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The Naderites also point to the preponderance of “me-too” drugs, that is, drugs that are a lot like existing popular drugs. Until 1992, there was a way of determining whether or not a drug was truly a revolutionary breakthrough, or simply a variation on a theme, as Paxil and Zoloft are to Prozac. The Food and Drug Administration used to classify all new drugs based on one of three categories. Class A drugs were important therapeutic gains, Class B modest ones, and Class C the copycats that duplicated existing products. The Bush
père
administration scuttled this classification system at the urging of the pharmaceutical lobby. The lobbyists were pleased about their success, and no wonder: Half the drugs approved between 1982 and 1991 were class C, and 31 percent class B. A measly 16 percent made grade A. It’s not just the Naderites who are fuming, either. The former editor of
The New England Journal of Medicine,
Dr. Marcia Angell, argues that two-thirds of the new drugs the FDA approves are mere me-toos. If you’re going to brag about the innovation, Big Pharma, how’s about you magic up a cancer cure that doesn’t make other cancer, instead of making Antidepressant Potion Number Nine or Viagra: The Sequel?

The $500 million per drug figure seems awfully generous, too, when you consider the way research is being conducted by a growing clinical trial industry. In 1999, the
New York Times
ran a couple of deeply creepy investigative reports about cost-cutting and outsourcing in the drug industry. Clinical research has traditionally been the work of academics working under the auspices of universities or teaching hospitals. But academics are not particularly speedy people, and speed is the new watchword in the highly competitive drug-testing market. Consequently, more and more private research companies are conducting clinical trials. Universities have lost about a third of their clinical trials over the past couple of years to other forms of testing. More independent doctors are also performing tests. In 1990, only about four thousand U.S. doctors performed clinical trials for new drugs. By 1997, that number had reached 11,662. Doctors were frequently offered bonuses for signing up enough patients for a trial; one was offered $50,000 if he could round up fourteen guinea pigs for a test of a Merck hypertension drug. Other doctors regularly receive faxes encouraging them to cash in by either running trials or simply recruiting test subjects. The
Times
investigation also found that many of the doctors running tests had little experience doing so, and often ran studies outside their areas of expertise. And wherever and however the research occurs, drug companies ultimately control which results get published and publicized and which ones get buried.

Speed isn’t just the watchword for pharmaceutical companies, either. The Food and Drug Administration, which approves all new drugs in the U.S., has picked up its pace. Part of the reason it has picked up the pace is that the industry is paying it to do so. Sick and tired of a balky, underfunded, ponderous drug approval process, industry began paying user fees to get their dope stamped with the federal okay. A 1992 bill called the Pharmaceutical Drug User Fee Act (PDUFA) meant that industry ponied up six-digit fees for every new drug they submitted, in exchange for approval processes that took only six months or a year, rather than two or three years. While the PDUFA has funded more staff at the FDA, and the government hails the program as a success for patients, some critics have argued that the snappier turnaround time for more new drugs may well have something to do with a rise in adverse drug reactions.

Don’t misunderstand me: Our prodigious appetite for legal drugs is not entirely misguided. Pills sure do beat a poultice or a good bleeding, and they are less invasive and traumatic than surgery. In fact, it is their very convenience that makes us so dependent on them, and that offers grounds for worry. After all, William S. Burroughs described junkies as the ultimate consumers. They’ll pay any price, and they’ll wait for the man, so long as they can get their soma. But God only knows what effects any of the current blockbuster drugs will have in twenty-five years, or in the children of people who take them.

Oh, sure, you pay the man and you takes your chances, but maybe it’s not the best idea to go swallowing and wallowing in all sorts of relatively new chemicals in a big rush. In the eighties, 233 prescription drugs came to market; in the nineties, that was up to 370, thanks in part to clinical trial and FDA approval times being shortened in the interest of getting drugs to market as quickly as possible. Big Pharma’s line is pretty simple: Callooh callay, o frabjous day, more people can get their hands on more medicine. This is the same basic argument you hear from the up-with-the-stock-market types. If more people are doing it, and there is increased participation in the market, it must be good. At the risk of pissing on the progress parade, an increased market share is also an increased radius of consequences. If the markets tank now, more people feel it. If a bad drug somehow makes it to market, more people run the risk of taking it. The most recent example of a drug gone wrong is Vioxx, the arthritis blockbuster that Merck withdrew from the market in fall 2004. Clinical trials found, in the euphemese of the press release, “there was an increased relative risk for confirmed cardiovascular events.” If 488,000 Google hits for the phrase “vioxx recall” are any indication, then the class action suit filed against Merck should be a mother. The other big arthritis drugs, such as Celebrex and Bextra, are also being subjected to side-effect scrutiny and the specter of litigation.

The idea that the people have spoken, and have asked for drugs, glosses over the fact that the people are spoken to before they speak. According to a few estimates, those great Big Pharma research budgets are only half as big as the corresponding advertising and marketing budgets. This brings us back to the pharma ads. There have been prescription drug ads running in newspapers and magazines since the early eighties, but it was not until 1997 that the FTC relaxed standards to allow electronic advertising. Since then, ad spending has mushroomed. In 1991, pharmaceutical manufacturers spent about $50 million on “ask your doctor” advertising. In 2001, they spent $2.7 billion. Big Pharma also spent about 12 billion clams in 2000 on marketing to doctors—in the form of samples, paraphernalia, and junkets to exotic places.

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.