Happy New Year, everyone! I've been mostly off-line this past week, attempting to enjoy the "break" while cleaning and sorting out our fresh-from-construction home. But even in that daze, I couldn't help noticing all the fuss about MannKind's Afrezza, which was supposed to be ruled upon by the FDA on Dec. 29.
The FDA has requested an additional four weeks to make a decision on this new inhalable insulin, after having postponed the decision by six months earlier on. Investors are in a frenzy now over whether or not the delay is a death knell, i.e. whether MannKind stock is a great tip or a just another flop waiting to happen.
As a patient, all this stock talk makes me kind of nauseas. For goodness' sake, didn't the Powers That Be learn anything from the Exubera debacle?! So little attention seems to be directed at the reaction / potential impact on us actual people living with diabetes.
A Forbes financial blogger got closest this weekend, by stating that "the market should decide" on Afrezza:
Mannkind's inhaled insulin is not a me-too drug. It's been developed at a price tag of close to $1 billion. It's an example of homegrown innovation that has the potential to help a very sick group of patients. Despite concerns about its impact on the lungs, its safety record is impeccable. Its efficacy has also been overwhelmingly positive, though it's hard to make an apples to apples comparison with other modalities of insulin. What's left for the FDA to decide? It's time wave the green flag and start the race to give doctors and patients the option to use it.
His point is well taken, although the drug's safety record may not be as rock-solid as the company claims. Something you ought to know:
In October, former company executive John Arditi, once responsible for quality assurance, filed a lawsuit claiming that portions of MannKind's clinical data were fraudulent (see details here). Although the suit was settled out of court last month, it's still not clear whether Arditi was simply retaliating for what he believed to be wrongful termination, or whether he was pushed out for being a whistle-blower.
Seminal pharma blogger Ed Silverman of Pharmalot writes that the allegations "underscore ongoing concerns in some quarters ... regarding clinical trials that are run in Russia and Eastern Europe. Arditi's charges are likely to cement impressions that studies relying too heavily on data collected in such locations may be viewed as questionable."
Still, somehow MannKind has come out smelling like a rose. The lawsuit seems to have been pretty much brushed under the rug. And despite the fact that long-term lung damage is a complete unknown, the stock is up and the general sentiment seems to be that Afrezza will eventually hit it big.
It's got to be connected to the personal charisma of billionaire founder Al Mann, is all I can figure.
But in this new era of Empowered Patients, my point is this:
Just like with Exubera, what it's going to come down to is just how hot we patients are to get our hands on inhalable insulin. How much risk in terms of lung damage or snafus with dosing are we willing to accept? My guess is not as much as investors think. Besides the fundamentals of safety and efficacy, ease of use and quality of life issues trump all, do they not? Plus most of us are not running scared from needles as much as they believe we are... agreed?