[back] Professor Michael Baum

Professor Michael Baum: The Trials of a Cancer Doctor

 by Martin Walker MA

[Chapter Thirty: DIRTY  MEDICINE]

'No consideration was given to my personal circumstances, my possible wishes or my individuality 1

 'As a sick patient I am at my most vulnerable. I must have absolute trust in those doctors treating me'. 2

Like Vincent Marks, Professor Michael Baum comes from a 'medical family'; not long after he had helped set up the Campaign Against Health Fraud, his brother Professor Harold Baum joined.  Both Harold and Michael are very successful in their chosen fields. Unlike his brother's, Professor Michael Baum's career has not however been free from controversy. In fact, at the very time that he was helping to found the Campaign Against Health Fraud, which intended to disseminate information about science and medicine and put the case for clinical trials, he was at the centre of a major controversy over the issue of 'informed consent'. Criticism of Professor Baum had first been raised in an Observer article by Adam Raphael. The article brought to light, in detail, for the first time, the case of Evelyn Thomas who had been unwittingly subjected to a randomised drug trial in 1982 at King's College Hospital. Her consultant had been Professor Michael Baum.

† In 1986 Harold Baum and two other doctors were awarded a grant of over half a million pounds for the period 1986-7 by Wellcome. Harold Baum has also received funding from CRC, SERC, MRC, Nuffield, NATO, and Eisa Pharmaceuticals Ltd. Michael Baum has carried out most of his research work for the CRC and ICRF, but he has also received funding from ICI for work on Tamoxifen.

Conflicts between the patient's right to know and understand what is likely to happen to them, and the progress of medical science or the careers of surgeons, have been endemic to scientific medicine from its beginning. Such conflicts, although inherent in the everyday relation­ship between the physician and the patient, are brought into sharper focus in the circumstances of a drug trial. In the randomised and blinded trial, one group of patients are, unknown to themselves, given a non-effective treatment, a placebo, while others are given the treatment on trial.

At the heart of such conflicts is the single principle of 'informed consent'. A doctor who is completely open and honest with a patient, who gives the full information about the nature of the trial and the drug being used, before obtaining the consent of the patient, is unlikely to be criticised on ethical grounds. However, many doctors and scientists argue that to forewarn a patient about the exact nature of a trial is to reduce its scientific usefulness, increasing the chances of subjective responses distorting the outcome.

Drug trials are at the very heart of industrial medicine, and it is at this interface between the loyalty doctors feel to science and industry and the individual patient in need of care, that the most seminal medical conflicts emerge. Trials not only take place in hospitals but are also organised by general practitioners who can give unknowing patients new and unproven drugs. To organise drug testing in any other way would, according to orthodox doctors and scientists, involve bringing the individual's subjective response to illness into the relationship and erode the principles of science.

If patients were fully informed, there is a possibility they might refuse to take part in trials. Hard commercial considerations also come into the frame, some patients might take the view that medicine is not a philanthropic affair and by making themselves available for experimentation, they will in the long run help a drug company to make profit. This being the case, they might ask for payment commensurate with risk, or commensurate with the failure to be effectively treated. They might also ask for insurance contracts covering the eventuality of adverse effects or serious mishap. Such an eventuality would put the relationship of the doctor and the patient into a clearly different alignment than presently is the case; it would perhaps be a more honest relationship.

The pressure to introduce informed consent and to democratise drug trialling has inevitably opened up a market for agencies which recruit subjects for drug trials on a commercial basis. Governed entirely by commercial contracts, there is the possibility that the work of such trial centres and their recruiting agencies could exploit populations such as students, the unemployed, the low paid and captive populations such as prisoners. It has been estimated that in excess of 10,000 human volunteers were used for drug trials in 1988; they were paid fees of about £2million, by drug companies. 3

Hospitals which opt out of the National Health Service could well consider making a proportion of their money by using their facilities and patients for drugs trials. In 1988, it was estimated that individual doctors and hospitals in Britain were paid sums 'ranging up to £100,000 to test new drugs on human volunteers'. 4

Spurred on by two deaths in 1984, the Royal College of Physicians produced a report entitled Research on Healthy Volunteers in 1986.  They concluded specifically that large amounts of money should not be used as an inducement to get people to take part in trials and that all volunteers should be fully informed. The report, however, dealt only with 'healthy volunteers' and not with those people who turned to their doctor wanting treatment for an illness and later became the subject of a trial.

Many critics of scientific medicine believe that science and its needs should never take precedence over the rights of the sentient human being. They argue that one of the most fundamental human rights is the right not to be subjected unwittingly to experimentation. Another basic right is that, on turning to a doctor, a sick person should receive the most proven, effective and available treatment.

† Deaths occurred during drug trials in May 1984 and July 1984.5

* * * 

Evelyn Thomas (1932-89) came from a family of which four members had died of cancer; she herself was in her late fifties when she found out that she had cancer of the breast. After diagnosis, she went into King's College Hospital, one of London's most prestigious teaching hospitals, accepting the fact that she would have to have her left breast removed. The operation for the removal of a breast is called a mastectomy; one of the surgical alternatives to mastectomy is lumpectomy in which only the tumour and surrounding area IS removed from the breast.

Shortly after her operation, Evelyn Thomas noticed that the woman in the bed next to her, who had been through a similar operation, was being treated with a different regime. While her neighbour had received counselling and been given useful information, the counsellor, she said, had 'avoided me, and a breast prosthesis was given to me by a male fitter more used to fitting artificial limbs'. It took Evelyn Thomas four years to find out that she had been included without her consent in a trial, and a little longer to find out the full details of the trial, the treatment she had been given and the treatment she had been denied. †

† Evelyn Thomas claimed that besides the trial to which it transpired she was unknowingly subjected, she was also involved without her knowledge in a trial of surgical alternatives. However, although there had been at least one known mastectomy versus lumpectomy trial at Guy's Hospital, this trial had finished by 1982 when Evelyn Thomas was admitted to King's.

The randomised trials of which Evelyn Thomas had been a part were initiated in 1980 by the Cancer Research Campaign, under the auspices of Professor Michael Baum. They were titled the 'Collaborative trial for adjuvant systemic therapy in the management of early carcinoma of the breast'. Translated, this means simply that the trials were looking at supportive treatment following breast cancer surgery. Besides the granting and denial of counselling, two hormonal drug therapies, Tamoxifen and Cyclophosphamide, were given to the different trial groups.

The trials involved 2,230 women at thirty hospitals across the country between 1980 and 1985. None of the women involved in the trials were informed that they were subjects. The progress and condition of one group of women who were given the different treatments singly or in combination with or without the counselling, were compared with the condition and progress of another group who were given no adjunct treatments at all.

When Evelyn Thomas read about the results of the trial in 1986, it confirmed her suspicions that she had been part of a randomised trial. She was furious.

"I placed absolute trust in those treating me and assumed our relationship was based on openness and frankness. Actually patients at that time had their treatment determined by computer randomisation. My rights to have information and to choose, and my responsibility for my own body were denied. My trust was abused." 6

 Evelyn Thomas's anger was the anger of the just, and it was not to be placated by excuses later offered by doctors and others who sprang to defend the medical and scientific establishment. To further her argument, Evelyn Thomas quoted the Nuremburg Code, drawn up after Nazis had experimented on concentration camp inmates: 'the voluntary consent of the human subject is absolutely essential'.

The defence of those who had experimented on Evelyn Thomas without her consent was weak. King's College Hospital claimed that their Ethics Committee had originally stipulated that informed consent must be obtained. However, after a nurse counsellor pointed out that some patients became distressed when faced with the uncertainty of having to choose their treatment, informed consent was waived for all trial subjects who passed through the hospital. This explanation did not really tell the whole story. The trial administrators had been against allowing informed consent but had found themselves compelled to compromise with the Hospital Ethics Committee.

Following the compromise, the trial administrators arranged for women coming into King's for this serious and frightening treatment, to be asked the night before their operation for their consent to be included in the trial. The raising of this complex and worrying issue on the eve of an awesome operation threw most women into a state of immobility and confusion. The majority declined to be included in the trial. When the poor results of trial subject selection were brought to the attention of the Hospital Ethics Committee, they withdrew their demand for informed consent.

In the public debate which followed Evelyn Thomas's campaign, Professor Michael Baum, who headed the trial and was Thomas's consultant, failed to tackle the important issue and chose instead to take offence at the wording of Evelyn Thomas's complaint as it was presented in the Observer:

Professor Baum said that he deeply resented Mrs Thomas's charges (that her trust had been abused) as he was one of the leading advocates of giving patients greater information. 7

Only six years previously, Baum had entered his patients into the trial without obtaining their informed consent. In a long letter to the Observer the week following Adam Raphael's first article, 8 Baum claimed that, with hindsight, Evelyn Thomas was not actually denied any treatment, because after randomisation she had been one of the subjects given Tamoxifen. He side-stepped the mention of counselling, which some would consider a vital aspect of recovery, and of which Evelyn Thomas was deprived.

† Another future member of the Campaign Against Health Fraud, the barrister and medical journalist Diana Brahams, makes the same irrelevant comment in the aftermath of the Evelyn Thomas case, saying that as it turned out, she got the 'preferred regime'. 9

In his attempts to defend himself, Professor Baum went through intellectual contortions, drawing attention to such facts as: 'Mrs Thomas was a victim of breast cancer, not of human experimentation.' 10 This was not denied. What was in question was Professor Baum's right to administer or withhold experimental treatments to patients without their consent. In the same letter to the Observer, Baum complained that the paper used a photograph of him which made him look like Mussolini. In a debate which touches upon mastectomy and its resultant problems for the patient's self image, such a remark might be judged vain in the extreme.

In his letter, Baum asks what he considers to be the seminal question of the debate: 'Was her [Evelyn Thomas's] treatment in any way compromised by my concern to improve the quality of cancer care for future generations of women?' Again, he evaded the central issue. While it is clearly within the authority of a physician to ruminate in the abstract about what mayor may not be best for future generations, in the present it is the patient's choice of treatment, not the doctor's, which is primary. Many patients may not wish to make the same personal sacrifices as Professor Baum for the glory of medicine's future.

Also writing to the Observer in support of Michael Baum was Caroline Richmond. Richmond, who made clear her friendship with Baum, argued in favour of science and randomised clinical trials, while at the same time failing to address the matter of informed consent. 'I respect and admire Professor Michael Baum of King's College Hospital, and was disturbed by Adam Raphael's one-sided report last week.' 11

† In May 1992, Caroline Richmond reported a surgeon to the police and the Director of Public Prosecutions, after he performed a hysterectomy on her, without informed consent, during the course of a routine operation.12

Richmond's letter was sent from the Wellcome Institute for the History of Medicine and was written in the same month that she called the first steering committee meeting of the Campaign Against Health Fraud, of which Baum was a member and which was to campaign, amongst other things, for randomised clinical trials.

When Evelyn Thomas found that she had been used as a guinea pig, she complained to the South East Thames Regional Health Authority. The complaint was dealt with by professional medical and health workers, whose system of complaints investigation makes the Police Complaints Authority look like something from the Magic Roundabout. Her case was reviewed by two assessors, a cancer specialist and a consultant surgeon. The cancer specialist who oversaw the complaint was a close colleague of Baum, and another future member of the Campaign Against Health Fraud, Professor Tim McElwain. Unsurprisingly, the professional review found that Evelyn Thomas had been treated in a correct and professional manner.

* * *

Regardless of what many doctors say in public, those like Michael Baum who are involved in and under pressure from the drugs industry, are secretive about drug trials and their accountability, or lack of it, to the patient. Doctors involved in drug trials see themselves as a beleaguered community.

Despite a number of deaths which have occurred as a consequence of uninformed trialling † throughout the eighties, attempts to change medical research methodology have not been completely successful.

 † In 1982, an 84 year old widow died after having been involved in a secret randomised trial, in Birmingham. 13 In 1983, another trial patient died; the woman had been reluctant to take part in the trial. 14

Carolyn Faulder, a writer with a history of taking up women's issues, has been writing about breast cancer since 1977. In 1986, she was the first person to publicise the case of Evelyn Thomas. The circumstances of Carolyn Faulder's involvement with the Evelyn Thomas case and the issue of informed consent are ironic.

In December 1980 Carolyn Faulder was invited by Professor Baum to sit on a Cancer Research Campaign committee, 'The Working Party on Breast Conservation', which serviced the 'Breast Cancer Trials Co-ordinating Sub-Committee'. Carolyn Faulder was invited, Michael Baum said in correspondence, as 'a member of the public to help us with our deliberations on "informed consent" '. 15

The breast conservation working party was formally set up in 1981, to prepare the protocols for a further trial which measured the effectivity of mastectomy against lumpectomy similar to the one which had been carried out earlier at Guy's Hospital. The new trial was to take place at the Rayne Institute, the trial centre at King's College Hospital where Professor Baum was the consultant. It was due to begin in 1983.

Carolyn Faulder accepted the invitation to join the working party, thinking that she could make a real contribution to the debate about informed consent. Besides Professor Baum, the Working Party on Breast Conservation included some of the most influential heavy­weights of the cancer industry.†

† A number of these doctors were to appear in the late eighties aiding the Campaign Against Health Fraud to attack the Bristol Cancer Help Centre, in particular Dr Jeffrey Tobias and Dr Lesley Fallowfield. See Chapter Thirty Six.

Carolyn Faulder's time on the working party began well; she was treated courteously, and apparently included in the important discussions. Over the five years that she remained a member of the committee, however, she became increasingly uneasy about the reality of informed consent and her use to the committee. More than anything else, her involvement as a well-known woman writer and adviser appeared to fulfil a useful public relations role for the doctors, who did not appear that interested in changing their own ideas about the scientific method.

In 1983, at the time the new trial began at King's, Carolyn Faulder wrote an article entitled 'A Conspiracy of Silence'. 16 Before it was submitted, the article was shown to members of the working party, some of whom felt that it was 'too hard on members of the medical profession'. Carolyn Faulder, seeing the consensus in the group turn against her, made it clear to the committee that it was her article, and though she was willing to 'soften' some of its points, she would not change its central theme.

After 1983, and the article, the feeling in the working party became hostile to her, with disagreements being expressed about her criticisms of doctors, both inside and outside the group. For her part, Carolyn Faulder had become so concerned about information coming to light during her ongoing research into informed consent, that she began work on a book.

When women were properly informed about the trial at King's, few of them wanted to take part in it. After just over a year, with only 160 women signed up for the trial, the administrators were forced to close it down. With the trial closed down, the working party also became imperilled because its sole job had been to work out protocols for the trial.

As far as Carolyn Faulder was concerned, the working party could not close down a minute too soon. By late 1984, some members of the working party had all but stopped speaking to her. In October, at a working party meeting, from which she was absent, Dr Jeffrey Tobias expressed considerable dissatisfaction with Carolyn Faulder's role on the committee. The minutes record him as saying: 'Although Ms. Carolyn Faulder had been recruited to the working party to introduce the subject [informed consent] to the National Press, it would seem that a disproportionate emphasis was now being placed on the issue.' 17

When she saw these minutes, Carolyn Faulder was hurt and amazed; the comment had reduced her role on the working party to one of public relations. It crossed her mind that this may have been the role the group had in fact wanted her to perform. She re-read the letter from Professor Baum, in which it was unambiguously stated that she was invited onto the group so that she could give her advice and help about informed consent from the patient's point of view.

Before the working party was closed down in early 1985, Carolyn Faulder forced an apology and a retraction of the minuted remarks. The atmosphere had become so bad that she felt she was being deliberately ignored. Later that year, Carolyn Faulder's book Whose body is it? was published by Virago. 18

In 1986, Carolyn Faulder was able to redress the balance in the case of Evelyn Thomas, by helping to get her case made public. Even then, it was not until 1988, six years after she was the subject of the trial, that her case was taken up by Adam Raphael and became a real issue of concern.

1. Evelyn Thomas. 
2. Evelyn Thomas, cited in the Observer, 2 October 1988. 
3. Clayton, Paul. Evening Standard Magazine, January 1992. Raphael, Adam. Wanted: human guinea pigs. Observer, 2 October 1988. 
4. Ibid. 
5. Ibid. 
6. From unpublished writings of Evelyn Thomas. 
7. Observer, 9 October 1988. 
8. Observer, 16 October 1988. 
9. Brahams, Diana. Informed consent and randomised controlled trials. Law Society Gazette, 25, 28 June 1989. 
10. Observer, 16 October 1988. 
11. Ibid. 
12. Daily Mail, 29 June 1992. 
13. Brahams, Diana. Death of a patient who was unwitting subject of randomised controlled trial of cancer treatment. Lancet 1982; i: 1028-9. 
14. Brahams, Diana. Lancet 1984; i: 1083-4. 
15. Correspondence between Michael Baum and Carolyn Faulder. 
16. Faulder, Carolyn. A conspiracy of silence. Good Housekeeping, February 1984. 
17. Minutes of the Working Party on Breast Conservation, October 1984. 
18. Faulder, Carolyn. Whose body is it? The troubling issue of informed consent. London: Virago, 1985.