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To address the need for medical and pharmacy professionals to reconsider their central role as a target for pharmaceutical marketing, the World Health Organization (WHO) and Health Action International (HAI) developed a manual, called Understanding and Responding to Pharmaceutical Promotion: A Practical Guide. Direct-to-consumer advertising (DTCA) of prescription medicines through television, radio, magazines, newspapers and billboards is legal in only two countries: New Zealand and the US. In countries with well-enforced laws governing prescription-only status, people who view advertisements for a prescription-only medicine cannot buy the product directly; they must first ask a physician for a prescription. All health professionals face the dilemma of how to respond to patient requests for advertised medicines.
The aim of this chapter is to introduce you to the research evidence on consumer-directed advertising of medicines and the way that promotion targeting the general public affects prescribing decisions. Do patients request advertised medicines from their doctors and do doctors prescribe requested medicines? There is also evidence from the US that advertising affects the choice of medicine that is used.
The research arm of the US Congress, the US General Accounting Office, estimated in 2002 that eight million Americans requested and received medicines in response to DTCA each year, based on consumer surveys (Heinrich, 2002). If a prescription medicine is advertised on television in New Zealand or the US, the viewer cannot simply go to the store and buy it, as they might buy an advertised pair of shoes or a soft drink. Two prospective studies in doctors? offices have compared consultations in which patients requested advertised medicines with consultations in which they did not.
In the first study, patients filled in a questionnaire in the waiting room, which was matched with a physician questionnaire following the consultation.
In the second study, the ?standardised patients? made nearly 300 unannounced visits to family doctors in three cities (Kravitz, 2005). The doctors prescribed antidepressants in just over half of the visits in which Paxil was requested for both clinical depression and adjustment disorder. In this study, those with a depression diagnosis were also more likely to receive standard follow-up care (i.e.
These studies suggest that advertising affects prescribing, both because doctors sometimes prescribe and pharmacists provide medicines they might not prescribe otherwise, and because if a patient asks for a medicine, the doctor is likely to prescribe it. In many countries, including both those where DTCA is and is not allowed, companies sometimes run unbranded disease awareness or ?help-seeking? promotional campaigns.
In the Netherlands, Novartis, manufacturer of the antifungal medicine Lamisil (terbinafine) ran a televised advertising campaign about toenail fungus in 2000 and 2001. The authors of this study raised concerns about the effects of these advertisements on the workload of family doctors. In an earlier US study, Basara (1996) also found that an unbranded advertising campaign for Imitrex (sumatriptan) a migraine medicine, led to more prescriptions.
Since 2005, Australian disease awareness advertisements can legally direct viewers to branded Internet advertising. World Health Organization staff raised concerns in a letter to the UK journal The Lancet about a disease awareness advertising campaign in France promoting cholesterol testing, by the manufacturer of a leading brand, Lipitor (atorvastatin) (Quick, 2003). Advertised medicines are mainly new, expensive treatments for regular or intermittent long-term use among large population groups.
One of the main claims made for medicines? advertising is that it informs the public about the newest available medicines. Of the four other medicines in Table 1, three have been subject to safety advisories, and one, Zelnorm (tegaserod) was withdrawn from the US market in March 2007 due to increased risks of heart attack, angina and stroke (US FDA, 2007).
The choice to intensively advertise a specific brand is a marketing decision, based on the likely return on investment (Arnold, 2005). There is some evidence that people who are exposed to more advertising for medicines for conditions that are affected by lifestyle are less likely to pursue healthy activities. Between 1999 and 2004, one of the most heavily advertised medicines was Vioxx (rofecoxib), an arthritis treatment.
On the basis of clinical trial findings and population patterns of use, senior US Food and Drug Administration (FDA) official David Graham estimated that between 88,000 and 140,000 extra heart attacks in the US were due to the use of Vioxx (rofecoxib) (Graham, 2005).
Although Vioxx (rofecoxib) is the highest profile medicine to feature in DTCA and later be withdrawn for safety reasons, it was not the first or the last. Advertising campaigns are usually most intensive in the first few years of a medicine?s marketing life. There is good reason to be cautious in prescribing or using a new medicine when an acceptable treatment is already available. How well does advertising inform the public about medicines? benefits, risks and contribution to therapy? This is an advertisement for the sleeping pill Ambien CR (zolpidem), offering a free trial of the medicine, which is, in fact, a drug of dependency.
Another study of US magazine advertisements appearing in ten consumer magazines over a one-year period found that nearly 9 out of 10 ?described the benefits of a medication in vague, qualitative terms? and failed to provide any evidence to support claims (Woloshin, 2001). In two national US FDA surveys of public attitudes and responses to advertising, more than a quarter of consumers thought that only the safest medicines could be advertised to the public (Aikin, 2004).
Whether it occurs in an environment where advertising of prescription medicines is legal or in the form of unbranded promotional messages where advertising is illegal, certain messages ? and certain omissions ? can be expected from pharmaceutical advertising.
Where people see pharmaceutical advertisements on television each day, they hear the message repeatedly to ?ask your doctor? for a new medicine that may help you.
The messages in advertising are sometimes inconsistent with a doctor?s recommendations for treatment.
Another New Zealand physician, responding to the same survey, believes that sometimes advertising can lead to frustrations and other times it can result in a useful discussion: Although I always resist DTCA generated requests to initiate or change medications, these patients simply go to another practitioner (in the same practice!), who gives them anything they ask for. If a patient is convinced that an advertised medicine may help him or her, especially with a problem that has been difficult to treat, it can be tempting to simply ?give it a try?. It is important to remember that some medicines are classified as prescription-only because they have greater potential for harm than other medicines. When advertisements blur the line between normal life and a medical problem needing treatment this is called medicalisation or disease mongering (Moynihan, 2002).
Shifting the conversation back to the patient and the problem they are experiencing is a good technique for dealing with patient requests for advertised medicines. Advertising of medicines directly to consumers strikes at the heart of interactions between patients and health professionals. This is a consultation in which a woman in her mid-twenties presents and requests (forcefully) that you prescribe a new weight loss pill for her. The medicine requested, like many slimming pills, is known to raise blood pressure and pulse in some people, and has been associated with strokes and one or two unexplained deaths and unusual psychiatric symptoms.
Compare the information in this advertisement to an independent assessment of donepezil and of medicines for Alzheimer?s disease. Over 900,000 critically needed healthcare services are provided at MFH projects on an annual basis.
Our MissionMedicines for Humanity is a non-profit organization dedicated to saving the lives of children in impoverished communities worldwide. Sister Meyer, a Sister of the Presentation of the Blessed Virgin Mary, served for many years as executive director of the Conrad N.
Antipsychotics are medicines that are mainly used to treat schizophrenia or mania caused by bipolar disorder.
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The term Alternative Medicine means a system which is not generally considered a part of conventional medicine. Clipping is a handy way to collect and organize the most important slides from a presentation. This nine-chapter book helps health professionals-in-training learn how to recognise and respond to pharmaceutical promotion before they start prescribing and dispensing medicines.
In countries that do not allow advertising of prescription medicines, however, other forms of direct and indirect promotion to the public often occur.
In lower-income countries, prescription-only status is often poorly enforced, and a person can generally buy any medicine directly without first seeing a doctor.
Patient requests are sometimes based on inaccurate beliefs about a medicine's effects or appropriateness for their own situation. The chapter also provides some guidance on ways to respond to patient requests for advertised medicines. Research from both New Zealand and the US suggests that advertising of medicines does affect prescribing and use.
For example, a US analysis of a large administrative database of prescriptions found that more patients began use of an advertised brand of proton pump inhibitor (a medicine for gastric reflux and ulcers) than a similarly effective non-advertised brand when advertising levels were high and when their insurance plan covered most of the cost of their medicines (Hansen, 2005). One was a comparison between patients of family doctors in Sacramento, US, where DTCA is legal, and Vancouver, Canada, where DTCA is illegal but there is some cross-border exposure from the US (Mintzes, 2003). The physicians reported on all new prescriptions they had provided and any that the patient had requested. In other words, if a patient requested this antidepressant, physicians were equally likely to provide an antidepressant prescription whether or not the patient had depression, the condition the medicine has been tested for and is approved to treat. This is consistent with other research showing that even in the absence of advertising, doctors are more likely to prescribe a medicine if they believe the patient wants one (Britten, 1997; Cockburn, 1997).
These discuss symptoms of a condition and suggest that viewers or readers ?ask your doctor? about a new treatment. The brand name was not mentioned, but the commercials strongly suggested asking your doctor for treatment for toenail fungus. They felt that the time spent with patients with this minor and mainly cosmetic condition took time away from patients with more serious health problems. These analyses show that even when a brand name is not mentioned, companies can successfully promote sales of a prescription medicine through advertising that tells the public to go to their doctor to seek treatment.
This provision was introduced within a bilateral trade agreement with the US (Australian Govt., DFAT, 2006). There is evidence of greater risks of rhabdomyolysis, a muscle-wasting disorder, with Crestor (rosuvastatin) than other medicines in the class (Public Citizen, 2003).


Iizuka and Zhe Jin (2005) compared results of a national US health survey with advertising spending for medicines for diabetes, high cholesterol, obesity and hypertension. The medicine?s manufacturer, Merck, spent more than US$550 million advertising this product to the US public (Topol, 2004).
Merck?s intensive advertising of this medicine is controversial not only because of the evidence of serious harm, but because the first major study to show an increased risk of heart attacks, the VIGOR trial, was published in late 2000, four years before advertising stopped (Bombardier, 2000). Other examples include the cholesterol-lowering medicine Baycol (cerivastatin), the diabetes medicine Rezulin (troglitazone) and the irritable bowel syndrome medicine for women Zelnorm (tegaserod). In 2000, US researchers published an analysis of more than 300 magazine advertisements published over ten years for the presence or absence of key information needed for informed treatment choice (Bell, 2000). Nearly one-quarter offered financial incentives to use the medicine, such as free trial offers.
Nearly one-third of total US retail prescription medicine costs went toward these 50 brands, or US$41 billion. In a California survey, 4 out of 10 people thought only completely safe medicines could be advertised on television (Bell, 1999). The main messages are that a person?s problem is likely to be serious and that a new medicine exists that can help. They also get the message, again and again, that a medicine may be a solution to their problems. I spend a great deal of time explaining the evidence-based option, the non-drug-based options and the options that will lead to better outcomes at lower doses.
This is the path of least resistance: The patient has what he or she wants, the health professional has listened and has appeared to be helpful. Some patients may request an advertised medicine when they do not have a health problem requiring treatment. It is important to discuss the range of treatments available and how this advertised medicine compares to others as well as the outcome with no treatment. A person who asks for an advertised medicine may be much more skeptical of other forms of consumer advertising. At its worst, it turns the patient-doctor or patient-pharmacist relationship into a ?health consumer-provider? interaction, the means to obtain a desired brand. She has read about this amazing breakthrough product in a magazine and also watched it discussed on television. Despite having been on the market for less than three years, it has been prescribed to many hundreds of thousands of patients worldwide and the manufacturers steadfastly claim it is safe. List the main messages in the advertisement.What is implied about beneficial and harmful effects? How does the message in the advertisement compare with this evaluation of the clinical trial evidence on its effects? Hilton Fund for Sisters, a grant making organization supporting the works of Catholic sisters globally.
There are two main types of antipsychotics: atypical antipsychotics and older antipsychotics. The following article is Chapter 5 from the manual, which can be downloaded in its entirety from the HAI website. These include industry- sponsored disease awareness campaigns, patient compliance and disease management programmes, promotional material on the Internet and sponsored television ?infomercials?.
In these countries, it is pharmacists who are likely to be most affected by patient requests for advertised medicines. Figure 1 shows the rates of prescribing for two types of asthma inhalers before and after a DTCA campaign for one of the inhalers, Flixotide (fluticasone). This study suggests that when consumers are not paying directly for their medicines they are especially likely to be influenced by advertising.
In other words, advertising of medicines does lead directly to patient requests that result in increased prescription rates and rates of use. However, prescriptions are medical treatments with inherent dangers, not consumer products, and doctors are legally responsible for the prescriptions they provide. The other was an experimental study that compared consultations in which actresses pretending to be patients (?standardised patients?) did and did not request an advertised medicine (Kravitz, 2005). US patients and those with more self-reported exposure to DTCA were more likely to request an advertised medicine. The ?patients? either described symptoms of clinical depression or of an ?adjustment disorder? - a normal response to a stressful life problem, moving to a new city and being unemployed. An analysis of effects on consultations and prescribing was carried out in a Dutch primary care research database covering 150 physicians? practices and more than 470,000 patients (?t Jong, 2004).
As of mid-2007, the effect of this change on attitudes to medicines, medicine use, health or costs has not been studied. What is debatable is whether promoting widespread use of these newest medicines is beneficial. Cialis (tadalafil) and Levitra (vardenafil) are similar to Viagra (sildenafil) and all can cause visual abnormalities (US FDA, 2005).
In these examples, prescriptions stimulated by intensive advertising may not be the best answer for individual patients, either because a more cost-effective or safer alternative exists or because a non-drug solution might be a better option, especially for mild problems. They found that when there was more advertising for medicines for these conditions, people were less likely to report that they had regular, moderate exercise.
In 2000, more was spent on advertisements for Vioxx (rofecoxib) than on Pepsi-Cola advertisements (Findlay, 2001). An analysis of all medicines approved in the US between 1975 and 1999 found that half of medicine safety withdrawals occurred within the first two years a medicine was marketed (Lasser, 2002). Frosch and colleagues? (2007) content analysis of television advertising in the US found that more than half ? 58% ? presented the medicine as a breakthrough. In a survey of 263 older Americans in the state of Kansas, many of whom were low-income, nearly half said that they would phone a number listed in an advertisement if a discount coupon or free sample was offered (Marinac, 2004). These same medicines were responsible for more than half of the increase in retail spending between 1999 and 2000 (Findlay, 2001). Even if a person does not consciously think that there is ?a pill for every ill?, seeing the message every day can lead to a shift in their understanding of medicines. The patient?s request may be based on incomplete and misleading information and a misunderstanding of the likely effectiveness and safety of the medicine or how it compares to alternatives.
Not long afterwards, a systematic review of studies of long-acting ?-agonist showed an increase in asthma mortality (Salpeter, 2006). Apparently it has only been available in this country for a few months and some of her friends say it is great. Short-term studies of efficacy in obese patients show a modest improvement of a few kilos over diet and exercise alone after several months of treatment.
Go back to your list of positive and negative aspects of the advertising message:Having seen an evaluation of the scientific evidence on the medicine?s effects, do you have any additional comments?How accurately does this advertisement convey that evidence? The impact of a direct-to-consumer prescription medication advertising campaign on new prescription volume. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. Direct-to-consumer prescription drug advertising builds bridges between patients and physicians.
The presentation was made during the annual MFH Humanitarian Awards Dinner held at the Harvard Club in Boston. Her experience includes five years in Zambia as a missionary and as executive director for the Zambia Association of Sisterhoods. Medical diagnosis enables the physician to attach a pre-determined disease classification to the set of symptoms presented by the patient.
Since the 1990s, pharmaceutical manufacturers have increasingly begun to promote their medicines directly to the public. Some countries allow unbranded advertising campaigns that prompt consumers to ?ask your doctor? for a new treatment.
The graph shows that many patients who had been prescribed beclamethasone switched to fluticasone. For each condition, the ?patient? either asked for a prescription for the antidepressant Paxil (paroxetine), which was advertised on television, for an antidepressant in general, or did not request a medicine. The ?adjustment disorder? scenario was a normal response to a stressful life event; it should not have been treated with a medicine. They were less likely to receive this level of care, which involved repeat visits and either pharmacotherapy or psychotherapy, if they did not ask for a medicine. As shown in the graph, the prescribing rate for this medicine doubled after the campaign started. This is consistent with a content analysis of US television advertising, which found that none of the advertisements portrayed lifestyle change as an alternative to taking the product and 18% conveyed the message that lifestyle change was insufficient (Frosch, 2007). In total, one in five new medicines received ?black box? safety warnings or was withdrawn because of serious risks. The authors did not examine the accuracy, completeness or relevance of information that was provided, only whether it was present or absent. In contrast, without the mention of a discount, only 1 in 9 believed they would make the phone call. These survey findings suggest that a considerable minority of people mistakenly believe that they are better protected by regulation than is the case. In some cases, doing what patients want may mean providing them with inferior care ? an unnecessarily risky treatment.
Where it is available, direct patients to reliable information sources (see Chapter 8 for additional information).
In many countries, there is strong pressure from the pharmaceutical and advertising industries and media to introduce DTCA of prescription medicines. The patient has a body mass index (BMI) of 28 and is very keen to reduce her weight for an upcoming social function (she is getting married in six weeks and wishes to go down two dress sizes to fit into her mother?s wedding dress).


The influence of patients? hopes of receiving a prescription on doctors? perceptions and the decision to prescribe: a questionnaire survey. Prescribing behaviour in clinical practice: Patients? expectations and doctors? perceptions of patients? expectations ? a questionnaire study.
Creating demand for prescription drugs: a content analysis of television direct-to-consumer advertising.
Risk of acute myocardial infarction and sudden cardiac death in patients treated with cyclo-oxygenase 2 selective and non-selective non-steroidal anti-inflammatory drugs: nested case-control study. The association of consumer cost-sharing and direct-to-consumer advertising with prescription drugs.
Marketing in the lay media and prescriptions of terbinafine in primary care: Dutch cohort study. Influence of patients? requests for direct-to-consumer advertised antidepressants: a randomised controlled trial. Meta-analysis: Effect of long-acting beta-agonists on severe asthma exacerbations and asthma-related deaths. Direct-to-consumer advertising of prescription drugs in New Zealand: For health or for profit. Pulse versus continuous terbinafine for onychomycosis: A randomized, double-blind, controlled trial. Direct to consumer advertising - Is at the crossroads of competing pressures from industry and health needs.
Following her time in Africa, Sister Meyer served as president of the board of the Presentation Health System based in Sioux Falls, South Dakota, and on the sponsorship committee of the Catholic Health Association of the U.S.
This makes medical treatment relatively easy because patients can be prescribed drugs according to symptoms which will enslave him to life-long dependence. This marketing has been shown to lead to more prescriptions and therefore more sales of medicines (Gilbody, 2005). Disguised promotion, in the form of promotional press and video news releases and resultant news coverage, is also common.
Although these were actors, the study raises strong concerns about the negative effects of DTCA on prescribing quality. However, after controlling for whether or not they received a prescription, there was no difference in whether ?patients? with adjustment disorder or depression received follow-up care (Epstein, 2007).
In a large randomised, controlled trial, only 25% of patients were completely cured at 18 months (Warshaw, 2005). Companies spent more than US$800 million advertising just five medicines to the US public in 2004 (see Table 1).
It was withdrawn from the market in 2004 when it was found to increase the risk of heart attacks and strokes. The WHO Ethical Criteria for Medicinal Drug Promotion recommend against the use of financial incentives to influence prescribing decisions (WHO, 1988). You may not always have the information on hand that allows you to know whether a medicine would or would not be useful for a specific patient. The motivation for this is clear: Advertising is very effective at stimulating sales and increasing profits by driving the consultation in a particular direction. List positive and negative aspects of the message in the advertisement.How do you think the doctor-patient relationship might be affected?
Relationship between direct-to-consumer advertising and physician diagnosing and prescribing.
She also helped establish the International Presentation Sisters Association, a non-governmental organization in special consultative status with the United Nations. It also has profound implications for the public perception of medicines and the relationship between patients and health professionals. Advertising campaigns targeting the public have thus become a reality in many countries despite their sometimes questionable legal status. It is important for health professionals to understand the mechanisms behind promotion-influenced patient requests and develop appropriate responses.
At the time of this campaign, Flixotide (fluticasone) was more expensive than beclamethasone.
In contrast, physicians judged only one out of eight prescriptions for medicines not requested by patients to be ?possible? or ?unlikely? choices for other similar patients. Nearly half said they would feel disappointed, one-quarter would try to change the physician's mind and one-quarter would go to another doctor for a prescription.
From a public health perspective, however, there is little rationale for emotive advertising, with its promise of an easy, magical solution in the form of a glittery brand. It is no more effective at equivalent doses, but is more potent per microgramme, which can be a problem when switching, especially with treatment of children. For example, Nexium (esomeprazole) ? the medicine with the top advertising budget in 2004 ? is simply one of the two enantiomers or isomers of the racemic mixture which makes up omeprazole, a medicine for which less costly generic equivalents are available. Analysis of advertising messages about a health condition and pharmaceutical treatmentWhat is its main message about depression?Is self-diagnosis encouraged?
This switch in medication resulted in expenditure of nearly US$3 million more than if the less expensive inhaler had been used. This type of information cannot be provided by industry advertising, which primarily aims to sell a product.
In Europe, a struggle for legalisation for advertising of prescription medicines to the public ended in a resounding defeat for industry in 2002. This has now been followed by a second- wave attempt at introduction in 2006 and 2007 (Brown, 2007).
This time, the ?A? word, ?advertising?, goes unmentioned, and instead the discussion is of ?medicines information? provided by pharmaceutical companies about their products, including within public-private-partnerships. The pharmaceutical industry is equally clearly unable to provide this whilst fulfilling its primary duty to its shareholders. These are sometimes called first-generation antipsychotics and include: chlorpromazine, flupentixol, haloperidol, levomepromazine, pericyazine, perphenazine, pimozide, sulpiride, trifluoperazine, and zuclopenthixol. DTCA of prescription medicines is highly profitable, and commercial versus public health struggles over its introduction are likely to continue. Increasingly, even where this advertising is illegal, forms of product promotion that skirt the boundaries of the law ? and beyond ? are also becoming more and more common. It can be a challenge to maintain a shared understanding of when treatment is and is not needed, and which of a range of available treatments is most appropriate.
Both frank discussions with patients and public access to independent appraisals of the scientific evidence on the effectiveness and safety of medicines are part of the solution.
It was originally thought that these medicines would have fewer side-effects than the older type of antipsychotics. This is because these medicines are thought to increase the risk of stroke and early death - by a small amount. Even then, it should only be used for short period of time (less than six weeks) and for severe symptoms.
The medicine from a depot injection is slowly released into the body and is given every 2-4 weeks. The main advantage of depot injections is that you do not have to remember to take tablets every day. Unfortunately, antipsychotics do not always make the symptoms go away completely, or for ever. Even if you take these medicines on a long-term basis and they are helping, sometimes your symptoms can come back. Symptoms may take 2-4 weeks to ease after starting medication, and it can take several weeks for full improvement. The dose of the medicine is usually built up gradually to help to prevent side-effects (including weight gain).
This is in order to help you decide if stopping is the best thing for you, and how you should stop taking your medicine. If you stop taking an antipsychotic medicine suddenly, you may become unwell quite quickly.
Your doctor will usually advise you to reduce the dose slowly to see what effect the lower dose has on your symptoms.
These include: Parkinsonism - this can cause symptoms similar to those that occur in people with Parkinson's disease - for example, tremor and muscle stiffness. This reduced incidence of movement disorder is the main reason why an atypical antipsychotic is often used first-line. If movement disorder side-effects occur then other medicines may be used to try to counteract them.
The tests needed and how often you will need to have them depend on which antipsychotic you are taking. In general, your doctor will take a sample of blood for certain tests before you start treatment. The tests look at how many blood cells you have, how well your kidneys and liver are working, how much lipid (fat) is in your blood, and if you have diabetes. The prolactin level is measured because sometimes antipsychotics can make you produce too much of this hormone. If you make too much prolactin it can lead to your breasts growing bigger and breast milk being produced.



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