Envisioning 2.0

A few months ago, I mentioned an initiative that I’ve been working on that’s been stretching me to the limit and beyond.  Today, I’m pleased to announce that the Path of the Blue Eye project has been officially launched.

The goal of this initiative is to bring people working in health marketing communications together.  I’m trying to help to break down the silos that exist between industry sub-segments (e.g., PR, advertising, digital marketing) and geographic regions.

I’ve decided to launch the project a bit differently.  Once you go to the Website you’ll understand what I mean. Some may react negatively to the approach, while others will think it’s interesting. Whatever your reaction, know that  I believe so strongly in what I’m doing that I don’t mind literally going for broke in order to grab people’s attention and interest them in working together toward a common cause.

Together, we are stronger.  Not only will we be better prepared to serve our clients and others, but the general public will benefit as well.

I hope you decide to join me on this journey.  Learn more about my thinking on this project by visiting the official blog.

kmmad

A significant part of the recently signed stimulus package (at least for people in the health industry) is comparative effectiveness research.  Now that the bill has become law, government agencies will be required to conduct large-scale head-to-head clinical trials to determine which prescription medications are truly superior.

Some pharmaceutical industry stakeholders and physicians do not like comparative trials, and their experience with the ALLHAT trial illustrates some of the reasons why.  The ALLHAT trial demonstrated that generic blood pressure medications are better than more expensive alternatives.  The results sounded good until prominent physician thought leaders began to take the data apart and suggested that the government skewed the study results.

More troubling is that some doctors said the government based the study on poor outcomes experienced by African American patients taking certain types of blood pressure pills.  Differences in how people from various ethnic and racial backgrounds respond to medications is one reason minority advocacy organizations are resisting the push to launch more comparative effectiveness studies.

The Congressional Black Caucus expressed concern that “comparative effectiveness research will be based on broad population averages that ignore the differences between patients.”  While House and Senate negotiators inserted language in the final bill requiring government-funded trial to include adequate numbers of minorities (and women), some are still concerned that this isn’t enough.

The issue of differences in how people of various racial and ethnic groups respond to medications was a major topic of the interview series I conducted a few years ago focusing on race and medicine.  You can read one scientist’s comments about this issue here.

Much has been said about the ongoing health disparities between minority groups and whites.  While some have attributed these differences to racism, new evidence indicates that disparities may be caused by equality rather than inequality.

A new study published in the Archives of Internal Medicine indicates that by treating all patients the same, physicians may be doing people from diverse backgrounds a disservice.  Dr. Thomas Sequist, lead author of the study told the New York Times: “It isn’t that providers are doing different things for different patients, it’s that we’re doing the same thing for every patient and not accounting for individual needs.  Our one-size-fits-all approach may leave minority patients with needs that aren’t being met.”

For example, telling a Hispanic or African American patient that they need to reduce their intake of carbohydrates may not be effective if rice is at the center of their diet.

While this study is interesting, it is not highlighting a new problem.  For many years medical and public health officials have focused on the need for health providers to become culturally competent.  Hopefully this study will accelerate cultural competency efforts by helping us get to the heart of racial and ethnic disparities in care.

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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