Ethnic Drug Manufacture and Marketing

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Ethnic Drug Manufacture and Marketing

From Kahn J, "Race In A Bottle," Scientific American, Aug. 2007, p. 40- 45.

ethnic-drugContinuing in my expose' on some of the drugs that are prevalent in the U.S. (see our page on "Anti-Depressants"), we have this new page discussing how drugmakers are targeting ethnic groups for specific drug sales. According to this essay, the choices have been poor and the science illusory.

On June 25, 2005, the U.S. Food and Drug Adminstration (FDA) approved the first ever ethnic drug. It is called BiDil (bye-dill). The objective and indeed the main selling point of this medication was that it was engineered to treat congestive heart failure for one segment of the population only. This a condition where the heart gradually looses it's ability to circulate blood. People with this disease start appearing  bloated and puffy over the course of time. Eventually, their heart just stops one day. Other early symptoms include fatigue, inability to exercise and shortness of breath. The swelling inevitably starts because the kidneys begin to starve. When the kidneys can't excrete salt and water, the body retains these elements and the characteristic swelling starts. Cardiovascular Disease in all of it's forms kills close to one million Americans per year according to The Franklin Institute. About 2500 American die every day from cardiovascular disease. It is utterly staggering how many Americans die this way. The twist in this case is that BiDil was developed only for African Americans. At the time of it's approval. BiDil was hailed as ushering in a new era of pharmaceuticals; new drugs developed specifically for certain segments of the U.S. population. The new word coined for this was "Pharmacogenomics." This "new" approach in drug developement promised to reduce the cost and boost the efficacy and safety of this new chemical therapeusis. Additionally, BiDil was further hailed as a ethnic friendly drug that would greatly help the underserved African American community in America that has seemingly been somewhat shunned by the U.S. medical establishment. Add to all of this hoopla, organizations such as the Assoc. of Black Cardiologists and the Congressional Black Caucus strongly supported BiDil's approval.

A forensic investigation of the history of this "new" drug tells a different story. First and foremost, BiDil is NOT NEW. What it is, is a combination of two other generic drugs into a single pill. The generic drugs in question are hydralazine and isosorbide dinitrate; both of which have been around for at least a decade and both of which have been used to treat heart failure in all patients, including white and African Americans. Secondly, BiDil simply is not a pharmacogenomic drug as advertised. While some studies have shown the hydralazine and isosorbide dinitrate have apparently delayed hospitalization and death is some patients over the years, the fact remains that no one knows exactly how it works. Thirdly, there is no firm evidence that BiDil actually works better or any differently for African Americans than anyone else. The FDA's approval of BiDil was based on primarily one clinical trial that enrolled only self-identified African Americans and did NOT compare their health outcomes with those of other ethnic races or any racial group. Thus, the study was not blinded or double blinded. No legitimate outcome studies were conducted. The clinical "study" was terribly flawed and it should never have passed muster with the FDA. While the overall impact of BiDil has remained low thus far, with only a few million dollars in sales, it does graphically represent the danger of hyping a new drug under any kind of new-age rubric, in this case "ethnic drug" which in turn lets a product virtually sail through the FDA approval process.

Although African-Americans are dying from heart disease and other related circulatory illnesses at younger ages than their white counterparts, current critical literature suggests that the issue of premature death from cardiovascular illnesses arises from a complex array of social and economic forces. Nevertheless, some "experts" still tout BiDil as "proof" that genetic differences can explain health disparity. Worse still, some pharmaceutical companies are now using this bogus argument to persue other treatment protocols targeting other ethinic groups. This is a concerning trend that may segregate entire portions of the pharmaceutical industry thus ushering in entire families of drugs that all work similarly but are targeted to different ethnic groups all of which will no doubt fatten the pockets of the pharmaceuticals without actually addressing the health issues they were alleged to be helping. See the original article for more details on this important issue.

 

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