The “Black” Drug That Isn’t

The “Black” Drug That Isn’t

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Ethnic Americans—whether black, Hispanic, Asian or members of other groups— face different and usually more serious health risks than our majority-group compatriots. We face higher rates of cancer, diabetes and heart disease, as well as greater difficulty in accessing the U.S. healthcare system to get needed technology and medicines.

Although healthcare disparities often result in higher disease rates and lower life expectancies for ethnic groups, you and your family do not have to fall victim to an imperfect healthcare system.

Patients can help level the playing field when they partner with their doctor to take responsibility for their health. The savvy patient— that’s you— knows that finding an expert doctor you trust is the first step to evening the odds.

Can Your Doctor Trust Medical Journals?

A doctor you trust, who keeps up with the most current solutions to the healthcare challenges Americans face, can make all the difference in avoiding or managing chronic illnesses that bedevil people of diverse ethnic or racial groups. But disturbing revelations in recent years raise concerns about the trustworthiness of the sources doctors look to for the latest medical information.

To learn what is new, what works and what doesn’t, doctors trust peer-reviewed medical journals such as the New England Journal of Medicine, Journal of the National Medical Association and Journal of the American Medical Association to stay on top of current medical research.

But what happens when the doctor you trust cannot trust what those journals publish?

Consider the case of BiDil. In 2005, BiDil, a congestive heart-failure medication, became the first medication approved by the Food and Drug Administration (FDA) for African Americans only. But BiDil is not the “black” drug that medical-journal reports have claimed it is.

BiDil was not tailored for African Americans, as its proponents and journal reports often claimed, but it began life as the only patented drug of the Lexington, Mass., biotech firm NitroMed.

BiDil’s proponents -- some of whom had a financial interest in the success of the drug--published studies supporting their claim of a racial genetic anomaly that made BiDil an ideal drug for blacks, but not for whites.

However, physicians who wrote papers arguing for this genetic racial difference, could do so only by giving short shrift to critically important environmental and behavioral differences between black and white patients, such as disparate diets, smoking rates, environmental exposures and exercise levels.

The journal articles made BiDil seem like a special blessing for black patients, but was it really?

The clinical trials on which the FDA based its approval were deeply flawed. For example, the researchers tested no white subjects to provide comparison data. Furthermore, BiDil was tested not alone, but only together with heart medications that are already known to work, such as diuretics, beta-blockers and angiotensin-converting enzyme or ACE inhibitors. Yet, these journal articles helped convince the FDA to allow tests of BiDil in black patients and to approve it for blacks only.

How could researchers exclude whites from a study meant to show that a drug worked better in blacks than in whites? Excluding whites was a medically illogical but financially strategic move because it eliminated the possibility that the drug would test well in whites, thereby robbing NitroMed of its thin rationale for calling BiDil a black drug.

The “black” label was crucial, because BiDil’s patent covering use in all ethnic groups expired in 2007. The patent for blacks only allows NitroMed to extend its patent protection—and profit from the drug until 2020.

Not only is BiDil not a “black” drug, it can actually be more harmful for some blacks because one of its components, hydralazine, is associated with an increased risk of lupus, which strikes black women at four times the rate of whites.

BiDil is no isolated exception. Some journal articles have been manipulated by the $310 billion pharmaceutical industry. The journals are financially dependent on drug-company advertising, which is often deceptive and is sometimes used to induce journals to publish favorable reports of advertised drugs.

Researchers whose work is funded by drug companies find that those companies forbid them from mentioning side effects or poor trial outcomes. Researchers often have conflicts of interest and will benefit financially, if a drug does well in studies. So they use strategies that are calculated to make a dodgy drug look good on paper, for profit. For example, they will end a trial early, if they see signs that it is about to reveal side effects or other problems.

Ploys for Rigging Clinical Trials

Journals also publish “advertorials,” frequently misleading mixtures of advertising and editorial content. Moreover, journals often selectively publish good drug outcomes and bury the bad ones.

Company-sponsored clinical trials have been rigged by a strategy, such as pairing the tested drug with one known to work well. This can make the tested medication look effective whether it is or not and can mask the fact that its “efficacy” is due to synergistic effects of the two drugs. Or researchers may test the company’s drug against a competitor’s medication in the wrong strength: Too low a dose makes the rival drug look ineffective. Too high a dose tends to elicit worrisome side effects.

In addition, journals are also haunted by “ghostwriters.” These are unnamed writers, who tend to be neither doctors nor scientists. Drug companies have hired them to clothe the company’s marketing messages in medical-journal language. Then a doctor signs the ghostwriter’s report without acknowledging the writer’s role.

Even though medical journals claim to reject this use of ghostwriters, internal drug company documents entered into evidence during court trials have exposed this practice. No one knows how many company-paid ghostwriters actually produce the manuscripts signed by the official “authors.”

From pharmacological race-baiting to the haunting of journal articles by paid scribes, interpreting medical journal articles presents yet another hurdle that separates ethnic Americans from the top-flight healthcare they so desperately need.

For more about this issue and possible solutions, read Harriet A. Washington’s cover story in the latest issue of The American Scholar, “Flacking for Big Pharma." Washington won the 2007 National Book Critics Circle Award for her book Medical Apartheid: The Dark History of Medical Experimentation on Black Americans from Colonial Times to the Present. Washington's new book, Deadly Monopolies: The Shocking Corporate Takeover of Life Itself and the Consequences for Your Health an Our Medical Future (Doubleday) will be published this October.

 

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