HEALTH :: DECEMBER 15, 2004

If you want to compare a thoughtful, sophisticated analysis of a complicated medical topic with a superficial, stupid analysis of that same topic, I have an assignment for you. First, read the commentary on a congestive heart failure medication called BiDil by Dr. M.Gregg Bloche in the New England Journal of

Medicine of Nov. 11, 2004 (http://content.nejm.org/cgi/content/abstract/NEJMp048271). Next, read the Detroit Free Press editorial on the same drug, dated Nov. 9 (http://www.freep.com/voices/editorials/eheart10_20041110.htm).

The New England Journal report tells of a study in which black patients with severe heart failure were given either BiDil or a placebo. The study had to be stopped early because only 6.2 percent of the BiDil patients died, compared to 10.2 percent of the placebo patients. The BiDil patients also had fewer hospitalizations and better quality of life overall.

The Free Press editorial could have been written by the drug company’s PR manager. This pill, said the editorial, is good news, period. Blacks suffer more from heart failure than whites. Anything that helps them is a wonderful thing. Anyone who says that there is any problem here is a weird racist. End of story.

Dr. Bloche agrees that anything that helps black patients do better with a serious disease is good news. He knows there is a serious racial imbalance among those who suffer from heart failure. But he also mentions some wrinkles that the Free Press ignores.

BiDil is a combination of two generic drugs: isosorbide dinitrate and hydralazine. When the drug was subjected to a large trial in 1996, it failed to show overall improvement among heart failure patients, and the FDA refused to give it new-product approval back then. Going back over the 1996 data, one firm, NitroMed, saw evidence that the black patients assigned to BiDil did better than any other subgroup. NitroMed bought the patent rights to the BiDil combination, and also a patent to the idea of targeting black patients only. The new trial just now reported will almost certainly result in FDA approval to market BiDil “for blacks only.”

We don’t know what NitroMed will charge for BiDil when it hits the stores. If you combined generic isosorbide and generic hydralazine to get as close as you could to the BiDil mixture, it would cost 44 cents a dose. Chances are good that NitroMed will charge a good deal more.

Dr. Bloche also reminds us of what we still don’t know about the BiDil drug combo. In 1996, drug treatment for congestive heart failure was much less advanced than it is today. So in the older study, the patients were given quite a different combination of drugs alongside BiDil, compared to what the black patients were given in the new study just reported.

That leads to a scientific question: Suppose we gave both black and white patients a combination of BiDil plus today’s other, modern drugs for heart failure. Would there still be the same marked difference between black and white patients? Or would both groups now benefit more from having BiDil added?

We don’t know the answer to that question, because the newer NitroMed research study only enrolled black patients. The company had no financial incentive to study what happens in non-blacks, because they hold the patent for using BiDil only in blacks. They cannot make a real profit selling the new drug combo outside of the blacks-only marketing scheme.

So let’s add up the balance sheet. We have a new drug that seems to be effective for a group of patients who need help urgently with a severe, potentially fatal disease. Great news. This new drug especially helps a group that too often gets the short end of the stick. Great news. The supporting research, according to Dr. Bloche’s careful analysis, was driven more by money and regulatory concerns than by science. That’s bad news.

Next time we’ll look at why this bad news has important ramifications.