October 5, 2006 – Vol. 42, No. 8
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NAACP goes to the grassroots for BiDil

Dan Devine

When Juan M. Cofield announced his goal at a luncheon during last weekend’s annual meeting of the New England Area Conference of the National Association for the Advancement of Colored People, it elicited a few giggles.

“I would like to see the name BiDil as common in our community as Viagra is in the general public,” said Cofield, NEAC’s president.

But a presentation by the pharmaceutical company marketing the only pill approved by the Food and Drug Administration for the treatment of African American heart failure patients proved to the audience that the issue is no joke.

It took about an hour for NitroMed senior vice president of sales Gerald Bruce to impress upon NAACP delegates from across New England the impact of heart failure on the African American community. He cited studies showing that blacks tend to develop heart failure younger than whites, along with estimates that blacks between the ages of 45 and 64 are 2.5 times more likely to die from heart failure than non-African Americans in the same range.

A clinical study has shown that NitroMed’s drug BiDil, which combines fixed doses of two generic medications that make it easier for the heart to pump, can help even the odds for black heart failure patients, reducing the risk of death by 43 percent and the risk of first hospitalization for heart failure by 39 percent. The findings led the FDA to approve BiDil in June 2005, and the pill became part of the new standard of best care for African American heart failure patients by both the American Heart Association/American College of Cardiology and Heart Failure Society of America.

Despite those results, HMOs, pharmacy benefit managers and the federal government’s Medicare and Medicaid plans have been slow to add BiDil to their preferred drug lists, reluctant to pay brand-name prices for a drug combining two inexpensive and already-covered generic medications.

According to Jane Kramer, vice president of corporate communications at NitroMed, BiDil is currently included on about 40 percent of Medicare Part D plans. “Which means that 60 percent of those patients are not eligible, and that is just unacceptable,” Kramer said. “It is a tragedy.”

Some believe part of the blame lies with the company. While NitroMed has worked to defray costs for both providers and patients, critics have said such measures might not be necessary had the company not set the drug’s price at $1.80 per pill, significantly higher than initial projections.

And with cost a significant issue for many who might benefit from the drug, one audience member suggested NitroMed wasn’t doing a great job explaining the advantages of its more expensive drug in a convincing fashion — or even one most people can understand.

After Bruce’s talk, Francisca Charlton of the NAACP’s New Bedford branch asked him to clarify the differences between taking the generic pills and taking BiDil. Bruce said that because clinical trials studied the two generics in a fixed-dose combination, he couldn’t accurately predict the outcome of taking them individually, but said you can’t guarantee the same results.

Following the luncheon, Charlton said she didn’t feel the NitroMed executive’s response effectively answered her question. “He kind of went into a spiel that went over my head,” she said.

In the past, Charlton has taken isosorbide dinitrate (ISDN) — one of the two generics contained in BiDil, along with hydralazine hydrochloride — to treat arterial blockage and to lower her blood pressure. But despite becoming familiar with BiDil at last year’s NEAC meeting, she has never asked her doctor whether it would be right for her.

Charlton said that if the biggest problem with the cheaper generic medications is just taking two pills instead of one, then that’s not really a problem at all.

“You still have to be careful with generics, because it doesn’t work all the time the same way as the name brand,” Charlton said. “But I know that taking that one generic pill has worked for me in the past.”

Only about 6 percent of the roughly 750,000 African American heart failure patients currently receive the combination treatment of ISDN and hydralazine. That includes patients taking the generic components individually, which Bruce called “substandard care.”

Ultimately, Bruce said, it’s about demand. NitroMed can continue to lobby managed care organizations for inclusion, but unless insurers see high levels of demand for a particular medication, they’re unlikely to put it on their preferred drug lists.

“This,” he said, “is the part where I’m going to ask you for help.”

Earlier this year, the NAACP and NitroMed formed a three-year, $1.5 million partnership to help address health care disparities. In general, the joint “health justice campaign” promotes better health habits and access to medical care for black people. More specifically, the NAACP puts NitroMed representatives in front of its delegates at meetings like NEAC to present information about BiDil’s benefits, a grassroots marketing approach aimed at spreading the word about the pill the old-fashioned way.

“What you can do to help is just building awareness in the community,” Bruce said. “Talk to your family members, your constituents, your friends, your neighbors. Tell them you heard about a lifesaving medication that makes patients feel better and be able to function better. Let’s, as Juan said, make BiDil as commonly known in the African American community as Viagra is in the broader community.”

This time, nobody laughed.

But that kind of public profile doesn’t come cheap. And without the budget or marketing force of industry giants, Kramer called grassroots promotional opportunities like the NEAC meeting essential to BiDil’s success.

“We don’t want to overstate or exaggerate the extent of our outreach — we don’t have a lot of people working for us, and we don’t have the reach of some of the larger pharmaceutical companies,” she said. “Word of mouth is very, very important to us.”

NitroMed is, however, attempting to expand that reach. Last month, the company initiated an advertising campaign comprised of radio spots and print ads in black newspapers in Detroit, Houston and Washington, D.C., cities with three of the nation’s largest African American populations. After reaching out to doctors for feedback on patient interest and new prescriptions written in those markets, NitroMed will determine whether or not to expand the campaign nationwide. Bruce said that NitroMed did not have the money for television spots, but indicated that the company’s ads will appear in Jet magazine. At present, no plans are in place for advertising in Boston.

Meanwhile, Cofield and NEAC work to ensure that area residents get informed. One of the NAACP’s leading advocates for BiDil, was introduced to the medication several years ago when he attended a presentation given by Dr. Michael Loberg, then NitroMed’s president and CEO. He has invited NitroMed representatives to speak at NEAC’s annual meetings each year since.

“I thought it was so important that NEAC get involved because [BiDil]’s saving the lives of folk,” Cofield said. “That’s the reason I’ve developed the passion about it that I have.”

That passion led him to send letters to executives at six of the nation’s top prescription drug insurers — WellCare, Prime Therapeutics, MemberHealth, National Medical Health Card, Aetna and ExpressScripts — requesting meetings to discuss their poor coverage of BiDil.

“I am concerned that, by placing BiDil out of reach for some patients … you are inadvertently denying necessary treatment to African-American patients,” Cofield wrote in the letter, dated Sept. 18. “Anything short of immediate and full, affordable access to BiDil for African-American heart failure patients enrolled in your Part D plan is inadequate.”

Cofield reported a strong response to the letters, but said that if that response doesn’t translate into BiDil showing up on more formularies, NEAC has an obligation to let the community know that the plans “are not addressing this important issue.”

“And then we have a choice,” said NEAC public relations chair Famebridge S. Witherspoon, “as employees who determine what health plan we want to select, as to whether or not we will continue to support insurers who don’t make this drug available.”

The issue, both Cofield and Bruce said, stretches much farther than just one company or pill — it affects the future of medicine for all ethnic groups.

“The pharmaceutical industry has known for a long time that certain populations respond differently to certain medications. NitroMed was the first company that tried to develop a medication for a specific population, and we feel that it’s very important that this process of research and development continues,” Cofield said. “If BiDil is not a financial success for NitroMed, it might be a long time before any other pharmaceutical company steps up and move this [process] forward.”

“This is bigger than me. It’s bigger than NitroMed,” Bruce said. “Because from my vantage point, when the pharmaceutical industry sees that we can be successful with BiDil in the black community — that we can be profitable and that lives can be saved — they will follow. Better therapies will be studied and launched to help our community.”

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