[an error occurred while processing this directive]
BBC News
watch One-Minute World News
Last Updated: Friday, 24 June, 2005, 15:00 GMT 16:00 UK
US approves first 'ethnic drug'
Black man being injected
African Americans are twice as likely to develop heart failure than whites
US drugs regulators have approved a heart failure drug specifically for treating black patients.

The Food and Drug Administration gave BiDil the go-ahead after tests found it cut by 43% deaths in heart patients who identified themselves as black.

The FDA says the drug is a step towards the promise of tailored medicine.

But critics say there are no biological differences between ethnic groups and the move is more about making money than helping patients.

Trial halted early

BiDil was not designed with the specific aim of treating to treat black people, but early clinical trials involving a multi-racial group of patients found that while it benefited the black patients, it had little impact on the others.

Blacks suffering from heart failure will now have an additional safe and effective option for treating their condition
Dr Robert Temple
FDA

In 2004 a new trial was conducted on 1,050 black-heart failure patients.

It proved so successful that it was halted ahead of time to ensure that those patients being administered placebos would also have the chance to switch to BiDil.

The study showed a 43% drop in deaths and a 39% decrease in hospitalisations compared with the placebo.

"The information presented to the FDA clearly showed that blacks suffering from heart failure will now have an additional safe and effective option for treating their condition," Dr Robert Temple, the agency's associate director of medical policy, said.

"In the future, we hope to discover characteristics that identify people of any race who might be helped by BiDil," he added.

New weapon

The decision to approve BiDil has been praised by The National Medical Association, a group campaigning to dispel inequalities in the healthcare given to black people versus white people, and to promote the interests of black medical staff.

This approval of BiDil isn't about personalising medicine. It's about exploiting race to make money by extending patent protection
Jonathan Kahn
Hamline University

"It is our hope that BiDil will be brought to market as quickly as possible to enhance its lifesaving impact. Any day of delay represents an unacceptable missed opportunity to save lives," the group's president, Dr Winston Price, said.

BiDil's approval is made even more significant because black heart patients are known have a poorer response to beta-blockers and Ace inhibitors, both of which are used to treat heart disease.

Patent controversy

However, some doctors and ethicists have objected to the licensing of BiDil saying there is no biological reason why it should work differently on patients of different races.

"This approval of BiDil isn't about personalising medicine. It's about exploiting race to make money by extending patent protection," Jonathan Kahn, a law professor and ethicist at Hamline University in Minnesota who has studied BiDil's development told Reuters.

The patent for BiDil for general use is due to expire in 2007, but the FDA's approval for its use on black people will extend until 2020.

In the US, African Americans are twice as likely to develop heart failure than white people.

About 750,000 African Americans have been diagnosed with heart failure.

Half of heart failure patients in the US die within five years of the condition being identified.




SEE ALSO:
A question of genetics?
07 Nov 04 |  Health
Ethnic minority health targeted
10 Mar 03 |  Health
Ethnic health inequalities
24 Jan 01 |  Health
Ethnic risk for disease
23 Jul 98 |  Health


RELATED INTERNET LINKS:
The BBC is not responsible for the content of external internet sites


PRODUCTS AND SERVICES

News Front Page | Africa | Americas | Asia-Pacific | Europe | Middle East | South Asia
UK | Business | Entertainment | Science/Nature | Technology | Health
Have Your Say | In Pictures | Week at a Glance | Country Profiles | In Depth | Programmes
Americas Africa Europe Middle East South Asia Asia Pacific