Friday, May 04, 2007

BiDil Sales Disappoint: Blame Genes or Marketing?

Jim Edwards, editor at Brandweek and author the BrandweekNRX blog, reports that sales of BiDil, a heart failure drug for African Americans, "suck." His opinion as to why this is so: "One possible factor is that the FDA approval was for 'self-identified black patients.' The problem with that is that a lot of people turn out to be not as black -- or white, or whatever -- as they think they are when their DNA is examined." (See "BiDil Falters, Casting Doubts on Race-Based Medicine").

Jim cites a couple of anecdotal cases to make his point. One is a woman who thought she was white but who has some African DNA in her mitochondria. From this evidence, she now claims to be African American.

Give me a break! Mitochondrial DNA is not genetic material. Nuclear and mtDNA are thought to be of separate evolutionary origin, with the mtDNA being derived from bacteria that were engulfed by early precursors of eukaryotic cells. So, at best, one of this woman's white ancestors may have been infected by bacteria from feces-contaminated lettuce picked by an African farm laborer!

But I digress. Back to BiDil.

Although the "not as black as I thought" argument may have some merit, the percentage of black Americans who are not be "as black as they think they are" must be very small! Too small to affect sales of BiDil.

Even if the percent of "not-as-black-as-they-think-they-are" African Americans were large enough to affect sales, the effect would not be evident until much later in the sales cycle when doctors and patients realized it wasn't working in a large group of "self-identified" black Americans. BiDil just hasn't been around long enough for that.

The fact is, according to Nitromed -- the company that is marketing BiDil -- and the FDA, "the FDA based the approval of BiDil primarily on results from the African American Heart Failure Trial (A-HeFT), which was halted early, in July 2004, due to the significant survival benefit seen with BiDil."

So, there is evidence that BiDil is effective.

The real problem with BiDil sales may have more to do with inadequate or ineffective marketing than with less-black-than-you-think genes.

It is notoriously difficult to market to minorities and I don't believe the pharmaceutical industry knows how to do it well or invests enough time or effort figuring out how to do it. You don't see, for example, very many industry conferences devoted to the subject. The best minority-targeted pharma marketing efforts so far involve outdoor advertising (billboards) and local radio stations.

Faith-Based Targeted Disease-Awareness Marketing
Recently, I had the opportunity to interview Jay Bolling, President of Roska Healthcare Advertising, and David D. Comey, Managing Partner at Healthy National Network about their "Multi-cultural Outreach Initiative" to improve the disease awareness of African Americans and other minorities (see "Targeted Faith-based Disease Awareness Marketing"). Key to the plan is involving the church community and African American physicians.

I think this is an innovative approach that may be effective. The initiative is focused on identifying and reaching out to African American with cardio-metabolic conditions (ie, heart disease and other cardiovascular problems and diabetes). "We are currently in discussions with pharmaceutical companies about getting on board to support this program and to 'own' a disease category," says Bolling.

Perhaps Nitromed should talk to Jay, get on board and "own" the heart failure category. Maybe that will improve sales of BiDil.

Listen to the Podcast!
If you are a Nitromed marketer, you should listen to my Pharma Marketing Talk interview with Bolling and Comey in an upcoming FREE live podcast on Tuesday, May 15, 2007 at 1 PM Eastern. Obviously, everyone reading this is invited too! For more information about listening live, calling in with questions, or downloading the audio archive after the show, see "Faith-based Unbranded Marketing: How to Educate, Engage and Empower members of the African American Community."

For more information about the disparity of health issues among African Americans and the Multi-cultural Outreach Initiative, see the "A Faith-based Multi-cultural Outreach Initiative" synopsis below.
DISCLAIMER: While I often publish "advertorial" campaigns, which include editorial content and non-adjacent advertising, in my Pharma Marketing News (PMN) newsletter, neither Roska Direct Advertising nor Healthy National Network are current advertorial clients. If you wish to learn more about PMN advertorials, please see Advertising Information and/or fill out the Rate Card Request Form.

A Faith-based Multi-cultural Outreach Initiative

There is a great disparity of health issues among African Americans, in particular with regard to cardiovascular disease, diabetes, obesity, cancer, HIV/AIDS and asthma. This is complicated by the fact that cultural, economic and other factors have sustained a low level of awareness for the heightened risk of these diseases.

The African American experience in America has left many of them mistrustful of mainstream institutions/providers who are members of the dominant culture. While studies show that this community is receptive to DTC advertising, there are gaps in the healthcare delivery system and many at-risk patients never receive treatment.

This suggests that a distinct need exists for an alternate, targeted program that can help motivate African Americans toward self-healthcare awareness and caregiving.

The goal is to educate, engage and empower members of the African American community by creating a foundation of disease awareness, activating the influential elements within the community and creating 'teachable moments' that help translate awareness/education to action.

African American physicians represent a powerful influence on the community’s health. And, at the core of the African American physician community is the National Medical Association. The NMA serves as the voice of the African American medical community and represents more than 25,000 physicians, many of whom are intimately involved in faith-based organizations. These physicians are well positioned to encourage congregations to proactively engage in the program’s objectives.

The church community is extremely influential among African Americans as the gatekeeper for the soul and health and can have a strong impact on behavior. By engaging the churches, messages are delivered to the congregations:
  • Directly from the pulpit
  • Through ads and announcements in church newsletters
  • With posters and hand out materials on-site at the churches
  • By engaging the Health Ministry
Targeted marketing allows us to create a ‘surround sound’ effect to support the physician and faith-based communications through community-centered communications.

What makes this program unlike any other is that, in addition to physician, church and targeted consumer communications, it will provide not just information, but specially trained staff who will screen and test church members and provide on-the-spot referrals or appointments for follow-up treatment. These 'teachable moments' will identify at-risk patients and help translate education/information into action.


  1. IMO, the key BiDil problem is not self-identification of being black, as reported on BrandeekNRX, nor is it ineffective marketing, as reported by here(although this is an important factor in all disappointing launches). The key problem is one of strategy. NitroMed conducted a great trial that proved 2 generic drugs, in combination, worked very effectively in black HF patients. They assumed insurers/patients would pay a premium for a re-formulated version of these 2 drugs that was much more convenient to take (less pills and less pill taking events per day). This proved to be dead wrong, and all NitroMed did was increase the sales of these generics (and possibly provide a nice public service).

    Additionally, I don't think I agree with your comment on mitochondrial DNA. The bacterial origin of mitocondria into eukaryotic cells occured on the order of billions of years ago. Humans do not pick up new mitochondrial DNA from bacterial infections. While clearly distinct from nuclear DNA, mtDNA IS genetic material that codes for proteins in the mitochondria, and is different person to person. mtDNA also has distinct lineage patterns (mother to offspring). Not to say mtDNA might not change over time, in evolutionary terms, but I don't think it is from acquiring new mitochodria from bacterial infection!

  2. Chris,

    Thanks for your comments.

    Too bad about the mtDNA -- it was a good opportunity to interject a connection between a topical story (America's tainted food supply) and class divisions between people of color and whites. Sometimes, facts get in the way of a good story, so I tend to ignore them. Thank God for comments from more knowledgeable people like yourself ;-)


  3. One thing that hasn't been discussed, and that is the idea of medications just for African-Americans and the Tuskegee factor. Ten years ago, as part of the FDA Modernization Act, guidance was introduced: “The Secretary shall, in consultation with the Director of the National Institutes of Health and with
    representatives of the drug manufacturing industry, review and develop guidance, as appropriate, on the inclusion of women and minorities in clinical trials..."

    The FDA acknowledges that medications may work differently in women and minorities--and that's a good thing. However, the reality in the market may be quite different when a company tries to say that a medication is for a certain racial group. Will there be trust? The African-American community has a long memory, and it's as if the Tuskegee Syphilis Study happened yesterday. This is quite different from outreach for diabetes and heart disease when the answer involves medication such as insulin or the statins; it may be a factor, for some time to come, with any medication marketed "for African-Americans only."


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