Posted on 06/19/2005 7:13:19 AM PDT by Turbopilot
Gaithersburg, Md. — A panel of Food and Drug Administration advisers recommended Thursday that the agency license the heart failure medication BiDil for black patients only.
If the agency follows the 9-0 recommendation and licenses the drug, which could occur by next week, BiDil would become the first pharmaceutical targeted exclusively at a specific racial group.
The drug's manufacturer, NitroMed Inc. of Lexington, Mass., has presented the FDA with trial results that it says show a 43 percent reduction in mortality among black men and women who have had heart attacks. Only those who had experienced severe heart failure were tested.
The drug does not appear to be effective for white heart attack victims.
"This therapy is very powerful, and I have to vote to approve a drug that reduces mortality by 43 percent," said Cleveland Clinic cardiologist Steven Nissen, chairman of the FDA's Cardiovascular and Renal Drugs Advisory Committee.
Because using the drug would lump African-Americans in a presumed genetic category, the proposed use of BiDil is controversial.
In a day of hearings at a motel in the Maryland suburbs of Washington, the committee heard occasionally impassioned arguments against the use of race as a "surrogate" for genetic differences.
Besides overtones of racial stereotyping that hung over the development of BiDil, some black scientists and others are concerned that approving a medication for a racial class could shortcut truly genetics-based medical research.
Black Americans, they point out, are descendants of people from a continent of great genetic diversity.
"Some people are offended by the whole idea [of a race-based drug for heart disease] and some are asking why don't we do it more?" said Dr. Robert Temple, acting director of the FDA's Office of Drug Evaluation.
As members of the panel voted to recommend the drug's approval, several said they were concerned that blacks have more than twice the rate of heart failure as whites.
Two members recommended that the FDA require the manufacturer to include a label stating the drug is licensed for use by blacks only.
In the trials leading up to the company's request for a license, patients were given BiDil in addition to standard heart attack drugs, such as beta blockers and ACE inhibitors. Research has indicated ACE inhibitors do not work as well in blacks as in whites.
"It increased survival by 43 percent in a population that was already on the best therapy available for congestive heart failure," Nissen said.
FDA advisory panels' decisions are not binding on the agency.
BiDil is the company's trade name for a combination of artery opening drugs developed by researchers at the University of Minnesota in the 1990s. It was turned down for an FDA license in 1996 on the grounds that clinical trials had failed to demonstrate it was effective.
However, when the Minnesota group analyzed the data from these trials, they said they noticed a marked racial difference in the way patients responded. It appeared that nearly half of the black patients had longer survival periods as a result of taking the drug.
A trial using about 1,000 black heart attack victims was organized, giving one group a placebo, along with customary ACE inhibitors and beta blockers.
The second group was given BiDil, as well as the traditional drugs.
The experiment was halted when a midtrial review indicated that 43 percent of the patients in the BiDil group were living longer.
It was deemed unethical to continue to deny other trial participants the benefits of the drug, sponsors said.
Saying there are differences genetically is a ball of fire.
Jefferson would surely be reading and commenting on this.
Having read what he's said about black people in the past, I can only imagine what he'd say.
I am very curious as to whether these were tested on black Americans or just black people in general. Not all black people are the same and some people who call themselves black aren't even black.
The PC crowd and Sharpton/Jackson race baiters would rather have Black people die than allow such a "racist" treatment. I'm surprised the researchers even had access to the data on the test subject's race.
The conspiracy theorist in me wonders about exploitation on this sort of designation (if I can put my tin foil hat on for a moment).
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Well duh!
Given that it was an FDA advisory committee and that the study in question was performed at the University of Minnesota, it seems reasonable to assume the test group consisted of Americans, and possibly Canadians.
I hope it doesn't get overused as a lot of drugs are already. If this drug helps people, great.
The drug is a combo of Isorbide dinitrate and Hydralazine. Two long time commonly used Blood Pressure meds.
I hit Post to soon, amend that to include vaso dilators too.
But, if it is signficantly better for blacks than whites, Sharpton.Jesse won't fight IT, but will demand that more money (and jobs) be allocated to finding other drugs for blacks.
The racially unacceptable issue arrises only if money is wasted on a health issue that effects white men and a superior drug is found. The effort, itself, would get Sharpton's, well, blood pressure up.
The black racist thugs here, won't be upset by the medicine, but by some silliness like te study should have been done 10 years ago or "if they hired more black scientists, these black problems would be better addressed."
And, if you want to see Jesse, Sharpton and the step-n-fetchit Congressional Black Caucus watch and see should there be some yet unnoticed but nasty side effect of any drug touted as being for blacks!
Let them protest - the test results came about as a result of a trial called A-HeFT - African-American Heart Failure Trial - where they were specifically testing this medication. They'll also be protesting groups such as the ABC (Association of Black Cardiologists), and members of the Congressional Black Caucus.
What's going to be really interesting will be what is done about pricing to begin with. Most new drugs hit the market as a non-preferred medication, with a significantly higher copay than preferred or generic medications. Since it's a combination of two already available generic medications, depending on the dosing, it may be less expensive to go ahead and get two RXs for the generics. Also, since it is targeting a specific group (like Zelnorm originally did), it may even require a prior authorization before you can get it filled. And of course, the benefits managers will be accused of being racist oppressors - but I've been called that before.
Hesitating to approve the drug might be viewed by some blacks as an attempt withold treatment that would save blacks. On the other hand, if actual results after the drug is approve result in more deaths, there might be a few who claim it is a plot to kill blacks.
I could understand a drug that would interact with say Sicle Cell Anemia [sp] but heart problems are general at best effecting almost everyone in some form or another !
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