An Ode to The FDA

The Food and Drug Administration’s idea of a “fast track” review that led to approval of Yervoy for certain Stage IV patients was a regulatory process that took about five years (and who knows how many dollars). Consequently, one can only wonder how long it will be before Stage III patients have any FDA-approved treatment option other than Interferon, which a lot of our docs think is only marginally effective in delaying, but not preventing, a recurrence.

Faced with a rather grim prognosis after receiving a Stage IIIc diagnosis and my doc’s opinion that Interferon wasn’t likely to significantly improve my odds, I opted for a biochemo clinical trial. It literally just about killed me before buying me eight years to date of remission, and I’d sure like to see some widely available and less toxic treatment options for newly diagnosed Stage III patients.

Clinical trials of Yervoy as an adjuvant treatment for Stage III patients are now underway so, FDA, please “get a move on” and do your job as quickly as possible. Maybe, just maybe, given the dearth of effective treatment options currently available, you bureaucrats ought to err on the side of speed and perhaps grant provisional approval for Yervoy (as you did with Avastin for breast cancer) pending continuing study of its effectiveness? If Yervoy becomes available to Stage III patients sooner rather than later, we just might see fewer melanoma deaths and bring down the drug’s enormous cost per dosage. When all the medical evidence is in, if Yervoy doesn’t prove effective then you can revoke its approval as you did with Avastin as a breast cancer treatment.

I’ll end this rant with a request, a new version of the Bee Gees’ “Jive Talkin’”…



It's just your jive stallin'. You're risking some lives, yeah.
Jive stallin', you’re making me sigh.
Jive stallin', new meds might do good, yeah.
Jive stallin', you’re sittin’ like wood.

Oh, dear ‘crats, you'll never know
Just what you mean to we.
Oh, dear ‘crats, you ask so much;
You're gonna take away my N.E.D.
With all your jive stallin', you're risking some lives, yeah.
Good druggin' might save some more lives.
More options might bring a new day.
It's just your jive stallin' that gets in the way.

Oh, dear ‘crats, you're so good at treating me like fool.
There you go with your fancy trials,
Leavin' me lookin' at that Stage IV cruel.
With all your jive stallin', you're risking some lives, yeah.
Jive stallin', you claim I’m not wise.
Jive stallin', I knew where I stood, yeah.
Jive stallin', new meds might do good.

You know now, drug trialin' is all very fine, yeah.
Jive stallin' just should be a crime.
And if there's somebody you'll love till you die,
Then all that jive stallin' might end loved one’s life.

Jive stallin', you're risking our lives, yeah.
Good druggin' might end Black C cries.
Nobody believes what we pay.
It's just your jive stallin' that gets in the way.

You know now, drug trialin' is all very fine, yeah.
Jive stallin' just should be a crime.
And if there's somebody you'll love till you die,
Then all that jive stallin' might end loved one’s life.

Ooh, jive stallin', jive stallin’, ooh, jive stallin'.