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Medication for Blacks Only

Posted on: Friday, 29 July 2005, 21:00 CDT

Jul. 29--Big cities with large black populations quietly became the launch pad this month for a product at the cutting edge of American health care, commerce and racial identity.

BiDil, a pill for congestive heart failure, is the first to get government approval for use in one race group - African Americans.

As scientists and physicians ponder the implications for medicine, race and ethnicity, Massachusetts drugmaker NitroMed Inc. is forging ahead with its multimillion-dollar gamble on a business some call "ethnic drugs."

"This is groundbreaking," said equity analyst David Moskowitz, of Friedman Billings Ramsey, in Virginia. "This sends a major signal that companies can and will be rewarded when they target special patient populations."

BiDil (pronounced BYE-dill) is more marketing coup than scientific breakthrough. Still, it may pave the way for future ethnic drugs and even "personalized medicine" based on genetic codes.

"It's the kind of tailoring and targeting of drugs that we're going to see more of," said Stephen B. Thomas, director of the University of Pittsburgh's Center for Minority Health.

Shelley Hankins, a Drexel University cardiologist who helped study BiDil, said she might switch 15 percent to 20 percent of her patients to BiDil if they can afford its high price.

"It's a good drug," she said.

But BiDil faces a big hurdle in beating cheaper generic versions already on the market, a key factor in the African American market. And some physicians are cool toward the whole idea of ethnic drugs.

David Knox, chief of cardiology at St. Joseph's Hospital in Philadelphia, said he probably would prescribe BiDil, but faulted the Food and Drug Administration's interpretation of the data.

"There is a tendency to apply what's good for white people to everybody, but if it's done in African Americans, it's only good for the African American community," Knox said, adding that BiDil was probably useful for non-blacks, too.

BiDil is made from two inexpensive generic drugs, hydralazine hydrochloride and isosorbide dinitrate, long used to dilate blood vessels, hence the name BiDil. It appears to work by increasing nitric oxide in the walls of blood vessels, in turn reducing the incidence of congestive heart failure.

Trials of BiDil in the 1990s showed no benefit for patients overall. Then a 2001-04 trial of patients who identified themselves as African American and were taking other heart drugs found 43 percent fewer deaths and 39 percent fewer hospital admissions when they added BiDil, compared with a placebo. It did not study non-blacks.

The FDA on June 23 approved BiDil for "self-identified African Americans," leaving room for interpretation. The agency has looked at race before, but only to warn against, not encourage, patients' use of certain drugs.

On July 5, NitroMed began stocking pharmacies and doctors' sample closets. Its 195 newly hired salespeople began making calls on 10,000 selected physicians in Philadelphia, Atlanta, New York and Washington and other big cities.

Minority health advocates who have complained about drug-industry neglect are promoting BiDil, led by the respected Association of Black Cardiologists, which NitroMed targeted early for support.

Equity analysts have estimated that U.S. sales could reach $200 million by 2007, a small share of the $18.3 billion hypertension market, according to NDC Health, an Atlanta market-research firm.

For patients with insurance, NitroMed will ask prescription plans to pay about $1.80 per pill, or as much as $200 per month, far more than generics at 30 cents per pill. The price is comparable to other new brand-name drugs, such as Coreg or Norvasc.

NitroMed's challenge is persuading insurers and Medicare to cover BiDil over the generics.

"Medically speaking, the drug works. But economically, it has not won over the heart-failure community" on cost, said Shashank Desai, a heart-failure transplant cardiologist at the Hospital of the University of Pennsylvania.

To capture more prescriptions, NitroMed is targeting uninsured patients with a patient-assistance program that will dispense BiDil free with just a one-page enrollment form. It estimates the program will provide 15 percent of prescriptions initially, more than typical.

NitroMed's advertising firms include Vigilante, a black-run agency specializing in urban ethnic markets. It plans to run consumer ads in print publications soon and will air TV commercials "once we're satisfied that we've saturated physicians," said William "B.J." Jones, vice president for marketing.

Jones declined to reveal the ads' theme. "It's really about the drug. Race would not be a central theme," he said.

Some African Americans have a deep suspicion of pharmaceutical research, stemming in part from the Tuskegee experiments when scientists withheld treatment from 400 black men with syphilis over 40 years in order to study the disease.

"The fact that science targets African Americans is not necessarily the way it can be successfully marketed," said Thomas, of the University of Pittsburgh. "The issue of trust is serious and real."

NitroMed, for its part, calls BiDil "the antithesis of Tuskegee," but has no plans to address the topic head-on. "We don't want to create an issue where there isn't one," Jones said.

Nobody is sure why BiDil works in certain blood vessels. Most scientists, including BiDil's patent-owner Jay Cohn at the University of Minnesota, attribute its effect in blacks to environment and lifestyle, and secondarily to genetics. NitroMed is still studying to find out.

"If we can find a drug that works, by all means we should use that," said Charles R. Bridges, chief of cardiothoracic surgery at Pennsylvania Hospital. "But this should not be misinterpreted to reinforce the concept that race is a useful way of defining" biological differences.

At least one other company, Mylan Labs Inc., in Canonsburg near Pittsburgh, is conducting trials to see whether its blood-pressure drug Nebivolol works better than a placebo in African Americans.

NitroMed expects BiDil to be prescribed to 10 percent to 15 percent of African Americans with congestive heart failure, who number between 250,000 and 750,000 nationwide, according to government and company estimates. It also anticipates sizable "off-label" use among all 4.9 million Americans with heart failure, since the trial never ruled out other races.

"That's the whole issue: What is race? Is it about nose, hair, skin?" said Elijah Anderson, a University of Pennsylvania sociologist. "Most quote-unquote black people are quite mixed up anyway. They can trace their ancestry to whites and blacks and Native Americans."

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NTMD,

Source: The Philadelphia Inquirer

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