The Tragedy of NitroMed (NTMD) :: Michael Shulman's Biotech Blitz

The Tragedy of NitroMed (NTMD)

NitroMed is shrinking itself -- radically -- and looking for strategic options.

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, it 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?

No. The drug has failed in the marketplace for a variety of reasons, one being the incompetence of the company in getting the right co-payments from companies like Aetna and Medicare. That, and the lack of political support and pressure from politicians and other public figures, doomed the drug.

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 payers -- 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 heritage - thousands of our fellow citizens die needlessly every year because a drug that would help or save them is either unavailable to too expensive.

There have probably been more of these needless deaths from heart disease since the drug was approved, than soldiers who have died in Iraq. Sad thought, that -- either way.

Comments

My regrets about missing a week of blogging -- with the markets in turmoil, I used the opportunity to take a hard look at some smallish companies. Today though, before I get to some of those, I am gong to vent about a small company getting much smaller -- NitroMed (NTMD) -- and this is just venting, not exploring an opportunity. NitroMed is shrinking itself -- radically -- and looking for strategic options. 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, it 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? No. The drug has failed in the marketplace for a variety of reasons, one being the incompetence of the company in getting the right co-payments from companies like Aetna and Medicare. That, and the lack of political support and pressure from politicians and other public figures, doomed the drug. 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 payers -- 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 heritage - thousands of our fellow citizens die needlessly every year because a drug that would help or save them is either unavailable to too expensive. There have probably been more of these needless deaths from heart disease since the drug was approved, than soldiers who have died in Iraq. Sad thought, that -- either way.