Color, Medicine and Trust

My buddy Sean Hudson, who works for Pfizer in their H.I.V. Marketing organization, recently sent me a story about how the pharmaceutical company Schering-Plough is being criticized because they have purposely excluded Blacks from the early stages of clinical trials for their new hepatitis C virus (HCV) protease inhibitor, SCH 503034.

In general people of color do not trust ‘the man’… whether that man represents the government, medicine, education, or business. Of course we don’t have to look very far back in history to understand where those fears may come from. However with medicine this mistrust can be more damaging. If I don’t trust my government I may not vote and avoid police. If it don’t trust the education system I won’t embrace the curriculum and will perhaps drop out of school. If I don’t trust the business community I’ll be cynical about how companies are only in business to exploit me and I’ll begrudgingly work for them only if my lack of options mandate it. However if I don’t trust medicine or health care in general I could die earlier than I have to. I could also influence my Black friends and family to avoid interventions that could prolong their life. Granted there is good reason not to trust medicine. The Tuskegee Experiment was a 40 year 'study' sponsored by the US Public Health Service where they ‘experimented’ on 400 Black men in the deep south to see how late stages of untreated syphilis impacted them. Their scientists essentially withheld treatment and information from their subjects to sit back and observe how syphilis progresses in Black men. They told them they had 'bad blood' and didn't offer any clue as to what they were up to. This remains the shining example as to why people of color do not (should not?) trust medicine.

A recent University of Houston study published in the March Journal of Acquired Immune Deficiency Syndromes reported 30% of Texas African Americans and 22% of Texas Latinos believe HIV is a government conspiracy to kill minorities.

Schering-Plough maintains that its recruiting practices for its clinical trials are legit, their spokesman Robert Cansalvo argues because Blacks are known to respond poorly to one of the drugs SCH 503034 is being tested with that including them in the early trials is ‘unnecessary' and that they will definitely be in the next round of trials. Says Cansalvo, “It’s a question of timing when to include them.”

Some HCV scientists and activists agree that their approach to selecting subjects is sound and Schering-Plough should proceed so that this potentially valuable product moves closer to becoming available to those in need. However critics from community based organizations to Hep C advocacy organizations see their selection practices as an egregious disservice to Blacks who are in the most need. HCV is three times more common among Blacks than among Whites. Cure rates are lower for Blacks on existing meds and Blacks are more susceptible to complications of HCV like liver cancer, liver failure, and cirrhosis, all of which can lead to death.

This is a tough issue. It is a bit unsettling that Blacks are excluded from the early stages of a clinical trial for a drug that could address a virus that disproportionally impacts them. Also these protests and bad press do nothing but fan the flames of mistrust that many people of color have regarding the medical establishment.

I understand the urgent need to develop, test, and bring to market drugs that will treat some of our most pressing viruses, and diseases they cause, to market. I also understand this work is done against a backdrop of fear and mistrust.

Given both these factors I think Schering-Plough is wrong here. I don’t have a problem with the exclusion in the early stages, they seem to have solid clinical rationale here. I do think they could be more sensitive to the context in which they operate and should proactively reach out to the advocacy groups and other organizations who question their selection and work with them to explain, and discuss, why their selection rationale makes sense and their selection plans for future stages of their trial.

Their work is too important, and the scars are too deep, to ignore history and these important issues around trust that are still with us all.

30% of Texas African Americans and 22% of Texas Latinos believe HIV is a government conspiracy to kill minorities.