October 26

A Disease for Every Pill – FDA Hearing Drug Advertising

A Disease for Every Pill – FDA Hearing Drug Advertising

Wed, 5 Oct 2005

The FDA has called for a public hearing to address direct to consumer drug advertising. Hearing Date: November 1 and 2, 2005 Hearing Name: Direct-To-Consumer Promotion Location: National Transportation Safety Board Boardroom and Conference Center 429 L’Enfant Plaza, SW., Washington, DC. Time: 9:00 a.m. – 5:00 p.m.

An excerpt from "Selling Sickness" by Ray Moynihan and Alan Cassels is published in the current issue of The Nation. It provides a perfect case example that encapsulates the insidious influence that drug advertisements have in convincing normal people that they have a mental illness for which they need a pill. The case involves PMDD, an exclusive US manufactured “disorder” affecting young women. Pre-menstrual cramps and attendant emotional ups and downs – which are experienced to a greater or lesser degree by every normal young woman–was elevated to the level of disease by a Columbia University psychiatrist who had an idea fixe, and the Eli Lilly marketing apparatus.

Lilly’s blockbuster antidepressant, Prozac, was about to lose its patent exclusivity when Professor Jean Endicott came to its rescue with a new disorder – premenstrual dysphoric disorder – for which Prozac could be prescribed.

Endicott claims that PMDD is a psychiatric condition suffered by up to 7 percent of women. PMDD joins a long list of dubious "mental disorders" that have been recently invented and classified in the dragnet of psychiatry – the DSM-IV diagnostic guide (the brainchild of another Columbia psychiatrist). Inclusion in the DSM IV, qualifies a "condition" to be treated with a psychotropic drug. But unlike any other medical diagnostic guidebook, nowhere in the DSM-IV is a state of sanity defined or described. This reveals the psychiatry’s Achiles heel, the essential flaw in all psychiatric diagnoses is that psychiatry lacks benchmark criteria for differentiating normal from abnormal. This explains psychiatry’s penchant for inventing psychiatric illness linked to the marketing of a therapy (most often, a drug). Among DSM-IV invented illenesses:

ADHD – attention deficit hyperactivity disorder ( 314.00, 314.01, and 314.9): clumsiness (315.4); conduct disorder (213.8); oppositional defiance disorder (313.81); Disruptive Behavior Disorder Not Otherwise Specified (312.9); SAD–Social anxiety disorder; GAD – general anxiety disorder; compulsive shopping disorder; Reactive Attachment Disorder in Infancy or Early Childhood (313.89). bad writing (315.2, and its associated symptom, poor handwriting); coffee drinking, including coffee nerves (305.90), bad coffee nerves (292.89), inability to sleep after drinking too much coffee (292.89), shyness (299.80), also known as Asperger’s Disorder); sleepwalking (307.46); jet lag (307.45); snobbery (301.7, a subset of Antisocial Personality Disorder); insomnia (307.42); having a nightmare (307.47); so is doing just about anything “vigorously.”

PMDD was roundly rejected by the European Agency for the Evaluation of Medicinal Products (2003) which stated: “PMDD is not a well-established disease entity across Europe." The EA panel was especially concerned "that women with less severe premenstrual symptoms might erroneously receive a diagnosis of PMDD resulting in widespread inappropriate short- and long-term use of fluoxetine.”

The FDA, by contrast, lent its authority to the marketing of a "condition"–even in the absence of any scientific evidence–thereby validating a bogus "condition" for which millions of otherwise healthy adolescents and young women would be prescribed a powerful antidepressant with severe adverse side effects. The FDA gave Eli Lilly the green light to market Prozac – which was repackaged and renamed, Sarafem, "a brand" that, according to the marketing specialist who worked on Lilly’s Sarafem campaign, is "better aligned with the personality of the condition for a hand-in-glove fit." The FDA approved the use of this antidepressant for pre-menstrual cramps–despite a laundry list of serious adverse side effects – including evidence of a twofold increased risk of drug-induced suicidal behavior for adolescents, who are the most likely to be distressed by pre-menstrual cramps.

The FDA bears the major responsibility for perverting the practice of medicine by giving drug manufacturers what no other regulatory agency does: the FDA permits drug manufacturers to advertise their drugs to consumers by marketing previously non-existing "conditions."

“When you’re giving drugs to healthy people you’re shifting the balance,” says Barbara Mintzes, a drug researchers.

“If you’re already healthy, the likelihood of benefit becomes much, much smaller, and then there’s a concern that what we are actually doing at a population level is causing much more harm than benefit through drug treatment.”

FDA Notice of Public Meeting http://www.fda.gov/cder/ddmac/dtc2005/default.htm
transcript to be posted at later date

Contact for Meeting Information:
Rose Cunningham,
telephone: 301-443-5595 and fax: 301-594-5493,
email: cunninghamr@cder.fda.gov

Contact: Vera Hassner Sharav


A Disease for Every Pill
[from the October 17, 2005 issue]

An anonymous woman tries to disentangle a shopping cart from an interlocked row of them, outside a suburban store. She is frustrated and angry. She becomes even more exasperated when another shopper enters the frame, calmly unhooks a cart and glides smoothly on her way. Watching this TV advertisement unfold, it might look like the woman is experiencing little more than a normal bout of tension or stress. But the folks at the drug company Lilly know better. This woman may need a powerful antidepressant because she is suffering from a severe form of mental illness known as PMDD. “Think it’s PMS? It could be PMDD,” intones the voiceover.

Columbia University Professor Jean Endicott tells us premenstrual dysphoric disorder (PMDD) is a psychiatric condition suffered by up to 7 percent of women. Paula Caplan of Brown University claims that the condition has essentially been invented and that there is no strong scientific evidence to distinguish it from normal premenstrual difficulties. Even worse, argues Caplan, using a medical label to explain away the severe distress some women experience in the lead-up to their period runs the risk of masking the underlying causes of their suffering.

In the United States, the Food and Drug Administration has accepted that the condition PMDD exists and has approved Lilly’s Prozac and several similar antidepressants for its treatment, yet in other parts of the world it is not even a recognized disease. It is not listed as a separate disorder in the World Health Organization’s International Classification of Diseases. And even in the United States, despite the hard work of Endicott, Lilly and other pharmaceutical companies, PMDD still has only a partial listing in the psychiatrists’ manual of diseases, the DSM, and is therefore not seen as a fully official category of illness.

Yet this scientific controversy is invisible in the avalanche of television and magazine advertisements about PMDD in the United States–much of it targeting young women. The $500 billion pharmaceutical industry has identified another new mega-market–women of childbearing age–and the world of marketing demands simple, clear messages. The emotional ups and downs preceding your period are no longer a part of normal life–they are now a telltale sign you could have a psychiatric condition. As Caplan puts it, by watching these ads “women are learning to consider themselves mentally ill.”

A friendly and hardworking academic, Endicott operates from a small office buried in the basement of a psychiatric hospital in New York City. In stark contrast to Caplan, she insists PMDD is a genuine disorder that can be “very disabling” and is often not properly diagnosed or treated. She welcomes drug company efforts to have the condition taken more seriously. It was Endicott who led the key scientific meeting–funded by Lilly and attended by company representatives–that paved the way for two of the most important developments in the life of this young disorder: FDA acceptance of the condition and approval of Lilly’s antidepressant as the first drug to treat it. As to the appropriateness of drug companies advertising disorders like this on television, Endicott is a strong believer. “I think it educates people,” she says.

The pharmaceutical industry in the United States now spends more than $3 billion a year on direct-to-consumer advertising, promoting its most lucrative brands. Increasingly, however, these commercials are not just selling drugs but also the diseases that go with them. The shopping-cart ad for PMDD is part of a new form of TV advertising designed to introduce millions of people to previously unheard-of conditions. While the advertising claims made about the benefits and risks of medicines are regulated by law–albeit very loosely–claims about diseases remain a virtual free-for-all.

The story behind the “discovery” of PMDD illustrates how an unknown, unofficial and, for some, unreal condition can be pushed from the back pages of the psychiatrist’s manual into glossy magazines and onto TV screens. In the late 1990s Lilly’s antidepressant Prozac–whose chemical name is fluoxetine–was about to lose its patent, and the manufacturer stood to lose hundreds of millions of dollars because of the emergence of cheaper generic competitors. Winning approval of the drug for a new disease might re-energize sales of this blockbuster chemical.

In late 1998 Lilly helped fund a small meeting, impressively titled a “Roundtable” of researchers, which discussed PMDD. The meeting of just sixteen key experts took place in Washington, and it was attended by a group of FDA staff and at least four Lilly representatives. The chair was Columbia University’s Endicott, who had by then been pushing for the acceptance of this disorder for more than a decade. This time, though, Endicott had a giant pharmaceutical company on her side.

The meeting reached two important conclusions, both highly favorable to Lilly: There was now an alleged consensus that the disorder existed, and most people present thought there was sufficient evidence to support the use of antidepressants like Prozac to treat it.

By Christmas of 1999 a meeting of advisers to the FDA had voted unanimously to approve Lilly’s fluoxetine for the treatment of PMDD. Soon after, the FDA formally gave Lilly the green light to market its drug for PMDD, and Lilly organized a launch to do just that. But in an extraordinary turn of events, the pill did not debut under the name Prozac. After doing some market research with doctors and potential patients, Lilly decided to repaint Prozac in attractive lavender and pink and rename it Sarafem.

For specialists in pharmaceutical marketing like Vince Parry, the story of PMDD and Sarafem is a great example of a company “fostering the creation of a condition and aligning it with a product.” He worked for Lilly on the campaign, which he describes as helping to “build awareness for both the condition and the drug.” To kick it off, he says, the company sponsored a “pre-launch initiative” to raise awareness of the condition. “By changing the brand name from Prozac to Sarafem–packaged in a lavender-colored pill and promoted with images of sunflowers and smart women–Lilly created a brand that better aligned with the personality of the condition for a hand-in-glove fit.” Lilly’s market research investigated how best to brand both the drug and the condition to come up with language women felt most comfortable with.

Lilly’s shopping-cart commercial duly followed and provoked a complaint from the FDA alleging that the ad was “lacking in fair balance” because it minimized information about the drug’s side effects. In the end, the FDA simply asked Lilly to withdraw the offending ad. This is typical. Despite repeated violations across the industry, and tens of millions of Americans being regularly exposed to misleading information about the risks and benefits of widely prescribed drugs, companies are rarely fined and executives are not held accountable.

Another theme has recently emerged in pharmaceutical industry advertising. Researchers are finding more and more ads helping to sell the idea that everyday human experiences are symptoms of medical conditions requiring treatment with drugs. Together with colleagues, two doctors from Dartmouth Medical School, Steven Woloshin and Lisa Schwartz, recently analyzed some seventy drug company ads in ten popular magazines. They found that almost half tried to encourage consumers to consider medical causes for their common experiences, most often urging them to consult a physician. The ads targeted aspects of ordinary life including sneezing, hair loss and being overweight–things many people could clearly manage without seeing a doctor–and portrayed them as though they were part of a medical condition. The researchers speculated that advertising was increasingly medicalizing ordinary experience, and pushing the boundaries of medical influence far too wide.

Watching these trends closely is Canadian researcher Barbara Mintzes, who included in her PhD thesis at the University of British Columbia in Vancouver a rigorous examination of drug company advertising. She also discovered that many ads now promote medical conditions, rather than just drugs, and are helping to medicalize life, as she puts it. “To an unprecedented degree they portray the educational message of a pill for every ill–and increasingly an ill for every pill. It’s a shift from a drug that’s approved to treat people who are actually suffering from an illness to the idea that you just take a pill to deal with normal life situations.”

Mintzes is particularly outraged by the promotion of PMDD, which has been aggressively advertised in magazines read by teenagers, as well as in TV commercials. In her view it seems designed to make younger women feel there is something wrong with the normal emotional fluctuations they experience in the lead-up to their monthly period. While accepting that for some people the problem can be severe, Mintzes worries that the ads paint a shallow picture of what it means to be a young woman. “There is pressure on people to be someone other than who they are.”

With all treatments there is a balance between benefits and harms. For someone who is very sick, the chances of a great improvement may easily outweigh the risks of side effects from a drug. The antidepressants like Prozac that are being prescribed for PMDD carry many side effects, including serious sexual difficulties, and for teenagers an apparent increase in the risk of suicidal behavior. Such risks might be worth taking for someone severely debilitated by chronic clinical depression, but for a woman arguing with a boyfriend or frustrated by a shopping cart?

“When you’re giving drugs to healthy people you’re shifting the balance,” says Mintzes. “If you’re already healthy, the likelihood of benefit becomes much, much smaller, and then there’s a concern that what we are actually doing at a population level is causing much more harm than benefit through drug treatment.”

Professor Endicott bluntly rejects the concern that PMDD is an example of ordinary life being medicalized. “It’s an insult to suggest that women with less severe symptoms would even be seeking treatment. Women are not running around saying, Give me a pill for everything.”

Finding hard scientific evidence to help settle this difference of opinion is difficult. Mintzes’s research has added to a body of studies suggesting that these ads do drive many people into doctors’ offices, and that some doctors will prescribe the advertised drugs even when they may doubt their appropriateness for the problem at hand. But there have been few, if any, large studies that rigorously investigated whether direct-to-consumer advertising causes unnecessary medical labeling or leads to inappropriate or harmful prescription of drugs. What is crystal clear, however, is that the ads boost drug sales.

Industry executives argue that the most powerful case for direct-to-consumer advertising is evidence of underdiagnosis and undertreatment among people with serious health problems, including high cholesterol, high blood pressure, depression and, presumably, PMDD. In a special issue of the British Medical Journal devoted to the topic of medicalization titled “Too Much Medicine?” two senior officials from the drug company Merck wrote that the rules governing drug advertising should be loosened in Europe to help fix the urgent problem of undertreatment. They claimed there was little good evidence to support the view of Mintzes and others that advertising leads to inappropriate prescribing or harm: “Unfounded fears” about advertising, they wrote, were restricting people’s rights “to have all the information they need to make informed choices about their health.”

One of the weaknesses in this argument is the failure to acknowledge the controversy and uncertainty surrounding the definitions of the common conditions said to be massively underdiagnosed. If estimates of the numbers of people suffering from these conditions and requiring treatment are inflated to start with, as some observers consider to be the case with high cholesterol and depression, for example, then claims of widespread undertreatment deserve to be taken with extra-large doses of scrutiny and skepticism. With PMDD, claims of underdiagnosis and undertreatment make little sense if the condition itself doesn’t even exist.

There is little doubt that many people in genuine need are not getting the medical attention or medication they require, particularly among the poor of wealthy nations and the wider developing world. Whether spending billions advertising disorders like PMDD on television and in women’s magazines is the best way to correct that problem is highly questionable. Undertreatment may often have more to do with lack of money or access than lack of information. And as to the claim that advertising is the best way to inform, educate and encourage more choice, the deputy editor at the Journal of the American Medical Association, Dr. Drummond Rennie, disagrees. “Direct-to-consumer advertising,” he says, “has got nothing to do with the public’s education and it has got absolutely everything to do with…boosting product sales.”

Postscript. In Europe Lilly’s marketing of Sarafem/Prozac came to an abrupt stop. In mid-2003 a panel from the European Agency for the Evaluation of Medicinal Products noted that “PMDD is not a well-established disease entity across Europe…. There was considerable concern that women with less severe premenstrual symptoms might erroneously receive a diagnosis of PMDD resulting in widespread inappropriate short- and long-term use of fluoxetine.”

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