Skip to Content

Patients and Medical Journals: From Objects to Partners

ByRichard Smith, former editor of the BMJAugust 5, 2020

The relationship between doctors and patients is undergoing a profound change, which is reflected in medical journals. Until recently patients expected to do as the doctor told them. The doctor was an authority. Now patients and doctors are becoming partners — sharing uncertainty and decision-making. This change can be uncomfortable for both parties, but the evidence shows that with such a partnership patients do better and costs are lower. Medical journals have reflected this change by moving from a world where patients’ involvement with journals was to be described within them, usually without consent, to a world where patients are partners in creating journals. I mustn’t pretend that the changes within medicine and journals are complete. They are not. The changes are messy, patchy, often backwards rather than forwards, and still have a long way to go.

When I was training in medicine in the early 1970s we usually did not tell patients that they had cancer. We’d mutter something to them about ‘a small growth’ and tell the relatives that the patient had cancer. I never stopped to think at the time that this conflicted fundamentally with the ethic that the doctor’s relationship with the patient was confidential.

I remember too watching a television programme where a professor of surgery worked with actors who acted out a real case. The professor had operated on a man and discovered that he had inoperable cancer. He asked to see the man’s wife and daughter. They were naturally anxious. ‘Is everything all right? Did the operation go well?’

‘Everything is fine’, answered the role playing professor. ‘The operation went very well. I’m afraid, however, that Mr Jones has cancer and that we won’t be able to cure it.’

‘This is the technique of the Spanish inquisition’, said a commentator on the television after the role play was over. ‘You tell the victim that everything is fine and follow it up with the bad news.’

This was also a world where it was routine for students as part of their training to perform vaginal examinations on anaesthetized women without their consent. A study of medical students in Bristol published at the beginning of 2003 shows that unfortunately this world still exists (256).

In 1974 I went to Africa as a medical student. A friend and I planned to do a study on gastritis in Africans. We wanted to put tubes into patients’ stomachs and take samples. We didn’t think about consent from patients either for the procedure or for participation in an ‘experiment’ — an experiment which in retrospect was scientifically hopeless and therefore, I would say now, unethical.

I don’t think that either my friend (now a consultant cardiologist) or I were bad people. Indeed, we thought of ourselves as highly principled. We were very concerned about injustice in the world. I tell these stories to illustrate how unconsciously we adopted practices that now seem almost barbaric.

Most doctors practising today trained in a world where patients were expected to follow the commands of doctors, not to ask too many questions, and to be grateful for the attention they received. In fact, of course, patients often ignored the commands of doctors, but they pretended to comply. About one-half of patients, for example, do not take the drugs they are prescribed in the way that doctors advise (111). It isn’t easy — for either doctors or patients — to change from the old world to the new world of partnership. The tendency is always to slip back.

I can remember when as an editor I was expelled — hardly too strong a word — from the old world. It was the early 1990s, and we had published a picture that looked like six stones. In fact they were pieces of fetal skull that had leaked out from the uterus of a woman who had had a termination of pregnancy some months previously that had gone wrong. The gynaecologist had failed to remove all of the fetus. I’m not sure all these years afterwards why we wanted to publish such a picture — but it was probably because it was a dramatic story and had some lesson, albeit an unoriginal one. There was probably, if I’m honest, some ‘freak show’ element to the decision.

Some weeks after the publication I was rung by the woman. Her sister was a nurse and had seen the picture and recognized the story. We hadn’t, of course, published the woman’s name, but we had published the names and addresses of the doctors who had sent us the report. It was easy for the woman and her sister to be sure that this was the woman’s story. And what to us was a picture of six stones was to the woman a picture of her dead baby — a lost baby for whom she was still grieving. Plus she was suing the doctors who had performed the termination. She was both furious and very upset that we had published the picture. ‘I feel like killing myself’, she told me.

We simply hadn’t thought through our actions. We did what we had always done and what other journals did. We never published the names of patients, but we didn’t think it necessary to get consent. We might ‘anonymize’ the story as much as we could by cutting out detail, and some journals would even change a few facts in order to make it more difficult to identify the case. But the journal was intended for doctors, and the vast majority of readers wouldn’t be able to identify the patient. We somehow overlooked the fact that we tended to publish only case reports that we thought were remarkable in some way. They would thus always be identifiable to some people, particularly to the patient. Plus a journal like the BMJ is seen by hundreds of thousands of people, many of them not doctors. Indeed, now that the journal is available in full text and for free on the World Wide Web almost anybody can access the journal.

The Lancet had a similar experience. It published a hugely important paper that gave details on the first patients to develop new variant Creutzfedlt-Jakob disease — the ‘human form’ of bovine spongiform encephalopathy (‘mad cow disease’) (257). This paper was important for science, public health, politics and business. It was the first clinical evidence that an animal disease caused by prions (infectious agents made only of protein) could cross to humans. It might presage (and still could) an epidemic that could kill hundreds of thousands. The British government was greatly embarrassed because it had repeatedly said that there was no risk of the disease crossing from cows to man. The effect on business was a dramatic drop in the consumption of beef and a worldwide ban on British beef exports.

The Lancet study, which must have been carefully scrutinized by hundreds of thousands of people, gave fairly limited information on 10 patients. But it wasn’t difficult to identify patients because deaths from new variant Creutzfedlt-Jakob disease were of course very rare. One patient happened to be from a religious group who were not supposed to eat meat, and the paper made it clear that she had done. The published paper thus included information that seemed innocuous to most readers (and to the editors) but which was highly damaging to the girl’s memory and her family.

Doctors generally, or at least in Britain, became more aware of this problem of disclosing information about patients without consent when in 1995 three doctors were accused of serious professional misconduct for doing so. They had published a study in the British Journal of Psychiatry that described three patients with bulimia nervosa who had bled themselves (258). The journal included the information that one of these patients was ‘a 26-year-old preregistration doctor’. Perhaps nobody should have been surprised when a story appeared in the Aberdeen Press and Journal giving the medical history of the junior doctor. She was not named but a friend identified her.

The doctor made a complaint to the General Medical Council about the three authors. She had given consent for her case to be used in research but not to be published. ‘I would absolutely not have given the go ahead to the article which appeared. I was very shocked, very angry, very upset. Several things stated in the article were untrue. They were really hurtful and judgemental because they blocked out everything I had based my healing and therapy on because it was based on trust’ (259).

The council held a public hearing but did not find the doctors guilty of serious professional misconduct. This case — and the changing climate — did, however, lead the council to issue guidance on the subject. If any doctors were today to publish a paper like that in the British Journal of Psychiatry then they probably would be found guilty of serious professional misconduct.

The council, the International Committee of Medical Journal Editors and various journals, including the BMJ, shifted in the mid 1990s from a policy of anonymizing reports to requiring written consent from patients (81, 260, 261). Patients should see what was written about them before publication. The argument behind this policy is that patients rightly assume that information disclosed in their relationship with doctors is confidential. Such information needs to be confidential so that patients are willing to tell doctors everything. Only then can doctors be fully helpful to patients, understand their problem, make the correct diagnosis and advise the best treatment. The confidentiality of that information extends to every use of it, including publication in a medical journal. Breaching confidentiality requires the consent of the patient.

Some thought this policy extreme. It would stand in the way of science. Sigmund Freud, some said, would never have been able to publish his classic case reports with such a policy. Public health doctors were worried that it might be impossible to report cases that could be of great importance for public health. The needs of individuals were being put before those of the broader community. Forensic psychiatrists were worried because their discipline is based very much on detailed case reports of the activities of highly disturbed people who had committed serious and often gory offences. Would it ever be possible to get informed consent from such patients? And what about confidential inquiries, where doctors examined in detail cases where things had gone badly wrong — perhaps mothers had died in childbirth or patients had died on the operating table? Such inquiries are very important for the progress of medicine.

Perhaps most difficult of all — and this problem is far from solved — what about consent for the publication of family trees, an essential part of genetics? They may give very important (and possibly damaging) information on large numbers of people. Clearly it could be extremely distressing for people to learn from a medical journal that they might have serious genetic traits that they didn’t know about. (I do not know of a case of this happening, but it surely could.) But could it ever be possible to get consent from everybody included in a family tree, including perhaps people who had no idea that they were at risk? An option might be to leave out some members of the family tree, but this could mean publishing untrue and scientifically misleading information. Readers will understand why the problem is not solved.

I know of a case where doctors had tested the fetus of pregnant women for Huntington’s disease without the consent or even knowledge of their partners. Huntington’s disease is a condition that leads to early dementia and severe neurological problems. It is genetically dominant, meaning that if one of your parents has the condition you have a one in two chance of developing the disease. The doctors, with ethical guidance, had decided that they would test the women, and they — rightly — thought that a paper should be published so that the dilemma could be widely discussed. The journal decided that it could not publish the case reports without the consent of the partners, and such consent could clearly not be obtained. Part of the argument was that it was possible to discuss the general problem without disclosing information on specific cases.

One response that I as an editor make to critics who think the policy of obtaining consent extreme is that patients almost always will give consent. People want to be helpful. My next response is that there could be circumstances where the public benefit from publishing is so great that it would be right to override the objections of a patient to publication. This is analogous to the circumstances where a doctor might judge it right to break confidentiality. I’ve already referred to the hypothetical case of a jumbo jet pilot who refuses to report his epilepsy. But it is hard to think of an analogy for such an urgent need for publication, and I don’t know of an example. One example might have arisen if one of the patients who first had AIDS had denied consent to publication. But there was a series of patients, and was it necessary to report all of them?

Because this is such a complex subject on which to have simple rules editors have both toughened and weakened their policies. The BMJ toughened — or at least clarified — its policy after a high profile court case. We had published a very dramatic radiograph of a patient’s skull with a long knife embedded in the skull. The patient had made a remarkable recovery and given written consent for the publication of the picture in the BMJ. Problems arose when the radiograph was presented in the trial of the man who had stabbed the patient. The media, unsurprisingly, were keen to reproduce the picture, and somebody made a connection between the trial and our picture. Despite the patient not wanting the radiograph reproduced in the mass media, they simply took (perhaps I should say stole) it from our website. Some asked permission. We denied it, but they still took the picture.

We threatened to sue the media for breach of copyright and to make complaints to the various regulatory authorities — like the Press Complaints Commission. We thought that the media should have the same standards as us and use the pictures only with written consent. The case was, however, complicated by the pictures having been presented in court. This perhaps meant that they could be reproduced. We didn’t pursue the case, but we did introduce a consent form that made clear to patients who gave us consent just how widely the pictures would be distributed and what the risks are. So now authors must get patients to sign the BMJ‘s consent form rather than produce one themselves.

The BMJ‘s policies were also made less stringent. We had problems with brief anecdotes that we publish in the journal. These anecdotes are often about patients. They tell a story, usually with some sort of lesson. But they are slight, sometimes amusing, often strange, and very much about the art rather than the science of medicine. Readers like them a lot, and we had many submitted. Many are stories from years ago or from brief encounters in distant places. Did we need to get written consent for these as we did for contemporary case reports? We thought that sometimes we probably didn’t need to, and we introduced a set of conditions for when consent wasn’t needed (82).

We could not, we concluded, produce completely specific guidelines on when we might be able to publish a patient’s story without consent. The decision depends on balancing the importance and interest of the information against the likelihood that a patient might be damaged. Publication without consent may be acceptable in the following cases:

  • The patient is long dead and has no living relatives.
  • The interaction with the patient was long ago — perhaps more than 15 years.
  • Because the interaction was long ago and the patient was elderly or terminally ill, the patient is likely to be dead.
  • The piece is to be published without the authors’ names attached, making it unlikely that anybody could identify the patient.
  • All extraneous information that might help identification is excluded.
  • Even if the patient were to identify himself or herself, the events described are unlikely to cause offence. We must remember, however, that it is difficult to know what will cause offence: some patients will be offended simply by the fact that the information they gave to their doctors was published without consent.

Various authors and editors still thought that these guidelines were still too restrictive and insufficiently clear. We thus took the issue to our ethics committee, and it agreed with the critics. There were two particular cases that prompted a debate. One was a story of a doctor briefly encountering a patient in a very poor country in South America. The story was poignant and illustrated the extreme difference between what patients in the rich and poor world might expect — an issue of the greatest importance. Another case told the story of a doctor in a patriarchal society failing to convince a father that his daughter ought to be allowed to attend school.

The committee drafted the following policy:

  1. Publication of any personal information about a patient will normally require the consent of the patient. This will be so even if identifying details are removed.
  2. Personal information about a patient will not be published over the patient’s refusal, except in the most exceptional circumstance of overriding importance to public health.
  3. Publication without the consent of the patient will be permitted if all of the following conditions are met:

a)  The patient who is the focus of the article is untraceable without an unduly burdensome effort and it is also impossible or unreasonable to expect consent to be obtained from the patient or the patient’s next of kin.

b)  The article contains a worthwhile clinical lesson or public health point which could not be as effectively made in any other way. (‘Worthwhile’ is intended to sit on a spectrum between ‘interesting’, which is the publication threshold with patient consent, and ‘overriding public health importance’, which is the publication threshold over patient refusal.

c)  A reasonable person in the patient’s position would not be expected to object to the publication of the case. (This requires an assessment of the intrusiveness of the disclosure and the potential that it has for causing the patient, or the patient’s family, embarrassment or distress. Particular attention must be paid here to differences of cultural and social attitudes. It must not be assumed that what is a matter of indifference in one society will have the same status in another.)

d)  The risk of identification of the patient is minimized by measures designed to prevent the identity of the patient being revealed either to others or to the patient himself or herself. (These measures will include anonymization of the case and/or the author. The publication without consent of photographs will require particular scrupulous attention to anonymization.)

The BMJ is auditing these guidelines, and it might well be that they will prove to be more restrictive than those they replaced. Requirement 3b may well disallow pieces that could have been published under the previous policy. The committee applied these criteria to the two particular cases that had prompted a review of the policy. It recommended publication of the case from South America but recommended against publication of the case of the patriarchal family on the grounds the patient might well be embarrassed and so a reasonable person would object to publication.

One issue that arises repeatedly is the BMJ‘s apparent ‘double standard’ when it comes to the news section of the BMJ. The BMJ has a policy of publishing a picture on every page of the news section — to make the pages look ‘newsy’ and to distinguish them from other parts of the journal. (This in itself gives rise to objections: ‘If you didn’t publish all those silly pictures you might have had space to publish my important paper.’) Sometimes the BMJ publishes pictures of patients on the news pages, and we did so without signed consent. These pictures, we argued, did not arise from the doctor-patient relationship, and so there was not the same logic of breaking confidentiality without consent. News photographers do sometimes get some form of consent, but it is not the same quality of consent as we expect for information about patients coming from doctors. Next, nothing would be gained by the BMJ declining to publish photographs that are in the public domain. So we do have a ‘double standard’, but it is thought through and intentional. We debated the ‘double standard’ with the ethics committee, and it supported the policy.

Another issue that flows from the policy is whether or not doctors are entitled to the same kind of confidentiality as patients. So if a patient wants to tell stories about their interactions with doctors, does the BMJ need consent from the doctors? The answer is ‘no’. The duty of confidentiality runs one way.

Patients sometimes want to tell stories about doctors because they are highly critical of doctors. Journals are interested in improving medical care and so should be interested in stories of things that have gone wrong. In the credo of continuous quality improvement ‘every defect is a treasure’ — because it shows a route for improvement. Journals must be careful, however, of ‘trial by media’. If serious accusations are made against people — as I’ve argued in chapter 8 with research misconduct — they have a right to due process being used in any hearing. Journals cannot apply due process.

The BMJ‘s policy did, however, allow us to publish stories of poor practice where the point of publication is not to accuse the doctors involved but to allow learning. We anonymized the stories, but we knew that anonymization is not 100% effective. That’s why we needed consent from patients, but we did not from doctors in these circumstances. This upset some doctors who argued that ‘there are two sides to every story’ and that we were telling only one side. A particularly sore point was that if doctors wanted to respond to criticisms of themselves that they had identified then they might be restricted from doing so because they were bound by confidentiality when the patient was not. We debated this issue with our ethics committee and agreed that if we were going to publish stories by patients that were critical of doctors then we should ask the patients to agree — in writing — that if the doctors should choose to respond they were not bound by confidentiality.

The publication of material about individual patients is a very direct concern of journals, but they are also concerned with the quality of informed consent in studies that they publish. This is primarily a concern for ethics committees or institutional review boards (as they are called in the United States), but, as I argue in chapter 18, journals also have a role. We did not accept that a study was automatically ‘ethical’ because it was approved by an ethics committee.

The Committee on Publication Ethics (COPE) dealt with a case where it thought that an ethics committee — or at least its chairman — had behaved unethically (262). A journal was considering for publication a study that involved an allergic challenge to a group of children known to be allergic. A reviewer thought the study unethical because he could not believe that parents would consent to a study where their children might experience a severe allergic reaction and even die. The editor agreed and investigated.

He discovered that the ethics committee had recognized the problem and asked for further expert advice. But instead the author talked to the chairman of the ethics committee and convinced him that the study was part of normal clinical practice and so did not require ethics committee approval. The study went ahead, and the information leaflet given to parents did mention the possibility of an allergic reaction but did not mention the possibility of death. The editor’s judgement was that the test was not part of normal practice and that parents had not been adequately informed. He asked the authorities to investigate.

In 1997 the BMJ became embroiled in what proved to be a rich and productive debate over studies where patients have not given informed consent (263). We published two such studies in one issue together with a collection of articles arguing that we were very wrong to do so and another collection arguing the opposite (264-272). The journal received some 50 letters in response, most of them remarkably well argued, and they split 50-50 into those who thought us wrong and those who thought us right (273). Subsequently we held a conference that extended the debate beyond research into clinical practice and education, and in 2001 we published a major book on informed consent in medical research (274).

The issue of informed consent leads back inevitably to the Nuremberg trials that followed the Second World War. Nazi doctors had conducted wholly unacceptable experiments on people, many of them Jews. The Nuremberg Code, which emerged in the final judgement of the trials, determined that consent for research was essential and should be voluntary, informed and prospective.

Later the World Medical Association built on the Nuremberg Code and produced the Declaration of Helsinki. It distinguished between ‘non-therapeutic’ and ‘therapeutic’ research and was less than absolute in the requirement for informed consent in therapeutic research. The version that was current when the BMJ published the two studies that did not include informed consent allowed doctors sometimes to do without informed consent in the context of ‘medical research combined with professional care (clinical research)’ (275). There is a general requirement for informed consent, but a ‘let out’ paragraph said: ‘If the physician considers it essential not to obtain informed consent, the specific reasons for this proposal should be stated in the experimental protocol for transmission to the independent committee.’

Both the studies that the BMJ published complied with the Declaration of Helsinki and both were approved by ethics committees. One of the studies, from Edinburgh, investigated whether ‘stroke family care workers’ made life better for patients with stroke and their families (265). The authors decided against seeking consent for the experiment because they thought that a full understanding of what was being investigated would bias the result of the experiment, making it impossible to conclude anything with confidence. In addition, the authors couldn’t see how being looked after by the ‘stroke family care worker’ could be harmful and the patients and their families could always decline to see the worker.

Sheila McLean, a professor of law and ethics in medicine, argued that their reasons were insufficient to justify deviation from the general rule that good research must at all times respect the subject (266). ‘Any failure,’ she writes, ‘to offer this respect is in itself a harm, even if its consequences are not physical.’ People are being treated as objects not people.

The second study, from South Africa, looked at whether patients infected with the human immunodeficiency virus (HIV) did worse when admitted to an intensive care unit than patients not infected (267). This was an important question because many intensive care units would not admit patients infected with HIV — partly because they thought that they would inevitably do badly. The scarce resource of intensive care should be kept for those who could most benefit. Patients did not give consent to be in the study or to have their blood tested for HIV. The authors argued that consent could not be obtained from most cases because they were too sick and that the research was of such importance that the patients’ right to informed consent could be waived (268).

The chairman of the ethics committee explained in an accompanying commentary why the committee supported the research after its immediate reaction that it would not be possible to give ethical approval (269). The explanations included the facts that the study entailed no interventions of any sort different from those that are necessary and are carried out in standard intensive care, and that the injury done to the patients would be small.

Rajendra Kale, an Indian neurologist at the time but now an editor at the BMJ, argued that the ethics committee was wrong to approve the research and that the BMJ was wrong to publish it (270). He thought that such research would not have been allowed in a fully developed country and worried that it may be too easy to flout fundamental human rights in the developing world.

Editors at the BMJ were divided on whether we should publish these papers. In the end we decided that, rather than restrict the debate to ourselves, we would do better to invite our readers to join in. (This is something we did regularly and might be described as a ‘value’ of the journal.) We accompanied the papers together with an argument from Len Doyal, a professor of medical ethics, that the BMJ should not in future publish papers like these (271). He proposed a policy that all medical journals might follow.

‘Our abilities to deliberate, to choose, and to plan for the future are,’ he wrote, ‘the focus of dignity and respect which we associate with being an autonomous person capable of participation in civic life.’ To deny patients participating in research full information on that research was, he argued, a clear breach of their moral rights. He then examined the arguments against fully informed consent: patients may be distressed by detailed information; it may not be necessary when the risks of the research are negligible; and the interests of the public in medical progress will be undermined by too much emphasis on the rights of individual patients. He found all these arguments unconvincing.

But he then identified three sets of circumstances in which informed consent may not be necessary. First, so long as a set of conditions are met then research might be allowed without consent on patients not competent to give consent — including children, patients with learning difficulties, and unconscious or semiconscious patients. Otherwise, such patients might be denied the benefits of research. Second, epidemiological research on medical records might be acceptable in certain strict circumstances when, for practical reasons, consent could not be obtained. Third, research without informed consent might sometimes be acceptable on stored tissue from anonymous donors.

Jeffrey Tobias, a radiotherapist and researcher, argued that the BMJ was right sometimes to publish studies where patients had not given informed consent (272). His argument revolved around the facts that patients trust their doctors and that what is clear in ‘fine and lofty places’ like the letters pages of medical journals was much less clear in the ‘real world’, where ‘the doctor must somehow juggle the multiple responsibilities of expert, humane, and above all respectful support for the patient … with the wider healthcare concerns and requirements of society as a whole’.

The patient’s voice was provided with an anonymous patient who was included in 1987 in a British trial of a new radiotherapy protocol for cervical cancer without being asked for fully informed consent (267). She suffered severe consequences from the treatment and later discovered that she was one of many patients who had been included in trials without consent. She felt abused and quoted another patient who wrote, ‘Somewhere, somehow, I have to expose this abuse of power. The doctors never got my informed consent. This is abuse of society’s most vulnerable people. Where is there a platform for my voice to be heard, to make the public aware and the establishment accountable?’

One point that was raised repeatedly by researchers in the correspondence was the hypocrisy of demanding elaborate consent for research while accepting that consent within clinical practice is rudimentary. (At our conference a professor of surgery put up a slide of a signed consent form that said, ‘Removal of right leg.’ It was supposed to say, ‘Removal of varicose veins from right leg.’) Much of the time doctors are working with inadequate evidence. The best treatment is not clear. If — in an ethically responsible way — a doctor decided that she ought to conduct a trial then she would need to get ethics committee approval and fully informed consent for not only the different treatment options, perhaps including a placebo, but also for randomization — and randomization often doesn’t feel comfortable to patients. If, however, the doctor chose to follow her hunch she would probably simply get consent for the treatment she recommended. (She should really explain all options plus her uncertainty, but doctors rarely do this.) Those who want the easy life — and most do — will not opt for research.

When the furious debate that followed the BMJ issue that included the trials without consent began to abate we asked Len Doyal and Jeff Tobias whether they wished to change their position (277). Neither did. We also sought the help of others, including Mary Warnock, one of Britain’s leading philosophers who chaired Britain’s Committee of Inquiry into Human Fertilization. She argued that ‘the principle of non-exploitation has come to seem to many to be by far the most important moral principle that should govern research using human subjects’ (277). She thought it a ‘misuse of words’ to suggest that not obtaining informed consent in itself constituted a harm, ‘sometimes it amounts to exploitation, sometimes it does not’. She encouraged editors to continue to live in a morally hazardous world, to shun dogma and to follow a prayer from Hertford College Chapel, ‘to distinguish things that differ’.

This encouragement was impossible to resist because morally hazardous worlds are, I believe, right and proper for journals. Dogma is not only dangerous but also boring. Reflecting the world from which we are slowly emerging, we largely forgot about the voices of patients themselves first time round. This time we commissioned several to comment. Heather Goodare, who had been a participant in the notorious Bristol Cancer Help Centre study (see chapter 2), argued that we should take a strong line and reject all studies that do not include informed consent (277). Lisa Power, health advocacy manager for the Terrence Higgins Trust (an AIDS charity), asked us to consider the broader issue of patients in planning research and thought that ‘any hard and fast rule that the BMJ made about publication would probably have to be broken at some point’ (277). Hazel Thornton, chairwoman of the Consumer’s Advisory Group of Clinical Trails, took a similar line: ‘Collaboration is the name of the game. Research is for the benefit of us all: all should be involved in debates about its improvement and promotion’ (278).

Patients, in other words, should cease to be ‘subjects’ — ‘human guineapigs’, as Maurice Pappworth called them in his book on how patients had been abused by researchers (see p. 226) — and become ‘participants’. They should be part of the planning, designing, carrying out and interpreting of research. This does, of course, depend on learning new skills and jargon, and there is an anxiety that by the time that the patients have learnt what is necessary they are no longer patients. I have, however, watched many ‘patients’ make important contributions to research that could not have been made by researchers who didn’t have that patient perspective. Such people will, I hope, be one of the major audiences for this book.

We decided at the BMJ to continue not having an absolute policy on informed consent in studies but rather to make up our minds on the merits of particular cases.

The Declaration of Helsinki was substantially revised in 2000, and it doesn’t now have the ‘let out’ clause that allows doctors to forego informed consent when they think it right in the context of therapeutic research (279). It does touch on the very difficult question of where research and clinical practice merge, requiring the doctor to make clear what is research.

The declaration is now much more specific on what is meant by ‘informed consent’:

‘In any research on human beings, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail. The subject should be informed of the right to abstain from participation in the study or to withdraw consent to participate at any time without reprisal. After ensuring that the subject has understood the information, the physician should then obtain the subject’s freely-given informed consent, preferably in writing. If the consent cannot be obtained in writing, the non-written consent must be formally documented and witnessed.’

This is, I’m sure, a counsel of perfection. I doubt very much that consent is obtained in this way in every trial. The declaration does elsewhere allow research without consent when patients are too sick to give it.

The study that the BMJ published on ‘stroke family care workers’ would not, I think, be acceptable with the revised declaration (264). It does not allow researchers to avoid consent in order to improve the scientific quality of their study. It might perhaps be argued that the introduction of the care worker was part of routine practice (see below), but I think not. The study of the patients infected with HIV in intensive care in South Africa might perhaps be allowed under the revised declaration (267).

Those who drafted the new declaration (and did it well, I judge) clearly had difficulty drafting the section on the point where practice and research merge. As the following passage shows, doctors can when necessary venture into the unknown when treating a patient — but they must get informed consent and would need to make the uncertainty clear. The declaration also urges that doctors try to make the exploration research. Again, this is a counsel of perfection. Doctors are regularly in the unknown and usually do not share their uncertainty with patients. Even less often do they turn their uncertainty into research.

‘In the treatment of a patient, where proven prophylactic, diagnostic and therapeutic methods do not exist or have been ineffective, the physician, with informed consent from the patient, must be free to use unproven or new prophylactic, diagnostic and therapeutic measures, if in the physician’s judgement it offers hope of saving life, re-establishing health or alleviating suffering. Where possible, these measures should be made the object of research, designed to evaluate their safety and efficacy. In all cases, new information should be recorded and, where appropriate, published.’

Together with lain Chalmers, one of the founders of the Cochrane Collaboration, I have described a way in which what the Declaration of Helsinki advises could begin to become a reality (280). All doctors (and perhaps all patients) would be supplied with information on what the evidence says on medical problems. Doctors in many countries already have access to such information — for example, through the Cochrane Library or Clinical Evidence. If no evidence is available then the doctor and patient would look to see if a trial was underway. Already there are registers of trials underway. If a trial was underway, the patient might decide to enter the trial. There is evidence that patients in trials do better than patients receiving routine treatment, even if they receive a placebo. If no relevant trial could be found then the doctor would inform a central database of questions arising in practice. In this way research could then be concentrated on the questions arising in practice. This too is a pipedream — but an achievable one.

Interestingly, the revised declaration now puts duties onto authors and publishers (but not, surprisingly, editors):

‘Both authors and publishers have ethical obligations. In publication of the results of research, the investigators are obliged to preserve the accuracy of the results. Negative as well as positive results should be published or otherwise publicly available. Sources of funding, institutional affiliations and any possible conflicts of interest should be declared in the publication. Reports of experimentation not in accordance with the principles laid down in this Declaration should not be accepted for publication.’

So publishers who allow editors to turn down negative studies as ‘boring’ are now in breach of the Declaration of Helsinki. I doubt if you could find a single publisher who is aware of this responsibility.

The revised declaration is a very progressive document, although it ran into problems by suggesting that placebo controlled trials were often unethical. I will discuss this further in chapter 15 on medical journals and the developing world. The progressiveness of the declaration is shown by the following short paragraph: ‘The subjects must be volunteers and informed participants in the research project.’

Patients, although somewhat confusingly called ‘subjects’ in the first part of the sentence, are to become ‘informed participants’. The declaration doesn’t explain what it means by this, but it is, I think, the future of medicine and medical journals. Perhaps the next revision of the Declaration of Helsinki will be drafted not by an organization of doctors but by one that has a much broader representation.

‘Nothing about me without me’, is the slogan of those who believe that patients must become partners in healthcare. Wherever decisions are being made that will affect patients they must be there. It applies at every level — the interaction of individual doctors and patients, the setting of clinical policies, the planning of healthcare, and every aspect of research.

There are broadly three ways in which doctors and patients can make decisions. First, the patient might describe his or her symptoms, and the doctor will then decide what should be done. This is how medicine has been mostly practised. Second, the doctor and patient will decide together the best thing to do, or, third, the doctor could offer advice but the patient will decide. During a morning’s work when a doctor might see 20 patients decisions will probably be made in all three ways. Clearly if the patient is unconscious then the doctor will decide (although relatives might well be involved or the patient might have left an advanced directive, ‘a living will’), and different patients like different ways of making decisions. The same patient will want different sorts of decisions made in different ways: if I’m sick and weak I might prefer the doctor to decide; but if I’m deciding whether or not to take a drug for high blood pressure for the rest of my life then I’d either like to decide myself or to decide with the doctor.

The current trend is very much in the direction of doctors and patients making decisions together, which is not always easy for either the patient or the doctor. After a professional lifetime of taking decisions on behalf of patients it isn’t easy for doctors to change.

Doctors like to think that they fully understand the needs of patients, and they resent any suggestion that they and their practices are not ‘patient-centred’ in the new jargon. But there is a growing mountain of evidence that doctors and patients do not see the world in the same way. Let me illustrate with four stories.

‘For doctors Parkinson’s disease is mostly above the neck, something to do with the substantia nigra. For patients it’s mostly below the waist. Can they walk? Can they get their knickers on? Are they continent? Can they have sex?’ These are the words of Mary Baker, former chief executive of the Parkinson’s Disease Association and once the patient editor of the BMJ. It’s the same, much evidence suggests, for other conditions. Doctors and patients think differently and have different concerns. This theme is further illustrated by personal accounts of doctors of their own illnesses. Stereotypically, they read: ‘Until I had X I never knew what it was like to be a patient. Now I do. This illness has changed me forever as a doctor.’ My thought is that it doesn’t. After a while they are back to being doctors again. This [is] not a fault. It is the way of the world.

Or consider the story of a colleague Rhona (told with her consent). She is a doctor in her early 30s and has a severe and unusual form of scleroderma. Rhona has had the fingers amputated on both hands. Her bowel is also severely affected. She is very thin and needs repeated blood transfusions.

The specialists who look after Rhona were shocked by the severity of her disease. They thought that everything possible must be done if not to cure her then to hold back her disease. She’s so young. They have tried aggressive, experimental treatments — with little success, it has to be said — and they want to try more. Rhona is far from keen. For her work is very important, and she doesn’t want to lose time from work undergoing poisonous treatments. To Rhona quality of life is more important than quantity.

Despite Rhona being a determined person and despite her doctors being caring, she has had the greatest difficulty getting this message across to her doctors. To them she has a serious disease that must be fought. She is much too young to be giving so much emphasis to work and putting quality before quantity of life. Her doctors, I’m sure, consider themselves patient-centred, but they are not — at least in her case at the moment.

My third and fourth stories are about the system rather than individuals. Consider parking in hospitals, always a contentious matter. Usually there is restricted and expensive parking for patients. Often they have to walk past the cars of hospital staff in order to reach the hospital. This would be inconceivable in a supermarket. Or consider doctors’ letters about patients. These traditionally are written from one doctor to another in language that the patient cannot understand. It has been for them to transport the letter not read it. Now an increasing number of doctors write to the patient and copy the letter to the other doctor, but it’s still not the norm.

So a profound change — of patients becoming partners and equals — is happening. But what does this mean for medical journals? They are, I think, following not leading — and they are following slowly.

There have always been some patients who read medical journals, and with the arrival of internet journals there are many more. Increasingly patients have access to the same information as doctors, and all doctors have had the experience of patients arriving with printouts from the internet. Journals are usually willing to consider for publication articles by patients, and sometimes publish them. Sometimes journals even commission patients to write pieces. Some journals — particularly American journals — publish ‘patient versions’ of their studies. But mostly, I think it would be true to say, medical journals are written by doctors for doctors. Patients appear mostly within the pages rather than on editorial boards. They have been tolerated not encouraged.

We made an attempt to change this at the BMJ, but it is still at the beginning — and considerably behind what is happening in other places in healthcare. When we first appointed an editorial board — in the mid-1990s — we included a patient representative. Later we appointed two when it was pointed out to us that to be one — token — patient in a room of 30 professionals is hard. In 2002 we appointed a patient editor — Mary Baker. She came one day a fortnight, and her remit was to remind us constantly of the patient perspective. Then we appointed a board of patient advisers, and in the spring of 2003 we published a theme issue of the journal that was designed for an imaginary, future world where doctors and patients are equals and work in partnership. Some doctors liked it; others cancelled their subscriptions immediately.

The aim was not to make the BMJ a publication for patients. Nor was the aim — although it might be in the longer term — to create a journal that was intended for both doctors and patients. The aim was to help doctors understand how the world has changed, how patients have different perspectives from doctors, and how to be the best possible doctor you need both to understand the perspective of patients and know how to work with them. ‘It’s very hard for doctors,’ says Mary Baker, ‘they need help.’

Some other journals have taken such initiatives, but they are still rare. Medical journals remain cocooned in a world where doctors are dominant while most of healthcare has moved on.

So in about 40 years medical journals have tried to move from a world where they included abusive experiments conducted on patients without their consent to a world where patients are equals and partners in both healthcare and research. Progress is at best ‘patchy’.


More From The Trouble With Medical Journals


References

  1. Wakefield AJ, Murch SH, Linnell AAJ et al. Ileal-lymphoid-nodular hyperplasia, non-specific colitis and pervasive developmental disorder in children. Lancet 1998;351:637-41.
  2. Laumann E, Paik A, Rosen R. Sexual dysfunction in the United States: prevalence and predictors. JAMA 1999;281:537-44 (published erratum appears in JAMA 1999;281:1174).
  3. Moynihan R. The making of a disease: female sexual dysfunction. BMJ 2003;326:45-7.
  4. Hudson A, McLellan F. Ethical issues in biomedical publication. Baltimore: Johns Hopkins University Press, 2000.
  5. Sackett DL, Haynes RB, Guyatt GH, Tugwell P. Clinical epidemiology: a basic science for clinical medicine. London: Little, Brown, 1991.
  6. Haynes RB. Where’s the meat in clinical journals? ACP Journal Club 1993;119:A23-4.
  7. Altman DG. The scandal of poor medical research. BMJ 1994;308:283-4.
  8. Shaughnessy AF, Slawson DC, Bennett JH. Becoming an information master: a guidebook to the medical information jungle. J Fam Pract 1994;39:489-99.
  9. Bartrip P. Mirror of medicine: a history of the BMJ. Oxford: British Medical Journal and Oxford University Press, 1990.
  10. Chen RT, DeStefano F. Vaccine adverse events: causal or coincidental? Lancet 1998;351:611-12.
  11. Pobel D, Viel JF. Case-control study of leukaemia among young people near La Hague nuclear reprocessing plant: the environmental hypothesis revisited. BMJ 1997;314:101.
  12. Horton R. A statement by the editors of the Lancet. Lancet 2004;363:820-1.
  13. Murch SH, Anthony A, Casson DH et al. Retraction of an interpretation. Lancet 2004;363:750.
  14. Smith R. The discomfort of patient power. BMJ 2002;324:497-8.
  15. Antithrombotic Trialists’ Collaboration. Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death, myocardial infarction and stroke in high risk patients. BMJ 2002;324:71-86.
  16. Cleland JGF. For debate: Preventing atherosclerotic events with aspirin. BMJ 2002;324:103-5.
  17. Bagenal FS, Easton DF, Harris E et al. Survival of patients with breast cancer attending Bristol Cancer Help Centre. Lancet 1990;336:606-10.
  18. Fox R. Quoted in: Smith R. Charity Commission censures British cancer charities. BMJ 1994;308:155-6.
  19. Richards T. Death from complementary medicine. BMJ 1990;301:510.
  20. Goodare H. The scandal of poor medical research: sloppy use of literature often to blame. BMJ 1994;308:593.
  21. Bodmer W. Bristol Cancer Help Centre. Lancet 1990;336:1188.
  22. Budd JM, Sievert ME, Schultz TR. Phenomena of retraction. Reasons for retraction and citations to the publications. JAMA 1998;280:296-7.
  23. McVie G. Quoted in: Smith R. Charity Commission censures British cancer charities. BMJ 1994;308:155-6.
  24. Smith R. Charity Commission censures British cancer charities. BMJ 1994;308:155-6.
  25. Feachem RGA, Sekhri NK, White KL. Getting more for their dollar: a comparison of the NHS with California’s Kaiser Permanente. BMJ 2002;324:135-41.
  26. Himmelstein DU, Woolhandler S, David DS et al. Getting more for their dollar: Kaiser v the NHS. BMJ 2002;324:1332.
  27. Talbot-Smith A, Gnani S, Pollock A, Pereira Gray D. Questioning the claims from Kaiser. Br J Gen Pract 2004;54:415-21.
  28. Ham C, York N, Sutch S, Shaw R. Hospital bed utilisation in the NHS, Kaiser Permanente, and the US Medicare programme: analysis of routine data. BMJ 2003;327:1257-61.
  29. Sanders SA, Reinisch JM. Would you say you ‘had sex’ If…? JAMA 1999;281:275-7.
  30. Anonymous. lfs over, Debbie. JAMA 1988;259:272.
  31. Lundberg G. ‘lfs over, Debbie,’ and the euthanasia debate. JAMA 1988;259:2142-3.
  32. Smith R. Euthanasia: time for a royal commission. BMJ 1992;305:728-9.
  33. Doyal L, Doyal L. Why active euthanasia and physician assisted suicide should be legalised. BMJ 2001;323:1079-80.
  34. Emanuel EJ. Euthanasia: where The Netherlands leads will the world follow? BMJ 2001;322:1376-7.
  35. Angell M. The Supreme Court and physician-assisted suicide-the ultimate right N Eng J Med 1997;336:50-3.
  36. Marshall VM. lfs almost over — more letters on Debbie. JAMA 1988;260:787.
  37. Smith R. Cheating at medical school. BMJ 2000;321:398.
  38. Davies S. Cheating at medical school. Summary of rapid responses. BMJ 2001;322:299.
  39. Ewen SWB, Pusztai A. Effects of diets containing genetically modified potatoes expressing Galanthus nivalis lactin on rat small intestine. Lancet 1999;354:1353-4.
  40. Horton R. Genetically modified foods: ‘absurd’ concern or welcome dialogue? Lancet 1999;354:1314-15.
  41. Kuiper HA, Noteborn HPJM, Peijnenburg AACM. Adequacy of methods for testing the safety of genetically modified foods. Lancet 1999;354:1315.
  42. Bombardier C, Laine L, Reicin A et al. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. N Eng J Med 2000;343:1520-8.
  43. Curfman GD, Morrissey S, Drazen JM. Expression of concern: Bombardier et al., ‘Comparison of Upper Gastrointestinal Toxicity of Rofecoxib and Naproxen in Patients with Rheumatoid Arthritis.’ N Eng J Med 2000;343:1520-8. N Eng J Med 2005;353:2813-4.
  44. Curfman GD, Morrissey S, Drazen JM. Expression of concern reaffirmed. N Eng J Med 2006;354: 1193.
  45. Laumann E, Paik A, Rosen R. Sexual dysfunction in the United States: prevalence and predictors. JAMA 1999;281:537-44 (published erratum appears in JAMA 1999;281:1174).
  46. Smith R. In search of ‘non-disease.’ BMJ 2002;324:883-5.
  47. Hughes C. BMJ admits ‘lapses’ after article wiped £30m off Scotia shares. Independent 10 June 2000.
  48. Hettiaratchy S, Clarke J, Taubel J, Besa C. Burns after photodynamic therapy. BMJ 2000;320:1245.
  49. Bryce R. Burns after photodynamic therapy. Drug point gives misleading impression of incidence of burns with temoporfin (Foscan). BMJ 2000;320:1731.
  50. Richmond C. David Horrobin. BMJ 2003;326:885.
  51. Enstrom JE, Kabat GC. Environmental tobacco smoke and tobacco related mortality in a prospective study of Californians, 1960-98. BMJ 2003;326:1057-60.
  52. Roberts J, Smith R. Publishing research supported by the tobacco industry. BMJ 1996;312:133-4.
  53. Lefanu WR. British periodicals of medicine 1640-1899. London: Wellcome Unit for the History of Medicine, 1984.
  54. Squire Sprigge S. The life and times of Thomas Wakley. London: Longmans, 1897.
  55. Bartrip PWJ. Themselves writ large: the BMA 183~1966. London: BMJ Books, 1996.
  56. Delamothe T. How political should a general medical journal be? BMJ 2002;325:1431-2.
  57. Gedalia A. Political motivation of a medical joumal [electronic response to Halileh and Hartling. Israeli-Palestinian conflict]. BMJ 2002. http://bmj.com/cgi/eletters/324173331361#20289 (accessed 10 Dec 2002).
  58. Marchetti P. How political should a general medical journal be? Medical journal is no place for politics. BMJ 2003;326:1431-32.
  59. Roberts I. The second gasoline war and how we can prevent the third. BMJ 2003;326:171.
  60. Roberts IG. How political should a general medical journal be? Medical journals may have had role in justifying war. BMJ 2003;326:820.
  61. Institute of Medicine. Crossing the quality chasm. Anew health system for the 21st century. Washington: National Academy Press, 2001.
  62. Oxman AD, Thomson MA, Davis DA, Haynes RB. No magic bullets: a systematic review of 102 trials of interventions to improve professional practice. Can Med Assoc J 1995;153:1423-31.
  63. Grimshaw JM, Russell IT. Effect of clinical guidelines on medical practice: a systematic review of rigorous evaluations. Lancet 1993;342:1317-22.
  64. Grol R. Beliefs and evidence in changing clinical practice. BMJ 1997;315:418-21.
  65. Smith R. What clinical information do doctors need? BMJ 1996;313:1062-8.
  66. Godlee F, Smith A, Goldman D. Clinical evidence. BMJ 1999;318:1570-1.
  67. Smith R. The BMJ: moving on. BMJ 2002;324:5-6.
  68. Milton J. Aeropagitica. World Wide Web: Amazon Press (digital download), 2003.
  69. Coulter A. The autonomous patient ending paternalism in medical care. London: Stationery Office Books, 2002.
  70. Muir Gray JA. The resourceful patient. Oxford: Rosetta Press, 2001.
  71. World Health Organization. Macroeconomics and health: investing in health for economic development. Report of the commission on macroeconomics and health. Geneva: WHO, 2001.
  72. Mullner M, Groves T. Making research papers in the BMJ more accessible. BMJ 2002;325:456.
  73. Godlee F, Jefferson T, eds. Peer review in health sciences, 2nd edn. London: BMJ Books, 2003.
  74. Reiman AS. Dealing with conflicts of interest. N Eng J Med 1984;310:1182-3.
  75. Hall D. Child protection: lessons from Victoria Climbié. BMJ 2003;326:293-4.
  76. McCombs ME, Shaw DL. The agenda setting function of mass media. Public Opin Q 1972;36:176-87.
  77. McCombs ME, Shaw DL. The evolution of agenda-setting research: twenty five years in the marketplace of ideas. J Commun 1993;43:58-67.
  78. Edelstein L. The Hippocratic oath: text, translation, and interpretation. Baltimore: Johns Hopkins Press, 1943.
  79. www.pbs.org/wgbhlnova/doctors/oath_modem.html (accessed 8 June 2003).
  80. Weatherall DJ. The inhumanity of medicine. BMJ 1994;309:1671-2.
  81. Smith R. Publishing information about patients. BMJ 1995;311:1240-1.
  82. Smith R. Informed consent: edging forwards (and backwards). BMJ 1998;316:949-51 .
  83. Calman K. The profession of medicine. BMJ 1994;309:1140-3.
  84. Smith R. Medicine’s core values. BMJ 1994;309:1247-8.
  85. Smith R. Misconduct in research: editors respond. BMJ 1997;315:201-2.
  86. McCall Smith A, Tonks A, Smith R. An ethics committee for the BMJBMJ 2000;321:720.
  87. Smith R. Medical editor lambasts journals and editors. BMJ 2001;323:651.
  88. Smith R, Rennie D. And now, evidence based editing. BMJ 1995;311:826.
  89. Weeks WB, Wallace AE. Readability of British and American medical prose at the start of the 21st century. BMJ 2002;325:1451-2.
  90. O’Donnell M. Evidence-based illiteracy: time to rescue ‘the literature’. Lancet 2000;355:489-91 .
  91. O’Donnell M. The toxic effect of language on medicine. J R Coli Physicians Lond 1995;29:525-9.
  92. Berwick D, Davidoff F, Hiatt H, Smith R. Refining and implementing the Tavistock principles for everybody in health care. BMJ 2001;323:616-20.
  93. Gaylin W. Faulty diagnosis. Why Clinton’s health-care plan won’t cure what ails us. Harpers 1993;October:57-64.
  94. Davidoff F. Reinecke RD. The 28th Amendment. Ann Intern Med 1999;130:692-4.
  95. Davies S. Obituary for David Horrobin: summary of rapid responses. BMJ 2003;326: 1089.
  96. Butler D. Medical journal under attack as dissenters seize AIDS platform. Nature 2003;426:215.
  97. Smith R. Milton and Galileo would back BMJ on free speech. Nature 2004;427:287.
  98. Carr EH. What is histoty? Harmondsworth: Penguin, 1990.
  99. Popper K. The logic of scientific discovery. London: Routledge, 2002.
  100. Kuhn T. The structure of scientific revolutions. London: Routledge, 1996.
  101. www.guardian.co.uklnewsroomlstory/0,11718,850815,00.html (accessed 14 June 2003).
  102. Davies S, Delamothe T. Revitalising rapid responses. BMJ 2005;330:1284.
  103. Morton V, Torgerson DJ. Effect of regression to the mean on decision making in health care. BMJ 2003;326:1 083-4.
  104. Horton R. Surgical research or comic opera: questions, but few answers. Lancet 1996;347:984-5.
  105. Pitches D, Burls A, Fry-Smith A. How to make a silk purse from a sow’s ear — a comprehensive review of strategies to optimise data for corrupt managers and incompetent clinicians. BMJ 2003;327:1436-9.
  106. Poloniecki J. Half of all doctors are below average. BMJ 1998;316:1734-6.
  107. Writing group for the Women’s Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women. JAMA 2002;288:321-33.
  108. Shumaker SA, Legault C, Thai L et al. Estrogen plus progestin and the incidence of dementia and mild cognitive impairment in postmenopausal women: the Women’s Health Initiative Memory Study: a randomized controlled trial. JAMA 2003;289:2651-62.
  109. Yusuf S, Collins R, Peto R. Why do we need some large, simple randomized trials? Stat Med 1984;3:409-22.
  110. Leibovici L. Effects of remote, retroactive intercessory prayer on outcomes in patients with bloodstream infection: randomised controlled trial. BMJ 2001;323:1450-1.
  111. Haynes RB, McKibbon A, Kanani R. Systematic review of randomised trials of interventions to assist patients to follow prescriptions for medications. Lancet 1996;348:383-6.
  112. Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA 1995;273:408-12.
  113. Altman DG, Schulz KF, Moher D et al., for the CONSORT Group. The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med 2001;134:663-94.
  114. Moher D, Jones A, Lepage L; CONSORT Group (Consolitdated Standards for Reporting of Trials). Use of the CONSORT statement and quality of reports of randomized trials: a comparative before-and-after evaluation. JAMA 2001;285:1992-5.
  115. Garattini S, Bertele V, Li Bassi L. How can research ethics committees protect patients better? BMJ 2003;326:1199-201.
  116. Sackett Dl, Oxman AD. HARLOT pic: an amalgamation of the world’s two oldest professions. BMJ 2003;327:1442-5.
  117. loannidis JPA. Why most published research findings are false. PLoS Med 2005;2:e124.
  118. Greenhalgh T. How to read a paper. London: BMJ Books, 1997.
  119. Sterne JAC, Davey Smith G. Sifting the evidence: what’s wrong with significance tests? BMJ 2001;322:226-31.
  120. Le Fanu J. The rise and fall of modem medicine. New York: Little, Brown, 1999.
  121. Lock S. A difficult balance: editorial peer review in medicine. London: Nuffield Provincials Hospital Trust, 1985.
  122. Rennie D. Guarding the guardians: a conference on editorial peer review. JAMA 1986;256:2391-2.
  123. Martyn C. Slow tracking for BMJ papers. BMJ 2005;331:1551-2.
  124. Hwang WS, Roh Sl, Lee BC et al. Patient-specific embryonic stem cells derived from human SCNT blastocysts. Science 2005;308:1777-83.
  125. Normile D, Vogel G, Holden C. Stem cells: cloning researcher says work is flawed but claims results stand. Science 2005;310:1886-7.
  126. Jefferson T, Alderson P, Wager E, Davidoff F. Effects of editorial peer review: a systematic review. JAMA 2002;287:2784-6.
  127. Godlee F, Gale CR, Martyn CN. Effect on the quality of peer review of blinding reviewers and asking them to sign their reports: a randomized controlled trial. JAMA 1998;280:237-40.
  128. Schroter S, Black N, Evans S et al. Effects of training on quality of peer review: randomised controlled trial. BMJ 2004;328:673.
  129. Peters D, Ceci S. Peer-review practices of psychological journals: the fate of submitted articles, submitted again. Behav Brain Sci 1982;5:187-255.
  130. McIntyre N, Popper K. The critical attitude in medicine: the need for a new ethics. BMJ 1983;287:1919-23.
  131. Horton R. Pardonable revisions and protocol reviews. Lancet 1997;349:6.
  132. Rennie D. Misconduct and journal peer review. In: Godlee F, Jefferson T, eds. Peer review in health sciences. London: BMJ Books, 1999.
  133. McNutt RA, Evans AT, Fletcher AH, Fletcher SW. The effects of blinding on the quality of peer review. A randomized trial. JAMA 1990;263:1371-6.
  134. Justice AC, Cho MK, Winker MA, Berlin JA, Rennie D, the PEER investigators. Does masking author identity improve peer review quality: a randomized controlled trial. JAMA 1998;280:240-2.
  135. van Rooyen S, Godlee F, Evans S et al. Effect of blinding and unmasking on the quality of peer review: a randomized trial. JAMA 1998;280:234-7.
  136. Fabiato A. Anonymity of reviewers. Cardiovasc Res 1994;28:1134-9.
  137. Fletcher RH, Fletcher SW, Fox R et al. Anonymity of reviewers. Cardiovasc Res 1994;28:1340-5.
  138. van Rooyen S, Godlee F, Evans S et al. Effect of open peer review on quality of reviews and on reviewers’ recommendations: a randomised trial. BMJ 1999;18:23-7.
  139. Lock S. Research misconduct 1974-1990: an imperfect history. In: Lock S, Wells F, Farthing M, eds. Fraud and misconduct in biomedical research, 3rd edn. London: BMJ Books, 2001.
  140. Rennie D, Gunsalus CK. Regulations on scientific misconduct: lessons from the US experience. In: Lock S, Wells F, Farthing M, eds. Fraud and misconduct in biomedical research, 3rd edn. London: BMJ Books, 2001.
  141. Royal College of Obstetricians and Gynaecologists. Report of the independent committee of inquiry into the circumstances surrounding the publication of two articles in the British Journal of Obstetrics and Gynaecology in August 1994. London: RCOG, 1995.
  142. Lock S. Lessons from the Pearce affair: handling scientific fraud. BMJ 1995;310:1547.
  143. Pearce JM, Manyonda IT, Chamberlain GVP. Tenn delivery after intrauterine relocation of an ectopicpregnancy. Br J Obstet Gynaecol 1994;101:716-17.
  144. Pearce JM, Hamid RI. Randomised controlled trial of the use of human chorionic gonadotrophin in recurrent miscarriage associated with polycystic ovaries. Br J Obstet Gynaecol 1994;101:685-8.
  145. Wilmshurst P. Institutional corruption in medicine. BMJ 2002;325:1232-5.
  146. Smith R. What is research misconduct? In: Nimmo WS, ed. Joint Consensus Conference on Research Misconduct in Biomedical Research. J R Coli Phys Edin 2000;30 (Suppl 7): 4-8.
  147. Integrity and misconduct in research. Report of the Commission on Research Integrity to the Secretary of Health and Human Services, the House Committee on Commerce, and the Senate Committee on Labor and Human resources. 3 November 1995. gopher.faseb.org/opar/cri.html (accessed 10 July 2003).
  148. Office of Science and Technology Policy, Executive office of the President. Federal policy on research misconduct. Federal Register 6 December 2000, pp 76260-4. frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2000_register&docid=00-30852-filed (accessed 10 July 2003).
  149. Nylenna M, Andersen D, Dahlquist G et al. on behalf of the National Committees on Scientific Dishonesty in the Nordic Countries. Handling of scientific dishonesty in the Nordic countries. Lancet 1999;354:57-61.
  150. Joint Consensus Conference on Misconduct in Biomedical Research. Consensus statement. 28 and 29 October 1999. www.rcpe.ac.uk/esd/consensuslmisconduct_99.html (accessed 10 July 2003).
  151. Zuckerman H. Scientific elite: Nobel laureates in the United States. New York: Free Press, 1977.
  152. Rennie SC, Crosby JR. Are ‘tomorrow’s doctors’ honest? Questionnaire study exploring medical students’ attitudes and reported behaviour on academic misconduct. BMJ 2001;322:274-5.
  153. Lock S. Misconduct In medical research: does it exist In Britain? BMJ 1988;297:1531-5.
  154. Smith R. Draft code of conduct for medical editors. BMJ 2003;327:1010.
  155. Stoa-Birketvedt G. Effect of cimetidine suspension on appetite and weight in overweight subjects. BMJ 1993;306:1091-3.
  156. Rasmussen MH, Andersen T, Breum L et al. Cimetidine suspension as adjuvant to energy restricted diet in treating obesity. BMJ 1993;306:1093-6.
  157. Garrow J. Does cimetidine cause weight loss? BMJ 1993;306:1084.
  158. White C. Suspected research fraud: difficulties of getting at the truth. BMJ 2005;331:281-8.
  159. Smith R. Investigating the other studies of a possibly fraudulent author. BMJ 2005;331 :288-91.
  160. Chandra RK. Effect of vitamin and trace-element supplementation on cognitive function in elderly subjects. Nutrition 2001;17:709-12.
  161. Chandra RK. Effect of vitamin and trace-element supplementation on immune responses and infection in elderly subjects. Lancet 1992;340:1124-7.
  162. Meguid M. Retraction of: Chandra RK. Nutrition 2001;17:709-12. Nutrition 2005;21:286.
  163. Carpenter RK, Roberts S, Sternberg S. Nutrition and immune function: a 1992 report. Lancet 2003;361:2247.
  164. Shapiro OW, Wenger WS, Shapiro MF. The contributions of authors to multiauthored biomedical research papers. JAMA 1994;271:438-42.
  165. Goodman N. Survey of fulfilment of criteria of authorship in published medical research. BMJ 1994;309:1482.
  166. Flanagin A, Carey LA, Fontanarosa PB et al. Prevalence of articles with honorary authors and ghost authors in peer-reviewed medical journals. JAMA 1998;280:222-4.
  167. Horton R. The signature of responsibility. Lancet 1997;350:5-6.
  168. International Committee of Medical Journal Editors. Uniform requirements for manuscripts submitted to biomedical journals: writing and editing for biomedical publication. www.icmje.org/ (accessed 15 April 2006).
  169. Bhopal R, Rankin J, McColl E et al. The vexed question of authorship: views of researchers in a British medical faculty. BMJ 1997;314:1009.
  170. Wilcox LJ. Authorship. The coin of the realm. The source of complaints. JAMA 1998;280:216-17.
  171. Eysenbach G. Medical students and scientific misconduct: survey among 229 students. www.bmj.com/cgi/eletters/322/7281/274#12443, 3 February 2001.
  172. Rennie D, Yank V, Emanuel L. When authorship fails: a proposal to make contributors accountable. JAMA 1997;278:579-85.
  173. Horton R. The hidden research paper. JAMA 2002;287:2775-8.
  174. MAST-I Group. Randomised controlled trial of streptokinase, aspirin, and combination of both in treatment of acute ischaemic stroke. Lancet 1995;346:1509-14.
  175. Tognoni G, Roncaglioni MC. Dissent: an alternative interpretation of MAST-I. Lancet 1995;346:1515.
  176. Docherty M, Smith R. The case for structuring the discussion of scientific papers. BMJ 1999;318:1224-5.
  177. Gotzsche PC. Multiple publication of reports of drug trials. Eur J Clin Pharmacol 1989;36:429-32.
  178. Waldron T. ls duplicate publishing on the increase? BMJ 1992;304:1029.
  179. Tramer MR. Reynolds DJM, Moore RA, McQuay HJ. Impact of covert duplicate publication on meta-analysis: a case study. BMJ 1997;315:635-40.
  180. Melander H, Ahlqvist-Rastad J, Meijer G, Beermann B. Evidence b(i)ased medicine — selective reporting from studies sponsored by pharmaceutical industry: review of studies in new drug applications. BMJ 2003;326:1171-3.
  181. Chalmers I. Underreporting research is scientific misconduct. JAMA 1990;263:1405-8.
  182. Dickersin K. The existence of publication bias and risk factors for its occurrence. JAMA 1990;263:1385-9.
  183. Dickersin K, Min Yi. Publication bias: the problem that won’t go away. Ann N Y Acad Sci 1993;703:135-46; discussion 146-8.
  184. Egger M, Davey Smith G, Schneider M, Minder C. Bias in meta-analysis detected by a simple, graphical test. BMJ 1997;315:629-34.
  185. Olson CM, Rennie D, Cook D et al. Publication bias in editorial decision making. JAMA 2002;287:2825-8.
  186. Egger M, Bartlett C, Juni P. Are randomised controlled trials in the BMJ different? BMJ 2001;323:1253.
  187. Lexchin J, Bero LA, Djulbegovic 8, Clark O. Pharmaceutical industry sponsorship and research outcome and quality: systematic review. BMJ 2003;326:1167-70.
  188. Kjaergard LL, Als-Nielsen B. Association between competing interests and authors’ conclusions: epidemiological study of randomised clinical trials published in the BMJBMJ 2002;325:249.
  189. Saunders MC, Dick JS, Brown IM et al. The effects of hospital admission for bed rest on duration of twin pregnancy: a randomised trial. Lancet 1985;11:793-5.
  190. Smith R, Roberts I. An amnesty for unpublished trials. BMJ 1997;315:622.
  191. De Angelis C, Drazen JM, Frizelle FA et al. Is this clinical trial fully registered? A statement from the International Committee of Medical Journal Editors.
  192. Bekelman JE, Li Y, Gross CP. Scope and impact of financial conflicts of interest in biomedical research. Asystematic review. JAMA 2003;289:454-65.
  193. Thompson DF. Understanding financial conflicts of interest. N Engl J Med 1993;329: 573-6.
  194. Smith R. Animal research: the need for a middle ground. BMJ 2001;322:248-9.
  195. Campbell EG, Louis KS, Blumenthal D. Looking a gift horse in the mouth: corporate gifts supporting life sciences research. JAMA 1998;279:995-9.
  196. Krimsky S, Rothenberg LS, Stott P, Kyle G. Scientific journals and their authors’ financial interests: a pilot study. Sci Eng Ethics 1996;2:395-410.
  197. Stelfox HT, Chua G, O’Rourke K, Detsky AS. Conflict of interest in the debate over calcium channel antagonists. N Engl J Med 1998;338:101-5.
  198. International Committee of Medical Journal Editors. Conflict of interest. Lancet 1993;341:742-3.
  199. Hussain A, Smith R. Declaring financial competing interests: survey of five general medical journals. BMJ 2001;323:263-4.
  200. Davidoff F. DeAngelis CD, Drazen JM et al. Sponsorship, authorship, and accountability. N Engl J Med 2001;345:825-6.
  201. Smith R. Journals fail to adhere to guidelines on conflicts of interest. BMJ 2001;323:651.
  202. Gross CP, Gupta AR, Krumholz HM. Disclosure of financial competing interests in randomised controlled trials: cross sectional review. BMJ 2003;326:526-7.
  203. Fontanarosa PB, Flanagin A, DeAngelis CD. Reporting conflicts of interest, financial aspects of research, and role of sponsors in funded studies. JAMA 2005;294:110-11.
  204. Rothman KJ, Evans S. Extra scrutiny for industry funded trials. BMJ 2005;331:1350-1.
  205. Fontanarosa PB, DeAngelis CD. Conflicts of interest and independent data analysis in industry-funded studies-reply. JAMA 2005;294:2576-7.
  206. Haivas I, Schroter S, Waechter F, Smith R. Editors’ declaration of their own conflicts of interest. Can Med Assoc J 2004:171:475-6.
  207. Wilkinson P. ‘Self referral’: a potential conflict of interest. BMJ 1993;306:1083-4.
  208. Hillman BJ, Joseph CA, Mabel MR et al. Frequency and costs of diagnostic imaging in office practice: a comparison of self referring and radiologist referring physicians. N Engl J Med 1990;323:1504-8.
  209. Hillman AI, Pauly MV, Kerslein B. How do financial incentives affect physicians’ clinical decisions and the financial performance of health maintenance organizations. N Engl J Med 1989;321:86-92.
  210. Chren MM, Landefeld CS. Physicians’ behaviour and their interactions with drug companies. JAMA 1994;271:684-9.
  211. Murray SF. Relation between private health insurance and high rates of Caesarean section in Chile: qualitative and quantitative study. BMJ 2000;321:1501-5.
  212. Roberts CL, Tracy S, Peat B. Rates for obstetric intervention among private and public patients In Australia: population based descriptive study. BMJ 2000;321:137-41 .
  213. Rochon PA, Gurwitz JH, Simms RW et al. A study of manufacturer supported trials of non-steroidal anti-inflammatory drugs in the treatment of arthritis. Arch Intern Med 1994;154:157-63.
  214. Lilford RJ. Ethics of clinical trials from a bayesian and decision analytic perspective: whose equipoise is it anyway? BMJ 2003;326:98Q-1.
  215. Barnes DE, Bero LA. Why review articles on the health effects of passive smoking reach different conclusions. JAMA 1998;279:1566-70.
  216. Barnes DE, Bero LA. Industry funded research and conflict of interest an analysis of research sponsored by the tobacco Industry through the Center for Indoor Air Research. J Health Policy Law 1996;21:515-42.
  217. Hope S. 12% of women stopped taking their pill immediately they heard CSM’s warning. BMJ 1996;312:576.
  218. Vandenbroucke JP. Competing interests and controversy about third generation oral contraceptives. BMJ 2000;320:381.
  219. Sheldon T. Research on third generation pill remains unpublished. BMJ 2001 ;322:1086.
  220. Kemmeren JM, Algra A, Grobbee DE. Third generation oral contraceptives and risk of venous thrombosis: meta-analysis. BMJ 2001;323:131.
  221. Skegg DCG. Oral contraceptives, venous thromboembolism, and the courts. BMJ 2002;325:504-5.
  222. Spitzer WO, Lewis MA, Heinemann LAJ et al. Third generation oral contraceptives and risk of venous thromboembolic disorders: an international case-control study. BMJ 1996;312:83-8.
  223. Lewis MA, MacRae KD, Kuhi-Habich D et al. The differential risk of oral contraceptives: the impact of full exposure history. Hum Reprod 1999;14:1493-9.
  224. Wright J. Kenneth David MacRae. BMJ 2002;324:1041.
  225. Abbasi K, Smith A. No more free lunches. BMJ 2003;326:1155-6.
  226. Wilkes MS, Doblin BH, Shapiro MF. Pharmaceutical advertisements in leading medical journals: experts’ assessments. Ann Intern Med 1992;116:912-19.
  227. Chaudhry S, Schroter S, Smith R, Morris J. Does declaration of competing interests affect reader perceptions? A randomised trial. BMJ 2002;325:1391-2.
  228. Schroter S, Morris J, Chaudhry S et al. Does the type of competing interest statement affect readers’ perceptions of the credibility of research? Randomised trial. BMJ 2004;328:742-3.
  229. Monmaney T. Medical journals may have flouted own ethics 8 times. Los Angeles Times 21 October 1999.
  230. Drazen JM, Curfman GO. Financial associations of editors. N Engl J Med 2002;346:1901-2.
  231. World Medical Association. Declaration of Helsinki. Ethical principles for medical research involving human subjects. http://www.wma.net/e/policylb3.htm (accessed 25 June 2006).
  232. Smith R. Beyond conflict of interest. BMJ 1998;317:291-2.
  233. Smith R. Conflict of interest and the BMJBMJ 1994;308:4.
  234. Smith R. Making progress with competing interests. BMJ 2002;325:1375-6.
  235. Smith R, Roberts I. Patient safety requires a new way of publishing trials. PLoS Clinical Trials 2006;1:e6 DOI: 10.1371journal.pctr.0010006.
  236. Pelosi AJ, Appleby L. Psychological influences on cancer and ischaemic heart disaasa. BMJ 1992;304:1295-a.
  237. Altman DG, Chalmers I, Herxheimer A. Is there a case for an international medical scientificpress council? JAMA 1994;272:166-7.
  238. Herxheimer A, Chalmers I, Altman D. Have we made progress in exposing and dealing with editorial misconduct? www.publicationethics.org.uk/reports/2003/ (accessed 16 April 2006).
  239. Shashok K. Pitfalls of editorial miscommunication. BMJ 2003;326:1262-4.
  240. Amaiz-Villena A, Elaiwa N, Silvera C et al. The origin of Palestinians and their genetic relatedness with other Mediterranean populations. Hum lmmunol 2001;62:889-900 (retracted in Hum Immunol 2001;62:1063).
  241. Godlee F. Dealing with editorial misconduct. BMJ 2004;329:1301-2.
  242. Committee on Publication Ethics. Who ensures the integrity of the editor? The COPE report 2000. London: COPE, 2000.
  243. Committee on Publication Ethics. Editorial compliance with duplicate publication. The COPE report 2000. London: COPE, 2000.
  244. Committee on Publication Ethics. Publication bias arising from an editor’s activities. The COPE report 2000. London: COPE, 2000.
  245. Smith R. A fierce and independent editor: Hugh Clegg. BMJ 1982;11:32-4.
  246. Anonymous. The gold-headed cane. BMJ 1956;1:791-3.
  247. Hoey J, Caplan CE, Elmslie T et al. Science, sex and semantics: the firing of George Lundberg. Can Med Assoc J 1999;160:507-8.
  248. Davies HT, Rennie D. Independence, governance, and trust: redefining the relationship between JAMA and the AMA. JAMA 1999;281:2344-6.
  249. www.publicationethics.org.uk/reports/2005/code/ (accessed 22 April 2006).
  250. www.pcc.org.uk/ (Accessed 22 April 2006)
  251. Lord Wakeham. www.pcc.org.uk/10YearBook/introduction.html (accessed 17 July 2003).
  252. Sen A. Food and freedom. www.worldbank.org/html/cgiar/publications/crawford/craw3.pdf (accessed 17 July 2003).
  253. McGoldrick S. Obituary for David Horrobin: original mind will be missed. BMJ 2003;326: 1089.
  254. Kane P. Obituary for David Horrobin: work inspired and continues to nurture positive clinical outcomes. BMJ 2003;326:1089.
  255. Charlton BG. Obituary for David Horrobin: medicine has lost something unique and irreplaceable. BMJ 2003;326:1088.
  256. Coldicott V, Pope C, Roberts C. Tha ethics of intimate examinations —teaching tomorrow’s doctors. BMJ 2003;326:97-101.
  257. Will RG, Ironside JW, Zeidler M et al. A new variant of Creutzfeldt-Jakob disease in the UK. Lancet 1996;347:921-5.
  258. Parkin JR, Eagles JM. Blood-letting in bulimia nervosa. Br J Psychiatry 1993;162:246-8.
  259. Court C. GMC finds doctors not guilty in consent case. BMJ 1995;311:1245.
  260. International Committee of Medical Journal Editors. Protection of patients’ rights to privacy. BMJ 1995;311:1272.
  261. General Medical Council. Guidance from the General Medical Council: confidentiality. London: General Medical Council, 1995.
  262. Committee on Publication Ethics. An unethical ethics committee? The COPE Report 2002. London: COPE, 2002.
  263. Smith R. Informed consent: the intricacies. BMJ 1997;314:1059.
  264. Dennis M, O’Rourke S, Slattery J et al. Evaluation of a stroke family care worker: results of a randomised controlled trial. BMJ 1997;314:1071-6.
  265. Dennis M, O’Rourke S, Slattery J et al. Commentary: evaluation of a stroke family care worker: why we didn’t ask patients for their consent to be randomised. BMJ 1997;314:1077.
  266. McLean S. Commentary: not seeking consent means not treating the patient with respect. BMJ 1997;314:1076.
  267. Bhagwanjee S, Muckart D, Jenna PM, Moodley P. HIV status does not influence outcomes of patients admitted to a surgical intensive care unit. BMJ 1997;314:1077-81.
  268. Bhagwanjee S, Muckart D, Jenna PM, Moodley P. Commentary: why we did not seek informed consent before testing patients for HIV. BMJ 1997;314:1082-3.
  269. Seedat YK. Commentary: no simple and absolute ethical rule exists for every conceivable situation. BMJ 1997;314:1083-4.
  270. Kale R. Commentary: falling to seek patients’ consent to research Is always wrong. BMJ 1997;314:1081-2.
  271. Doyal L. Journals should not publish research to which patients have not given fully informed research — with three exceptions. BMJ 1997;314:1107-11.
  272. Tobias JS. BMJ‘s present policy (sometimes approving research in which patients have not given fully informed consent) is wholly correct. BMJ 1997;314:1111-14.
  273. Bratt DE, Sautter P, Bland M et al. Informed consent in medical research. BMJ 1997;314:1477.
  274. Doyal L, Tobias JS, et al. Informed consent in medical research. London: BMJ Books, 2001.
  275. Declaration of Helsinki. BMJ 1996;313:1448-9.
  276. Anonymous. All treatments and trials must have informed consent. BMJ 1997;314:1134-5.
  277. Doyal L, Tobias JS, Warnock M et al. Ethical debate: informed consent in medical research. Informed consent a response to recent correspondence. Changing the BMJ‘s position on Informed consent would be counterproductive. Informed consent a publisher’s duty. Trial subjects must be fully involved In design and approval of trials. Studies that do not have informed consent from participants should not be published. BMJ 1998;316:1Q00-5.
  278. Thornton H. Informed consent In medical research. BMJ 1997;314:1477.
  279. Declaration of Helsinki. www.wrna.netlelpollcylb3.htrn (accessect 22 April 2006).
  280. Smith R, Chalmers I. Britain’s gift: a ‘Medline’ of synthesised evidence. BMJ 2001 ;323:1437-8.
  281. Reiman AS. The lngelfinger rule. N Engl J Med 1981 ;305:824-6.
  282. Gough A, Chapman S, Wagstaff K et al. Minocycline induced autoimmune hepatitis and systemic lupus erythematosus-like syndrome. BMJ 1996;312:169-72.
  283. Ferner RE, Moss C. Minocycllne for acne. BMJ 1996;312:138.
  284. Ferguson JJ, Jenkins MGV, Field J. Paper in BMJ influenced prescribing of minocycllne. BMJ 1998;316:72-3.
  285. Phillips DP, Kanter EJ, Bednarczyk B, Tastad PL. Importance of the lay press in the transmission of medical knowledge to the scientific community. N Engl J Med 1991;325:1180-3.
  286. Davey Smith G, Frankel S, Yarnell J. Sex and death: are they related? Findings from the Caerphilly cohort study. BMJ 1997;315:1641-4.
  287. Karpf A. Doctoring the media: the reporting of health and medicine. London: Routledge, 1988.

Comments on Patients and Medical Journals: From Objects to Partners

Comments

Comment thread URL copied!