Envisioning 2.0

After generating significant media attention and controversy, NitroMed announced recently that it would be ending its efforts to market BiDil, the first medication approved by the FDA for a specific racial group, African Americans.  BiDil’s sales have been less than stellar, partly because it is a combination of medications currently available in generic form.

According to a company statement:

“NitroMed . . . announced today that it has implemented a restructuring plan that will eliminate approximately 70 positions over the next month, reducing headcount from approximately 90 to 20. The Company anticipates that headcount may be further reduced over the next several months. The Company is discontinuing its sales and promotional activities for BiDil, although the Company intends to keep BiDil available and on the market for patients.”

Currently, NitroMed is developing an extended release version of BiDil that it hopes will be better accepted by physicians and patients.  However, the drug is years away from approval.  Observers also expect that NitroMed will be sold before the drug hits the market.

Although the BiDil saga is over, don’t expect race-based (or to use a more accurate term, personalized medicine) to go away.  With so many people responding to medications differently because of their genetic makeup and physiology, drug makers will have little choice but to continue efforts to tailer drugs to different populations.

Moreover, although BiDil didn’t succeed in a harsh and competitive marketplace it did lead to a valuable and wide ranging national conversation about the value (and validity) of using race in medical care and health disparities.  We’ll be debating these issues (and using BiDil as an example) for many years.

I’ve covered BiDil extensively on this blog.  Those interested in commentary about BiDil by NitroMed’s former chief medical officer Dr. Michael Sabolinski should click here.

Late last week, the Boston Globe highlighted a disturbing study indicating that medical students may provide African American patients with substandard care because of hidden or unconscious biases.  According to the Globe:

“In the new study, trainee doctors in Boston and Atlanta took a 20-minute computer survey designed to detect overt and implicit prejudice. They were also presented with the hypothetical case of a 50-year-old man stricken with sharp chest pain; in some scenarios the man was white, while in others he was black.

We found that as doctors’ [white and non-white, including a small percentage of African American physicians] unconscious biases against blacks increased, their likelihood of giving [clot-busting] treatment decreased,” said the lead author of the study, Dr. Alexander R. Green of Massachusetts General Hospital. “It’s not a matter of you being a racist. It’s really a matter of the way your brain processes information is influenced by things you’ve seen, things you’ve experienced, the way media has presented things.”

What this study also demonstrates is that negative ideas, images and words have a significant impact on us all – no matter what our race or ethnicity.  We need to work doubly hard – especially those in health communications – to overcome the barriers to outstanding care faced by African American patients.

Last week Jim Edwards of BrandWeek reported on the lackluster sales of NitroMed�s flagship medication, BiDil. This drug, developed for “self-identified” African American patients with heart failure, has been a disappointment. Last quarter it only racked up $3.2 million in sales.

BiDil received a great deal of publicity when it was launched because it was the first drug approved by the FDA for the treatment of a specific racial group. Edwards suggests that BiDil’s woes cast “doubts on race-based medicine.” He argues this is because blacks may not be as black (genetically) as many may think.

John Mack, who writes Pharma Marketing Blog, disagrees. He blames NitroMed’s failed marketing campaign for BiDil’s woes. He says that 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.”

I know at least one person who would agree. In an interview I conducted with noted researcher Dr. George Bakris, who has done a lot of work with minority populations, Bakris gave the pharmaceutical industry a D on its communications efforts. He believes “drug firms spend more time educating on the product rather than the disease.”

While their arguments about the failure of BiDil are compelling, neither Edwards or Mack are correct. BiDil failed because it is simply a new formulation of two generic medications with a tedious dosing schedule. Dr. Keith Ferdinand, who helped to study BiDil, had this to say when I asked him whether marketing was to blame for BiDil’s poor performance:

“I do not believe that the slow uptake of BiDil (isosorbide dinitrate/hydralazine HCl) 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.”

There you have it. Despite compelling clinical evidence and pressure from the NAACP, NitroMed has not been able to sell BiDil because it is hard to convince physicians (and insurers) to use a medication that has an equally effective generic counterpart. The company is currently developing an extended release, once daily formulation of BiDil. It remains to be seen whether the drug will be approved or successful.

Rather than focusing on race or marketing, BiDil’s failure can be traced to economics 101. It’s all about price.

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.”

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Early last month, PLoS Medicine published a disturbing, but very important study that sheds new into the vast gaps in life expectancy rates between people of different racial backgrounds and socioeconomic status. This study has significant implications for people involved in health promotion, social marketing and other efforts to improve the health of diverse communities.

Authors of the study found that (when measured by life expectancy) we live in eight different Americas. See images below for definitions and gaps in mortality (click images to view larger versions).

What’s interesting about the data is that the differences in life expectancy cannot be explained by “race, income, basic healthcare access or utilization alone.” According to the authors of the study: “The causes of death that were mainly responsible for . . . [variations in life expectancy] were various chronic diseases and injury.” In addition, the in mortality rates were between middle-aged Americans of different races and socioeconomic status, not the elderly or children.

In sum, people are dying earlier due to illnesses like high blood pressure, abnormal cholesterol, smoking, obesity, diabetes and pre-diabetes. All of these conditions are highly treatable and preventable.

The study authors note that “expanding health insurance coverage alone will not reduce disparities.” Instead, we need improved disease prevention strategies, especially in the area of cardiovascular disease.

These data indicate that we need to increase efforts to educate diverse populations about risk factors that contribute to early death, including high cholesterol and high blood pressure. Intensive communication, social marketing and behavioral modification programs are needed now more than ever.

Today’s Washington Post has an interesting article about race and medicine. In the article, researchers talk about the differences within black populations in health status and disparities.

As it turns out immigrants of African descent arrive in the US with better health status than African Americans. However, over time these differences narrow. Researchers are concerned about the data and struggling to explain this shift in health status.

Read the Washington Post article by clicking here.

Over the past several months, I have had the privilege of speaking with a number of well-regarded scientists, physicians, epidemiologists and social scientists about a very contentious issue: race and medicine. I have been pleased that so many distinguished individuals have been willing to speak publicly and candidly about this difficult subject.

Although those I have interviewed have many different perspectives on this subject, a few common themes shone through. Most importantly:

-Race is social construct with biologic and economic consequences: I was speaking about race and medicine with the head of a major medical association the other day. During that conversation he said: “What is the difference between a white horse and a black horse? None. Yet, we make a big deal of differences between whites and blacks. Why do we do this?”

As many of the people I interviewed observed: At its simplest, race is a social construct, a means of grouping people. Yet, race has many consequences: social, economic and medical. While there are no significant differences between groups of people, race has consequences. Especially on health outcomes and how people metabolize different medications.

-The pharmaceutical industry and government need to do more to address racial disparities: Many of the people I interviewed said that drug companies need to do more to educate ethnic minority patients on risk factors and behaviors that can result in improved health. Some companies, like NitroMed (see the interview below) are making an effort, but more needs to be done. Especially in areas where there is little or no financial incentive to do so. Government can and should play a role in promoting social and health equity.

-Health disparities are real and persistent: A major theme of my interviews was disparities in healthcare. Everyone agreed that disparities are real, persistent and deserve increased attention.

I hope you have enjoyed this interview series and found it informative. While this is my final interview, I will certainly touch on this issue in the future. Click here to read the other interviews I have published on race and medicine over the last few months.

Read on for my interview with Dr. Michael Sabolinski of NitroMed.

About Dr. Sabolinski: Dr. Sabolinski is Chief Medical Officer of NitroMed. He has more than 20 years of experience in clinical research and medical products development. He joined NitroMed in 2002 after completing a distinguished decade long career with Organogenesis, Inc. where he held several positions including President and Chief Executive Officer, Head of Clinical Research, Regulatory Affairs and Corporate Development. During his tenure, he successfully managed the team that secured two FDA approvals of a living skin substitute, pioneering the path for stem cell products and other cell therapies.

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Race-based medicine, or the practice of treating people differently based on their racial and ethnic background, has long been a subject of interest to healthcare providers, public health practitioners, communicators and others. Now, with the introduction of BiDil, the first medication approved for the treatment of a condition in a specific race (African Americans), the topic is once again gaining increased attention.

Given the intense interest in this subject, I am conducting a series of periodic interviews with physicians, social scientists and others. Each interview subject provides his or her unique perspective on race-based medicine, which I then publish on this blog. Please click here to read the other interviews in this series.

Interview Subject: Dr. Brian Smedley

About Dr. Smedley: Dr. Smedley is research director and co-founder of the Opportunity Agenda, a communications, research, and advocacy organization dedicated to building the national will to expand opportunity in America. Prior to joining the Opportunity Agenda, Dr. Smedley was senior program officer in the Division of Health Sciences Policy of the Institute of Medicine (IOM), where he was study director for the IOM report, Unequal Treatment: Confronting Racial and Ethnic Disparities in Health Care.

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Last month, I posted a brief item regarding a study Schering-Plough had initiated for a new hepatitis C drug that excluded self-identified African Americans from the trial. Today, I came across an interesting post on “Open Letters” a blog written by Karama Neal, PhD. In the post, or open letter to Schering-Plough, Neal states:

“I have difficulty understanding why African-American patients are being excluded from this trial, particularly since that is the only ethnic group specifically excluded.”

It turns out that Schering-Plough was monitoring the blogosphere and decided to respond to Neal’s post. Four executives at the company participated in an April conference call where they “addressed [Neal’s] questions, and gave [Neal] a clearer understanding of their rational for this study design.”

Although Neal continues to believe that the Schering-Plough study “misuses the concept of race,” she appreciated the company taking the time to answer her questions.

I’m not surprised that pharma companies are proactively engaging bloggers, as my recent interview with NitroMed on the topic of race and medicine indicates, however, I’m always impressed when they decide to be proactive.

(By the way, if anyone from Schering-Plough is visiting this blog, you might be interested in my ongoing interview series re: race and medicine. Feel free to comment on any of the interviews I’ve published thus far.)

Click here to see Neal’s post re: the Schering-Plough conference call.

Race-based medicine, or the practice of treating people differently based on their racial and ethnic background, has long been a subject of interest to healthcare providers, public health practitioners, communicators and others. Now, with the introduction of BiDil, the first medication approved for the treatment of a condition in a specific race (African Americans), the topic is once again gaining increased attention.

Given the intense interest in this subject, I am conducting a series of periodic interviews with physicians, executives from medical societies, communications experts and others. Each interview subject provides his or her unique perspective on race-based medicine, which I then publish on this blog. Please click here to read the other interviews in this series.

Interview Subject: Dr. Esteban González Burchard

About Dr. Burchard: Dr. Burchard is assistant professor of medicine at the University of San Francisco Medical Center. Dr. Burchard’s research interests center around identifying “ethnic-specific” genetic and biologic risk factors for asthma, asthma severity and drug responsiveness among U.S. ethnic and racial minority groups. In addition, he focuses on how race and racially specific genetic differences influence disease and response to pharmaceutical therapies.

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