Death Grip (25 page)

The pain in my leg has been intense, but I'm committed to not taking narcotics, so stave it off with Tylenol and ice packs. I'm so committed, in fact, that I've been attending NA meetings despite hating group-anything. I don't really like talking about myself, especially in front of strangers. I don't like being around people. I go to the meetings, plop down in my chair, and then nod off midway through because I'm nuked by Trileptal, garnering hateful glances from the other attendees who must think I'm still “using.” I quickly realize I don't click with NA—it's cultish, weird, and doctrinaire, unquestioningly placing faith in rigid structure and some unseen and unknowable higher power instead of in personal responsibility, substituting hokey “days clean” chips and key tags for whatever drug you've been addicted to, succumbing to an absolutist world view instead of searching inside for the core malfunction. To me, it's simple: I've stopped abusing Vicodin, and I recognize my problem with benzos and am working hard to get off. As a climber used to realizing the fruits of my will, it couldn't be any clearer that once I've decided to quit, I will simply and finally do so. Meanwhile the psychiatrist, who has himself urged the meetings, warns that NA takes an “all or nothing” approach—that they frown on psychiatric medicine and might request that you quit your meds cold turkey, which I will not do. So I also feel conflicted, hypocritical, like I'm living a lie and have no choice during meetings but to sit back with the doctor's chemicals coursing through my bloodstream and clamp my mouth shut. Which begs the question, Why even go? One evening, I sit beside a flannel-n-jeans she-skeleton with zombie hair and tobacco teeth who proclaims, “I'm tweeking right now. OH FUCK OH SHIT I feel so bad I can't help it but I came to a FUCKING meeting FUCKING TWEEKING!” It's the last straw. NA and AA may work for many people, and that's great, but they're not for me. This sideshow only makes me feel more depressed, these hopeless meth-heads and key tag collectors and born-again exercise junkies with their doe-eyed prattle about “milestones” and “cravings.” The used-up lifers who loiter outside whatever venue before the meetings chain-smoking, chatting each other up, giving the stink-eye to newcomers. The stale, coffee-soaked church basements and airless, humming-fluorescent addiction centers with names like “Hopeful Vistas” and “New Beginnings.” Having to leave the house and be around these joiner-weirdos when it's the last thing I need. To hell with them and their lame-ass cult—these cats are as addicted as ever, to NA and to each other. Me, I'd rather
live.

“Well, Matt, I know you've been resisting, but one drug I still think might help is Lamictal,” the doctor continues. “It's a very effective mood stabilizer and antidepressant. I've seen it be a literal lifesaver.”

Lamictal, eh? This again …

“Is that the one with the risk of—”

“Yes, Stevens-Johnson Syndrome.”

Doctor Porridge has explained it before—he'd said there's a roughly one in one thousand chance that Lamictal will cause an adverse skin reaction, which in the worst case can end in the ICU with third-degree burns covering your entire body as your dermis sloughs off and you die of sepsis and/or shock. Thanks, but no thanks—if someone told me a climb horribly killed one in a thousand suitors, I'd find another climb.

“No thanks. I'm just too scared.” And it's true.

“Well, then, I'd like you to think about adding Zyprexa. I'm going to give you a few samples to take home. It's a good ‘freak-out' pill, to take when you're having a really bad day.”

“Umm, okay, a bad day … I have a lot of those. What kind of medicine is it?”

“More or less a mood stabilizer. It's a new drug that's proving to be very effective, but again, it's nonaddictive and it has no street value.”

The psychiatrist is quite proud of this tidbit; he smirks a little. That's been his new selling point lately—not that whatever new drug he's pushing doesn't come with the usual litany of oppressive, mind- and body-numbing side effects, but that it doesn't have any street value and hence can be taken “safely.” His spiel has come to feel hollow, like a used-car salesman pushing a Ford Pinto onto unsuspecting buyers because it's “safer in front-end collisions”—safer, that is, than the rear-end collisions that blow the cars up. That's what I've begun to realize: For every condition that the pills allegedly “cure,” you can pile on a half-dozen side effects orders of magnitude more depression-inducing and reality-obfuscating than the original condition itself, perhaps with more pills prescribed to temper
these
side effects like an endless hall of mirrors. (Seen an antidepressant commercial lately and heard the side effects, listed rapidly and at sotto voce over images of those weird, rubber-skinned, space-alien drug-commercial actors bouncing back to life upon ingesting said nostrum? “In certain cases, Koflaxalon has been known to cause complications not limited to worsening depression, suicidal ideation, green urine, a third eyeball sprouting from the back of your neck, Exploding Heart Syndrome, homicidal rage, and rubberization of your bone structure. Koflaxalon should not be taken by teenagers, the elderly, pregnant women, ladies, men, or children. Consult your doctor if any of these extremely rare side effects occur.”)

I pocket the samples and leave the office. Outside in the parking lot, I pour a few Zyprexa into my hand—brown rabbit turds seemingly named for a Klingon serial rapist. I stash them in the side panel of my car and forget about them. I dislike the idea of blindly, unquestioningly taking another medication.

Zyprexa, it turns out, is not exactly a mood stabilizer like the doctor told me. It is rather, like its chemical cousins Seroquel and Risperdal, an atypical antipsychotic, a schizophrenia and bipolar disorder drug that's been linked to complications such as massive weight gain (Eli Lilly's largest pre-FDA-approval study of the drug found that on average Zyprexa packs on twenty-four pounds in year, while later clinical trials showed one in six patients gaining sixty-six-plus pounds total
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), dizziness, hyperglycemia, and high cholesterol. It is a serious, heavy chemical. A stellar investigative article, “Bitter Pill” by Ben Wallace-Wells, in the February 5, 2009, issue of
Rolling Stone,
examines the blockbuster drug's troubled history: how such a potent molecule, due to its developer Eli Lilly's naked profit motive, found mainstream prescription through a campaign that illegally promoted off-label usage for unindicated conditions like dementia, anxiety, and garden-variety depression. (It is not illegal for doctors to prescribe drugs off label; it is, however, illegal for drug companies to market off-label prescription.) According to the article, Eli Lilly paid out $62 million to thirty-two states in October 2008 over its Zyprexa campaign, as well as $1.4 billion “to settle federal charges of illegal marketing” the following January.
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Let's examine how a drug like Zyprexa might find its way to an off-label patient like me, who's not psychotic, not bipolar, and certainly not schizophrenic. First, a drug company—a
for-profit
entity—might spend on average $4 billion developing a molecule.
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It will thus do everything in its power to earn back its money and start showing profit. Step one is to pass FDA muster, which is not as difficult as you might think. In the end, the company need provide only two “adequate and well-controlled” studies showing that their new drug outperforms a placebo to be approved (though the companies must submit all clinical studies to the agency); the catch is, you can run as many studies as you like, without having the negative ones count against you.
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The data deck comes stacked in other ways as well: As Irving Kirsch, Ph.D., puts it in his statistical examination of the profound placebo effect with antidepressants,
The Emperor's New Drugs,
“most of the clinical trials evaluating new medications are sponsored financially by the companies that produce and stand to profit from them.”
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Thus these companies, as owners of the data, might exploit spin tools like publication bias (making only positive studies available to medical journals or to doctors), pooling the negative studies with positive ones so that they “disappear” in the amalgam, and/or subtly tweaking the inputs and data to put a positive luster on their results. If that involves burying or smoothing over troubling side effects like massive weight gain and metabolic disorder, then so be it. A further complication is a law enacted in 1992 that lets the FDA charge drug companies for evaluation. With the goal of getting AIDS drugs into patients' hands more quickly, this law has nonetheless produced the side effect that 40 percent of the FDA's budget now comes from such funding: what Kirsch calls a “financial entanglement.”
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In other words, the FDA gets two-fifths of its funding from an industry it was set up to regulate. This relationship is too cozy for scientific objectivity in my opinion.

Now rubber-stamped, Company X will put together an aggressive marketing campaign to promote their new drug. The companies hold a patent for only twenty years from the date of a molecule's invention, so the pressure is on to sell as many pills as possible before generic and copycat versions hit the market. Common sense would dictate that it financially benefits the company to find the greatest number of uses for their drug—hooking the most possible customers with the most possible diagnoses.

Enter the
Diagnostic and Statistical Manual of Mental Disorders
(
DSM
), psychiatry's ever-metastasizing, description-based “diagnostic” tome that attempts to apply disease labels to an expanding universe of mental conditions that edge increasingly closer to normalcy. Distractible? You have ADHD and need Adderall. Shy? You have Social Anxiety Disorder and need Paxil. Got a moody and irritable two-year-old, or have mood swings yourself? Your child and you are certainly bipolar, and need Zyprexa for psychotic episodes, an SSRI for depression, an antiepileptic mood stabilizer like Depakote for mania, Adderal for focus, Klonopin for anxiety, and Ambien for sleep. The answer, of course, must always be more pills. An army goes forth to preach the gospel: drug reps, aka “detail” men and women, in America a one-hundred-thousand-person-strong squadron
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of generally good-looking, genial types, precision hired like those comely coeds down at your local espresso shop. I'm sure you've seen them in the waiting area at your doctor's office, peering intently at tablet computers—engaging in “prescription-data mining” to help tailor their sales pitch before meeting the physician. This obnoxious practice has, since its inception in the 1990s, allowed pharmacies to sell to drug companies a doctor's prescribing history, such that the companies' reps can see exactly which drugs a doctor is prescribing and in which percentages.
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The reps can then go into their meetings armed and upsell any drugs the doctor is not prescribing “enough” of.

More nefariously, your doctor himself, particularly if he's in academia, could be in cahoots with a pharmaceutical company as one of its “key opinion leaders” (KOLs, also known as “thought leaders”). At essence a hired gun on the Big Pharma take, often to the tune of millions of dollars, a KOL can wear myriad hats: He might be a paid research consultant for a drug company, helping oversee its studies; write textbooks, scholarly papers, or sit on FDA panels related to his area of expertise; go around to other doctors, proselytizing about the benefits of a particular drug via symposia or one-on-one meetings; or lend his name and some nominal academic input to “studies” ghostwritten by drug companies or their affiliates, which show the benefits of a particular drug. In his book
Unhinged
, the psychiatrist Daniel J. Carlat estimates that there are two hundred thousand KOLs in America,
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for whom teaming up with Big Pharma is a lucrative side business: During his year as a KOL for Wyeth Pharmaceuticals, touting its antidepressant Effexor to other psychiatrists, Carlat, for example, cleared $30,000, paid in $750 per lunch meeting with the doctors,
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while former
New England Journal of Medicine
editor in chief Marcia Angell has estimated that one way or another U.S. drug companies provide tens of billions of dollars a year to physicians.
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Meanwhile, sleek TV and magazine advertising conditions would-be consumers to “Ask your doctor if Koflaxalon is right for you.” Other than New Zealand, no other country in the world allows this odious direct-to-consumer hucksterism, marketing money that's exploded from $1.3 billion spent in 1999 to $4.8 billion in 2008.
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That's how off-label marketing campaigns arise like the one with Zyprexa: a spam blast on all possible fronts.

The system skews radically in favor of the companies and the doctors. As a patient, you can never quite know why your doctor recommends one particular medicine over another—is it because of the research, his clinical experience, or the far-reaching tentacles of the pharmaceutical industry?

On the political side, as with Wall Street's naked symbiosis with the SEC—you know, the cozy “oversight” that helped catalyze the current economic depression—the ties between business and regulators are murky, fluid, and byzantine, with drug-company execs routinely leaving to work as FDA regulators and vice-versa, and with untold examples of the KOL physician-academics who supervise the drug trials—again, most often funded by the drug companies and
not
an independent agency—themselves being well-paid consultants for said corporations. Now throw in a wolf pack of slavering lobbyists pushing Big Pharma's agenda within the Beltway, and you begin to see, if not exactly a conspiracy, at the minimum a cash cow in which the profiteers unite to protect their shared interests. Lest you think I'm a conspiracy nut, I'd urge you to pay particular attention to Big Pharma's well-documented, decades-long history of bringing toxic, ineffective, and even fatal agents to market even as they knew the risks: Thalidomide, Vioxx, Darvocet, Serzone, and so on. And consider the fact that we Americans, all too credulous in our institutions, tend to blindly trust any drug with FDA approval, assuming that must mean it's “safe” or without any perilous side effects. (An online survey of nearly three thousand Americans revealed that 39 percent believed that the FDA only approves drugs that are “extremely effective,” while 25 percent held that the FDA only approves drugs without serious side effects.”)
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