The Tragedy of Nitromed
by Michael Shulman
BiotechBlitz
Skip this today if you are looking for investment ideas – I am venting today.
Two days ago I sat on a set of Fox Business Channel in Washington and was to be part of a discussion that never happened – and before I was to be on I listened to bumped as Magic Johnson and the president of Aetna (AET), Ronald Williams. It was a puff piece about some community health initiative targeting African Americans and as I listened to it I longed to be able to cut into this discussion – and cut these two frauds into pieces.
What does this have to do with disintegrating Nitromed (NTMD) -- the company is laying off most of its employees and throwing in the toweltrying to market its drug BiDil. In 2005 the company got FDA approval for the first ever drug targeted at an ethnic group – African Americans with heart disease. The drug, BiDil, was no me too drug – it was a resounding success in clinical trials. Called the A-HeFT trial, this was a typical double-blind, placebo-controlled trial. The trial was co-sponsored by the Association of Black Cardiologists -- the right … no, the perfect group of influencers for this drug. More than a thousand patients were in the trial, which was abruptly halted in July 2004 on the recommendation of the independent Data and Safety Monitoring Board and the steering committee for the trial. Why? Were there problems? Did the molecules get stuck somewhere? No -- long before the trial was scheduled to end, there were 43% fewer deaths and 39% fewer hospitalizations in the group receiving BiDil than the group taking a placebo. It was considered unethical to keep the placebo group on trial, so they were immediately switched to the real thing.
A hit you say? The drug has failed in the marketplace for a variety of reasons, one being the incompetence of the company in getting the right copayments from companies like Aetna and Medicare. And the lack of political support and pressure from public figures such as Magic Johnson, a man kept alive the last 16 years by HIV drugs – he, more than most, should understand the value of access to life saving drugs.
I asked a former CEO of Nitromed why they did not explicitly take the political route to get better co pays form Medicare and other payors – these are important because 80% of the target population has insurance. He shrugged as if embarrassed – remember, even morons get to be CEOs occasionally. And where are the members of the Congressional Black Caucus? Or the professional race baiters like Al Sharpton?
So, thousands of African Americans – oh, to hell with their heritage – thousands of my fellow citizens die needlessly every year because a drug that would help or save them is either unavailable to too expensive. Probably more needless deaths from heart disease since the drug was approved than have died in Iraq.
OK, I have vented. By the way, Ronald Williams of Aetna (AET) is African American. Ron, go home and explain to your kids how your company reimburses for BiDil.
BiotechBlitz is a regular contributor to BioHealth Investor
_______________
BiotechBlitz
Skip this today if you are looking for investment ideas – I am venting today.
Two days ago I sat on a set of Fox Business Channel in Washington and was to be part of a discussion that never happened – and before I was to be on I listened to bumped as Magic Johnson and the president of Aetna (AET), Ronald Williams. It was a puff piece about some community health initiative targeting African Americans and as I listened to it I longed to be able to cut into this discussion – and cut these two frauds into pieces.
What does this have to do with disintegrating Nitromed (NTMD) -- the company is laying off most of its employees and throwing in the toweltrying to market its drug BiDil. In 2005 the company got FDA approval for the first ever drug targeted at an ethnic group – African Americans with heart disease. The drug, BiDil, was no me too drug – it was a resounding success in clinical trials. Called the A-HeFT trial, this was a typical double-blind, placebo-controlled trial. The trial was co-sponsored by the Association of Black Cardiologists -- the right … no, the perfect group of influencers for this drug. More than a thousand patients were in the trial, which was abruptly halted in July 2004 on the recommendation of the independent Data and Safety Monitoring Board and the steering committee for the trial. Why? Were there problems? Did the molecules get stuck somewhere? No -- long before the trial was scheduled to end, there were 43% fewer deaths and 39% fewer hospitalizations in the group receiving BiDil than the group taking a placebo. It was considered unethical to keep the placebo group on trial, so they were immediately switched to the real thing.
A hit you say? The drug has failed in the marketplace for a variety of reasons, one being the incompetence of the company in getting the right copayments from companies like Aetna and Medicare. And the lack of political support and pressure from public figures such as Magic Johnson, a man kept alive the last 16 years by HIV drugs – he, more than most, should understand the value of access to life saving drugs.
I asked a former CEO of Nitromed why they did not explicitly take the political route to get better co pays form Medicare and other payors – these are important because 80% of the target population has insurance. He shrugged as if embarrassed – remember, even morons get to be CEOs occasionally. And where are the members of the Congressional Black Caucus? Or the professional race baiters like Al Sharpton?
So, thousands of African Americans – oh, to hell with their heritage – thousands of my fellow citizens die needlessly every year because a drug that would help or save them is either unavailable to too expensive. Probably more needless deaths from heart disease since the drug was approved than have died in Iraq.
OK, I have vented. By the way, Ronald Williams of Aetna (AET) is African American. Ron, go home and explain to your kids how your company reimburses for BiDil.
BiotechBlitz is a regular contributor to BioHealth Investor
_______________
posted by Nico at
4:47 PM
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