by Penny, Laura
There are three main types of DTC ads. The help-seeking ad describes the ailment and suggests you consult a clinician. The reminder ad mentions the company and product. The product claim ad puts the pill and the ill together and lists the benefits of the drug. Most companies rely on all three kinds—an advertising trifecta!—to roll out a new blockbuster. Supporters of DTC advertising claim that it helps increase public awareness about genuinely harmful conditions that often remain undiagnosed and untreated. Big Pharma even goes so far as to take credit for getting people off their duffs and into doctors’ offices. The industry insists that DTC ads increase diagnoses of undertreated conditions, improve treatment compliance, destigmatize disease, and inform patients. No longer does all the knowledge and power rest with the doctor, they say: the ads empower consumers to take charge of their health and ask for treatments by name.
Whether or not they’re “empowering,” a word that sounds especially suspect coming from a marketing department, drug ads are certainly among the odder spots you’ll see on TV and in magazines: strange dialogues between marvelous benefits and uncomfortable or potentially lethal side effects. TV ads are also duty-bound to mention a toll-free number, website, or print ad where the consumer can find the full FDA product insert, listing all the contraindications and potential consequences.
The most advertised drugs are remedies for chronic conditions like heartburn, cholesterol, allergies, and depression. A typical spot begins with a disembodied voice oozing concern: “Are you suffering from [random disorder]?” In case you’re not up on said disorder, the voice then describes the symptoms, usually an assemblage of banal complaints: no energy, trouble sleeping, various pains. But then the voice warns that these minor hobgoblins may well be a more serious business. Voilà: the pill. This is followed by some improbable image, like Dorothy Hamill doing a few triple axles at the rink (Vioxx) or a social anxiety disorder sufferer turned smooth operator (Paxil). The very end is a fast, breezy, by-the-way list of all the side effects and contraindications.
The ad for Nexium, the new proton pump inhibitor (PPI) from AstraZeneca, the makers of hit PPI Prilosec, is a good example of the standard script. Pleasant-looking middle-aged folks before a computer-generated backdrop of eroded cliffs urge you to try today’s purple pill. Then the voice-over describes the trauma of esophageal erosions—and you thought you had heartburn—and reminds you, again, about today’s purple pill. The by-the-way for Nexium is that it may cause abdominal pain, diarrhea, and headaches. This is to say that your heartburn pill may well do nothing more than move your stomachache two inches south, and give you the trots to boot. Oh, and what is Nexium made of? There were two different chemicals in Prilosec. One of them is Nexium. Prilosec is en route to generic cheapness, and so they are trying to sell you half the pill for many times the dough with a new name for your flaming gnaw in the gut. But, hey, ask your doctor! Maybe the little purple pill will allow you to keep on eating at Taco Bell with gay abandon, free of fiery belches, well past your college years. Or maybe the very idea of the purple pill will prove so psychologically powerful that you’ll be willing to ignore the fact that the side effects are worse than the malady itself.
The term for the cure that is worse than the ailment is “disease-switching,” chemo being the most horrific example. Plenty of people have adjusted to lesser, routine side effects ranging from loss of appetite to loss of libido. But what happens when the side effects of the latest wonder drug seem to include going postal at one’s place of employ? Lilly has faced more than two hundred lawsuits with respect to Prozac, many for horrific wrongful deaths, including suicides and murder-suicides. The majority of these suits have been settled out of court, or have failed to draw an arrow from violent behavior to Prozac use. Similar suits have also been filed against the makers of Paxil and Zoloft.
Thus far, the standard Big Pharma defense has been threefold. First, the FDA approved the drug ages ago, and the FDA don’t make no mess, no sir. Second, millions and millions of people take the drug, and only a teeny-tiny percentage of them exhibit these aberrant behaviors. What is the loopiness of one, compared to the salvation of the multitudes? The last line of defense is simply to shift the blame from the cure to the disease. Of course the dude snapped and killed his family—he was depressed, remember? If only we could have given him more drugs, sooner. Still, critics of pharmaceutical manufacturers like to point to the presence of our most popular pills in the medicine chests of the infamously deranged. Police found Prozac capsules in the van belonging to Mark Barton, the Atlanta day trader who killed his family, opened fire at his brokerage, and then committed suicide. Young school-shooter Kip Kinkel was on Prozac, and Eric Harris, one of the Columbine killers, was prescribed Luvox, a Prozac copycat.
The last two examples point to another disturbing trend in prescription drug use, namely, increased drug use by children. In 1998, approximately 500,000 folks under eighteen took one of the leading SSRIs. The number doubled by 2002, in spite of the fact that there was scant scientific literature about the effects of such drugs on children. Some kids even got double-dosed, having been prescribed an SSRI together with the popular juvenile cure-all, Ritalin. In 2004, inspired by a British crackdown on the overprescription of SSRIs for kids and studies that indicated the drugs sometimes caused more frequent thoughts of suicide, the FDA put a black box warning, the most severe, on antidepressants. Antidepressant prescriptions for young people have declined since the suicide studies became headline news.
The FDA has started to look into the effects of adult drugs on the kids who take them and has come up with something called the pediatric exclusivity clause, which allows drug makers to receive six-month extensions on their patents to study the effects of their drugs on children. Since the FDA introduced pediatric exclusivity, approximately three hundred drugs have been submitted for pediatric testing, a dramatic increase over the dozen or so pediatric tests that took place over the previous decade. My big problem with pediatric exclusivity is that the financial incentive may well motivate manufacturers to test drugs on children, regardless of whether or not kids actually need those drugs. For example, tamoxifen has been undergoing pediatric trials. I guess they weren’t fooling around about using their product as a preventative measure, if they’re giving it to kids who don’t even have breasts yet. . . .
If we are going to treat kids with drugs, then it is obvious that we will have to test drugs on kids. But shouldn’t that pediatric testing be incorporated into the initial drug review process for drugs kids actually need? Maybe we should see how drugs affect kids before we actually release them to the general public, particularly if thousands of doctors have proven themselves willing to write off-label prescriptions for the under-eighteen set.
Pediatric exclusivity is but one way Big Pharma tries to duck the inevitable day when the patent runs out and lower-priced generics begin to dilute the market. Another way to try to stave it off is to apply for new patents based on slight changes to original formulas, like moving from tablets to caplets, or fiddling with the dosage delivery system. Recent examples of this phenomenon include Paxil CR and Wellbutrin XL, both allegedly longer lasting than their previous incarnations. This hardly seems a significant improvement, however, given that all SSRIs take a few days to work their way out of your system. Some pharmaceutical companies stave off the coming of cheap generics by striking sweetheart deals with generic manufacturers, paying them off to delay their product launches. Still others are notorious for filing phony patents on superficial aspects of the pill, or specific parts of the active ingredient, to delay the inevitable. Patent infringement lawsuits against generic makers, which can delay the launch of a generic for up to thirty months, or for the length of the court case, are par for the course. Even an extra six months without competition can add up to hundreds of millions.
There’s a world of global patent debates raging beyond all this domestic intellectual property chicanery. Both the World Trade Organization and the United Nations have
been addressed by many activists arguing that epidemics in poor countries justify the emergency production of mass quantities of cheap generics. An Indian company, Cipla, was ready to prepare a retroviral cocktail for Doctors Without Borders to distribute in Uganda and Ghana, when GlaxoSmithKline got all shirty and legal, accusing the Indians of piracy. By the end of 2001, however, all the bad publicity and angry people in the streets shamed Big Pharma into allowing the manufacture of generics in Africa and selling their products at reduced prices. Activists insist that the drugs remain far too pricey for most people with AIDS in poor countries, and that more assistance is required.
But let’s go back to the patent—and hanging on to it at all costs. If all the legal and semilegal stalling doesn’t work, makers unveil an ostensibly improved version of the old drug. Claritin is trumped by Clarinex. Prilosec, the original purple pill, gives way to today’s purple pill, Nexium. The other way to hang on to your patent is to find a new use for the old drug. Lilly tried to stave off the horrors of patent expiration by rebranding its greatest hit, Prozac, as Sarafem, a cure for premenstrual dysmorphic disorder. PMDD is basically PMS Turbo. PMS has always mystified me, not because it doesn’t exist, but because it does, and almost every woman I have met in my life has some twinge or symptom of it. And the stats back up my anecdotal tales of gal pals having backaches or bursting into tears; about two-thirds of women are affected. This makes me wonder how anything that afflicts that much of a given population can possibly be considered a disease. Aren’t the minority of the sisterhood who flounce through the month unhindered the anomalous ones? If almost everybody feels something to the point where it is the stuff of coffee-mug and T-shirt slogans, then surely it is not a disorder, but normal—a thing simply to be endured, and tamed with the usual low-grade anodynes.
Lilly insisted that PMDD, Xtreme PMS, was downright debilitating, and sold Sarafem with the classic pitch-to-the-ladies, the empowerment message, encouraging women to liberate themselves from the tyranny of bloat and moods. The ads for the little lavender and pink pills encourage gals to “be more like the woman you are.” Lilly got its knuckles rapped by the FDA for one ad in particular. It showed a young woman struggling unsuccessfully, and with increasing hysteria, with a fiendishly uncooperative grocery cart. The FDA argued that the ad trivialized the disorder, which strikes me as pretty funny, considering that the whole point of Lilly’s campaign was to give PMDD the gravitas of a disease so that they could supply the cure.
Paxil, never far behind Prozac, took a similar tack with a campaign about social anxiety disorder, and then generalized anxiety disorder, providing shiny new diseases for a drug known primarily as an antidepressant. In case you aren’t up on your disorders, those are Turbo Shyness and Xtreme Jitters, respectively. Many pharmaceutical marketing campaigns don’t sell the cure. They sell the disease, identifying a cluster of symptoms and giving them a name. And once a company finds a best-selling malaise, they start marketing all the adjacent feelings. Depression begets a host of anxiety and panic disorders. Viagra and Cialis prove an astounding success, and so we are treated, or soon will be, to campaigns about the scourge that is female sexual dysfunction.
This is not to discount the genuine therapeutic benefits of prescription drugs, which have helped people recover from debilitating conditions. Depression is bloody awful, and if Prozac can shake you out of it, more power to you and Lilly and your caring clinicians. But it’s not as easy to diagnose a depression as it is to spot a tumor or a blood pressure problem. There’s no way to really test people for many of the disorders for which antidepressants are prescribed, other than some shrinky-dinky quizzes, which seem to get more and more general with each passing drug. CNN recently did a spot on a new drug for attention deficit disorder called Strattera. The anchors joked about the website’s diagnostic questions: Do you feel unfocused, disorganized, or restless? Yes! Are you unable to concentrate on any one thing for any length of time? So true! Meanwhile, the crawl beneath the picture carried the latest blips about Bush and Laci Peterson, while the current temperatures and sports scores flashed in another corner and, in the background, more monitors blinked. Who could focus on anything for any length of time? The Lilly website even compares the condition to a “channel [that] keeps changing in your mind and you don’t have control of the remote.”
The snappier turnaround times demanded by an overburdened health care system mean that way too many doctor appointments are little more than ill-defined complaints and pitches for a quick fix. You tell ’em you feel like six pounds of shit in a five-pound bag and that you’ve heard of this new miracle cure, and then they hand you a couple of sample packs, a pamphlet, and a scrip. The laundry list of disorders for which antidepressants are prescribed has increased and now includes everything from body dysmorphic disorder to posttraumatic stress disorder to gambling, shopping, and sex addictions. And every one of these relatively new disorders has enjoyed at least fifteen minutes of fame, often in the form of designated celebrity sufferers, magazine spreads, or a very special day on The Oprah Winfrey Show or Dr. Phil.
Feeling like six pounds of shit in a five-pound bag is nothing new. There have been melancholias and manias on the medical books since the Ancient Greeks. In a more churchy time, these symptoms might have been interpreted as demonic possession and treated with exorcism, or maybe a trepanning, or perhaps a good bleeding to get your humors back in working order. In the early days of psychoanalysis, the same symptoms might have been evidence of a neurosis or a block, and the patient would have had to talk his or her way through it, in search of primordial trauma, perhaps under the influence of hypnosis or cocaine. Over the course of the last century, doctors developed brutal surgical interventions like lobotomies to try to tame mental illness, but pharmaceuticals have been the preferred form of treatment since the seventies. The first few classes of antidepressants, the tricyclics and the MAOIs, had rotten side effects like dry mouth, blurry vision, sweating, and severe, sometimes fatal, allergic reactions that discouraged their widespread use.
It was not until the early nineties that things began to change. In the post-Prozac world, a World Health Organization study on depression estimated that 121 million people suffered from the disorder, and that only a quarter of them had access to treatment. Now I hate to make chicken and egg arguments, but which came first, the miracle cures or the global depression epidemic? My money’s on the cures. Since the new, ostensibly side-effect-free SSRIs became available, the number of people who seek treatment for depression has tripled, and the use of antidepressants has more than doubled. Hell, I’ve taken one, too. Paxil was another one of those drugs that I did briefly, and didn’t much care to continue doing. I took it for a couple of months, until I wasn’t freaking out anymore, and then stopped because it made me feel fizzy, numb, and wired. I know plenty of people, more cranky than crazy, who have also given one of the SSRIs a whirl, and I suspect you know a few, too.
According to a report by the American Medical Association, part of the reason for this is the increased public profile of such drugs, as well as the general destigmatization of mental illness. Once upon a time you might have kept your mad relatives in the attic, away from prying eyes; now we blab in locker rooms and chat rooms about our meds. The shift was suspiciously sudden. Granted, the freedom to discuss our own bouts of insanity seems an improvement over locking ourselves or our loved ones up, but it also testifies to the awesome power of marketing.
Are millions of us really that fucked-up? And if, indeed, the fucked-up are legion, then shouldn’t we be sniffing around for the reasons behind the depression epidemic? Either way you look at it, it’s pretty depressing. Millions of people may well be taking drugs they don’t need to clear up a medical condition that is nothing more than a glorified bad mood. On the other hand, millions of men, women, and children might be seriously ill for reasons we don’t understand, and might find themselves dependent on drugs, with all the side effects, long-term effects, and costs that situation implie
s. Take your pick: a massive snake-oil swindle or a ginormous public health crisis.
SSRIs clearly have their uses. For those afflicted with severe depression, the four food groups and a daily stroll will not suffice. However, I suspect that too many people label themselves depressed and turn to pills too quickly, since they provide the promise of a much easier fix than the kind of lifestyle changes that actually lead to better physical and mental health. If your day consists of sitting in a car snorting fumes, sitting in front of a computer screen, sitting in a car again, and then sitting in front of a television screen while grazing on all manner of toxins and worrying intermittently about your debts, your job, and your relationships, then it is little wonder you do not feel very good. You should not feel good. That pain is your body saying quit it with the shitty life. Doing the good-health thing requires rearranging your schedule, which you might not have the leeway and resources to do, and waiting a while for the effects to kick in. With a pill, you just buy it and swallow it. We’re good at buying and swallowing.
If you look at the top killers in the U.S.—heart disease, stroke, cancer, chronic lower respiratory disease, pneumonia/ influenza, liver disease—you will see that there is not one blockbuster pill that cures any of them. There are some peripherals, sure, to keep your cholesterol down and maybe help with the heart. But most of these diseases spring from a lifetime of bad habits. These are the diseases of a stressed-out people who do not get enough exercise, eat too much lousy food, and marinate in a soup of chemicals. So when the works inevitably begin to rot, why not throw more chemicals into the mix? Fire with fire, baby. Here’s another list: the top ten global pharmaceuticals in 2003 were Lipitor, Zocor, Zyprexa, Norvasc, Procrit, Prevacid, Nexium, Plavix, Advair, and Zoloft, for cholesterol, cholesterol, depression, hypertension, anemia, heartburn, heartburn, blood clots, asthma, and depression, respectively. The list of mortality leaders and wonder drugs doesn’t match up as nicely as one might hope it would. Throw in estrogen therapy, antibiotics, painkillers, Accutane, and Viagra, and that about sums it up for the fifty best-selling drugs, which account for half of all drug sales.