- Email: [email protected]
Imperial Cancer Research Fund and The Lancet
THE LANCET
COMMENTARY
CORRESPONDENCE Imperial Cancer Research Fund and The Lancet SIR—Richard Horton, in his Oct 11 Commentary,1 under the inappropriate and misleading headline “ICRF: from mayhem to meltdown”, makes a series of unjustified allegations against the Imperial Cancer Research Fund. In 1994 the Charities Commissioners offered guidance to the medical research charities that they should not only check the quality of publications based on research that they fund, but also ensure that important work is disseminated in an appropriate way. In respect of the Collaborative Group on Hormonal Factors in Breast Cancer’s report (Oct 11, p 1047)2 on the effects of hormone replacement therapy (HRT) on the incidence of breast cancer, this required introducing the results responsibly into the public domain. It was the role of the director of clinical research Peter Selby, working through the chairman of the ICRF prevention and control grouping Jack Cuzick, with the authors of the paper, to ensure that this was carried out satisfactorily. We worked hard to achieve those goals and, judging by the subsequent responsible media coverage, we succeeded. The publication was, we judged, one with a particular risk of causing public anxiety and distress. To keep these to a minimum we worked closely with the Department of Health, the Chief Medical Officer, and the chairman of the Committee on the Safety of Medicines. Because of the sensitivity of the issue, we took additional advice so as to ensure a proper and balanced content to our public presentation by consulting one of the paper’s authors, Richard Doll. He was involved, with Richard Peto, in drafting the news release, in consultation with the senior author Valerie Beral, and they both participated in the news conference panel, together with another author, Gillian Reeves. The aim was to minimise anxiety and distress, not to increase our fundraising profile; this is not merely an assertion but is a matter of record, as follows. In a letter to Beral on Sept 11, following the meeting with Doll, Selby wrote: “We . . . all recognise that there is a genuine concern that the publication of these data will promote serious anxiety among women who
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have been taking HRT and that we should do our utmost to keep this to a minimum and to ensure thorough briefing and good communication with the Health Departments and general practitioners. . . . We do not see this as a platform for fundraising or increasing the ICRF profile”. Furthermore, in a briefing note to all senior interested parties Selby recorded, on Oct 1, “ICRF policy is to take a cautious and responsible line and try to do everything we can to minimise the anxiety and distress that might be caused to women who have been taking HRT and everything that we can do to ensure that these women and their medical advisers have access to a good interpretation of the research paper. . . . It is not ICRF policy to seek to enhance our profile or achieve any fundraising advantage from the publication of this paper”. We informed the Department of Health of our concerns, invited their representatives to the news conference, and adopted the Committee on the Safety of Medicines’ views and guidance in the wording of our news release. It is against this background that the following allegation made by Horton should be considered. Horton writes that “decisions have been driven by greed for publicity and the fundraising image of ICRF seems to have become the charity’s over-riding priority”. This is contrary to the facts and is irresponsible for an influential journal of The Lancet’s standing. With respect to the Sunday Times article, I am completely in sympathy with Horton’s anger. On learning, late on Saturday evening Oct 4, that the newspaper intended to publish a report, I attempted to persuade the duty night editor not to do so. As Horton stated, the Sunday Times reporter Lois Rogers telephoned a senior ICRF employee, who wrongly broke the embargo by answering some of her questions. Appropriate action is being taken with the individual concerned. Horton implies that someone at ICRF may have sent a copy of the paper to the Sunday Times. Our internal and external inquiries thus far indicate that the newspaper’s source was in fact among the hundred or so authors outside ICRF. Much is made by Horton about Ardi
Kolah’s unsuccessful attempts to contact The Lancet. Kolah, head of ICRF’s communications department, was simply making arrangements for the news conference to take place at the time of the paper’s publication in The Lancet and wished to inform the journal of our plans. The further claim that ICRF’s scientists are not allowed to represent their data in the public domain is rebutted by the authors’ involvement in the news release and news conference as outlined earlier. The communications department was placed within the fundraising directorate because much of its day-today business is concerned with fundraising events and materials. Horton alleges that, with this move, ICRF is wilfully or inadvertently pursuing a policy of subordinating the presentation of scientific results to its fundraising message and profile. ICRF’s fundraisers neither seek nor are given responsibility for the interpretation of scientific data. Moreover, what Horton fails to mention is that when dealing with the public presentation of our research the head of communications is and always has been directly responsible to me. The inaccuracies, the failure to check facts, and the intemperate language of Horton’s Commentary are distressing. ICRF deserves an apology; The Lancet’s readers deserve better from its editor. Paul Nurse, Director General Imperial Cancer Research Fund, PO Box 123, London WC2A 3PX, UK 1 2
Horton R. ICRF: from mayhem to meltdown. Lancet 1997; 350: 1043–44. Collaborative Group on Hormonal Factors in Breast Cancer. Breast cancer and hormone replacement therapy: collaborative reanalysis of data from 51 epidemiological studies of 52 705 women with breast cancer and 108 411 women without breast cancer. Lancet 1997; 350: 1047–59.
SIR—We write as the senior officers of the Council of the Imperial Cancer Research Fund, the body of Charitable Trustees ultimately responsible for its affairs. We very much concur with Horton’s1 disquiet at the prepublication leak to a national newspaper of the report of the study published in The Lancet of Oct 11.2 However, we are both concerned and amazed at the interpretations Horton chooses to place on the
Vol 350 • November 29, 1997
THE LANCET
other events surrounding the publication. We entirely endorse the response made in the accompanying letter from the Director General Paul Nurse. Characteristically, Nurse has declined to comment on the attack you have made on him personally as Director General. Those who are acquainted with him will regard it as inconceivable that he would permit any tailoring of scientific interpretation, or of communication with the public of research results, so as to enhance fundraising at the expense of scientific evidence and the need for proper explanation of the findings. All the evidence we have at our disposal specifically negates your speculation. Furthermore, Council regards Nurse’s leadership since he took over the director generalship in September, 1996, as exemplary. We have sent your editorial and commentary, together with Nurse’s response and this letter to the Chief Charity Commissioner. *R D Cohen, T J H Clark, Nigel Althaus, John Skehel Imperial Cancer Research Fund, PO Box 123, London WC2A 3PX, UK 1 2
Horton R. ICRF: from mayhem to meltdown. Lancet 1997; 350: 1043–44. Collaborative Group on Hormonal Factors in Breast Cancer. Breast cancer and hormone replacement therapy: collaborative reanalysis of data from 51 epidemiological studies of 52 705 women with breast cancer and 108 411 women without breast cancer. Lancet 1997; 350: 1047–59.
Author’s reply In a letter to Ardi Kolah (head of communications, ICRF) dated Aug 29, 1997, Peter Selby (ICRF’s director of clinical research) wrote that the HRT overview “needs cautious interpretation if widespread panic is to be avoided with ladies stopping HRT all over the place. The absence of evidence for increased mortality and the likelihood of increased diagnosis not incidence needs more emphasis and specific cautions against over-interpretation would be wise. The importance of single vs combination HRT could be brought out more. For ICRF, Jack Cuzick should be the decider of our position and speak to the paper now and when published. That is his role” (underlinings in original). The final version of the paper—recall that the writing committee consisted of V Beral, D Bull, R Doll, T Key, R Peto, and G Reeves—was submitted to The Lancet over 2 weeks previously, on Aug 14. Selby’s letter was sent while the paper was undergoing qualitative and statistical peer review. Why was someone not responsible for either
Vol 350 • November 29, 1997
analysis of data or drafting of the report writing about the spin that the ICRF communications department should put on the HRT overview? Why, if “ICRF’s fundraisers neither seek nor are given responsibility for the interpretation of scientific data”, was this letter copied to Peter Vicary-Smith, head of ICRF fundraising? And why, given that Beral is the director of ICRF’s Cancer Epidemiology Unit, should Cuzick “be the decider of [ICRF’s] position”? The responses from Nurse and senior officers of ICRF’s Council thus raise many more perplexing questions than they answer. As Nurse points out, ICRF is justifiably anxious about any criticism it receives. In 1994, the UK Charity Commission concluded that ICRF’s “procedures for the supervision of research and control of the research results were not entirely satisfactory”. 3 years on, disconcerting problems still seem to exist, problems that should rekindle the charity commissioners’ concern. And readers might ask why, if Nurse and the members of his council are correct, no member of the overview writing committee has contacted The Lancet to support ICRF’s management of the HRT episode. Their silence seems telling. My principal charges remain unanswered. ICRF scientists do not have control over the presentation and interpretation of their data, as Selby’s letter to Kolah shows. The extraordinary attempts to induce The Lancet to collaborate with the ICRF communications department without the involvement of the HRT paper’s writing committee are dismissed too hastily by Nurse. Kolah’s first two telephone calls to me took place before the HRT paper was even accepted. How could he possibly have been calling, as Nurse claims, to make “arrangements for the news conference to take place at the time of the paper’s publication” when no decision to publish had been made? Nurse has been poorly informed about this sequence of events. Kolah’s Sept 29 letter to me (12 days after we had accepted the paper) invited a discussion about “how we will manage the publication” of the HRT overview; his concerns focused on “handling the publicity”. It is surely incredible that ICRF could allow any discussion about the publication of research conducted at one of their units without the full participation of the senior investigators. The fact that they were not invited to take part in that conversation and that Kolah first contacted us before The Lancet had made a decision to accept the overview
is surely proof that ICRF’s image comes before its science. Finally, although Nurse reassures us that it was not an ICRF scientist who leaked the paper, his response stops short of decisive action. ICRF’s “internal and external inquiries” need to be continued and published. Not to take this leak more seriously contradicts our shared view that the early disclosure of the paper led to an appalling mistake in the Sunday Times, London, UK with potentially damaging consequences to women. Richard Horton The Lancet, London, UK
SIR—We hugely enjoyed Richard Horton’s commentary1 about the ICRF. So have many of our concerned patients. It was beautifully composed, provided essential background information, and asked direct questions of the ICRF’s behaviour and motives. He does not comment upon the need for the Sunday Times to address the inaccuracies in Lois Roger’s original report (Sunday Times, Oct 5). Presumably, Horton thought that a correction would automatically appear. To state that the risk of developing breast cancer is 2·3 times higher, or more than double, that of non-users, rather than the relative risk being 1·023 per year of use—a hundredfold error— is so obvious that any reputable newspaper would have corrected it immediately. As far as we are aware the Sunday Times has issued no statement, correction, or apology. We have written but have had no response. The ICRF and the Sunday Times seem equally driven by a need for publicity, irrespective of accuracy, and are equally incapable of apologising when errors are made. It is difficult to understand why either organisation merits our trust or respect. *Malcolm Whitehead, Val Godfree Research Centre for Women’s Health, Amarant Centre at the Churchill Clinic, London SE1 7PW, UK 1
Horton R. ICRF: from mayhem to meltdown. Lancet 1997; 350: 1043–44.
Hormone replacement therapy and breast cancer S IR —In their meta-analysis of hormonal replacement therapy (HRT) and breast cancer the Collaborative Group on Hormonal Factors in Breast Cancer (Oct 11, p 1047)1 conclude that there was an increased cancer risk only among current or recent users, and that the tumours diagnosed in
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COMMENTARY
CORRESPONDENCE Imperial Cancer Research Fund and The Lancet SIR—Richard Horton, in his Oct 11 Commentary,1 under the inappropriate and misleading headline “ICRF: from mayhem to meltdown”, makes a series of unjustified allegations against the Imperial Cancer Research Fund. In 1994 the Charities Commissioners offered guidance to the medical research charities that they should not only check the quality of publications based on research that they fund, but also ensure that important work is disseminated in an appropriate way. In respect of the Collaborative Group on Hormonal Factors in Breast Cancer’s report (Oct 11, p 1047)2 on the effects of hormone replacement therapy (HRT) on the incidence of breast cancer, this required introducing the results responsibly into the public domain. It was the role of the director of clinical research Peter Selby, working through the chairman of the ICRF prevention and control grouping Jack Cuzick, with the authors of the paper, to ensure that this was carried out satisfactorily. We worked hard to achieve those goals and, judging by the subsequent responsible media coverage, we succeeded. The publication was, we judged, one with a particular risk of causing public anxiety and distress. To keep these to a minimum we worked closely with the Department of Health, the Chief Medical Officer, and the chairman of the Committee on the Safety of Medicines. Because of the sensitivity of the issue, we took additional advice so as to ensure a proper and balanced content to our public presentation by consulting one of the paper’s authors, Richard Doll. He was involved, with Richard Peto, in drafting the news release, in consultation with the senior author Valerie Beral, and they both participated in the news conference panel, together with another author, Gillian Reeves. The aim was to minimise anxiety and distress, not to increase our fundraising profile; this is not merely an assertion but is a matter of record, as follows. In a letter to Beral on Sept 11, following the meeting with Doll, Selby wrote: “We . . . all recognise that there is a genuine concern that the publication of these data will promote serious anxiety among women who
1626
have been taking HRT and that we should do our utmost to keep this to a minimum and to ensure thorough briefing and good communication with the Health Departments and general practitioners. . . . We do not see this as a platform for fundraising or increasing the ICRF profile”. Furthermore, in a briefing note to all senior interested parties Selby recorded, on Oct 1, “ICRF policy is to take a cautious and responsible line and try to do everything we can to minimise the anxiety and distress that might be caused to women who have been taking HRT and everything that we can do to ensure that these women and their medical advisers have access to a good interpretation of the research paper. . . . It is not ICRF policy to seek to enhance our profile or achieve any fundraising advantage from the publication of this paper”. We informed the Department of Health of our concerns, invited their representatives to the news conference, and adopted the Committee on the Safety of Medicines’ views and guidance in the wording of our news release. It is against this background that the following allegation made by Horton should be considered. Horton writes that “decisions have been driven by greed for publicity and the fundraising image of ICRF seems to have become the charity’s over-riding priority”. This is contrary to the facts and is irresponsible for an influential journal of The Lancet’s standing. With respect to the Sunday Times article, I am completely in sympathy with Horton’s anger. On learning, late on Saturday evening Oct 4, that the newspaper intended to publish a report, I attempted to persuade the duty night editor not to do so. As Horton stated, the Sunday Times reporter Lois Rogers telephoned a senior ICRF employee, who wrongly broke the embargo by answering some of her questions. Appropriate action is being taken with the individual concerned. Horton implies that someone at ICRF may have sent a copy of the paper to the Sunday Times. Our internal and external inquiries thus far indicate that the newspaper’s source was in fact among the hundred or so authors outside ICRF. Much is made by Horton about Ardi
Kolah’s unsuccessful attempts to contact The Lancet. Kolah, head of ICRF’s communications department, was simply making arrangements for the news conference to take place at the time of the paper’s publication in The Lancet and wished to inform the journal of our plans. The further claim that ICRF’s scientists are not allowed to represent their data in the public domain is rebutted by the authors’ involvement in the news release and news conference as outlined earlier. The communications department was placed within the fundraising directorate because much of its day-today business is concerned with fundraising events and materials. Horton alleges that, with this move, ICRF is wilfully or inadvertently pursuing a policy of subordinating the presentation of scientific results to its fundraising message and profile. ICRF’s fundraisers neither seek nor are given responsibility for the interpretation of scientific data. Moreover, what Horton fails to mention is that when dealing with the public presentation of our research the head of communications is and always has been directly responsible to me. The inaccuracies, the failure to check facts, and the intemperate language of Horton’s Commentary are distressing. ICRF deserves an apology; The Lancet’s readers deserve better from its editor. Paul Nurse, Director General Imperial Cancer Research Fund, PO Box 123, London WC2A 3PX, UK 1 2
Horton R. ICRF: from mayhem to meltdown. Lancet 1997; 350: 1043–44. Collaborative Group on Hormonal Factors in Breast Cancer. Breast cancer and hormone replacement therapy: collaborative reanalysis of data from 51 epidemiological studies of 52 705 women with breast cancer and 108 411 women without breast cancer. Lancet 1997; 350: 1047–59.
SIR—We write as the senior officers of the Council of the Imperial Cancer Research Fund, the body of Charitable Trustees ultimately responsible for its affairs. We very much concur with Horton’s1 disquiet at the prepublication leak to a national newspaper of the report of the study published in The Lancet of Oct 11.2 However, we are both concerned and amazed at the interpretations Horton chooses to place on the
Vol 350 • November 29, 1997
THE LANCET
other events surrounding the publication. We entirely endorse the response made in the accompanying letter from the Director General Paul Nurse. Characteristically, Nurse has declined to comment on the attack you have made on him personally as Director General. Those who are acquainted with him will regard it as inconceivable that he would permit any tailoring of scientific interpretation, or of communication with the public of research results, so as to enhance fundraising at the expense of scientific evidence and the need for proper explanation of the findings. All the evidence we have at our disposal specifically negates your speculation. Furthermore, Council regards Nurse’s leadership since he took over the director generalship in September, 1996, as exemplary. We have sent your editorial and commentary, together with Nurse’s response and this letter to the Chief Charity Commissioner. *R D Cohen, T J H Clark, Nigel Althaus, John Skehel Imperial Cancer Research Fund, PO Box 123, London WC2A 3PX, UK 1 2
Horton R. ICRF: from mayhem to meltdown. Lancet 1997; 350: 1043–44. Collaborative Group on Hormonal Factors in Breast Cancer. Breast cancer and hormone replacement therapy: collaborative reanalysis of data from 51 epidemiological studies of 52 705 women with breast cancer and 108 411 women without breast cancer. Lancet 1997; 350: 1047–59.
Author’s reply In a letter to Ardi Kolah (head of communications, ICRF) dated Aug 29, 1997, Peter Selby (ICRF’s director of clinical research) wrote that the HRT overview “needs cautious interpretation if widespread panic is to be avoided with ladies stopping HRT all over the place. The absence of evidence for increased mortality and the likelihood of increased diagnosis not incidence needs more emphasis and specific cautions against over-interpretation would be wise. The importance of single vs combination HRT could be brought out more. For ICRF, Jack Cuzick should be the decider of our position and speak to the paper now and when published. That is his role” (underlinings in original). The final version of the paper—recall that the writing committee consisted of V Beral, D Bull, R Doll, T Key, R Peto, and G Reeves—was submitted to The Lancet over 2 weeks previously, on Aug 14. Selby’s letter was sent while the paper was undergoing qualitative and statistical peer review. Why was someone not responsible for either
Vol 350 • November 29, 1997
analysis of data or drafting of the report writing about the spin that the ICRF communications department should put on the HRT overview? Why, if “ICRF’s fundraisers neither seek nor are given responsibility for the interpretation of scientific data”, was this letter copied to Peter Vicary-Smith, head of ICRF fundraising? And why, given that Beral is the director of ICRF’s Cancer Epidemiology Unit, should Cuzick “be the decider of [ICRF’s] position”? The responses from Nurse and senior officers of ICRF’s Council thus raise many more perplexing questions than they answer. As Nurse points out, ICRF is justifiably anxious about any criticism it receives. In 1994, the UK Charity Commission concluded that ICRF’s “procedures for the supervision of research and control of the research results were not entirely satisfactory”. 3 years on, disconcerting problems still seem to exist, problems that should rekindle the charity commissioners’ concern. And readers might ask why, if Nurse and the members of his council are correct, no member of the overview writing committee has contacted The Lancet to support ICRF’s management of the HRT episode. Their silence seems telling. My principal charges remain unanswered. ICRF scientists do not have control over the presentation and interpretation of their data, as Selby’s letter to Kolah shows. The extraordinary attempts to induce The Lancet to collaborate with the ICRF communications department without the involvement of the HRT paper’s writing committee are dismissed too hastily by Nurse. Kolah’s first two telephone calls to me took place before the HRT paper was even accepted. How could he possibly have been calling, as Nurse claims, to make “arrangements for the news conference to take place at the time of the paper’s publication” when no decision to publish had been made? Nurse has been poorly informed about this sequence of events. Kolah’s Sept 29 letter to me (12 days after we had accepted the paper) invited a discussion about “how we will manage the publication” of the HRT overview; his concerns focused on “handling the publicity”. It is surely incredible that ICRF could allow any discussion about the publication of research conducted at one of their units without the full participation of the senior investigators. The fact that they were not invited to take part in that conversation and that Kolah first contacted us before The Lancet had made a decision to accept the overview
is surely proof that ICRF’s image comes before its science. Finally, although Nurse reassures us that it was not an ICRF scientist who leaked the paper, his response stops short of decisive action. ICRF’s “internal and external inquiries” need to be continued and published. Not to take this leak more seriously contradicts our shared view that the early disclosure of the paper led to an appalling mistake in the Sunday Times, London, UK with potentially damaging consequences to women. Richard Horton The Lancet, London, UK
SIR—We hugely enjoyed Richard Horton’s commentary1 about the ICRF. So have many of our concerned patients. It was beautifully composed, provided essential background information, and asked direct questions of the ICRF’s behaviour and motives. He does not comment upon the need for the Sunday Times to address the inaccuracies in Lois Roger’s original report (Sunday Times, Oct 5). Presumably, Horton thought that a correction would automatically appear. To state that the risk of developing breast cancer is 2·3 times higher, or more than double, that of non-users, rather than the relative risk being 1·023 per year of use—a hundredfold error— is so obvious that any reputable newspaper would have corrected it immediately. As far as we are aware the Sunday Times has issued no statement, correction, or apology. We have written but have had no response. The ICRF and the Sunday Times seem equally driven by a need for publicity, irrespective of accuracy, and are equally incapable of apologising when errors are made. It is difficult to understand why either organisation merits our trust or respect. *Malcolm Whitehead, Val Godfree Research Centre for Women’s Health, Amarant Centre at the Churchill Clinic, London SE1 7PW, UK 1
Horton R. ICRF: from mayhem to meltdown. Lancet 1997; 350: 1043–44.
Hormone replacement therapy and breast cancer S IR —In their meta-analysis of hormonal replacement therapy (HRT) and breast cancer the Collaborative Group on Hormonal Factors in Breast Cancer (Oct 11, p 1047)1 conclude that there was an increased cancer risk only among current or recent users, and that the tumours diagnosed in
1627