A new drug in the pipeline offers new hope for blacks, who as a group suffer high rates of heart failure, but raises many issues about the importance of genetic information and social factors in health care.
BiDil will potentially be the first drug in the nation to be marketed exclusively for blacks. A study published in the New England Journal of Medicine Nov. 11 showed a 43 percent improvement in survival rates among black patients who had congestive heart failure. The finding could mark the first time a drug will be prescribed for a specific race, pending Food and Drug Administration approval. NitroMed, the biotechnology company that designed BiDil, originally tested the drug in the general population and found no significant efficacy.
If BiDil is released, doctors said they are concerned about how they will decide who would benefit from the drug.
“A new patient walks in. You don’t know anything about him, but he’s got congestive heart failure. Are you going to ask him, ‘What race are you?’ or are you going to make your own judgment whether or not he is African American?” said Robert Cook-Deegan, director of the Institute for Genome Sciences and Policy’s Center for Genome Ethics, Law and Policy.
Cook-Deegan added physicians will need to have explicit discussions about race, and the doctor-patient relationship may change.
Researchers said the next step would be to see if there is a biological factor in black patients that makes BiDil effective.
“There are many drugs that seem to have higher efficacy or safety profiles that are race-associated, but it’s just an association,” said Dr. Geoff Ginsburg, director of genomic medicine for IGSP. “There are many confounding factors associated such as the environment, dietary habits and physiology.”
Other doctors have pointed out that there will be more long-term consequences for a drug that should only be administered to certain groups.
“It can only be an interim solution to use the drug as an ethnically indicated medicine,” said David Goldstein, Wolfson professor of genetics at University College London. “In the long term, that’s a mistake because that will serve to reinforce the notion that racial and ethnic groups are distinct.”
But other doctors said understanding the relationship between certain racial groups and drug efficacy are important for overcoming many of the nation’s health care problems.
“We know that some diseases are suffered disproportionately by certain groups that we’ve identified in this country,” said Dr. Hasan Shanawani, a fellow at GELP.
Doctors said another issue arises about the value of biology and genetics over environmental and social factors in a patient’s life.
“Education, social upbringing, productive jobs and other socioeconomic factors are already things we know that deal with many [medical] conditions. Somewhere along the line, people increasingly see genes as easier to fix than the environment,” said Dr. Jenny Reardon, also a fellow at GELP.
Ginsburg said addressing societal issues is necessary to bring this genetic research into the clinic.
Other doctors said scientists should focus on data garnered from patients’ genes. Genomic medicine could improve the accuracy in clinical diagnoses, avoiding side effects and unnecessary treatments. Currently doctors are relying more on genes when only limited information is available about a patient’s medical history. By using the information from genetic technology, doctors may be able to prescribe the best possible therapies for their patients.
“What we’re striving for is genomic-based predictions for patients’ responses to drugs,” said Joseph Nevins, director of IGSP’s Center for Genome Technology. “Predictions based on individual [genetic] differences will allow doctors to see who will have the appropriate characteristics for the appropriate drug.”
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