Monday, February 22, 2010

Black Heart Health Month

February is considered by many to be Black History Month when many African American churches and organizations recognize the contributions made by many historical figures of African American descent. This year includes many health related concerns and issues as part of their celebratory events. Just in our jurisdictions along were these events:
According to Kelly Morin, director of marketing and physician relations at Saint Agnes, the event educates women about maintaining their hearts physically and spiritually. “Our mission is to educate women, specifically African-American women, about the risk factors of heart disease and the behaviors and conditions that increase their chances,” said Morin. Throughout the day, church leaders will supply worshippers with information regarding heart disease prevention and many churches will also provide free health screenings. (Maryland)
One of many events available this month in the nation's capital include:
SEIU/CIGNA Healthcare Health Fair. John D. Ruffin, Ph.D., the Director of the National Center on Minority Health and Health Disparities at the National Institutes of Health will be on hand to lead a discussion about the several medical conditions afflicting Americans at large. Insurance provider CIGNA Healthcare is providing information and health screenings as part of the event. Howard University and Washington Sports Clubs are also participating. -(DC)
Even in the tarheel state churches included health information and screenings as part of their "African American History" programs:
It’s a celebration of African American History at the Koinonia Church in Greenville, and there’s no shortage of things to do.“We have had education through exhibits, we’ve had entertainment, we’ve had musical entertainment, and health screens, specifically screenings that are important to the African American community. We’ve also had some great food - just a lot of fun in celebration of Black History,” said Theresa Holley. - WNCT TV 9 (North Carolina)
We included this bit of information from our US Food and Drug Adminstration (FDA) concerning information released in reverse. According to the New York Times, which has obtained an advance report concerning the possible recall of a diabetes medication by the FDA. What does that have to do with Black History Month? High blood pressure (hypertension), cardiovascular disease and diabetes all affect the African American community in disproportionate numbers contributing to premature, preventable andunnecessary. Maybe the FDA doesn't want to interrupt Black History Month with the warning.
After carefully reviewing several sources of study data, FDA concluded there is not enough evidence to indicate that the risks of heart attacks or death are different between Avandia and some other oral type 2 diabetes treatments. Because available data are inconclusive—studies have neither confirmed nor excluded the risk—FDA is allowing Avandia to stay on the market while a new long-term study to evaluate the potential cardiovascular risk of Avandia, compared to an active control agent, is conducted by GSK. The company agreed to add new information to the drug's labeling, warning of the potential for increased risk of heart attacks. People with type 2 diabetes who have underlying heart disease or who are at high risk of heart attack should talk with their health care provider about the revised warning as they evaluate treatment options. FDA advises health care providers to closely monitor patients who take Avandia for cardiovascular risks. - FDA (Nov. 14, 2007)
Slow to act the U.S. Food and Drug Administration (FDA) knew long before they considered releasing a warning to "we the people" some almost two years later. "Two drugs used to treat Type 2 diabetes have been found to cause or worsen a serious vision impairment known as macular edema, Health Canada warned Wednesday. The advisory was released after GlaxoSmithKline Inc., the manufacturer of Avandia and Avandamet, informed Health Canada of reports that some diabetics on the drugs had developed the eye condition or had a pre-existing case worsen." (Dec 2005)

That the company released information about their own research at the same time that the Canadian government released an advisory for the medication for which it was developed may seem suspicious but that's true for all dependent research.
"Glaxo undertook a study of 500 patients with mild forms of Alzheimer's who were being treated in Europe and New Zealand. After six months, Avandia showed no benefit when compared with a placebo. When Glaxo separated patients on the basis of their genetics, it found that those who didn't have the type 4 variant of the gene showed a ``statistically significant'' improvement in memory." - The Pharmacogenomics Journal (Dec 2005)
While releasing information on the European and New Zealand study at the same time in Winston Salem a study was just beginning to determine the effect of the drug on adults 21-65 years of age who had been taking only Avandia for at least three (3) months advertising for participants in the local newspaper called: The Dispatch (Lexington, NC)

We don't know the results of this study but we do know that the participants received $375 and something as unclear as "study related care and study medication at no charge." It's not clear if this is the same thing as free health care but maybe that's implied. What's most interesting is that in February of the same year the drug Avandia was licensed for use as part of "triple therapy in combination" with two (2) other drugs. This was the case some ten (10) months prior to the study being undertaken in Winston Salem, NC where the individuals selected for the study could not be taking any other medication.

The New York Times has obtained internal reports from the Food and Drug Administration (FDA) that have not yet been released to the public. A search of the FDA website reveals no new specific information so we will just have to take the NY Times word for it. What we should learn from this African American History Month is that the history of the FDA is too little critical health information provided too late. If history of the African American experience tells us anything is that to wait can be too late. "How long? Not long, (Yes, sir) because "no lie can live forever."

1 comment:

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