USA’s First Ethnically Targetted Medicine for African Americans

Original Post Date: 2005-06-13 Time: 17:17:13  Posted By: Jan

[This fascinating article from the UK discusses the new medicine just developed for African Americans and their heart disease. There is some healthy discussion about race in this.

Take note near the end, where a scientist says that Skin Colour, is a “blunt instrument” but it is “better than nothing”. Aha!

The logic is really simple. Everything in your body is determined by DNA – even skin colour and eye colour. It follows therefore, that the slightest differences outwardly, are determined by slight differences inwardly (DNA). It is therefore, completely impossible, to assert that when people’s bodies are different (and any Doctor, Biologist or Scientist can list the myriad of subtle differences between “races”), that what lies inside must also be the same. This is raw science. And there have been many studies correlating IQ to Race, etc.

I won’t comment on all the issues relating to race and medicine, except to say that it is a statistical game. But statistics, used properly do have Scientific validity – and ALL OF PHYSICAL SCIENCE is based on the same concept. You do measurements, you get results (which are not always precisely consistent), and then you use that, statistically to deduce physical laws (e.g. gravity). Biology is the same.

Those people with political agendas, who try to befuddle human thinking, then come along and query statistical methods and try to introduce a fog of ignorance. But in reality, they are challenging scientific method which, in any other field, would not be questioned.

The concept of skin colour=race – is the most basic level, and yes, it is rough-and-ready. But science is going much deeper and I am convinced that even more will be discovered. I am sure there would be even more revelations, about racial differences, and race-related information, from scientists, if it were not for Political Correctness getting in the way.

Take note of a book, written by a lecturer in medicine at Yale University, Sally Matel MD. Her site is: http://www.sallysatelmd.com/html/r-bsun.htmlbr>
She takes race into account when treating people. I wonder how many doctors do? And I wonder too, how many more people would not benefit, if more race-related research were to be done? Political Correctness is getting in the way of science, and progress. But, the TRUTH cannot be suppressed indefinitely.

People in the rest of the world have yet to discover how accurately we White people in Africa understood things, and that virtually everything we said about Race is true… not only that… but it will be proven true, right there in your own country.

Take note, the original study included Whites and Blacks, and only Blacks responded positively to the medicine and that is what triggered the resultant process.

I can’t help wondering, how many African Americans, who would swear blind on a stack of Bibles, that Race does not exist, will yet have their lives saved by this medicine? I find that ironic, and downright funny!! Jan]

Medical authorities in the US are about to license a new heart drug (151)— but only for black patients. Trials of the drug have ignited an explosive debate on the role of race, colour and genetics in health treatment

ON JULY 19 a clinical trial involving more than 1,000 patients with heart disease was halted prematurely. A phase III trial, as this was, is usually the final, expensive step before a therapy is licensed or canned, and an early end can spell very bad or very good news.

In this case, the news was spectacularly good. The data on BiDil, a heart drug developed by a Massachusetts company called NitroMed, had become “so compelling”, according to those steering the trials, that it had become unethical to withhold the medication from the patients receiving a placebo, as opposed to BiDil, on top of their existing medication.

But there was another factor that marked this particular investigation as extraordinary. Every single patient in the BiDil experiment, held at 170 medical centres throughout America, was black. A Food and Drugs Administration licence will mean that BiDil can be prescribed only to black patients. BiDil is thus likely to become the first “ethnic medicine”, a therapy designed to be prescribed to one race, in this case African-Americans, with moderate to severe heart failure.

The drug is now a leading protagonist in the debate over what role, if any, race should play in medicine, and whether frontline health workers really should judge patients by the colour of their skin. The topic is a hot one: only last week, Nature Genetics revealed research from University College London showing that 29 medicines have safety or efficacy profiles that vary between ethnic or racial groups. The list is peppered with familiar names: the anticoagulant warfarin, for which ideal dosage differs across ethnicity; interferon, which shows a lesser response in African Americans; insulin, to which Hispanics and African Americans show lower sensitivity than Europeans.

BiDil has been welcomed by some as a dramatic way of bridging the health crevasse that separates whites from non-whites (151)— African-Americans are twice as likely to suffer heart failure than white Americans, and more likely to die from it. The Association of Black Cardiologists in America, for example, supported Nitro-Med's study, and has embraced BiDil as a potential corrective to the disturbingly high death rates among African-Americans with certain types of heart disease.

The trial results are due to be disclosed at the meeting of the American Heart Association in New Orleans in early November.

Dr Michael D. Loberg, president of NitroMed, is optimistic that an FDA licence will be granted next year. “It is in the FDA's hands now but we are very excited. If you could see me now, you would see that I am smiling.” Others, however, view the BiDil study as misguided, cynical or downright dangerous. Their objections are many. The palette of skin colours that falls under the umbrella of “black” is expansive, and so colour may not be a reliable indicator of underlying health. So while ancestry appears to be important genetically (151)— meaning that certain ethnic groups are particularly afflicted by certain diseases (151)— skin colour can be a misleading way of measuring ancestry.

And while chemically plugging the health gap that undeniably exists between races seems like a good idea, it risks diverting attention away from the complex reasons (151)— for example, dietary, environmental and socio-economic (151)— why the gap has opened up in the first place.

A more sinister outcome is that, potentially, it endorses the view that races are biologically different, a view which is, genetically speaking, fallacious, and, politically speaking, explosive. Dr Jonathan Kahn, assistant professor of law at Hamline University, Minnesota, and a bioethicist, recently published a highly critical analysis of BiDil's history and its implications in the Yale Journal of Health Policy, Law, and Ethics.

Kahn believes that the repackaging of BiDil as an ethnic drug was driven by legal and commercial, rather than biomedical, concerns (the formulation has been around for 20 years and was previously rejected by the FDA as ineffective for patients in general). Kahn says that NitroMed's failure to test it in whites, and establish whether it does indeed act differently, constitutes bad science.

“It's great that the drug looks so promising but this trial was carried out only with African-Americans and so tells you nothing about how BiDil works in anyone else,” Kahn says. “Even though NitroMed is seeking race approval for BiDil, there's nothing in this trial that says it doesn't work in other groups.

“It lends credence to the idea that blacks and whites are genetically different. We know that with regard to genetics, race is a sloppy construct.”

Kahn says he is not making a stance for colour-blind medicine (151)— after all, certain conditions do appear to cluster along racial lines, such as hypertension and heart disease (151)— but that greater care is needed to establish that assumed biological difference do genuinely exist. The danger, Kahn says, is that “it's easier to fix molecules than social inequality”.

NitroMed counters that the trial design was agreed directly with the FDA. Dr Manuel Worcel, the company's chief medical officer, says that while no study has been done to compare explicitly the use of BiDil in black patients and white patients, there is firm evidence for ethnic differences. Worcel says the original 1986 studies into BiDil with a mixed patient group (151)— around a quarter of the 640-strong group was black (151)— show definite discrepancies along racial lines. “In 1999, we reanalysed the 1986 study and saw a very clear benefit in African-American patients.”

Worcel says there is plenty of other data showing that black patients benefit particularly from nitric oxide enhancers, the class of drugs to which BiDil belongs. And ultimately, he admits, to widen the study to white patients would have multiplied its size and cost. NitroMed is now trying to develop a test that can identify other patients who could benefit.

One clinician who already admits to taking race into account when prescribing is Dr Sally Satel, author of PC, MD: How Political Correctness is Corrupting Medicine. In 2002 she wrote an article for The New York Times admitting she was a “racially profiling doctor . . . I always take note of my patient's race.”

Alan Goodman, president of the American Anthropological Association, condemned this as “scientific malpractice”, saying that every disease shows a spectrum in racial variation and therefore racial profiling in medicine was unhelpful.

Satel's response today to such criticisms remains vigorous: “To be more clear, when we talk about race in the medical context we are talking about population genetics. And no respectable scientist refutes the idea that people who share an ancestry have more genes in common than indivi- duals descended from other groups.

“Sometimes those genes have implications for greater frequency of certain diseases, cell receptor structure or certain metabolic enzymes.”

Satel adds: “If anyone gets huffy it is typically white academics. Most black people I have spoken to have an appreciation that there are some physiological differences.”

Dr Jim Kennedy, prescribing spokesman for the Royal College of GPs and himself a practising GP in Middlesex, agrees that those physiological differences are real. For example, some people are so-called fast acetylators and some slow acetylators (151)— this becomes important in the breakdown of alcohol and explains why, for example, Japanese people feel the effects of alcohol more quickly. Medical treatment is not to do with skin colour per se, he says, but with genetics. That, Kennedy says, is where the confusion arises.

“The reason race makes an impact is to do with genetics, and what your liver, kidney and blood cells are doing to the drugs, and is nothing to do with skin colour,” Kennedy says. “For example, we know that Afro-Caribbeans and West Africans with cardiovascular disease tend to have a poorer response to beta-blockers and Ace inhibitors. So there's the potential for those groups to be undertreated.”

Kennedy calls skin colour a “blunt instrument but it's better than nothing”. He knows from his own Irish background that appearance doesn't tell the whole story. He points to the existence of a small but significant population in southwest Ireland who look Irish and have Irish names but, because of their ancestry, carry Mediterranean diseases, such as thalassaemia (a blood disease). For that reason, Kennedy thinks that denying BiDil to white patients (151)— as would happen if FDA approval is granted (151)— would be “completely unacceptable” unless there was clear evidence of no benefit or harm in those patient groups.

However, he adds, to close one's eyes to colour is tantamount to a neglect of clinical duties: “As a practising professional, I took an oath not to pay any attention to a patient's race, creed, colour or background, and I take it this very seriously. But if there is real evidence that because of your genetic inheritance you should be offered a certain drug, I would be negligent in not offering it to you. There may be people of African descent who will benefit from Ace inhibitors but trying to guess what genes someone has inherited is impossible. So doctors make a reasonable stab at a first-choice drug and if it doesn't work we'll use our second choice.

“I think it's far worse if, for reasons of political correctness, we choose to ignore real hard scientific facts.”

MAGIC OF GENETICS

GENETICISTS are like magicians when it comes to race (151)— they can make it disappear. Every person on the planet shares 99.9 per cent of their genes, meaning that the remaining 0.1 per cent variation encodes for the immense diversity of human life.

The slice of diversity linked to traditional notions of “race” is startlingly small. For example, population geneticists have found that there can be greater genetic similarity between an African and an Outer Hebridean than between two Africans.

This counter-intuitive finding, and many more like it, render a genetic view of race meaningless to most scientists.

Source: The Sunday Times (UK)

URL: http://www.timesonline.co.uk/article/0,,8123-…/p>

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