Marcus Greenback, CEO of the titanic new pharmaceutical conglomerate, Phizerckaxobbottartis, Inc. thinks he has found a “cure” for the flagging the anti-depressant market: targeting the despondent dead. News that he is planning to tap what analysts are referring to as the “dirt nap demographic” for his company’s blockbuster SSRI, Panazea, has created waves of excitement in both the investor and healthcare communities. Below are excerpts from a recent Wise Investor Weekly interview of Greenback on the day of a news release announcing positive interim results the phase II clinical trial of Panazea in 200 deceased patients;
WIW:
Okay, I’ll come right out and ask . . .why the dead?
Greenback:
The dead represent a hugely underserved market that has been virtually ignored by the pharmaceutical industry. Yet, given that millions of Americans die each year, and that death is essentially an irreversible condition, the potential profitability for developing treatments targeted to this population is enormous. This represents an opportunity to pull the SSRI market out of its recent slump.
WIW:
So, what’s behind the dip in the anti-depressant market? Since they were introduced, this has been one of the most consistently lucrative product classes out there . . . the darling of the pharmaceutical industry!
Greenback:
You’re telling me . . . when the first SSRI hit the market 2 decades ago, it usurped the depression market nearly overnight. But that was just the tip of the iceberg . . .Thanks to the many brilliant psychiatrists who collaboratively worked with us to confabulate a multitude of additional treatable syndromes and disorders affecting scores upon scores of people of all ages and demographics, it soon became accepted that virtually every nuance of behavior . . . shyness, excessive fidgeting, or fear of ventriloquist’s dummies are not just pesky idiosyncrasies, but serious psychosocial disorders with big, serious names like sociophobia, psychomotor agitation, and automatonophobia meriting intensive psychopharmacotherapeutic management. In fact, prescriptions were being written for these disorders just fast as we could think them up . . . and our market soared off the charts.
WIW:
I remember that . . . in the mid to late nineties, it looked as though there was no limit to the profits these products could make . . . as long as the patents remained exclusive.
Greenback:
Ah, but even the prospect of expiring patents failed to deflate this golden parachute. Thanks to the newfound ability to manipulate molecules of patented formulas just enough to allow legal re-patenting under a different name, we were able to re-launch what was essentially the same drug and market it as a new “more potent” or “safer” product.
WIW:
Sounds like a market that might have potentially broken the billion barrier and risen into the trillions! What happened?
Greenback:
Unfortunately, due to the perception that these products have been overprescribed and may be related to an increase in suicidal behavior among teens, enthusiasm has begun to wane for treating the seemingly bottomless well-spring of new psychological disorders, especially in the adolescent population. Over the last year, we’ve seen a dramatic downshift in the adoption of SSRI therapy for newly recognized disorders.
For example, just a year and a half ago, Panazea was approved for late adolescent-onset rhinotillexoma, a socially crippling nose-picking disorder, and doctors were all over it. Sales increased by a third within three months of launch, and jumped further upon publication of a landmark study in which patients reported a 40% reduction in the rate of getting caught with an index finger jammed up a nostril at stoplights after starting treatment.
Six months ago, however, when Panazea gained approval for Macroporophobia, a devastating condition that causes young women to obsess over the size of their pores, we barely saw a ripple in our sales despite the fact that our research showed a statistically significant 20% reduction in paranoid ideations about others staring at their pores and silently gagging, along with a concurrent increase in self-confidence, as measured by the standard AWESOME (Adolescent Worthiness Evaluation Score – Outlook for Makeover Eligibility) Score. Market research showed that doctors were hesitant to accept a very small risk of suicide for a condition they consider to be minor and treatable with an OTC product like Clearasil. What they don’t understand is that, while Clearasil may absorb excess oil and tighten the pores a bit, it does nothing to correct the neurochemical imbalance underlying this disease.
WIW:
It was hard, I take it, to face an end to the antidepressant “salad days”
Greenback:
Yes . . . we knew that, in order to recover our growth, we needed to identify a large, yet less “loaded” demographic than kids and teens. We considered neonates, in whom suicide or violent behavior would be next to impossible. Research indicates that a majority of 1 to 6 week old infants sleep over 12 hours a day and frequently cry for no apparent reason – both hallmarks of serious depression. And since linguistic skills are nominal in this cohort, we presumed complaints about side effects would be minimal. However, the American Academy of Pediatrics was not receptive to our initial research in this sub-group of patients. In fact, a few of the doctors pelted us with cans of a new banana-flavored formula that were being sampled out on the exhibit floor . . . my poor associate sustained a concussion before security was able to get us out of the seminar room.
WIW: Wow. That’s kind of harsh, no?
Geenback:
Not atypical of the pediatric community; Peds tend to be a bit overly protective of their patient base. Anyway, we did not let this discourage us . . . we continued to put intensive efforts into identifying a demographic that offered the most potential, while being the least vulnerable to Scientology-inspired conspiracy theories about adverse effects. After two years of exhaustive research, we believe we have hit upon the ideal population – the vitally challenged.
WIW:
And where exactly does the opportunity with the non-living lie?
Greenback:
Six feet under, right there with the patient. As I said before, this is an underserved population in dire need of a treatment options, particularly for depression. Despite problems these patients have in communicating their emotional states, research has shown that major depression is rampant among the deceased. Indeed, in a recent break-through study of risk factors among the non-viable sector, objective observers of 3,200 recently deceased subjects found that most, if not all, fit HAM-D criteria for major depressive disorder. In fact, 100% of all evaluated patients were suffering from withdrawal, anhedonia, lack of interest or motivation, and severe motor retardation. Results of this research were truly exciting, although not unanticipated . . . being dead can severely impair quality of life.
As soon as news of this research was made public, we recognized the untapped potential for this market and decided to pursue clinical studies of our agent Panazea in this demographic.
WIW:
Tell me about your current clinical study . . .
Greenback:
We recruited approximately 300 patients for this phase II open label study. Inclusion criteria were pretty basic: no breath sounds, flat EKG, and no response to light touch. Patients who giggled when touched or protested during embalming were excluded from the study. Patients who met inclusion criteria were initiated to therapy within 5 hours of passing away.
WIW:
Is it important to begin treatment soon after expiration?
Greenback:
Yes. Animal studies indicated that the earlier treatment is started after a subject passes away, the longer the subject will be able to stay on treatment, which can be continued until complete soft tissue decomposition makes it too difficult to administer drug properly. At this six month interval, none of our patients have had to stop or reduce therapy due to excessive decay. We anticipate most patients being able to remain on treatment for at least two years if not three, depending on the type of embalming fluid used.
WIW:
Was it difficult designing a viable (no pun intended!) study protocol for this population?
Greenback:
Due to the inertia that is common among this population, the study protocol did require some adapting. For one, we needed to include family members as active participants. Their role in driving the study subjects to and from the facility for assessments and holding them in upright position during evaluation is essential. Family members have also been helpful in filling out questionnaires regarding depressive symptoms on behalf of the patients, most of whom are unable to write.
WIW:
You’ve just completed an interim analysis of results so far . . . what are the findings?
Greenback:
Patients were evaluated for response at one week, then once monthly for 6 months after initiating treatment. Final results will not be available until after all participants have completed one year of therapy, however, at this 6 month interim point, results have been nothing short of remarkable. Within 7 days, 100% a complete absence of moribund thoughts, feelings of sadness or emptiness, and somatic aches, pains, or GI distress was observed. Moreover, reports indicated that patients treated for a week had no co-existing anxiety symptoms, such as tremors, racing thoughts, and excessive worry. This level of response has been maintained through six months with no sign of attenuating. You simply do not see this kind of result this quickly in the respirating, sentient population.
WIW:
What about side effects?
Greenback:
This is the most positive thing about this particular patient population. Side effects are virtually absent, with the exception of muscle stiffness, which appears to be transient, and resolves upon myonecrosis. Side effects common in the living, such as decreased appetite, nausea, or insomnia have not been reported. Weight loss does occur over time, but most reports indicate this is a desirable effect. And, unlike living subjects, we believe there is virtually no risk of suicide or violent behavior, drug-related or otherwise; physicians can feel fully confident that these adverse events will not occur in this population.
WIW:
You mentioned that family members are an integral part of the study… what are their feelings about the treatment?
Greenback:
Children, spouses, and siblings have generally been very pleased with the effects of treatment on their departed family member. One fellow, Bob B. told me: “Mom used to bitch and complain from sun up ‘til sun down. I’ve never seen her so calm and serene. And, I no longer have to live with the guilt of secretly being glad she choked on that piece of steak . . . thanks to Panazea, she has become ‘dearly departed’ to me.”
WIW:
Wow. That’s powerful.
Greenback:
I know . . . I well up just thinking about it. And you know . . . that’s what it’s all about. Not the profits, not the yearly bonuses . . . but the knowledge that you have really helped make a difference in people’s lives . . . whether living or dead.
WIW:
What do you feel the biggest obstacles will be in marketing Panezea to this demographic?
Greenback:
Aside from gaining FDA approval, the biggest hurdle will be reimbursement. Most health insurance companies will not extend coverage beyond death, but we are negotiating with some of the major carriers now to see if we can’t come up with some attractive incentives for covering this patient group, such as steep discounts on medications that are about to lose their patents, or breaks on price increases over the next 6 years. We are also considering innovative billing and payment programs to accommodate non-covered deceased patients, as we recognize that earning power is greatly diminished upon cessation of breathing.
WIW:
How will you do that without cutting into profits?
Greenback:
We are exploring many “out of the box” alternatives, including the possibility of accepting personal items and effects none of the surviving relatives really want in lieu of cash payments, so long as they are assessed by experts from Ebay as having auction value equivalent to the average retail price of the drug.
WIW:
Any plans to expand the possibilities in the post-mortem marketplace?
Greenback:
Absolutely. Right now, our internal review board is reviewing protocol for study of Panazea in deceased anxiety disorder (DAD) and there are plans in the works for a study of severe post-mortem claustrophopia, which is common among patients buried in small narrow caskets who are afraid of the dark.
Dark as the inside of a casket may be, with such promising prospects for Panazea, the future of Phizerckaxobbott, Inc looks brighter than ever. According to Mr. Greenback, phase II studies should be complete by the summer of 2005. Since the company has applied for accelerated approval based on the complete lack of treatment options for depressed dead people, the product could be approved as early as January 2006. And if Greenback has his way, that fateful day of approval will go down in history as “The Dawn of the Delighted Dead.”