line in Sheffield. Mrs McKay decided to contact her GP. He looked at her notes. Yes, she had had treatment in 1974 at one of the hospitals which had used the pituitary- derived drug. But, no, it wasn't clear from the records whether she had been given the offending treatment, or a similar one which also involved injections but not of a pitu- itary-derived product. She should call the Sheffield help-line.

She did. An efficiently official voice at the other end sounded reassuring. 'We're going through all the details right now. We await information from the hospitals. We'll get back to you in four to six weeks.'

It was not a pleasant wait. Headaches, pins and needles, spells of mild dizziness they could all be interpreted as the onset of the fatal disease. The attempt to stay calm was not helped by the arrival of a dour Patient Information Fact Sheet from the Department of Health which posed, and offered answers to, seven questions, none of which helped Mrs McKay determine whether or not she fell into the fatal group. The two weeks passed, slowly. There was a call from a woman at the help- line — but not with news. She merely apologised for its absence and reiterated the promise that they would contact Mrs McKay as soon as they knew, which would be in a month.

A month passed, and there was no call from the help-line. Mrs McKay dialled the number again. This time, there was no reassuring female voice. There was an answering machine. She left a mes- sage and waited for the help-line to return her call. When two more weeks had passed and she still hadn't heard, she called again. This time there wasn't even an answering machine: the phone simply rang unanswered, until Mrs McKay had to hang up.

That was October 1993. It is now nearing the end of February 1994. Mrs McKay has heard nothing from the Department of Health for nearly five months. Her GP has contacted the office concerned in an attempt to squeeze out information, but he fared no better than she did. She still awaits an answer: is the gun loaded with bullets or blanks?

It was the Department of Health who first alerted women like Mrs McKay to the risk that they might be infected with CJD. The failure to reassure promptly those who were not in any danger, and to help those who were, looks like another awful NHS bureaucratic bungle. It should not be too difficult to identify exactly who had the dangerous treatment. All that the depart- ment has to do is look up the files — not exactly a demanding task. What excuse can there be for keeping hundreds of women in agonising suspense for months on end?

'It's not that we're lazy, or inefficient, or don't care,' counters Professor Ian Cooke, the doctor at Sheffield's Jessop Hospital in charge of the programme to track down and counsel the women treated with the corpse-derived fertility treatment. 'It's that we actually don't know. And we don't seem able to find out.' It seems incredible, but the Department of Health is not able to locate the records which would enable its officials to determine who has been treated with the dangerous drug, and who has not. 'It's not incredible at all,' explains Profes- sor Cooke. 'The treatment was abandoned nine years ago. There is no legal obligation to keep records for longer than eight years. That's sensible, both for reasons of space and because the overwhelming majority of clinical problems related to drugs or other forms of treatment present themselves in that time.' But not, unfortunately, CJD, which has an incubation period of up to 25 years.

So the Department of Health decided to warn thousands of women that they might have been treated with the corpse-derived drug, knowing that it could never tell them whether they actually had or had not? It sounds a peculiarly refined form of bureau- cratic torture.

'You don't understand,' says an exasper- ated Professor Cooke. 'The point of the announcement was to try and track down recipients of the dangerous drug.' But the department must have known that it could not locate the records which would enable its officials to determine who those women were. 'Many of the clinicians were not in favour of the announcement. It was a min- isterial decision.' As it was, the response was overwhelming.

'We had twenty thousand calls on the first day,' sighs Professor Cooke. 'Even when we had sixty-five operators in place, we still had three hundred calls queuing.' No one seems to have had the foresight to predict that if you announce that you're trying to identify which women had a cer- tain kind of potentially lethal fertility treat- ment, you may generate anxiety in a large section of the population. The result of that lack of foresight was as chaotic as one would expect. Mistakes were made in the most painful ways. Women who had not had the treatment were told they had, whilst women who had been given the dan- gerous drug were told they had not, only to receive a call later explaining that . . . um . . . actually there was a possibility that they fell in the at-risk group.

The whole debacle could have been avoided if the women who had been treat- ed with the drug had been told of the risk they faced when the Chief Medical Officer first recognised it — which was in 1985. In that year, two deaths from CJD were unambiguously attributed to a drug used to promote growth in children. That drug, like the fertility treatment, was prepared from the pituitary glands of corpses. Pituitary glands were identified as the source of the infection.

It was decided not to inform women in 1985 — although at that time it would have been perfectly feasible to track down and identify who was at risk. According to the Department of Health, the decision to keep quiet was taken because it was felt an announcement would only generate anxi- ety. Which, of course, is exactly what the decision to break the news in 1993 did. The difference is that in 1985 the anxiety would have been confined to those who had actu- ally had the treatment. In 1993, it was not.

There may have been other, less altruis- tic motives for official silence in 1985. CJD had been identified as a possible risk from corpse-derived products, including pituitary glands, since at least the mid-Seventies. An article in the New England Journal of Medicine had shown that whatever it was that transmitted CJD, it wasn't killed by normal sterilising procedures. Dr Alan Dickenson, a British expert on scrapie, the sheep version of CJD, wrote to the Medical Research Council warning of the dangers of using preparations derived from pitu- itary glands.

Dr Ann Stockle-Hartree, who was in charge of the preparation of pituitary- derived products at the Medical Research Council Laboratory in Cambridge, was concerned about the risks. She felt the pro- gramme was not paying enough attention to the dangers, and, having had her pleas ignored, or been told they would be too difficult or costly to implement, she asked to be transferred out of the project. That was in 1979, five years before the deaths 'Fancy a dance?' from CJD forced the abandonment of the treatment. When I asked her about this, Dr Stockle-Hartree politely but firmly told me she 'could not speak about it. My employ- ers have instructed me not to.' She still works for the Medical Research Council. The council seems also to have persuaded her not to give evidence at the inquest into the death from CJD of a recipient of a pituitary-derived product.

The decision not to inform the women in 1985 could have ominous public health implications. Professor Michael Preece, who has been involved in the project to contact those who received the pituitary- derived growth drug, told me, 'We felt that, apart from considerations deriving from the right to know, there was the vital fact that these people had to be instructed not to become organ donors. If they were infected, they might infect the recipient. They might also give blood. Though the evidence is against thinking that CJD can be transmitted in blood, no one can be absolutely certain.'

What made the Department of Health change its mind and go public on the dan- gers of the fertility drug in 1993? Simply the fact that by then it was no longer possi- ble to keep it secret. Too many people had died from CJD as a result of pituitary- derived treatment: 45 worldwide, including ten in the UK alone. CJD in two women had been specifically traced to the fertility treatment. One of them died in the UK, though both had been treated in Australia.

However benign the idea behind it, the result of the eight-year cover-up is exactly what the Department of Health sought to avoid: the creation of widespread panic. The department says it cannot dispel that panic because it can't find the records. But David Body, a solicitor representing some of those who have already died of CJD, finds it hard to believe that it is impossible to discover exactly who had the dangerous fertility treatment. 'Do you think if these people were suspected of not paying income tax that the Inland Revenue couldn't find them? You can nearly always trace people. It's simply a question of how many resources you're willing to put in.'

He's also adamant that the Government should set up a compensation scheme for the families of those who have died — and will die — from CJD contracted as a result of medical treatment. So far, the Govern- ment has paid out £96 million in compen- sation to farmers whose cows have been infected with mad cow disease, the cattle form of CJD. 'And how much has it offered the families of the humans who have died? Nothing. The Government insists that it will contest every case. We're going to have to prove someone was negli- gent if we're going to win anything for these families.' It is a revealing glimpse of the Government's priorities.

Proving that medical negligence was involved in the preparation of the pituitary glands from corpses will be a long and expensive process. Since most of the plain- tiffs will be legally aided, it will also cost tax-payers' money — money which many will feel would be better spent simply on compensating the families. The French have already set up a scheme for their vic- tims, who are going to receive around £200,000 each.

The Department of Health does not emerge from the episode smelling of roses. Pituitary glands were indiscriminately har- vested from mortuaries. Around 70,000 were required a year. Mortuary assistants were even given a financial incentive to remove pituitaries: 50p per gland. These were the days before the Human Tissue Act, so the legal situation was murky, but even so there seems to have been no attempt to get permission from relatives for the operation. And it is unclear how the Department of Health could 'buy' the glands from the mortuary assistants when they were not theirs to sell.

But at least the Department of Health stopped the manufacture of drugs derived from pituitary glands as soon as people who had received them started dying of CJD in 1985. That was unfortunately not true of other European countries. The French went on using the drug for four years after it was shown to be potentially lethal. Sure enough, France now has the highest rate of CJD in the world. The doc- tor in charge of the programme, Jean Claude Job, is now under indictment for 'accidental homicide'.

Even more depressing is the behaviour of one of the commercial manufacturers of corpse-pituitary-derived drugs. The Specta- tor has obtained a copy of a letter from Nelson Bento, a marketing director for Serono, a multinational drug company headquartered in Geneva and with offices in Welwyn Garden City. The letter, written in Portuguese, is addressed to doctors in Brazil and dated 1991 — six years after corpse-pituitary-derived products were shown to carry the risk of CJD contamina- tion. It stresses that 'patients who cannot afford the synthetic product can now opt for Grorm (Serono's pituitary-derived growth hormone), which, apart from being secure and efficacious, will cost less than half the price'. The letter makes no men- tion of the possibility that a patient using the product might end up dying of CJD. It ends with the hope 'that this information will help your patients with less buying power'.

Serono, like other companies, was dealt a cruel.blow by the discovery that pituitary- derived drugs were a possible cause of CJD. Large markets for their product col- lapsed. Serono was left with a significant investment in machinery and expertise ded- icated to producing the drug. Unable to sell the drug in most of the developed world, Serono continued to market the product in countries like Brazil, stressing the considerable price advantage of the corpse-derived drug over the synthetic alternative. A spokesman for Serono emphasised to me that because of the com- pany's special manufacturing procedure, scientists had shown that the chances of anyone being infected with CJD from Serono's product were infinitesimally small. `And so far no one has been shown to have got CJD from Serono's product.'

But Professor Bryan Matthews, one of the world's greatest authorities on CJD, argues that that could be simply because of the long latency period of the disease, which may last up to 25 years. He was appalled when I informed him that Serono had been actively marketing the human product only two years ago. 'There is no way of being sure that products derived from human pituitary glands are safe. No one can be one hundred per cent certain. It simply isn't possible. The tests are all done by analogy with animal versions of the dis- ease, like scrapie. You have to make a whole string of assumptions about the application of those results to the human disease, each of which can be criticised. When you know that there is a risk involved with the corpse-derived product — and when there is a perfectly safe syn- thetic version — how could any rational person choose the human product, still less try to persuade others to do so?'

Professor Pocchiari, one of the independent scientists whose work Serono cites in defence of its policy, points out that his study shows that Serono's product is much safer than the serum used by the NHS. But he agrees that 'you cannot be one hundred per cent sure of the product's safety — but then you can't be one hun- dred per cent sure of the safety of any drug'. All the same, Professor Pocchiari was surprised to hear that the company was still marketing the drug in 1992. He thought it had been withdrawn years earli- er. Would he inject Serono's product into his daughter? 'Very difficult question . . . No.'

Serono's spokesman stressed that the company had now stopped manufacturing the drug — which suggests that Serono may have now changed its mind about the drug's 'security and safety'. It would be interesting to know how many of the direc- tors of Serono would be happy to use Serono's product on themselves or their families. I suspect the number would be rather fewer than those who were happy to market it to children in Brazil, Japan and Spain — countries in which Serono was certainly marketing its pituitary-derived product two years ago.

Meanwhile, in this country, there are scores, and possibly hundreds, of women who, as a result of the Department of Health's actions, are going to have to live with not knowing whether or not they are at risk of developing CJD. Patricia McKay seems to be coping. Others may not be so lucky.

Alasdair Palmer is home affairs editor of The Spectator.