Direct to Consumer Advertising of Prescription Medications by jde13576

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									       Direct to Consumer Advertising of Prescription Medications

                                  By: Elizabeth Garrod

        As our population continues to grow and age, the medical and pharmaceutical
industries are both expanding at an exponential rate. This has led to an increasing
amount of pharmaceutical products available which has produced a market driven by
advertising. The question arises, however, whether it is ethical for pharmaceutical
companies to be advertising to the general public, medications that require a prescription
from a doctor. Can this really be in the best interest of the patients or are the
pharmaceutical companies simply trying to find a way to sell their product and make a
profit without regard for the patients they serve? How truthful or biased are these
advertisements? Can you really present the information needed to make an informed
decision in a 30 to 60 second television commercial or a one page advertisement? It is
my belief that these advertisements are not in the best interest of the public. I intend to
show that these advertisements can lead to a situation where a patient is self-diagnosing
or being taught to overreact to normal everyday symptoms and this can lead to a negative
outcome which is not in their best interest. I will put forth the argument that advertising
compromises a patient’s autonomy through manipulation.
        In recent years I have noticed an increasing amount of advertisements for
prescription medications. These ads appear in magazines, on television, at the movies
and even in the stall of the ladies washroom. Pharmaceutical advertisements have always
caught my attention since I have a long standing interest in medications and the field of
pharmacy. Prior to pharmacy school, I looked at advertisements as a way to research and
learn more about medications to further my own education but not as a consumer in the
general public. After expanding my knowledge through two years of pharmacy school, I
began to look at these ads differently. Direct to consumer (DTC) advertising can be quite
confusing to the general public. The layperson doesn’t have the background on
prescription medications to make an informed decision and I believe that not all ads
accurately depict the uses, advantages and disadvantages of these medications. The
public may feel that these ad help to educate them and help them to make informed
decisions, thereby enhancing their autonomy. However, there is a price to be paid if a
patient makes the wrong decision and for self-diagnosis.
        There is a delicate balance between all the players involved in DTC advertising.
The pharmaceutical companies have the right to free speech but should also have an
obligation to protect the public from adverse outcomes. The FDA has the power to
regulate medications, and therefore, the advertising of those medications and to protect
the public by ensuring that prescription drug information is truthful, balanced, and
accurately communicated. Pharmacists, as the gatekeeper to medications, have the
responsibility to provide patients with necessary medications but also to protect their
patients from harm. These roles are all intertwined with the patients’ right to assert
autonomy.
      Prescription drugs are a huge commodity and, in a capitalist society,
pharmaceutical companies will try to maximize profits any way they can. The recent

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trend is DTC advertising. In this type of marketing, the pharmaceutical company
advertises directly to the general public. However, there is no way to mass market an
advertisement to a specific population of people so these ads and messages are seen by
most of the general population. The two most widely used forms of DTC marketing are
achieved via television ads and print ads such as those in popular magazines. Since the
mid-1990s, pharmaceutical companies have tripled the amount of money they spend on
DTC advertising. Dr. Sidney M. Wolfe, of the Public Citizen Health Research Group in
Washington, DC points out that one study found that a substantial proportion of people
mistakenly believe that the FDA reviews all ads before they are released and allows only
the safest and most effective drugs to be promoted directly to the public. Although a ban
on direct-to-consumer advertising would be unconstitutional, Wolfe urges the FDA to
increase its control over such ads. 1,2
        To understand this topic more fully, I first need to establish how the FDA
currently regulates these ads, exactly what the FDA has power over and the different
types of advertisements. The Food and Drug Administration (FDA) regulates the
promotion of prescription drugs, including the content of DTC advertisements, under the
authority of the Federal Food, Drug and Cosmetic Act (FFDCA) through the Division of
Drug Marketing, Advertising, and Communications (DDMAC).                These regulations
require that pharmaceutical companies put forth accurate information and fairly represent
both the benefits and the risks of the drug being advertised. Under these regulations,
pharmaceutical companies are required to submit all drug advertisements to the FDA
when these ads are first disseminated to the public, through television broadcast or
written publication, however they are distributed. 3 One downside to these regulations is
that the FDA cannot generally require that prescription drug advertisements be reviewed
and approved prior to their publication. Any prior FDA review of advertisements
happens only within very narrow circumstances, for example, in the case of products
receiving accelerated approvals. Essentially, the FDA review of DTC advertising only
happens once the materials have appeared in public. Along the same lines, any
enforcement actions for advertising violations are generally intended to be taken post hoc
as well. The most common requests that the FDA will make are that the sponsors stop
using the material in question. This means that even if an ad was deemed to be biased,
many consumers will have already seen the ad and been influenced by it.4
        There are three different types of ads that product pharmaceutical companies use
to communicate with consumers and the FDA regulates two of them: “product-claim”
and “reminder” ads. The third type is called a “help-seeking” ad which is not regulated by
the FDA. Product-claim ads are those ads which generally include the name of a product
and its use, or make a claim or representation about a prescription drug. Any claims of
drug benefits, such as safety and effectiveness, must be balanced with relevant
disclosures of risks and limitations of efficacy. For product-claim print ads, the
pharmaceutical sponsor must provide a brief summary of risk information like that
included in the product’s FDA-approved labelling and for broadcast product-claim ads,
sponsors must provide convenient access to the approved labelling. Reminder ads are ads
that may disclose the name of the product and certain specific descriptive information
such as dosage form or price information, but they are not allowed to give the product’s
indication or to make any claims or representations about the product. These types of ads
are specifically not allowed for products with black box warnings in their labelling.
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Help-seeking ads discuss a disease or condition and advise the audience to “see your
doctor” for possible treatments. They do not need to include any risk information. Since
no drug product is mentioned or implied, this type of ad is not considered to be a
pharmaceutical advertisement and is not regulated by FDA. 4
        Many of the pharmaceutical companies initially started their advertising
campaigns with print ads. These ads typically included a promotional message together
with the brief summary of adverse effects. In the 1990s, product sponsors also started
using television advertisements in a limited fashion. Television advertisements were
limited due to the extensive disclosure required to fulfill the brief summary requirement
and the FDA and pharmaceutical companies did not believe that it was feasible to
disseminate the product’s approved labelling in this format. By the mid-1990s, sponsors
were placing reminder ads on television since these ads are not required to include the
brief summary. Some of these ads were confusing to consumers who were not
knowledgeable about the name and use for these products. In August 1997, the FDA
issued a draft guidance entitled, “Guidance for Industry: Consumer-Directed Broadcast
Advertisements” that clarified the Agency’s interpretation of the existing regulations.
This paper described an approach, which is widely used these days, for ensuring that
audiences that are exposed to DTC marketing have convenient access to the advertised
product’s FDA approved labelling. This approach allows for reference in the ad to four
different sources the consumer can use to obtain more detailed labelling information if
they so desire. These sources include a toll-free telephone number, a website address, a
concurrently running print advertisement, and health care professionals. Television ads
have become more common place as a result of this change. Now the pharmaceutical
company only has to balance any claims of drug benefits, such as safety and efficacy,
with a relevant disclosure of risks and limitations of efficacy and instruct the patient on
how to obtain convenient access to the approved labelling. 4
        Since these regulation changes, DTC advertising has skyrocketed and,
consequently, so has the amount of money that pharmaceutical companies spend on
advertising. Pharmaceutical companies have tripled the amount of money they spend on
advertising prescription drugs directly to consumers since the mid-1990’s. 2 So, the
question now arises, is this in the best interests of the public? Previous research by the
FDA and others has documented that accurate DTC prescription drug promotion can lead
to significant increases in detecting under-treated conditions like high blood pressure,
diabetes, and depression, leading to health benefits for Americans. FDA surveys in 1999
and 2002 showed that DTC advertising encouraged substantial numbers of patients to ask
a doctor about a medical condition or illness that they had not talked to a doctor about
before. 4 It is obvious that DTC advertising has is benefits but at the same time, it has is
detractions as well.
        Diseases such as hypertension and diabetes have high morbidity and mortality
associations. Educating patients on the signs and symptoms of these diseases and the
risks associated with failing to control these diseases is important. In the case of these
diseases, help-seeking ads seem appropriate. However, television advertisements
promoting specific drugs as a remedy seem inappropriate. I recently viewed an
advertisement for Toprol XL. It showed many different patients being examined by their
doctors and talking about their hypertension. These patients went on to say that they only

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take their blood pressure medication when they feel like it because they don’t feel sick.
The doctor went on to say that maybe Toprol XL was for them. This was a perfect
opportunity to educate television viewers that hypertension is a silent killer and that they
may not feel ill due to hypertension and, therefore, may not feel much different when
they take their medication but that lowering their blood pressure reduces their chances of
having a heart attack or stroke. The advertisement then went on to say in a lower, faster
voice that Toprol XL is “not for everyone” and named of a host of conditions as you see
the patients in the background smiling because they are now taking their Toprol XL.
This advertisement had the opportunity to educate but falls short. Instead, it promotes a
brand name medication whose advantages consist of once daily dosing which is
wonderful for those who have compliance issues. However, generic metoprolol used
twice daily will work just as well for most people and can save patients and insurance
companies money. Now, though, patients have Toprol XL stuck in their head like a
jingle.
        Advertisements for drugs used to treat hypertension, diabetes and cholesterol
appear to have a place in society as they open the lines of communication. Encouraging
patients to go their doctors regularly and to be tested for these conditions is very
important. There is no questioning whether or not someone has one of these conditions
because the diagnosis is based on objective data. Where this line becomes a bit more
blurry is when pharmaceutical companies begin advertising drugs used for depression
and other psychiatric diseases. What I find to be even more disturbing is the extended
spectrum of labelled uses for anti-depressants and the recent increases in the sale of these
medications. A paper by Janet Currie called “The Marketization of Depression:
Prescribing SSRI Antidepressants to Women” examines this phenomenon.
        This paper outlines the dramatic increase in the amount of SSRI antidepressants
being prescribed, especially to women, the lack of non-pharmacologic therapy being used
and the consequences of these actions. In 2003, Canadians spent fifteen billion dollars on
prescription drugs which is an increase of 14.5% over 2002 figures. Psychotropic drugs
were the driving factor behind this increase with SSRIs as the major drug in the
psychotropic drug class. To what degree are these enormous prescription drug
expenditures appropriate or sustainable? As well, why aren’t proven non-pharmacologic
alternatives such as exercise, social support, psychotherapy, and nutritional
improvements, being supported, funded and prioritized by the government? Between
1981 and 2000, total prescriptions for all antidepressants increased by 353% from 3.2
to14.5 million.5
        In the past 15 years, the prevalence of depression appears to have soared.
According to the World Health Organization, depression is projected to be the world’s
second most debilitating disease by 2020. This dramatic increase in depression rates
raises some important questions. Is depression that is serious enough to require treatment
with psychiatric drugs actually on the rise in the general population, or are there other
factors at play? Before SSRIs were introduced, depression was thought to affect only
100 people per million. Now prevalence rates for depression are considered to be in the
range of 50,000 to 100,000 cases per million (a 500 to 1,000 fold increase). 5
        One controversy Currie addresses is the idea that there is no scientific evidence
that a serotonin imbalance exists in people who are depressed or that they need serotonin

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drugs to operate normally. Granted, there are not many disease states where the
mechanism of action of an effective drug has been scientifically proven. However, I do
agree with Currie that it is disheartening that the number of prescriptions for a drug
whose mechanism of action is unproven and, whose diagnosis alone can be called
subjective at best, is growing in exponential terms. Patients who suffer from clinical
depression certainly need psychiatric counselling and possibly medication but it seems
that medication has come to replace, not augment, psychological counselling.
Pharmaceutical companies seem to not only be marketing their drug but the disease of
depression, as well. Advertisements often provide vague symptoms of depression that
almost any one can relate to. In addition, many patients are going to be seeing a family
physician and not a psychiatrist to request these medications, and so the physician may
not be familiar with the DSM-IV criteria for a specific disorder and, therefore, be more
likely to follow simple questionnaire criteria they have received from pharmaceutical
representatives. 5
         It appears that pharmaceutical companies are shaping and defining what the
public perceives as depression and what needs to be treated. Why would the companies
want to redefine the symptoms of a disorder? Pharmaceutical companies know that if
they market a drug with a broad range of symptoms, patients will see themselves in the
advertisement and possibly ask their physician for a prescription. Not just any
prescription, however, the brand name medication they saw on television. Consequently,
if a patient is subjected to biased DTC advertising, that patient will not be able to increase
their autonomy. In order for a patient to assert total autonomy over their medication
choices, there would have to be an equal amount of requests for different brands of
medication within the same class. However, patient requests will lean towards those
brands that they see advertised. It is in this way that pharmaceutical companies are
controlling the public through DTC advertising, thereby, manipulating the autonomy of
the patient.
         A randomized clinical control trial by Kravitz et al., conducted in 2003-2004,
aimed to ascertain the effects of patients’ DTC advertising related requests on physicians’
initial treatment decisions in patients with depressive symptoms. In this study, Kravitz
hired female actors to mimic different forms of depression and to make various requests
of physicians during unscheduled visits. When mock patients made a general request for
drugs, saying they had seen a TV segment on depression, the pretend patients left the
office with a prescription for their feigned condition 76 per cent of the time. When they
asked for the heavily advertised antidepressant Paxil by name, they were prescribed that
specific drug 53 per cent of the time. And when the mock patients made no request for
drugs, they were nonetheless prescribed an antidepressant 31 per cent of the time.
Although this study did not address the impact of DTC advertising on consumer
awareness or care seeking, this study supplies direct experimental evidence that DTC
advertising driven requests dramatically boost prescribing. 6
       In recent years, antidepressant medications have been approved for an even more
broad range of disorders. To expand market share and maximize profits, drug companies
have extended their scope outwards to include a variety of specific new disorders related
to depression and anxiety. With the development of new disorders, such as social anxiety
disorder, panic disorder, premenstrual dysphoric disorder and generalized anxiety

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disorder, pharmaceutical companies are also able to extend patent protection for specific
SSRIs. Again, the criteria for these medications are presented to the public as general list
of subjective feelings that most people have at one time or another. 5
        To gage the perspectives of various populations regarding the controversy
surrounding DTC advertising, I distributed surveys to students at the Eugene Applebaum
School of Pharmacy and Health Sciences and employees of Shoppers Drug Mart. Sixty-
three percent of subjects were female and 37% male. Sixty-four percent were between
the ages of 18 and 30, 6% between 31 and 40 years old, 17% between 41 and 50 years
old, 8% between 51 and 60 years old and 5% did not indicate their age. Of those
surveyed, 58% were third-year pharmacy students, 7% were second-year pharmacy
students, 5% were first-year pharmacy students, 3% were fourth-year pharmacy students,
6% were pharmacy technicians, 6% were pharmacists, 11% did not answer this question
and 14% were other occupations including post office clerks, sales clerks and registered
nurses. The first section of the survey consisted of general questions related to DTC
advertising and the second section contained specific questions about a specific drug
advertisement that I attached to the questionnaire.
        The advertisement I chose for respondents to look at was a Zoloft® ad from US
magazine. The ad consists of a short story showing “Cynthia”, a cartoon ball, sitting in
the shadow by a window. As the frames goes by, it explains that Cynthia felt scared,
relieved and sad all at the same time after her divorce from Tom but that the sadness had
stayed with her. She says her life seems pointless and lost and that she has felt this way
for a long time. She then goes to see her doctor, who is another cartoon ball, who
explains that her physical health was fine but that she was suffering from depression.
The doctor tells her that Zoloft® has helped millions of people like her and is the number
one prescribed brand for depression and anxiety. We then see Cynthia in a park, smiling
and hanging out with other cartoon balls with birds singing. I chose this ad because of
the increasing incidence in the prescribing of SSRI antidepressants and I was curious as
to others opinions on this subject. The results of this survey are summarized in Table 1
on the following pages.
Table 1
1. From a moral perspective, do you think it is acceptable for a drug company to
advertise directly to consumers (via television, radio ads etc.) for medications that you
need a prescription from your doctor to obtain?
Yes (36%)                                      No (64%)
If you answered Yes, please indicate why
a) We live in a democratic society and have the right to make 13%
our own decisions
b) I might suffer from a condition and not know about it, but 38%
now I know and I know what I can do about it
c) The drug companies have a right to try and make a profit         0%
Other and those who did not answer:                                 50%


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Lets the consumer know they can get help from their doctor
Informs patients about different drugs and problems
Increases awareness
Starts conversation with doctors
If you answered No, please indicate why
a) The ad may be misleading either about drug information or 28%
symptoms of the condition
b) Physicians are the only people qualified to make a decision 10%
regarding prescription only medication
c) Due to the possibility of drug interactions and other 41%
conditions, patients should always get their drug information
from a physician or pharmacist
Other and those who did not answer:                               21%
Creates a market for a drug not needed – enough
hypochondriacs
Generates a demand for a controlled substance
Pushes the doctor to prescribe
If you answered No, would you change your mind if the advertisement were something
the patient had to find for themselves (i.e. a drug company website) as opposed to in a
magazine or television ad?
Yes 45%                                       No 55%
2. Do you think that most drug advertisements are misleading?
Yes 61%                                       No 39%
If you answered Yes, do you think drug companies do this on purpose?
Yes 86%                                       No 14%



Table 1 continued
3. Do you think that patients will go to their physician with the specific reason to get a
prescription for a medication that they have seen advertised?
Yes 94%                                       No 6%
4. Do you think drug companies have the right to advertise their medications directly to
the public?
Yes 78%                                       No 22%
5. Do you think there are any specific drug classes or medications that should NOT be

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allowed to be advertised to the public?
Yes 64%                                        No 36%
If Yes, please specify:
There was a wide range with the most votes going to Plan B, birth control pills and
antidepressants and a few votes for no acceptable drugs to be advertised
The following questions relate to the Zoloft advertisement
1. Did you know what this drug was for before you saw this advertisement?
Yes 83%                                        No 17%
2. I think this ad accurately describes depression.
Strongly       Agree           Somewhat        Unsure        Disagree       Strongly
agree                          agree                                        disagree
               8%                              8%            33%
4%                             33%                                          14%
3. I think this ad provides the patient with all the important information they need to
know about this drug.
Strongly       Agree           Somewhat        Unsure        Disagree       Strongly
agree                          agree                                        disagree
               8%                              8%            53%
0%                             14%                                          17%
4. I think this ad sufficiently explains the risks and potential side effects of this
medication.
Strongly       Agree           Somewhat        Unsure        Disagree       Strongly
agree                          agree                                        disagree
               16%                             11%           28%
0%                             28%                                          17%
5. I think the drug company is misleading the public with this ad.
Strongly       Agree           Somewhat        Unsure        Disagree       Strongly
agree                          agree                                        disagree
               17%                             8%            28%
11%                            28%                                          8%
6. I think the use of cartoon characters is inappropriate.
Strongly       Agree           Somewhat        Unsure        Disagree       Strongly
agree                          agree                                        disagree
               17%                             10%           35%
17%                            17%                                          4%
7. I think this ad might encourage those who need help with depression to talk to their
doctor or pharmacist.
Strongly       Agree           Somewhat        Unsure        Disagree       Strongly
agree                          agree                                        disagree
               47%                             17%           0%
5%                             28%                                          3%

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        The majority of those surveyed believed that it is not morally acceptable for
pharmaceutical companies to advertise directly to consumers. The main reason cited was
that there is the possibility of drug interactions and other co-morbid conditions that
require the input of a doctor or pharmacist. This helped to reaffirm my belief that
pharmacists are vital to the healthcare and the general well being of the public. I also
asked if those who believed it was not morally acceptable to promote prescription
medications whether their opinion would change if the advertisement were something
that the public wasn’t randomly exposed to but, rather some material the consumer had to
actively seek. This question was quite close with 45% saying no and 55% saying yes.
        Most people surveyed believed that most drug advertisements are misleading. Of
those who thought most ads are misleading, the majority believed that the pharmaceutical
companies do this on purpose. If pharmaceutical companies are purposely making biased
ads, they are stripping away the patients’ autonomy and possibly, their ability to make an
informed choice. Since most people believed that ads were biased, hopefully, patients
will be skeptical and see any biased ads for what they are and protect their autonomy.
        When asked whether they think patients will go to their physician with the
specific reason to get a prescription for a medication that have seen advertised, 94% of
those surveyed said yes. This is confirmed by studies that show patients are going to
their doctors to get medication they have seen advertised such as the 2002 FDA
sponsored survey. According to the FDA survey, primary care physicians were more
likely to receive requests for prescription medication than specialists and primary care
physicians granted a request for a brand name prescription medication 65% of the times
they were requested. 7
        In contrast to the first question regarding the morality of DTC advertising, the
majority of those surveyed believe that the drug companies have the right to advertise to
the public. Essentially, the majority of people I surveyed believe it is unethical for the
pharmaceutical companies to advertise but at the same time, agree that they do have that
right under the constitution. When asked whether there were specific classes of
medication that should not be advertised, the majority of people surveyed said yes. There
was a wide range of drugs that were listed but the most votes went to Plan B, birth
control pills and antidepressants.
       With regards to the Zoloft advertisement, most people surveyed knew what the
drug was for before seeing the ad. Those surveyed were split down the middle with
regards to whether the ad accurately describes depression. Thirty-three percent
somewhat agreed whereas 33% disagreed. Only 53% of those surveyed thought that the
ad provided a patient with all of the information they needed to know about Zoloft.
Again, survey takers were split as to whether the ad sufficiently explained the risks and
potential side effects of Zoloft with 28% somewhat agreeing and 28% disagreeing. With
regards to whether the makers of Zoloft were trying to mislead the public with this ad,
28% somewhat agreed and 28% disagreed.



                                                                             Page 9 of 11
        One thing that struck me as suspicious about this ad was the use of a cartoon ball
character. I decided to ask the question concerning whether the use of a cartoon character
was inappropriate. Fifty-one percent of respondents answered with any of the choices
available to agree, 39% disagreed and 10% were undecided. The majority of survey
takers agreed that this ad might encourage those who need help with depression to talk to
their doctor or pharmacist.
       Any study will have limitations and mine is certainly no exception. The majority
of those surveyed were female and between the ages of 18 and 31. Most people were
third year pharmacy students. Those that weren’t, were most likely to work in a
pharmacy. Unfortunately for my survey, the population I distributed the survey out to
was not characteristic of the general population but rather those I have the most access to.
If more males and more people outside of the pharmacy community were surveyed, there
might have been drastically different answers
        Despite the conflicting answers for some of the questions, the overall consensus
for my survey was that while people might see DTC advertising as unethical, they agree
that the companies have the right to do so. Many feel that most advertisements are rather
biased and misleading. Herein lies the problem. DTC advertising may be federally
regulated but many people can still be objected to biased misinformation due to the fact
that these ads are not usually viewed by the DDMAC until after the information is
disseminated to the public. As stated before, if a patient is subjected to DTC advertising
that has been presented in a biased manner; this patient cannot increase their autonomy.
Pharmaceutical companies have the legal right to advertise and will not withdraw that
right. The solution to this problem seems to be possibly tighter control by the DDMAC
such as pre-screening of DTC advertising. This would require extensive manpower and
seems unlikely to occur. Another possibility is that pharmacists, as professionals, need to
remain unbiased to these advertisements ourselves and instruct and educate our patients
to the best of our ability to protect their autonomy. Many people subjected to DTC
advertising are not versed in medical knowledge and we need to help them to be
skeptically cautious of this advertising and guide them to make sound, informed choices.


                                        References

   1. Bell RA, Kravitz RL, Wilkes MS. Direct-to-Consumer prescription drug
      advertising and the public. J Gen Intern Med. 1999;14:651-657
   2. Wolfe SM. Direct-to-Consumer Advertising – Education or Emotion Promotion.
      NEJM. 2002;346:524-526
   3. United States General Accounting Office. Prescription Drugs: FDA Oversight of
      Direct-to-Consumer Advertising Had Limitations. October 2002. Documents 03-
      177
   4. Statement by Janet Woodcock MD. Director, Center for Drug Evaluation and
      Research Before the Senate Special Committee on Aging. July 22, 2003
   5. Curie J. The Marketization of Depression: Prescribing SSRI Antidepressants to
      Women. Women and Health Protection. May 2005. 1-27

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6. Kravitz RL et al. Influence of Patients’ Requests for Direct-to-Consumer
   Advertised Antidepressants A Randomized Controlled Trial. JAMA. April
   2005;293(16):1995-2436
7. U.S. Department of Health and Human Services Food and Drug Administration
   Center for Drug Evaluation and Research. Patient and Physician Attitudes and
   Behaviours Associated With DTC Promotion of Prescription Drugs – Executive
   Summary of FDA Survey Research Results. November 19, 2004




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