How the Drug Companies Want Us to Be Sick
You see a TV show or a commercial featuring medical problems, and you start feeling the symptoms yourself: a twinge in the leg or maybe a moment of doubt about your emotional stability.
If so, you, like millions of Americans, could be suffering from a serious condition known as telechondria. But help is here, with new Advertil(R) in the green-and-yellow caplet. Ask your doctor Ã¢â‚¬Â¦
No, wait, don't really ask. Telechondriacs have not yet been recognized by science. Pharmacists are not dispensing drugs like "Advertil," and they probably never will. The last chemical that pharmaceutical executives would want to sell you is one that makes it harder for them to convince you that you're sick and need their products.
Drug corporations and their "awareness" groups, as we're all painfully aware, have defined and redefined a host of medical conditions -- including female sexual dysfunction, erectile dysfunction, restless legs, sleeplessness, bipolar disorder, attention deficit disorder, social anxiety disorder and irritable bowel syndrome -- to include larger and larger segments of the population in the United States and other Western nations.
Accepting for a moment the industry's claims about the numbers of people suffering from the eight diseases listed above, we could do some simple calculations showing that up to 93 percent of adult women and men in the United States suffer from at least one of them. Throw in a few more conditions like depression, bone density loss and premenstrual dysphoric disorder, and industry figures make it appear that virtually every American has a disease in need of a treatment.
Last year, Ray Moynihan and Alan Cassels called attention to the epidemic of disease marketing in their book "Selling Sickness." Last month, health professionals, academics, journalists and consumers gathered in Newcastle, Australia, for the Inaugural Conference on Disease Mongering. A set of papers from that meeting was published free by the online journal PLoS Medicine. Also last month, the Prescription Access Litigation Project (PALP) in Boston announced its "2006 Bitter Pill Awards," recognizing drug companies that engaged in the year's worst "overzealous and questionable marketing practices."
These and other recent activities make it all too clear that the profitable practices exposed in Lynn Payer's 1992 book "Disease Mongers: How Doctors, Drug Companies, and Insurers Are Making You Feel Sick" have been refined and amplified in recent years, with the apparent goal of medicating an entire population.
Unruly body parts
The evolution of "restless legs syndrome," documented by Steven Woloshin and Lisa Schwartz in a paper from the Disease Mongering Conference, is a case study in how a pharmaceutical company, with help from the media, can turn what is a serious problem for some people into a contrived medical condition for millions more.
Woloshin and Schwartz analyzed media coverage in the interval between 2003, when GlaxoSmithKline Inc. first issued press releases about trials of its drug Requip for relief of restless legs syndrome, and 2005, when the U.S. Food and Drug Administration (FDA) approved that use.
Of 187 major newspaper articles published during those two years, 64 percent relayed without comment the industry's claims that millions of Americans -- as many as "1 in 10 adults" -- suffer restless leg. Forty-five percent of the articles stressed that many people may be unaware they're sick, even though, according to 73 percent of the articles, the syndrome can have extreme physical, social and emotional consequences. Reports of the relief provided by drug treatment used "miracle language" 34 percent of the time, while 93 percent of articles failed to quantify Requip's side effects.
Yet the relief people get from Requip appears to be anything but miraculous. In one trial, 73 percent of subjects saw improvement -- compared with 57 percent whose symptoms improved with a placebo! Side effects that occurred in clinical trials at least twice as often with Requip as with a placebo included nausea (40 percent of subjects), vomiting (11 percent), somnolence (12 percent), dizziness (11 percent) and fatigue (8 percent).
My attempts to obtain responses from several drug companies to charges of mongering restless leg and other conditions went unanswered. Quoted last month by the Guardian (U.K.) as he defended his company against bad publicity generated by the conference, David Stout of GlaxoSmithKline said, "You need to talk to the patients. Things like restless leg syndrome can ruin people's lives. It is easy to trivialize things when you don't have them. If people did not want the treatments, they would not seek them."
Restless leg syndrome in its most serious form is indeed no joke. My father was tormented for years by near-constant symptoms, until, without ever having seen an advertisement, he sought treatment.
But, says Dr. David Henry, who is a physician, professor at the University of Newcastle and co-organizer of the Disease Mongering conference, "When you extend a drug beyond the [most severely afflicted] group on which claims of its effectiveness are based, you see a falling ratio of good to harm. The benefits of the drug diminish, while the side effects tend to stay the same."
Henry told me, "The companies know quite consciously that they're going into areas where they're doing net harm."
In their conference paper, Woloshin and Schwartz note that restless legs syndrome is one of those "disease promotion stories" that the press loves to cover: "The stories are full of drama: a huge but unrecognized public health crisis, compelling personal anecdotes, uncaring or ignorant doctors, and miracle cures."
Irritable everything syndrome
The story of another disease, irritable bowel syndrome, has all of those dramatic elements, plus dead patients.
In "Selling Sickness," Moynihan and Cassels describe public-relations offensives by Novartis Pharmaceuticals and GlaxoSmithKline to popularize a condition called irritable bowel syndrome (symptoms of which are described as "abdominal pain or discomfort associated with changes in bowel habits in the absence of any apparent structural abnormality").
The companies stood to gain billions in sales if, as they claimed, as many as 20 percent of Americans had the syndrome. GlaxoSmithKline's drug Lotronex received FDA approval for treatment of irritable bowel in 2000, and Novartis' Zelnorm was approved in 2002. In statements to the FDA and the public, the companies tended to characterize irritable bowel syndrome as it is experienced by the worst-afflicted patients -- a tiny percentage of the total -- while emphasizing claims that the syndrome hits vast numbers of Americans.
TV star Kelsey Grammer and his wife Camille Grammer, who suffers from the disease, made the rounds of talk shows in a publicity effort quietly funded by GlaxoSmithKline, while Novartis deployed former Wonder Woman Lynda Carter to stress that common stomach problems might be irritable bowel, a "real medical condition." The FDA wrote to Novartis in 2003, demanding that the company discontinue other advertising that it considered misleading because it exaggerated the drug's benefits and the numbers of people who need it while minimizing its side effects.
Lotronex can now be prescribed only by doctors who have enrolled in a GlaxoSmithKline "Prescribing Program." According to Moynihan and Cassels, the drug came under fire in late 2000 when three FDA scientists wrote to their superiors expressing alarm over a rising toll of deaths and hospitalizations of irritable-bowel patients during the nine months that Lotronex had been on the market. (The concern was spurred by the remarkably increased rates; the deaths had not been shown in a clinical trial to have been caused by Lotronex.)
"Selling Sickness" contains this frightening description of one side effect: "For some of those who experienced severe constipation after taking the drug, their feces would become so impacted within their bowel that the bowel wall perforated, leading to potentially fatal infections inside the body."
A conference paper by David Healy traced the expanding definition of bipolar disorder over the past quarter century. The disease officially entered the manual of mental disorders in 1980, and based on its original diagnostic criteria -- which included an episode of hospitalization -- bipolar disorder is a devastating disease for 0.1 percent of the U.S. population. Over time, it has been broadened with additional criteria based on community surveys, so that the disease once known as "manic depression" is now said to affect 5 percent or more of Americans.
According to Healy, there is "almost no evidence" that drug treatment works for that much broader group of "community-based" disorders. Yet manufacturers like Eli Lilly and Co. and Janssen L.P. have heavily promoted pharmaceutical treatment of bipolar, as broadly defined, through websites, patient literature and new scientific journals devoted to the disease.
Evidence is accumulating that one drug prescribed for bipolar disorder (Lilly's Zyprexa) causes withdrawal symptoms, that patients on drugs for bipolar tend to be hospitalized more often than those who are not, that the drugs are associated with a heightened risk of suicide and that antipsychotic drugs in general are associated with increased death rates.
Despite such problems, says Healy, there is a recent "surge of diagnoses of bipolar disorder in American children." He cites one book that actually appears to accept the possibility that bipolar disorder may first show up in hyperactive fetuses.
The drug industry has thoroughly penetrated the juvenile market for another well-known disease, attention deficit disorder (ADD, also called attention deficit hyperactivity disorder, ADHD). The numbers of prescriptions to be written are huge; the National Institutes of Mental Health estimates that there's an average of at least one afflicted child per typical-size classroom. But people spend many more years as adults than as children, and stiff competition among the major ADD drugmakers -- among them Shire PLC, Novartis and Lilly -- guaranteed that the larger pool of potential adult patients would be targeted.
All three companies contribute or have contributed funds to the organization Children and Adults with Attention Deficit/Hyperactivity Disorder (CHADD), which calls ADD "a lifespan disorder, affecting children, adolescents and adults." In "Selling Sickness," Moynihan and Cassels describe a talk by a Shire executive at a CHADD charity golf event, in which he estimated that 8 million U.S. adults could benefit from treatment. CHADD gets about 20 percent of its funding from drug firms, and its website provides detailed advice on medication for ADD. One example:
Although there is little research on utilizing short-acting and long-acting medications together, many individuals, especially teenagers and adults, find that they may need to supplement a longer-acting medication taken in the morning with a shorter-acting dose taken in mid- to late afternoon. The "booster" dose may provide better coverage for doing homework or other late afternoon or evening activities and may also reduce problems of "rebound" when the earlier dose wears off.The marketing of ADD can venture into bewildering territory. One of PALP's 2006 Bitter Pill Awards went to Lilly for a TV commercial plugging its drug Strattera. In the ad, information on approved uses and risks is accompanied by wildly distracting sights and sounds of a video game. The FDA issued Lilly a mild rebuke over the ad: "The overall effect of the distracting visuals and graphics is to undermine the consumer's ability to pay attention and comprehend the risk information Ã¢â‚¬Â¦"
The Bitter Pill Awards stressed the obvious irony of an attention-confounding ad targeted at a clientele who have difficulty paying attention. It could also be that the well-known practice of drawing notice away from side-effects information had to be cranked up a couple of notches in this ad to help persuade people who don't really have a serious ADD problem that they might just need Strattera.
"Selling Sickness" traces another history of market expansion: the memorable publicity blitz that started with the FDA's 1999 approval of GlaxoSmithKline's antidepressant Paxil for a condition called "social anxiety disorder." An early press release insisted that social anxiety disorder is "not just shyness" but something far worse.
Enough people were convinced that they had that "something worse" to make Paxil the country's biggest-selling antidepressant for a time in 2000. Moynihan and Cassels write that GlaxoSmithKline avoided the term "social phobia," which was preferred by psychiatry for what can be a seriously debilitating condition, probably because "a lot more people can be categorized as being ill if you apply the definition of an anxiety disorder rather than a phobia."
It also couldn't have hurt that the initial letters of GlaxoSmithKline's name for the disease spelled "SAD."
The pinking of Viagra
Seeing the continuing deluge of advertising for impotence remedies in the American media, a visitor from the planet Zefitor could be forgiven for wondering how Earth, with such seemingly dysfunctional male humans, ever came to be inhabited by 6.5 billion of the species.
At the Disease Mongering Conference, Joel Lexchin traced the history of the Pfizer Inc. campaign that transformed the father of all impotence drugs, Viagra, "from an effective product for erectile dysfunction due to medical problems, such as diabetes and spinal-cord damage, into a drug that 'normal' men can use."
Pfizer spent $303 million in direct-to-consumer advertising for Viagra in 1999-2001, often featuring younger-looking men and sports stars. That effort paid off handsomely, by extending the market well beyond men with well-defined medical conditions and attaining its greatest sales growth in the 18 to 45 age group. Pfizer's salesmanship broke the age barrier for Viagra, but the company failed to extend the drug's market to that half of the human population that is completely immune to erectile dysfunction: women.
A paper by conference speaker Leonore Tiefer traced the term "female sexual dysfunction" (FSD) back to 1997. In the years that followed, demand for a "pink Viagra" was boosted by sisters Jennifer and Laura Berman, who, says Tiefer, "became the female face of FSD, opening a clinic at UCLA in 2001, and continuing to popularize FSD and off-label drug treatments on their television program, website and books; in appearances on the television show Oprah; and in innumerable women's magazines."
Pfizer aggressively promoted FSD, which it labeled "female sexual arousal disorder." But its plans for a women's Viagra eventually fizzled because of "consistently poor clinical-trial results."
Tiefer is coordinator of the Campaign for a New View of Women's Sexual Problems, which runs the media-watchdog website fsd-alert.org. The Campaign and other groups have been fighting back against the medicalization of sex with some success.
What latest malady is the pharamaceutical industry selling? It's turning out to be a hard-to-escape one-two punch: sleeplessness and sleepiness.
In the past year, any TV viewer who's managed to stay awake through commercials knows that the drugmakers' latest target is sleeplessness. The media blitzes of two companies, the sanofi-aventis Group (that's their lower-case), which makes Ambien, and Sepracor Inc., which makes Lunesta, earned them a 2006 Bitter Pill Award "for overmarketing insomnia medications to anyone who's ever had a bad night's sleep."
Last month, at the request of government- and industry-funded groups, the National Institute of Medicine issued a report concluding that 50 million to 70 million Americans suffer from sleep problems and that U.S. businesses lose as much as $100 billion a year because of sleepy workers.
In a Baltimore Sun op-ed column, Ira R. Allen, vice president of the Center for the Advancement of Health, blasted the Institute for having been "co-opted." He stressed to me that he was not criticizing the report's methods or results, that "sleep is an important issue" and that "there were some legitimate partners in sponsoring the report." But, he said, "The report was issued right on the heels of National Sleep Awareness Week (March 27-April 2), and just as advertising for sleep aids was reaching a peak."
That, he said, is just too much of a coincidence: "I doubt that the United States has suddenly been invaded by tsetse flies! I'm not naive; I know the country's economy is built on advertising. But our organization's message is 'Transparency, transparency, transparency.' Don't hide your motive."
Even if we accept the Institute's and the drug industry's claims of a sleep-loss epidemic, other research has shown that the benefits of drug treatment are far from overwhelming. The class of drugs to which Ambien and Lunesta belong provide an extra half-hour of sleep per night, on average. (And Ambien made headlines earlier this year when reports revealed that some patients who took the drug were eating and even cooking in their sleep.)
The lack of a clearly superior pharmaceutical solution to sleeplessness may partly explain the recent orgy of advertising for sleep problems and sleep aids in general. Drug companies spent $345 million on ads for sleep drugs in 2005 alone, and that's expected to increase this year.
Wake up and smell the coffee
But, you say, you're already getting enough sleep? Well, maybe it's too much! The latest, and perhaps most disturbing, wave of sleep-controlling drugs are designed to let you stay awake for up to 48 hours with no ill effects.
According to the Feb. 18, 2006, print edition of the British magazine New Scientist, Cephalon Inc., the maker of one such product called Provigil, insists that the drug is meant only for treating serious diseases like narcolepsy and sleep apnea. But Provigil is also becoming a "lifestyle drug" for people who can't fit everything they want to do into 16 hours a day. And it can't help but beckon employers with the promise of an always-alert work force.
New Scientist reports that the Pentagon's Defense Advanced Research Projects Agency (the notorious DARPA) "is one of the most active players in the drive to conquer sleep." Sometime this year, DARPA will test an experimental wakefulness drug, CX717, on combat soldiers engaged in hard work for four straight nights with only four hours of "recovery sleep" in between. Tests have shown that monkeys awake on CX717 for 36 straight hours had better memory and alertness than undrugged monkeys after normal sleep.
Yet another generation of drugs that skew sleep toward the most restorative, so-called "slow wave" phase are on the horizon. Due for release as early as next year, Merck & Co. Inc.'s gaboxadol, says New Scientist, holds out "the promise of a power nap par excellence." The temptation to seek approval for the broadest possible labeling (and profit base) for drugs like Provigil, CX717 and gaboxadol will likely be overwhelming.
What kinds of medical conditions will expand to embrace millions of newly diagnosed "patients" in the coming months and years? I put that question to Dr. Richard Lippin, an occupational-health physician, health forecaster, and co-founder of a health-care reform blog, Critical Condition. His response:
"My guess is anything to do with pain, fatigue or feeling stressed. The first two are related to medicalizing the avoidance of aging and death among baby boomers and the third -- stress -- is due to very real anxiety people should feel about a host of worldwide and U.S. megatrends that legitimately create anxiety and depression -- trends like global warming, wars, economic collapse, political corruption, etc. But the answers are not pills. The answer is to elect sane political leaders. There is no pill for the 'white water' that's ahead for all of us."
David Henry says that the disease-mongering documented at his conference "can't be stopped. It's a consequence of our political economy, the domination of marketing in all areas of life. So we need to build counterforces. People are becoming more skeptical, and that needs to be encouraged. We should exercise the same healthy skepticism when being sold a drug as we do when being sold a secondhand car."
He says greater use of the attention-getting term "disease mongering" will prove useful in changing the behavior of medical professionals, the media and even pharmaceutical public-relations departments. "We want it to be an idea that pops up in their heads, so PR people will say, 'Hey, we don't want to run this ad and be accused of disease mongering!'"
Where would be a good place for average Americans to start exercising the healthy skepticism that's needed to fight disease mongering by the pharmaceutical industry? Ask your doctor.