Envisioning 2.0

An intriguing article published today in the Wall Street Journal (subscription required) highlights an ongoing battle between the NAACP and the government over coverage of the controversial cardiovascular medication BiDil. NitroMed, which makes the drug, has run into financial trouble because sales have not taken off.

BiDil, the first and only medication approved for use by a single racial group (African Americans), combines two generic medications: isosorbide dinitrate and hydralazine. NitroMed has had trouble securing insurance coverage for the medication because the manufacturer’s fixed-dose combination therapy is more expensive than its separate components. The government has not required private insurers running Medicare Part D plans to cover BiDil. However, in November, NitroMed announced that it had “entered into final agreements to place BiDil on preferred formularies of 2 of the nation’s 5 largest Medicare Part D payors.”

Despite this progress, the NAACP, which received $1.5 million from NitroMed to improve healthcare for African Americans, is crying foul. According to the Journal the NAACP said:

“Medicare’s stance ‘is so contrary to evidence-based medicine and so extraordinary that it arouses suspicions of institutional racism,’ said the letter, from Juan M. Cofield, president of the NAACP’s New England council. If BiDil ‘were not a medication for blacks, their response might be different,’ Mr. Cofield added in an interview. Until a clinical trial shows that generics work as well as BiDil, the letter argues that Medicare should require all of the Part D drug plans to cover the drug.”

Wow. Does refusing to require coverage of BiDil mean that the government is practicing institutional racism? Let’s look at this issue from a medical perspective. Last year, I conducted an extensive interview with NitroMed about BiDil. Here is what Michael Sabolisnki, Chief Medical Officer of NitroMed, had to say about the drug’s clinical development:

“From a clinical development standpoint, we saw that African Americans responded to BiDil. We did not see as strong of a response in other groups. These observations led us to launch the African American Heart Failure Trial (A-HeFT), which was conducted in a population of 1050 self-identified black heart failure patients. . . We are proud to have run a study that showed the best possible outcomes in a self-identified African American population. When we saw that black patients taking BiDil were 43 percent less likely to die and 39 percent less likely to be hospitalized due to heart failure, we knew that were helping a population in desperate need of adequate treatment.”

I also spoke with Keith Ferdinand, a well-respected cardiologist about why uptake of BiDil has been disappointing. He told me:

“I do not believe that the slow uptake of BiDil can be attributed to weak or inappropriate marketing. Perhaps clinicians were reluctant to use a branded medication when generics are available. Another barrier may have been the fact that patients must take the medication three times per day when they already have complex medical regimens.”

So, although patients on BiDil have good clinical outcomes, clinicians are reluctant to use it because generics are available. In addition, BiDil’s dosing schedule is less than optimal.

Overall, there are good clinical, scientific and financial reasons why BiDil has not caught on with the some insurers and physicians. However, it is worth saying that the FDA recently confirmed that there are no medications (generic or branded) that are equivalent to or can be substituted for BiDil. Despite this, BiDil remains a tough medication to convince insurers to cover.

Clearly NitroMed recognizes this because they are working very hard to accelerate development of their new extended release, once daily formulation of BiDil. Doing so will solve the convenience and compliance problems associated with the medication. The company should also consider conducting a clinical trial testing BiDil’s generic components versus the new formulation (if it hasn’t already). If the trial is positive, NitroMed will have a stronger argument as to why physicians, insurers and patients should use BiDil.

So, is this a case of institutional racism? I don’t think so. Instead the Medicare Part D flap highlights some of the problems NitroMed has always faced convincing insurers to cover the drug. The NAACP has played the wrong card.

This entry was posted on January 25, 2007 at 6:19 pm and is filed under Race and Medicine. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.