When Jay V.’s pharmacist told him about the nationwide Adderall shortages last weekend, he reacted as any economically rational finance professional would, and attempted to bribe her. Whatever the cost, “it’s cheaper than cocaine,” his reasoning went. And even if it isn’t, you can’t put a price on never having to go back to doing bumps in the work bathroom to get through late night deal committee meetings, can you?

Jay’s pharmacist said she was reserving her supply for regular customers, but that the price had doubled and the clock was ticking. “They’re down to one bottle,” Jay said, “and if I don’t get them a prescription by the end of next week I forfeit my right to it.” So long as he can tear himself away from one of the 16-hour days he cites as the reason he needs Adderall to begin with, he’ll be fine. At least, for the next month or so….

If addiction is the kind of thing you think about a lot, it’s easy to overlook its significance in the cold, objective Realpolitik scheme of things, which is this: it’s a great business model. From the British East India Company to the Bronfman clan to Duke University, history is redolent of abject mediocrities who owe their billions to Big Addiction.

The early rumblings of the Adderall drought came from flyover country in March, when ADD sufferers in Texas, Georgia and a few other states told tales of panicked multi-state manhunts and exorbitant drug ransoms. The real panic set in around mid-August, when a supply shock attributed to “back-to-school” season ravaged the suburbs.

The best of the addiction-based business models are “addiction-proof” addictive drug, and the Adderall story is at its core the saga of a nearly century-long quest for this unattainable ideal. Amphetamine salt—Adderall’s active ingredient—has been the subject of heady dispute within the medical profession since the drug company Smith, Kline and French began peddling the stuff in 1935, but for decades just about the only thing medical community generally agreed about was that it was not addictive. The SKF sales department did, however, have a term for the loyalty it engendered among consumers: “stick.”

The dawn of the Drug War eventually in the early 1970s eventually brought an end to the widespread use of those first-generation amphetamines, but naturally they “stuck” around in some circles. And then in the nineties, when upper-middle class America was stricken with a modern epidemic of ADD (and its “hyperactive” variant ADHD) necessitating widespread amphetamine use while simultaneously the nation’s truck stops and trailer parks began falling prey to the scourge of illegal amphetamines—and yet no one ever seemed to link the two—it appeared as though an element of cognitive dissonance about the stuff had also “stuck.” For the same reason crystal meth never found much “stick” as an ADD drug—although it’s out there, under the brand name Desoxyn—Adderall users for the most part never identified as “addicts” before the nightmare shortages of this year.

You can map the spread of this rude (albeit unbearably drowsy) awakening on the message boards at ADDForums.com, whose administrators have painstakingly aggregated all Amphetamine Famine-relevant posts into a single “sticky” thread, starting with its early rumblings across flyover country in March, when the first unlucky ADD sufferers in pockets of Texas, Georgia and a few other states began to chronicle tales of the panicked multi-state manhunts and exorbitant ransoms to which they’d been subjected following the inevitable 15-minute pharmacy trip that wasn’t. The real panic set in around mid-August, when a supply shock attributed to “back-to-school” season ravaged the suburbs.

A guy in New Jersey who’d been paying $9 for his monthly prescription for years suddenly had to scour every pharmacy in a 50-mile radius and cough up $99. A woman in Massachusetts reported calling 25 pharmacies and only finding one that would fill her prescription—for $408; a man from Massachusetts advised her to take his advice offered to share the spreadsheet of eastern Massachusetts and New Hampshire drug stores he’d compiled a few days while making the rounds trying to figure out where to fill his own prescription. (He’d listed 142 by the time he found—at #48—his meds.) Finally this month came the first plaintive posts from New York, where a young woman who’d spent all day running to different drug stores wondered whether it was more dehumanizing to be gazed upon as some sort of “crack addict” by so many pharmacists, or just “feel[ing] like a junky” to begin with, and Los Angeles, where an electrician on his third day without meds wrote plaintively:

“Been taking adderall for over 13 years and now I can’t refill my script…What am I supposed to do? Just get over it? Just suck it up, go cold turkey and maybe I’ll get my script filled in a few months? How can I keep working on dangerous equipment with high voltage everywhere and I can’t focus? How can I commute 2 hours a day without falling asleep at the wheel? I feel so alone. Don’t know where to go at this point.”

(Brief PSA, if this is presently your problem, you have options: Try every Walgreen’s outlet first, followed by independents; expect higher prices; the 48th number you call just might be the charm; talk to your shrink about switching meds; and until you can get an appointment one ADD Forums user recommends something called Muscletech Neurocore. And don’t hold your breath. By most estimates, for reasons elucidated below, it will probably be several months before the Adderall supply is back to normal again.)

Adderall is one of hundreds of drugs from which the American health system is suffering a wrenching withdrawal. Across the spectrum of drugs, the crisis is so dire that earlier this month President Obama issued an executive order directing the Food and Drug Administration to take urgent (albeit not entirely specified) action to address it. But the vast majority of the drugs on the shortage lists are generic injectable drugs used in hospitals—delicate, low-profit, highly sensitive substances whose manufacturing plants can be decommissioned for months (or ever) over a few stray microbes. But Adderall is a high-margin pill or capsule (Adderall XR, or exended release—marketed as “abuse proof”) made from simple amphetamine salts; with close to a dozen manufacturers that rake in billions of dollars a year, its factories have suffered no major interruptions all year.

So what happened to all that Adderall? Actually, it goes back to that great business model: the manufacturing shortage appears to many skeptics to be itself manufactured—orchestrated by the same company that got everyone hooked on the drug in the first place, Shire Plc, formerly Richwood Pharmaceuticals, which two generic competitors now accuse of hoarding.

Then as now, amphetamine-based ADD drugs have suffered periodic supply hiccups stemming from their strict regulation by the Drug Enforcement Administration, which levies annual quotas on the aggregate amount of stimulants it will allow to be legally produced each year.

Adderall itself was introduced by a then-unknown Richwood during another American attention deficit drug crisis, the Great Ritalin Scare of 1993. Back then, drastic shortages of that groundbreaking ADD drug prompted thousands of panicked parents to switch to Adderall, despite Richwood’s dubious pedigree as the startup of a former Kentucky schoolteacher, Roger Griggs. Following in the tradition, Shire is now attempting to use contrived Adderall shortages as a chance to convert ADD sufferers (and their long-suffering parents) to the cause of their new(ish) ADD drug, Vyvanase.

Then as now, amphetamine-based ADD drugs have suffered periodic supply hiccups stemming from their strict regulation by the Drug Enforcement Administration, which levies annual quotas on the aggregate amount of stimulants it will allow to be legally produced each year.

By 1993 Griggs had spent a few years trying to sell pediatricians on what seemed like a no-brainer Ritalin alternative: dexedrine, marketed under his proprietary brand “Dextrostat.” But dexedrine had a lot of negative abuse baggage from its heyday in the ‘60s and ‘70s, so Dextrostat never really took off. No matter: a less infamous diet drug of the era, Obetrol, concocted from a mixture of amphetamine salts containing 75% dexedrine with (supposedly) none of the baggage, and its factory was up for sale. Richwood pounced. By June 1994 it’d renamed Obetrol “Adderall,” and was selling it to pediatricians as a cheaper, more plentiful and longer-lasting alternative to Ritalin. They hadn’t bothered notifying the FDA, which ordered the company to suspend Adderall marketing in November and conduct clinical trials. When the agency officially approved Adderall for ADD just over a year later, it still gave Richwood a two year headstart over the competition, and the indication in kids as young as three was an added bonus that allowed them to make up for lost time.

Today the $4 billion ADD drug industry is about ten times its 1996 size, and Adderall is the reigning market leader. Shire ultimately seeks to unseat with its latest drug, Vyvanse, a reformulated, “cleaner” version of dexadrine. This has been Shire’s goal for four years now, since the company—which is now domiciled in Ireland to avoid taxes—spent a staggering $2.6 billion in cash acquiring New River Pharmaceuticals, the biotech that developed Vyvanse, in 2007. With the patent on Adderall XR set to end in 2009, Shire otherwise faced the prospect of a market flooded with cheap generics, a collapse in sales of its cash cow, and nothing in its pipeline because it didn’t actually develop drugs but merely sold them.

But where Adderall had a cheaper price and more potent effect in its favor the last time around, the selling point of Vyvanse is the opposite: it’s considerably more expensive than Adderall—this is, after all, the whole point of getting people to switch—and its primary competitive advantage over other drugs is a certain kind of diminished potency: its molecular structure is specifically designed to render the drug impervious to serious junkie behavior. In clinical trials conducted on intravenous substance abusers, for example, injected Vyvanse proved barely more appealing than a placebo. Functionally, this makes Vyvanse a lot like Adderall XR, which is equally impossible to snort, crush, inject and whatever else junkies supposedly do. But from a business perspective it was the holiest of Holy Grails, because its active ingredient was an entirely new molecule, with its own dedicated line item within the DEA’s roster of controlled substances and patent protection until 2023.

Initially, the company had been vying for the DEA to classify its new substance, “lisdexamphetamine”, on a less restrictive schedule than other amphetamines, enabling doctors to write prescriptions for refills and other such conveniences. Its lobbying failed, though the agency can always reclassify it if Shire can marshal enough evidence of its magical “addiction proof” characteristics.

In the meantime Shire must convert devotees of all the old patent-expired amphetamines. This would be a tall order, since the effect of Vyvanse on the user is almost indistinguishable from that of Adderall (not to mention dexedrine) but the price tag is five or ten times as high. But nearly 50 years since “Obetrol” lost its patent, Shire maintains a partial corner on the Adderall market by the terms of two legal settlements it reached in 2006 with the generic manufacturers Teva Pharmaceuticals and Impax Laboratories. Those settlements awarded Teva and Impax the rights to sell generic Adderall XR starting in 2009—and subcontracted Shire with the job of actually manufacturing the drugs for both companies until Teva and Impax could handle production themselves. (Their applications to produce the drugs had been held up by Shire.)

This seemed to work the way it usually does at first. In the spring of 2009 the price of Adderall XR plummeted along with Shire’s profits. Sales nosedived to $67 million in the second quarter of the year from about $300 million in most of the quarters since it had been introduced. But the next year its Adderall XR numbers started creeping up again, reaching $100 million for the third quarter of 2010. Then in November, Impax sued Shire, alleging that the company was botching its orders, supplying fewer pills than desired or bailing altogether. Teva quickly filed an intervenor lawsuit, making similar allegations while maintaining its own right to “first dibs” on Shire’s drugs, having been first to file its application with the FDA back in 2003. At the same time, insurance companies inexplicably began refusing to cover generic Adderall XR, variously claiming the generic wasn’t yet FDA approved or that its “therapeutic equivalence” to the branded drug was still unproven.

That case is in discovery and slated to go to trial in spring. But all year, as users scoured the ends of the earth to fill their prescriptions, Shire’s Adderall sales numbers kept edging up, finally hitting $150 million for the quarter that ended last month, while Impax—which booked $47 million in Adderall XR sales for the same quarter—continued to grouse about getting shortchanged. Without breaking out Adderall numbers, Teva announced that its generic drug sales in the U.S. for the same quarter had cratered by half. It was also a record $200 million quarter for Vyvanse.

But it was a most torturous quarter for ADD sufferers lacking the kind of health care plans that cover $400-a-month brand-name drugs, because if you couldn’t afford to switch to Vyvanse or brand-name Adderall XR, you were stuck trying to switch to generic instant-release Adderall at the same time as a million other panicked tweakers…or failing that, Ritalin, which ran out of stock shortly thereafter…or failing that, ponying up the better part of an extra rent check to fill your prescription.

Shire has publicly blamed DEA quota restrictions for its anemic generic shipments; the DEA has issued an apparent denial, albeit one short on specifics. A chemist at one of the five authorized “active ingredient” manufacturers in the business of supplying pharmaceutical companies with amphetamine says he and his colleagues “have all been scratching our heads trying to figure out what’s actually going on.”

The prevailing “water cooler” theory, according to the chemist, is that Shire is trying to “embarrass [the generic drugmakers] by making them look unreliable”—which could theoretically threaten some of their accounts, which could also in turn hurt their case in future applications to the DEA for a share of the annual amphetamine production quota. The DEA’s decisions to award quota of controlled substances is a somewhat mysterious process, but the aggregate number of about 26 million kilograms for 2011, up from 1.3 million in 1996, the year Adderall was introduced. And even that 26 million wasn’t high enough to accommodate the applications; the chemist says the agency recently granted the generic drugmaker CorePharma, which makes generic Adderall and dexedrine, just half the amphetamine allotment for which it had applied. So it stands to reason that if the agency lowers the quota in response to lower unit sales this year, the great amphetamine famine could be here to stay. And since Shire’s own quota for Vyvanse’s lisdexamphetamine is 9 million kilograms—hugely generous for such a new drug—it is more than prepared to accommodate a surge in new customers.

And what’s more, Shire has also been hard at work conceiving “sticky” new non-addictive addictions. The New River molecular innovation that makes lisdexamphetamine so underwhelming to shoot up could also soon take the Cindy McCain stigma out of opiates, and another Shire subsidiary discovered a mechanism by which cocaine can be safely administered in lab rats at up to 10 times the typically lethal dose. So while the stock is trading around an all-time high, it might be something to think about, if you have any disposable income left after filling this month’s prescription.

Source: https://www.activistpost.com/2011/11/pay-attention-how-big-pharma-contrived.html