Payola from Portola?

By Dr KSS MD PhD (former columnist), November 12, 2014

In his tearjerker “Sisters of Mercy,” Leonard Cohen sings,

I’ve been
where you’re hanging
and think
I can see
how you’re pinned.

Although I am less inclined to bash the FDA than many, it has recently let modern medical practice place many patients in an undesirable situation. What if there was a very powerful drug, one with a death-preventing effect, but also one for which there is literally no way out of its over-effect if you get too much in your system? Digoxin we can “undo” with anti-digoxin monoclonal antibodies. Acetaminophen overdose is mostly very effectively treated with N-acetylcysteine, and though one thinks of that overdose as lethal unless the patient gets a new liver, in fact it only uncommonly leads to liver transplant. Take too much OxyContin or methadone and Narcan saves you. Coumadin can be reversed with vitamin K or, in dire straits, with plasma.

But rather like a room with no door or a stairway to nowhere, therapy with one new class of medications can place patients in a life-threatening fix that doctors can do little about. It’s as if pharma companies and the FDA have given patients a one-way ticket: although treatment with these drugs can save lives, it can also leave patients dangling without a safety net.

Is there a way to profit from this mess? I believe there is.

Liver is my favorite organ and liver disease my favorite topic in medicine. But just by a nose. I love coagulation medicine, and would have become a specialist in it except that doing so would mean becoming a hematologist, and the rest of hematology holds no appeal for me. In fact, I mostly faint doing bone marrow biopsies. My PhD work was in the biochemistry of coagulation in the context of liver cells, which make most of the clotting factors. I browbeat my medical school dean into letting me spend a quarter of my final year doing coagulation consultations on inpatients with bleeding or clotting problems, as I wanted to graduate from medical school with genuine expertise in something rather than diffuse familiarity with a panoply of topics. Unexplained bleeding, unexplained clotting, unexplained abnormalities in clotting tests, I exult in fixing these issues by invoking a molecular understanding of their basis. During residency and fellowship, I was given the clout of an attending physician in managing coagulation issues, ...

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