Posted on 06/24/2005 12:03:53 PM PDT by aculeus
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.
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.
"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.
© BBC MMV
amazing and frankly, unbelievable... where are all the black conspiracists that will exclaim that this is a genocidal plot hatched by the CIA...?
Well, it apparently has been scientifically demonstrated that it does, in fact, work differently on patients of different races, so those doctors and ethicists should figure out the root cause of this unexplained effect and expand the body of medical knowledge, instead of just sniping from the sidelines.
"But critics say there are no biological differences between ethnic groups and the move is more about making money than helping patients."
Tell that to the next white man you see with sickle cell anemia.
They're professors at California colleges and universities.
Give them time. However, I would like for these "scientist to explain what criteria they used to "select" the "BLACK" model.
Scientifically, how is race and ethnicity defined?
I wonder if bill clinton will be put on this medication for his heart problems.
Better yet - wait to hear the screams from the conspiracists when the plans cover the RX only as a non-preferred medication due to the fact that it is a new RX, and the fact that it is a combination of two generics that are readily available as separate RXs.
Does this count toward reparations?
Believe it or not, there are genetic tests for race. DNA Print Genomics of Florida, I believe, makes the tests available for law enforcement and others.
For the studies used to back this drug, race was self-defined. There was no effort to define "African American" or "black", other than noting the race identified by the study participants.
"Tell that to the next white man you see with sickle cell anemia."
Excellent point....lost a good black friend to this horrible disease five years ago.
"where are all the black conspiracists that will exclaim that this is a genocidal plot hatched by the CIA...?"
Wait until the inevitable side effects become known, and they'll be crawling out of the woodwork.
Interesting how something pertaining to race is newspeak'ed into "ethnic".
Racist drug. I like the sound of it. Racist drug.
"Tell that to the next white man you see with sickle cell anemia."
It's somewhat rare, but not inconceivable. I have a second cousin, caucasian, who died of sickle cell. It set off quite a row in the family, and a lot of renewed interest in genealogy, suffice it to say. No evidence of a black ancestor that I am aware, but should that be the case, we'll honor her just as much as all the others.
Yes, but the doctors are using drugs that treat sickle cell anemia, not being black.
Approving a drugThis drug has already been on the market for treating heart disease, and it apparently is especially effective in treating types of heart disease that are more prevalent in black people.
"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."
There's no reason for this. The drug was already approved for treating human beings, including black human beings. There's no practical need for the FDA to approve it for treating specifically black people.
There's no justification for extending patent protection.
Doctors should be made aware that the drug is good for treating types on heart disease more commonly found in black people. That's all that should have been done.
Different does not mean unequal or lesser. It just means different.
My question is, if researchers can develop drugs tailored to specific ethnicities, couldn't they also design a bio-weapon tailored to specific ethnicities?
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