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 specificallyapproved 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.