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a colour coded prescription

analysis, bbc radio 4, 17 november 2005

KENAN MALIK   Earlier this year the US government licensed a heart drug called BiDiL, for use solely on African Americans. It's the first ever racially-targeted drug. Is this something we should welcome or deplore?

PRITTI MEHTA   In some ways we should celebrate the emergence of BiDiL. This drug is a first in that it has been shown to be particularly effective in a group that is other than white Northern European.

MARTIN RICHARDS   To try and say that you can isolate some kind of racial groups and say that they have better results from treatment from certain drugs and therefore that drugs should be targeted to that population and not to other populations is pretty dodgy.

KENAN MALIK   The debate about BiDiL gets to the heart of one of the most explosive issues in current medicine. Does race matter in health care? Or should doctors be colour-blind?

SALLY SATEL   I think race does have a place in medicine. Diseases and responses to medications are not colour-blind, so doctors shouldn't be either.

JIM KENNEDY   I would emphasise that race is a poor indicator of genetic inheritance. Now we know that some Afro-Caribbean people respond better to certain medications. However, there are a lot of Caucasian and other ethnic groups that also respond well to those medications.

KENAN MALIK   So who's right? In ten years' time will your GP be prescribing different drugs for blacks, whites and Asians? And if so, what will be the consequences for the health service and for society?

BiDiL is the kind of drug you'd expect to be welcomed with open arms. It's used to treat congestive heart failure, a debilitating chronic disease that affects some five million Americans, one in five of whom are black. A clinical trial suggested that among black Americans it cut deaths from heart disease by nearly a half. Such spectacular results must be a good thing, surely? Not necessarily, say the drug's critics, like Dr Helen Wallace, deputy director of the pressure group Gene Watch UK.

HELEN WALLACE   BiDiL was essentially an attempt to rescue a failed drug that had been found to be ineffective in its first trial, and the company that's trying to sell it now has a new patent which is greatly extended to try and sell it as a race specific drug. But the study they've done doesn't really compare how it works in different groups of people. It only looks at how it works in a group of African Americans. That means we don't really know whether it would be effective say in Asians or in people actually living in Africa, for example, and we have very limited evidence then about who should be given the drug.

KENAN MALIK   Are you suggesting that it's financial rather than medical reasons that are creating the drive towards race-based medicines?

HELEN WALLACE   Well, if you look at how drug development works, then it's very clearly driven by the markets where the biggest profits are. We already know that many diseases are neglected altogether because they occur mainly only in developing countries, and we also know that lifestyle drugs - drugs for baldness or drugs to prevent conditions in the worried well - sell and get a lot of money in their research. So I think it's very clear that those financial factors will play an important role.

KENAN MALIK   It's true that in 1997, the American Food and Drug Administration, or FDA, refused to grant a licence to BiDiL. NitroMed, the Massachusetts-based makers of the drug, weren't able to give us an interview but they did supply us with a statement.

NITROMED STATEMENT   This medicine has the potential to save ten thousand lives a year and save our health systems millions of dollars. The Food and Drug Administration didn't approve BiDiL when first submitted to it because the data did not show statistically significant clinical benefit. The data accompanying that first FDA submission strongly suggested effectiveness and improvement in blacks with heart failure, who represented a small sub-population of that study. In the late 90s, NitroMed met with the FDA who encouraged us to study BiDiL in blacks, based on the suggested benefits in that first study. Together with the FDA and the Association of Black Cardiologists, we designed a clinical trial that would thoroughly evaluate its possible utility in blacks. It compared
all modern cardiovascular therapies with and without BiDiL in the patients. Indeed the results were so remarkable that the trial was halted early, so that all of the patients in the trial could have BiDiL together with all standard cardiovascular therapies and gain the enormous clinical benefits. To deny the patients BiDiL would have been unethical.

KENAN MALIK   Armed with the new data NitroMed won an FDA licence to market BiDiL as a drug for African Americans. It also won a new patent - as a race-specific drug BiDiL is now protected until 2020.

NITROMED STATEMENT   Not all drugs, no matter how effective and safe, work in all people. BiDiL represents the first step anyone has ever taken towards true personalised medicine. The FDA has said exactly that. Identifying a medicine that is suited to one's ethnic and genetic makeup is a laudable medical goal, which when achieved hastens care, avoids the need to try treatments that are of uncertain benefit, restores well-being while avoiding complications and costlier care. We believe we are paving the way for others.

KENAN MALIK   Mind you, if BiDiL had won an FDA licence in 1997, it's unlikely that NitroMed would have tried to develop it as a race-specific drug. So does the contested history of BiDiL damage its credibility? Not at all, says the writer Dr Sally Satel. She's a psychiatrist at a Washington DC drug clinic, a fellow of the American Enterprise Institute, and author of a controversial book on How Political Correctness is Corrupting Medicine. Whatever the motivation behind BiDiL, she says, and for whatever reason it has been labelled a black drug, this has not made any difference to medical practice in the USA.

SALLY SATEL   The fact is, at least in this country, we can prescribe anything off label, which means just because the FDA approved a drug for a certain disease or for a certain category of patient – in this case African American. Frankly I think it was the first time the FDA has ever done that, what I mean is approved for a specific type of race. But we can prescribe for any patient that we feel the medication would help, so in no way are white patients denied that medication.

KENAN MALIK   So you'd say it's a good thing that BiDiL is being marketed as an African American drug?

SALLY SATEL   Personally it doesn't matter to me that it's specifically approved for African Americans, but I'm certainly not offended by it and it does give you the relevant information up front.

KENAN MALIK   In principle, perhaps, BiDiL could be prescribed to everyone. In practice, however, it is being aggressively marketed as an African American drug. George Ellison, Professor of Health Studies at St George's Medical School in London, isn't surprised.

GEORGE ELLISON   There is a political demand for treatments for African Americans in America that makes the production of an ethnic drug for African Americans a highly palatable political event. At the same time, as we're well aware within our racialised societies, African Americans have a social and political identity that makes them a powerful lobbying group and a powerful market in their own right. So it's possible to develop a drug for African Americans because we can identify them, we can market to them, we can sell it to them, we can justify it to them, and that makes it a commercially sensitive, commercially successful enterprise. So there's something unique about BiDiL in the way it's used race in this way. And what's problematic of course is that in accepting that race is a valid way of allocating medicine and in the way in which the Food and Drug Administration in the States has recognised and licensed the drug, they've recognised that race is a biological construct and that is deeply problematic.

KENAN MALIK   For George Ellison the lobbying power of African Americans helped create BiDiL. For others though, the problem is not that some groups are efficient at lobbying for their interests, but that many groups don't have sufficient political clout. Dr Pritti Mehta is Access and Equity Officer for the Genetics Interest Group, which campaigns on behalf of patients with genetic disorders.

PRITTI MEHTA  I am in favour of BiDiL because it is effective. The datashows there are increased survival rates in at least 43% of those that were included in the clinical trial. I think five, ten years down the line, we may have different drugs for different populations. Developing medicines that are more population based will benefit the developing world. We already know that in the developing world people are under served. This is because current drug markets are mostly directed towards Northern European, American populations. I think in Britain, we may well see population based medicine, but I think the concern here - and this is the important point to note - that whilst we may be aiming for a more targeted approach minorities may still become excluded from that process because market forces will drive drugs to be created for the majority of the population. So drugs companies will target the majority of the population because there's a bigger market there and minorities then, because they may not have similar genetic backgrounds to those within the majority, they may end up being excluded from that process.

KENAN MALIK   In America, by law researchers, pharmaceutical companies must include different sections of the population when they do clinical trials, for instance. Do you think we should have a similar kind of law in this country?

PRITTI MEHTA   Absolutely, absolutely. This is the only way we're going to develop medicines in the future that will be inclusive for all members of society. And what I want to say here is that we may even need to go a step beyond proportional representation because we need sufficient numbers in clinical trials to be able to do meaningful analyses.

KENAN MALIK  This is a highly contentious argument. It is difficult to argue both that minority groups should not be singled out for discriminatory treatment and that they should be singled out for special consideration. Yet once we strip it of its political claims, Pritti Mehta's argument is really a case for pragmatism. We should use BiDiL on African Americans because it works on African Americans. We should investigate other ethnic and racial groups because it might be possible to develop similar drugs for them. The problem for such pragmatism is that there is an elephant in the room called race. Pritti Mehta favours race-based research because it might help disadvantaged groups. But others fear the return of racial science. The American psychiatrist Sally Satel dismisses such concerns as political correctness.

SALLY SATEL   The fear of being called racist limits research into anything having to do with race as a variable unless, in the case of medicine, you're looking at what we call the social determinants of health. That's a big area here and given a lot of funding. I mean my attitude is, look, we need a big portfolio and we're putting tons of money, federal and private, into looking at social determinants of health, which is fine. And yes there's certainly research going on into so - called race based therapies, but you know one does wonder if there might be a somewhat more aggressive research programme if people weren't skittish about it and if people weren't accused at times of, I don't know, suspect motives for pursuing it.

KENAN MALIK   Do you see any ethical problems in developing different drugs for different races?

SALLY SATEL   I don't see any ethical problems with that. The problems I see are when people who don't understand start waving their hands in an alarmist way about the potential for eugenic research and these kinds of things, which are just completely hysterical.

KENAN MALIK   In making this programme I've discovered how uneasy many people are when talking about race, medicine and genetics. It would be unkind to describe it as hysteria, but there is certainly a deep-felt anxiety about the return of racial science through the medical backdoor. But making this programme has also revealed the continuing research into population-based medicines, though no pharmaceutical company wants to talk publicly about such drugs until it is ready to go to the market. Suppose that BiDiL is only the first of many racially-specific drugs and that in ten years' time, not just in America but in Britain too, we have a suite of different drugs for different races. Pritti Mehta.

PRITTI MEHTA  I would hope that somewhere down the line in the future that we would be able to have a bank of drugs, each of which can be specifically targeted towards particular population groups. I think patients from minority ethnic groups would welcome wider representation of minorities across both biomedical research, clinical research, and therefore I think that they would welcome a wider recognition on the basis of race, ethnicity.

KENAN MALIK   For others, however, such a future has the whiff of an apartheid health system. Already there are major controversies about what drugs the NHS should make available. How much more controversial will such decisions be if they are race-based? Judges recently agreed that it was a woman's human right for the NHS to provide her with herceptin, a drug to treat her breast cancer. It's not too far-fetched to imagine that in the future members of different races might claim that it is their human right to have a particular race-based drug. What price then a universal health service? George Ellison of St George's Medical School.

GEORGE ELLISON   It would require a very different approach to the way in which resource allocation is administered. At the moment, of course, it is mandatory for public services to collect data on race and ethnicity, and it has been for some years now, in order to monitor equity to make sure that there was an equitable uptake of services for the groups that have the most need. The extent to which the data that are collected in that sense are a) useful and b) used in that way is questionable.And that's not because I think any of those services are keen to disadvantage particular groups. I just think it's a particularly difficult issue to put forward both from an analytical sense and in a practical context. But I think if we changed the meaning of race in that way, if we accepted the biological consequences of race as useful clinically - and clearly this is the lesson that BiDiL can teach us - then under those circumstances the imperative to develop services differently for different groups increases dramatically.

HELEN WALLACE   The NHS will have to decide what evidence it needs to make these decisions in the first place and then of course it'll have to be very careful that certain groups of the population do not become excluded. But the NHS may not be able to control those decisions if the decisions are first being made about what drugs will be produced. Those decisions will be commercial decisions, not health service decisions.

KENAN MALIK   Helen Wallace of Gene Watch. The impact of commercial forces on the NHS is not the only issue that worries her. The debate about racial differences in medicine, she suggests, reflects an unhealthy obsession we have with genetics.

HELEN WALLACE   There are many situations where different diseases and different rates of diseases tend to be blamed on genetic differences and that's been made worse really by the hype around the Human Genome Project and the idea that genetic differences really are important. So perhaps we do need to look at the different rates of different diseases in different ethnic groups, but we have to be careful to consider that they may be due to poverty or other differences and not simply due to the different colours of different people's skin. Obesity and diabetes, for example, are very important diseases that are growing at the moment, which are known to occur more frequently in Native Americans and in Pacific Islanders and you can blame that on genetic differences or you can look at what's happening in those populations in terms of them living on food aid, very fatty products, lots of sugar and being socially disadvantaged.

KENAN MALIK   These are important warnings but they're not insurmountable problems. After all, even now the health service organises different services for different communities. For example, in Britain Asians tend to suffer disproportionately from diabetes and Afro-Caribbeans from sickle cell anaemia. The health service is geared up accordingly and resources are allocated to meet those different needs. The idea of targeting drugs according to people's race raises far more complex issues about equity and resource allocation, but they're not impossible to resolve. So - on pragmatic grounds - should we give race-based medicine a cautious welcome? Not so fast responds Dr Jim Kennedy, a GP from Hayes in Middlesex and Chair of the Prescribing Committee of the Royal College of GPs. The science may be a problem.

JIM KENNEDY   I think there are big issues about licensing a drug for one particular ethnic group. The first is how do you define that group? There are plenty of people in America that have an African inheritance even though they think they're white and they pass for white. But if you look at their genes or their family ancestry, you can find that there's a significant African influence in their genetic inheritance and that that is one of the factors that may influence how they express that genetic inheritance through how they handle drugs. There are also plenty of Caucasians who would have similar characteristics in how they handle drugs, so I think defining the users of the drug by race or ethnicity is a very poor way in which to do it.

KENAN MALIK   In other words, there are lots of African Americans who wouldn't respond to BiDiL and there are lots of white Americans who won't be given BiDiL because it's labelled a black drug but who might respond to it?

JIM KENNEDY   Yes, that is the danger that we are concerned about and it would be much more accurate to look at the genetic inheritance that people have, the way they've handled drugs in the past, the way their family has responded to drugs, and that would give us a much clearer indicator than just race on its own.

KENAN MALIK   This gets to the heart of a newly resurgent scientific debate. For decades scientists have been telling us that race is a fiction. That it has no biological reality. Recently, though, there's been a change in the zeitgeist. Leaf through any genetics journal these days and you'll find dozens of papers investigating genetic differences between racial and ethnic groups. So have scientists changed their minds? Dr Martin Richards is a geneticist at Leeds University whose work involves unravelling the genetic histories of different populations. Does he think that race is a meaningful term?

MARTIN RICHARDS   It's meaningful, but that's not necessarily the same thing as saying that it's either helpful or really valuable. There are a number of aspects to the popular idea of race, and obviously some of them do bear on genetics but geneticists differ on whether they think that the term is actually useful to genetics or not. So for many of us the term just has so much baggage that to try and resuscitate it and give it scientific credibility just doesn't seem worthwhile. That's not the same thing as saying that all humans are identical under the skin or you know the kind of popular statement that you often do hear. It's just to say that talking about human variation in terms of race is not very helpful. It's more helpful to think about genetic variation in humans in historical terms rather than in those sort of rather static terms that we’ve inherited.

KENAN MALIK   So why the disagreement among geneticists?

MARTIN RICHARDS   I think the problem is that race has never really been a biological concept, at least not a purely biological concept, so in a way it's fair enough for geneticists to say that there's no such thing in a purely biological or genetic sense. Historically the idea's been tied up with all sorts of cultural and social factors as well, so you just can't really talk in biological terms about race. And thinking in terms of race and types of people like Caucasian or Negroid or whatever seems a very crass and old-fashioned way of sort of talking about them in comparison to that kind of understanding that we have now.

KENAN MALIK   The further apart two populations are geographically, the more distinct they are likely to be genetically. Icelanders are genetically different from Greeks, but they are genetically closer to Greeks than they are to Nigerians. The difference is tiny, but it can have a medical impact. North Europeans, for instance, are more likely to suffer from cystic fibrosis than other groups. Beta blockers appear to be less effective on African Americans than those of European descent. George Ellison, of St George's Medical School in London, favours research into racial and ethnic differences. But he worries that the meaning of such differences too easily gets distorted.

GEORGE ELLISON   Science has this unfortunate tendency that it will look for difference, and when it finds difference, the finding of the difference will justify looking for it. So you will have numerous studies that will include race, for example, as a category or as a variable in their analyses but find no differences and will not report it, but as soon as a difference is found it's reportable, it's publishable, it hits the headlines and scientists and clinicians start to pay attention to race even though the majority of findings may find no difference.

KENAN MALIK  It's not difficult to see why race may not be a good guide to illness. We all know, for instance, that sickle cell anaemia is a black disease. Except that it isn't. It afflicts populations originating from areas with high incidence of malaria such as those in equatorial Africa, southern Europe, parts of the Middle East, and much of central India. But because people know that African Americas suffer disproportionately from the trait, so they assume that what applies to black Americans applies to all blacks and only to blacks. The real debate is not whether or not there are genetic differences between human populations but how we understand and handle those differences. What has given new relevance to this debate is the emergence of pharmacogenetics, an exciting new discipline that looks for links between genes and disease and makes use of those links to help develop new drugs. Professor Chris Mathew is a molecular biologist at King's College London and head of the Complex Disease Genetics laboratory at Guy's Hospital.

CHRIS MATHEW   Most treatments for common diseases tend to treat symptoms, so if you have an inflamed area of the gut, for example, you might go to a surgeon and have it cut out or you might give the person a broad spectrum anti-inflammatory drug. But what you don't know is what the underlying molecular problem is, so we believe that if we can find the genes that create susceptibility to these conditions, then that gives us a handle on what the underlying molecular problem is; and once we know that, we at least have the opportunity to try to create so-called smart drugs. It won't be one drug that will be suitable for all the people with a particular disease.

KENAN MALIK   Do you think, therefore, that race is a useful diagnostic tool in medicine?

CHRIS MATHEW   I think race is a very blunt tool. There are certain instances where it's important and useful. So for example in rare single gene disorders, and we're talking about sickle cell anaemia, muscular dystrophy and so on, we know that there are very big differences in the frequency of these diseases in different populations - so for example in the Greek Cypriot community there's a higher carrier rate for thalassaemia, in the Afro Caribbean community there's a higher rate of carriership for sickle cell anaemia, and in the Ashkenazi Jewish population there's a higher carrier rate for Tay Sachs disease. So having ethnic information is a useful tool. It's part of the information that a health care professional would collect. But in the context of complex diseases things are indeed more complicated. Such information as we have at the moment is that if a particular genetic variant creates additional risk of a disease in one population, it will also do so in another. The degree of risk may be somewhat different, but it will be a risk factor. So in that sense anything that we might find in say the British population may well be relevant globally for other populations as well.

KENAN MALIK  So what you're saying is that a particular genetic marker for a particular disease or a particular response to a certain drug will be found, or is likely to be found in all populations even though it may be in slightly different amounts in every population?

CHRIS MATHEW   What we're really after are the genetic variants that are the true causal changes which create the susceptibility or might alter your response to a particular drug. So they may be present in all different populations, so if we test for them we don't need to worry about the race or ethnic group of our patient. We test for the thing that we know is important in terms of susceptibility to the disease.

KENAN MALIK   What doctors would ideally like to do is to map every individual's genome. Such individual genotyping might well be as common in the future as vaccinations are today. But currently it is both practically unfeasible and too costly. Doctors therefore often fall back on using surrogate indicators of an individual's risk profile - such as his or her race. Race acts as a 'poor man's clue' in medicine - which means that it may be as reliable as a sign in the Da Vinci Code. Dr Jim Kennedy of the Royal College of GPs.

JIM KENNEDY   When a patient comes into my consulting room, there are hundreds of things which I take into account, and amongst those would be potentially race in certain circumstances. In most circumstances it's not a major factor at all. There is certainly a need for us as clinicians to be pragmatic and we know that certain diseases are far more prevalent or have a much higher incidence in certain communities and therefore we should target those communities appropriately. That’s delivering good medicine. That's a lot different, however, to saying a patient should or should not get a drug purely on the basis of their skin colour or where they happen to be born. That I have significant concerns about. What I want is the best drugs that do the most good and the least harm for my patients. I don't care who brings them to me or how they get to me. I just want my patients to have the best things they possibly can get.

KENAN MALIK   Race, genes and drugs make a volatile mix. Race is not a scientific term. Yet there may be times it can play a role in medicine. Doctors can look at their patients, assign them to a racial or ethnic group, and crudely infer what disease they might suffer from or what drugs they may respond to. In some cases those judgements might be important; in others they may be useless. Or worse. The trouble is race carries a huge amount of cultural and social baggage. And that baggage tends to shape how we look at race and medicine.