ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
Promoting Openness, Full Disclosure, and Accountability www.ahrp.org
FYI
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
212-595-8974
veracare@ahrp.org
http://www.thenation.com/doc/20051017/moynihan
THE NATION
A Disease for Every Pill
by RAY MOYNIHAN & ALAN CASSELS
[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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