A Bitter Pill for Black Hearts

A drug recently approved to treat African-American heart disease seems to be just another case of the pharmaceutical industry's endless search for profits.

By Margaret Kimberly
The Black Commentator

It is hard to oppose an effort that purports to improve health care for African Americans. Black people suffer more from everything bad, including ill health.

When a drug company announced that it would market a heart failure treatment specifically for use by blacks, the silence from otherwise thoughtful persons and organizations was noticeable but not very surprising. In 1997 the federal Food and Drug Administration declined to approve BiDil, a treatment for heart failure. BiDil is actually a combination of two generic drugs used to treat chest pain and hypertension.

The FDA concluded that there was no proof of BiDil's effectiveness. That should have been the end of BiDil, until good old-fashioned capitalism and marketing turned its fortunes around. BiDil has now been approved for use in black heart failure patients. It is the first drug in America that has been approved specifically for the use of one racial or ethnic group. NitroMed, the pharmaceutical company that will produce BiDil, acted very shrewdly.

The drug maker achieved this success by giving the heads up to black leadership, lest it be accused of recreating the infamous Tuskegee experiment. NitroMed first went to the Congressional Black Caucus, the National Medical Association and the NAACP. The drug company was "aware of the political fallout if they did not have African American participation," said B. Waine Kong, executive director of the Association of Black Cardiologists. Too bad the participants didn't ask a question or two in the process.

We are told that BiDil showed great success in black patients. That doesn't mean very much because it was only tested on black patients. There is literally no evidence that the drug works better on one racial group than on another. NitroMed did what other pharmaceutical companies have always done. It gave money to people who later gave its medication the thumbs up. The Association of Black Cardiologists co-sponsored the clinical trials for BiDil, received $200,000 from NitroMed, and enthusiastically supported the drug's approval. That arrangement wasn't unusual.

In July 2004 the National Institutes of Health published a study urging millions of Americans to take statin drugs in order to lower their risk of heart disease. It was later revealed that eight of nine authors of the study had financial ties to makers of statin drugs. The ties were not made public when the dubious findings were first announced.

No one knows if BiDil is very effective or safe. If it isn't it will not be different from other drugs given FDA approval that were later discovered to be dangerous. Fenfluramine was marketed as Redux, a drug used to treat obesity. It was taken off the market after causing cases of heart valve damage and pulmonary hypertension. How many commercials exhorted consumes to ask their doctors about Vioxx and Celebrex? We now see commercials from law firms exhorting us to pursue malpractice suits against the makers of those drugs.

Past experience indicates that BiDil shouldn't be greeted as a health care panacea for anyone. It should be treated like all newly approved pharmaceuticals, with great caution if not suspicion. As Raymond Woosley, vice president for Health Sciences at the University of Arizona, advised Public Television, "Americans need to recognize that every time they put a pill in their mouth, especially a new pill that they've never taken before, it's an experiment. How big an experiment depends on the pill and how well it's been studied."

NitroMed is using black people to get a drug approved that it couldn't get approved otherwise and in the process maintaining a patent that keeps cheaper generics off the market until the year 2020. "[I]f BiDil is approved for African Americans only, the drug will have patent protection to 2020," wrote Motley Fool biotechnology industry analyst Karl Thiel. "That's because patents based on this demographic were filed after studies showed the drug was ineffective in a broader population.

If the drug is approved for a general heart failure audience, older use patents will apply and the drug would appear to have exclusivity only to 2007." BiDil isn't the 21st Century equivalent of the Tuskegee experiment. It is an example of what the pharmaceutical industry now does best, which is to produce drugs with dubious effectiveness that guarantee them large profits.

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Comments

[BlueBerry Pick'n]

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'cuz I'm thinking health insurance won't be the same for everybody... gee, aren't they eager to tell us that BLACK genetics are sooo much more difficult than the rest of the World? I mean, because Africa is the Cradle of Humanity, the DNA is supposed to be more diverse than in any other cultural group...

Think about it: doesn't that mean BLACK cloning or organ transplants are just that much harder to find? or MORE EXPENSIVE for insurance to be FORCED to drive up premiums? wouldn't that make it more expensive to have more blacks on a corporate health insurance....

hum... who OWNS the rights to 'repaired' DNA anyway?
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Race-based medicine: Just to make money?

Thursday, July 14, 2005 Frances Murphy

If you knew of a drug that could give you a 43 percent better chance of getting well, would you take it despite the fact it is called a race-based drug?

This seems to be the question some doctors are asking their patients about the new drug BiDil, which is being touted as a lifesaver for African-American heart patients ONLY.

The word "only" seems to be what is stirring most of the controversy, as well as the high price of the drug and the $825 billion projected profit the drug company will make in marketing it to Blacks only.

BiDil, which is really a combination of two old drugs -- isosorbide dinitrate and hydralazine -- was approved by the FDA after trials co-sponsored by NitroMed and the Association of Black Cardiologists. Studied were 1,050 "self-identified" African Americans.

Critics contend that FDA approval reinforces disproved beliefs of significant genetic differences between the races, or just plain ordinary prejudice. Marketing BiDil as a drug for Blacks is "a classical example of using race as a surrogate for biology," said Dr. Georgia Dunston, a medical geneticist at Howard University. Critics are also panning the price of the drug. According to the {New York Times}, "NitroMed, the company that makes BiDil, says it will sell the drug for $1.80 a pill, a price much higher than analysts had expected and nearly double the cost of other heart-failure drugs." Depending on the dosage required by individual patients, the {Times} reported, the BiDil treatment could cost from $5.40 to $10.80 a day.

It's estimated that about 750,000 Black Americans suffer from heart failure, the newspaper said.What is so bad about using self-identified racial groupings for targeting drugs? Bio-IT World, the life sciences/technology magazine, says that "Genetic variation within and between different populations generally exists as a continuum rather than discrete clusters." And Dr. Charles Rotimi of the National Human Genome Center at Howard University cautions: "We are all Africans beneath our skin. We all moved out of Africa at some point. Slaves were brought to America from vast swathes of Africa -- hardly common ancestry -- and the subsequent European admixture among African Americans is well documented.

"Benin Dakar, an independent journalist, asks: "Are Black Americans encountering another 'Tuskegee Experiment?' Are misguided scientists and greedy pharmaceutical companies purposely confusing the social construct of race and the biology of genetics for monetary gain by marketing BiDil as a drug specifically for Black Americans?"

And conveniently for NitroMed, if BiDil had been approved for use as a general-use medicine, its patent would last until 2007. But because it was approved as a specialized race-based medicine, NitroMed's patent now extends until 2020 -- a great difference.

Maybe the sad thing in all of this is that people with heart failure who really need the drug may not get it for fear of being labeled "African American," and those people who label themselves as African Americans and do get the medication may not get well because they are really a mixture of everything but African and American. But that is the way a prejudiced society works -- and that is really sad.

[Benin Dakar]

The First Race-Based Medicine BiDil Are Black Americans Encountering Another “Tuskegee Experiment"?

"Are misguided scientists and greedy pharmaceutical companies, purposely confusing the social construct of race and the biology of genetics for monetary gain by marketing BiDil as a drug specifically for black Americans?"

Recently the Food and Drug Administration (FDA) advisory panel recommended the approval of a heart drug called BiDil to be specifically used for African-Americans. This is making way for the first drug ever manufactured and marketed based on race.

BiDil which is a combination of two generic drugs was tested several years ago and its usefulness at the time was deemed as inconclusive for use in the general population by the FDA.

The drug's maker, NitroMed, a small Massachusetts company, however noticed that BiDil seemed to work best in persons who were self-identified as black American.

NitroMed used this as an opportunity to perform a less costly study exclusively focusing on self-identified black Americans and determined that BiDil significantly reduced the death rate in black heart patients.

NitroMed stands to gain even more, if BiDil is approved for use as a race based medicine. If approved the patent for BiDil as a general use medicine would only last until 2007. But if BiDil is approved as a specialized race based medicine NitroMed’s patent will be extended until 2020.

With there being an historical paucity of concern for black American health care and with so much financial gain to be made by NitroMed and its backers, there is an eerie silence in the black community about BiDil.

Let me among the first black Americans to ask some tough questions and make some important observations.

Are misguided scientists and greedy pharmaceutical companies, purposely confusing the social construct of race and the biology of genetics for monetary gain by marketing BiDil as a drug specifically for black Americans?

I can understand how some medications can be designed for persons who have a very specific genetic background.

Moreover, the next and most promising frontier for medicine will be individualized therapies based on the unique biology of an individual or an isolated genetically same group of human beings.

However, black Americans are not an isolated genetic group. To the contrary, black Americans are probably one of the most genetically diverse groups of people who have ever existed.

Black Americans beyond having an eclectic genetic connection to the multiple peoples who inhabit West Africa, many black Americans have both European and Native American ancestry.

And let us not fail to mention about blacks immigrating from Africa and the Caribbean to the United States, who become “black Americans”, once they reach these shores. Are medications made for “black Americans” beneficial to the newest arriving black Americans?

My brother, who is a black American, suffers with idiopathic torsion dystonia, a neurological movement disorder that has its highest incidence among the European Jewry. Many of his doctor’s are baffled that a black man has this rare disease, until they probe for my brother’s less obvious genetic history.

Our maternal great grandfather was a German Jew. Many black Americans have similar mixed ethnic identities, although we are socially and self-identified as black Americans.

We must be careful that the development of race based drugs like BiDil is not directed by misguided science and unabashed greed.

I hope that scientists are not confusing the social construct of race with the biology of genetics.

I also hope that pharmaceutical companies are not purposely fusing race and genetics for their selfish monetary gain.

The sudden concern by both the scientific community and pharmaceutical companies in the cardiovascular health of black Americans is curious, especially when one considers the “cash cow” that BiDil will become for each of those communities.

Scientists, health professionals, and concerned lay people must work to ensure that BiDil will not become a 21st century medical catastrophe for black Americans, like the earlier Tuskegee Experiment.

If BiDil is inappropriately marketed as a drug for black American heart patients, the negative consequences may be long-term.

The inappropriate marketing of BiDil to the African-American community may lead to an unanticipated further suspicion of the health care system by black Americans.

Moreover, if BiDil is a marketing ruse, it could inadvertently set back more hardcore genetic research and the promise of its results.