You don't know how tempted I am to dump the whole show to something streamable.
The guests were Dr. Patricia Davidson, cardiologist at Washington Hospital Center, Washington, DC, and Dr. Charles Curry, Professor Emeritus at Howard University College of Medicine. Though the whole discussion was fascinating, Dr. Davidson put the key information outthere right at the start of the show.
The two points:
- The reason trials specifically for Black folk were necessary is that Black folk are under-represented in such trial so the statistical validity of the result is questionable
- This is not a new drug. Nitroglycerin and Hydralazine, tested in 1985 and 1990s
And the quote:
"Now we know that there are four classes of drugs that save lives with heart failure, and by adding this on in combination we ended up having a greater benefit. That doesn't mean that the white population, the Hispanic population, the Asian population may not benefit, it's just that there were financial reasons why they chose to do it in the African American population, because they wanted to make sure they got a longer patent rather than a shorter patent. If you just reformulate a drug that's been tested before then you cannot have more than a two year patent.
The first point is one we became familiar with during the run-up to the 2004 election. 'Nuff said about that.
NitroMed would dispute the second point because their description of the product doesn't mention nitroglycerin.
NitroMed's lead product, BiDil, is an orally-administered nitric oxide-enhancing medicine that is being investigated for its potential to reduce mortality and hospitalization and improve the quality of life of African Americans diagnosed with heart failure. BiDil is a combination of two drugs, isosorbide dinitrate and hydralazine. Isosorbide dinitrate is a nitric oxide donor. Hydralazine is an antioxidant and vasodilator agent, which means it dilates blood vessels and protects the nitric oxide formed by isosorbide dinitrate from deactivating. Through these properties, BiDil is intended to provide a number of beneficial effects for African-American heart failure patients, including increasing levels of nitric oxide in the body. Because heart failure is a chronic disease, we expect that, if approved, BiDil, like other medicines taken for chronic heart disease, will be taken for the duration of the patient's life.
I suspect isosorbide dinitrate is a precursor to nitroglycerin...that bodily processes convert it to nitro, when then affects the body like a nitro pill would. Still, it and hydralazine are known quantities...which brings us to the quote.
What, exactly, is being patented here...a recipe?
Does this mean no one is allowed to prescribe isosorbide dinitrate and hydralazine in combination anymore (Dr. Davidson said it's been done for the last 20 years)?
What justifies NitroMed's doubling the expected price of the product?
